e40f12b
U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 40-F
(Check One)
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Registration statement pursuant to Section 12 of the
Securities Exchange Act of 1934 |
or
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Annual report pursuant to Section 13(a) or 15(d) of the
Securities Exchange Act of 1934 |
For the fiscal year ended
Commission file number:
THERATECHNOLOGIES INC.
(Exact name of registrant as specified in its charter)
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Québec, Canada
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2834 |
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Not applicable |
(Province or other jurisdiction
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(Primary
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(I.R.S. Employer |
of incorporation or
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Industrial
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Identification Number) |
organization)
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Industrial
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Classification
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Code Number
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(if applicable)
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2310 Alfred-Nobel Boulevard
Montreal, Québec, Canada H4S 2B4
(514) 336-7800
(Address and Telephone Number of Registrants Principal Executive Offices)
CT Corporation System
111-8th Avenue, New York, New York 10011
(212) 894-8940
(Name, Address (Including Zip Code) and Telephone Number (Including Area Code) of Agent For Service in the United States)
Copies to:
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Jocelyn Lafond
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Lawrence S. Wittenberg |
Theratechnologies Inc.
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Martin C. Glass |
2310
Alfred-Nobel Blvd.
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Goodwin Procter LLP |
Montreal, Québec, H4S 2B4
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Exchange Place |
CANADA
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Boston, Massachusetts 02109 |
(514) 336-4804
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(617) 570-1000 |
Securities registered or to be registered pursuant to Section 12(b) of the Act.
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Title Of Each Class
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Name Of Exchange On Which Registered |
Common Shares
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The NASDAQ Stock Market LLC |
Securities registered or to be registered pursuant to Section 12(g) of the Act: None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None
For annual reports, indicate by check mark the information filed with this Form:
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o Annual Information Form
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o Audited Annual Financial Statements |
Indicate the number of outstanding shares of each of the issuers classes of capital or common
stock as of the close of the period covered by the annual report: Not applicable
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period
that the registrant was required to file such reports); and (2) has been subject to such filing
requirements for the past 90 days.
Yes o No þ
Indicate by check mark whether the Registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulations S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the Registrant was required to submit and post such files).
Yes o No o
FORWARD-LOOKING STATEMENTS
This registration statement and the exhibits attached hereto contain forward-looking statements and
forward-looking information within the meaning of applicable securities laws that are based on our
managements belief and assumptions and on information currently available to our management,
collectively, forward-looking statements. In some cases, you can identify forward-looking
statements by terms such as may, will, should, could, would, expect, plan,
anticipate, believe, estimate, project, predict, intend, potential, continue and
similar expressions intended to identify forward-looking statements. Although we believe that the
expectations reflected in these forward-looking statements are reasonable, these statements relate
to future events or our future performance, and involve known and unknown risks, uncertainties and
other factors that may cause our actual results, levels of activity, performance or achievements to
be materially different from any future results, levels of activity, performance or achievements
expressed or implied by these forward-looking statements. Forward-looking statements in this
registration statement include, but are not limited to, statements about:
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our ability, and the ability of our commercial partners, to commercialize EGRIFTA® in
the United States and other territories; |
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whether we will receive regulatory approvals for tesamorelin from regulatory agencies in territories other
than the United States in which we wish to expand the commercialization of tesamorelin, and the timing and
costs of obtaining such regulatory approvals; |
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our recognition of milestones, royalties and other revenues from our commercial partners related to future
sales of EGRIFTA®; |
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our plans to conduct a new clinical program for tesamorelin in muscle wasting in chronic obstructive
pulmonary disease, or COPD, including the timing and results of these clinical programs; |
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the continuation of our collaborations and other significant agreements with our existing commercial
partners and our ability to establish and maintain additional development collaborations; |
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our estimates of the size of the potential markets for EGRIFTA®, tesamorelin and our
other product candidates; |
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the rate and degree of market acceptance of EGRIFTA® and our other product candidates; |
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our success in obtaining, and the timing and amount of, reimbursement for EGRIFTA®
and our other product candidates; |
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the benefits of tesamorelin and our other product candidates as compared to others; |
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the success and pricing of other competing drugs or therapies that are or may become available; |
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our ability to maintain and establish intellectual property rights in tesamorelin and our other product
candidates; |
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the manufacturing capacity of third-party manufacturers, including the manufacturer of tesamorelin in
commercial quantities; |
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our expectations regarding our financial performance, including revenues, expenses, gross margins,
liquidity, capital expenditures and income taxes; and |
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our need for additional financing and our estimates regarding our capital requirements and future revenues
and profitability. |
2
Such statements reflect our current views with respect to future events and are subject to certain
risks, uncertainties and assumptions which may cause our actual results, performance or
achievements to be
materially different from any future results, performance or achievements expressed in or implied
by the forward-looking statements. Certain assumptions made in preparing the forward-looking
statements include that:
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tesamorelin for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy
will receive approval in territories other than the United States covered in our
commercialization agreements; |
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no additional clinical studies will be required to obtain said regulatory approval of tesamorelin; |
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EGRIFTA® will be accepted by the marketplace in the United States and will
be on the list of reimbursed drugs by third-party payors; |
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our relations with third-party suppliers of EGRIFTA® will be conflict-free
and that such third-party suppliers will have the capacity to manufacture and supply
EGRIFTA® to meet market demand and on a timely basis; |
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we will obtain positive results from our clinical program for the development of tesamorelin for
muscle wasting in COPD patients; and |
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our business plan will not be substantially modified. |
Forward-looking statements reflect our views as of the date of the statements with respect to
future events and are based on assumptions and subject to risks and uncertainties. Given these
risks and uncertainties, the forward-looking events and circumstances discussed in this
registration statement may not occur, and you should not place undue reliance on these
forward-looking statements. We discuss many of these risks in greater detail under the heading
Risk Factors in our Annual Information Form for the fiscal year ended November 30, 2010, which is
filed as exhibit 99.1 to this Registration Statement, as well as in the other documents attached as
exhibits to this Registration Statement. Also, these forward-looking statements represent our
estimates and assumptions only as of the date of the statements. We undertake no obligation and do
not intend to update or revise these forward-looking statements, unless required by law. We qualify
all of the information presented in this registration statement, and particularly our
forward-looking statements, with these cautionary statements.
DIFFERENCES IN UNITED STATES AND CANADIAN REPORTING PRACTICES
The Corporations financial statements, including those in the exhibits attached to this
Registration Statement, are prepared in accordance with the International Financial Reporting
Standards (IFRS) as issued by the International Accounting Standards Board (IASB). IFRS
differ in some significant respects from U.S. GAAP, and thus the Corporations financial statements
may not be comparable to the financial statements of United States companies. These differences
between IFRS and U.S. GAAP might be material to the financial information presented in this
registration statement. In addition, differences may arise in subsequent periods related to changes
in IFRS or U.S. GAAP or due to new transactions we enter into. We are not required to prepare a
reconciliation of our consolidated financial statements and related footnote disclosures between
IFRS and U.S. GAAP and have not quantified such differences.
3
NASDAQ QUORUM REQUIREMENT
Nasdaq Marketplace Rule 5615(a)(3) permits a foreign private issuer to follow its home country
practice in lieu of certain of the requirements of the Rule 5600 Series. A foreign private issuer
that follows a home country practice in lieu of one or more provisions of the Rule 5600 Series
shall disclose in its registration statement related to its initial public offering or first U.S.
listing on Nasdaq, or on its website, each requirement of the Rule 5600 Series that it does not
follow and describe the home country practice followed by the issuer in lieu of those requirements.
The Corporation does not follow Rule 5620(c), but instead follows its home country practice. The
Nasdaq minimum quorum requirement under Rule 5620(c) for a meeting of shareholders is 33.33% of the
outstanding common shares. In addition, Rule 5620(c) requires that an issuer listed on Nasdaq state
its quorum requirement in its bylaws. On February 8, 2006, as permitted by Part IA of the Companies
Act (Québec), the Corporations directors approved a by-law amendment, which amendment was ratified
by the Corporations shareholders on March 30, 2006, providing that one or more persons present in
person or duly represented and holding not less than 10% of our common shares shall constitute a
quorum at a meeting of our shareholders. The foregoing is consistent with the laws, customs, and
practices in Canada.
DOCUMENTS FILED PURSUANT TO GENERAL INSTRUCTIONS
In accordance with General Instruction B.(1) of Form 40-F, the Corporation hereby incorporates by
reference Exhibit 99.1 through 99.91 as set forth in the Exhibit Index attached hereto. In
accordance with General Instruction D.(9) of Form 40-F, the Corporation has filed a written consent
of an expert named in the foregoing Exhibit 99.92, as set forth in the Exhibit Index attached
hereto.
OFF-BALANCE SHEET ARRANGEMENTS
The Corporation does not have any off-balance sheet arrangements.
DISCLOSURE OF CONTRACTUAL OBLIGATIONS
The following table lists as of November 30, 2010 information with respect to the Corporations
known contractual obligations (stated in Canadian dollars).
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Less than 1 |
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More than |
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Contractual Obligations |
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Total |
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Year |
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1 to 3 Years |
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3 to 5 Years |
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5 years |
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Long Term Debt Obligations |
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Capital Lease Obligations |
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Operating Lease Obligations |
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$ |
6,237,000 |
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$ |
55,000 |
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$ |
1,311,000 |
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$ |
928,000 |
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$ |
3,943,000 |
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Purchase Obligations |
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Other Long-Term Liabilities |
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Total |
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$ |
6,237,000 |
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$ |
55,000 |
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$ |
1,311,000 |
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$ |
928,000 |
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$ |
3,943,000 |
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Long-term procurement agreements:
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During and after the years ended November 30, 2010 and 2009, the Corporation entered into
long-term procurement agreements with third-party suppliers in anticipation of the
commercialization of EGRIFTA®. |
Credit facility:
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The Corporation has a $1,800,000 revolving credit facility, bearing interest at prime plus
0.5%. Under the terms of the credit facility, the market value of investments held must always
be equivalent to 150% of amounts drawn under the facility. If the market value falls below
$7,000,000, the Corporation will provide the bank with a first rank movable hypothec (security
interest) of $1,850,000 on securities judged satisfactory by the bank. |
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As at November 30, 2010 and 2009, the Corporation did not have any borrowings outstanding
under this credit facility. |
UNDERTAKINGS
The Registrant undertakes to make available, in person or by telephone, representatives to respond
to inquiries made by the staff of the SEC, and to furnish promptly, when requested to do so by the
staff of the SEC, information relating to the securities registered pursuant to this Registration
Statement or transactions in said securities.
CONSENT TO SERVICE OF PROCESS
Concurrently with the filing of this Registration Statement, the Registrant will file with the SEC
an Appointment of Agent for Service of Process and Undertaking on Form F-X.
Any change to the name or address of the agent for service of the Registrant shall be communicated
promptly to the SEC by amendment to Form F-X referencing the file number of the Registrant.
4
SIGNATURES
Pursuant to the requirements of the United States Securities Exchange Act of 1934, as amended, the
Registrant certifies that it meets all of the requirements for filing on Form 40-F and has duly
caused this Registration Statement to be signed on its behalf by the undersigned, thereto duly
authorized.
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THERATECHNOLOGIES INC.
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By: |
/s/ Luc Tanguay |
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Name: |
Luc Tanguay |
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Title: |
Senior Executive Vice President and
Chief Financial Officer |
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Date: June 13, 2011 |
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5
EXHIBIT INDEX
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Exhibit |
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Description |
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Annual Information |
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99.1
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Annual information form, for the year ended November 30, 2010 |
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99.2
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Managements Discussion and Analysis, for the twelve months ended November 30, 2010 and 2009 |
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99.3
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Audited annual financial statements, for the years ended November 30, 2010 and 2009, and as
of December 1, 2008 |
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99.4
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Annual information form, for the year ended November 30, 2009 |
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99.5
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Annual report, for the year ended November 30, 2009 |
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99.6
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Managements Discussion and Analysis (amended), for the twelve months ended November 30,
2009 and 2008 |
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99.7
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Managements Discussion and Analysis, for the twelve months ended November 30, 2009 and 2008 |
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99.8
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Audited annual financial statements, for the years ended November 30, 2009 and 2008 |
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Quarterly Information |
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99.9
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Managements Discussion and Analysis, for the three months ended February 28, 2011 and 2010 |
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99.10
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Interim financial statements/report, for the three months ended February 28, 2011 and 2010 |
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99.11
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Managements Discussion and Analysis, for the three and nine months ended August 31, 2010
and 2009 |
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99.12
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Interim financial statements (amended), for the nine months ended August 31, 2010 and 2009 |
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99.13
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Managements Discussion and Analysis (amended), for the three and nine months ended August
30, 2010 and 2009 |
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99.14
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Interim financial statements, for the nine months ended August 30, 2010 and 2009 |
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99.15
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Managements Discussion and Analysis (amended), for the three and six months ended May 31,
2010 and 2009 |
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99.16
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Interim financial statements (amended), for the six months ended May 31, 2010 and 2009 |
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99.17
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Managements Discussion and Analysis, for the three and six months ended May 31, 2010 and
2009 |
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99.18
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Interim financial statements, for the six months ended May 31, 2010 and 2009 |
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99.19
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Managements Discussion and Analysis (amended), for the three months ended February 28,
2010 and 2009 |
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99.20
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Interim financial statements (amended), for the three months ended February 28, 2010 and
2009 (as of February 9, 2011) |
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Exhibit |
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Description |
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99.21
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Interim financial statements (amended), for the three months ended February 28, 2010 and
2009 (as of July 27, 2010) |
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99.22
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Managements Discussion and Analysis, for the 3 months ended February 28, 2010 and 2009 |
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99.23
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Interim financial statements, for the three months ended February 28, 2010 and 2009 |
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99.24
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Managements Discussion and Analysis, for the three months ended November 30, 2009 and 2008 |
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99.25
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Interim financial statements, for the periods ended November 30, 2009 and 2008 |
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Shareholder Meeting Materials |
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99.26
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Notice of annual and special meeting of shareholders, dated April 14, 2011, for the Annual
and Special Meeting of Shareholders on May 18, 2011 |
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99.27
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Form of proxy for the Annual and Special Meeting of Shareholders on
May 18, 2011 |
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99.28
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Management information circular, dated April 14, 2011 |
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99.29
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Notice of annual and special meeting of shareholders, dated February 23, 2010, for the
Annual and Special Meeting of Shareholders on March 25, 2010 |
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99.30
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Form of proxy for the Annual and Special Meeting of Shareholders
on March 25, 2010 |
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99.31
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Management information circular, dated February 23, 2010 |
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Material Change Reports |
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99.32
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Material change report, dated
June 3, 2011 |
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99.33
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Material change report, dated May 27, 2011 |
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99.34
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Material change report, dated February 22, 2011 |
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99.35
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Material change report, dated February 10, 2011 |
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99.36
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Material change report, dated December 16, 2010 |
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99.37
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Material change report, dated November 19, 2010 |
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99.38
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Material change report, dated September 1, 2010 |
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99.39
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Material change report, dated June 8, 2010 |
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99.40
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Material change report, dated February 11, 2010 |
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Press Releases |
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99.41
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Press release, dated June 6, 2011,
announcing filing of european marketing authorization application of
tesamorelin |
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99.42
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Press release, dated June 2, 2011
adopting new R&D Business Model |
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99.43
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Press release, dated May 18, 2011, regarding annual and special meeting of the shareholders |
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99.44
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Press release, dated May 16, 2011, announcing annual and special meeting of the shareholders |
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99.45
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Press release, dated April 12, 2011, announcing results for the first quarter 2011 |
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99.46
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Press release, dated March 8, 2011, announcing decision to withdraw the cross-border
offering |
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99.47
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Press release, dated February 22, 2011, announcing filing of preliminary prospectus for
cross-border offering |
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Exhibit |
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Description |
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99.48
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Press release, dated February 22, 2011, announcing new clinical program in muscle wasting
in Chronic Obstructive Pulmonary Disease (COPD) |
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99.49
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Press release, dated February 9, 2011, announcing results for the 2010 fiscal year |
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99.50
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Press release, dated February 3, 2011, announcing a distribution and licensing agreement
for tesamorelin in Europe |
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99.51
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Press release, dated February 2, 2011, concerning a conference call to announce a
partnership agreement |
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99.52
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Press release, dated December 6, 2010, announcing a distribution and licensing agreement
for EGRIFTA in Latin America, Africa and the Middle East with sanofi-aventis |
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99.53
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Press release, dated December 5, 2010, concerning a conference call to announce a
partnership agreement |
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99.54
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Press release, dated December 2, 2010, announcing plans of early adoption of International
Financial Reporting Standards |
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99.55
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Press release, dated December 1, 2010, welcoming the arrival of its new President and CEO |
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99.56
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Press release, dated November 11, 2010, announcing FDA approval of EGRIFTA |
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99.57
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Press release, dated November 10, 2010, concerning a conference call to announce FDAs
final decision on its new drug application for tesamorelin |
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99.58
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Press release, dated October 14, 2010, announcing the retirement date for the President and
CEO: Mr. Yves Rosconi |
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99.59
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Press release, dated October 12, 2010, announcing results for the third quarter 2010 |
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99.60
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Press release, dated October 5, 2010, announcing presentation at BioContact Quebec |
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99.61
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Press release, dated September 20, 2010, announcing presentation at UBS Global Life
Sciences Conference |
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99.62
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Press release, dated September 13, 2010, announcing presentation at the Interscience
Conference on Antimicrobial Agents and Chemotherapy 50th annual meeting |
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99.63
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Press release, dated September 1, 2010, announcing the appointment of a new President and
CEO |
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99.64
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Press release, dated August 2, 2010, announcing presentations at both BMO and Canaccord
Genuity conferences |
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99.65
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Press release, dated July 26, 2010, announces receipt of a motion of authorization to
institute a class action |
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99.66
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Press release, dated July 20, 2010, updates timeline for FDA action date for tesamorelins
New Drug Application |
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99.67
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Press release, dated July 7, 2010, announcing results for second quarter 2010 |
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99.68
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Press release, dated June 29, 2010, announcing addition to the Russell Global Index |
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99.69
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Press release, dated June 24, 2010, announcing publication of combined tesamorelin Phase 3
results in JCEM |
iii
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Exhibit |
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Description |
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99.70
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Press release, dated June 8, 2010, announcing presentation at both Jefferies and Needham
conferences |
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99.71
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Press release, dated June 2, 2010, announcing that Yves Rosconi, President & CEO of
Theratechnologies, will retire on December 31, 2010 |
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99.72
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Press release, dated May 27, 2010, announcing positive vote by FDA Advisory Committee for
tesamorelin |
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99.73
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Press release, dated April 5, 2010, announcing presentation at BioFinance 2010 conference |
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99.74
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Press release, dated March 25, 2010, reporting positive outcome at its annual and special
meeting of shareholders |
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99.75
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Press release, dated March 23, 2010, announcing financial results for the first quarter 2010 |
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99.76
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Press release, dated March 22, 2010, announcing Annual and Special Meeting of Shareholders |
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99.77
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Press release, dated March 22, 2010, announcing that FDA confirmed date for Advisory
Committee review of tesamorelins New Drug Application |
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99.78
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Press release, dated March 1, 2010, announcing publication of second Phase 3 results in
JAIDS |
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99.79
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Press release, dated February 25, 2010, announcing a tentative new date for the FDA
Advisory Committee review of the tesamorelin New Drug Application |
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99.80
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Press release, dated February 10, 2010, announcing that milestones met in 2009 lead to
optimistic outlook |
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99.81
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Press release, dated February 10, 2010, announcing adoption of shareholder rights plan |
|
|
|
99.82
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|
Press release, dated January 25, 2010, reporting that the FDA will reschedule for
administrative reasons the Advisory Committee meeting to review tesamorelins NDA |
|
|
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99.83
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|
Press release, dated January 18, 2010, reporting the date for FDA Advisory Committee Review
of the Tesamorelin New Drug Application |
|
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99.84
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|
Press release, dated January 11, 2010, announcing presentation at Biotech Showcase 2010 |
|
|
|
99.85
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|
Press release, dated December 29, 2009, announcing patent protection in Brazil for
tesamorelin |
|
|
|
|
|
Other Material Documents Filed with Canadian Securities Regulators |
|
|
|
99.86
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|
Shareholder Rights Plan Agreement, dated as of February 10, 2010 |
|
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99.87
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|
Supply Agreement, by and between Theratechnologies Inc. and Gruppo Cartotecnico abar
litofarma SRL, dated January 5, 2010 |
|
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99.88
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|
OEM Agreement, by and between Theratechnologies Inc. and Becton Dickinson Canada Inc.,
dated November 6, 2009 |
|
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99.89
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|
Development and Supply Agreement, by and between Theratechnologies Inc. and Hospira
Worldwide, Inc., dated as of
March 26, 2009 |
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99.90
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|
Manufacturing and Supply Agreement, by and among Theratechnologies Inc., Bachem Americas
Inc., and Bachem, Inc., dated March 11, 2009 |
iv
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Exhibit |
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Description |
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99.91
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Manufacture and Supply Agreement, by and between Draxis Pharma General Partnership and
Theratechnologies Inc., dated as of December 23, 2009 |
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Consent |
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99.92
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|
Consent of KPMG LLP |
v
ex-99.1
Exhibit 99.1
ANNUAL INFORMATION FORM
Financial Year Ended November 30, 2010
February 22, 2011
FORWARD-LOOKING STATEMENTS
This Annual Information Form, or AIF, contains forward-looking statements and forward-looking
information within the meaning of applicable securities laws that are based on our managements
belief and assumptions and on information currently available to our management, collectively,
forward-looking statements. In some cases, you can identify forward-looking statements by terms
such as may, will, should, could, would, expect, plan, anticipate, believe,
estimate, project, predict, intend, potential, continue and similar expressions
intended to identify forward-looking statements. Although we believe that the expectations
reflected in these forward-looking statements are reasonable, these statements relate to future
events or our future performance, and involve known and unknown risks, uncertainties and other
factors that may cause our actual results, levels of activity, performance or achievements to be
materially different from any future results, levels of activity, performance or achievements
expressed or implied by these forward-looking statements. Forward-looking statements include, but
are not limited to, statements about:
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our ability, and the ability of our commercial partners, to commercialize
EGRIFTA® in the United States and other territories; |
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whether we will receive regulatory approvals for tesamorelin from regulatory agencies in
territories other than the United States in which we wish to expand the commercialization
of tesamorelin, and the timing and costs of obtaining such regulatory approvals; |
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our recognition of milestones, royalties and other revenues from our commercial partners
related to future sales of EGRIFTA®; |
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our plans to conduct a new clinical program for tesamorelin in muscle wasting in chronic
obstructive pulmonary disease, or COPD, including the timing and results of these clinical
programs; |
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the continuation of our collaborations and other significant agreements with our
existing commercial partners and our ability to establish and maintain additional
development collaborations; |
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our estimates of the size of the potential markets for EGRIFTA®, tesamorelin
and our other product candidates; |
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the rate and degree of market acceptance of EGRIFTA® and our other product
candidates; |
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our success in obtaining, and the timing and amount of, reimbursement for
EGRIFTA® and our other product candidates; |
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the benefits of tesamorelin and our other product candidates as compared to others; |
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the success and pricing of other competing drugs or therapies that are or may become
available; |
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our ability to maintain and establish intellectual property rights in tesamorelin and
our other product candidates; |
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the manufacturing capacity of third-party manufacturers, including the manufacturer of
tesamorelin in commercial quantities; |
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our expectations regarding our financial performance, including revenues, expenses,
gross margins, liquidity, capital expenditures and income taxes; and |
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our need for additional financing and our estimates regarding our capital requirements
and future revenues and profitability. |
Such statements reflect our current views with respect to future events and are subject to certain
risks, uncertainties and assumptions which may cause our actual results, performance or
achievements to be materially different from any future results, performance or achievements
expressed in or implied by the forward-looking statements. Certain assumptions made in preparing
the forward-looking statements include that:
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tesamorelin for the reduction of excess abdominal fat in HIV-infected patients with
lipodystrophy will receive approval in territories other than the United States covered in
our commercialization agreements; |
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no additional clinical studies will be required to obtain said regulatory approval of
tesamorelin; |
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EGRIFTA® will be accepted by the marketplace in the United States and will
be on the list of reimbursed drugs by third-party payors; |
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our relations with third-party suppliers of EGRIFTA® will be conflict-free
and that such third-party suppliers will have the capacity to manufacture and supply
EGRIFTA® to meet market demand and on a timely-basis; |
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we will obtain positive results from our clinical program for the development of
tesamorelin for muscle wasting in COPD patients; and |
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our business plan will not be substantially modified. |
Forward-looking statements reflect our current views with respect to future events and are based on
assumptions and subject to risks and uncertainties. Given these risks and uncertainties, the
forward-looking events and circumstances discussed in this AIF may not occur, and you should not
place undue reliance on these forward-looking statements. We discuss many of these risks in greater
detail under the heading Risk Factors. Also, these forward-looking statements represent our
estimates and assumptions only as of the date of this AIF. We undertake no obligation and do not
intend to update or revise these forward-looking statements, unless required by law. We qualify all
of the information presented in this AIF, and particularly our forward-looking statements, with
these cautionary statements.
This AIF also contains estimates and other statistical data made by independent parties and by us
relating to market size and growth and other data about our industry and target indications. This
data involves a number of assumptions and limitations, and you are cautioned not to give undue
weight to such estimates. In addition, projections, assumptions and estimates of our future
performance and the future performance of the markets in which we operate are necessarily subject
to a high degree of uncertainty and risk.
BASIS OF PRESENTATION
We obtained the industry, market and competitive position data in this AIF from our own internal
estimates and research as well as from industry and general publications and research surveys and
studies conducted by third parties. Certain statistical data and other information regarding the
size of our potential markets are based on industry publications and/or derived from our own
internal analysis of such industry publications. While we believe our internal company research is
reliable and the market definitions, methodology and hypotheses we use are appropriate, such
research, analysis, methodology or definitions have been verified by an independent source. We
cannot and do not provide any assurance as to the accuracy or completeness of such information.
Market forecasts, in particular, are likely to be inaccurate, especially over long periods of time.
In this AIF, the use of EGRIFTA® refers to tesamorelin for the reduction of excess
abdominal fat in HIV-infected patients with lipodystrophy regardless of the trade name used for
such product in any particular territory. EGRIFTA® is the trade name used in the United
States for tesamorelin for the
reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. EGRIFTA®
is our trademark. Other trademarks and service marks appearing in this AIF are the property of
their respective holders.
All monetary amounts set forth in this AIF are expressed in Canadian dollars, except where
otherwise indicated. References to $ and C$ are to Canadian dollars and references to US$ are
to U.S. dollars.
In this AIF, references to Theratechnologies, we, our and us refer to Theratechnologies
Inc. and its subsidiaries, unless the context otherwise states.
All information provided in this AIF is provided as of February 21, 2011, except where otherwise
stated.
TABLE OF CONTENTS
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ITEM 1 CORPORATE STRUCTURE |
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6 |
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1.1 NAME, ADDRESS AND INCORPORATION |
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1.2 SUBSIDIARIES |
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6 |
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ITEM 2 OUR BUSINESS |
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7 |
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2.1 OVERVIEW |
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7 |
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2.2 RECENT DEVELOPMENTS |
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8 |
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2.3 THREE YEAR HISTORY |
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2.4 OUR STRATEGY |
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11 |
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2.5 OUR PRODUCT AND PRODUCT CANDIDATES |
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12 |
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2.6 INTELLECTUAL PROPERTY |
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19 |
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2.7 MANUFACTURING |
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22 |
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2.8 COMPETITION |
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23 |
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2.9 GOVERNMENT REGULATION |
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23 |
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2.10 PHARMACEUTICAL PRICING AND REIMBURSEMENT |
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31 |
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2.11 EMPLOYEES |
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33 |
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2.12 FACILITIES |
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33 |
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2.13 ENVIRONMENT |
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34 |
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ITEM 3 RISK FACTORS |
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35 |
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3.1 RISKS RELATED TO THE COMMERCIALIZATION OF OUR PRODUCT AND PRODUCT CANDIDATES |
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35 |
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3.2 RISKS RELATED TO THE REGULATORY REVIEW PROCESS |
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41 |
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3.3 RISKS RELATED TO OUR INTELLECTUAL PROPERTY |
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44 |
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3.4 OTHER RISKS RELATED TO OUR BUSINESS |
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46 |
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3.5 RISKS RELATED TO OUR COMMON SHARES |
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50 |
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ITEM 4 DIRECTORS AND EXECUTIVE OFFICERS |
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53 |
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4.1 DIRECTORS |
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53 |
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4.2 AUDIT COMMITTEE |
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56 |
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4.3 EXECUTIVE OFFICERS |
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57 |
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4.4 DECLARATION OF THE DIRECTORS AND OFFICERS ANTECEDENTS |
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60 |
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4.5 SECURITIES HELD BY THE DIRECTORS AND EXECUTIVE OFFICERS |
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60 |
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ITEM 5 INTERESTS OF EXPERTS |
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61 |
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ITEM 6 SECURITIES OF THE COMPANY |
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62 |
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6.1 AUTHORIZED SHARE CAPITAL |
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62 |
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6.2 DIVIDEND POLICY |
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62 |
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6.3 TRANSFER AGENT AND REGISTRAR |
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62 |
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ITEM 7 MARKET FOR SECURITIES |
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63 |
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7.1 TRADING PRICE AND VOLUME |
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63 |
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7.2 PRIOR SALES |
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63 |
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ITEM 8 LEGAL PROCEEDINGS |
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64 |
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ITEM 9 MATERIAL CONTRACTS |
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65 |
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ITEM 10 ADDITIONAL INFORMATION |
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67 |
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APPENDIX A AUDIT COMMITTEE CHARTER |
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68 |
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ITEM 1 CORPORATE STRUCTURE
1.1 NAME, ADDRESS AND INCORPORATION
We were incorporated under the name Theratechnologies Inc. on October 19, 1993 under Part IA of the
Companies Act (Québec) (now the Business Corporations Act (Québec)) by Certificate of
Incorporation. We amended our articles on October 20, 1993 by repealing the restrictions applicable
to private companies. On December 6, 1993, we again amended our articles to increase the number of
directors and to modify our share capital. Finally, on March 26, 1997, we further modified our
share capital to consist of an unlimited number of common shares and an unlimited number of
preferred shares. Our common shares are listed on the Toronto Stock Exchange, or TSX, under the
symbol TH. See Item 6.1 for a complete description of our authorized share capital.
Our head office is located at 2310 Alfred-Nobel Boulevard, Montréal, Québec, Canada H4S 2B4. Our
phone number is (514) 336-7800. Our website is www.theratech.com. The information contained on our
website is not part of this AIF.
1.2 SUBSIDIARIES
As of February 21, 2011, Theratechnologies had the following three wholly-owned subsidiaries:
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Theratechnologies Intercontinental Inc., a company incorporated under Part 1A of the
Companies Act (Québec) and governed by the Business Corporations Act (Québec).
Theratechnologies Intercontinental Inc., formerly Theratechnologies ME Inc., controls the
worldwide rights to commercialize EGRIFTA® except in the United States, Europe,
Russia, South Korea, Taiwan, Thailand and certain central Asian countries, and Canada; |
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Theratechnologies Europe Inc., a company incorporated under Part 1A of the Companies Act
(Québec) and governed by the Business Corporations Act (Québec). Theratechnologies Europe
Inc., formerly 9176-5057 Québec Inc., controls the rights to commercialize
EGRIFTA® in Europe, Russia, South Korea, Taiwan, Thailand and certain central
Asian countries; and |
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Pharma-G Inc., a company incorporated under Part 1A of the Companies Act (Québec) and
governed by the Business Corporations Act (Québec). Pharma-G Inc. is no longer an active
subsidiary. |
Theratechnologies has retained the rights to commercialize EGRIFTA® in the United
States and in Canada.
- 6 -
ITEM 2 OUR BUSINESS
2.1 OVERVIEW
We are a specialty pharmaceutical company that discovers and develops innovative therapeutic
peptide products with an emphasis on growth-hormone releasing factor, or GRF, peptides. Our
strategy is to leverage our expertise in the field of metabolism and GRF peptides to address
serious health disorders while remaining actively involved in the commercialization of our future
products. Our first product, EGRIFTA® (tesamorelin for injection), was approved by the
United States Food and Drug Administration, or FDA, in November 2010. EGRIFTA® is
currently the only approved therapy for the reduction of excess abdominal fat in HIV-infected
patients with lipodystrophy.
We estimate that excess abdominal fat in HIV-infected patients affects approximately 29% of
HIV-infected patients treated with antiretroviral therapies and approximately 12% of untreated
patients. In HIV-infected patients, lipodystrophy may be caused by the viral infection itself, the
use of antiretroviral therapy, or both. Lipodystrophy is characterized by abnormalities in the
production and storage of fat, which lead to excess abdominal fat, or lipohypertrophy, and the loss
of fat tissue, or lipoatrophy, generally occurring in the limbs and facial area.
Excess abdominal fat in HIV-infected patients is associated with significant health risks beyond
the mortality risk of the HIV infection itself. These health risks include metabolic disturbances
such as hyperlipidemia, an increase in the amount of fat in the blood (such as triglycerides and
cholesterol), and hyperglycemia, an increase in the amount of sugar in the blood, characterized by
insulin resistance, both of which lead to increased risks of cardiovascular disease and diabetes.
While there is evidence that suggests that lipoatrophy may be reduced with certain newer HIV
therapies, we are not aware of any evidence showing that any currently-marketed HIV therapy reduces
lipohypertrophy or the incidence of lipohypertrophy.
EGRIFTA® is currently marketed exclusively in the United States by EMD Serono Inc., or
EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, pursuant to a collaboration and
licensing agreement. We have also recently entered into distribution and licensing agreements for
EGRIFTA® with Sanofi Winthrop Industries S.A., or Sanofi, granting Sanofi the exclusive
commercialization rights in Latin America, Africa and the Middle East and with Ferrer Internacional
S.A., or Ferrer, granting Ferrer the exclusive commercialization rights in Europe, Russia, South
Korea, Taiwan, Thailand and certain central Asian countries. For a description of these agreements,
see Item 2.5. Using data compiled by the United States Center for Disease Control, or CDC, and the
World Health Organization and UNAIDS, or WHO/UNAIDS, we estimate that in 2012 there will be
approximately 190,000 HIV-infected patients treated with antiretroviral therapies with
lipohypertrophy in the United States, 170,000 in Europe, and 180,000 in Latin America, or 540,000
patients in total. We also estimate that in 2012, there will be an additional 47,000 HIV-infected
untreated patients with lipohypertrophy in the United States, 42,000 in Europe, and 28,000 in Latin
America, or an additional 117,000 patients in total.
In January 2011, EMD Serono launched EGRIFTA® in the United States. EMD Serono is
executing a launch program that consists of medical education, advertising, marketing and promotion
through their experienced sales force, and supporting market access through co-pay programs,
reimbursement education and support for payors. We believe EGRIFTA® will achieve a high
degree of physician and payor acceptance, driven by our products safety and efficacy, the lack of
approved alternative therapies for these patients and the prominent medical and social need to
treat HIV/AIDS patients.
- 7 -
EGRIFTA® is the trade name used for our first marketed product using our most advanced
compound, tesamorelin. Tesamorelin is a GRF analogue that stimulates the synthesis and pulsatile
release of endogenous growth hormone. Tesamorelin was synthesized using our internally-developed
peptide stabilization method. This method increases a proteins resistance to enzymatic
degradation, which prolongs its duration of action and enhances its effectiveness in clinical use.
We believe this compound and future GRF analogues that we are developing can be used in a number of
additional high-value indications. Clinical data have shown tesamorelin to have both lipolytic
(fat-burning) and anabolic (muscle-building) properties. Our initial development of
EGRIFTA® focused on the lipolytic properties of the compound.
Tesamorelins anabolic properties have led us to pursue its development for muscle wasting in COPD
patients as our second indication. COPD is characterized by progressive airflow obstruction due to
chronic bronchitis or emphysema leading in certain cases to muscle wasting, a decrease of muscle
mass and deterioration in functionality. We have completed a Phase 2 trial which demonstrated a
statistically significant increase in lean body mass. Based upon these trial results, we intend to
randomize our first patient in a new Phase 2 clinical study in the second half of 2011. Based on
available market data, we estimate that in 2009, the number of diagnosed COPD patients with muscle
wasting was approximately 3.1 million in the United States, France, Germany, Italy, United Kingdom,
Spain and Japan.
To solidify our leadership position in the field of GRF therapeutics, we have embarked on a program
to discover new generations of GRF analogues. We believe that GRF compounds have the potential to
improve patient outcome in many high-value indications, such as wasting in chronic heart failure
and renal failure, as well as growth deficiency with abdominal obesity. We also believe that we can
improve the route of administration of GRF peptides to make them quicker and easier to use for
patients. Our early-stage pipeline also includes compounds for the treatment of Acute Kidney
Injury, or AKI, and certain cancers.
2.2 RECENT DEVELOPMENTS
Since the end of our most recently completed financial year, we have been engaged in the following
activities:
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COPD indication for EGRIFTA®. On February 22, 2011, we announced a new
clinical program in muscle wasting in COPD using tesamorelin. Tesamorelins anabolic
properties have led us to pursue the development of tesamorelin for muscle wasting in COPD
patients for its second indication. The program will be conducted in stable ambulatory COPD
patients with muscle wasting in the Global Initiative for Chronic Obstructive Lung Disease,
or GOLD, stage II and III severity experiencing decreased functionality in daily
activities. |
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Execution of distribution and licensing agreement for EGRIFTA® for European
market. On February 3, 2011, we announced the execution, through Theratechnologies Europe
Inc., of a distribution and licensing agreement with Ferrer granting it the exclusive
commercialization rights of tesamorelin in Europe, Russia, South Korea, Taiwan, Thailand
and certain central Asian countries for the reduction of excess abdominal fat in
HIV-infected patients with lipodystrophy. For a description of this agreement, see Item
2.5. |
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Execution of distribution and licensing agreement for EGRIFTA® for the Latin
American, African and Middle Eastern Markets. On December 6, 2010, we announced the
execution, through Theratechnologies Intercontinental Inc., of a distribution and licensing
agreement with sanofi-aventis S.A., granting one of its subsidiaries, Sanofi Winthrop
Industries, the exclusive distribution rights to EGRIFTA® in Latin America,
Africa and the Middle East for the reduction |
- 8 -
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of excess abdominal fact in HIV-infected patients with lipodystrophy. For a description of
this agreement, see Item 2.5. |
2.3 THREE YEAR HISTORY
2010
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FDA approval received for EGRIFTA®. On November 11, 2010, we announced that
the FDA approved EGRIFTA® as the first and only drug indicated for the reduction of excess
abdominal fat in HIV-infected patients with lipodystrophy (abdominal lipohypertrophy). The
FDA approval triggered a US$25 million milestone payment pursuant to our collaboration and
licensing agreement with EMD Serono. |
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Appointment of new President and Chief Executive Officer. On September 1, 2010, we
announced the appointment of Mr. John-Michel T. Huss as President and Chief Executive
Officer of the Company, following the retirement of Mr. Yves Rosconi, effective November
30, 2010. Mr. Huss assumed his position on December 1, 2010. |
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Execution of research collaboration agreement with UQAM, Gestion Valeo and Transfert
Plus. On November 16, 2010, we entered into a research collaboration agreement with the
Université du Québec à Montréal, or UQAM, Gestion Valeo, L.P., or Gestion Valeo, and
Transfert Plus, L.P, or Transfert Plus, with the goal of discovering short peptide mimics
of melanotransferrin with the hope of developing a novel cancer treatment. For a
description of this agreement, see Melanotransferrin peptides (Anti-cancer compounds) at
Item 2.5. |
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Adoption of shareholder rights plan. On February 10, 2010, we announced that our board
of directors had adopted a shareholder rights plan, effective as of such date. The plan was
later ratified by our shareholders at our annual meeting held on March 23, 2010. The plan
is designed to provide adequate time for the board of directors and the shareholders to
assess an unsolicited takeover bid for Theratechnologies, to provide the board of directors
with sufficient time to explore and develop alternatives for maximizing shareholder value
if a takeover bid is made, and to provide shareholders with an equal opportunity to
participate in a takeover bid and receive full and fair value for their common shares. For
a description of the plan, see ITEM 9. |
2009
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Advisory Committee reviews NDA for tesamorelin. On November 5, 2009, we announced that
the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA would be reviewing our
New Drug Application, or NDA, for tesamorelin in the reduction of excess abdominal fat in
HIV-infected patients with lipodystrophy. |
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Filing of NDA for tesamorelin. On June 1, 2009, we announced the filing of an NDA with
the FDA for tesamorelin, an analogue of the growth hormone-releasing factor, proposed for
the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. |
2008
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Closing of transaction with EMD Serono. On December 16, 2008, we announced that we
closed the transaction related to the collaboration and licensing agreement with EMD
Serono. As part of this transaction, we received an upfront payment of US$30 million which
includes a license fee of US$22 million from EMD Serono. In addition, Merck KGaA purchased
US$8 million of our common shares at a price of US$3.67 per share. |
- 9 -
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52-week confirmatory Phase 3 clinical trial results for tesamorelin. On December 15,
2008, we announced the 52-week results of our confirmatory Phase 3 clinical trial,
evaluating the long-term safety profile of tesamorelin in patients with HIV-associated
lipodystrophy. The results reported from both the 26-week confirmatory clinical study and
52-week confirmatory clinical study were consistent with the efficacy and safety profile
observed in the first Phase 3 clinical study. This announcement concluded the Phase 3
clinical studies for tesamorelin for the reduction of excess abdominal fat in HIV-infected
patients with lipodystrophy. |
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Execution of collaboration and licensing agreement with EMD Serono for tesamorelin in
the United States. On October 29, 2008, we announced the execution of a collaboration and
licensing agreement with EMD Serono for the exclusive commercialization rights to
tesamorelin in the United States for the reduction of excess abdominal fat in HIV patients
with lipodystrophy. For a description of this collaboration and licensing agreement, see
Item 2.5. |
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26-week confirmatory Phase 3 clinical trial results for tesamorelin. On June 18, 2008,
we announced our 26-week results of our confirmatory Phase 3 clinical trial, evaluating the
efficacy of tesamorelin in patients with HIV-associated lipodystrophy. The study was
powered to detect an 8% reduction in visceral adipose tissue versus placebo. The study met
its primary endpoint as well as important secondary endpoints confirming the positive
results obtained in our initial Phase 3 study. |
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Execution of strategic agreement with Dr. Grinspoon. On May 15, 2008, we announced our
entering into an agreement with both the MGH and Dr. Grinspoon to explore the use of
tesamorelin in relative growth hormone deficient abdominally obese, or GHDAO, subjects.
MGH, under the direction of Dr. Grinspoon, is the sponsor and is conducting a Phase 2
clinical trial with tesamorelin in subjects who have excess visceral adipose tissue, or
VAT, with a moderate growth hormone deficiency and who are abdominally obese. We accepted
to provide tesamorelin for this study and the MGH will retain the rights to the results
generated by this study, and we obtained an exclusive worldwide license to commercialize
any results. Dr. Grinspoon completed subject enrolment in December 2010. |
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Initiation of process to explore strategic options. On January 29, 2008, we announced
that our board of directors initiated a process to explore strategic options available to
the Company to further enhance shareholder value. |
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US patent for tesamorelin issued. On January 8, 2008, we announced that the United
States Patent and Trademark Office, or USPTO, issued Patent Number 7,316,997 entitled GH
Secretagogues and Uses Thereof to Theratechnologies. This patent covers methods of
treatment of HIV-associated lipodystrophy using tesamorelin. The granting of this patent
extended the patent term protection of tesamorelin in HIV-associated lipodystrophy for
eight additional years, until 2023. |
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Phase 3 first clinical trial results for tesamorelin. On December 5, 2007, we announced
that the results of our first Phase 3 clinical trial using tesamorelin were published in
the December 6, 2007 New England Journal of Medicine (www.nejm.org). The study, entitled
Metabolic Effects of a Growth Hormone-Releasing Factor in Patients with HIV, outlines, in
detail, the 26-week data of the trial. Top-line results of this Phase 3 trial were
initially disclosed in December 2006. |
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Preclinical work for AKI. We conducted some preclinical work on a molecule known as
THG213.29 with the intent of pursuing a clinical program in AKI. Through our research and
development, we discovered a new bifunctional peptide that appears to have favourable
properties in the treatment of AKI in animal models of AKI. During our 2008 fiscal year, we |
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replaced THG213.29 with the new bifunctional peptide TH0673 in the event we decide to
develop a clinical program for AKI. |
2.4 OUR STRATEGY
Our goal is to leverage our expertise in the field of metabolism and GRF peptides to become a
leading specialty pharmaceutical company with the necessary infrastructure to take innovative
therapeutic products from research and development to full commercialization in worldwide markets.
Key elements of this strategy include:
Maximize the global commercial potential of EGRIFTA®
In order to maximize the commercial potential of EGRIFTA® we have entered into
licensing agreements with EMD Serono, Sanofi and Ferrer for different territories around the world.
We intend to continue to support our commercial partners to ensure the successful commercialization
of EGRIFTA® in their respective territories. This will include regulatory support,
manufacture and supply of EGRIFTA®, and potential co-promotion.
We have developed a new presentation of EGRIFTA® which is quicker and easier to use
than its current presentation. We are also developing a new and more concentrated formulation of
tesamorelin. Compared to our current formulation, this new formulation requires a smaller volume of
injection and is expected to be stable at room temperature. In addition, this new formulation could
potentially be used with a new delivery device such as a pen, to facilitate patient
self-administration. We expect the new presentation and the new formulation will have a positive
impact on our manufacturing capacity and will significantly reduce our unit costs.
Develop tesamorelin for muscle wasting in COPD
We will be conducting a new clinical program in muscle wasting in COPD. We have demonstrated in a
first Phase 2 clinical trial that tesamorelin has increased muscle mass in COPD patients. We
believe tesamorelin could improve patients functionality in daily activities and address a
significant unmet need in a large and potentially lucrative market.
Solidify our position as a leader in the field of novel GRF products
We will leverage our expertise in peptide discovery, drug development and regulatory affairs to
continue our development of new peptides, primarily GRF peptides, in order to expand our portfolio
of product candidates and solidify our position as a leader in this field.
Be actively involved in the commercialization of our products
We intend to retain commercial rights to our future products for indications and territories where
we believe we can effectively market them. We may also co-promote EGRIFTA® in certain
territories and tesamorelin in other indications.
Pursue external growth opportunities
In addition to developing products internally, we will opportunistically pursue in-licensing
arrangements or acquisitions of complementary businesses, compounds or products. We will also
identify and evaluate commercial growth opportunities that may include collaborations with drug
delivery companies.
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2.5 OUR PRODUCT AND PRODUCT CANDIDATES
The following table provides an overview of our product and product candidates and their current
stages of development:
EGRIFTA® Our Lead Product
EGRIFTA® induces the release of growth hormone which causes a reduction in excess
abdominal fat (lipohypertrophy) in HIV-infected patients without reducing or interfering with
subcutaneous fat, and, as such, has no clinically significant effect on undesired loss of
subcutaneous fat (lipoatrophy).
EGRIFTA® is currently available in the United States as a once-daily two unit dose (two
vials, each containing 1 mg of tesamorelin) of sterilized lyophilized powder to be reconstituted
with sterile water for injection. To administer EGRIFTA®, 1 ml is retrieved from each
vial into one syringe to prepare a single 2 ml patient self-administered subcutaneous injection.
EGRIFTA® is injected under the skin into the abdomen once a day.
For the purposes of FDA approval, EGRIFTA® was evaluated in two clinical trials
involving 816 HIV-infected adult men and women with lipodystrophy and excess abdominal fat. In both
studies, patients treated daily with EGRIFTA® experienced greater reductions in
abdominal fat as measured by CT scan and greater improvements in belly appearance distress,
compared with patients receiving another injectable solution (placebo). Once the treatment was
terminated, the patients condition reversed to its status prior to the beginning of the treatment.
The most commonly reported adverse effects in the studies included reactions due to the release of
endogenous hormone, such as joint pain (arthralgia), pain in the extremities, swelling in the lower
limbs and muscle pain (myalgia), injection site reactions such as skin redness (erythema), itching
(pruritis) and pain and clinically manageable changes in blood sugar control. Our clinical trials
did not seek to measure any potential cardiovascular benefits of EGRIFTA® on
cardiovascular events.
In connection with its approval, the FDA has required the following three post-approval
commitments:
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to develop a single vial presentation of the existing formulation of
EGRIFTA®. We have developed a new presentation of EGRIFTA® which is
quicker and easier to use than its current presentation. In the new presentation,
EGRIFTA® will be available as a single unit dose (one vial containing 2 mg of
tesamorelin) of sterile, lyophilized powder to be reconstituted with sterile water for
injection. The FDA requires that this new presentation be available by |
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November 2013 and we expect it to be commercially available before that date. The
development of the new presentation is complete and the dossier is ready for regulatory
submission. |
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to conduct a long-term observational safety study using EGRIFTA®. The
purpose of the long-term observational study required by the FDA is to evaluate the safety
of long-term administration of EGRIFTA®. |
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to conduct a Phase 4 clinical trial using EGRIFTA®. The primary purpose of
the Phase 4 clinical trial is to assess whether EGRIFTA® increases the
incidence or progression of diabetic retinopathy in diabetic HIV-infected patients with
lipodystrophy and excess abdominal fat. |
The FDA requires that the proposed protocols for the long-term observational safety study and Phase
4 clinical trial be submitted by the second quarter of 2011. Under the terms of our collaboration
and licensing agreement, EMD Serono is responsible for finalizing and obtaining approval of such
protocols. We will continue to support EMD Serono in developing and finalizing such protocols.
Lipodystrophy
Lipodystrophy is characterized by abnormalities in the production and storage of fat. It has two
components: lipohypertrophy, abnormal and excessive fat accumulation, and lipoatrophy, the
noticeable, localized loss of fat tissue under the skin. In patients with lipohypertrophy, fat
accumulation occurs mostly around the waist and may also occur in other regions, including breast
tissue and in dorsocervical tissues in the neck, resulting in a buffalo hump. Excess fat also
appears as lipomas, or benign tumors composed of fat cells. In patients with lipoatrophy, the loss
of fat tissue generally occurs in the limbs and facial area.
Excess abdominal fat in HIV-infected patients is associated with significant health risks beyond
the mortality risk of the HIV infection itself. These health risks include metabolic disturbances
such as hyperlipidemia, an increase in the amount of fat in the blood (such as triglycerides and
cholesterol), and hyperglycemia, an increase in the amount of sugar in the blood, characterized by
insulin resistance, both of which lead to increased risks for cardiovascular disease and diabetes.
In HIV-infected patients, lipodystrophy may be caused by the viral infection itself, the use of
antiretroviral therapy, or both. While there is evidence that suggests that lipoatrophy may be
reduced with certain newer HIV therapies, we are not aware of any evidence showing that any
currently-marketed HIV therapy reduces lipohypertrophy or the incidence of lipohypertrophy. Recent
data suggest that different pathophysiological mechanisms are involved in the development of
lipohypertrophy and lipoatrophy. The most common statistically significant independent risk factors
identified for lipohypertrophy are duration of antiretroviral therapy, markers of disease severity
and protease inhibitor use. Other factors include age, genetics, and gender.
Market Opportunity
Based on our analysis of 20 independent medical studies published from 2000 to 2004, we estimate
that excess abdominal fat in HIV-infected patients affects approximately 29% of HIV-infected
patients treated with antiretroviral therapies. According to a separate 2003 independent medical
study, we estimate that an additional 12% of untreated HIV-infected patients are also affected by
excess abdominal fat.
Based on the above-mentioned data, we have identified the following potential markets for
EGRIFTA®.
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United States. The United States market represents the largest commercial opportunity
for EGRIFTA®. We estimate the prevalence of HIV/AIDS in the United States will
rise to 1.3 million people in 2012. Of this amount, approximately 650,000 people will be
treated for HIV/AIDS and, of those patients treated, approximately 190,000 will suffer from
excess abdominal fat. In addition, approximately 47,000 untreated patients will suffer from
excess abdominal fat. |
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Europe. We estimate the prevalence of HIV/AIDS in Europe will rise to 1.4 million people
in 2012. Of this amount, approximately 590,000 people will be treated for HIV/AIDS and, of
those patients treated, approximately 170,000 will suffer from excess abdominal fat. In
addition, approximately 42,000 untreated patients will suffer from excess abdominal fat. |
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Latin America. We estimate the prevalence of HIV/AIDS in Latin America will rise to 2.2
million people in 2012. Of this amount, approximately 630,000 people will be treated for
HIV/AIDS and, of those patients treated, approximately 180,000 will suffer from excess
abdominal fat. This number is proportionately lower than the other territories due to a
lower percentage of diagnosed and treated patients. With approximately 60,000 treated
patients who will suffer from excess abdominal fat, Brazil offers the largest market in
Latin America for EGRIFTA®. In addition, approximately 28,000 untreated
patients will suffer from excess abdominal fat. |
We estimate that the total number of patients diagnosed with and treated for HIV/AIDS who will
suffer from excess abdominal fat in our primary target markets will be 540,000 in 2012. We estimate
that an additional 117,000 untreated patients may develop lipohypertrophy in such markets.
The foregoing information is based on historical data from the CDC for the United States, and
WHO/UNAIDS for Europe and Latin America. We used the historical growth rates derived from that data
to estimate the prevalence of HIV/AIDS in 2012.
EGRIFTA® Commercialization Activities
We are working closely with EMD Serono to support the commercialization of EGRIFTA®. We
are also working closely with Sanofi and Ferrer to obtain regulatory approval for and the
subsequent commercialization of EGRIFTA®. Each of our commercial partners were chosen
due to their commercial and regulatory capabilities in their respective territories.
EMD Serono Agreement United States
On October 28, 2008, we entered into a collaboration and licensing agreement granting EMD Serono
the exclusive commercialization rights to EGRIFTA® for the reduction of excess
abdominal fat in HIV-infected patients with lipodystrophy in the United States.
Under the terms of the agreement, EMD Serono has the exclusive right to conduct
EGRIFTA® commercialization activities in the United States. We are responsible for the
manufacturing and supply of EGRIFTA® and for the development of a new formulation. The
agreement also entitles us to conduct additional clinical programs to develop tesamorelin for
potential additional indications. EMD Serono has the option to commercialize products resulting
from such additional clinical programs in the United States. If EMD Serono exercises this option,
it will pay half of the development and regulatory costs incurred and to be incurred by us in
connection with such additional clinical programs. If EMD Serono decides not to exercise its
option, we have the right to commercialize tesamorelin for such indications on our own or with
third parties. We also have the option to co-promote any product resulting from such clinical
programs under terms and conditions to be agreed with EMD Serono. This agreement extends until the
expiration of the last valid claim based on a patent right (including patent applications)
controlled by us in the United States covering EGRIFTA®
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or any other product based on an additional indication for tesamorelin that EMD Serono has elected
to commercialize under the agreement.
We may receive up to US$215 million in upfront and milestone payments in addition to royalties and
revenues from the sale of EGRIFTA® to EMD Serono. To date, we have received US$65
million which includes an upfront payment and regulatory milestone payments of US$57 million and an
equity investment of US$8 million. Future milestone payments will be made based on the achievement
of certain sales milestones. We will also be entitled to receive royalties at an increasing rate
based on achieving specified levels of annual net sales of EGRIFTA® in the United
States.
We made our first delivery of EGRIFTA® to EMD Serono on December 13, 2010. In January
2011, EMD Serono launched EGRIFTA® in the United States. EMD Serono is executing a
launch program that consists of increasing disease awareness through medical education to doctors,
patient advocacy and advertising, marketing and promotion through their experienced sales force,
and supporting market access through patient support, co-pay programs, reimbursement education and
support for payors.
EMD Serono is responsible for establishing the sale price of EGRIFTA® in the United
States. The wholesale acquisition cost has been set at US$23,900 per patient per year. We expect to
receive our first royalty payments in the second quarter of 2011.
Sanofi Agreement Latin America, Africa and the Middle East
On December 6, 2010, we entered into a distribution and licensing agreement granting Sanofi, a
subsidiary of Sanofi-aventis S.A., the exclusive commercialization rights to EGRIFTA®
for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy in Latin
America, Africa and the Middle East.
Under the terms of the agreement, we will sell EGRIFTA® to Sanofi at a transfer price
equal to the higher of a percentage of Sanofis net selling price and a predetermined floor price.
Sanofi will be responsible for conducting all regulatory and commercialization activities for
EGRIFTA® for the reduction of excess abdominal fat in HIV-infected patients with
lipodystrophy in the territories subject to the agreement. We will be responsible for the
manufacture and supply of EGRIFTA® to Sanofi. We have retained all development rights
to EGRIFTA® for other indications and will be responsible for conducting development
activities for any additional potential indications. We also granted Sanofi an option to
commercialize tesamorelin for other indications in the territories mentioned above. If such option
is not exercised, or is declined, by Sanofi, we may commercialize tesamorelin for such indications
on our own or with a third party. The initial term of this agreement extends until December 2020.
Ferrer Agreement Europe, Russia, South Korea, Taiwan, Thailand and certain central Asian
countries
On February 3, 2011, we entered into a distribution and licensing agreement granting Ferrer the
exclusive commercialization rights to EGRIFTA® for the reduction of excess abdominal
fat in HIV-infected patients with lipodystrophy in Europe, Russia, South Korea, Taiwan, Thailand
and certain central Asian countries.
Under the terms of the agreement, we will sell EGRIFTA® to Ferrer at a transfer price
equal to the higher of a percentage of Ferrers net selling price and a predetermined floor price.
Ferrer will be responsible for conducting all regulatory and commercialization activities in
connection with EGRIFTA® for the reduction of excess abdominal fat in HIV-infected
patients with lipodystrophy in the territories subject to the agreement. We will be responsible for
the manufacture and supply of
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EGRIFTA® to Ferrer. We have retained all development rights to EGRIFTA® for
other indications and will be responsible for conducting development activities for any additional
potential indications. We have the option to co-promote EGRIFTA® for the reduction of
excess abdominal fat in HIV-infected patients with lipodystrophy in the territories. Ferrer has the
option to enter into a co-development and commercialization agreement using tesamorelin for
potential additional indications. The terms and conditions of such a co-development and
commercialization agreement will be negotiated based on any additional program chosen for
development. This agreement extends until the later of the expiration of the last valid claim based
on a patent right (including patent applications) controlled by us covering a product licensed
under the agreement or ten years from the date of the first commercial sale of EGRIFTA®
for each country covered by the agreement.
Unpartnered Territories
We have retained full commercial rights for EGRIFTA® in certain territories, including
Canada. In territories where we do not currently have commercial partners, we may commercialize
EGRIFTA® directly or in collaboration with commercial partners.
Tesamorelin Our Lead Compound
Tesamorelin is a stabilized 44 amino acid human GRF analogue, which was synthesized in our
laboratories in 1995 using our long-acting peptide method. Although natural peptides have
significant therapeutic potential, they are subject to enzymatic degradation which severely limits
their effectiveness in clinical use. Our long-acting peptide method is a peptide stabilization
process which increases the target proteins resistance to enzymatic degradation, while maintaining
its natural specificity. This usually results in a more stable and efficient compound, which can
thus prolong its duration of action. Tesamorelin induces growth hormone secretion in a natural and
pulsatile way. The clinical results obtained to date using tesamorelin suggest a therapeutic
potential in both anabolic and lipolytic indications. EGRIFTA® has demonstrated the
ability to significantly reduce visceral adipose tissue, increase muscle mass and reduce waist
circumference.
Mechanism of action
In vitro, tesamorelin binds and stimulates human GRF receptors with similar potency as the
endogenous GRF. GRF is a hypothalamic peptide that acts on the pituitary somatotroph cells to
stimulate the synthesis and pulsatile release of endogenous growth hormone, which is both anabolic
and lipolytic. Growth hormone exerts its effects by interacting with specific receptors on a
variety of target cells, including chondrocytes, osteoblasts, myocytes, hepatocytes, and
adipocytes, resulting in a host of pharmacodynamic effects. Some, but not all these effects, are
primarily mediated by insulin-like growth factor one, IGF-1, produced in the liver and in
peripheral tissues.
The effects of recombinant human growth hormone, or rhGH, and tesamorelin have been the subject of
several clinical trials in the area of HIV-associated lipodystrophy. Based on these clinical
trials, the safety profiles of rhGH and tesamorelin appear to be very different. The natural
synthesis of growth hormone is regulated by a feedback mechanism preventing its overproduction.
Tesamorelin induces optimal activity of the somatotrope function and retains the natural rhythm
(pulsatility) of the physiological secretion of growth hormone without interfering with the
feedback mechanism mentioned above. With the exogenous administration of rhGH, the feedback
mechanisms are short-circuited, which gives rise to higher levels of growth hormone. The side
effects associated with rhGH include nerve, muscle or joint pain, swelling due to fluid retention
(edema), carpal tunnel syndrome, numbness and tingling of skin and increased risk of diabetes.
These side effects are particularly frequent among older people. In addition, rhGH can cause
hyperglycemia which makes it contraindicated for patients with diabetes or pre-diabetic conditions.
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Muscle Wasting in COPD New Indication for Tesamorelin
We have selected COPD as our second clinical program with tesamorelin. We chose to consider muscle
wasting in COPD patients with decreased functioning in daily activities for a clinical program
based on the anabolic properties of tesamorelin. The goal of the program is to show an improvement
in functionality in daily activities in COPD patients with loss of muscle mass.
We completed a three-month Phase 2 clinical study involving 109 stable ambulatory COPD patients.
Patients were randomized to receive either 1 mg or 2 mg doses of tesamorelin, or a placebo each
day. Patients treated using 1 mg or 2 mg doses of tesamorelin experienced a statistically
significant increase in lean body mass compared with patients receiving a placebo. In addition to
the increase in lean body mass, such patients experienced improvements in three functional measures
associated with tesamorelin, particularly for the 2 mg group. The three functional measures were:
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Respiratory symptoms, as assessed by St. Georges Respiratory Questionnaire; |
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Leg discomfort, as assessed by the Borg Scale following an exercise endurance test; and |
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Breathing discomfort, as assessed by the Borg Scale following an exercise endurance
test. |
COPD
COPD is characterized by progressive airflow obstruction due to chronic bronchitis or emphysema,
two commonly co-existing lung diseases. COPD results in a limitation of the flow of air to and from
the lungs resulting in a shortness of breath. In contrast to asthma, the limitation of airflow is
not easily reversible and usually gets progressively worse over time.
Many COPD patients are affected by a systemic manifestation which may lead to muscle wasting.
Muscle wasting (cachexia or involuntary weight loss), a decrease or thinning of the muscle mass, is
associated with several abnormalities, including impaired exercise capacity and functioning and
decreased muscle strength. Muscle wasting is an independent predictor of a COPD patients
functional deterioration and mortality, and it is a common symptom in patients with moderate to
severe COPD. The importance of improving not only muscle strength, but other functional parameters
and quality of life is well recognized in order to improve the well being of patients with COPD and
decreased functionality. We are not aware of any treatment for muscle wasting in COPD approved by
any regulatory authorities.
Market opportunity
According to independent research, 26 million adults aged 40 or over were diagnosed with COPD in
the United States, France, Germany, Italy, the United Kingdom, Spain and Japan in 2009. The
prevalence of COPD increases with age and is much higher in adult males. The diagnosed population
is expected to increase at a compound annual growth rate of 2.5%.
Treatment varies across countries and region, however 17.9 million patients were receiving
treatment for COPD management in 2009 in the United States, France, Germany, Italy, the United
Kingdom, Spain and Japan. COPD can be classified using four levels of severity, from mild to very
severe (stages I to IV) using the GOLD classification. Our program will focus primarily on COPD
patients in GOLD stage II and III. Based on available market data, we estimate that in 2009, the
number of diagnosed COPD patients in GOLD stage II and III suffering from a muscle wasting
condition, with a body mass index of under 25, was approximately 3.1 million in those markets.
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Clinical development plan
Tesamorelins anabolic properties have led us to pursue its development for muscle wasting in COPD
patients as our second indication. This clinical development program will be conducted in stable
ambulatory COPD patients, GOLD stage II and III, with muscle wasting experiencing decreased
functionality in daily activities. It will include three studies:
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One Phase 2 study: This study will be a randomized, placebo controlled study in
approximately 200 COPD patients with muscle wasting. Patients will be randomized to receive
either one of two different dosages of tesamorelin or placebo each day for six months. We
intend to randomize our first patient in this Phase 2 clinical study in the second half of
2011. The Phase 2 study will evaluate the safety and efficacy of using tesamorelin in COPD
patients, GOLD stage II and III, with muscle wasting. The primary endpoint will be an
increase in lean body mass. Other efficacy endpoints will be measured, such as a six minute
walking distance test, exercise endurance time, and quality of life (daily activities).
Safety assessments will include monitoring of adverse events and laboratory evaluations. |
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Two Phase 3 studies: If the Phase 2 study is successful, we anticipate there will be two
12-month Phase 3 studies (one pivotal and one confirmatory) to be conducted in parallel. We
expect a total of approximately 1,200 patients will be included in this program. |
We currently believe that the clinical trials will last approximately four years and that the
program will cost between approximately $55 and $65 million. A significant portion of the costs
will be borne by our commercial partners if they elect to exercise their option to commercialize
under their respective agreements.
Other Product Candidates
Novel Growth Hormone-Releasing Factor Analogues
We are working on several novel analogues of GRF that have improved chemical stability compared to
tesamorelin. To date, we have synthesized over 80 different compounds. We believe that GRF
compounds have the potential to improve patient outcome in many high-value indications. We also
believe we can improve the route of administration of GRF peptides to make them quicker and easier
to use for patients.
Compounds for Acute Kidney Injury
AKI is the acute deterioration of kidney function leading to increased urea waste products and
electrolyte imbalance in blood. AKI is common among hospitalized patients and complicates the
management of patients in intensive care units. According to a 2008 medical publication, AKI
affected 3% to 7% of patients admitted to hospital and approximately 25% to 30% of patients in the
intensive care unit within days of major surgery. The incidence of AKI was approximately 600,000 to
900,000 patients in the United States per year. Despite hospitalization and renal replacement, the
mortality rate is 50% to 60% for dialyzed patients. We believe that hemodialysis is the only
approved treatment for post-surgical AKI.
We have identified AKI as a potential clinical program for internal development. We have developed
novel peptides specifically tailored for the prevention or treatment of AKI. One of these peptides,
TH0673, is a peptide that is currently in preclinical development. We have tested TH0673 in animal
models of AKI and have found that it increases creatinine clearance, improves excretion of
nitrogenous waste compounds and limits kidney damage. We expect to have additional preclinical
results in AKI in the first half of 2011.
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Other Discovery Activities Melanotransferrin Peptides (Anti-cancer compounds)
In November 2010, we entered into a discovery and collaboration agreement with the UQAM, Gestion
Valeo and Transfert Plus in connection with research led by Dr. Richard Béliveau seeking to
discover short peptide mimics of melanotransferrin for the development of a new cancer treatment.
Melanotransferrin is related to the transferrin family of proteins and is expressed normally in
melanocytes, but also in several cancer cells. Dr. Béliveaus research has demonstrated that
soluble melanotransferrin reduces cell migration, invasion and angiogenesis, which are hallmarks of
tumorigenesis and metastasis. We have identified small peptides from the melanotransferrin protein
which could replicate the functions of the full length protein. Currently, we are optimizing the
peptides for better pharmaceutical properties so that the optimized peptides can be tested in
animal models of cancer and tumor angiogenesis.
2.6 INTELLECTUAL PROPERTY
Our Current Patent Portfolio
Our current patent portfolio is comprised of patents and patent applications for the following
compounds:
Tesamorelin
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In the United States, we own a patent covering the composition of matter (tesamorelin),
which is scheduled to expire in 2015. We have applied for a patent term extension
requesting an extension of five years to this patent term. If our request for patent term
extension for the entire five year term is granted, the patent protection for tesamorelin
in the United States would be extended until 2020. In addition, we own an issued United
States patent relating to the use of tesamorelin in the treatment of HIV-associated
lipodystrophy, which is scheduled to expire in 2023. Because tesamorelin qualifies as a new
chemical entity, we benefit from data protection for a five year period for
EGRIFTA® ending November 2015. See Regulatory Exclusivity. |
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In Europe, tesamorelin is covered by granted patents scheduled to expire in 2016. In the
event of receipt of marketing approval from the European Medicines Agency, or EMA, we
intend to apply for supplementary protection certificates, or SPCs, in certain countries
which, if granted, could extend the patents covering tesamorelin in the countries where
SPCs are approved until 2021. We have also filed two patent applications relating to the
use of tesamorelin in the treatment of HIV-associated lipodystrophy where, if such patents
were granted, they would be scheduled to expire in 2023 and 2025, respectively. As
discussed below, the first time a new product is approved in Europe, the regulation
provides for a 10 year exclusivity period. Assuming approval in 2012, we would benefit from
protection until 2022. See Regulatory Exclusivity. |
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We have obtained a patent covering the composition of matter (tesamorelin) in Brazil
that expires in 2019. |
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We have filed patent applications for the therapeutic indication of muscle wasting in
COPD in several countries, including the United States, where, if such patents were
granted, they would be scheduled to expire in 2024, with the exception of a
recently-granted patent in the United States which benefits from a patent term adjustment
extending its term to 2027. |
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We have filed United States and international patent applications, for the new
formulation of tesamorelin where, if such patents were granted, they would be scheduled to
expire in 2028. |
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We have filed United States and international Patent Cooperation Treaty applications,
relating to combination therapies of tesamorelin with certain drugs indicated for the
treatment of HIV which, if patents issued from these applications were granted, would be
scheduled to expire in 2030. |
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Novel GRF Peptides |
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We have recently filed a United States provisional patent application relating to new
GRF analogues. Patents claiming priority to this application may be pursued and, if such
patents were granted, they would be scheduled to expire in 2032. |
AKI
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We have filed patent applications in several countries, including the United States,
relating to our peptide TH0673 and related peptides, and their use in the treatment of AKI,
where, if such patents were granted, they would be scheduled to expire in 2028. |
Our Trademarks & Other Intellectual Property
EGRIFTA® is the trademark used for tesamorelin for the reduction of excess abdominal
fat in HIV-infected patients with lipodystrophy. Trademark registration in the United States
necessitates a prior commercial use in the territory in order to be granted. We are in the process
of filing the declaration of use to obtain trademark registration.
We have obtained registration for EGRIFTA® in Europe, Japan, Australia, Norway,
Switzerland, Mexico and Lebanon and have filed trademark applications for this trademark in other
countries. The use of the trademark in each jurisdiction generally requires the approval of the
regulatory authorities in such jurisdictions.
Other trademarks related to tesamorelin have been filed as part of our business strategy. We have
also reserved certain domain names in order to support future activities.
Our Policy on Intellectual Property
Our intellectual property practice is to keep all information relating to proprietary compounds,
inventions, improvements, trade secrets, know-how and continuing technological innovation
confidential and, where practicable, file patent and trademark applications. In particular, as part
of our intellectual property protection practice, we:
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perform surveillance of third party patents and patent applications in order to identify
any third party patent or third party patent application which, if granted, could be
infringed by our activities; |
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where practicable, file patent applications for any new and patentable invention,
development or improvement in the United States and in other countries; |
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prosecute all pending patent applications in conformity with applicable patent laws and
in a manner that efficiently covers our activities; |
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file trademark applications in countries of interest for our trademarks; |
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register domain names in countries of interest; and |
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maintain our intellectual property rights by paying government fees as may be necessary
to ensure such rights remain in force. |
Regulatory Exclusivity
The regulatory regimes of the United States and Europe may provide market exclusivity for a
pharmaceutical product. Data protection and patent term extension provide a patent holder with
additional protection against third parties who may wish to commercialize a product similar to an
approved product.
Data Protection
In the United States, the Drug Price Competition and Patent Term Restoration Act of 1984, also
known as the Hatch-Waxman Act, awards, in certain circumstances, non-patent marketing exclusivities
to pioneer drug manufacturers. The Hatch-Waxman Act provides five years of non-patent marketing
exclusivity within the United States to an applicant who gains approval of a New Drug Application,
or NDA, for a new chemical entity, a drug for which the FDA has not previously approved any other
new drug with the same active moiety, which is the molecule or ion responsible for the action of
the drug. This marketing exclusivity prevents the FDA from approving, in certain circumstances, any
abbreviated new drug application for a generic drug or any 505(b)(2) NDA. See Government
Regulation United States FDA Process below.
In Europe, when a product based on a new compound is approved, the EMA grants a 10 year exclusivity
period beginning on the date of such approval. When the same compound is approved for a second
indication within the first eight years of this 10 year period, the exclusivity period is extended
by one year, providing a total exclusivity period of 11 years for the compound.
Patent Term Extension
In the United States, the Hatch-Waxman Act permits patent term extension for one patent per
approved drug of up to five years for patent term lost during product development and the FDA
regulatory review process. However, patent term extension cannot extend the remaining patent term
beyond a total of 14 years from the products approval date. The patent term extension period is
generally one-half the time between the effective date of an Investigational New Drug Application,
or IND, and the submission date of an NDA plus the time between the submission date of an NDA and
the NDA. We have applied for a patent term extension with respect to tesamorelin.
In the European Union, SPCs for medicinal products are governed by Regulation 469/2009 with effect
from May 2009. An SPC has the effect of extending the term of a patent relating to protection of a
particular medicinal product by compensating the patentee for some lost patent protection caused by
the length of time taken to obtain marketing authorisation for the product in question. An SPC is a
national right, available in member states of the European Union by application to the national
patent office of each state for which a certificate is desired. The SPC must be based on a patent
but since an SPC is only granted in respect of a very specific active ingredient in a product, it
is generally of rather more limited scope than the patent on which it is based. Typically, the term
of the SPC is equal to the period which has elapsed between filing of the patent application and
grant of the first European Union marketing authorisation less five years. The term of the SPC may
not, generally, exceed five years. However, some European Union legislation regarding pediatric
medicines provides for a six-month extension of the basic SPC term in certain circumstances. The
SPC takes effect on expiry of the basic patent. In each country for which SPC protection is sought,
a separate SPC application must
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be filed within six months of the grant of the first marketing authorisation in that country for
the active ingredient(s) in question.
2.7 MANUFACTURING
We do not own or operate commercial scale manufacturing facilities for the production of our
product or any of our product candidates, nor do we have plans to develop our own manufacturing
operations in the foreseeable future. We currently depend on third-party contract manufacturers for
all of our required raw materials, drug substance and finished product for clinical trials and
commercial sale.
We are responsible for the manufacture and supply of tesamorelin to ensure the commercialization of
EGRIFTA® under our agreements with EMD Serono, Sanofi and Ferrer. As part of our
agreement with EMD Serono, we are required to maintain certain levels of inventory. In order to
fulfill these contractual obligations, we have negotiated and entered into various third-party
supply agreements.
Bachem
We have an agreement with Bachem Inc., an American subsidiary of Swiss-based Bachem AG, providing
for the manufacturing and supply of the active pharmaceutical ingredient of tesamorelin for
clinical programs and EGRIFTA® for commercial sale in the United States.
Draxis
We have an agreement with Draxis Pharma, a division of Draxis Specialty Pharmaceuticals, Inc., or
Draxis, providing for the manufacture and supply of the finished form of tesamorelin for clinical
programs and EGRIFTA® for commercial sale. Under our agreement, Draxis must fill vials
with tesamorelin, lyophilize it, label and package those vials and deliver them to locations in
accordance with our instructions.
We have identified and initiated discussions with possible secondary suppliers of these products.
We believe that there are alternate sources of supply for these products that will be able to
satisfy our needs and will be able to receive FDA qualification. We expect our new presentation as
well as our new formulation of tesamorelin will significantly increase our production capacity for
EGRIFTA® due to the smaller quantity of vials, shorter manufacturing process times and
increased batch sizes.
We have also entered into the following manufacturing agreements as a result of our undertakings
under the distribution and licensing agreement with EMD Serono wherein we agreed to supply the
injection tool kits for EGRIFTA® namely:
Becton Dickinson
On November 6, 2009, we entered into a supply agreement with Becton Dickinson Canada Inc., or
Becton Dickinson. Under this agreement, Becton Dickinson is responsible for supplying us with
syringes and hypodermic needles which are provided with EGRIFTA® in the United States.
Hospira
On March 26, 2009, we entered into a development and supply agreement with Hospira Worldwide, Inc.,
or Hospira. Under this agreement, Hospira is responsible for manufacturing and supplying us with
sterile water for injection, filled and finished in plastic vials, in connection with the sale of
EGRIFTA® in the United States.
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ABAR
On January 5, 2010, we entered into a supply agreement with Gruppo Cartotecnico ABAR Litofarma
S.R.L., or ABAR, an Italian company, in order to ensure the commercial supply of pharmaceutical
mass market folding boxes for the sale of EGRIFTA® in the United States.
2.8 COMPETITION
The pharmaceutical industry is characterized by intense competition and rapid innovation. Our
potential competitors include large pharmaceutical and biotechnology companies, specialty
pharmaceutical and generic drug companies, academic institutions, government agencies and research
institutions, many of whom have greater financial, technical and human resources than us. We
believe the key competitive factors that will affect the development and commercial success of
EGRIFTA® and our product candidates are efficacy, safety and tolerability profile,
reliability, product acceptance by physicians and other healthcare providers, convenience of
dosing, price and reimbursement. Also, the development of new treatment methods for the indications
we are targeting could render our drugs non-competitive or obsolete. We are not aware of other GRF
products being commercialized or in development for the reduction of excess abdominal fat in
HIV-infected patients with lipodystrophy although we may face indirect competition for
EGRIFTA® from other drugs that may be prescribed by physicians. The use of these other
drugs for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy has not
been approved by the FDA nor any other regulatory authority.
We believe that competition in the area of muscle wasting in COPD patients is limited. We are aware
of one other compound which has completed a Phase 1 clinical study in COPD muscle wasting (GOLD
stage I and II). We may face indirect competition from other drugs such as anabolic steroids,
testosterone and growth hormone that may be prescribed by physicians. However, these drugs have not
been approved by the FDA for muscle wasting in COPD.
2.9 GOVERNMENT REGULATION
Overview
The research, development, manufacture and marketing of pharmaceutical products are governed by
various governmental authorities throughout the world to ensure efficacy and safety.
Governmental authorities in the United States at the federal, state and local level, and other
countries, extensively regulate, among other things, the research, development, testing,
manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion,
advertising, distribution, marketing, export and import of products, such as EGRIFTA®
and other product candidates that we are developing. The process of obtaining regulatory approvals
and the subsequent compliance with appropriate federal, state, local and foreign statutes and
regulations require the expenditure of substantial time and financial resources. Failure to comply
with the applicable United States or foreign requirements at any time during the product
development process, approval process or after approval, may subject an applicant to administrative
or judicial sanctions. Sanctions could include refusal to approve pending applications, withdrawal
of an approval, a clinical hold, warning letters, product recalls, product seizures, total or
partial suspension of production or distribution injunctions, fines, refusals of government
contracts, restitution, disgorgement or civil or criminal penalties.
On November 10, 2010, the FDA approved EGRIFTA® as the first approved treatment for
excess abdominal fat in HIV-infected patients with lipodystrophy. Our other product candidates must
receive regulatory approval from the FDA or other relevant foreign regulatory authorities before
they may legally be marketed in the United States or other countries.
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In Canada, these activities are governed by the provisions of the Food and Drugs Act and its
regulations, which is enforced by the Therapeutic Products Directorate of the Health Products and
Food Branch of Health Canada. We have not yet applied to market EGRIFTA® in Canada.
United States FDA Process
Before new pharmaceutical products may be sold in the United States, clinical trials of the product
candidates must be conducted and the results submitted to the FDA for approval. The drug approval
process requires, among other things, a demonstration of product safety and efficacy. Generally, a
demonstration of safety and efficacy includes preclinical testing and clinical trials of product
candidates. The testing, manufacture and marketing of pharmaceutical products in the United States
requires the approval of the FDA. The FDA enforces laws and regulations which apply to preclinical
testing, clinical trials, and manufacture of these products. The drug approval process in the
United States is described in brief below.
Pre-Clinical Testing: Before testing of any compounds with potential therapeutic value in human
subjects may begin in the United States, stringent government requirements for pre-clinical data
must be satisfied. Pre-clinical testing includes laboratory evaluations of product pharmacology and
toxicity in animal studies of the drug candidates. In parallel, the chemistry of the drug
candidates must be elucidated and their manufacturing, including formulation and stability, clearly
defined and controlled.
Investigational New Drug Application: Among other things, pre-clinical testing results obtained
from animal studies and in vitro studies, are submitted to the FDA as part of an IND application
and are reviewed by the FDA prior to the commencement of human clinical trials. An IND sponsor must
also include a protocol detailing, among other things, the objectives of the initial clinical
trial, the parameters to be used in monitoring safety and the effectiveness criteria to be
evaluated if the initial clinical trial lends itself to an efficacy evaluation. Some preclinical
testing may continue even after the IND is submitted. Unless the FDA objects to an IND (referred to
as a clinical hold), the IND becomes effective 30 days following its receipt by the FDA. Once
trials have commenced, the FDA may stop the trials at any time by placing them on clinical hold
because of safety concerns or noncompliance. If the FDA issues a clinical hold, the IND sponsor and
the FDA must resolve any outstanding concerns before the clinical study can begin. Accordingly, we
cannot be sure that submission of a IND will result in the FDA allowing clinical trials to begin or
that, once began, issues will not arise that suspend or terminate such trials.
Clinical Trials: Clinical trials involve the administration of the drug to healthy human volunteers
or to patients under the supervision of a qualified investigator pursuant to an FDA-approved
protocol. Each clinical trial must be conducted under the auspices of an Institutional Review
Board, or IRB, that considers, among other things, ethical factors, the safety of human subjects
and approves the patient informed consent, which must be agreed to by all participants prior to
participation in the clinical trial. Once an IND is in effect, each new clinical protocol and any
amendments to the protocol must be submitted to the FDA for review, and to the IRBs for approval.
Protocols detail, among other things, the objectives of the clinical trial, dosing procedures,
subject selection and exclusion criteria, and the parameters to be used to monitor subject safety.
Human clinical trials are typically conducted in three sequential phases, although the phases may
overlap with one another.
All phases of clinical trials must be conducted in conformance with Good Clinical Practices, or
GCP, which are ethical and scientific quality standards for conducting, recording, and reporting
clinical trials to assure that the rights, safety, and well-being of trial participants are
protected, and the FDAs regulations for the protection of human subjects.
Phase 1 Clinical Trials: Phase 1 clinical trials represent the initial administration of the
investigational drug to a small group of healthy human subjects or, more rarely, to a group of
select patients with the
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targeted disease or disorder. The goal of Phase 1 clinical trials is typically to test for safety,
dose tolerance, absorption, bio-distribution, metabolism, excretion and clinical pharmacology and,
if possible, to gain early evidence regarding efficacy.
Phase 2 Clinical Trials: Phase 2 clinical trials involve a small sample of the actual intended
patient population and seek to assess the efficacy of the drug for specific targeted indications,
to determine dose response and the optimal dose range and to gather additional information relating
to safety and potential adverse effects.
Phase 3 Clinical Trials: Once an investigational drug is found to have some efficacy and an
acceptable safety profile in the targeted patient population, Phase 3 clinical trials are initiated
to establish further clinical safety and efficacy of the investigational drug in a broader sample
of the patient population with the target disease or disorder at geographically dispersed study
sites in order to determine the overall risk-benefit ratio of the drug and to provide an adequate
basis for regulatory approval and product labeling.
New Drug Application: All data obtained from a comprehensive development program including research
and product development, manufacturing, pre-clinical and clinical trials and related information
are submitted in an NDA to the FDA. In addition to reports of the trials conducted under the IND,
the NDA includes information pertaining to the preparation of the new drug, chemistry manufacturing
and controls, or CMC, analytical methods, details of the manufacture of finished products and
proposed product packaging and labeling. The submission of an application is no guarantee that the
FDA will find the application complete and accept it for filing. The FDA may refuse to file the
application and request additional information rather than accept the application for filing, in
which case, the application must be resubmitted with the supplemental information. The re-submitted
application is also subject to review before the FDA accepts it for filing. Once an application is
accepted for filing, an FDA review team medical doctors, chemists, statisticians,
microbiologists, pharmacologists, and other experts evaluates whether the studies the sponsor
submitted show that the drug is safe and effective for its proposed use and whether the applicants
manufacturing complies with Good Manufacturing Practices, or GMP, to assure and preserve the
products identity, strength, quality and purity. As part of the approval process, the FDA will
inspect the facility or facilities where the product is manufactured. The FDA review process may be
extended by FDA requests for additional information or clarification. In some cases, the FDA may
decide to expedite the review of new drugs that are intended to treat serious or life threatening
conditions and demonstrate the potential to address unmet medical needs.
As part of its review, the FDA may refer the application to an advisory committee for evaluation
and a recommendation as to whether the application should be approved. The FDA is not bound by the
recommendation of an advisory committee, but it generally follows such recommendations.
Under legislation enacted in 2007, the FDA may determine that a risk evaluation and mitigation
strategy, or REMS, is necessary to ensure that the benefits of a new product outweigh its risks. If
required, a REMS may include various elements, such as publication of a medication guide, patient
package insert, a communication plan to educate healthcare providers of the drugs risks,
limitations on who may prescribe or dispense the drug, or other measures that the FDA deems
necessary to assure the safe use of the drug.
In reviewing an NDA, the FDA may grant marketing approval, request additional information or deny
the application if it determines the application does not provide an adequate basis for approval.
The FDA may require larger or additional clinical trials, leading to unanticipated delay or
expense. Even if such additional information and data are submitted, the FDA may ultimately decide
that the NDA does not satisfy the criteria for approval. Data from clinical trials may be subject
to different interpretation, and the FDA may interpret data differently than the applicant. The
receipt of regulatory approval often
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takes a number of years, involving the expenditure of substantial resources and depends on a number
of factors, including the severity of the disease in question, the availability of alternative
treatments and the risks and benefits demonstrated in clinical trials. The FDA may require, as a
condition of approval, restricted distribution and use, enhanced labeling, special packaging or
labeling, expedited reporting of certain adverse events, pre-approval of promotional materials, or
restrictions on direct-to-consumer advertising or commitments to conduct additional research
post-approval. The FDA will issue a complete response letter if the agency decides not to approve
the NDA in its present form. The complete response letter usually describes all of the specific
deficiencies in the NDA identified by the FDA. The deficiencies may be minor, for example,
requiring labeling changes, or major, for example, requiring additional clinical studies. If a
complete response letter is issued, the applicant may either resubmit the NDA, addressing all of
the deficiencies identified in the letter, or withdraw the application. In addition, changes in FDA
approval policies or requirements may occur, or new regulations may be promulgated, which may
result in delay or failure to receive FDA approval.
Changes to an approved product, such as adding a new indication, making certain manufacturing
changes, or changing manufacturers or suppliers of certain ingredients or components requires
review and approval of the FDA.
Under the Hatch-Waxman Act, the U.S. Congress created an abbreviated FDA review process for generic
versions of pioneer (brand name) drug products. The Hatch-Waxman Act requires NDA applicants and
NDA holders to provide certain information about patents related to the drug for listing in the
FDAs publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly
known as the Orange Book. The Hatch-Waxman Act allows for, under certain circumstances, an
abbreviated NDA, or ANDA, where an applicant seeks to determine that its proposed product is
biologically equivalent to the reference drug. ANDA applicants do not have to conduct extensive
clinical trials to prove the safety or efficacy of the drug product; rather, they are required to
conduct less rigorous bioequivalence testing. Drugs approved in this way are commonly referred to
as generic equivalents to the listed drug, are listed as such by the FDA, and can often be
substituted by pharmacists under prescriptions written for the original listed drug. In addition,
in certain cases, an application for marketing approval may include information regarding safety
and efficacy of a proposed drug that comes from studies not conducted by or for the applicant and
for which the applicant has not obtained a specific right to reference those studies.
Such applications, known as a 505(b)(2) NDA, are permitted for new drug products that incorporate
previously approved active ingredients, even if the proposed new drug incorporates an approved
active ingredient in a novel formulation or for a new indication. Section 505(b)(2) also permits
the FDA to rely for such approvals on literature or on a finding by the FDA of safety and/or
efficacy for a previously approved drug product. In addition, a 505(b)(2) NDA for changes to a
previously approved drug product may rely on the FDAs finding of safety and efficacy of the
previously approved product coupled with new clinical information needed by FDA to support the
change. FDA approval of the NDA or ANDA is required before marketing of the product may begin in
the United States.
The Pediatric Research Equity Act, or PREA, requires NDAs (or NDA supplements) for a new active
ingredient, new indication, new dosage form, new dosing regimen, or new route of administration to
contain data assessing the safety and efficacy for the claimed indication in all relevant pediatric
subpopulations. Data to support dosing and administration also must be provided for each pediatric
subpopulation for which the drug is safe and effective. FDA may grant deferrals for the submission
of data, or full or partial waivers from the PREA requirements. Unless otherwise required by
regulation, PREA does not apply to any drug for an indication for which orphan designation, as
described below, has been granted.
If a product receives regulatory approval, the approval may be significantly limited to specific
diseases and dosages or the indications for use may otherwise be limited, which could restrict the
commercial value of the product. Further, the FDA may require that certain contraindications,
warnings or
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precautions be included in the product labeling. In addition, the FDA may require Phase 4
testing which involves clinical trials designed to further assess a drug safety and effectiveness
and may require testing and surveillance programs to monitor the safety of approved products that
have been commercialized.
Post-Approval Studies and Registries: Post-approval studies, also referred to as Phase 4 clinical
trials are studies that are conducted after a product has been approved. These trials can be
conducted for a number of purposes, including to collect long-term safety information or to collect
additional data about a specific population. As part of a product approval, the FDA may require
that certain Phase 4 studies be conducted post-approval, and in these cases these Phase 4 studies
are called post-marketing commitments.
Adverse Event Reporting: Regulatory authorities track information on side effects and adverse
events reported during clinical studies and after marketing approval. Non-compliance with FDA
safety reporting requirements may result in FDA regulatory action that may include civil action or
criminal penalties. Side effects or adverse events that are reported during clinical trials can
delay, impede or prevent marketing approval. Similarly, adverse events that are reported after
marketing approval can result in additional limitations being placed on the products use and,
potentially, withdrawal or suspension of the product from the market. Furthermore, in September
2007 the Food and Drug Administration Amendments Act of 2007 was enacted, which provides the FDA
with expanded authority over drug products after approval. This legislation enhances the FDAs
authority with respect to post-marketing safety surveillance including, among other things, the
authority to require additional post-approval studies or clinical trials and mandate label changes
as a result of safety findings, including the development and implementation of a REMS.
Orphan Drug Designation
Under the Orphan Drug Act, the FDA may grant orphan designation to a drug intended to treat a rare
disease or condition, which is a disease or condition that affects fewer than 200,000 individuals
in the United States, or more than 200,000 individuals in the United States and for which there is
no reasonable expectation that the cost of developing and making a drug available in the United
States for this type of disease or condition will be recovered from sales in the United States of
the drug. Orphan product designation must be requested before submitting an NDA. After the FDA
grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use
are disclosed publicly by the FDA. Orphan product designation does not convey any advantage in, or
shorten the duration of the regulatory review and approval process.
If a drug that has orphan designation subsequently receives the first FDA approval for the disease
or condition for which it has such designation, the product is entitled to orphan drug exclusivity,
which means that the FDA may not approve any other applications to market the same drug for the
same indication for seven years, except in limited circumstances, such as a showing of clinical
superiority to the product with orphan exclusivity. Competitors, however, may receive approval of
different drugs for the indication for which the orphan product has exclusivity or may obtain
approval for the same drug but for a different indication for which the orphan product has
exclusivity. Orphan product exclusivity also could block the approval of one of our product
candidates for seven years if a competitor obtains approval of the same drug or if our product
candidate is determined to be contained within the competitors product for the same indication or
disease. If a drug designated as an orphan drug receives marketing approval for an indication
broader than what is designated, it may not be entitled to orphan product exclusivity. Orphan drug
status in the European Union has similar but not identical benefits in the European Union.
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Expedited Development and Review Programs
The FDA has a fast track program that is intended to expedite or facilitate the process for
reviewing new drugs that meet certain criteria. Specifically, new drugs are eligible for fast track
designation if they are intended to treat a serious or life-threatening condition and demonstrate
the potential to address unmet medical needs for the condition. Fast track designation applies to
the combination of the product and the specific indication for which it is being studied. Unique to
a fast track product, the FDA may consider for review sections of the NDA on a rolling basis before
the complete application is submitted, if the sponsor provides a schedule for the submission of the
sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule
is acceptable, and the sponsor pays any required user fees upon submission of the first section of
the NDA.
Any product submitted to the FDA for market, including a fast track program, may also be eligible
for other types of FDA programs intended to expedite development and review, such as priority
review and accelerated approval. Any product is eligible for priority review if it has the
potential to provide safe and effective therapy where no satisfactory alternative therapy exists or
a significant improvement in the treatment, diagnosis or prevention of a disease compared to
marketed products. The FDA will attempt to direct additional resources to the evaluation of an
application for a new drug designated for priority review in an effort to facilitate the review.
Additionally, a product may be eligible for accelerated approval. Drug products studied for their
safety and effectiveness in treating serious or life-threatening illnesses and that provide
meaningful therapeutic benefit over existing treatments may receive accelerated approval, which
means that they may be approved on the basis of adequate and well-controlled clinical studies
establishing that the product has an effect on a surrogate endpoint that is reasonably likely to
predict a clinical benefit, or on the basis of an effect on a clinical endpoint other than survival
or irreversible morbidity. As a condition of approval, the FDA may require that a sponsor of a drug
receiving accelerated approval perform adequate and well-controlled post-marketing clinical
studies. In addition, the FDA currently requires as a condition for accelerated approval
pre-approval of promotional materials, which could adversely impact the timing of the commercial
launch of the product. Fast track designation, priority review and accelerated approval do not
change the standards for approval but may expedite the development or approval process.
Non-U.S. Regulation
In addition to regulations in the United States, we will be subject to a variety of regulations
governing clinical studies and commercial sales and distribution of our products in other
jurisdictions around the world. Whether or not we obtain FDA approval for a product, we must obtain
approvals from the comparable regulatory authorities of foreign countries before we can commence
clinical studies or marketing of the product in those countries. The approval process varies from
country to country and the time may be longer or shorter than that required for FDA approval. The
requirements governing the conduct of clinical studies, product licensing, pricing and
reimbursement vary greatly from country to country. In some international markets, additional
clinical trials may be required prior to the filing or approval of marketing applications within
the country.
In the European Union, medicinal products must be authorized either through the decentralized
procedure by the competent authorities of the European Union Member States, or through the
centralized procedure by the European Commission following an opinion by the EMA. The centralized
procedure provides for the grant of a single marketing authorization that is valid for all European
Union member states. The centralized procedure is compulsory for medicines produced by certain
biotechnological processes, products with a new active substance indicated for the treatment of
certain diseases such as neurodegenerative disorder or diabetes and products designated as orphan
medicinal products, and optional for those products which are highly innovative or for which a
centralized process is in the interest of patients. The decentralized approval procedure provides
for approval by one or more concerned member states based on an assessment of an application
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performed by one member state, known as the reference member state. Under the decentralized
approval procedure, an applicant submits an application, or dossier, and related materials (draft
summary of product characteristics, draft labeling and package leaflet) to the reference member
state and concerned member states. The reference member state prepares a draft assessment and
drafts of the related materials within 120 days after receipt of a valid application. Within 90
days of receiving the reference member states assessment report, each concerned member state must
decide whether to approve the assessment report and related materials. If a member state objects to
approval of the assessment report and related materials on the grounds of potential serious risk to
public health, the disputed points may eventually be referred to the European Commission, whose
decision is binding on all member states. In many European Union countries, pricing and
reimbursement negotiations must also take place before the product is sold in their national market
between the company marketing the product and the competent national authorities.
In order to obtain approval for commercializing new drugs in Canada, we must satisfy many
regulatory conditions. We must complete preclinical studies in order to file a Clinical Trial
Application, or CTA, in Canada. We then receive different clearance authorizations to proceed with
Phase 1 clinical trials, which can then lead to Phase 2 and Phase 3 clinical trials. Once all three
phases of trials are completed, we file a registration file named a New Drug Submission, or NDS, in
Canada. If the NDS demonstrates that the product was developed in accordance with the regulatory
authorities rules, regulations and guidelines and demonstrates favourable safety, efficacy and
receives a risk/benefit analysis, then the regulatory authorities issue a notice of compliance,
which allows us to market the product.
Good Manufacturing Practices
The FDA, the EMA, the competent authorities of the European Union Member States and other foreign
regulatory agencies regulate and inspect equipment, facilities, and processes used in the
manufacturing of pharmaceutical and biologic products prior to approving a product. Among the
conditions for NDA or equivalent foreign approval is the requirement that the prospective
manufacturers quality control and manufacturing procedures adhere to the FDAs or other competent
authorities current GMP. Before approval of an NDA or equivalent foreign approval, the FDA or
other competent authority may perform a pre-approval inspection of a manufacturing facility to
determine its compliance with GMP and other rules and regulations. In complying with GMP,
manufacturers must continue to expend time, money and effort in the area of production and quality
control to ensure full technical compliance. Similarly, NDA or equivalent foreign approval may be
delayed or denied due to GMP non-compliance or other issues at contract sites or suppliers included
in the NDA or equivalent foreign approval, and the correction of these shortcomings may be beyond
our control. Facilities are also subjected to the requirements of other government bodies, such as
the U.S. Occupational Safety & Health Administration and the U.S. Environmental Protection Agency.
If, after receiving clearance from regulatory agencies or competent authorities, a company makes
certain changes in manufacturing equipment, location, or process, additional regulatory review and
approval may be required. Our third-party suppliers must adhere to GMP and product-specific
regulations enforced by the FDA or other competent authorities following product approval. The FDA,
the European Union and other national competent authorities and regulatory agencies also conduct
regular, periodic visits to re-inspect equipment, facilities and processes following the initial
approval of a product. If, as a result of these inspections, it is determined that our suppliers
equipment, facilities or processes do not comply with applicable regulations and conditions of
product approval, regulatory agencies may seek civil, criminal or administrative sanctions and/or
remedies against them, including the suspension of manufacturing operations.
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Good Clinical Practices
The FDA, the EMA and other competent authorities promulgate regulations and standards, commonly
referred to as GCP, for designing, conducting, monitoring, auditing and reporting the results of
clinical trials to ensure that the data and results are accurate and that the trial participants
are adequately protected. The FDA, the European Union and other foreign national competent
authorities and regulatory agencies enforce GCP through periodic inspections of trial sponsors,
principal investigators and trial sites. We rely on third-party service providers to conduct our
clinical trials. If our study sites fail to comply with applicable GCP, the clinical data generated
in our clinical trials may be deemed unreliable and relevant regulatory agencies may require us to
perform additional clinical trials before approving our marketing applications.
Good Laboratory Practices
The FDA and other regulatory authorities promulgate regulations and standards, commonly referred to
as Good Laboratory Practices, or GLP, for the conduct of non-clinical, commonly referred to as
preclinical, non-human studies to provide a framework within which laboratory studies are
planned, performed, monitored, recorded, reported and archived. Compliance with GLP is intended to
assure regulatory authorities of the quality and integrity of the results obtained during the
preclinical studies. Before we may test our product candidates on humans in clinical trials, we
must first conduct preclinical testing, including animal studies, in accordance with GLP. The FDA
or other regulatory authorities may inspect the testing facilities where our pre-clinical studies
are conducted. The results of preclinical studies in the United States, Europe or other countries,
not conducted in accordance with GLP, might be inadmissible in support of an NDA in the United
States, or comparable applications in other countries.
United States Sales and Marketing
Our commercial partner, EMD Serono, will be subject to various United States regulations relating
to the sales and marketing of EGRIFTA® in the United States. The FDA regulates all
advertising and promotion activities for products under its jurisdiction both prior to and after
approval. A company can make only those claims relating to safety and efficacy that are approved by
the FDA. Drugs may be promoted only for the approved indications and in accordance with the
provisions of the approved label. The FDA actively enforces the laws and regulations prohibiting
the promotion of off-label uses, and a company that is found to have improperly promoted off-label
uses may be subject to significant sanctions. The FDA does not regulate the practice of medicine by
physicians in their choice of treatment, but FDA regulations do impose stringent restrictions on
manufacturers communications regarding off-label uses. Failure to comply with applicable FDA
requirements may subject a company to adverse publicity, enforcement action by the FDA, corrective
advertising, and the full range of civil and criminal penalties available to the FDA.
Marketing of EGRIFTA® within the United States is also subject to various federal and
state laws pertaining to health care fraud and abuse, including anti-kickback laws and false
claims laws. Anti-kickback laws make it illegal for a prescription drug manufacturer to solicit,
offer, receive, or pay any remuneration in exchange for, or to induce, the referral of business,
including the purchase or prescription of a particular drug. Due to the breadth of the statutory
provisions and the absence of guidance in the form of regulations and very few court decisions
addressing industry practices, it is possible that our commercial partners practices might be
challenged under anti-kickback or similar laws. False claims laws prohibit anyone from knowingly
and willingly presenting, or causing to be presented for payment to third-party payors (including
Medicare and Medicaid) claims for reimbursed drugs or services that are false or fraudulent.
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In addition, several states require that companies implement compliance programs or comply with
industry ethics codes, adopt spending limits, and report to state governments any gifts,
compensation, and other remuneration provided to physicians. The recently enacted health care
reform legislation will require record-keeping and disclosure to the federal government of payments
to physicians commencing in 2012. Any activities relating to the sale and marketing of our products
may be subject to scrutiny under these laws. Violations of fraud and abuse laws may be punishable
by criminal and/or civil sanctions, including fines and civil monetary penalties, as well as the
possibility of exclusion from federal health care programs (including Medicare and Medicaid). If
the government were to allege or convict our commercial partner of violating these laws, our
business could be harmed. In addition, there is ability for private individuals to bring similar
actions.
Further, there are an increasing number of state laws that require manufacturers to make reports to
states on pricing and marketing information. Our activities could be subject to challenge for the
reasons discussed above and due to the broad scope of these laws and the increasing attention being
given to them by law enforcement authorities.
2.10 PHARMACEUTICAL PRICING AND REIMBURSEMENT
In the United States and in other countries, sales of EGRIFTA® and our other product
candidates will depend in part on the availability of reimbursement from third-party payors.
Third-party payors include government health administrative authorities (such as the Centers for
Medicare & Medicaid Services in the United States), managed care providers, private health insurers
and other organizations. We believe EGRIFTA® will achieve a high degree of physician
and payor acceptance, driven by our products safety and efficacy, the lack of approved alternative
therapies for these patients and the prominent medical and social need to treat HIV/AIDS patients.
However, these third-party payors are increasingly challenging the price and examining the
cost-effectiveness of medical products and services. In addition, significant uncertainty exists as
to the reimbursement status of newly approved healthcare product candidates. We, or our commercial
partners, may need to conduct expensive pharmacoeconomic studies in order to demonstrate the
cost-effectiveness of EGRIFTA® or our other product candidates. EGRIFTA® or
our other product candidates may not be considered cost-effective. It is time consuming and
expensive for us, and our commercial partners, to seek reimbursement from third-party payors.
Reimbursement may not be available or sufficient to allow us to sell EGRIFTA® or our
other product candidates on a competitive and profitable basis.
United States
Pursuant to our agreement with EMD Serono, they are responsible for identifying and obtaining
possible reimbursements under such government programs in the United States. The U.S. Congress and
state legislatures from time to time propose and adopt initiatives aimed at cost containment, which
could impact our ability to sell our products profitably. For example, in March 2010, President
Obama signed into law the Patient Protection and Affordable Care Act, and the associated
reconciliation bill, which we refer to collectively as the Health Care Reform Law, a sweeping law
intended to broaden access to health insurance, reduce or constrain the growth of healthcare
spending, enhance remedies against fraud and abuse, add new transparency requirements for
healthcare and health insurance industries, impose new taxes and fees on the health industry and
impose additional health policy reforms. Effective October 1, 2010, the Health Care Reform Law
revises the definition of average manufacturer price for reporting purposes, which could increase
the amount of Medicaid drug rebates to states once the provision is effective. Further, beginning
in 2011, the new law imposes a significant annual fee on companies that manufacture or import
certain branded prescription drug products and biologic agents. Substantial new provisions
affecting compliance also have been enacted, which may require us, or EMD Serono, to modify our
business
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practices with healthcare practitioners. We will not know the full effects of the Health Care
Reform Law until applicable federal and state agencies issue regulations or guidance under the new
law. Although it is too early to determine the effect of the Health Care Reform Law, the new law
appears likely to continue the pressure on pharmaceutical pricing, especially under the Medicare
program, and also may increase our regulatory burdens and operating costs.
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or MMA, imposed new
requirements for the distribution and pricing of prescription drugs for Medicare beneficiaries, and
included a major expansion of the prescription drug benefit under a new Medicare Part D. Medicare
Part D went into effect on January 1, 2006. Under Part D, Medicare beneficiaries may enroll in
prescription drug plans offered by private entities which will provide coverage of outpatient
prescription drugs. Part D plans include both stand-alone prescription drug benefit plans and
prescription drug coverage as a supplement to Medicare Advantage plans. Unlike Medicare Part A and
B, Part D coverage is not standardized. Part D prescription drug plan sponsors are not required to
pay for all covered Part D drugs, and each drug plan can develop its own drug formulary that
identifies which drugs it will cover and at what tier or level. However, Part D prescription drug
formularies must include drugs within each therapeutic category and class of covered Part D drugs,
though not necessarily all the drugs in each category or class. Any formulary used by a Part D
prescription drug plan must be developed and reviewed by a pharmacy and therapeutic committee.
It is not clear what effect the MMA will have on the prices paid for EGRIFTA® and our
other product candidates. Some studies indicate that Part D lowered the average price and increased
the utilization of prescription drugs by Medicare beneficiaries. Government payment for some of the
costs of prescription drugs may increase demand for products for which we receive marketing
approval. However, any negotiated prices for our products covered by a Part D prescription drug
plan will likely be lower than the prices we might otherwise obtain. Moreover, while the MMA
applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare
coverage policy and payment limitations in setting their own payment rates. Any reduction in
payment that results from the MMA may result in a similar reduction in payments from
non-governmental payors.
There are also laws that govern a companys eligibility to participate in Medicare and Medicaid
reimbursements. For example, a company may be debarred from participation if it is found to have
violated federal anti-kickback laws, which could have a significant effect on a companys ability
to operate its business.
The cost of pharmaceuticals continues to generate substantial governmental and third-party payor
interest. We expect that the pharmaceutical industry will experience pricing pressures due to the
trend toward managed healthcare, the increasing influence of managed care organizations, and
additional legislative proposals. Indeed, we expect that there will continue to be a number of U.S.
federal and state proposals to implement governmental pricing controls and limit the growth of
healthcare costs, including the cost of prescription drugs. At the present time, Medicare is
prohibited from negotiating directly with pharmaceutical companies for drugs. However, the U.S.
Congress is considering passing legislation that would lift the ban on federal negotiations. While
we cannot predict whether such legislative or regulatory proposals will be adopted, the adoption of
such proposals could harm our business, financial condition and results of operations.
Some third-party payors also require pre-approval of coverage for new or innovative drug therapies
before they will reimburse healthcare providers that use such therapies. While we cannot predict
whether any proposed cost-containment measures will be adopted or otherwise implemented in the
future, the announcement or adoption of these proposals could have a material adverse effect on our
ability to obtain adequate prices for our product candidates and operate profitably.
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Europe and other countries covered by our agreements
Outside of the United States, sales of EGRIFTA® and our other product candidates will
depend in part on the availability and level of reimbursement from third-party payers. Third-party
payers can be public or private or a combination of both. In order to obtain public reimbursement,
prescription drugs are often evaluated by specialized bodies in a country. This process is in many
cases independent of marketing approval and the time to carry out the evaluation differs in each
country, often extending beyond the initial regulatory approval date of the drug.
The requirements and aspects considered during the assessment of a new prescription drug are not
necessarily the same in each country and are given different weight depending on the countries
attitudes towards providing public healthcare and the governments willingness to pay for these new
drugs. We or our commercial partners could be required to conduct specific health economic and
other studies or analyses in order to satisfy such requirements. The decision to comply with such
requirements will depend on the prospects of obtaining a positive opinion and the costs involved in
the process and the profitability of the market.
In many jurisdictions, pricing plays an important role in the evaluation of prescription drugs for
reimbursement and in most cases, there are price controls that can include, but are not limited to,
reference pricing to drugs sold within the country and in other countries, the evaluation of what a
fair price would be based on the condition that is being treated and innovative quality of the new
drug.
Many countries, particularly in Europe, have initiated cost-cutting measures which have been
reflected in reduced budgets for drugs, higher discounts imposed on manufacturers and price
negotiations between authorities and manufacturers among other actions. We expect the current
reimbursement evaluation process and pricing policies to keep evolving in ways that we may not
foresee.
In Latin America, Brazil has a formal price procedure through Agência Nacional de Vigilância
Sanitoria (ANVISA) which determines the price of a pharmaceutical based on five reference
countries, including the United States. However, there is uncertainty in pricing of pharmaceutical
drugs in Latin America in general.
Pursuant to our agreements with Sanofi and Ferrer, each is responsible for identifying and
obtaining possible reimbursements under such government programs in their respective territories.
2.11 EMPLOYEES
As at November 30, 2010, we had 99 employees, all of whom were employed in Canada. All of our
employees are engaged in administration, finance, research and development, regulatory and business
development functions. None of our employees are unionized. We believe the relations with our
employees are good.
2.12 FACILITIES
We carry out our activities at 2310 Alfred-Nobel Boulevard in the Technoparc Montréal in Ville
Saint-Laurent, Québec, Canada. We lease a 36,400 square-foot building, which houses both offices
and laboratories which enable us to conduct small-scale peptide manufacturing, discovery and manage
preclinical and clinical research.
The facilities contain laboratories which enable us to conduct small-scale peptide manufacturing,
discovery and preclinical research. Peptide compounds are synthesized by our pharmaceutical
development department using manual and semiautomatic methods with reactors of different sizes
(from 50 to 8000 ml) and also a 12-channel automated peptide synthesizer. The peptides are purified
using preparative high performance liquid chromatography, or HPLC, comprising either the Dynamic
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Axial Compression column, or a number of pre-packed columns. The final peptides are dried to a
solid form using lyophilization equipment. The analyses on the quality of the peptides are done
using a variety of equipment including HPLC instruments Agilent 1100 and 1200, UV
spectrophotometers and a water content analyzer.
We also have discovery and preclinical research laboratories which include two cell culture rooms
and several chemical hoods. A Mesoscale chemiluminometer (Sector PR100) is used for sensitive
immunological and cell-based assays. Several HPLC instruments for preformulation and purity
determinations, scintillation spectrophotometers for radioactivity measurements, and
fluorospectrophotometers and colorimetric plate readers for cell-based screens and immunoassays
enable in-house discovery and preclinical research. A designated laboratory section is equipped to
conduct studies according to GLP.
2.13 ENVIRONMENT
To our knowledge, at our current development stage, environmental protection requirements do not
have a significant financial or operational impact on our capital expenditures, income or
competitive position within the normal course of our operating activities.
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ITEM 3 RISK FACTORS
Before you invest in our common shares, you should understand the high degree of risk involved. You
should consider carefully the following risks and uncertainties described below before you decide
to purchase our common shares. The following risks may adversely impact our business, financial
condition, operating results and prospects. Additional risks and uncertainties, including those
that we do not know about or that we currently believe are immaterial, may also adversely affect
our business, financial condition, operating results or prospects. As a result, the trading price
of our common shares could decline and you could lose all or part of your investment.
3.1 RISKS RELATED TO THE COMMERCIALIZATION OF OUR PRODUCT AND PRODUCT CANDIDATES
Our commercial success depends largely on the commercialization of EGRIFTA®; the
failure of EGRIFTA® to obtain commercial acceptance would have a material adverse
effect on us.
Our ability to generate revenues in the future is primarily based on the commercialization of
EGRIFTA® for the reduction of excess abdominal fat in HIV-infected patients with
lipodystrophy. In the short-term, these revenues should be primarily derived from the U.S. market
alone. Although we have entered into a collaboration and licensing agreement with EMD Serono for
the commercialization of EGRIFTA® in the United States, there can be no assurance that
EGRIFTA® will be successfully commercialized in the United States, or in any other
country. Although we are developing other peptides, all of them are at earlier stages of
development and none of them may reach the clinical trial phase, obtain regulatory approval or,
even if approved, be successfully commercialized.
The overall commercialization success of EGRIFTA® for the reduction of excess abdominal
fat in HIV-infected patients with lipodystrophy will depend on several factors, including:
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receipt of regulatory approvals for EGRIFTA® from regulatory agencies in the
territories other than the United States in which we wish to expand the commercialization
of tesamorelin; |
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market acceptance of EGRIFTA® by the medical community, patients and
third-party payors (such as governmental health administration authorities and private
health coverage insurers); |
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the amount of resources devoted by our commercial partners to commercialize
EGRIFTA® in their respective territories; |
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maintaining manufacturing and supply agreements to ensure the availability of commercial
quantities of EGRIFTA® through validated processes; |
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the number of competitors in our market; and |
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protecting and enforcing our intellectual property and avoiding patent infringement
claims. |
The inability to successfully commercialize EGRIFTA® in the United States for the
reduction of excess abdominal fat in HIV-infected patients with lipodystrophy in the short term
would delay our capacity to generate revenues and would have a material adverse effect on our
financial condition and operating results.
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We are or will be dependent on a limited number of collaboration and licensing agreements for
the commercialization of EGRIFTA® in the United States, Europe, Latin America, Africa
and the Middle East. These agreements place the commercialization of EGRIFTA® in these
markets outside of our control.
Although our collaboration and licensing agreements with EMD Serono, Sanofi and Ferrer contain
provisions governing their respective responsibilities as partners for the commercialization of
EGRIFTA® in their respective territories, our dependence on these partners to
commercialize EGRIFTA® is subject to a number of risks, including:
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our limited control of the amount and timing of resources that our commercial partners
will be devoting to the commercialization, marketing and distribution of tesamorelin,
including obtaining patient reimbursement for EGRIFTA®, which could adversely
affect our ability to obtain or maximize our royalty payments; |
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disputes or litigation that may arise between us and our commercial partners, which
could adversely affect the commercialization of tesamorelin, all of which would divert our
managements attention and our resources; |
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our commercial partners not properly defending our intellectual property rights or using
them in such a way as to expose us to potential litigation, which could, in both cases,
adversely affect the value of our intellectual property rights; and |
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corporate reorganizations or changes in business strategies of our commercial partners,
which could adversely affect a commercial partners willingness or ability to fulfill its
obligations under its respective agreement. |
Our collaboration and licensing agreements may be terminated by our partners in the event of a
breach by us of our obligations under such agreements, including our obligation to supply
EGRIFTA®, for which we rely on third parties. Our collaboration and licensing agreement
with EMD Serono can also be terminated by EMD Serono for their convenience on 180 days notice to
us. Such a termination could have an adverse effect on our revenues related to the
commercialization of EGRIFTA® in the United States. In addition, EMD Serono has listed
a patent held by one of its affiliates in the Orange Book under the Hatch-Waxman Act with respect
to EGRIFTA® in HIV-associated lipodystrophy. In the event of a termination of our
agreement with EMD Serono, EMD Serono could assert that such patent would be infringed by our
continued sale of EGRIFTA® in the United States. Any such assertion would divert our
managements attention and, if successful, could expose us to damages or require us to obtain a
license from EMD Serono in order to continue selling EGRIFTA® in the United States, all
of which could have a material adverse effect on our results of operations, cash flows and
financial conditions.
If any one of our commercial partners terminates their agreement with us or fails to effectively
commercialize EGRIFTA®, for any of the foregoing or other reasons, we may not be able
to replace the commercial partner and any of these events would have a material adverse effect on
our business, results of operations and our ability to achieve future profitability, and could
cause our share price to decline.
We rely on third parties for the manufacture and supply of EGRIFTA® and
tesamorelin and such reliance may adversely affect us if the third parties are unable or unwilling
to fulfill their obligations.
The manufacture of pharmaceutical products requires significant expertise and capital investment,
including the development of advanced manufacturing techniques and process controls. We do not
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own or operate manufacturing facilities for the production of tesamorelin or any of our other
product candidates, nor do we have plans to develop our own manufacturing operations in the
foreseeable future. We currently rely on third parties to manufacture and supply all of our
required raw materials, drug substance and drug product for our preclinical research, clinical
trials and commercial sales. For tesamorelin for clinical studies and EGRIFTA® for
commercial sales, we are currently using, and relying on, single suppliers and single manufacturers
for starting materials and the final drug substance. Although potential alternative suppliers and
manufacturers have been identified, we have not qualified these vendors to date and no assurance
can be given that such suppliers will be qualified in the future or receive necessary regulatory
approval.
Our reliance on third-party manufacturers exposes us to a number of risks. We may be subject to
delays in or suspension of the manufacturing of EGRIFTA® and tesamorelin if a
third-party manufacturer:
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becomes unavailable to us for any reason, including as a result of the failure to comply
with GMP regulations; |
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experiences manufacturing problems or other operational failures, such as equipment
failures or unplanned facility shutdowns required to comply with GMP or damage from any
event, including fire, flood, earthquake, business restructuring or insolvency; or |
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fails to perform its contractual obligations under our agreement, such as failing to
deliver the quantities requested on a timely basis. |
Any delay in or suspension of the supply of EGRIFTA® could delay or prevent the sale of
EGRIFTA® and, accordingly, adversely affect our revenues and results of operations. In
addition, any manufacturing delay or delay in delivering EGRIFTA® may result in our
being in default under our collaboration agreements. If the damage to a suppliers manufacturer
facility is extensive, or, for any reason, it does not operate in compliance with GMP or the
third-party manufacturer is unable or refuses to perform its obligations under our agreement, we
would need to find an alternative third-party manufacturer. The selection of a replacement
third-party manufacturer would be time-consuming and costly since we would need to validate the
manufacturing facility of such new third-party manufacturer. The validation process would include
an assessment of the capacity of such third-party manufacturer to produce the quantities that we
may request from time to time, the manufacturing process and its compliance with GMP. In addition,
the third-party manufacturer would have to familiarize itself with our technology. Any delay in
finding an alternative third-party manufacturer of tesamorelin and EGRIFTA® could
result in a shortage of such analogue or product, which could materially adversely affect our
business and results of operations.
Any delay in or suspension of the supply of tesamorelin could delay or interrupt the conduct of
clinical trials of our new clinical programs relating to muscle wasting in COPD.
Even though we have received regulatory approval for EGRIFTA® in the United
States, we still may not be able to successfully commercialize it if we do not gain market
acceptance and the revenue that we generate from its sales, if any, may be limited.
The commercial success of EGRIFTA® or any future products for which we obtain marketing
approval from the FDA or other regulatory authorities, will depend upon the acceptance of such
product by the medical community, including physicians, patients and health care payors. The degree
of market acceptance of any of our products will depend on a number of factors, including:
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acceptance of the product by physicians and patients as safe and effective treatments
and addressing a significant unmet medical need; |
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product price; |
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the effectiveness of our sales and marketing efforts (or those of our commercial
partners); |
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storage requirements and ease of administration; |
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dosing regimen; |
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safety and efficacy; |
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prevalence and severity of side effects; |
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competitive products; |
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the ability to obtain and maintain sufficient third-party coverage or reimbursement from
government health care programs, including Medicare and Medicaid, private health insurers
and other third-party payors; and |
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the willingness and ability of patients to pay out-of-pocket in the absence of
third-party coverage. |
If EGRIFTA® does not achieve an adequate level of acceptance by physicians, health care
payors and patients, we may not generate sufficient revenue from this product, and we may not be
able to achieve profitability. Our efforts, and the efforts of our commercial partners, to educate
the medical community and third-party payors on the benefits of tesamorelin may require significant
resources and may never be successful.
We have no internal sales, marketing or distribution capabilities so we must rely on strategic
alliance agreements with third parties for the sale and marketing of EGRIFTA® or any
future products.
We currently have no internal sales, marketing or distribution capabilities and we rely on our
commercial partners to market and sell EGRIFTA® in their respective territories. Our
agreements with our commercial partners contain termination provisions which, if exercised, could
delay or suspend the commercialization of EGRIFTA® or any future products.
In the event of any such termination, in order to continue commercialization, we would be required
to build our own sales force or enter into agreements with third parties to provide such
capabilities. We currently have limited marketing capabilities and we have limited experience in
developing, training or managing a sales force. The development of a sales force would be costly
and would be time-consuming given the limited experience we have in this area. To the extent we
develop a sales force, we could be competing against companies that have more experience in
managing a sales force than we have and that have access to more funds than we with which to manage
a sales force. Consequently, there can be no assurance that a sales force which we develop would be
efficient and would maximize the revenues derived from the sale of EGRIFTA® or any
future products.
We are substantially dependent on revenues from EGRIFTA®.
Our current and future revenues depend substantially upon sales of EGRIFTA® by our
commercial partners, EMD Serono, Sanofi and Ferrer. Any negative developments relating to this
product, such as safety or efficacy issues, the introduction or greater acceptance of competing
products, including those marketed and sold by our commercial partners, or adverse regulatory or
legislative developments, would have a material adverse effect on our business, prospects and
results of
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operations. Although we continue to develop additional product candidates for commercialization, we
expect to be substantially dependent on sales from EGRIFTA® for the foreseeable future.
A decline in sales from this product would have a material adverse affect on our business and
financial condition.
Our levels of revenues are highly dependent on obtaining patient reimbursement for
EGRIFTA®.
Market acceptance and sales of EGRIFTA® will substantially depend on the availability
of reimbursement from third party payors such as governmental authorities, including U.S. Medicare
and Medicaid, managed care providers, and private insurance plans and may be affected by healthcare
reform measures in the United States and elsewhere. Government authorities and third-party payors,
such as private health insurers and health maintenance organizations, decide which medications they
will pay for and establish reimbursement levels. A primary trend in the U.S. healthcare industry
and elsewhere is cost containment. Government authorities and these third-party payors have
attempted to control costs by limiting coverage and the amount of reimbursement for particular
medications. Increasingly, third-party payors have been challenging the prices charged for
products.
Under our agreements with our commercial partners, they are responsible for seeking reimbursement
of EGRIFTA® in their respective territories and as a result we have no control over
whether or what level of reimbursement is achieved.
We cannot be sure that reimbursement by insurers, government or other third parties will be
available for EGRIFTA® and, if reimbursement is available, the level of reimbursement
provided to patients. Reimbursement may impact the demand for, or the price of,
EGRIFTA® and our future products for which we obtain marketing approval. If
reimbursement is not available or is available only in limited amount, our commercial partners may
not be able to successfully commercialize EGRIFTA® or our future products and it will
have a material adverse effect on our revenues and royalties, business and prospects.
A variety of risks associated with our international business relationships could materially
adversely affect our business.
International business relationships in the United States, Europe, Latin America, Africa, the
Middle East and elsewhere subject us to additional risks, including:
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differing regulatory requirements for drug approvals in foreign countries; |
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potentially reduced protection for intellectual property rights; |
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potential third-party patent rights in foreign countries; |
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the potential for so-called parallel importing, which is what happens when a local
seller, faced with high or higher local prices, opts to import goods from a foreign market,
with low or lower prices, rather than buying them locally; |
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unexpected changes in tariffs, trade barriers and regulatory requirements; |
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economic weakness, including inflation, or political instability, particularly in
foreign economies and markets; |
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compliance with tax, employment, immigration and labour laws for employees traveling
abroad; |
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foreign taxes; |
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foreign exchange contracts and foreign currency fluctuations, which could result in
increased operating expenses and reduced revenue, and other obligations incident to doing
business in another country; |
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workforce uncertainty in countries where labour unrest is more common than in the United
States and Canada; |
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production shortages resulting from any events affecting raw material supply or
manufacturing capabilities abroad; and |
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business interruptions resulting from geo-political actions, including war and
terrorism, or natural disasters, including earthquakes, volcanoes, typhoons, floods,
hurricanes and fires. |
These and other risks of international business relationships may materially adversely affect our
business, prospects, results of operations and financial condition.
Governments outside the United States tend to impose strict price controls, which may
adversely affect our revenues, if any.
In several countries, including countries which are in Europe, Latin America, Africa, and the
Middle East, the pricing of prescription drugs may be subject to governmental control. In these
countries, pricing negotiations with governmental authorities can take considerable time and delay
the marketing of a product. To obtain reimbursement or pricing approval in some countries, a
clinical trial that compares the cost-effectiveness of a product candidate to other available
therapies may be required. If reimbursement of our product is unavailable or limited in scope or
amount, or if pricing is set at unsatisfactory levels, our commercial partners may not be willing
to devote resources to market and commercialize EGRIFTA® or may decide to cease
marketing such product. In such case, our business, prospects and results of operations could be
materially adversely affected.
We face competition and the development of new products by other companies could materially
adversely affect our business and products.
The biopharmaceutical and pharmaceutical industries are highly competitive and we must compete with
pharmaceutical companies, biotechnology companies, academic and research institutions as well as
governmental agencies for the development and commercialization of products, most of which have
substantially greater financial, technical and personnel resources than us. Although we believe
that we have no direct competitors for the reduction of excess abdominal fat in HIV-infected
patients with lipodystrophy, we could face indirect competition from other companies developing
and/or commercializing metabolic products and/or other products that reduce or eliminate the
occurrence of lipodystrophy.
In the other clinical programs that we are currently evaluating for development, there may exist
companies that are at a more advanced stage of developing a product to treat the diseases for which
we are evaluating clinical programs. Some of these competitors could have access to capital
resources, research and development personnel and facilities that are superior to ours. In
addition, some of these competitors could be more experienced than we are in the development and
commercialization of medical products and already have a sales force in place to launch new
products. Consequently, they may be able to develop alternative forms of medical treatment which
could compete with our products and which could be commercialized more rapidly and effectively than
our products.
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If we fail to comply with government regulations regarding the import and export of products
and raw materials, we could be subject to fines, sanctions and penalties that could adversely
affect our ability to operate our business.
We import and export products and raw materials from and to several jurisdictions around the world.
This process requires us and our commercial partners to operate in a number of jurisdictions with
different customs and import/export regulations. The regulations of these countries are subject to
change from time to time and we cannot predict the nature, scope or impact of these changes upon
our operations. We and our commercial partners are subject to periodic reviews and audits by U.S.
and foreign authorities responsible for administering these regulations. To the extent that we or
our commercial partners are unable to successfully defend against an audit or review, we may be
required to pay assessments, penalties and increased duties, which may, individually or in the
aggregate, negatively impact our business, operating results and financial condition.
3.2 RISKS RELATED TO THE REGULATORY REVIEW PROCESS
Even after regulatory approval has been obtained regulatory agencies may impose limitations on
the indicated uses for which our products may be marketed, subsequently withdraw approval or take
other actions against us that would be adverse to our business.
Even though we have obtained marketing approval of EGRIFTA® in the United States, the
FDA and regulatory agencies in other countries have the ability to limit the indicated use of a
product. Also, the manufacture, marketing and sale of our products will be subject to ongoing and
extensive governmental regulation in the country in which we intend to market our products. For
example, although we obtained marketing approval of EGRIFTA® for the reduction of
excess abdominal fat in HIV-infected patients with lipodystrophy in the United States, the
marketing of EGRIFTA® will be subject to extensive regulatory requirements administered
by the FDA, such as adverse event reporting and compliance with marketing and promotional
requirements. The FDA has also requested that we comply with certain post-approval requirements in
connection with the approval of EGRIFTA® for the reduction of excess abdominal fat in
HIV-infected patients with lipodystrophy, namely, the development of a single vial formulation of
EGRIFTA® (the development of a new presentation of the same formulation), a long-term
observational safety study using EGRIFTA®; and a Phase 4 clinical trial. Although we
have received marketing approval from the FDA of tesamorelin for the reduction of excess abdominal
fat in HIV-infected patients with lipodystrophy, there can be no guarantee that regulatory agencies
in other countries will approve tesamorelin for this treatment in their respective countries.
Our third party manufacturing facilities for EGRIFTA® will also be subject to
continuous reviews and periodic inspections and approval of manufacturing modifications by
regulatory agencies, including the FDA. The facilities must comply with GMP regulations. The
failure to comply with FDA requirements can result in a series of administrative or judicial
sanctions or other setbacks, including:
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restrictions on the use of the product, manufacturers or manufacturing processes; |
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warning letters; |
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civil or criminal penalties; |
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fines; |
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injunctions; |
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product seizures or detentions; |
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import or export bans or restrictions; |
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product recalls and related publicity requirements; |
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suspension or withdrawal of regulatory approvals; |
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total or partial suspension of production; and |
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refusal to approve pending applications for marketing approval of new product candidates
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Addressing any of the foregoing or any additional requirements of the FDA or other regulatory
authorities may require significant resources and could impair our ability to successfully
commercialize our product candidates.
To date, we do not have the required regulatory approvals to commercialize
EGRIFTA® outside of the United States and cannot guarantee that we will obtain such
regulatory approvals or that any of our product candidates will be approved for commercialization
in any country, including the United States.
The commercialization of EGRIFTA® outside of the United States and our future products
first requires the approval of the regulatory agencies in each of the jurisdictions where we intend
to sell such products. In order to obtain the required approvals, we must demonstrate, following
preclinical and clinical studies, the safety, efficacy and quality of a product.
The rules and regulations relating to the approval of a new drug are complex and stringent.
Although we have received marketing approval in the United States from the FDA for
EGRIFTA®, there can be no guarantee that regulatory agencies in other territories will
approve EGRIFTA® in their respective countries.
All of our product candidates are subject to preclinical and clinical studies. If the results of
such studies are not positive, we may not be in a position to make any filing to obtain the
regulatory approval for the product candidate or, even where a product candidate has been filed for
approval, we may have to conduct additional clinical trials or testing on such product candidate in
an effort to obtain results that further support the safety and efficacy of such product candidate.
Such studies are often costly and may also delay a filing or, where additional studies or testing
are required after a filing has been made, the approval of a product candidate.
While an application for a new drug is under review by a regulatory agency, it is standard for such
regulatory agency to ask questions regarding the application that was submitted. If these questions
are not answered quickly and in a satisfactory manner, the marketing approval of the product
candidate subject to the review and its commercialization could be delayed or, if the questions are
not answered in a satisfactory manner, denied. If EGRIFTA® is not approved by the
appropriate regulatory agencies for commercialization outside of the United States, our capacity to
generate revenues in the long-term will be impaired and this will have an adverse effect on our
financial condition and our operating results.
Obtaining regulatory approval is subject to the discretion of regulatory agencies in each relevant
jurisdiction. Therefore, even if we obtain regulatory approval from one agency, or succeed in
filing the equivalent of an NDA, in other countries, or have obtained positive results relating to
the safety and efficacy of a product candidate, a regulatory agency may not accept the filing or
the results contained therein as being conclusive evidence of the safety and efficacy of a product
candidate in order to allow us to sell the product candidate in its country. A regulatory agency
may require that additional
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tests on the safety and efficacy of a product candidate be conducted prior to granting approval of
such product candidate. These additional tests may delay the approval of such product candidate,
can have a material adverse effect on our financial condition and results of operations based on
the type of additional tests to be conducted and may not necessarily lead to the approval of the
product candidate.
We have only obtained FDA approval for EGRIFTA®
and we must complete several
preclinical studies and clinical trials for our other product candidates which may not yield
positive results and, consequently, could prevent us from obtaining regulatory approval.
Obtaining FDA approval for the commercialization of drug products requires a demonstration through
preclinical studies and clinical trials that the drug is safe and effective. All of our product
candidates are at the discovery stage, except our peptide for the treatment of AKI, which is in
preclinical development. In addition, in order to market tesamorelin for other indications, we will
need to demonstrate its effectiveness and safety through additional studies and clinical trials.
Favourable results in our trials of tesamorelin for the reduction of excess abdominal fat in
HIV-infected patients with lipodystrophy may not be predictive of the efficacy and safety results
in our Phase 2 clinical trials of tesamorelin for the treatment of muscle wasting in COPD.
If any of our preclinical studies or clinical trials fail to show positive efficacy data or result
in adverse patient reactions, we may be required to perform additional preclinical studies or
clinical trials, to extend the term of our studies and trials, to increase the number of patients
enrolled in a given trial or to undertake ancillary testing. Any of these events could cause an
increase in the cost of product development, delay filing of an application for marketing approval
or result in the termination of a study or trial and, accordingly, could cause us to cease the
development of a product candidate. In addition, the future growth of our business could be
negatively impacted since there can be no guarantee that we will be able to develop new compounds,
license or purchase compounds or product candidates that will result in marketed products.
Recently enacted and future legislation may increase the difficulty and cost for us to obtain
marketing approval of and commercialize our product candidates and affect the prices we may obtain.
In the United States and some foreign jurisdictions, there have been a number of legislative and
regulatory changes and proposed changes regarding the healthcare system that could prevent or delay
marketing approval for our product candidates, restrict or regulate post-approval activities and
affect our ability to profitably sell EGRIFTA® or any of our other product candidates
for which we intend to seek marketing approval.
Legislative and regulatory proposals have been made to expand post-approval requirements and
restrict sales and promotional activities for pharmaceutical products. We are not sure whether
additional legislative changes will be enacted, or whether the FDA regulations, guidance or
interpretations will be changed, or what the impact of such changes on the marketing approvals of
our product candidates, if any, may be. In addition, increased scrutiny by the U.S. Congress of the
FDAs approval process may significantly delay or prevent marketing approval, as well as subject us
to more stringent product labeling and post-marketing testing and other requirements.
In the United States, the MMA changed the way Medicare covers and pays for pharmaceutical products.
The legislation expanded Medicare coverage for drug purchases by the elderly and introduced a new
reimbursement methodology based on average sales prices for drugs. In addition, this legislation
authorized Medicare Part D prescription drug plans to use formularies where they can limit the
number of drugs that will be covered in any therapeutic class. As a result of this legislation and
the expansion of federal coverage of drug products, we expect that there will be additional
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pressure to contain and reduce costs. These cost reduction initiatives and other provisions of this
legislation could decrease the coverage and sales price that we receive for EGRIFTA® or
any other approved products and could seriously harm our business. While the MMA applies only to
drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and
payment limitations in setting their own reimbursement rates, and any reduction in reimbursement
that results from the MMA may result in a similar reduction in payments from private payors.
More recently, in March 2010, U.S. President Obama signed into law the Health Care Reform Law, a
sweeping law intended to broaden access to health insurance, reduce or constrain the growth of
healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements
for healthcare and health insurance industries, impose new taxes and fees on the health industry
and impose additional health policy reforms. Effective October 1, 2010, the Health Care Reform Law
revised the definition of average manufacturer price for reporting purposes, which could increase
the amount of Medicaid drug rebates to states. Further, beginning in 2011, the new law imposes a
significant annual fee on companies that manufacture or import branded prescription drug products.
We will not know the full effects of the Health Care Reform Law until applicable U.S. federal and
state agencies issue regulations or guidance under the new law. Although it is too early to
determine the effect of the Health Care Reform Law, the new law appears likely to continue to apply
the pressure on pharmaceutical pricing. Pressure on pharmaceutical pricing may adversely affect the
amount of our royalties in the United States.
3.3 RISKS RELATED TO OUR INTELLECTUAL PROPERTY
Our failure to protect our intellectual property may have a material adverse effect on our
ability to develop and commercialize our products.
We will be able to protect our intellectual property rights from unauthorized use by third parties
only to the extent that our intellectual property rights are covered and protected by valid and
enforceable patents or are effectively maintained as trade secrets. We try to protect our
intellectual property position by, among other things, filing patent applications related to our
proprietary technologies, inventions and improvements that are important to the development of our
business.
Because the patent position of pharmaceutical companies involves complex legal and factual
questions, the issuance, scope, validity, and enforceability of patents cannot be predicted with
certainty. Patents, if issued, may be challenged, invalidated or circumvented. If our patents are
invalidated or found to be unenforceable, we would lose the ability to exclude others from making,
using or selling the inventions claimed. Moreover, an issued patent does not guarantee us the right
to use the patented technology or commercialize a product using that technology. Third parties may
have blocking patents that could be used to prevent us from developing our product candidates,
selling our products or commercializing our patented technology. Thus, patents that we own may not
allow us to exploit the rights conferred by our intellectual property protection.
Our pending patent applications may not be issued or granted as patents. Even if issued, they may
not be issued with claims of sufficient breadth to protect our product candidates and technologies
or may not provide us with a competitive advantage against competitors with similar products or
technologies. Furthermore, others may independently develop products or technologies similar to
those that we have developed or may reverse engineer or discover our trade secrets through proper
means. In addition, the laws of many countries do not protect intellectual property rights to the
same extent as the laws of Canada, the United States and the European Patent Convention, and those
countries may also lack adequate rules and procedures for defending intellectual property rights
effectively.
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Although we have received patents from the USPTO for the treatment of HIV-related lipodystrophy
with tesamorelin, there can be no guarantee that, in the other countries where we filed patent
applications for the treatment of HIV-related lipodystrophy, we will receive a patent or obtain
granted claims of similar breadth to those granted by the USPTO.
We also rely on trade secrets, know-how and technology, which are not protected by patents, to
maintain our competitive position. We try to protect this information by entering into
confidentiality agreements with parties who have access to such confidential information, such as
our current and prospective suppliers, distributors, manufacturers, commercial partners, employees
and consultants. Any of these parties may breach the agreements and disclose confidential
information to our competitors. It is possible that a competitor will make use of such
information, and that our competitive position could be disadvantaged.
Enforcing a claim that a third party infringes on, has illegally obtained or is using an
intellectual property right, including a trade secret or know-how, is expensive and time-consuming
and the outcome is unpredictable. In addition, enforcing such a claim could divert managements
attention from our business. If any intellectual property right were to be infringed, disclosed to
or independently developed by a competitor, our competitive position could be harmed. Any adverse
outcome of such litigation or settlement of such a dispute could subject us to significant
liabilities, could put one or more of our pending patent applications at risk of being invalidated
or interpreted narrowly, could put one or more of our patents at risk of not issuing, or could
facilitate the entry of generic products. Any such litigation could also divert our research,
technical and management personnel from their normal responsibilities.
Our ability to defend ourselves against infringement by third parties of our intellectual property
in the United States with respect to tesamorelin for the treatment of HIV-related lipodystrophy
depends, in part, on our commercial partners decision to bring an action against such third party.
Under the terms and conditions of our collaboration and licensing agreement with EMD Serono, EMD
Serono has the first right to bring an action against a third party for infringing our patent
rights with respect to tesamorelin for the treatment of HIV-related lipodystrophy. Any delay in
pursuing such action or in advising us that it does not intend to pursue the matter could decrease
sales, if any, of tesamorelin for the treatment of HIV-related lipodystrophy and adversely affect
our revenues.
Furthermore, because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our confidential information could
be compromised by disclosure during this type of litigation. For example, confidential information
may be disclosed, inadvertently or as ordered by the court, in the form of documents or testimony
in connection with discovery requests, depositions or trial testimony. This disclosure would
provide our competitors with access to our proprietary information and may harm our competitive
position.
Our commercial success depends, in part, on our ability not to infringe on third party patents
and other intellectual property rights.
Our capacity to commercialize our product candidates, and more particularly tesamorelin, will
depend, in part, upon our ability to avoid infringing third party patents and other third-party
intellectual property rights. The biopharmaceutical and pharmaceutical industries have produced a
multitude of patents and it is not always easy for participants, including us, to determine which
patents cover various types of products, processes of manufacture or methods of use. The scope and
breadth of patents is subject to interpretation by the courts and such interpretation may vary
depending on the jurisdiction where the claim is filed and the court where such claim is litigated.
The fact that we own patents for tesamorelin and for the treatment of HIV-related lipodystrophy
does not guarantee that we are not infringing one or more third-party patents and there can be no
guarantee that we will not infringe or
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violate third-party patents and other third-party intellectual property rights in the United States
or other jurisdictions.
Patent analysis for non-infringement is based in part on a review of publicly available databases.
Although we review from time to time certain databases to conduct patent searches, we do not have
access to all databases. It is also possible that we will not have reviewed some of the information
contained in the databases or we found it to be irrelevant at the time we conducted the searches.
In addition, because patents take years to issue, there may be currently pending applications that
have not yet been published or that we are unaware of, which may issue later as patents. As a
result, there can be no guarantee that we will not violate third-party patents.
Because of the difficulty in analyzing and interpreting patents, there can be no guarantee that a
third party will not assert that we infringe such third-partys patents or any of its other
intellectual property rights. Under such circumstances, there is no guarantee that we would not
become involved in litigation. Litigation with any third party, even if the allegations are without
merit, is expensive, time-consuming and would divert managements attention from the daily
execution of our business plan. Litigation implies that a portion of our financial assets would be
used to sustain the costs of litigation instead of being allocated to further the development of
our business.
If we are involved in patent infringement litigation, we would need to prevail in demonstrating
that our products do not infringe the asserted patent claims of the relevant patent, that the
patent claims are invalid or that the patent is unenforceable. If we are found to infringe a
third-party patent or other intellectual property right, we could be required to enter into royalty
or licensing agreements on terms and conditions that may not be favourable to us, and/or pay
damages, including up to treble damages in the United Sates (for example, if found liable of wilful
infringement) and/or cease the development and commercialization of our product candidates. Even if
we were able to obtain a license, the rights may be nonexclusive, which could result in our
competitors gaining access to the same intellectual property and to compete with us.
We have not been served with any notice alleging that we infringe a third-party patent, but there
may be issued patents that we are unaware of that our products may infringe, or patents that we
believe we do not infringe but ultimately could be found to infringe. We are aware of third-party
patents for the reduction of accumulation of fat tissue in HIV patients and, if a patent
infringement suit was brought against us, we believe that we should not be found to infringe any
valid claims of these patents. If we were to challenge the validity of a competitors issued United
States patent in a United States court, we would need to overcome a statutory presumption of
validity that attaches to every United States patent. This means that, in order to prevail, we
would have to present clear and convincing evidence as to the invalidity of the patents claims. We
cannot guarantee that a court would find in our favour on questions of infringement and validity.
Any finding that we infringe or violate a third-party patent or other intellectual property right
could materially adversely affect our business, financial condition and operating results.
3.4 OTHER RISKS RELATED TO OUR BUSINESS
We have a history of net losses and we may never achieve high profitability.
We have been reporting losses since our inception (except for the financial years ended November
30, 2010, 2001 and 2000) and, as at November 30, 2010, we had an accumulated deficit of
$235,116,000. We do not expect to generate significant recurrent revenues sufficient to cover our
overall activities in the immediate future. As a result of the foregoing, we will need to generate
significant revenues to achieve profitability.
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Our profitability will depend on, among other things, our commercial partners ability and
willingness to successfully commercialize EGRIFTA® and to obtain regulatory approval
for the use of tesamorelin in the reduction of excess abdominal fat in HIV-infected patients with
lipodystrophy in Europe, Latin America, Africa and the Middle East. However, there is no guarantee
that our commercial partners will succeed in commercializing EGRIFTA® or that our
product candidates will ever receive approval for commercialization in any jurisdiction and,
accordingly, we may never sustain profitability.
We rely on third-party service providers to conduct our preclinical studies and clinical
trials and the failure by any of these third parties to comply with their obligations may delay the
studies which could have an adverse effect on our development programs.
We have limited human resources to conduct preclinical studies and clinical trials and must rely on
third-party service providers to conduct our studies and trials and carry out certain data
gathering and analyses. If our third-party service providers become unavailable for any reason,
including as a result of the failure to comply with the rules and regulations governing the conduct
of preclinical studies and clinical trials, operational failures such as equipment failures or
unplanned facility shutdowns, or damage from any event such as fire, flood, earthquake, business
restructuring or insolvency or, if they fail to perform their contractual obligations pursuant to
the terms of our agreements with them, such as failing to perform the testing, compute the data or
complete the reports further to the testing, we may incur delays which may be significant in
connection with the planned timing of our trials and studies which could adversely affect the
timing of the development program of a product candidate or the filing of an application for
marketing approval in a jurisdiction where we rely on third-party service providers to make such
filing. In addition, where we rely on such third-party service provider to help in answering any
question raised by a regulatory agency during its review of one of our files, the unavailability of
such third-party service provider may adversely affect the timing of the review of an application
and, could ultimately delay the approval. If the damages to any of our third-party service
providers are material, or, for any reason, such providers do not operate in compliance with GLP or
are unable or refuse to perform their contractual obligations, we would need to find alternative
third-party service providers.
If we needed to change or select new third-party service providers, the planned working schedule
related to preclinical studies and/or clinical trials could be delayed since the number of
competent and reliable third-party service providers of preclinical and clinical work in compliance
with GLP is limited. In addition, if we needed to change or select new third-party service
providers to carry out work in response to a regulatory agency review of one of our applications,
there may be delays in responding to such regulatory agency which, in turn, may lead to delays in
commercializing a product candidate.
Any selection of new third-party service providers to carry out work related to preclinical studies
and clinical trials would be time-consuming and would result in additional delays in receiving
data, analysis and reports from such third-party service providers which, in turn, would delay the
filing of any new drug application with regulatory agencies for the purposes of obtaining
regulatory approval to commercialize our product candidates. Furthermore, such delays could
increase our expenditures to develop a product candidate and materially adversely affect our
financial condition and operating results.
The conduct of clinical trials requires the enrolment of patients and difficulties in
enrolling patients could delay the conduct of our clinical trials or result in their
non-completion.
The conduct of clinical trials requires the enrolment of patients. We may have difficulties
enrolling patients for the conduct of our future clinical trials as a result of design protocol,
the size of the patient population, the eligibility criteria to participate in the clinical trials,
the availability of competing therapies, the patient referral practices of physicians and the
availability of clinical trial sites. Difficulty
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in enrolling patients for our clinical trials could result in the cancellation of clinical trials
or delays in completing them. Once patients are enrolled in a clinical trial, the occurrence of any
adverse drug effects or side effects observed during the trial could result in the clinical trial
being cancelled. Any of these events would have material adverse consequences on the timely
development of our product candidates, the filing of an NDA, or its equivalent, with regulatory
agencies and the commercialization of such product candidates.
We may require additional funding and may not be able to raise the capital necessary to fund
all or part of our capital requirements, including to continue and complete the research and
development of our product candidates and their commercialization.
We do not generate significant recurrent revenues and may need financing in order to fund all or
part of our capital requirements to sustain our growth, to continue research and development of new
product candidates, to conduct clinical programs, to develop our marketing and commercial
capabilities and to meet our compliance obligations with various rules and regulations to which we
are subject. In the past, we have been financed through public equity offerings in Canada and
private placements of our equity securities and we may need to seek additional equity offerings to
raise capital, the size of which cannot be predicted. However, the market conditions or our
business performance may prevent us from having access to the public market in the future at the
times or in the amounts necessary. Therefore, there can be no guarantee that we will be able to
continue to raise additional equity capital by way of public or private equity offerings in the
future. In such a case, we would have to use other means of financing, such as issuing debt
instruments or entering into private financing or credit agreements, the terms and conditions of
which may not be favourable to us. If adequate funding is not available to us, we may be required
to delay, reduce, or eliminate our research and development of new product candidates, our clinical
trials or our marketing and commercialization efforts to launch and distribute new products,
curtail significant portions of our product development programs that are designed to identify new
product candidates and sell or assign rights to our technologies, products or product candidates.
In addition, the issuance and sale of substantial amounts of equity, or other securities, or the
perception that such issuances and sales may occur could adversely affect the market price of our
common shares.
If product liability lawsuits are brought against us, they could result in costly and
time-consuming litigation and significant liabilities.
Despite all reasonable efforts to ensure the safety of EGRIFTA® and our other product
candidates, it is possible that we or our commercial partners will sell products which are
defective, to which patients react in an unexpected manner, or which are alleged to have side
effects. The manufacture and sale of such products may expose us to potential liability, and the
industries in which our products are likely to be sold have been subject to significant product
liability litigation. Any claims, with or without merit, could result in costly litigation, reduced
sales, significant liabilities and diversion of our managements time and attention and could have
a material adverse effect on our financial condition, business and results of operations.
If a product liability claim is brought against us, we may be required to pay legal and other
expenses to defend the claim and, if the claim is successful, damage awards may be substantial
and/or may not be covered, in whole or in part, by our insurance. We may not have sufficient
capital resources to pay a judgment, in which case our creditors could levy against our assets. We
may also be obligated to indemnify our commercial partners and make payments to other parties with
respect to product liability damages and claims. Defending any product liability claims, or
indemnifying others against those claims, could require us to expend significant financial and
managerial resources.
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The development and commercialization of our drugs could expose us to liability claims which
could exceed our insurance coverage.
A risk of product liability claims is inherent in the development and commercialization of human
therapeutic products. Product liability insurance is very expensive and offers limited protection.
A product liability claim against us could potentially be greater than the available coverage and,
therefore, have a material adverse effect upon us and our financial condition. Furthermore, a
product liability claim could tarnish our reputation, whether or not such claims are covered by
insurance or are with or without merit.
We depend on our key personnel to research, develop and bring new products to the market and
the loss of key personnel or the inability to attract highly qualified individuals could have a
material adverse effect on our business and growth potential.
The operation of our business requires qualified scientific and management personnel. The loss of
scientific personnel or members of management could have a material adverse effect on our business.
In addition, our growth is and will continue to be dependent, in part, on our ability to hire and
retain the employment of qualified personnel. There can be no guarantee that we will be able to
continue to retain our current employees or will be able to attract qualified personnel to achieve
our business plan.
We may be unable to identify and complete in-licensing or acquisitions. In-licensing or
acquisitions could divert managements attention and financial resources, may negatively affect our
operating results and could cause significant dilution to our shareholders.
In the future, we may engage in selective in-licensing or acquisitions of products or businesses
that we believe are complementary to our products or business. There is a risk that we will not be
able to identify suitable in-licensing or acquisition candidates available for sale at reasonable
prices, complete any in-licensing or acquisition, or successfully integrate any in-licensed or
acquired product or business into our operations. We are likely to face competition for
in-licensing or acquisition candidates from other parties including those that have substantially
greater available resources. In-licensing or acquisitions may involve a number of other risks,
including:
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failure to retain key acquired personnel; |
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difficulties in integrating acquired operations, technologies, products or personnel; |
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inappropriate valuation of the acquired in-process research and development, or the
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difficulties in maintaining customer relations. |
If we do not successfully address these risks or any other problems encountered in connection with
an acquisition, the acquisition could have a material adverse effect on our business, results of
operations and financial condition. Inherited liabilities of or other issues with an acquired
business
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could have a material adverse effect on our performance or our business as a whole. In addition, if
we proceed with an acquisition, our available cash may be used to complete the transaction,
diminishing our liquidity and capital resources, or shares may be issued which could cause
significant dilution to our existing shareholders.
We may not achieve our publicly announced milestones on time.
From time to time, we publicly announce the timing of certain events to occur. These statements are
forward-looking and are based on the best estimate of management at the time relating to the
occurrence of such events. However, the actual timing of such events may differ from what has been
publicly disclosed. Events such as completion of a clinical program, discovery of a new product
candidate, filing of an application to obtain regulatory approval, beginning of commercialization
of our products or announcement of additional clinical programs for a product candidate may vary
from what is publicly disclosed. These variations may occur as a result of a series of events,
including the nature of the results obtained during a clinical trial or during a research phase,
problems with a supplier or a commercial partner or any other event having the effect of delaying
the publicly announced timeline. We undertake no obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise, except as otherwise
required by law. Any variation in the timing of certain events having the effect of postponing such
events could have an adverse material effect on our business plan, financial condition or operating
results.
The outcome of scientific research is uncertain and our failure to discover new compounds
could slow down the growth of our portfolio of products.
We conduct research activities in order to increase our portfolio of product candidates. The
outcome of scientific research is uncertain and may prove unsuccessful and, therefore, may not lead
to the discovery of new molecules and progression of existing compounds to an advanced development
stage. Our inability to develop new compounds or to further develop the existing ones could slow
down the growth of our portfolio of products.
3.5 RISKS RELATED TO OUR COMMON SHARES
Our share price has been volatile, and an investment in our common shares could suffer a
decline in value.
Since our initial public offering in Canada, our valuation and share price have had no meaningful
relationship to current or historical financial results, asset values, book value or many other
criteria based on conventional measures of the value of common shares. The market price of our
common shares will fluctuate due to various factors including the risk factors described herein and
other circumstances beyond our control.
In the past, when the market price of a stock has been volatile, shareholders have often instituted
securities class action litigation against that company. If any of our shareholders brought a
lawsuit against us, we could incur substantial costs defending the lawsuit. The lawsuit could also
divert the time and attention of our management.
Our quarterly operating results may fluctuate significantly.
We expect our operating results to be subject to quarterly fluctuations. Our net loss and other
operating results will be affected by numerous factors, including:
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|
variations in the level of expenses related to our development programs; |
|
|
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|
addition or termination of clinical trials; |
|
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|
any intellectual property infringement lawsuit in which we may become involved; |
|
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|
regulatory developments affecting our product candidates; |
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|
our execution of any collaborative, licensing or similar arrangements, and the timing of
payments we may make or receive under these arrangements; and |
|
|
|
|
the achievement and timing of milestone payments under our existing strategic
partnership agreements. |
If our quarterly operating results fall below the expectations of investors or securities analysts,
the price of our common shares could decline substantially. Furthermore, any quarterly fluctuations
in our operating results may, in turn, cause the price of our stock to fluctuate substantially.
We do not intend to pay dividends on our common shares and, consequently, your ability to
achieve a return on your investment will depend on appreciation in the price of our common shares.
We have never declared or paid any cash dividend on our common shares and do not currently intend
to do so for the foreseeable future. We currently anticipate that we will retain future earnings
for the development, operation and expansion of our business and do not anticipate declaring or
paying any cash dividends for the foreseeable future. Therefore, the success of an investment in
our common shares will depend upon any future appreciation in their value. There is no guarantee
that our common shares will appreciate in value or even maintain the price at which our
shareholders have purchased their shares. See Dividend Policy.
Our revenues and expenses may fluctuate significantly and any failure to meet financial
expectations may disappoint securities analysts or investors and result in a decline in the price
of our common shares.
Our revenues and expenses have fluctuated in the past and are likely to do so in the future. These
fluctuations could cause our share price to decline. Some of the factors that could cause revenues
and expenses to fluctuate include the following:
|
|
|
the inability to complete product development in a timely manner that results in a
failure or delay in receiving the required regulatory approvals or allowances to
commercialize product candidates; |
|
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|
the timing of regulatory submissions and approvals; |
|
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|
the timing and willingness of any current or future collaborators to invest the
resources necessary to commercialize the product candidates; |
|
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|
the outcome of any litigation; changes in foreign currency fluctuations; |
|
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|
the timing of achievement and the receipt of milestone payments from current or future
third parties; |
- 51 -
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failure to enter into new or the expiration or termination of current agreements with
third parties; and |
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|
|
failure to introduce the product candidates to the market in a manner that generates
anticipated revenues. |
We may be adversely affected by currency fluctuations.
A substantial portion of our revenue is earned in U.S. dollars, but a substantial portion of our
operating expenses are incurred in Canadian dollars. Fluctuations in the exchange rate between the
U.S. dollar and other currencies, such as the Canadian dollar, may have a material adverse effect
on our business, financial condition and operating results. We do not currently engage in
transactional hedging schemes but we do attempt to hedge or mitigate the risk of currency
fluctuations by actively monitoring and managing our foreign currency holdings relative to our
foreign currency expenses.
Our shareholder rights plan and certain Canadian laws could delay or deter a change of
control.
Our shareholder rights plan entitles a rights holder, other than a person or group holding 20% or
more of our common shares, to subscribe for our common shares at a discount of 50% to the market
price at that time, subject to certain exceptions. See Material Contracts-Shareholder Rights Plan
Agreement.
The Investment Canada Act (Canada) subjects an acquisition of control of a company by a
non-Canadian to government review if the value of the assets as calculated pursuant to the
legislation exceeds a threshold amount. A reviewable acquisition may not proceed unless the
relevant minister is satisfied that the investment is likely to be a net benefit to Canada.
Any of the foregoing could prevent or delay a change of control and may deprive or limit strategic
opportunities for our shareholders to sell their shares.
- 52 -
ITEM 4 DIRECTORS AND EXECUTIVE OFFICERS
4.1 DIRECTORS
The following table lists the names of our directors, their province or state and country of
residence, their principal occupation, their position or office held (if any), the year in which
each of them first became a director and the number of common shares and deferred share units each
of them beneficially owned, directly or indirectly, or over which they exercised control or
direction as of February 21, 2011. Each elected director remains in office until the next annual
meeting of shareholders, unless he resigns or his position becomes vacant following his death,
destitution or for any other reason before the next annual meeting of shareholders.
- 53 -
DIRECTORS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
Number of |
Name and Place of |
|
Principal |
|
Director |
|
Common |
|
Deferred |
Residence |
|
Occupation |
|
Since |
|
Shares |
|
Share Units |
Paul Pommier(1) (2) (3) (4) (5) Québec, Canada |
|
Chairman of the Board |
|
|
1997 |
|
|
|
190,100 |
|
|
|
20,998 |
|
|
John-Michel T. Huss(4) Québec, Canada |
|
President and Chief
Executive Officer of the Company |
|
|
2010 |
|
|
|
|
|
|
|
44,248 |
|
|
Gilles Cloutier(3) (5) North Carolina,United States |
|
Corporate Director |
|
|
2003 |
|
|
|
71,000 |
|
|
|
3,000 |
|
|
A. Jean de Grandpré(2) (3) (4) (5) Québec, Canada |
|
Corporate Director |
|
|
1993 |
|
|
|
200,000 |
|
|
|
5,250 |
|
|
Robert G. Goyer(3) Québec, Canada |
|
Emeritus Professor Faculty of Pharmacy Université de Montreal |
|
|
2005 |
|
|
|
10,000 |
|
|
|
5,250 |
|
|
Gérald A. Lacoste(1) (3) (5) Québec, Canada |
|
Corporate Director |
|
|
2006 |
|
|
|
11,000 |
|
|
|
5,250 |
|
|
Bernard Reculeau(2) Paris, France |
|
Corporate Director |
|
|
2005 |
|
|
|
18,100 |
|
|
|
3,000 |
|
|
Jean-Denis Talon(1) (2) (4) Québec, Canada |
|
Chairman of the Board AXA Canada (Insurance Company) |
|
|
2001 |
|
|
|
60,000 |
|
|
|
3,000 |
|
|
Luc Tanguay(4) Québec, Canada |
|
Senior Executive Vice President and Chief Financial Officer of the Company |
|
|
1993 |
|
|
|
83,000 |
|
|
|
27,572 |
|
|
|
|
(1) |
|
Member of the Audit Committee |
|
(2) |
|
Member of the Compensation Committee |
|
(3) |
|
Member of the Nominating and Corporate Governance Committee |
|
(4) |
|
Member of the Finance Committee |
|
(5) |
|
Member of the Strategic Review Committee |
- 54 -
|
|
|
|
|
Biographical Notes of the Directors |
Paul Pommier, MBA. Chairman of the Board. Mr. Paul Pommier worked for more than 25 years at
National Bank Financial Inc., his last position being Senior Executive Vice President, Corporate
and Government Finance. Throughout his career, he oversaw public and private financings, mergers
and acquisitions, as well as the marketing of investment offerings. Under his leadership, National
Bank Financial Inc. developed notable expertise in tax-shelter financings.
John-Michel T. Huss, MBA. President & Chief Executive Officer. John-Michel T. Huss brings more than
20 years of global experience in the pharmaceutical industry to Theratechnologies. He began his
career at Merck & Co., occupying various sales and marketing positions in the United States and in
Europe. In 1996, he accepted an International Product Manager position at the headquarters of F.
Hoffman-La Roche, in Basel, Switzerland. Mr. Huss joined Sanofi-Synthelabo GmbH in 1999, where he
held positions in Germany and in Canada. He was appointed General Manager of the Swiss subsidiary
at Sanofi in 2007 (Sanofi-Synthelabo merged with Aventis in 2004), and in 2009 was promoted to the
position of Chief of Staff, Office of the CEO, in Paris.
Gilles Cloutier, Ph.D. Corporate Director. Dr. Gilles Cloutier has over 30 years of experience in
the pharmaceutical industry including five years with contract research organizations, providing
strategic support to biotechnology and pharmaceutical companies. Dr. Cloutier has also held key
positions with large North-American pharmaceutical companies, where he developed expertise in the
field of clinical research. His experience includes the development and approval of several drugs
in Canada, the United States and Europe. Dr. Cloutier sits on our board of directors and is also
Chairman of the Fondation André Delambre for amyotrophic lateral sclerosis (ALS).
A. Jean de Grandpré, C.C., Q.C. Corporate Director. A. Jean de Grandpré contributed to Bell
Canadas significant growth as Chairman of the Board and Chief Executive Officer, and went on to
become the founding Chairman of the Board and Chief Executive Officer of BCE. In recognition of
these achievements, he was inducted into the Canadian Business Hall of Fame. Mr. de Grandpré also
served on the boards of directors of other important Canadian and US corporations, namely Northern
Telecom Limited, Chrysler Corporation, Sun Life Financial Inc. and Toronto Dominion Bank, and as a
member of the international advisory boards of Chemical Bank and Goldman Sachs. He has been a
member of our board of directors since our founding in October 1993 and was appointed Chairman in
1996. He resigned his position as Chairman in March 2007.
Robert G. Goyer, Ph.D. Emeritus professor, Faculty of Pharmacy of the Université de Montréal. Dr.
Goyer has more than 40 years of experience in the pharmaceutical field. Dr. Goyer is the former
President of Jouveinal Canada and is also a former dean of the Faculty of Pharmacy of Université de
Montréal. Recognized for his broad expertise in drug development, he has served on the boards of
several companies and governmental organizations. He was notably Chairman of the Advisory Committee
on drug approval procedures of Health Canadas Therapeutic Products Directorate and a member of the
board of directors of the Régie de lassurance maladie du Québec. He was Chairman of the Conseil du
médicament du Québec from 2003 to 2005.
Gérald A. Lacoste, Q.C. Corporate Director. Gérald A. Lacoste is a lawyer with extensive experience
in the fields of securities regulation, financing and corporate governance. He was previously
Chairman of the Québec Securities Commission (now known as the Autorité des marchés financiers) and
was also President and CEO of the Montreal Stock Exchange. During his career, Mr. Lacoste acted as
legal counsel to the Canadian Standing Senate Committee on Banking, Trade and Commerce, he chaired
the Québec Advisory Committee on Financial Institutions, and was a member of the task force on the
capitalization of life insurance companies in Québec. Mr. Lacoste is currently a corporate
director, actively involved in the biotechnology industry, and is a member of the North American
Free Trade Agreement (NAFTA) arbitration panel.
- 55 -
Bernard Reculeau. Corporate Director. Mr. Bernard Reculeau brings over 25 years of pharmaceutical
industry experience to Theratechnologies. From September 2006 to December 2009, he was the
President of CIS Bio International, a French company specializing in nuclear medicine and
biomedical technologies. Prior to joining CIS Bio International, Mr. Reculeau was Senior Vice
President Pharmaceutical Operations of Sanofi for the InterContinental Region. In his previous
functions, he was responsible for product development and commercialization in numerous countries
around the world. Mr. Reculeau has close to 25 years in pharmaceutical operations, notably in
France where he ran the pharmaceutical operations for Rhône-Poulenc and Rhône-Poulenc Rorer as well
as in other countries in the European Union. Mr. Reculeau retired in early 2010.
Jean-Denis Talon. Chairman of the Board, AXA Canada. Mr. Jean-Denis Talon had a successful career
with AXA Insurance over a period of more than 20 years, ultimately becoming President and Chief
Executive Officer. He is currently Chairman of the Board of AXA Canada. Mr. Talon is also former
President of the Financial Affairs Committee at the Insurance Bureau of Canada.
Luc Tanguay, M.Sc., CFA. Senior Executive Vice President and Chief Financial Officer of the
Company. Mr. Luc Tanguay has been active in the biotechnology industry for over 15 years. As a
member of our senior management since 1996, he has contributed to our growth by facilitating access
to public and private capital funding. A member of the board of directors since 1993, he has held
various management positions since joining the Company. Prior to joining us, Mr. Tanguay had a
career in investment banking at National Bank Financial Inc.
4.2 AUDIT COMMITTEE
Our board of directors has established an Audit Committee to review our annual financial statements
prior to their approval by the board of directors and also to perform other duties, as is described
in the Audit Committees charter adopted by the board of directors and attached hereto as Appendix
A.
As of November 30, 2010, the Audit Committee was composed of three members: Paul Pommier, its
Chair, Jean-Denis Talon and Gérald A. Lacoste. All three are independent and financially literate.
The details mentioned hereunder describe the education and experience of the Audit Committee
members that is relevant to the performance of their responsibilities, in particular any experience
in preparing, auditing, analyzing and evaluating financial statements.
Paul Pommier. Mr. Pommier holds an MBA degree and has more than 25 years of experience in the
financial field, notably in public and private company financings, as well as in merger and
acquisition activities. While acting as a director of Royal Aviation Inc., he was also a member of
its audit committee.
Jean-Denis Talon. Mr. Talon has more than 20 years of experience in the insurance field as a senior
officer. Mr. Talon acted as a member of the audit committee of AXA Canada from March 1995 to April
2008. He has been a member of the audit committee of InnovAssur since March 1999 and since November
1999, he has been acting as Chairman of its audit committee.
Gérald A. Lacoste. Mr. Lacoste has more than 30 years of experience in the fields of securities
regulation, corporate finance and corporate governance. Mr. Lacoste was president of the audit
committee of Amisco Ltd. from 2002 to 2009 and was also a member of the audit committee of Andromed
Inc. from 2004 to 2007. Mr. Lacoste has been a member of the audit committee of Génome Québec from
2006 to 2009.
Each member of the Audit Committee has acquired in-depth financial expertise giving each the
ability to read and understand a set of financial statements which presents the breadth and level
of
- 56 -
complexity of accounting issues that are generally comparable to those that can reasonably be
expected to be raised in the issuers financial statements.
External Auditors Service Fees
|
|
|
|
|
|
|
|
|
|
|
Financial Year Ended |
|
Financial Year Ended |
|
|
November 30, 2010 |
|
November 30, 2009 |
Audit Fees |
|
$ |
122,000 |
|
|
$ |
80,000 |
|
Audit-Related Fees (1) |
|
$ |
158,025 |
|
|
$ |
17,500 |
|
Tax Fees (2) |
|
$ |
56,600 |
|
|
$ |
39,626 |
|
All Other Fees |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Audit-related fees relate principally to services rendered in connection with
our annual financial statements and, for the financial year ended November 30, 2010, audit
fees paid to KPMG also included fees related to services rendered in connection with the audit
of IFRS adjustments and the translation of the financial statements to IFRS standards. |
|
(2) |
|
Tax fees relate to services rendered in connection with the preparation of corporate
tax returns and general tax advice. |
4.3 EXECUTIVE OFFICERS
The following table lists the names of all executive officers, their province or state and country
of residence, their office and the number of common shares and deferred share units beneficially
owned, directly or indirectly, by each of them or over which they exercised control or direction as
at February 21, 2011.
- 57 -
EXECUTIVE OFFICERS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Common Shares |
|
|
|
|
|
|
of the Company |
|
|
|
|
|
|
over which |
|
|
|
|
|
|
Control or |
|
Number of |
Name and Place of |
|
|
|
Direction is |
|
Deferred |
Residence |
|
Office |
|
Exercised |
|
Share Units |
Paul Pommier Québec, Canada |
|
Chairman of the Board |
|
|
190,100 |
|
|
|
20,998 |
|
|
John-Michel T. Huss Québec, Canada |
|
President and Chief Executive Officer |
|
|
|
|
|
|
44,248 |
|
|
Luc Tanguay Québec, Canada |
|
Senior Executive Vice President and Chief Financial Officer |
|
|
83,000 |
|
|
|
27,572 |
|
|
Marie-Noël Colussi Québec, Canada |
|
Vice President, Finance |
|
|
10,075 |
|
|
|
3,182 |
|
|
Chantal Desrochers Québec, Canada |
|
Vice President, Business Development and Commercialization |
|
|
16,300 |
|
|
|
|
|
|
Andrea Gilpin Québec, Canada |
|
Vice President, Investor Relations and Communications |
|
|
6,000 |
|
|
|
2,005 |
|
|
Jocelyn Lafond Québec, Canada |
|
Vice President, Legal Affairs, and Corporate Secretary |
|
|
|
|
|
|
5,000 |
|
|
Christian Marsolais Québec, Canada |
|
Vice President, Clinical Research and Medical Affairs |
|
|
8,597 |
|
|
|
6,312 |
|
|
Martine Ortega Québec, Canada |
|
Vice President, Compliance and Regulatory Affairs |
|
|
3,000 |
|
|
|
7,532 |
|
|
Pierre Perazzelli Québec, Canada |
|
Vice President, Pharmaceutical Development |
|
|
1,800 |
|
|
|
4,061 |
|
|
Krishna Peri Québec, Canada |
|
Vice President, Research |
|
|
35,000 |
|
|
|
|
|
Biographical Notes of the Executive Officers
For the biographical notes of Paul Pommier, John-Michel T. Huss and Luc Tanguay, please refer to
ITEM 4 of this AIF.
Marie-Noël Colussi, CA. Vice President, Finance. Ms. Marie-Noël Colussi is a graduate of Université
du Québec à Montréal in business administration. Prior to joining us, Ms. Colussi worked for eight
years with KPMG, a major accounting firm. Ms. Colussi has experience in accounting, auditing,
control and taxation, particularly in research and development. She joined us in March 1997, and
prior to her appointment as Vice President, Finance in February 2002, she held the positions of
Director, Accounting and Internal Control and Controller.
Chantal Desrochers, B.Ph., MBA. Vice President, Business Development and Commercialization. Ms.
Chantal Desrochers obtained her degrees in pharmacy and business from the Université de Montréal.
She began her career at Schering-Plough in sales and ultimately became a Product Director. After
obtaining her M.B.A., Ms. Desrochers joined Bristol-Myers Squibb Company in Canada as Marketing
Director, Pharmaceuticals and became Vice President, Institutional Business in 1995. In 1997, Ms.
Desrochers was promoted to European Franchise Marketing Director, Cardiovascular, in
- 58 -
France where she contributed to the commercial development of cardiovascular products. This led to
her appointment as International Marketing Director, Cardiovascular, at Bristol-Myers Squibb in
Princeton, New Jersey. Prior to joining us in 2005, Ms. Desrochers offered consulting services in
business development and product development strategies.
Andrea Gilpin, Ph.D., MBA. Vice President, Investor Relations and Communications. Prior to joining
us in 2007, Dr. Gilpin was Director, Investor Relations at MethylGene Inc. and held various
positions at biotechnology companies. Dr Gilpin has a Ph.D. (Genetics/Biochemistry) from the
University of Toronto and an MBA from the Asper School of Business.
Jocelyn Lafond, LL.B., LL.M. Vice President, Legal Affairs, and Corporate Secretary. Mr. Lafond has
over 15 years of experience in the fields of corporate and securities law. Mr. Lafond holds a law
degree from Université Laval and a Masters Degree in Law from the University of Toronto. He has
been a member of the Barreau du Québec since 1992. Prior to joining us in 2007, Mr. Lafond was a
partner with the international law firm of Fasken Martineau DuMoulin LLP.
Christian Marsolais, Ph.D. Vice President, Clinical Research and Medical Affairs. Dr. Christian
Marsolais has over 15 years of experience in clinical research for large pharmaceutical companies,
such as Sandoz Canada Inc. and BioChem Therapeutics Inc. Before joining us in 2007, Dr. Marsolais
held various positions at Pfizer Global Pharmaceuticals, where he was appointed Director of Medical
Affairs, Therapeutic Areas, in 2004. In this position, Dr. Marsolais was responsible for the
clinical program and scientific initiatives development, as well as the integration of the
Scientific Affairs and Clinical Research for the oncology and HIV Franchise. Dr. Marsolais holds a
Ph.D. in Biochemistry from the Université de Montréal.
Martine Ortega, Pharm. D. Vice President, Compliance and Regulatory Affairs. Ms. Martine Ortega
joined us in 2006. A graduate in pharmacy from the Université dAix-Marseille II, she holds a
postdoctoral degree in dermatology. Ms. Ortega has close to 20 years of experience in the
pharmaceutical industry, where she has gained knowledge of the drug development process. During her
career, she has acquired broad expertise in GLP, GCP and GMP practices and procedures as well as in
computerized systems validation. She is also experienced in relations with US, European and
Canadian regulatory agencies. Prior to joining us, she held senior management positions at Ventana
Clinical Research Corporation, MDS Pharma Services and Sandoz Canada Inc.
Pierre Perazzelli, B. Sc. Vice President, Pharmaceutical Development. A graduate of Université
Laval, Mr. Perazzelli has been working in the pharmaceutical manufacturing industry for over 20
years. Throughout his career, he has held various positions in large pharmaceutical companies,
including Bristol Myers Squibb and Abbott Laboratories, Ltd. He was Director of the LAB Laboratory,
a research centre specializing in pharmaceutical formulation. He is also experienced in the
production of generic drugs. Mr. Perazzelli joined us in May 2000.
Krishna Peri, Ph.D. Vice President, Research. Co-inventor of the ExoPep technology and a founder
of Pharma-G, Dr. Krishna Peri holds a Ph.D. in biochemistry from the University of Saskatchewan,
Canada. He pursued post-doctoral research in cancer as an NCI fellow at McGill University and at
Ste. Justine Hospital Research Center. After our acquisition of Pharma-G in 2000, he served as
director of discovery research, and was subsequently appointed Vice-President, Research, in June
2004.
- 59 -
4.4 DECLARATION OF THE DIRECTORS AND OFFICERS ANTECEDENTS
Except as described below, to our knowledge, no director or executive officer (a) is, as at the
date of this Annual Information Form, or has been within the ten years before the date of this
Annual Information Form, a director or executive officer of any company (including us) that, while
that person was acting in that capacity, (i) was the subject of a cease trade or similar order or
an order that denied the relevant company access to any exemption under securities legislation, for
a period of more than thirty consecutive days; (ii) was subject to an event that resulted, after
the director or executive officer ceased to be a director or executive officer, in the company
being the subject of a cease trade or similar order or an order that denied the relevant company
access to any exemption under securities legislation, for a period of more than thirty consecutive
days; or (iii) within a year of that person ceasing to act in that capacity, became bankrupt, made
a proposal under any legislation relating to bankruptcy or insolvency or was subject to or
instituted any proceedings, arrangement or compromise with creditors or had a receiver, receiver
manager or trustee appointed to hold its assets; or (b) has, within the ten years before the date
of this Annual Information Form, become bankrupt, made a proposal under any legislation relating to
bankruptcy or insolvency, or become subject to or instituted any proceedings, arrangement or
compromise with creditors, or had a receiver, receiver manager or trustee appointed to hold his
assets.
Paul Pommier was a member of the board of directors of Royal Aviation Inc. from September 1996
until it was acquired by Canada 3000 Inc. in March 2001. Subsequently, at the end of 2001, Canada
3000 Inc. and its subsidiaries, including Royal Aviation Inc., made assignments in bankruptcy under
Item 49 of the Bankruptcy and Insolvency Act (R.S. 1985, c. B-3), or Bankruptcy Act.
Jean-Denis Talon was a member of the board of directors of Toptent Inc., or Toptent, from August 1,
2007 to November 26, 2009. On December 3, 2009, Toptent filed a notice of intention to make a
proposal under the Bankruptcy Act. Subsequently, on May 7, 2010, Toptent filed a proposal under the
Bankruptcy Act. The proposal was accepted by Toptents creditors on May 20, 2010.
Luc Tanguay was a member of the board of directors of Ambrilia Biopharma Inc., or Ambrilia, from
August 22, 2006 to March 30, 2010. On July 31, 2009, Ambrilia obtained court protection from its
creditors under the Companies Creditors Arrangement Act (Canada). The purpose of the order issued
by the court granting Ambrilia protection from its creditors was to provide Ambrilia and its
subsidiaries the opportunity to restructure its affairs. On July 31, 2009, the TSX halted the
trading of Ambrilias shares pending its review of Ambrilias meeting the requirements for
continuous listing. On January 31, 2011, TSX determined to delist the common shares of Ambrilia at
the close of market on March 4, 2011 for failure to meet the continued listing requirements of TSX.
The common shares will remain suspended from trading.
4.5 SECURITIES HELD BY THE DIRECTORS AND EXECUTIVE OFFICERS
As at February 21, 2011, the total number of common shares (the only securities carrying a voting
right) held by our directors and executive officers amounted to 723,972, which represented 1.20% of
our outstanding common shares.
- 60 -
ITEM 5 INTERESTS OF EXPERTS
KPMG LLP, our auditors, is the only person or company who is named as having prepared or certified
a statement, report or evaluation, included or mentioned in a filing under securities regulations
during our most recently completed financial year.
KPMG LLP and its partners are independent in accordance with the auditors rules of professional
conduct in the jurisdiction of Québec.
- 61 -
ITEM 6 SECURITIES OF THE COMPANY
6.1 AUTHORIZED SHARE CAPITAL
We are authorized to issue an unlimited number of common shares and an unlimited number of
preferred shares issuable in series.
Subject to the priority rights of holders of preferred shares, holders of common shares are
entitled to any dividend declared by the board of directors, to one vote per share at meetings of
our shareholders and, in the event of our liquidation or dissolution, to participate in the
distribution of the assets.
Preferred shares carry no voting rights. Preferred shares may be issued at any time in one or more
series. Our articles of incorporation give our board of directors the power to fix the number of
preferred shares and the consideration per share, as well as to determine the provisions attached
to the preferred shares of each series (including dividends, redemption and conversion rights, if
any). The shares of every series of preferred shares will have priority over all our other shares,
including common shares, with respect to the payment of dividends and return of capital in the
event of our liquidation or dissolution.
The common shares issued represent the total voting rights pertaining to our securities.
6.2 DIVIDEND POLICY
We have never declared or paid cash dividends on our common shares and do not anticipate paying any
cash dividends on our common shares in the foreseeable future. We presently intend to retain future
earnings, if any, to finance the expansion and growth of our business. Any future determination to
pay dividends will be at the discretion of our board of directors and will depend on our financial
condition, results of operations, capital requirements and other factors the board of directors
deems relevant. In addition, the terms of any future debt or credit facility may preclude us from
paying dividends.
6.3 TRANSFER AGENT AND REGISTRAR
Our transfer agent and registrar is Computershare Trust Company of Canada which holds, at its
Montreal office, the registers related to our common shares, shareholders and transfers.
- 62 -
ITEM 7 MARKET FOR SECURITIES
7.1 TRADING PRICE AND VOLUME
The following table sets forth the high and low closing sale prices for our common shares for the
periods indicated, as reported on the TSX. However, you should not view this presentation as an
indication that the market price of our common shares will continue at such levels.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Price |
|
|
Period |
|
$ High |
|
$ Low |
|
Volume |
February 1 to February 18, 2011 |
|
$ |
5.88 |
|
|
$ |
5.01 |
|
|
|
4,371,300 |
|
January 2011 |
|
$ |
5.90 |
|
|
$ |
5.43 |
|
|
|
3,319,500 |
|
December 2010 |
|
$ |
5.69 |
|
|
$ |
5.27 |
|
|
|
4,038,000 |
|
November 2010 |
|
$ |
5.80 |
|
|
$ |
4.91 |
|
|
|
8,127,400 |
|
October 2010 |
|
$ |
5.15 |
|
|
$ |
4.44 |
|
|
|
2,944,000 |
|
September 2010 |
|
$ |
4.98 |
|
|
$ |
4.78 |
|
|
|
1,230,300 |
|
August 2010 |
|
$ |
5.08 |
|
|
$ |
4.75 |
|
|
|
1,934,900 |
|
July 2010 |
|
$ |
5.48 |
|
|
$ |
4.82 |
|
|
|
3,795,500 |
|
June 2010 |
|
$ |
5.59 |
|
|
$ |
4.61 |
|
|
|
6,188,600 |
|
May 2010 |
|
$ |
5.02 |
|
|
$ |
2.09 |
|
|
|
11,593,700 |
|
April 2010 |
|
$ |
5.20 |
|
|
$ |
4.82 |
|
|
|
1,960,000 |
|
March 2010 |
|
$ |
5.50 |
|
|
$ |
4.80 |
|
|
|
2,612,100 |
|
February 2010 |
|
$ |
5.03 |
|
|
$ |
4.67 |
|
|
|
2,205,500 |
|
January 2010 |
|
$ |
5.42 |
|
|
$ |
4.28 |
|
|
|
4,505,000 |
|
December 2009 |
|
$ |
4.45 |
|
|
$ |
3.55 |
|
|
|
5,517,800 |
|
7.2 PRIOR SALES
The following table summarizes the distribution of securities other than our common shares that we
issued during the most recently completed financial year, identifying the type of security, the
price per security, the number of securities issued, and the date on which the securities were
issued.
|
|
|
|
|
|
|
|
|
|
|
|
|
Date |
|
Type of Security |
|
Price per Security |
|
Number of Securities |
December 8, 2009 |
|
Options |
|
$ |
3.84 |
|
|
|
265,000 |
|
June 8, 2010 |
|
Options |
|
$ |
4.75 |
|
|
|
70,000 |
|
- 63 -
ITEM 8 LEGAL PROCEEDINGS
On July 26, 2010, we received a motion for authorization to institute a class action lawsuit
against us, our chairman and our former chief executive officer. This motion was filed in the
Superior Court of Québec, district of Montreal. The applicant is seeking to initiate a class action
suit and to certify and represent a class of persons who were shareholders at May 21, 2010 and who
sold their common shares on May 25 or 26, 2010. This applicant alleges that we did not comply with
our continuous disclosure obligations as a reporting issuer by failing to disclose certain alleged
adverse effects relating to the administration of EGRIFTA®. We are of the view that the
allegations contained in the motion are entirely without merit and intend to take all appropriate
actions to vigorously defend our position. The Motion has not yet been heard by the Superior Court
of Québec and no date has been set for the hearing. We have subscribed for insurance covering our
potential liability and the potential liability of our directors and officers in the performance of
all their duties for us subject to a $200,000 deductible and standard terms, conditions and
exclusions.
We are not otherwise currently subject to any material legal proceedings.
- 64 -
ITEM 9 MATERIAL CONTRACTS
Licensing Agreements. We have executed commercialization agreements with third parties for the
exclusive distribution rights to EGRIFTA® for the reduction of excess abdominal fact in
HIV-infected patients with lipodystrophy for (i) the United States; (ii) Latin America, Africa and
the Middle East; and (iii) Europe, Russia, South Korea, Taiwan, Thailand and certain central Asian
countries. For a description of these agreements, see Item 2.5.
Supply Agreements. We have executed five supply agreements with Bachem, Draxis, Becton Dickinson,
Hospira and ABAR. For a description of these agreements, see Item 2.7.
Shareholder Rights Plan Agreement. On February 10, 2010, we entered into a shareholder rights plan
agreement, or Rights Plan. The Rights Plan entitles a holder of rights (other than the Acquiring
Person, as defined below, or any affiliate or associate of an Acquiring Person or any person acting
jointly or in concert with an Acquiring Person or any affiliate or associate of an Acquiring
Person) to purchase to our common shares at a discount of 50% to the market price upon a person
becoming an Acquiring Person, subject to certain exceptions and the terms and conditions set out
in the Rights Plan. An Acquiring Person is defined in the Rights Plan as a beneficial owner of
20% or more of our common shares. The Rights Plan will expire at the close of our annual meeting of
shareholders in 2013.
In order to implement the Rights Plan, we issued one right in respect of each common share
outstanding as of 6:00 p.m. (Montreal time) on February 9, 2010, the Effective Date. One right
will also be issued and attached to each subsequently issued common share. The rights will separate
and trade separately from the common shares to which they are attached and will become exercisable
after the Separation Time, as defined below:
The Separation time is the close of business on the tenth business day following the earliest of:
|
(a) |
|
the date of the first public announcement made by us or an Acquiring Person that a
person has become an Acquiring Person; |
|
|
(b) |
|
the date of the commencement of, or first public announcement of the intent of any
Person to commence, a take-over bid (other than a Permitted Bid (as defined in the Rights
Plan) or a Competing Permitted Bid (as defined in the Rights Plan)) by any person for our
common shares; |
|
|
(c) |
|
the date upon which a Permitted Bid or Competing Permitted Bid ceases to be such; or |
|
|
(d) |
|
such later date as may be determined by the board of directors. |
After the time at which a person becomes an Acquiring Person, and subject to the terms and
conditions set out in the shareholder rights plan agreement, each right would, upon exercise,
entitle a rights holder, other than the Acquiring Person and related persons, to purchase common
shares at a 50% discount to the market price at the time.
Under the Rights Plan, a Permitted Bid is a bid made to all holders of the common shares and
which is open for acceptance for not less than 60 days. If at the end of 60 days at least 50% of
the outstanding common shares, other than those owned by the offeror and certain related parties,
have been tendered, the offeror may take up and pay for the common shares but must extend the bid
for a further 10 days to allow other shareholders to tender.
- 65 -
Lease Agreement. In October 2009, we entered into a new lease agreement with Société de
portefeuille immobilier GE Q-Tech inc. for the renewal of our lease for our offices and
laboratories located in Montréal, Québec. The new lease became effective on May 1, 2010 and will
expire on April 30, 2021. Under the terms of this new lease agreement, we have two five year
renewal options. If exercised, the first renewal option will start on May 1, 2021 and expire on
April 30, 2026 and the second renewal option, if exercised, will start on May 1, 2026 and expire on
April 30, 2031.
- 66 -
ITEM 10 ADDITIONAL INFORMATION
Additional information with respect to our company, including directors and officers
compensation, principal holders of our securities and securities authorized for issuance under
equity compensation plans, where applicable, is contained in our Management Proxy Circular for our
most recent annual and special meeting of shareholders. Our financial information is provided in
our comparative financial statements and Management Discussion & Analysis for our financial year
ended November 30, 2010.
Additional information regarding our company is available on SEDAR at www.sedar.com or upon request
addressed to Jocelyn Lafond, Corporate Secretary, at 2310 Alfred Nobel Boulevard, Montreal, Québec,
Canada H4S 2B4. Except when our securities are in the process of distribution pursuant to a
prospectus, we may charge reasonable fees if the request is from a person who does not hold any of
our securities.
- 67 -
APPENDIX A AUDIT COMMITTEE CHARTER
I. |
|
Mandate |
|
|
|
The Audit Committee (the Committee) is responsible for assisting the Companys Board of
Directors (the Board) in overseeing the following: |
|
A. |
|
the integrity of the Companys financial statements and related information; |
|
|
B. |
|
the internal control systems of the Company; |
|
|
C. |
|
the appointment and performance of the external auditor; and |
|
|
D. |
|
the supervision of the Companys Risk Management. |
II. |
|
Obligations and Duties |
|
|
|
The Committee carries out the duties usually entrusted to an audit committee and any other
duty assigned from time to time by the Board. Management has the responsibility to ensure
the integrity of the financial information and the effectiveness of the Companys internal
controls. The external auditor has the responsibility to verify and certify the accurate
presentation of the Companys financial statements; at the same time evaluating the internal
control process to determine the nature, extent and chronology of the auditing procedures
used. The Committee has the responsibility to supervise the participants involved in the
preparation process of the financial information and to report on this to the Board. |
|
|
|
Specifically, the Committee is charged with the following obligations and duties: |
|
A. |
|
Integrity of the Companys Financial Statements and Related Information |
|
1. |
|
Review annual and quarterly consolidated financial statements and
all financial information legally required to be disclosed by the Company, i.e.
financial information contained in the Management Discussion and Analysis
report, the annual information form and the press releases, as the case may be,
discuss such with management and the external auditor, and suggest
recommendations to the Board, as the case may be. |
|
|
2. |
|
Approve the interim Financial Statements, the interim Management
Discussion and Analysis reports and all supplements to these Management
Discussion and Analysis reports which have to be filed with regulatory
authorities. |
|
|
3. |
|
On a periodic basis, review and discuss with management and the
external auditor the following: |
|
a. |
|
major issues regarding accounting principles and
financial statement presentations, including any significant changes in
the Companys selection or application of accounting principles, and
major issues as to the adequacy of the Companys internal controls and
any special audit steps adopted in light of material control
deficiencies; |
|
|
b. |
|
the effect of regulatory and accounting
initiatives, as well as off-balance sheet structures, on the financial
statements of the Company; and |
|
|
c. |
|
the type and presentation of information to be
included in press releases dealing with financial results (paying
particular attention to any use of pro-forma information or information
adjusted by means of non-generally accepted accounting principles). |
- 68 -
|
4. |
|
Review and discuss reports from the external auditor on: |
|
a. |
|
all critical accounting policies and practices used
by the Company; and |
|
|
b. |
|
all material alternative treatments of financial
information within generally accepted accounting principles that have
been discussed with management, including the ramifications of the use of
such alternate treatments and disclosures and the treatment preferred by
the external auditor. |
|
B. |
|
Supervision of the Companys Internal Control Systems |
|
1. |
|
Review and discuss with management and with the external auditor
present reports and, when appropriate, provide recommendations to the Board on
the following: |
|
a. |
|
actual financial data compared with budgeted data; |
|
|
b. |
|
the Companys internal control system; |
|
|
c. |
|
the relationship of the Committee with the
management and audit committees of the Companys consolidated
subsidiaries. With respect to the subsidiaries, the Committee must: |
|
|
|
obtain precisions as to the mandate of the audit committees; |
|
|
|
|
enquire about internal controls and study related risks; |
|
|
|
|
obtain the external auditors report to the audit committees on
the planning of external auditing; |
|
|
|
|
obtain the external auditors report to the audit committees on
the auditing results; |
|
|
|
|
obtain copy of the minutes of the audit committees meetings;
and |
|
|
|
|
ensure that the critical accounting policies and practices are
identical to the Companys. |
|
2. |
|
Study the feasibility of implementing an internal auditing system
and when implemented, establish its responsibilities and supervise its work. |
|
|
3. |
|
Establish procedures for the receipt, retention and treatment of
complaints received by the Company regarding accounting, internal accounting
controls or auditing matters, and procedures for the confidential, anonymous
submission by employees of concerns regarding questionable accounting or
auditing matters. |
|
C. |
|
Appointment and Performance Supervision of the External Auditor |
|
1. |
|
Provide recommendations to the Board on the selection of the
external auditor to be appointed by the shareholders. |
|
|
2. |
|
Approve in advance and recommend to the Board the external
auditors remuneration and more specifically fees and terms of all audit, review
or certification services to be provided by the external auditor to the Company
and any consolidated subsidiary. |
|
|
3. |
|
Supervise the performance of the external auditor in charge of
preparing or issuing an audit report or performing other audit services or
certification services for the Company or any consolidated subsidiary of the
Company, |
- 69 -
|
|
|
where required, and review all related questions as to the terms of its
mission and the revision of its mission. |
|
4. |
|
Pre-approve all engagements for permitted non-audit services
provided by the external auditor to the Company and any consolidated subsidiary,
and to this effect and at its convenience, establish policies and procedures for
the engagement of the external auditor to provide to the Company and any
consolidated subsidiary permitted non-audit services, which shall include
approval in advance by the Committee of all audit/review services and permitted
non-audit services to be provided to the Company and any consolidated subsidiary
by the external auditor. |
|
|
5. |
|
At least annually, consider, assess and report to the Board on: |
|
a. |
|
the independence of the external auditor, including
whether the external auditors performance of permitted non-audit
services is compatible with the external auditors independence; |
|
|
b. |
|
the obtaining from the external auditor of a
written statement i) describing all relationships between the external
auditor and the Company; ii) assuring that lead audit partner rotation is
carried out, as required by law; and iii) describing any other
relationship that may adversely affect the independence of the external
auditor; and |
|
|
c. |
|
the evaluation of the lead audit partner, taking
into account the opinions of management and the internal auditor. |
|
6. |
|
At least annually, obtain and review a report by the external
auditor describing: |
|
a. |
|
the external auditors internal quality-control
procedures; and |
|
|
b. |
|
any material issues raised by the most recent
internal quality-control review (or peer review) of the external
auditors firm, or by any inquiry or investigation by governmental or
professional authorities, within the preceding five years, with respect
to one or more independent audits carried out by the external auditors
firm, and any steps taken to deal with any such issues. |
|
7. |
|
Resolve any disagreement between management and the external
auditor regarding financial reporting. |
|
|
8. |
|
Review the audit process with the external auditor. |
|
|
9. |
|
Review and discuss with the Chief Executive Officer and Chief
Financial Officer of the Company the process for the certifications to be
provided in the Companys public disclosure documents. |
|
|
10. |
|
Meet periodically with the external auditor in the absence of
management. |
|
|
11. |
|
Establish procedures with respect to hiring the external
auditors employees and former employees. |
|
D. |
|
Supervision of the Companys Risk Management |
|
|
|
|
Review, report and, where appropriate, provide recommendations to the Board on the
following: |
|
1. |
|
the Companys processes for identifying, assessing and managing
risk; |
|
|
2. |
|
the Companys major financial risk exposures and the steps the
Company has taken to monitor and control such exposures; |
- 70 -
|
3. |
|
the Companys insurance portfolio and the adequacy of the
coverage; and |
|
|
4. |
|
the Companys investment policy. |
III. |
|
External Advisors |
|
|
|
In discharging its duties and responsibilities, the Committee is empowered to retain
external legal counsel or other external advisors, as appropriate. The Company shall provide
the necessary funds to secure the services of such advisors. |
|
IV. |
|
Composition of the Committee |
|
|
|
The Committee is composed of any number of Directors, but no less than
three, as may be determined by the Board from time to time by
resolution. Each member of the Committee shall be independent from the
Company and is financially literate, as determined by the Board and in
conformity with applicable laws, rules and regulations. |
|
V. |
|
Term of the Mandate |
|
|
|
Committee members are appointed by Board resolution to carry out their mandate extending
from the date of the appointment to the next annual general meeting of the shareholders or
until their successors are so appointed. |
|
VI. |
|
Vacancy |
|
|
|
The Board may fill vacancies at any time by resolution. Subject to
the constitution of the quorum, the Committees members can continue
to act even if there is one or many vacancies on the Committee. |
|
VII. |
|
Chairman |
|
|
|
The Board appoints the Committee Chairman who will call and chair the meetings. The Chairman
reports to the Board the deliberations of the Committee and its recommendations. |
|
VIII. |
|
Secretary |
|
|
|
Unless otherwise determined by resolution of the Board, the Secretary of the Company shall
act as Committee Secretary. The Secretary must attend Committee meetings and prepare the
minutes. He/she must provide notification of meetings as directed by the Committee Chairman.
The Secretary is the guardian of the Committees records, books and archives. |
|
IX. |
|
Meeting Proceedings |
|
|
|
The Committee establishes its own procedures as to how meetings are called and conducted.
Unless it is otherwise decided, the Committee shall meet privately and independently from
Management at each regularly scheduled meeting. In the absence of the regularly appointed
Chairman, the meeting shall be chaired by another Committee member selected among attending
participants and appointed accordingly. In the absence of the regularly appointed Secretary,
Committee members shall designate someone to carry out this duty. |
|
|
|
The Committee shall meet at least four times a year with management and the external
auditor, and at least once a year, separately in executive session in the absence of
management and the external auditor. At least once a year, the Committee invites the Chief |
- 71 -
|
|
Financial Officer of each subsidiary to present the financial information and internal
control systems related to such subsidiary. |
X. |
|
Quorum and Voting |
|
|
|
Unless the Board otherwise specifies by resolution, two Committee
members shall constitute an appropriate quorum for deliberation of
items on the agenda. During meetings, decisions are reached by a
majority of votes from Committee members, unless the quorum is of two
members, in which case decisions are made by consensus of opinion. |
|
XI. |
|
Records |
|
|
|
The Committee keeps records that are deemed necessary of its
deliberations and reports regularly to the Board on its activities
and recommendations. |
|
XII. |
|
Effective Date |
|
|
|
This charter was adopted by the Directors at its May 3, 2004 Board
meeting. It was amended by the Directors during the April 13, 2005
and February 8, 2006 Board meetings. |
- 72 -
ex-99.2
Exhibit 99.2
Forward-Looking Information
This Managements discussion and analysis (MD&A) contains certain statements that are
considered forward-looking information within the meaning of applicable securities legislation.
This forward-looking information includes, but is not limited to, information regarding the
preparation and filing of applications seeking regulatory approval of EGRIFTATM in the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in various
territories outside of the United States, the revenue to be generated as a result of sales of
EGRIFTATM to EMD Serono, Inc., (EMD Serono), the receipt of royalties from EMD Serono
in connection with the sale of EGRIFTATM in the United States, and the development of
tesamorelin in a new clinical program for a new indication. Furthermore, the words will, may,
could, should, outlook, believe, plan, envisage, anticipate, expect and estimate,
or the negatives of these terms or variations of them and the use of future or conditional tenses
as well as similar expressions denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control, that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties are described under the section Risks and
Uncertainties on page 21 and include, but are not limited to, the risk that EGRIFTATM
is not approved in all or some of the territories referred to in this MD&A, the revenue and
royalties we expect to generate from sales of EGRIFTATM is lower than anticipated, the
supply of EGRIFTATM to our commercial partners is delayed or suspended as a result of
problems with our suppliers, EGRIFTATM is withdrawn from the market as a result of
defects or recalls, our intellectual property is not adequately protected and our liquidity level
decreases based on unexpected activities that must be carried out in order to achieve our business
plan.
Although the forward-looking information contained in this MD&A is based upon what we believe are
reasonable assumptions, investors are cautioned against placing undue reliance on this information
since actual results may vary materially from the forward-looking information contained in this
MD&A. Certain assumptions made in preparing the forward-looking information include the assumption
that tesamorelin for the reduction of excess abdominal fat in HIV-infected patients with
lipodystrophy will receive approval in the territories referred to in this MD&A, no additional
clinical studies will be required to obtain said regulatory approval of tesamorelin,
EGRIFTATM will be accepted by the marketplace in the United States and will be on the
list of reimbursed drugs by third-party payers, our relations with third-party suppliers of
EGRIFTATM will be conflict-free and that such third-party suppliers will have enough
capacity to manufacture and supply EGRIFTATM to meet its demand and on a timely-basis
and that our business plan will not be substantially modified.
Consequently, all of the forward-looking information contained in this MD&A is qualified by the
foregoing cautionary statements, and there can be no guarantee that the results or developments
that we anticipate will be realized or, even if substantially realized, that they will have the
expected consequences or effects on our business, financial condition or results of operation.
Managements Discussion and Analysis
The following discussion and analysis provides managements point of view on the financial
position and the results of operations of Theratechnologies Inc., on a consolidated basis for the
twelve-month periods ended November 30, 2010 (fiscal 2010) and November 30, 2009 (fiscal 2009).
Unless otherwise indicated or unless the context requires otherwise, all references in this MD&A to
Theratechnologies, the Company, we, us, our or similar terms refer to Theratechnologies
Inc. and its consolidated subsidiaries. This information is dated February 8, 2011, and should be
read in conjunction with the Audited Consolidated Financial Statements and the accompanying notes.
Unless specified otherwise, all amounts are in Canadian dollars. In this MD&A, the use of
EGRIFTATM refers to tesamorelin for the reduction of excess abdominal fat in
HIV-infected patients with lipodystrophy regardless of the trade name used for such product in any
particular territory. EGRIFTATM is the trade name used in the United States for
tesamorelin for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
Except as otherwise indicated, the financial information contained in this MD&A and in our Audited
Consolidated Financial Statements has been prepared in accordance with International Financial
Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB).
Our financial statements were previously prepared in accordance with Canadian Generally Accepted
Accounting Principles (GAAP). For more information regarding the conversion to IFRS, please refer
to the heading Conversion to IFRS in this MD&A and to note 27 of the Audited Consolidated
Financial Statements, which are our first consolidated financial statements prepared in accordance
with IFRS.
The Audited Consolidated Financial Statements and MD&A have been reviewed by our Audit Committee
and approved by our Board of Directors.
Overview
We are a specialty pharmaceutical company that discovers and develops innovative therapeutic
peptide products with an emphasis on growth-hormone releasing factor peptides. We are leveraging
our expertise in the field of metabolism to discover and develop products in specialty markets. Our
commercialization strategy is to retain all or a significant portion of the commercial rights to
our products. Our first product, EGRIFTA (tesamorelin for injection), was approved by the United
States Food and Drug Administration (FDA) in November 2010. To date, EGRIFTA is the only
approved therapy for the reduction of excess abdominal fat in HIV-infected patients with
lipodystrophy.
Lipodystrophy in HIV-infected patients presents a serious medical condition, affecting
approximately 29% of all diagnosed and treated HIV-infected patients. This condition is associated
with a range of physiological and psychological complications beyond the significant health and
mortality risks of the HIV infection itself. EGRIFTA is currently marketed in the United States by
EMD Serono, Inc. (EMD Serono), an affiliate of Merck KGaA, pursuant to a collaboration and
licensing agreement entered into by us and EMD Serono in October 2008. In addition, we have signed
distribution and licensing
agreements with Sanofi Winthrop Industries, an affiliate of Sanofi-aventis (collectively,
Sanofi), for the commercialization rights for EGRIFTA for the reduction of excess abdominal fat
in HIV-infected patients with lipodystrophy in Latin America, Africa and the Middle East and with
Ferrer Internacional S.A. (Ferrer) for the commercialization rights for EGRIFTA for the
reduction of excess abdominal fat in HIV-
- 2 -
infected patients with lipodystrophy in Europe, Russia, South Korea, Taiwan, Thailand and certain
central Asian countries. EGRIFTA is the trade name used in the United States for tesamorelin for
the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
The first six months of fiscal 2010 were devoted to preparing for a public meeting with the
Endocrinologic and Metabolic Drugs Advisory Committee, which the FDA of the United States had asked
us to attend in the context of its review of our New Drug Application (NDA) for EGRIFTA. As an
integral part of the FDA review process for a NDA, the principal role of an advisory committee is
to provide an independent point of view to enhance the quality of the agencys regulatory
decision-making process. At the public meeting held on May 27, 2010, the committee of experts
unanimously recommended to the FDA, the approval of EGRIFTA.
In the second half of fiscal 2010, we focused primarily on responding to the FDAs questions and
began building our inventory in anticipation of the launch of EGRIFTA in the United States. We
were also focused on securing strategic alliances for the commercialization of EGRIFTA in
territories outside of the United States.
On November 10, 2010, the FDA approved EGRIFTA as the first approved treatment in the United
States for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. By
virtue of the collaboration and licensing agreement entered into in 2008 with EMD Serono, we
received a milestone payment of US$25,000,000 associated with the FDA-approval of EGRIFTA. This
payment was received by us on November 30, 2010. Under the collaboration and licensing agreement,
EMD Serono has the exclusive right to commercialize EGRIFTATM in the United States for
the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
Concurrent with these regulatory activities in fiscal 2010, our third-party suppliers began
manufacturing inventory of EGRIFTA in preparation for the launch of EGRIFTA in the United States
by our commercial partner, EMD Serono. The first product shipment of EGRIFTA took place in
December 2010.
Fiscal 2010 was also marked by a change in our management. On December 1, 2010, John-Michel T.
Huss, previously Chief of Staff, Office of the CEO, of Sanofi in Paris, became our President and
Chief Executive Officer. Mr. Huss replaced Yves Rosconi who, in June 2010, announced his desire to
retire after six years as the head of the Company.
On December 6, 2010, we entered into a distribution and licensing agreement with Sanofi granting
them the exclusive commercialization rights of EGRIFTATM for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy in Latin America, Africa and the Middle
East.
On February 3, 2011, we entered into a distribution and license agreement with Ferrer granting them
the exclusive commercialization rights of tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy in Europe, Russia, South Korea, Taiwan, Thailand and
certain central Asian countries.
Financial Position
We completed fiscal 2010 with a liquidity position of $64,882,000, consisting of $64,550,000 of
cash and highly liquid bonds, and $332,000 of tax credits and grants receivable.
- 3 -
Economic Environment
In 2008 and 2009, capital markets were characterized by significant stock market volatility and a
notable decline in access to capital, particularly for the biotechnology industry. An economic
slowdown occurred in almost all sectors and the general decline of the capital markets had a
negative effect on the cost of capital for companies.
In early 2010, the situation remained challenging and it was only in the second half of the year
that we began to see an improvement in economic conditions, which resulted in better access to
capital and lower credit risk. Interest rates, however, remained extremely low throughout the year.
Despite the improvement in general market conditions, our investment policy continues to be
conservative. We have invested our funds in highly liquid, low-risk instruments as described under
the heading Liquidity and capital resources.
Perspectives for 2011
In 2011, our focus is to maximize the global opportunities for EGRIFTATM and
tesamorelin. In order to do so we intend to:
|
|
|
Support our commercial partner, EMD Serono, in commercializing EGRIFTATM
in the United States; |
|
|
|
|
Support our commercial partner, Sanofi, in seeking regulatory approval of
EGRIFTATM in Latin America, Africa and the Middle-East for potential
commercialization; |
|
|
|
|
Support our commercial partner, Ferrer, in seeking regulatory approval of
EGRIFTATM in Europe, Russia, South Korea, Taiwan, Thailand and certain central
Asian countries for potential commercialization; |
|
|
|
|
Assess expansion opportunities into other territories where EGRIFTATM
could be used for the reduction of excess abdominal fat in HIV-infected patients with
lipodystrophy; |
|
|
|
|
Initiate a new clinical program evaluating tesamorelin in a new indication; |
|
|
|
|
Continue working on EGRIFTATM. We have developed a new presentation of
EGRIFTATM which is easier to use than its current presentation. This new
presentation complies with one of the FDAs post-approval requirements. See Post-Approval
Commitments; and |
|
|
|
|
Develop a new formulation for EGRIFTATM pursuant to our agreement with
EMD Serono. |
- 4 -
Selected Annual Information
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated statement of comprehensive income |
|
|
|
|
|
|
|
|
|
YEARS ENDED NOVEMBER 30 (in thousands of |
|
|
|
|
|
|
|
|
|
Canadian dollars, except per share amounts) |
|
2010 |
|
|
2009 |
|
|
2008(1) |
|
|
Revenue(2) |
|
$ |
31,868 |
|
|
$ |
17,468 |
|
|
$ |
2,641 |
|
Research and development expenses, net of tax credits |
|
$ |
14,064 |
|
|
$ |
20,810 |
|
|
$ |
33,215 |
|
Results from operating activities |
|
$ |
6,663 |
|
|
$ |
(16,747 |
) |
|
$ |
(48,611 |
) |
Net financial income |
|
$ |
2,381 |
|
|
$ |
1,591 |
|
|
|
|
|
Net profit (loss) |
|
$ |
8,930 |
|
|
$ |
(15,156 |
) |
|
$ |
(48,611 |
) |
|
Basic and diluted earnings (loss) per share |
|
$ |
0.15 |
|
|
$ |
(0.25 |
) |
|
$ |
(0.85 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated statement of financial position |
|
|
|
|
|
|
|
|
|
AT NOVEMBER 30 (in thousands of Canadian |
|
|
|
|
|
|
|
|
|
dollars) |
|
2010 |
|
|
2009 |
|
|
2008(1) |
|
|
Liquidities (cash and bonds) |
|
$ |
64,550 |
|
|
$ |
63,362 |
|
|
$ |
46,337 |
|
Tax credits and grants receivable |
|
$ |
332 |
|
|
$ |
1,333 |
|
|
$ |
1,784 |
|
Total assets |
|
$ |
71,651 |
|
|
$ |
69,154 |
|
|
$ |
53,545 |
|
Total share capital |
|
$ |
279,398 |
|
|
$ |
279,169 |
|
|
$ |
269,219 |
|
Total equity |
|
$ |
52,656 |
|
|
$ |
43,048 |
|
|
$ |
46,347 |
|
|
|
|
|
(1) |
|
We adopted IFRS in fiscal 2010 with a transition date of December 1, 2008.
Consequently, the selected financial information for the year ended November 30, 2008, as
presented in our 2009 Audited Consolidated Financial Statements, which were presented in conformity
with Canadian GAAP, was not restated in terms of IFRS and accordingly, is not comparable with the
information for fiscal 2010 and 2009. See Conversion to IFRS for the policy differences between
Canadian GAAP and IFRS. |
|
(2) |
|
Revenue in 2008 includes interest income of $2,427,000. Revenue in 2009 includes a
milestone payment of $10,884,000 received from EMD Serono following the FDAs acceptance to file
our NDA for EGRIFTATM. Revenue in 2010 includes a milestone payment of $25,000,000
received from EMD Serono following marketing approval of EGRIFTATM by the FDA. |
- 5 -
Operating Results
Revenue
Our consolidated revenue for the year ended November 30, 2010 was $31,868,000, compared to
$17,468,000 in 2009. The increased revenue in fiscal 2010 was related to the milestone payment of
US$25,000,000 (C$25,000,000) received by us from EMD Serono on November 30, 2010 associated with
the satisfaction of the condition of approval of EGRIFTATM by the FDA. In fiscal 2009, a
payment of US$10,000,000 (C$10,884,000) was received by us from EMD Serono following the acceptance
by the FDA of the Companys NDA for EGRIFTATM in conformity with the collaboration and
licensing agreement with EMD Serono.
The initial payment of US$22,000,000 (C$27,097,000) received on December 15, 2008, upon the closing
of the transaction with EMD Serono, has been deferred and is being amortized over its estimated
service period of four years on a straight-line basis. For the year ended November 30, 2010, an
amount of $6,846,000 related to this transaction was recognized as revenue. At November 30, 2010,
the deferred revenue related to this transaction recorded on the consolidated statement of
financial position amounted to $13,692,000.
We expect to generate revenue from sales of EGRIFTATM to EMD Serono throughout fiscal
2011. We also expect to receive royalties on sales of EGRIFTATM in the United States by
EMD Serono beginning in the second quarter of fiscal 2011 upon receipt and confirmation of the
sales report relating to the previous quarter. The royalty rate we receive from EMD Serono is based
on the level of annual net sales achieved, with the rate increasing as higher levels of net sales
are attained.
R&D Activities
For the year ended November 30, 2010, consolidated research and development (R&D) expenses, net
of tax credits, amounted to $14,064,000, compared to $20,810,000 in 2009, a decrease of 32.4%. The
majority of R&D expenses incurred in fiscal 2010 are related to follow-up on work derived from the
regulatory filing with the FDA, notably responding to the FDAs questions, and preparation for the
FDA Advisory Committee meeting. In parallel with the United States FDA review, we continued to
advance our regulatory filing in Europe and to work on a new presentation of the existing
formulation of EGRIFTATM. Furthermore, we are in the process of evaluating the
initiation of a new clinical program to develop tesamorelin for a new indication. In our discovery
and preclinical groups, we continued to develop new peptides and to advance our preclinical program
for acute kidney injury (AKI). In fiscal 2009, the expenses incurred were principally associated
with completing the Phase 3 clinical trials evaluating tesamorelin in HIV-associated lipodystrophy
and the preparation of the NDA, which was submitted to the FDA in May 2009. The significant decline
in R&D expenses was in accordance with our projected R&D expenses for fiscal 2010. We expect the
amount of our R&D expenses for fiscal 2011 to be similar to those of 2010.
Cost of Sales
In fiscal 2010, we began producing through our third-party suppliers inventories in anticipation of
the launch of EGRIFTATM in the United States. Cost of sales in fiscal 2010 related to
this activity amounted to $469,000 which includes a charge of $192,000, in order to value the
inventories at their net realizable value. This write-down was due to raw materials that were not
originally bought under the conditions of our current long-term procurement agreements. Cost of
sales also included unallocated costs related to the production fees associated with the start-up
of the manufacturing process. We expect the cost of sales to increase significantly over the next
fiscal
- 6 -
year as sales of EGRIFTATM grow and as we secure additional suppliers for raw materials
and finished products.
General and Administrative Expenses
For the year ended November 30, 2010, general and administrative expenses were $8,002,000, compared
to $6,543,000 for the same period in fiscal 2009.
The higher expenses for the year ended November 30, 2010 are primarily due to the cost and expenses
associated with professional fees for the recruitment of the new President and Chief Executive
Officer, increased corporate communication associated with the FDA Advisory Committee meeting and
FDA approval, and conversion of our financial statements to IFRS, as well as costs and expenses
related to variations in share-based compensation expenses. The expenses for the year ended
November 30, 2009 include the costs associated with the revision of our three-year business plan
which were not repeated in fiscal 2010.
Selling and Market Development Expenses
For the year ended November 30, 2010, selling and market development expenses were $2,670,000,
compared to $6,862,000 in fiscal 2009.
The selling and market development expenses in fiscal 2010 are principally composed of business
development expenses and market research outside the United States and the costs of managing the
agreement with EMD Serono. In fiscal 2009, we incurred expenses totaling $4,269,000 in connection
with professional fees related to the transaction with EMD Serono.
Net Financial Income
For the year ended November 30, 2010, interest income was $1,562,000 compared to $2,123,000 in
fiscal 2009. The year-over-year decline is due to lower average cash positions and a decrease in
yield on our bond portfolio. Receipt of the $25,000,000 milestone payment from EMD Serono in
November 2010 strengthened the Companys cash position to a level comparable to that of year-end
2009. Finance costs in fiscal 2010 were a gain of $493,000 compared to an expense of $661,000 in
fiscal 2009. Finance costs in fiscal 2010 benefited from a net foreign currency gain of $511,000
compared to a net foreign currency loss of $635,000 in 2009.
Net Results
Reflecting the changes in revenue and expenses described above, we realized a net profit of
$8,930,000 ($0.15 per share) for the year ended November 30, 2010, compared to a net loss of
$15,156,000 ($0.25 loss per share) for the same period in fiscal 2009. The net profit included
revenue of $31,846,000 related to the collaboration and licensing agreement with EMD Serono.
- 7 -
Quarterly Financial Information
The following table is a summary of the unaudited consolidated operating results of the Company
presented in accordance with IFRS for the last eight quarters.
(in thousands of Canadian dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Revenue |
|
$ |
26,717 |
|
|
$ |
1,717 |
|
|
$ |
1,717 |
|
|
$ |
1,717 |
|
|
$ |
1,718 |
|
|
$ |
12,601 |
|
|
$ |
1,717 |
|
|
$ |
1,432 |
|
Net profit (net loss) |
|
$ |
21,299 |
|
|
$ |
(3,357 |
) |
|
$ |
(4,771 |
) |
|
$ |
(4,241 |
) |
|
$ |
(4,654 |
) |
|
$ |
5,779 |
|
|
$ |
(5,454 |
) |
|
$ |
(10,827 |
) |
Basic and diluted
earnings (loss) per
share |
|
$ |
0.35 |
|
|
$ |
(0.06 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.08 |
) |
|
$ |
0.10 |
|
|
$ |
(0.09 |
) |
|
$ |
(0.18 |
) |
As described above, the higher revenue in the third quarter of 2009 is related to the
milestone payment of $10,884,000 received from EMD Serono following the FDAs acceptance to file
the Companys NDA for EGRIFTATM. The higher revenue in the fourth quarter of 2010 is
related to the receipt from EMD Serono of a milestone payment of $25,000,000 following marketing
approval of EGRIFTATM by the FDA.
Fourth Quarter Comparison
Consolidated revenue for the three-month period ended November 30, 2010, amounted to
$26,717,000, compared to $1,718,000 for the same period in fiscal 2009. The higher revenue in the
three-month period ended November 30, 2010 is related to the milestone payment of $25,000,000
received at the end of the fourth quarter, following marketing approval of EGRIFTATM by
the FDA in the United States.
Consolidated R&D expenses, net of tax credits, totaled $3,172,000 for the fourth quarter of 2010,
compared to $4,212,000 for the same period in 2009, a decrease of 24.7%. The R&D expenses incurred
in 2009 principally included expenses related to preparing for the FDA Advisory Committee meeting,
which was held on May 27, 2010. The R&D expenses incurred in the fourth quarter of fiscal 2010 were
mainly related to managing responses to the FDAs questions and the FDA approval process, in
addition to the advancement of our regulatory filing in Europe and on a new presentation of the
existing formulation of EGRIFTATM. Furthermore, we are in the process of evaluating the
initiation of a new clinical program to develop tesamorelin for a new indication. In our discovery
and preclinical groups, we continued to develop new peptides and to advance our preclinical program
in AKI.
General and administrative expenses were $2,036,000 in the fourth quarter of 2010, compared to
$1,563,000 for the same period in 2009. The higher expenses for 2010 are
principally related to the conversion of our financial statements to IFRS and FDA approval of
EGRIFTATM in the United States.
Selling and market development expenses amounted to $761,000 for the fourth quarter of 2010,
compared to $1,069,000 for the same period in 2009. The sales and market development
- 8 -
expenses in fiscal 2010 are principally composed of business development expenses outside the
United States and the costs of performing our obligations under the agreement with EMD Serono. The
increased costs in 2009 were principally due to market development costs in Europe to increase the
awareness of lipodystrophy as a disease.
Consequently, we recorded a net profit for the three-month period ended November 30, 2010, of
$21,299,000 ($0.35 per share), compared to a net loss of $4,654,000 ($0.08 per share) for the same
period in 2009.
In the three-month period ended November 30, 2010, cash flows from operating activities, excluding
changes in operating assets and liabilities, was $22,037,000, compared to a use of cash of
$4,333,000 for the same period in 2009.
Liquidity and Capital Resources
Our objective in managing capital is to ensure a sufficient liquidity position to finance our
research and development activities, general and administrative expenses, working capital and
capital spending.
To fund our activities, we have relied primarily on public offerings of common shares in Canada and
private placements of our common shares as well as on up-front payments and milestone payments
primarily associated with the agreement with EMD Serono. When possible, we try to optimize our
liquidity position using non-dilutive sources, including investment tax credits, grants and
interest income.
For the year ended November 30, 2010, cash flow from operating activities, excluding changes in
operating assets and liabilities, was $11,160,000 compared to a use of cash of $13,547,000 in
fiscal 2009. The cash flow generated in fiscal 2010 is principally related to payments received
under the agreement with EMD Serono as well as decreases in R&D expenses and in selling and market
development expenses.
At November 30, 2010, cash and bonds amounted to $64,550,000 and tax credits and grants receivable
amounted to $332,000, for a total of $64,882,000.
At this time, apart from our unused $1,800,000 revolving credit facility, we do not have any
additional arrangements for external debt financings, and are not certain whether any proposed debt
financing in the future, would be available on acceptable terms, or available at all. We may seek
additional capital through the incurrence of debt, the issuance of equity or other financing
alternatives.
We invest our available cash in highly liquid fixed income instruments from governmental, municipal
and paragovernmental bodies ($37,542,000 at November 30, 2010) as well as corporate bonds with high
credit ratings ($359,000 at November 30, 2010).
In the year ended November 30, 2010, the Company received share subscriptions amounting to $15,000
($96,000 in fiscal 2009) for the issuance of 2,880 common shares (34,466 in 2009) in connection
with the share purchase plan. Under the terms of the
agreement with EMD Serono, we issued 2,179,837 common shares for a cash consideration of
US$8,000,000 (C$9,854,000) during the first quarter of 2009.
- 9 -
In fiscal 2010, our third-party suppliers began to manufacture inventory of EGRIFTATM
for commercialization in the United States. We expect to continue to build our inventory
until we reach an adequate level of finished goods to meet the needs of our partners and this will
significantly increase our working capital needs in fiscal 2011.
Contractual Obligations
Commitments
We rent our headquarters and main office pursuant to a lease expiring in April 2021. At November
30, 2010 and 2009, and at December 1, 2008, the minimum payments required under the terms of the
non-cancellable lease were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November 30, |
|
|
November 30, |
|
|
December 1, |
|
(in thousands of Canadian dollars) |
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
Less than one year |
|
|
55 |
|
|
|
340 |
|
|
|
816 |
|
Between one and five years |
|
|
2,239 |
|
|
|
2,020 |
|
|
|
340 |
|
More than five years |
|
|
3,943 |
|
|
|
4,216 |
|
|
|
|
|
|
|
|
|
6,237 |
|
|
|
6,576 |
|
|
|
1,156 |
|
Long-Term Procurement Agreements
During and after the years ended November 30, 2010 and 2009, we entered into long-term procurement
agreements with third-party suppliers in anticipation of the commercialization of
EGRIFTATM.
Credit Facility
We have a $1,800,000 revolving credit facility, bearing interest at prime plus 0.5%. Under the term
of the revolving credit facility, the market value of investments held must always be equivalent to
150% of amounts drawn under the facility. If the market value falls below $7,000,000, we will
provide the bank with a first rank movable hypothec (security interest) of $1,850,000 on securities
judged satisfactory by the bank. As at November 30, 2010, we did not have any borrowings
outstanding under this credit facility.
Post-Approval Commitments
In connection with its approval, the FDA has required the following three post-approval commitments:
|
|
|
a single vial formulation of EGRIFTATM (the development of a new presentation of the
same formulation); |
|
|
|
|
a long-term observational safety study using EGRIFTATM; and |
|
|
|
|
a Phase 4 clinical trial using EGRIFTATM. |
We have developed a new presentation of EGRIFTATM which is more user-friendly than its
current presentation because we expect it to be quicker and easier for a patient to manipulate. In
the new presentation of the same formulation, EGRIFTATM will be available as a single
unit dose (one vial containing 2 mg of tesamorelin) of sterile, lyophilized powder to be
reconstituted with
- 10 -
sterile water for injection. This new presentation complies with the first of the FDAs
post-approval requirements. The FDA requires that this new presentation be available by November
2013.
The purpose of the long-term observational study required by the FDA is to evaluate the safety of
long-term administration of EGRIFTATM. The primary purpose of the Phase 4 clinical trial
is to assess whether EGRIFTATM has an impact on diabetic retinopathy in diabetic
HIV-infected patients with lipodystrophy and excess abdominal fat. The FDA requires that the
proposals for the long-term observational safety study and Phase 4 clinical trial be completed
within six months of our having received approval to commercialize EGRIFTATM. Under the
terms of our collaboration and licensing agreement, EMD Serono is responsible for finalizing such
proposals. We will continue to support EMD Serono in developing and finalizing such proposals.
Contingent Liability
On July 26, 2010, we received a motion of authorization to institute a class action lawsuit against
the Company, a director and a former executive officer (the Motion). This Motion was filed in the
Superior Court of Quebec, district of Montreal. The applicant is seeking to initiate a class action
suit to represent the class of persons who were shareholders at May 21, 2010 and who sold their
common shares of the Company on May 25 or 26, 2010. This applicant alleges that the Company did not
comply with its continuous disclosure obligations as a reporting issuer by failing to disclose
certain alleged adverse effects relating to the administration of EGRIFTATM. The Company
is of the view that the allegations contained in the Motion are entirely without merit and intends
to take all appropriate actions to vigorously defend its position.
The Motion has not yet been heard by the Superior Court of Quebec and a date has not been set for
the hearing.
The Company has subscribed to insurance covering its potential liability and the potential
liability of its directors and officers in the performance of all their duties for the Company
subject to a $200,000 deductible. At November 30, 2010, an amount of $96,000 in legal fees had been
accrued and included in general and administrative expenses, of which $61,000 was paid during the
year and $35,000 remained in accounts payable and accrued liabilities.
Off-Balance Sheet Arrangements
We were not involved in any off-balance sheet arrangements for the year ended November 30,
2010, with the exception of the lease of our headquarters as described above.
Subsequent Events
Distribution and Licensing Agreements
On December 6, 2010, we announced the signing of a distribution and licensing agreement with Sanofi
covering the commercial rights for EGRIFTATM in Latin America, Africa, and the Middle
East for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
Under the terms of the Agreement, we will sell EGRIFTATM to Sanofi at a transfer price
equal to the higher of a percentage of Sanofis net selling price and a predetermined floor price.
We have retained all future development rights to EGRIFTATM and will be responsible for
conducting
- 11 -
research and development for any additional potential indications. Sanofi will be responsible for
conducting all regulatory activities for EGRIFTATM in the aforementioned territories,
including applications for approval in the different countries for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy. We also granted Sanofi an option to
commercialize tesamorelin for other indications in the territories mentioned above. If such option
is not exercised, or is declined, by Sanofi, we may commercialize tesamorelin for such indications
on our own or with a third-party.
On February 3, 2011, we entered into a distribution and licensing agreement with Ferrer covering
the commercial rights for EGRIFTATM for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy in Europe, Russia, South Korea, Taiwan, Thailand and
certain central Asian countries.
Under the terms of the Agreement, we will sell EGRIFTATM to Ferrer at a transfer price
equal to the higher of a significant percentage of Ferrers net selling price and a predetermined
floor price. We have retained all development rights to EGRIFTATM for other indications
and will be responsible for conducting research and development for any additional programs. Ferrer
will be responsible for conducting all regulatory and commercialization activities in connection
with EGRIFTATM for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in the territories subject to the agreement. We will be responsible for the
manufacture and supply of EGRIFTATM to Ferrer. We have the option to co-promote
EGRIFTATM for the reduction of excess abdominal fat in HIV-infected patients with
lipodystrophy in the territories. Ferrer has the option to enter into a co-development and
commercialization agreement using tesamorelin relating to any such new indications. The terms and
conditions of such a co-development and commercialization agreement will be negotiated based on any
additional program chosen for development.
Deferred Share Unit Plan
In December 2010, we adopted a deferred share unit plan (Plan) to provide long-term incentive
compensation for our directors and executive officers. Under the Plan, directors must receive their
annual remuneration as a board member in fully vested deferred share unites (DSUs) until they
reach a percentage of their annual remuneration and, once such percentage is attained, they have
the option to elect to receive part or all of their annual remuneration in DSUs. Under the plan,
executive officers have the option of receiving all or a portion of their annual bonus in the form
of fully-vested DSUs. The units are only redeemable for cash when a participant ceases to be an
employee or member of the Board of Directors. We manage the risk associated with the issuance of
the DSU by entering into a yearly forward contract with a third-party. As at February 7, 2011, all
of the 99,912 DSUs outstanding were covered by a prepaid forward contract.
Stock Option Plan
Between December 1, 2010 and February 7, 2011, the Company granted 250,000 options at an exercise
price of $5.65 per share. Also, 27,832 options were forfeited and expired at a weighted exercise
average price of $12.06 per share and 3,000 options were exercised at a weighted exercise average
price of $1.80 per share for a cash consideration of $5,000.
- 12 -
Financial Risk Management
This section provides disclosure relating to the nature and extent of our exposure to risks
arising from financial instruments, including credit risk, liquidity risk, currency risk and
interest rate risk, and how we manage those risks.
Credit Risk
The Companys exposure to credit risk currently relates to accounts receivables with only one
customer (see note 4 of the Audited Consolidated Financial Statements). Credit risk is the risk of
an unexpected loss if a customer or counterparty to a financial instrument fails to meet its
contractual obligations. We regularly monitor credit risk exposure and take steps to mitigate the
likelihood of this exposure resulting in losses.
Financial instruments other than cash and trade and other receivables that potentially subject the
Company to significant credit risk consist principally of bonds. We invest our available cash in
highly liquid fixed income instruments from governmental, paragovernmental and municipal bodies
($37,542,000 as at November 30, 2010) as well as from companies with high credit ratings ($359,000
as at November 30, 2010). As at November 30, 2010, we were not exposed to any credit risk over the
carrying amount of the bonds.
Liquidity Risk
Liquidity risk is the risk that we will not be able to meet our financial obligations as they
become due. We manage liquidity risk through the management of our capital structure, as outlined
under Liquidity and Capital Resources. We also manage liquidity risk by continuously monitoring
actual and projected cash flows. The Board of Directors and/or the Audit Committee reviews and
approves our operating and capital budgets, as well as any material transactions out of the
ordinary course of business.
We have adopted an investment policy in respect of the safety and preservation of capital to ensure
that our liquidity needs are met. The instruments are selected with regard to the expected timing
of expenditures and prevailing interest rates.
The required payments on the contractual maturities of financial liabilities, as well as the
payments required under the terms of the operating lease, as at November 30, 2010, are presented in
notes 20 and 23 of the Audited Consolidated Financial Statements.
Currency Risk
We are exposed to financial risk related to the fluctuation of foreign exchange rates and the
degree of volatility of those rates. Currency risk is limited to the portion of our business
transactions denominated in currencies other than the Canadian dollar, primarily revenues from
milestone payments and expenses for research and development incurred in U.S. dollars, euros and
pounds sterling (GBP). We do not use derivative financial instruments to reduce our foreign
exchange exposure.
We manage currency risk by maintaining cash in U.S. dollars on hand to support U.S. forecasted cash
budgets for a maximum 12-month period. We do not currently view our
exposure to the euro and GBP as a significant foreign exchange risk due to the limited volume of
transactions conducted by the Company in these currencies.
Exchange rate fluctuations for foreign currency transactions can cause cash flow as well as amounts
recorded in consolidated statement of comprehensive income to vary from period to
- 13 -
period and not necessarily correspond to those forecasted in operating budgets and projections.
Additional earnings variability arises from the translation of monetary assets and liabilities
denominated in currencies other than the Canadian dollar at the rates of exchange at each
consolidated statement of financial position date, the impact of which is reported as foreign
exchange gain or loss in the consolidated statement of comprehensive income. Given our policy on
the management of our U.S. foreign currency risk, we do not believe, a sudden change in foreign
exchange rates would impair or enhance our ability to pay our U.S. dollar denominated obligations.
The following table provides significant items exposed to currency risk as at November 30, 2010:
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November 30, |
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2010 |
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(in thousands of dollars) |
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$US |
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EURO |
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GBP |
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Cash |
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26,424 |
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1 |
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Trade and other receivables |
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Accounts payable and accrued liabilities |
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(465 |
) |
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(26 |
) |
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(81 |
) |
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Items exposed to currency risk |
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25,959 |
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(26 |
) |
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(80 |
) |
The following exchange rates applied during the year ended November 30, 2010:
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Average rate |
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Reporting date rate |
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$US C$ |
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1.0345 |
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1.0266 |
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EURO C$ |
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1.3848 |
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1.3326 |
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GBP C$ |
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1.6051 |
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1.5969 |
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In fiscal 2010, based on our foreign currency exposures noted above, varying the above foreign
exchange rates to reflect a 5% strengthening of the Canadian dollar would have increased the net
profit as follows, assuming that all other variables remained constant:
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(in thousands of dollars) |
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$US |
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EURO |
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GBP |
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Increase in net profit |
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1,298 |
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(1 |
) |
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(4 |
) |
|
An assumed 5% weakening of the Canadian dollar would have had an equal but opposite effect on the
above currencies to the amounts shown above, assuming that all other variables remain constant.
Interest Rate Risk
Interest rate risk is the risk that the fair value or future cash flows of a financial instrument
will fluctuate because of changes in market interest rates.
Our short-term bonds are invested at fixed interest rates and/or mature in the short-term.
Long-term bonds are also instruments that bear interest at fixed rates. The risk that we will
realize a
- 14 -
loss as a result of a decline in the fair value of our bonds is limited because these investments,
although they are classified as available for sale, are generally held to maturity. The unrealized
gains or losses on bonds are recorded in accumulated other comprehensive income.
Based on the value of our short and long-term bonds at November 30, 2010, an assumed 0.5% decrease
in market interest rates would have increased the fair value of these bonds and the accumulated
other comprehensive income by approximately $336,000; an assumed increase in interest rate of 0.5%
would have an equal but opposite effect, assuming that all other variables remained constant.
Cash bears interest at a variable rate. Trade and other receivables, accounts payable and accrued
liabilities bear no interest.
Based on the average value of variable interest-bearing cash during year ended November 30, 2010
($3,219,000), an assumed 0.5% increase in interest rates during such period would have increased
the future cash flow and the net profit by approximately $16,000; an assumed decrease of 0.5% would
have had an equal but opposite effect.
Financial Instruments
We have determined that the carrying values of our short-term financial assets and liabilities,
including cash, trade and other receivables as well as accounts payable and accrued liabilities,
approximate their fair value because of the relatively short period to maturity of the instruments.
Bonds are stated at estimated fair value, determined by inputs that are primarily based on broker
quotes at the reporting date (level 2 inputs see note 22 Determination of fair values).
Critical Accounting Estimates
Use of Estimates and the Exercise of Judgment
The preparation of our Audited Consolidated Financial Statements in conformity with IFRS requires
management to make estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the reporting period.
Information about critical judgments in applying accounting policies and assumption and estimation
uncertainties that have the most significant effect on the amounts recognized in the consolidated
financial statements is included in the following notes to the Audited Consolidated Financial
Statements:
Note 4 Revenue and deferred revenue
Note 15 (iv) Stock option plan
Note 16 Income taxes
Note 18 Contingent liability
Other areas of judgement and uncertainty relate to the estimation of accruals for clinical trial
expenses, the recoverability of inventories, the measurement of the amount and assessment of the
recoverability of tax credits and grants receivable and capitalization of development expenditures.
- 15 -
Reported amounts and note disclosure reflect the overall economic conditions that are most likely
to occur and the anticipated measures management intends to take. Actual results could differ from
those estimates.
The above estimates and assumptions are reviewed regularly. Revisions to accounting estimates are
recognized in the period in which the estimates are revised and in any future periods affected.
Conversion to IFRS
In February 2008, the Accounting Standards Board of Canada (AcSB) announced that accounting
standards in Canada, as used by public companies, would converge with IFRS, for financial periods
beginning on and after January 1, 2011 with the option to early adopt IFRS upon receipt of approval
from the Canadian Securities regulatory authorities. In the fourth quarter, we filed a request to
adopt IFRS two years in advance of the date required under the AcSB, using December 1, 2008 as the
date of transition and December 1, 2009 as the changeover date. Our request was granted and as a
result, the consolidated financial statements for the year ended November 30, 2010 are our first
annual financial statements prepared in conformity with IFRS.
Because we had previously filed financial statements and MD&As for the first, second and third
quarters of 2010 with comparisons to 2009 in accordance with Canadian GAAP, these statements were
restated and re-filed on February 8, 2011 to reflect our adoption of IFRS. Periods prior to
December 1, 2008 have not been restated.
In preparing these first IFRS financial statements, we used the IFRS accounting policies in effect
as at November 30, 2010, including IFRS 1 First-time Adoption of International Financial
Reporting Standards (IFRS 1). IFRS 1 provides guidance for an entitys initial adoption of IFRS
and outlines that, in general, an entity applies the principles under IFRS retrospectively with
adjustments arising on conversion from Canadian GAAP to IFRS being directly recognized in retained
earnings as of the beginning of the first comparative financial statements presented. IFRS 1 also
requires companies adopting IFRS to reconcile equity and net earnings from the previously reported
Canadian GAAP amounts to the restated IFRS amounts. Our reconciliation of equity under Canadian
GAAP as at December 1, 2008, the date of transition, and as at November 30, 2009 to the restated
IFRS amounts are included in note 27 of the consolidated financial statements, as is the
reconciliation of comprehensive income for the year-ended November 30, 2009.
IFRS 1 also provides certain optional exemptions from retrospective application of certain IFRS
requirements as well as mandatory exceptions which prohibit retrospective application of standards.
We elected to apply the following optional exemptions from full retrospective application:
(i) IFRS 2 Share-based Payment: IFRS 1 encourages the application of IFRS 2, Share-based Payment
provisions to equity instruments granted on or before November 7, 2002, but permits the application
only to equity instruments granted after November 7, 2002 that were not vested by the transition
date. As permitted by this exemption, the Company applied IFRS 2 only to equity instruments granted
after November 7, 2002 that were not vested by December 1, 2008.
(ii) Designation of financial assets and financial liabilities exemption: we elected to
redesignate cash from the held for trading category to loans and receivables.
- 16 -
We also followed the mandatory exemptions applicable to the Company as described below:
Estimates
Hindsight cannot be used to create or revise estimates. Estimates previously made under Canadian
GAAP cannot be revised for application of IFRS except where necessary to reflect any difference in
accounting policies.
Impact of IFRS on the Companys Financial Statements
The adoption of IFRS resulted in some changes to our accounting policies that were applied in the
recognition, measurement and disclosure of balances and transactions in our financial statements.
However, none of the changes to our accounting policies resulted in significant changes to line
items within our financial statements.
The following provides a summary of our evaluation of important changes to accounting policies in
key areas:
IFRS 2, Share-based Payment (IFRS 2)
Under IFRS, when stock option awards vest gradually, each tranche is to be considered as a separate
award, while under Canadian GAAP, companies can make a policy choice to consider gradually vested
tranches as a single award. Similarly, the IFRS standard requires that forfeiture estimates be
established at the time of the initial fair value assessment of share-based payments rather than to
account for the forfeitures as they occur. Therefore, the compensation expense will have to be
recognized over the expected term of each tranche and take into account the impact of the
differences in accounting for forfeitures. As a result of this change, an amount of $175,000 was
recorded to deficit at the transition date, with the counterpart to contributed surplus.
IAS 36, Impairment of Assets (IAS 36)
Under Canadian GAAP impairment standards for non-financial assets, a write-down to estimated fair
value is recognized if the estimated undiscounted future cash flows from an asset or group of
assets are less than their carrying value. IAS 36 requires a write-down to be recognized if the
recoverable amount, determined as the higher of the estimated fair value less costs to sell or
value in use, is less than carrying value. We performed impairment testing as of December 1, 2008
and concluded that no impairment charge was required under IFRS. No impairment indicators were
identified for the period between the transition date and November 30, 2009 and November 30, 2010.
IAS 36 also permits the reversal of certain impairment charges where conditions have changed. We
reviewed past impairment charges and concluded that there was no justification for reversal of past
impairment charges.
IAS 1, Presentation of Financial Statements (IAS 1)
Financial statement presentation is addressed in conjunction with the related IFRS standards.
Certain additional disclosures were required in the notes to the financial statements and the
statement of comprehensive income was modified to reflect a presentation by function. The
reclassifications required as a result of this change are described in note 27 (c) of the
consolidated financial statements.
Other Standards
Our examination of all other standards, including for example, IAS 21 The Effects of Changes in
Foreign Exchange Rates, IAS 37 Provisions, Contingent Liabilities and Contingent Assets, and IAS
18 Revenue, revealed no significant adjustment was necessary other than enhanced disclosures.
- 17 -
Note 27 of the consolidated financial statements for the year ended November 30, 2010 contains a
detailed description of our conversion to IFRS, including a line-by-line reconciliation of our
financial statements previously prepared under Canadian GAAP to those under IFRS as at November 30,
2009 and December 1, 2008.
Impact on the Business
The impact of the conversion to IFRS on the Company was minimal and therefore resulted in a limited
number of adjustments. Our systems easily accommodated the required changes. Our internal controls
and disclosure controls and procedures did not require significant modification as a result of its
conversion to IFRS. Furthermore, there was no impact on our contractual arrangements or compliance
thereto.
Impact on Information Systems and Technology
The transition had minimal impacts on our information systems. The areas where information systems
were most impacted were minor modifications to certain general ledger accounts, sub-ledgers and
end-user reports to accommodate IFRS accounting adjustments, recording, and heightened disclosures.
Impact on Internal Control over Financial Reporting and Disclosure Controls and Procedures
Our internal controls over financial reporting were also not significantly affected by the
transition to IFRS. The IFRS differences required presentation and process changes to report more
detailed information in the notes to the financial statements, as well as certain changes to the
recognition and measurement practices. Disclosure controls and procedures were adapted to take into
consideration the changes in recognition, measurement and disclosure practices but the impact was
minimal as well.
Impact on Financial Reporting Expertise
Training and education was provided to all members of the finance team who are directly affected by
the transition to IFRS. This training focused mainly on the process changes required and an
overview of the reasons behind the changes from a standards perspective.
New accounting policies
Certain pronouncements were issued by the IASB or International Financial Reporting Interpretation
Committee that are mandatory for annual periods beginning after January 1, 2010 or later periods.
Many of these updates are not applicable or are inconsequential to us and have been excluded from
the discussion below. The remaining pronouncements are being assessed to determine their impact on
our results and financial position:
Annual improvements to IFRS
The IASBs improvements to IFRS published in April 2009 contain fifteen amendments to twelve
standards that result in accounting changes for presentation, recognition or measurement purposes
largely for annual periods beginning on or after January 1, 2010, with early adoption permitted.
These amendments were considered by the Company and deemed to be not applicable to the Company
other than for the amendment to IAS 17 Leases relating to leases which include both land and
buildings elements. In this case, the Company early adopted this amendment.
- 18 -
The IASBs improvements to IFRS contain seven amendments that result in accounting changes for
presentation, recognition or measurement purposes. The most significant features of the IASBs
annual improvements project published in May 2010 are included under the specific revisions to
standards discussed below.
(i) |
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IFRS 3: |
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Revision to IFRS 3, Business Combinations: |
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Effective for annual periods beginning on or after July 1, 2010 with earlier adoption
permitted. |
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Clarification on the following areas: |
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the choice of measuring non-controlling interests at fair value or at the
proportionate share of the acquirees net assets applies only to instruments that
represent present ownership interests and entitle their holders to a proportionate
share of the net assets in the event of liquidation. All other components of
non-controlling interest are measured at fair value unless another measurement basis is
required by IFRS. |
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|
application guidance relating to the accounting for share-based payments in IFRS 3
applies to all share-based payment transactions that are part of a business
combination, including un-replaced awards (i.e., unexpired awards
over the acquiree shares that remain outstanding rather than being replaced by the acquirer) and
voluntarily replaced share-based payment awards. |
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|
Amendment to IFRS 7, Financial Instruments: Disclosures: |
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|
Effective for annual periods beginning on or after January 1, 2011 with earlier
adoption permitted. |
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|
Multiple clarifications related to the disclosure of financial instruments and in
particular in regards to transfers of financial assets. |
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Amendment to IAS 1, Presentation of Financial Statements: |
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|
Effective for annual periods beginning on or after January 1, 2011 with earlier
adoption permitted. |
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Entities may present the analysis of the components of other comprehensive income
either in the statement of changes in equity or within the notes to the financial
statements. |
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Amendment to IAS 27, Consolidated and Separate Financial Statements: |
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|
Effective for annual periods beginning on or after January 1, 2011 with earlier
adoption permitted. |
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The 2008 revisions to this standard resulted in consequential amendments to IAS 21, |
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|
The Effects of Changes in Foreign Exchange Rates, IAS 28, Investments in Associates,
and IAS 31, Interests in Joint Ventures. IAS 27 now provides that these amendments are
to be applied prospectively. |
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|
Amendment to IAS 34, Interim Financial Reporting: |
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|
Effective for annual periods beginning on or after January 1, 2011 with earlier
adoption permitted. |
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|
The amendments place greater emphasis on the disclosure principles for interim
financial reporting involving significant events and transactions, including changes to |
- 19 -
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fair value measurements and the need to update relevant information from the most
recent annual report. |
New or revised standards and interpretations
In addition, the following new or revised standards and interpretations have been issued but are
not yet applicable to the Company:
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|
Amendments to IAS 24, Related Party Disclosures: |
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|
Effective for annual periods beginning on or after January 1, 2011 with earlier
adoption is permitted. |
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|
There are limited differences in the definition of what constitutes a related party;
however, the amendment requires more detailed disclosures regarding commitments. |
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IFRS 8, Operating Segments: |
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|
Effective for annual periods beginning on or after January 1, 2010.
Requires purchase information about segment assets. |
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New standard IFRS 9, Financial Instruments: |
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Effective for annual periods beginning on or after January 1, 2013 with earlier
adoption permitted. |
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As part of the project to replace IAS 39, Financial Instruments: Recognition and
Measurement, this standard retains but simplifies the mixed measurement model and
establishes two primary measurement categories for financial assets. More specifically,
the standard: |
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deals with classification and measurement of financial assets |
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establishes two primary measurement categories for financial assets: amortized
cost and fair value |
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classification depends on entitys business model and the contractual cash flow
characteristics of the financial asset |
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eliminates the existing categories: held to maturity, available for sale, and loans
and receivables. |
Certain changes were also made regarding the fair value option for financial liabilities and
accounting for certain derivatives linked to unquoted equity instruments.
Outstanding share data
At February 7, 2011, the common shares issued and outstanding were 60,515,764 while outstanding
options granted under the stock option plan were 3,068,306.
- 20 -
Disclosure controls and procedures and internal control over financial reporting
As at November 30, 2010, an evaluation of the design and operating effectiveness of our disclosure
controls and procedures, as defined in the rules of Canadian Securities Administrators, was carried
out. Based on that evaluation, the President and Chief Executive Officer and the Senior Executive
Vice-President and Chief Financial Officer concluded that the design and operating effectiveness of
those disclosure controls and procedures were effective.
Also as November 30, 2010, an evaluation of the design and operating effectiveness of internal
controls over financial reporting, as defined in the rules of the Canadian Securities
Administrators, was carried out to provide reasonable assurance regarding the reliability of
financial reporting and financial statement compliance with IFRS. Based on that evaluation, the
President and Chief Executive Officer and the Senior Executive Vice-President and Chief Financial
Officer concluded that the design and operating effectiveness of internal controls over financial
reporting were effective.
These evaluations were based on the framework established in Internal Control Integrated
Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission, a
recognized control model, and the requirements of Multilateral Instrument 52-109 of the Canadian
Securities Administrators. A disclosure committee comprised of members of senior management assists
the President and Chief Executive Officer and the Senior Executive Vice-President and Chief
Financial Officer in their responsibilities.
All control systems, no matter how well designed, have inherent limitations, including the
possibility of human error and the circumvention or overriding of the controls or procedures. As a
result, there is no certainty that our disclosure controls and procedures or internal control over
financial reporting will prevent all errors or all fraud. There were no changes in our internal
controls over financial reporting that occurred during the year ended November 30, 2010 that have
materially affected, or are reasonably likely to materially affect, our internal controls over
financial reporting.
Risks and uncertainties
Investors should understand that we operate in a high risk industry. We have identified the
following risks and uncertainties that may have a material adverse effect on our business,
financial condition or operating results. Investors should carefully consider the risks described
below before purchasing our securities. The risks described below are not the only ones that we
face. Additional risks not presently known to us or that we currently believe are immaterial may
also significantly impair our business operations. Our business could be harmed by any of these
risks.
- 21 -
Risks Related to the Commercialization of our Product and Product Candidates
Our commercial success depends largely on the commercialization of EGRIFTATM; the
failure of EGRIFTATM to obtain commercial acceptance would have a material adverse
effect on us.
Our ability to generate revenues in the future is primarily based on the commercialization of
EGRIFTATM for the reduction of excess abdominal fat in HIV-infected patients with
lipodystrophy. In the short-term, these revenues should be primarily derived from the U.S. market
alone. Although we have entered into a collaboration and licensing agreement with EMD Serono for
the commercialization of EGRIFTATM in the United States, there can be no assurance that
EGRIFTATM will be successfully commercialized in the United States, or in any other
country. Although we are developing other peptides, all of them are at earlier stages of
development and none of them may reach the clinical trial phase, obtain regulatory approval or,
even if approved, be successfully commercialized.
The overall commercialization success of EGRIFTATM for the reduction of excess abdominal
fat in HIV-infected patients with lipodystrophy will depend on several factors, including:
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receipt of regulatory approvals for EGRIFTATM from regulatory agencies in the
territories other than the United States in which we wish to expand the
commercialization of tesamorelin; |
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market acceptance of EGRIFTATM by the medical community, patients and third-
party payors (such as governmental health administration authorities and private
health coverage insurers); |
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the amount of resources devoted by our commercial partners to commercialize
EGRIFTATM in their respective territories; |
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maintaining manufacturing and supply agreements to ensure the availability of
commercial quantities of EGRIFTATM through validated processes; |
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the number of competitors in our market; and |
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protecting and enforcing our intellectual property and avoiding patent infringement claims. |
The inability to commercialize EGRIFTATM in the United States for the reduction of
excess abdominal fat in HIV-infected patients with lipodystrophy in the short term would delay our
capacity to generate revenues and would have a material adverse effect on our financial condition
and operating results.
- 22 -
We are or will be dependent on a limited number of collaboration and licensing agreements for the
commercialization of EGRIFTATM in the United States, Europe, Latin America, Africa and
the Middle East. These agreements place the commercialization of EGRIFTATM in these
markets outside of our control.
Although our collaboration and licensing agreements with EMD Serono, Sanofi and Ferrer contain
provisions governing their respective responsibilities as partners for the commercialization of
EGRIFTATM in their respective territories, our dependence on these partners to
commercialize EGRIFTATM is subject to a number of risks, including:
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our limited control of the amount and timing of resources that our commercial
partners will be devoting to the commercialization, marketing and distribution of
tesamorelin, including obtaining patient reimbursement for EGRIFTATM, which
could adversely affect our ability to obtain or maximize our royalty payments; |
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disputes or litigation that may arise between us and our commercial partners,
which could adversely affect the commercialization of tesamorelin, all of which
would divert our managements attention and our resources; |
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our commercial partners not properly defending our intellectual property rights or
using them in such a way as to expose us to potential litigation, which could, in
both cases, adversely affect the value of our intellectual property rights; and |
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corporate reorganizations or changes in business strategies of our commercial
partners, which could adversely affect a commercial partners willingness or
ability to fulfill its obligations under its respective agreement. |
Our collaboration and licensing agreements may be terminated by our partners in the event of a
breach by us of our obligations under such agreements, including our obligation to supply
EGRIFTATM , for which we rely on third parties. Our collaboration and licensing
agreement with EMD Serono can also be terminated by EMD Serono for their convenience on 180 days
notice to us. Such a termination could have an adverse effect on our revenues related to the
commercialization of EGRIFTATM in the United States. In addition, EMD Serono has listed
a patent held by one of its affiliates in the Orange Book under the Hatch-Waxman Act with respect
to EGRIFTATM in HIV-associated lipodystrophy. In the event of a termination of our
agreement with EMD Serono, EMD Serono could assert that such patent would be infringed by our
continued sale of EGRIFTATM in the United States. Any such assertion would divert our
managements attention and could have a material adverse effect on our results of operations.
If any one of our commercial partners terminates their agreement with us or fails to effectively
commercialize EGRIFTATM, for any of the foregoing or other reasons, we may not be able
to replace the commercial partner and any of these events would have a material adverse effect on
our business, results of operations and our ability to achieve future profitability, and could
cause our stock price to decline.
We rely on third parties for the manufacture and supply of EGRIFTATM and tesamorelin and
such reliance may adversely affect us if the third parties are unable or unwilling to fulfill their
obligations.
The manufacture of pharmaceutical products requires significant expertise and capital investment,
including the development of advanced manufacturing techniques and process
- 23 -
controls. We do not own or operate manufacturing facilities for the production of tesamorelin or
any of our other product candidates, nor do we have plans to develop our own manufacturing
operations in the foreseeable future. We currently rely on third parties to manufacture and supply
all of our required raw materials, drug substance and drug product for our preclinical research,
clinical trials and commercial sales. For tesamorelin for clinical studies and EGRIFTATM
for commercial sales, we are currently using, and relying on, single suppliers and single
manufacturers for starting materials and the final drug substance. Although potential alternative
suppliers and manufacturers have been identified, we have not qualified these vendors to date and
no assurance can be given that such suppliers will be qualified in the future or receive necessary
regulatory approval.
Our reliance on third-party manufacturers exposes us to a number of risks. We may be subject to
delays in or suspension of the manufacturing of EGRIFTATM and tesamorelin if a
third-party manufacturer:
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becomes unavailable to us for any reason, including as a result of the failure to comply with
good manufacturing practices, or GMP, regulations; |
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experiences manufacturing problems or other operational failures, such as equipment failures
or unplanned facility shutdowns required to comply with GMP or damage from any event, including
fire, flood, earthquake, business restructuring or insolvency; or |
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fails to perform its contractual obligations under our agreement, such as failing to deliver
the quantities requested on a timely basis. |
Any delay in or suspension of the supply of EGRIFTATM could delay or prevent the sale of
EGRIFTATM and, accordingly, adversely affect our revenues and results of operations. In
addition, any manufacturing delay or delay in delivering EGRIFTATM may result in our
being in default under our collaboration agreements. If the damage to a suppliers manufacturer
facility is extensive, or, for any reason, it does not operate in compliance with GMP or the
third-party manufacturer is unable or refuses to perform its obligations under our agreement, we
would need to find an alternative third-party manufacturer. The selection of a replacement
third-party manufacturer would be time-consuming and costly since we would need to validate the
manufacturing facility of such new third-party manufacturer. The validation process would include
an assessment of the capacity of such third-party manufacturer to produce the quantities that we
may request from time to time, the manufacturing process and its compliance with GMP. In addition,
the third-party manufacturer would have to familiarize itself with our technology. Any delay in
finding an alternative third-party manufacturer of tesamorelin and EGRIFTATM could
result in a shortage of such analogue or product, which could materially adversely affect our
business and results of operations.
Even though we have received regulatory approval for EGRIFTATM in the United States, we
still may not be able to successfully commercialize it if we do not gain market acceptance and the
revenue that we generate from its sales, if any, may be limited.
The commercial success of EGRIFTATM or any future products for which we obtain marketing
approval from the FDA or other regulatory authorities, will depend upon the acceptance of such
product by the medical community, including physicians, patients and health care payors. The degree
of market acceptance of any of our products will depend on a number of factors, including:
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acceptance of the product by physicians and patients as safe and effective
treatments and addressing a significant unmet medical need; |
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product price; |
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the effectiveness of our sales and marketing efforts (or those of our commercial
partners); |
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storage requirements and ease of administration; |
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dosing regimen; |
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safety and efficacy; |
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prevalence and severity of side effects; |
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competitive products; |
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the ability to obtain and maintain sufficient third-party coverage or reimbursement
from government health care programs, including Medicare and Medicaid, private
health insurers and other third-party payors; and |
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the willingness and ability of patients to pay out-of-pocket in the absence of third-
party coverage. |
If EGRIFTATM does not achieve an adequate level of acceptance by physicians, health care
payors and patients, we may not generate sufficient revenue from this product, and we may not be
able to achieve profitability. Our efforts, and the efforts of our commercial partners, to educate
the medical community and third-party payors on the benefits of tesamorelin may require significant
resources and may never be successful.
We have no internal sales, marketing or distribution capabilities so we must rely on strategic
alliance agreements with third parties for the sale and marketing of EGRIFTATM or any
future products.
We currently have no internal sales, marketing or distribution capabilities and we rely on our
commercial partners to market and sell EGRIFTATM in their respective territories. Our
agreements with our commercial partners contain termination provisions which, if exercised, could
delay or suspend the commercialization of EGRIFTATM or any future products.
In the event of any such termination, in order to continue commercialization, we would be required
to build our own sales force or enter into agreements with third parties to provide such
capabilities. We currently have limited marketing capabilities and we have limited experience in
developing, training or managing a sales force. The development of a sales force would be costly
and would be time-consuming given the limited experience we have in this area. To the extent we
develop a sales force, we could be competing against companies that have more experience in
managing a sales force than we have and that have access to more funds than we with which to manage
a sales force. Consequently, there can be no assurance that a sales force which we develop would be
efficient and would maximize the revenues derived from the sale of EGRIFTATM or any
future products.
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We are substantially dependent on revenues from EGRIFTATM.
Our current and future revenues depend substantially upon sales of EGRIFTATM by our
commercial partners, EMD Serono, Sanofi and Ferrer. Any negative developments relating to this
product, such as safety or efficacy issues, the introduction or greater acceptance of competing
products, including those marketed and sold by our commercial partners, or adverse regulatory or
legislative developments, would have a material adverse effect on our business, prospects and
results of operations. Although we continue to develop additional product candidates for
commercialization, we expect to be substantially dependent on sales from EGRIFTATM for
the foreseeable future. A decline in sales from this product would adversely affect our business.
Our levels of revenues are highly dependent on obtaining patient reimbursement for
EGRIFTATM.
Market acceptance and sales of EGRIFTATM will substantially depend on the availability
of reimbursement from third party payors such as governmental authorities, including U.S. Medicare
and Medicaid, managed care providers, and private insurance plans and may be affected by healthcare
reform measures in the United States and elsewhere. Government authorities and third-party payors,
such as private health insurers and health maintenance organizations, decide which medications they
will pay for and establish reimbursement levels. A primary trend in the U.S. healthcare industry
and elsewhere is cost containment. Government authorities and these third-party payors have
attempted to control costs by limiting coverage and the amount of reimbursement for particular
medications. Increasingly, third-party payors have been challenging the prices charged for
products.
Under our agreements with our commercial partners, they are responsible for seeking reimbursement
of EGRIFTATM in their respective territories and as a result we have no control over
whether or what level of reimbursement is achieved.
We cannot be sure that reimbursement by insurers, government or other third parties will be
available for EGRIFTATM and, if reimbursement is available, the level of reimbursement
provided to patients. Reimbursement may impact the demand for, or the price of,
EGRIFTATM and our future products for which we obtain marketing approval. If
reimbursement is not available or is available only in limited amount, our commercial partners may
not be able to successfully commercialize EGRIFTATM or our future products and it will
have a material adverse effect on our revenues and royalties, business and prospects.
A variety of risks associated with our international business relationships could materially
adversely affect our business.
International business relationships in the United States, Europe, Latin America, Africa, the
Middle East and elsewhere subject us to additional risks, including:
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differing regulatory requirements for drug approvals in foreign countries; |
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potentially reduced protection for intellectual property rights; |
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potential third-party patent rights in foreign countries; |
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the potential for so-called parallel importing, which is what happens when a local
seller, faced with high or higher local prices, opts to import goods from a foreign
market, with low or lower prices, rather than buying them locally; |
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unexpected changes in tariffs, trade barriers and regulatory requirements; |
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economic weakness, including inflation, or political instability, particularly in
foreign economies and markets; |
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compliance with tax, employment, immigration and labor laws for employees
traveling abroad; |
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foreign taxes; |
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foreign exchange contracts and foreign currency fluctuations, which could result
in increased operating expenses and reduced revenue, and other obligations
incident to doing business in another country; |
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workforce uncertainty in countries where labor unrest is more common than in the
United States and Canada; |
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production shortages resulting from any events affecting raw material supply or
manufacturing capabilities abroad; and |
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business interruptions resulting from geo-political actions, including war and
terrorism, or natural disasters, including earthquakes, volcanoes, typhoons,
floods, hurricanes and fires. |
These and other risks of international business relationships may materially adversely affect our
business, prospects, results of operations and financial condition.
Governments outside the United States tend to impose strict price controls, which may adversely
affect our revenues, if any.
In several countries, including countries which are in Europe, Latin America, Africa, and the
Middle East, the pricing of prescription drugs may be subject to governmental control. In these
countries, pricing negotiations with governmental authorities can take considerable time and delay
the marketing of a product. To obtain reimbursement or pricing approval in some countries, a
clinical trial that compares the cost-effectiveness of a product candidate to other available
therapies may be required. If reimbursement of our product is unavailable or limited in scope or
amount, or if pricing is set at unsatisfactory levels, our commercial partners may not be willing
to devote resources to market and commercialize EGRIFTATM or may decide to cease
marketing such product. In such case, our business, prospects and results of operations could be
materially adversely affected.
We face competition and the development of new products by other companies could materially
adversely affect our business and products.
The biopharmaceutical and pharmaceutical industries are highly competitive and we must compete with
pharmaceutical companies, biotechnology companies, academic and research institutions as well as
governmental agencies for the development and commercialization of
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products, most of which have substantially greater financial, technical and personnel resources
than us. Although we believe that we have no direct competitors for the reduction of excess
abdominal fat in HIV-infected patients with lipodystrophy, we could face indirect competition from
other companies developing and/or commercializing metabolic products and/or other products that
reduce or eliminate the occurrence of lipodystrophy.
In the other clinical programs that we are currently evaluating for development, there may exist
companies that are at a more advanced stage of developing a product to treat the diseases for which
we are evaluating clinical programs. Some of these competitors could have access to capital
resources, research and development personnel and facilities that are superior to ours. In
addition, some of these competitors could be more experienced than we are in the development and
commercialization of medical products and already have a sales force in place to launch new
products. Consequently, they may be able to develop alternative forms of medical treatment which
could compete with our products and which could be commercialized more rapidly and effectively than
our products.
If we fail to comply with government regulations regarding the import and export of products and
raw materials, we could be subject to fines, sanctions and penalties that could adversely affect
our ability to operate our business.
We import and export products and raw materials from and to several jurisdictions around the world.
This process requires us and our commercial partners to operate in a number of jurisdictions with
different customs and import/export regulations. The regulations of these countries are subject to
change from time to time and we cannot predict the nature, scope or impact of these changes upon
our operations. We and our commercial partners are subject to periodic reviews and audits by U.S.
and foreign authorities responsible for administering these regulations. To the extent that we or
our commercial partners are unable to successfully defend against an audit or review, we may be
required to pay assessments, penalties and increased duties, which may, individually or in the
aggregate, negatively impact our business, operating results and financial condition.
Risks Related to the Regulatory Review Process
Even after regulatory approval has been obtained regulatory agencies may impose limitations on the
indicated uses for which our products may be marketed, subsequently withdraw approval or take other
actions against us that would be adverse to our business.
Even though we have obtained marketing approval of EGRIFTATM in the United States, the
FDA and regulatory agencies in other countries have the ability to limit the indicated use of a
product. Also, the manufacture, marketing and sale of our products will be subject to ongoing and
extensive governmental regulation in the country in which we intend to market our products. For
example, although we obtained marketing approval of EGRIFTATM for the reduction of
excess abdominal fat in HIV-infected patients with lipodystrophy in the United States, the
marketing of EGRIFTATM will be subject to extensive regulatory requirements administered
by the FDA, such as adverse event reporting and compliance with marketing and promotional
requirements. The FDA has also requested that we comply with certain post-approval requirements in
connection with the approval of EGRIFTATM for the reduction of excess abdominal fat in
HIV-infected patients with lipodystrophy, namely, the development of a single vial formulation of
EGRIFTATM (the development of a new presentation of the same formulation), a long-term
observational
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safety study using EGRIFTATM; and a Phase 4 clinical trial. Although we have received
marketing approval from the FDA of tesamorelin for the reduction of excess abdominal fat in
HIV-infected patients with lipodystrophy, there can be no guarantee that regulatory agencies in
other countries will approve tesamorelin for this treatment in their respective countries.
Our third party manufacturing facilities for EGRIFTATM will also be subject to
continuous reviews and periodic inspections and approval of manufacturing modifications by
regulatory agencies, including the FDA. The facilities must comply with GMP regulations. The
failure to comply with FDA requirements can result in a series of administrative or judicial
sanctions or other setbacks, including:
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restrictions on the use of the product, manufacturers or manufacturing processes; |
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warning letters; |
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civil or criminal penalties; |
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fines; |
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injunctions; |
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product seizures or detentions; |
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import or export bans or restrictions; |
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product recalls and related publicity requirements; |
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suspension or withdrawal of regulatory approvals; |
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total or partial suspension of production; and |
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refusal to approve pending applications for marketing approval of new product
candidates or supplements to approved applications. |
Addressing any of the foregoing or any additional requirements of the FDA or other regulatory
authorities may require significant resources and could impair our ability to successfully
commercialize our product candidates.
To date, we do not have the required regulatory approvals to commercialize EGRIFTATM
outside of the United States and cannot guarantee that we will obtain such regulatory approvals or
that any of our product candidates will be approved for commercialization in any country, including
the United States.
The commercialization of EGRIFTATM outside of the United States and our future products
first requires the approval of the regulatory agencies in each of the jurisdictions where we intend
to sell such products. In order to obtain the required approvals, we must demonstrate, following
preclinical and clinical studies, the safety, efficacy and quality of a product.
The rules and regulations relating to the approval of a new drug are complex and stringent.
Although we have received marketing approval in the United States from the FDA for
EGRIFTATM, there can be no guarantee that regulatory agencies in other territories will
approve EGRIFTATM in their respective countries.
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All of our product candidates are subject to preclinical and clinical studies. If the results of
such studies are not positive, we may not be in a position to make any filing to obtain the
regulatory approval for the product candidate or, even where a product candidate has been filed for
approval, we may have to conduct additional clinical trials or testing on such product candidate in
an effort to obtain results that further support the safety and efficacy of such product candidate.
Such studies are often costly and may also delay a filing or, where additional studies or testing
are required after a filing has been made, the approval of a product candidate.
While an application for a new drug is under review by a regulatory agency, it is standard for such
regulatory agency to ask questions regarding the application that was submitted. If these questions
are not answered quickly and in a satisfactory manner, the marketing approval of the product
candidate subject to the review and its commercialization could be delayed or, if the questions are
not answered in a satisfactory manner, denied. If EGRIFTATM is not approved by the
appropriate regulatory agencies for commercialization outside of the United States, our capacity to
generate revenues in the long-term will be impaired and this will have an adverse effect on our
financial condition and our operating results.
Obtaining regulatory approval is subject to the discretion of regulatory agencies in each relevant
jurisdiction. Therefore, even if we obtain regulatory approval from one agency, or succeed in
filing the equivalent of a new drug application, or NDA, in other countries, or have obtained
positive results relating to the safety and efficacy of a product candidate, a regulatory agency
may not accept the filing or the results contained therein as being conclusive evidence of the
safety and efficacy of a product candidate in order to allow us to sell the product candidate in
its country. A regulatory agency may require that additional tests on the safety and efficacy of a
product candidate be conducted prior to granting approval of such product candidate. These
additional tests may delay the approval of such product candidate, can have a material adverse
effect on our financial condition and results of operations based on the type of additional tests
to be conducted and may not necessarily lead to the approval of the product candidate.
We have only obtained FDA approval for EGRIFTATM
and we must complete several
preclinical studies and clinical trials for our other product candidates which may not yield
positive results and, consequently, could prevent us from obtaining regulatory approval.
If any of our preclinical studies or clinical trials fail to show positive efficacy data or result
in adverse patient reactions, we may be required to perform additional preclinical studies or
clinical trials, to extend the term of our studies and trials, to increase the number of patients
enrolled in a given trial or to undertake ancillary testing. Any of these events could cause an
increase in the cost of product development, delay filing of an application for marketing approval
or result in the termination of a study or trial and, accordingly, could cause us to cease the
development of a product candidate. In addition, the future growth of our business could be
negatively impacted since there can be no guarantee that we will be able to develop new compounds,
license or purchase compounds or product candidates that will result in marketed products.
Recently enacted and future legislation may increase the difficulty and cost for us to obtain
marketing approval of and commercialize our product candidates and affect the prices we may obtain.
In the United States and some foreign jurisdictions, there have been a number of legislative and
regulatory changes and proposed changes regarding the healthcare system that could prevent or delay
marketing approval for our product candidates, restrict or regulate post-approval
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activities and affect our ability to profitably sell EGRIFTATM or any of our other
product candidates for which we intend to seek marketing approval.
Legislative and regulatory proposals have been made to expand post-approval requirements and
restrict sales and promotional activities for pharmaceutical products. We are not sure whether
additional legislative changes will be enacted, or whether the FDA regulations, guidance or
interpretations will be changed, or what the impact of such changes on the marketing approvals of
our product candidates, if any, may be. In addition, increased scrutiny by the U.S. Congress of the
FDAs approval process may significantly delay or prevent marketing approval, as well as subject us
to more stringent product labeling and post-marketing testing and other requirements.
In the United States, the Medicare Modernization Act, or MMA, changed the way Medicare covers and
pays for pharmaceutical products. The legislation expanded Medicare coverage for drug purchases by
the elderly and introduced a new reimbursement methodology based on average sales prices for drugs.
In addition, this legislation authorized Medicare Part D prescription drug plans to use formularies
where they can limit the number of drugs that will be covered in any therapeutic class. As a result
of this legislation and the expansion of federal coverage of drug products, we expect that there
will be additional pressure to contain and reduce costs. These cost reduction initiatives and other
provisions of this legislation could decrease the coverage and sales price that we receive for
EGRIFTATM or any other approved products and could seriously harm our business. While
the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow
Medicare coverage policy and payment limitations in setting their own reimbursement rates, and any
reduction in reimbursement that results from the MMA may result in a similar reduction in payments
from private payors.
More recently, in March 2010, U.S. President Obama signed into law the Health Care Reform Law, a
sweeping law intended to broaden access to health insurance, reduce or constrain the growth of
healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements
for healthcare and health insurance industries, impose new taxes and fees on the health industry
and impose additional health policy reforms. Effective October 1, 2010, the Health Care Reform Law
revised the definition of average manufacturer price for reporting purposes, which could increase
the amount of Medicaid drug rebates to states. Further, beginning in 2011, the new law imposes a
significant annual fee on companies that manufacture or import branded prescription drug products.
We will not know the full effects of the Health Care Reform Law until applicable U.S. federal and
state agencies issue regulations or guidance under the new law. Although it is too early to
determine the effect of the Health Care Reform Law, the new law appears likely to continue to apply
the pressure on pharmaceutical pricing. Pressure on pharmaceutical pricing may adversely affect the
amount of our royalties in the United States.
Risks Related to Our Intellectual Property
Our failure to protect our intellectual property may have a material adverse effect on our ability
to develop and commercialize our products.
We will be able to protect our intellectual property rights from unauthorized use by third parties
only to the extent that our intellectual property rights are covered and protected by valid and
enforceable patents or are effectively maintained as trade secrets. We try to protect our
intellectual property position by, among other things, filing patent applications related to our
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proprietary technologies, inventions and improvements that are important to the development of our
business.
Because the patent position of pharmaceutical companies involves complex legal and factual
questions, the issuance, scope, validity, and enforceability of patents cannot be predicted with
certainty. Patents, if issued, may be challenged, invalidated or circumvented. If our patents are
invalidated or found to be unenforceable, we would lose the ability to exclude others from making,
using or selling the inventions claimed. Moreover, an issued patent does not guarantee us the right
to use the patented technology or commercialize a product using that technology. Third parties may
have blocking patents that could be used to prevent us from developing our product candidates,
selling our products or commercializing our patented technology. Thus, patents that we own may not
allow us to exploit the rights conferred by our intellectual property protection.
Our pending patent applications may not be issued or granted as patents. Even if issued, they may
not be issued with claims of sufficient breadth to protect our product candidates and technologies
or may not provide us with a competitive advantage against competitors with similar products or
technologies. Furthermore, others may independently develop products or technologies similar to
those that we have developed or may reverse engineer or discover our trade secrets through proper
means. In addition, the laws of many countries do not protect intellectual property rights to the
same extent as the laws of Canada, the United States and the European Patent Convention, and those
countries may also lack adequate rules and procedures for defending intellectual property rights
effectively.
Although we have received patents from the United States Patent and Trademark Office, or USPTO, for
the treatment of HIV-related lipodystrophy with tesamorelin, there can be no guarantee that, in the
other countries where we filed patent applications for the treatment of HIV-related lipodystrophy,
we will receive a patent or obtain granted claims of similar breadth to those granted by the USPTO.
We also rely on trade secrets, know-how and technology, which are not protected by patents, to
maintain our competitive position. We try to protect this information by entering into
confidentiality agreements with parties who have access to such confidential information, such as
our current and prospective suppliers, distributors, manufacturers, commercial partners, employees
and consultants. Any of these parties may breach the agreements and disclose confidential
information to our competitors. It is possible that a competitor will make use of such information,
and that our competitive position could be disadvantaged.
Enforcing a claim that a third party infringes on, has illegally obtained or is using an
intellectual property right, including a trade secret or know-how, is expensive and time-consuming
and the outcome is unpredictable. In addition, enforcing such a claim could divert managements
attention from our business. If any intellectual property right were to be infringed, disclosed to
or independently developed by a competitor, our competitive position could be harmed. Any adverse
outcome of such litigation or settlement of such a dispute could subject us to significant
liabilities, could put one or more of our patents at risk of being invalidated or interpreted
narrowly, could put one or more of our patents at risk of not issuing, or could facilitate the
entry of generic products. Any such litigation could also divert our research, technical and
management personnel from their normal responsibilities.
Our ability to defend ourselves against infringement by third parties of our intellectual property
in the United States with respect to tesamorelin for the treatment of HIV-related lipodystrophy
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depends, in part, on our commercial partners decision to bring an action against such third party.
Under the terms and conditions of our collaboration and licensing agreement with EMD Serono, EMD
Serono has the first right to bring an action against a third party for infringing our patent
rights with respect to tesamorelin for the treatment of HIV-related lipodystrophy. Any delay in
pursuing such action or in advising us that it does not intend to pursue the matter could decrease
sales, if any, of tesamorelin for the treatment of HIV-related lipodystrophy and adversely affect
our revenues.
Furthermore, because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our confidential information could
be compromised by disclosure during this type of litigation. For example, confidential information
may be disclosed, inadvertently or as ordered by the court, in the form of documents or testimony
in connection with discovery requests, depositions or trial testimony. This disclosure would
provide our competitors with access to our proprietary information and may harm our competitive
position.
Our commercial success depends, in part, on our ability not to infringe on third party patents and
other intellectual property rights.
Our capacity to commercialize our product candidates, and more particularly tesamorelin, will
depend, in part, upon our ability to avoid infringing third party patents and other third party
intellectual property rights. The biopharmaceutical and pharmaceutical industries have produced a
multitude of patents and it is not always easy for participants, including us, to determine which
patents cover various types of products, processes of manufacture or methods of use. The scope and
breadth of patents is subject to interpretation by the courts and such interpretation may vary
depending on the jurisdiction where the claim is filed and the court where such claim is litigated.
The fact that we own patents for tesamorelin and for the treatment of HIV-related lipodystrophy
does not guarantee that we are not infringing one or more third-party patents and there can be no
guarantee that we will not infringe or violate third-party patents and other third-party
intellectual property rights in the United States or other jurisdictions.
Patent analysis for non-infringement is based in part on a review of publicly available databases.
Although we review from time to time certain databases to conduct patent searches, we do not have
access to all databases. It is also possible that we will not have reviewed some of the information contained in the databases or we found it to be
irrelevant at the time we conducted the searches. In addition, because patents take years to issue,
there may be currently pending applications that have not yet been published or that we are unaware
of, which may issue later as patents. As a result, there can be no guarantee that we will not
violate third-party patents.
Because of the difficulty in analyzing and interpreting patents, there can be no guarantee that a
third party will not assert that we infringe such third-partys patents or any of its other
intellectual property rights. Under such circumstances, there is no guarantee that we would not
become involved in litigation. Litigation with any third party, even if the allegations are without
merit, is expensive, time-consuming and would divert managements attention from the daily
execution of our business plan. Litigation implies that a portion of our financial assets would be
used to sustain the costs of litigation instead of being allocated to further the development of
our business.
If we are involved in patent infringement litigation, we would need to prevail in demonstrating
that our products do not infringe the asserted patent claims of the relevant patent, that the
patent claims are invalid or that the patent is unenforceable. If we are found to infringe a
third-party
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patent or other intellectual property right, we could be required to enter into royalty or
licensing agreements on terms and conditions that may not be favourable to us, and/or pay damages,
including up to treble damages in the United Sates (for example, if found liable of wilful
infringement) and/or cease the development and commercialization of our product candidates. Even if
we were able to obtain a license, the rights may be nonexclusive, which could result in our
competitors gaining access to the same intellectual property and to compete with us.
We have not been served with any notice alleging that we infringe a third-party patent, but there
may be issued patents that we are unaware of that our products may infringe, or patents that we
believe we do not infringe but ultimately could be found to infringe. We are aware of third-party
patents for the reduction of accumulation of fat tissue in HIV patients and, if a patent
infringement suit was brought against us, we believe that we should not be found to infringe any
valid claims of these patents. If we were to challenge the validity of a competitors issued United
States patent in a United States court, we would need to overcome a statutory presumption of
validity that attaches to every United States patent. This means that, in order to prevail, we
would have to present clear and convincing evidence as to the invalidity of the patents claims. We
cannot guarantee that a court would find in our favour on questions of infringement and validity.
Any finding that we infringe or violate a third-party patent or other intellectual property right
could materially adversely affect our business, financial condition and operating results.
Other Risks Related to Our Business
We have a history of net losses and we may never achieve high profitability.
We have been reporting losses since our inception (except for the financial years ended November
30, 2010, 2001 and 2000) and, as at November 30, 2010, we had an accumulated deficit of
$235,116,000. We do not expect to generate significant recurrent revenues sufficient to cover our
overall activities in the immediate future. As a result of the foregoing, we will need to generate
significant revenues to achieve profitability.
Our profitability will depend on, among other things, our commercial partners ability and
willingness to successfully commercialize EGRIFTATM and to obtain regulatory approval
for the use of tesamorelin in the reduction of excess abdominal fat in HIV-infected patients with
lipodystrophy in Europe, Latin America, Africa and the Middle East. However, there is no guarantee
that our commercial partners will succeed in commercializing EGRIFTATM or that our
product candidates will ever receive approval for commercialization in any jurisdiction and,
accordingly, we may never sustain profitability.
We rely on third-party service providers to conduct our preclinical studies and clinical trials and
the failure by any of these third parties to comply with their obligations may delay the studies
which could have an adverse effect on our development programs.
We have limited human resources to conduct preclinical studies and clinical trials and must rely on
third-party service providers to conduct our studies and trials and carry out certain data
gathering and analyses. If our third-party service providers become unavailable for any reason,
including as a result of the failure to comply with the rules and regulations governing the conduct
of preclinical studies and clinical trials, operational failures such as equipment failures or
unplanned facility shutdowns, or damage from any event such as fire, flood, earthquake, business
restructuring or insolvency or, if they fail to perform their contractual obligations pursuant to
the terms of our agreements with them, such as failing to perform the testing,
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compute the data or complete the reports further to the testing, we may incur delays which may be
significant in connection with the planned timing of our trials and studies which could adversely
affect the timing of the development program of a product candidate or the filing of an application
for marketing approval in a jurisdiction where we rely on third-party service providers to make
such filing. In addition, where we rely on such third-party service provider to help in answering
any question raised by a regulatory agency during its review of one of our files, the
unavailability of such third-party service provider may adversely affect the timing of the review
of an application and, could ultimately delay the approval. If the damages to any of our
third-party service providers are material, or, for any reason, such providers do not operate in
compliance with Good Laboratory Practices, or GLP, or are unable or refuse to perform their
contractual obligations, we would need to find alternative third-party service providers.
If we needed to change or select new third-party service providers, the planned working schedule
related to preclinical studies and/or clinical trials could be delayed since the number of
competent and reliable third-party service providers of preclinical and clinical work in compliance
with GLP is limited. In addition, if we needed to change or select new third-party service
providers to carry out work in response to a regulatory agency review of one of our applications,
there may be delays in responding to such regulatory agency which, in turn, may lead to delays in
commercializing a product candidate.
Any selection of new third-party service providers to carry out work related to preclinical studies
and clinical trials would be time-consuming and would result in additional delays in receiving
data, analysis and reports from such third-party service providers which, in turn, would delay the
filing of any new drug application with regulatory agencies for the purposes of obtaining
regulatory approval to commercialize our product candidates. Furthermore, such delays could
increase our expenditures to develop a product candidate and materially adversely affect our
financial condition and operating results.
The conduct of clinical trials requires the enrolment of patients and difficulties in enrolling
patients could delay the conduct of our clinical trials or result in their non-completion.
The conduct of clinical trials requires the enrolment of patients. We may have difficulties
enrolling patients for the conduct of our future clinical trials as a result of design protocol,
the size of the patient population, the eligibility criteria to participate in the clinical trials,
the availability of competing therapies, the patient referral practices of physicians and the
availability of clinical trial sites. Difficulty in enrolling patients for our clinical trials
could result in the cancellation of clinical trials or delays in completing them. Once patients are
enrolled in a clinical trial, the occurrence of any adverse drug effects or side effects observed
during the trial could result in the clinical trial being cancelled. Any of these events would have
material adverse consequences on the timely development of our product candidates, the filing of an
NDA, or its equivalent, with regulatory agencies and the commercialization of such product
candidates.
We may require additional funding and may not be able to raise the capital necessary to fund all or
part of our capital requirements, including to continue and complete the research and development
of our product candidates and their commercialization.
We do not generate significant recurrent revenues and may need financing in order to fund all or
part of our capital requirements to sustain our growth, to continue research and development of new
product candidates, to conduct clinical programs, to develop our marketing and commercial
capabilities and to meet our compliance obligations with various rules and regulations to which
- 35 -
we are subject. In the past, we have been financed through public equity offerings in Canada and
private placements of our equity securities and we may need to seek additional equity offerings to
raise capital, the size of which cannot be predicted. However, the market conditions or our
business performance may prevent us from having access to the public market in the future at the
times or in the amounts necessary. Therefore, there can be no guarantee that we will be able to
continue to raise additional equity capital by way of public or private equity offerings in the
future. In such a case, we would have to use other means of financing, such as issuing debt
instruments or entering into private financing or credit agreements, the terms and conditions of
which may not be favorable to us. If adequate funding is not available to us, we may be required to
delay, reduce, or eliminate our research and development of new product candidates, our clinical
trials or our marketing and commercialization efforts to launch and distribute new products,
curtail significant portions of our product development programs that are designed to identify new
product candidates and sell or assign rights to our technologies, products or product candidates.
In addition, the issuance and sale of substantial amounts of equity, or other securities, or the
perception that such issuances and sales may occur could adversely affect the market price of our
common shares.
If product liability lawsuits are brought against us, they could result in costly and
time-consuming litigation and significant liabilities.
Despite all reasonable efforts to ensure the safety of EGRIFTATM and our other product
candidates, it is possible that we or our commercial partners will sell products which are
defective, to which patients react in an unexpected manner, or which are alleged to have side
effects. The manufacture and sale of such products may expose us to potential liability, and the
industries in which our products are likely to be sold have been subject to significant product
liability litigation. Any claims, with or without merit, could result in costly litigation, reduced
sales, significant liabilities and diversion of our managements time and attention and could have
a material adverse effect on our financial condition, business and results of operations.
If a product liability claim is brought against us, we may be required to pay legal and other
expenses to defend the claim and, if the claim is successful, damage awards may be substantial
and/or may not be covered, in whole or in part, by our insurance. We may not have sufficient
capital resources to pay a judgment, in which case our creditors could levy against our assets. We
may also be obligated to indemnify our commercial partners and make payments to other parties with
respect to product liability damages and claims. Defending any product liability claims, or
indemnifying others against those claims, could require us to expend significant financial and
managerial resources.
The development and commercialization of our drugs could expose us to liability claims which could
exceed our insurance coverage.
A risk of product liability claims is inherent in the development and commercialization of human
therapeutic products. Product liability insurance is very expensive and offers limited protection.
A product liability claim against us could potentially be greater than the available coverage and,
therefore, have a material adverse effect upon us and our financial condition. Furthermore, a
product liability claim could tarnish our reputation, whether or not such claims are covered by
insurance or are with or without merit.
We depend on our key personnel to research, develop and bring new products to the market and
the loss of key personnel or the inability to attract highly qualified individuals could have a
material adverse effect on our business and growth potential.
- 36 -
The operation of our business requires qualified scientific and management personnel. The loss of
scientific personnel or members of management could have a material adverse effect on our business.
In addition, our growth is and will continue to be dependent, in part, on our ability to hire and
retain the employment of qualified personnel. There can be no guarantee that we will be able to
continue to retain our current employees or will be able to attract qualified personnel to achieve
our business plan.
We may be unable to identify and complete in-licensing or acquisitions. In-licensing or
acquisitions could divert managements attention and financial resources, may negatively affect our
operating results and could cause significant dilution to our shareholders.
In the future, we may engage in selective in-licensing or acquisitions of products or businesses
that we believe are complementary to our products or business. There is a risk that we will not be
able to identify suitable in-licensing or acquisition candidates available for sale at reasonable
prices, complete any in-licensing or acquisition, or successfully integrate any in-licensed or
acquired product or business into our operations. We are likely to face competition for
in-licensing or acquisition candidates from other parties including those that have substantially
greater available resources. In-licensing or acquisitions may involve a number of other risks,
including:
|
|
|
diversion of managements attention; |
|
|
|
|
disruption to our ongoing business; |
|
|
|
|
failure to retain key acquired personnel; |
|
|
|
|
difficulties in integrating acquired operations, technologies, products or personnel; |
|
|
|
|
unanticipated expenses, events or circumstances; |
|
|
|
|
assumption of disclosed and undisclosed liabilities; |
|
|
|
|
inappropriate valuation of the acquired in-process research and development, or
the entire acquired business; and |
|
|
|
|
difficulties in maintaining customer relations. |
If we do not successfully address these risks or any other problems encountered in connection
with an acquisition, the acquisition could have a material adverse effect on our business, results
of operations and financial condition. Inherited liabilities of or other issues with an acquired
business could have a material adverse effect on our performance or our business as a whole. In
addition, if we proceed with an acquisition, our available cash may be used to complete the
transaction, diminishing our liquidity and capital resources, or shares may be issued which could
cause significant dilution to our existing shareholders.
We may not achieve our publicly announced milestones on time.
From time to time, we publicly announce the timing of certain events to occur. These statements are
forward-looking and are based on the best estimate of management at the time relating to
- 37 -
the occurrence of such events. However, the actual timing of such events may differ from what has
been publicly disclosed. Events such as completion of a clinical program, discovery of a new
product candidate, filing of an application to obtain regulatory approval, beginning of
commercialization of our products or announcement of additional clinical programs for a product
candidate may vary from what is publicly disclosed. These variations may occur as a result of a
series of events, including the nature of the results obtained during a clinical trial or during a
research phase, problems with a supplier or a commercial partner or any other event having the
effect of delaying the publicly announced timeline. Our policy on disclosure of forward-looking
information consists of not updating it if the publicly disclosed timeline varies, except as may be
required by law. Any variation in the timing of certain events having the effect of postponing such
events could have an adverse material effect on our business plan, financial condition or operating
results.
The outcome of scientific research is uncertain and our failure to discover new compounds could
slow down the growth of our portfolio of products.
We conduct research activities in order to increase our portfolio of product candidates. The
outcome of scientific research is uncertain and may prove unsuccessful and, therefore, may not lead
to the discovery of new molecules and progression of existing compounds to an advanced development
stage. Our inability to develop new compounds or to further develop the existing ones could slow
down the growth of our portfolio of products.
Risks Related to our Common Shares
Our share price has been volatile, and an investment in our common shares could suffer a decline in
value.
Since our initial public offering in Canada, our valuation and share price have had no meaningful
relationship to current or historical financial results, asset values, book value or many other
criteria based on conventional measures of the value of common shares. The market price of our
common shares will fluctuate due to various factors including the risk factors described herein and
other facts beyond our control.
In the past, when the market price of a stock has been volatile, shareholders have often instituted
securities class action litigation against that company. If any of our shareholders brought a
lawsuit against us, we could incur substantial costs defending the lawsuit. The lawsuit could also
divert the time and attention of our management.
Our quarterly operating results may fluctuate significantly.
We expect our operating results to be subject to quarterly fluctuations. Our net loss and other
operating results will be affected by numerous factors, including:
|
|
|
variations in the level of revenues and royalties received related to our
development programs; |
|
|
|
|
variations in the level of expenses related to our development programs; |
|
|
|
|
addition or termination of clinical trials; |
- 38 -
|
|
|
any intellectual property infringement lawsuit in which we may become involved; |
|
|
|
|
regulatory developments affecting our product candidates; |
|
|
|
|
our execution of any collaborative, licensing or similar arrangements, and the
timing of payments we may make or receive under these arrangements; and |
|
|
|
|
the achievement and timing of milestone payments under our existing strategic
partnership agreements. |
If our quarterly operating results fall below the expectations of investors or securities analysts,
the price of our common shares could decline substantially. Furthermore, any quarterly fluctuations
in our operating results may, in turn, cause the price of our stock to fluctuate substantially.
We do not intend to pay dividends on our common shares and, consequently, your ability to achieve a
return on your investment will depend on appreciation in the price of our common shares.
We have never declared or paid any cash dividend on our common shares and do not currently intend
to do so for the foreseeable future. We currently anticipate that we will retain future earnings
for the development, operation and expansion of our business and do not anticipate declaring or
paying any cash dividends for the foreseeable future. Therefore, the success of an investment in
our common shares will depend upon any future appreciation in their value. There is no guarantee
that our common shares will appreciate in value or even maintain the price at which our
shareholders have purchased their shares.
Our revenues and expenses may fluctuate significantly and any failure to meet financial
expectations may disappoint securities analysts or investors and result in a decline in the price
of our common shares.
Our revenues and expenses have fluctuated in the past and are likely to do so in the future. These
fluctuations could cause our share price to decline. Some of the factors that could cause revenues
and expenses to fluctuate include the following:
|
|
|
the inability to complete product development in a timely manner that results in a
failure or delay in receiving the required regulatory approvals or allowances to
commercialize product candidates; |
|
|
|
|
the timing of regulatory submissions and approvals; |
|
|
|
|
the timing and willingness of any current or future collaborators to invest the
resources necessary to commercialize the product candidates; |
|
|
|
|
the outcome of any litigation; |
|
|
|
|
changes in foreign currency fluctuations; |
|
|
|
|
the timing of achievement and the receipt of milestone payments from current or
future third parties; |
- 39 -
|
|
|
failure to enter into new or the expiration or termination of current agreements
with third parties; and |
|
|
|
|
failure to introduce the product candidates to the market in a manner that
generates anticipated revenues. |
We may be adversely affected by currency fluctuations.
A substantial portion of our revenue is earned in U.S. dollars, but a substantial portion of our
operating expenses are incurred in Canadian dollars. Fluctuations in the exchange rate between the
U.S. dollar and other currencies, such as the Canadian dollar, may have a material adverse effect
on our business, financial condition and operating results. We do not currently engage in
transactional hedging schemes but we do attempt to hedge or mitigate the risk of currency
fluctuations by actively monitoring and managing our foreign currency holdings relative to our
foreign currency expenses.
Our articles and certain Canadian laws could delay or deter a change of control.
On February 10, 2010, we entered into a shareholder rights plan agreement. In the event of certain
change of control transactions, the plan entitles a rights holder, other than the person or group
acquiring control, to subscribe to our common shares at a discount of 50 percent to the market
price at that time, subject to certain exceptions.
The Investment Canada Act (Canada) subjects an acquisition of control of a company by a
non-Canadian to government review if the value of the assets as calculated pursuant to the
legislation exceeds a threshold amount. A reviewable acquisition may not proceed unless the
relevant minister is satisfied that the investment is likely to be a net benefit to Canada.
Any of the foregoing could prevent or delay a change of control and may deprive or limit strategic
opportunities for our shareholders to sell their shares.
Further information on Theratechnologies
Further information on Theratechnologies, including the Companys Annual Information Form, is
available on the SEDAR site at www.sedar.com.
- 40 -
ex-99.3
AUDITORS
REPORT TO THE SHAREHOLDERS
We have audited the consolidated statements of financial
position of Theratechnologies Inc. as at November 30, 2010
and 2009 and December 1, 2008, and the consolidated
statements of comprehensive income, statements of changes in
equity and statements of cash flows for the years ended
November 30, 2010 and 2009. These financial statements are
the responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements based on our audits.
We conducted our audits in accordance with Canadian generally
accepted auditing standards. Those standards require that we
plan and perform an audit to obtain reasonable assurance whether
the financial statements are free of material misstatement. An
audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An
audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating
the overall financial statement presentation.
In our opinion, these consolidated financial statements present
fairly, in all material respects, the financial position of the
Company as at November 30, 2010 and 2009 and
December 1, 2008, and its financial performance and its
cash flows for the years ended November 30, 2010 and 2009
in accordance with International Financial Reporting Standards
as issued by the International Accounting Standards Board.
Chartered Accountants
Montreal, Canada
February 8, 2011
F-2
THERATECHNOLOGIES
INC.
CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED
NOVEMBER 30, 2010 AND 2009 AND AS AT DECEMBER 1,
2008
|
|
|
|
|
Financial Statements
|
|
|
|
|
|
|
|
F-4
|
|
|
|
|
F-5
|
|
|
|
|
F-6
|
|
|
|
|
F-7
|
|
|
|
|
F-8
|
|
F-3
THERATECHNOLOGIES
INC.
AS AT
NOVEMBER 30, 2010 AND 2009 AND DECEMBER 1,
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
DECEMBER 1,
|
|
|
|
NOTE
|
|
2010
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
(in thousands of Canadian dollars)
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
|
|
|
|
|
26,649
|
|
|
|
1,519
|
|
|
|
133
|
|
Bonds
|
|
8
|
|
|
1,860
|
|
|
|
10,036
|
|
|
|
10,955
|
|
Trade and other receivables
|
|
9
|
|
|
161
|
|
|
|
375
|
|
|
|
610
|
|
Tax credits and grants receivable
|
|
10
|
|
|
332
|
|
|
|
1,333
|
|
|
|
1,451
|
|
Inventories
|
|
11
|
|
|
4,317
|
|
|
|
2,225
|
|
|
|
|
|
Prepaid expenses
|
|
|
|
|
1,231
|
|
|
|
630
|
|
|
|
739
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
|
|
34,550
|
|
|
|
16,118
|
|
|
|
13,888
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bonds
|
|
8
|
|
|
36,041
|
|
|
|
51,807
|
|
|
|
35,249
|
|
Property and equipment
|
|
12
|
|
|
1,060
|
|
|
|
1,229
|
|
|
|
1,299
|
|
Other assets
|
|
|
|
|
|
|
|
|
|
|
|
|
2,776
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-current assets
|
|
|
|
|
37,101
|
|
|
|
53,036
|
|
|
|
39,324
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
|
|
|
71,651
|
|
|
|
69,154
|
|
|
|
53,212
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
13
|
|
|
4,977
|
|
|
|
5,568
|
|
|
|
6,865
|
|
Current portion of deferred revenue
|
|
4
|
|
|
6,847
|
|
|
|
6,847
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
|
|
11,824
|
|
|
|
12,415
|
|
|
|
6,865
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other liabilities
|
|
14
|
|
|
325
|
|
|
|
|
|
|
|
|
|
Deferred revenue
|
|
4
|
|
|
6,846
|
|
|
|
13,691
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-current liabilities
|
|
|
|
|
7,171
|
|
|
|
13,691
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
|
|
18,995
|
|
|
|
26,106
|
|
|
|
6,865
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital
|
|
15
|
|
|
279,398
|
|
|
|
279,169
|
|
|
|
269,219
|
|
Contributed surplus
|
|
|
|
|
7,808
|
|
|
|
6,757
|
|
|
|
5,760
|
|
Deficit
|
|
|
|
|
(235,116
|
)
|
|
|
(244,160
|
)
|
|
|
(229,004
|
)
|
Accumulated other comprehensive income
|
|
|
|
|
566
|
|
|
|
1,282
|
|
|
|
372
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total equity
|
|
|
|
|
52,656
|
|
|
|
43,048
|
|
|
|
46,347
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent liability
|
|
18
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments
|
|
23
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent events
|
|
26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity
|
|
|
|
|
71,651
|
|
|
|
69,154
|
|
|
|
53,212
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
On behalf of the Board,
|
|
|
|
|
(signed) Jean-Denis Talon
|
Director
|
|
Director
|
See accompanying notes to the consolidated financial statements.
F-4
THERATECHNOLOGIES
INC.
YEARS ENDED
NOVEMBER 30, 2010 AND 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
|
NOTE
|
|
2010
|
|
|
2009
|
|
|
|
|
|
$
|
|
|
$
|
|
|
|
|
|
(in thousands of Canadian dollars, except per share
amounts)
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
Research services:
|
|
|
|
|
|
|
|
|
|
|
Milestone payments
|
|
4
|
|
|
25,000
|
|
|
|
10,884
|
|
Upfront payments and initial technology access fees
|
|
4
|
|
|
6,846
|
|
|
|
6,560
|
|
Royalties and license fees
|
|
|
|
|
22
|
|
|
|
24
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
|
|
|
31,868
|
|
|
|
17,468
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
|
|
469
|
|
|
|
|
|
Research and development expenses, net of tax credits of $934
(2009 $1,795)
|
|
10
|
|
|
14,064
|
|
|
|
20,810
|
|
Selling and market development expenses
|
|
6
|
|
|
2,670
|
|
|
|
6,862
|
|
General and administrative expenses
|
|
|
|
|
8,002
|
|
|
|
6,543
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
|
|
25,205
|
|
|
|
34,215
|
|
|
|
|
|
|
|
|
|
|
|
|
Results from operating activities
|
|
|
|
|
6,663
|
|
|
|
(16,747
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Finance income
|
|
7
|
|
|
1,888
|
|
|
|
2,252
|
|
Finance costs
|
|
7
|
|
|
493
|
|
|
|
(661
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Total net financial income
|
|
|
|
|
2,381
|
|
|
|
1,591
|
|
|
|
|
|
|
|
|
|
|
|
|
Net profit (loss) before income taxes
|
|
|
|
|
9,044
|
|
|
|
(15,156
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense
|
|
16
|
|
|
114
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net profit (loss)
|
|
|
|
|
8,930
|
|
|
|
(15,156
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss), net of tax:
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value
available-for-sale
financial assets, net of tax
|
|
|
|
|
(390
|
)
|
|
|
1,039
|
|
Net change in fair value
available-for-sale
financial assets transferred to net profit (loss), net of tax
|
|
|
|
|
(326
|
)
|
|
|
(129
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(716
|
)
|
|
|
910
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income (loss) for the year
|
|
|
|
|
8,214
|
|
|
|
(14,246
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted earnings (loss) per share
|
|
15
|
|
|
0.15
|
|
|
|
(0.25
|
)
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the consolidated financial statements.
F-5
THERATECHNOLOGIES
INC.
YEARS ENDED
NOVEMBER 30, 2010 AND 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
UNREALIZED GAINS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OR LOSSES ON
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AVAILABLE-FOR-SALE
|
|
|
|
|
|
|
|
|
|
|
|
SHARE CAPITAL
|
|
|
CONTRIBUTED
|
|
|
FINANCIAL
|
|
|
|
|
|
|
|
|
|
NOTE
|
|
NUMBER
|
|
|
DOLLARS
|
|
|
SURPLUS
|
|
|
ASSETS (i)
|
|
|
DEFICIT
|
|
|
TOTAL
|
|
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
(in thousands of Canadian dollars)
|
|
|
Balance as at December 1, 2008
|
|
|
|
|
58,215,090
|
|
|
|
269,219
|
|
|
|
5,760
|
|
|
|
372
|
|
|
|
(229,004
|
)
|
|
|
46,347
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income (loss) for the year:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(15,156
|
)
|
|
|
(15,156
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value of
available-for-sale
financial assets, net of tax
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,039
|
|
|
|
|
|
|
|
1,039
|
|
Net change in fair value of
available-for-sale
financial assets transferred to net profit (loss), net of tax
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(129
|
)
|
|
|
|
|
|
|
(129
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income (loss) for the year
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
910
|
|
|
|
(15,156
|
)
|
|
|
(14,246
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transactions with owners, recorded directly in equity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue of common shares
|
|
15(i)
|
|
|
2,214,303
|
|
|
|
9,950
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,950
|
|
Share-based compensation for stock option plan
|
|
15(iv)
|
|
|
|
|
|
|
|
|
|
|
997
|
|
|
|
|
|
|
|
|
|
|
|
997
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contributions by owners
|
|
|
|
|
2,214,303
|
|
|
|
9,950
|
|
|
|
997
|
|
|
|
|
|
|
|
|
|
|
|
10,947
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as at November 30, 2009
|
|
|
|
|
60,429,393
|
|
|
|
279,169
|
|
|
|
6,757
|
|
|
|
1,282
|
|
|
|
(244,160
|
)
|
|
|
43,048
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income (loss) for the year:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,930
|
|
|
|
8,930
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value of
available-for-sale
financial assets, net of tax
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(390
|
)
|
|
|
|
|
|
|
(390
|
)
|
Net change in fair value of
available-for-sale
financial assets transferred to net profit (loss), net of tax
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(326
|
)
|
|
|
|
|
|
|
(326
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income (loss) for the year
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(716
|
)
|
|
|
8,930
|
|
|
|
8,214
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transactions with owners, recorded directly in equity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue of common shares
|
|
15(i)
|
|
|
2,880
|
|
|
|
15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15
|
|
Income tax related to share issue costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
114
|
|
|
|
114
|
|
Share-based compensation plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation for stock option plan
|
|
15(iv)
|
|
|
|
|
|
|
|
|
|
|
1,133
|
|
|
|
|
|
|
|
|
|
|
|
1,133
|
|
Exercise of stock options:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Monetary consideration
|
|
15(iv)
|
|
|
80,491
|
|
|
|
132
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
132
|
|
Attributed value
|
|
15(iv)
|
|
|
|
|
|
|
82
|
|
|
|
(82
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contributions by owners
|
|
|
|
|
83,371
|
|
|
|
229
|
|
|
|
1,051
|
|
|
|
|
|
|
|
114
|
|
|
|
1,394
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as at November 30, 2010
|
|
|
|
|
60,512,764
|
|
|
|
279,398
|
|
|
|
7,808
|
|
|
|
566
|
|
|
|
(235,116
|
)
|
|
|
52,656
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(i) |
|
Accumulated other comprehensive
income.
|
See accompanying notes to the consolidated financial statements.
F-6
THERATECHNOLOGIES
INC.
YEARS ENDED
NOVEMBER 30, 2010 AND 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
|
NOTE
|
|
2010
|
|
|
2009
|
|
|
|
|
|
$
|
|
|
$
|
|
|
|
|
|
(in thousands of Canadian dollars)
|
|
|
Operating activities:
|
|
|
|
|
|
|
|
|
|
|
Net profit (loss)
|
|
|
|
|
8,930
|
|
|
|
(15,156
|
)
|
Adjustments for:
|
|
|
|
|
|
|
|
|
|
|
Depreciation of property and equipment
|
|
12
|
|
|
466
|
|
|
|
612
|
|
Share-based compensation
|
|
|
|
|
1,133
|
|
|
|
997
|
|
Income tax expense
|
|
|
|
|
114
|
|
|
|
|
|
Write-down of inventories
|
|
11
|
|
|
192
|
|
|
|
|
|
Lease inducements and amortization
|
|
17
|
|
|
325
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities before changes in operating assets and
liabilities
|
|
|
|
|
11,160
|
|
|
|
(13,547
|
)
|
Change in accrued interest income on bonds
|
|
|
|
|
728
|
|
|
|
(923
|
)
|
Change in trade and other receivables
|
|
|
|
|
214
|
|
|
|
235
|
|
Change in tax credits and grants receivable
|
|
|
|
|
1,001
|
|
|
|
118
|
|
Change in inventories
|
|
|
|
|
(2,284
|
)
|
|
|
(2,225
|
)
|
Change in prepaid expenses
|
|
|
|
|
(601
|
)
|
|
|
109
|
|
Change in other assets
|
|
|
|
|
|
|
|
|
2,776
|
|
Change in accounts payable and accrued liabilities
|
|
|
|
|
(473
|
)
|
|
|
(1,424
|
)
|
Change in deferred revenue
|
|
|
|
|
(6,845
|
)
|
|
|
20,538
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,260
|
)
|
|
|
19,204
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from operating activities
|
|
|
|
|
2,900
|
|
|
|
5,657
|
|
Financing activities:
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issue of share capital
|
|
|
|
|
15
|
|
|
|
9,950
|
|
Proceeds from exercise of stock options
|
|
15
|
|
|
132
|
|
|
|
|
|
Share issue costs
|
|
|
|
|
|
|
|
|
(8
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities
|
|
|
|
|
147
|
|
|
|
9,942
|
|
Investing activities:
|
|
|
|
|
|
|
|
|
|
|
Acquisition of property and equipment
|
|
12
|
|
|
(415
|
)
|
|
|
(407
|
)
|
Proceeds from sale of bonds
|
|
|
|
|
22,498
|
|
|
|
15,305
|
|
Acquisition of bonds
|
|
|
|
|
|
|
|
|
(29,111
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from (used in) investing activities
|
|
|
|
|
22,083
|
|
|
|
(14,213
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net change in cash
|
|
|
|
|
25,130
|
|
|
|
1,386
|
|
Cash as at December 1
|
|
|
|
|
1,519
|
|
|
|
133
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash as at November 30
|
|
|
|
|
26,649
|
|
|
|
1,519
|
|
|
|
|
|
|
|
|
|
|
|
|
See note 19 for supplemental cash flow information.
See accompanying notes to the consolidated financial statements.
F-7
Theratechnologies Inc. is a specialty pharmaceutical company
that discovers and develops innovative therapeutic peptide
products with an emphasis on growth hormone releasing factor
peptides. Theratechnologies Inc. is leveraging its expertise in
the field of metabolism to discover and develop products in
specialty markets. Its commercialization strategy is to retain
all or a significant portion of the commercial rights to its
products. Its first product,
EGRIFTA®
(tesamorelin for injection), was approved by the United States
Food and Drug Administration (FDA) in November 2010.
To date,
EGRIFTA®
is the only approved therapy for the reduction of excess
abdominal fat in HIV-infected patients with lipodystrophy.
The consolidated financial statements include the accounts of
Theratechnologies Inc. and its wholly-owned subsidiaries
(together referred to as the Company and
individually as the subsidiaries of the Company).
Theratechnologies Inc. is incorporated under Part 1A of the
Québec Companies Act and is domiciled in Quebec,
Canada. The Company is located at 2310 boul. Alfred-Nobel,
Montreal, Quebec, H4S 2B4.
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(a)
|
Statement of
Compliance:
|
The consolidated financial statements of the Company have been
prepared in accordance with IFRSs as issued by the International
Accounting Standards Board (IASB). These are the
Companys first consolidated financial statements prepared
in accordance with International Financial Reporting Standards
(IFRSs). The Company has applied IFRS 1,
First-time Adoption of International Financial Reporting
Standards, using December 1, 2008 as the date of
transition to IFRSs.
An explanation of how the transition to IFRSs has affected the
reported financial position, financial performance and cash
flows of the Company is provided in note 27.
The consolidated financial statements were authorized for issue
by the Board of Directors on February 8, 2011.
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(b)
|
Basis of
Measurement:
|
The Companys consolidated financial statements have been
prepared on a going concern and historical cost basis, except
for
available-for-sale
financial assets which are measured at fair value.
The methods used to measure fair value are discussed further in
note 22.
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(c)
|
Functional and
Presentation Currency:
|
These consolidated financial statements are presented in
Canadian dollars, which is the Companys functional
currency. All financial information presented in Canadian
dollars has been rounded to the nearest thousand.
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(d)
|
Use of
Estimates and Judgements:
|
The preparation of the Companys consolidated financial
statements in conformity with IFRSs requires management to make
estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting
period.
Information about critical judgements in applying accounting
policies and assumption and estimation uncertainties that have
the most significant effect on the amounts recognized in the
consolidated financial statements is included in the following
notes:
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|
n
|
Note 4 Revenue and deferred revenue;
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n
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Note 15 (iv) Stock option plan;
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F-8
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
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|
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n
|
Note 16 Income taxes;
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|
|
n
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Note 18 Contingent liability.
|
Other areas of judgement and uncertainty relate to the
estimation of accruals for clinical trial expenses, the
recoverability of inventories, the measurement of the amount and
assessment of the recoverability of tax credits and grants
receivable and capitalization of development expenditures.
Reported amounts and note disclosure reflect the overall
economic conditions that are most likely to occur and
anticipated measures management intends to take. Actual results
could differ from those estimates.
The above estimates and assumptions are reviewed regularly.
Revisions to accounting estimates are recognized in the period
in which the estimates are revised and in any future periods
affected.
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3.
|
Significant
Accounting Policies:
|
The accounting policies set out below have been applied
consistently to all periods presented in these consolidated
financial statements and in preparing the opening IFRS statement
of financial position at December 1, 2008, the date of
transition to IFRSs.
The accounting policies have been applied consistently by the
subsidiaries of the Company.
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(a)
|
Basis of
Consolidation:
|
The financial statements of subsidiaries are included in the
consolidated financial statements from the date on which control
commences until the date on which control ceases. Subsidiaries
are entities controlled by the Company. Control is present where
the Company has the power to govern the financial and operating
policies of the entity so as to obtain benefits from its
activities. In assessing control, potential voting rights that
are exercisable currently are taken into consideration. The
accounting policies of subsidiaries are changed when necessary
to align them with the policies adopted by the Company.
Reciprocal balances and transactions, revenues and expenses
resulting from transactions between subsidiaries and with the
Company are eliminated in preparing the consolidated financial
statements.
Transactions in foreign currencies are translated to the
respective functional currencies of the subsidiaries of the
Company at exchange rates at the dates of the transactions.
Monetary assets and liabilities denominated in foreign
currencies at the reporting date are retranslated to the
functional currency at the exchange rate at that date. The
foreign currency gain or loss on monetary items is the
difference between amortized cost in the functional currency at
the beginning of the period, adjusted for effective interest and
payments during the period, and the amortized cost in foreign
currency translated at the exchange rate at the end of the
reporting period.
Foreign currency differences arising on translation are
recognized in net profit (loss), except for differences arising
on the translation of
available-for-sale
equity instruments, which are recognized in other comprehensive
income. Non-monetary assets and liabilities denominated in
foreign currencies that are measured at fair value are
translated to the functional currency at the exchange rate at
the date on which the fair value was determined. Non-monetary
items that are measured at historical cost in a foreign currency
are translated using the exchange rate at the date of the
transaction.
Collaboration agreements that include multiple deliverables are
considered to be multi-element arrangements. Under this type of
arrangement, the identification of separate units of accounting
is required and revenue is allocated among the separate units
based on their relative fair values.
F-9
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
Payments received under the collaboration agreement may include
upfront payments, milestone payments, research services,
royalties and license fees. Revenues for each unit of accounting
are recorded as described below:
Revenues from the sale of goods are recognized when the Company
has transferred to the buyer the significant risks and rewards
of ownership of the goods, there is no continuing management
involvement with the goods, and the amount of revenue can be
measured reliably.
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(ii)
|
Royalties and
License Fees:
|
Royalties and license fees are recognized when conditions and
events under the license agreement have occurred and
collectibility is reasonably assured.
Revenues from research contracts are recognized when services to
be provided are rendered and all conditions under the terms of
the underlying agreement are met.
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(a)
|
Upfront Payments and Initial Technology Access Fees:
|
Upfront payments and initial technology access fees are deferred
and recognized as revenue on a systematic basis over the period
during which the related products or services are delivered and
all obligations are performed.
Revenues subject to the achievement of milestones are recognized
only when the specified events have occurred and collectibility
is reasonably assured.
Cost of sales represents the cost of goods sold and includes the
cost of raw materials, supplies, direct overhead charges,
unallocated indirect costs related to production as well as
write-down of inventories. Other direct costs, such as
manufacturing
start-up
costs between validation and the achievement of normal
production, are expensed as incurred.
Salaries
and Short-Term Employee Benefits:
Salaries and short-term employee benefit obligations are
measured on an undiscounted basis and are expensed as the
related service is provided. A liability is recognized for the
amount expected to be paid under short-term profit-sharing or
cash bonus plans if the Company has a legal or constructive
obligation to pay an amount as a result of past services
rendered by an employee and the obligation can be estimated
reliably.
Post-Employment
Benefits:
Post-employment benefits include a defined contribution plan
under which an entity pays fixed contributions into a separate
entity and will have no legal or constructive obligation to pay
further amounts. Obligations for contributions to defined
contribution plans are recognized as an employee benefit expense
when due. Prepaid contributions are recognized as an asset to
the extent that a cash refund or a reduction in future payments
is available. The Companys defined contribution plan
comprises the registered retirement savings plan, the Quebec
Pension Plan and unemployment insurance.
Termination
Benefits:
Termination benefits are recognized as an expense when the
Company is committed demonstrably, without realistic possibility
of withdrawal, to a formal detailed plan to either terminate
employment before the normal retirement date, or to provide
termination benefits as a result of an offer made to encourage
voluntary redundancy.
F-10
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
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(f)
|
Finance Income
and Finance Costs:
|
Finance income comprises interest income on
available-for-sale
financial assets and gains (losses) on the disposal of
available-for-sale
financial assets. Interest income is recognized as it accrues in
profit (loss), using the effective interest method.
Finance costs are comprised of bank charges, impairment losses
on financial assets recognized in profit (loss) and of foreign
currency gains and losses which are reported on a net basis.
Inventories are presented at the lower of cost, determined using
the first-in
first-out method, or net realizable value. Inventory costs
include the purchase price and other costs directly related to
the acquisition of materials, and other costs incurred in
bringing the inventories to their present location and
condition. Inventory costs also include the costs directly
related to the conversion of materials to finished goods, such
as direct labour, and a systematic allocation of fixed and
variable production overhead, including manufacturing
depreciation expense. The allocation of fixed production
overheads to the cost of inventories is based on the normal
capacity of the production facilities. Normal capacity is the
average production expected to be achieved over a number of
periods under normal circumstances.
Net realizable value is the estimated selling price in the
Companys ordinary course of business, less the estimated
costs of completion and selling expenses.
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(h)
|
Property and
Equipment:
|
Recognition
and Measurement:
Items of property and equipment are recognized at cost less
accumulated depreciation and accumulated impairment losses. Cost
includes expenditure that is directly attributable to the
acquisition of the asset and the costs of dismantling and
removing the item and restoring the site on which it is located,
if any.
When parts of an item of property and equipment have different
useful lives, they are accounted for as separate items (major
components) of property and equipment.
Gains and losses on disposal of an item of property and
equipment are determined by comparing the proceeds from disposal
with the carrying amount of property and equipment, and are
recognized in net profit (loss).
Subsequent
Costs:
The cost of replacing a part of an item of property and
equipment is recognized in the carrying amount of the item if it
is probable that the future economic benefits embodied within
the part will flow to the Company, and its cost can be measured
reliably. The carrying amount of the replaced part is
derecognized. The costs of the
day-to-day
servicing of property and equipment are recognized in profit
(loss) as incurred.
Depreciation:
The estimated useful lives and the methods of depreciation for
the current and comparative periods are as follows:
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ASSET
|
|
METHOD
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RATE/PERIOD
|
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Computer equipment
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|
Declining balance
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50%
|
Laboratory equipment
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Declining balance
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20%
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and straight-line
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5 years
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Office furniture and equipment
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Declining balance
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20%
|
Leasehold improvements
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Straight-line
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Lower of term of lease
or economic life
|
This most closely reflects the expected pattern of consumption
of the future economic benefits embodied in the asset.
F-11
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
Estimates for depreciation methods, useful lives and residual
values are reviewed at each reporting period-end and adjusted if
appropriate.
Research
and Development:
Expenditure on research activities, undertaken with the prospect
of gaining new scientific or technical knowledge and
understanding, is expensed as incurred.
Development activities involve a plan or design for the
production of new or substantially improved products and
processes. Development expenditure is capitalized only if
development costs can be measured reliably, the product or
process is technically and commercially feasible, future
economic benefits are probable, and the Company intends to and
has sufficient resources to complete development and to use or
sell the asset. These criteria are usually met when a regulatory
filing has been made in a major market and approval is
considered highly probable. The expenditure capitalized includes
the cost of materials, direct labour, and overhead costs that
are directly attributable to preparing the asset for its
intended use. Other development expenditures are expensed as
incurred. Capitalized development expenditures are measured at
cost less accumulated amortization and accumulated impairment
losses.
During the years ended November 30, 2010 and 2009 and as at
December 1, 2008, no development expenditures were
capitalized.
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(j)
|
Financial
Instruments:
|
The Companys financial instruments are classified into one
of three categories: loans and receivables,
available-for-sale
financial assets and other financial liabilities. Loans and
receivables and other financial liabilities are measured at
amortized cost.
The Company has classified its bonds as
available-for-sale
financial assets. The Company has classified cash and trade and
other receivables as loans and receivables, and accounts payable
and accrued liabilities as other financial liabilities.
Available-for-sale
financial assets are non-derivative financial assets that are
designated as
available-for-sale
and that are not classified in any of the other categories.
Subsequent to initial recognition, they are measured at fair
value and changes therein, other than impairment losses and
foreign currency differences on
available-for-sale
debt instruments, are recognized in other comprehensive income
and presented within equity. When an investment is derecognized,
the cumulative gain or loss in other comprehensive income is
transferred to profit (loss).
Other assets consist of prepaid expenses for research supplies
that are not expected to be used within one year from the date
of the consolidated statement of financial position.
Research supplies are purchased in advance, in accordance with
specific regulatory requirements, to be used in connection with
the Companys clinical trials.
Operating lease payments are recognized in net profit (loss) on
a straight-line basis over the term of the lease.
Lease inducements arising from leasehold improvement allowances
and rent-free periods form an integral part of the total lease
cost and are deferred and recognized in net profit (loss) over
the term of the lease on a straight-line basis.
F-12
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
Financial
Assets:
A financial asset not carried at fair value through profit or
loss is assessed at each consolidated financial statement
reporting date to determine whether there is objective evidence
that it is impaired. The Company considers that a financial
asset is impaired if objective evidence indicates that one or
more loss events had a negative effect on the estimated future
cash flows of that asset that can be estimated reliably.
An impairment test is performed, on an individual basis, for
each material financial asset. Other individually non-material
financial assets are tested as groups of financial assets with
similar risk characteristics. Impairment losses are recognized
in net profit (loss).
An impairment loss in respect of a financial asset measured at
amortized cost is calculated as the difference between its
carrying amount and the present value of the estimated future
cash flows discounted at the assets original effective
interest rate. Losses are recognized in net profit (loss) and
reflected in an allowance account against the respective
financial asset. Interest on the impaired asset continues to be
recognized through the unwinding of the discount. When a
subsequent event causes the amount of impairment loss to
decrease, the decrease in impairment loss is reversed through
net profit (loss).
Impairment losses on
available-for-sale
investment securities are recognized by transferring the
cumulative loss that has been recognized in other comprehensive
income, and presented in unrealized gains/losses on
available-for-sale
financial assets in equity, to net profit (loss). The cumulative
loss that is removed from other comprehensive income and
recognized in net profit (loss) is the difference between the
acquisition cost, net of any principal repayment and
amortization, and the current fair value, less any impairment
loss previously recognized in net profit (loss). Changes in
impairment provisions attributable to time value are reflected
as a separate component of interest income.
If, in a subsequent period, the fair value of an impaired
available-for-sale
debt security increases and the increase can be related
objectively to an event occurring after the impairment loss was
recognized in net profit (loss), then the impairment loss is
reversed, with the amount of the reversal recognized in net
profit (loss). However, any subsequent recovery in the fair
value of an impaired
available-for-sale
equity security is recognized in other comprehensive income.
Non-Financial
Assets:
The carrying amounts of the Companys non-financial assets,
other than inventories and deferred tax assets, are reviewed at
each reporting date to determine whether there is any indication
of impairment. If such an indication exists, the recoverable
amount is estimated.
The recoverable amount of an asset or a cash-generating unit is
the greater of its value in use and its fair value less costs to
sell. In assessing value in use, the estimated future cash flows
are discounted to their present value using a pre-tax discount
rate that reflects current market assessments of the time value
of money and the risks specific to the asset. For the purpose of
impairment testing, assets are grouped together into the
smallest group of assets that generates cash inflows from
continuing use that are largely independent of cash inflows from
other assets or groups of assets (cash-generating
unit). Impairment losses recognized in prior periods are
determined at each reporting date for any indications that the
loss has decreased or no longer exists. An impairment loss is
reversed if there has been a change in the estimates used to
determine the recoverable amount. An assets carrying
amount, increased through reversal of an impairment loss, must
not exceed the carrying amount that would have been determined,
net of depreciation or amortization, if no impairment loss had
been recognized.
F-13
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
A provision is recognized if, as a result of a past event, the
Company has a present legal or constructive obligation that can
be estimated reliably, and it is probable that an outflow of
economic benefits will be required to settle the obligation.
Provisions are assessed by discounting the expected future cash
flows at a pre-tax rate that reflects current market assessments
of the time value of money and the risks specific to the
liability. The unwinding of the discount on provisions is
recognized in finance costs.
Onerous
Contracts:
A provision for onerous contracts is recognized when the
expected benefits to be derived by the Company from a contract
are lower than the unavoidable cost of meeting its obligations
under the contract. The provision is measured at the present
value of the lower of the expected cost of terminating the
contract and the expected net cost of continuing with the
contract. Before a provision is established, the Company
recognizes any impairment loss on the assets associated with
that contract. There were no onerous contracts as at
November 30, 2010 and 2009 and December 1, 2008.
Site
Restoration:
Where there is a legal or constructive obligation to restore
leased premises to good condition, except for normal aging on
expiry or early termination of the lease, the resulting costs
are provisioned up to the discounted value of estimated future
costs and increase the carrying amount of the corresponding item
of property and equipment. The Company amortizes the cost of
restoring leased premises and recognizes an unwinding of
discount expense on the liability related to the term of the
lease.
Contingent
Liability:
A contingent liability is a possible obligation that arises from
past events and of which the existence will be confirmed only by
the occurrence or non-occurrence of one or more uncertain future
events not wholly within the control of the Company; or a
present obligation that arises from past events (and therefore
exists), but is not recognized because it is not probable that a
transfer or use of assets, provision of services or any other
transfer of economic benefits will be required to settle the
obligation, or the amount of the obligation cannot be estimated
reliably.
Income tax expense comprises current and deferred tax. Current
tax and deferred tax are recognized in net profit (loss) except
to the extent that they relate to items recognized directly in
other comprehensive income or in equity.
Current
Tax:
Current tax is the expected tax payable or receivable on the
taxable income or loss for the year, using tax rates enacted or
substantively enacted at the reporting date, and any adjustment
to tax payable in respect of previous years. The Company
establishes provisions where appropriate on the basis of amounts
expected to be paid to the tax authorities.
Deferred
Tax:
Deferred tax is recognized in respect of temporary differences
between the carrying amounts of assets and liabilities for
financial reporting purposes and the amounts used for taxation
purposes. Deferred tax is measured at the tax rates that are
expected to be applied to temporary differences when they
reverse, based on the laws that have been enacted or
substantively enacted by the reporting date.
A deferred tax liability is generally recognized for all taxable
temporary differences.
A deferred tax asset is recognized for unused tax losses and
deductible temporary differences, to the extent that it is
probable that future taxable profits will be available against
which they can be utilized. Deferred tax assets are reviewed at
each reporting date and are reduced to the extent that it is no
longer probable that the related tax benefit will be realized.
F-14
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
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|
(p)
|
Share-Based
Compensation:
|
The Company records share-based compensation related to employee
stock options granted using the fair value based method
estimated using the Black-Scholes model. Under this method,
compensation cost is measured at fair value at the date of grant
and expensed, as employee benefits, over the period in which
employees unconditionally become entitled to the award. The
amount recognized as an expense is adjusted to reflect the
number of awards for which the related service conditions are
expected to be met, such that the amount ultimately recognized
as an expense is based on the number of awards that do meet the
related service and non-market performance conditions at the
vesting date.
Share-based payment arrangements in which the Company receives
goods or services as consideration for its own equity
instruments are accounted for as equity-settled share-based
payment transactions, regardless of how the equity instruments
are obtained by the Company.
As permitted by IFRS 1, the Company elected not to restate
options that were granted before November 7, 2002 and those
granted after November 7, 2002 that were fully vested prior
to the date of transition to IFRS.
Government grants consisting of grants and investment tax
credits, are recorded as a reduction of the related expense or
cost of the asset acquired. Government grants are recognized
when there is reasonable assurance that the Company has met the
requirements of the approved grant program and there is
reasonable assurance that the grant will be received.
Common
Shares:
Common shares are classified as equity. Incremental costs
directly attributable to the issue of common shares and share
options are recognized as a deduction from equity, net of any
tax effects.
The Company presents basic and diluted earnings per share
(EPS) data for its common shares. Basic EPS is
calculated by dividing the net profit or loss attributable to
common shareholders of the Company by the weighted average
number of common shares outstanding during the period, adjusted
for own shares held, if applicable. Diluted EPS is determined by
adjusting the profit or loss attributable to common shareholders
and the weighted average number of common shares outstanding,
adjusted for own shares held if applicable, for the effects of
all dilutive potential common shares, which consist of the stock
options granted to employees.
|
|
(t)
|
New Standards
and Interpretations not yet Applied:
|
Certain pronouncements were issued by the IASB or International
Financial Reporting Interpretation Committee that are mandatory
for annual periods beginning on or after January 1, 2010 or
later periods. Many of these updates are not applicable or are
inconsequential to the Company and have been excluded from the
discussion below. The remaining pronouncements are being
assessed to determine their impact on the Companys results
and financial position:
Annual
Improvements to IFRS:
The IASBs improvements to IFRS published in April 2009
contain fifteen amendments to twelve standards that result in
accounting changes for presentation, recognition or measurement
purposes largely for annual periods beginning on or after
January 1, 2010, with early adoption permitted. These
amendments were considered by the Company and deemed to be not
applicable to the Company other than for the amendment to IAS
17 Leases relating to leases which include both land
and buildings elements. In this case, the Company early adopted
this amendment.
The IASBs improvements to IFRS contain seven amendments
that result in accounting changes for presentation, recognition
or measurement purposes. The most significant features of the
IASBs annual
F-15
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
improvements project published in May 2010 are included under
the specific revisions to standards discussed below.
Revision
to IFRS 3, Business Combinations:
Effective for annual periods beginning on or after July 1,
2010 with earlier adoption permitted.
Clarification on the following areas:
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|
n
|
the choice of measuring non-controlling interests at fair value
or at the proportionate share of the acquirees net assets
applies only to instruments that represent present ownership
interests and entitle their holders to a proportionate share of
the net assets in the event of liquidation. All other components
of non-controlling interest are measured at fair value unless
another measurement basis is required by IFRS.
|
|
|
n
|
application guidance relating to the accounting for share-based
payments in IFRS 3 applies to all share-based payment
transactions that are part of a business combination, including
unreplaced awards (i.e., unexpired awards over the acquiree
shares that remain outstanding rather than being replaced by the
acquirer) and voluntarily replaced share-based payment awards.
|
Amendment
to IFRS 7, Financial Instruments: Disclosures:
Effective for annual periods beginning on or after
January 1, 2011, with earlier adoption permitted.
Multiple clarifications related to the disclosure of financial
instruments and in particular in regards to transfers of
financial assets.
Amendment
to IAS 1, Presentation of Financial Statements:
Effective for annual periods beginning on or after
January 1, 2011, with earlier adoption permitted.
Entities may present the analysis of the components of other
comprehensive income either in the statement of changes in
equity or within the notes to the financial statements.
Amendment
to IAS 27, Consolidated and Separate Financial
Statements:
Effective for annual periods beginning on or after
January 1, 2011, with earlier adoption permitted.
The 2008 revisions to this standard resulted in consequential
amendments to IAS 21, The Effects of Changes in Foreign
Exchange Rates, IAS 28, Investments in Associates,
and IAS 31, Interests in Joint Ventures. IAS 27 now
provides that these amendments are to be applied prospectively.
Amendment
to IAS 34, Interim Financial Reporting:
Effective for annual periods beginning on or after
January 1, 2011, with earlier adoption permitted.
The amendments place greater emphasis on the disclosure
principles for interim financial reporting involving significant
events and transactions, including changes to fair value
measurements and the need to update relevant information from
the most recent annual report.
New or revised standards and interpretations:
In addition, the following new or revised standards and
interpretations have been issued but are not yet applicable to
the Company:
Amendments
to IAS 24, Related Party Disclosures:
Effective for annual periods beginning on or after
January 1, 2011, with earlier adoption permitted.
F-16
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
There are limited differences in the definition of what
constitutes a related party; however, the amendment requires
more detailed disclosures regarding commitments.
IFRS
8, Operating Segments:
Effective for annual periods beginning on or after
January 1, 2010.
Requires purchase information about segment assets.
New
standard IFRS 9, Financial Instruments:
Effective for annual periods beginning on or after
January 1, 2013, with earlier adoption permitted.
As part of the project to replace IAS 39, Financial Instruments:
Recognition and Measurement, this standard retains but
simplifies the mixed measurement model and establishes two
primary measurement categories for financial assets. More
specifically, the standard:
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|
n
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deals with classification and measurement of financial assets
|
|
|
n
|
establishes two primary measurement categories for financial
assets: amortized cost and fair value
|
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|
n
|
classification depends on entitys business model and the
contractual cash flow characteristics of the financial asset
|
|
|
n
|
eliminates the existing categories: held to maturity, available
for sale, and loans and receivables.
|
Certain changes were also made regarding the fair value option
for financial liabilities and accounting for certain derivatives
linked to unquoted equity instruments.
|
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4.
|
Revenue and
Deferred Revenue:
|
On October 28, 2008, the Company entered into a
collaboration and licensing agreement with EMD Serono Inc.
(EMD Serono), an affiliate of the Group Merck KGaA,
of Darmstadt, Germany, regarding the exclusive commercialization
rights of tesamorelin in the United States for the treatment of
excess abdominal fat in HIV-infected patients with lipodystrophy
(the Initial Product). The Company retains all
tesamorelin commercialization rights outside of the United
States.
Under the terms of the agreement, the Company is responsible for
the development of the Initial Product up to obtaining marketing
approval in the United States, which was obtained on
November 10, 2010. The Company is also responsible for
product production and for developing a new formulation of the
Initial Product. EMD Serono is responsible for conducting
product commercialization activities.
At the closing of the agreement on December 15, 2008, the
Company received US$30,000 (C$36,951), which includes an initial
payment of US$22,000 (C$27,097) and US$8,000 (C$9,854) as a
subscription for common shares in the Company by Merck KGaA at a
price of US$3.67 (C$4.52) per share. The Company may receive up
to US$215,000, which amount includes the initial payment of
US$22,000, the equity investment of US$8,000, as well as
payments based on the achievement of certain development,
regulatory and sales milestones. The Company will also be
entitled to receive increasing royalties on annual net sales of
tesamorelin in the United States, if applicable.
The initial payment of $27,097 has been deferred and is being
amortized on a straight-line basis over the estimated period for
developing a new formulation of the Initial Product. This period
may be modified in the future based on additional information
that may be received by the Company. At November 30, 2010,
an amount of $6,846 (2009 $6,560) was recognized as
revenue. As at November 30, 2010, the deferred revenue
related to this transaction amounted to $13,692
(2009 $20,537).
F-17
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
On August 12, 2009, the FDA accepted the New Drug
Application (NDA) made by the Company for
tesamorelin. Under the terms of the Companys collaboration
and licensing agreement with EMD Serono, the acceptance of the
tesamorelin NDA resulted in a milestone payment of US$10,000
(C$10,884).
On November 10, 2010, the FDA approved
EGRIFTA®
as the first approved treatment in the United States for the
reduction of excess abdominal fat in HIV-infected patients with
lipodystrophy. By virtue of the collaboration and licensing
agreement entered into in 2008 with EMD Serono, the Company
received a milestone payment of US$25,000 (C$25,000) associated
with the FDA-approval of
EGRIFTA®.
This payment was received by the Company on November 30,
2010.
The Company may conduct research and development activities for
additional indications. Under the collaboration and licensing
agreement, EMD Serono will also have the option to commercialize
additional indications for tesamorelin in the United States. If
it exercises this option, EMD Serono will pay half of the
development costs related to such additional indications. In
such cases, the Company will also have the right, subject to an
agreement with EMD Serono, to participate in promoting these
additional indications.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
|
NOTE
|
|
|
2010
|
|
|
2009
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
Salaries and short-term employee benefits
|
|
|
|
|
|
|
11,577
|
|
|
|
10,779
|
|
Post-employment benefits
|
|
|
|
|
|
|
579
|
|
|
|
542
|
|
Termination benefits
|
|
|
|
|
|
|
20
|
|
|
|
275
|
|
Share-based compensation
|
|
|
15
|
(iv)
|
|
|
1,133
|
|
|
|
997
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total personnel expenses
|
|
|
|
|
|
|
13,309
|
|
|
|
12,593
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6.
|
Selling and
Market Development Expenses:
|
In 2008, the Company completed a formal review of the strategic
alternatives regarding its operations which culminated in the
signing of the collaborative licensing agreement with EMD Serono
(note 4). As a result of this process, $4,269 was recorded
in 2009 for professional fees related to the closing of the
agreement with EMD Serono.
|
|
7.
|
Finance Income
and Finance Costs:
|
Recognized in net profit (loss):
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
$
|
|
|
$
|
|
|
Interest income
|
|
|
1,562
|
|
|
|
2,123
|
|
Net gain on disposal of
available-for-sale
financial assets transferred from equity
|
|
|
326
|
|
|
|
129
|
|
|
|
|
|
|
|
|
|
|
Finance income
|
|
|
1,888
|
|
|
|
2,252
|
|
Bank charges
|
|
|
(18
|
)
|
|
|
(26
|
)
|
Net foreign currency gain (loss)
|
|
|
511
|
|
|
|
(635
|
)
|
|
|
|
|
|
|
|
|
|
Finance costs
|
|
|
493
|
|
|
|
(661
|
)
|
|
|
|
|
|
|
|
|
|
Net finance income recognized in net profit (loss)
|
|
|
2,381
|
|
|
|
1,591
|
|
|
|
|
|
|
|
|
|
|
F-18
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
Recognized in other comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
$
|
|
|
$
|
|
|
Net change in fair value of
available-for-sale
financial assets
|
|
|
(390
|
)
|
|
|
1,039
|
|
Net change in fair value of
available-for-sale
financial assets transferred to net profit (loss)
|
|
|
(326
|
)
|
|
|
(129
|
)
|
|
|
|
|
|
|
|
|
|
Finance (costs) income recognized in other comprehensive income,
net of tax
|
|
|
(716
|
)
|
|
|
910
|
|
|
|
|
|
|
|
|
|
|
Bonds are interest-bearing
available-for-sale
financial assets, with a carrying amount of $37,901 as at
November 30, 2010 ($61,843 in 2009, and $46,204 as at
December 1, 2008), have stated interest rates of 2.37% to
6.75% (2.37% to 6.75% in 2009 and 3.00% to 6.85% as at
December 1, 2008) and mature in 1.9 year (2.16 in
2009 and 1.8 in 2008).
The Companys exposure to credit and interest rate risks
related to bonds is presented in note 20.
|
|
9.
|
Trade and Other
Receivables:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
DECEMBER 1,
|
|
|
|
NOTE
|
|
|
2010
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Trade receivables
|
|
|
|
|
|
|
6
|
|
|
|
3
|
|
|
|
12
|
|
Sales tax receivable
|
|
|
|
|
|
|
100
|
|
|
|
190
|
|
|
|
419
|
|
Loans granted to employees under the share purchase plan
|
|
|
15
|
(iii)
|
|
|
25
|
|
|
|
74
|
|
|
|
91
|
|
Loans granted to related parties under the share purchase plan
|
|
|
15
|
(iii)
|
|
|
22
|
|
|
|
75
|
|
|
|
59
|
|
Other receivables
|
|
|
|
|
|
|
8
|
|
|
|
33
|
|
|
|
29
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
161
|
|
|
|
375
|
|
|
|
610
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Companys exposure to credit and currency risks related
to trade and other receivables is presented in note 20.
|
|
10.
|
Tax Credits and
Grants Receivable:
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
$
|
|
|
$
|
|
|
Balance at beginning of the year
|
|
|
1,333
|
|
|
|
1,451
|
|
Investment tax credits and grants received
|
|
|
(1,935
|
)
|
|
|
(1,913
|
)
|
Investment tax credits and grants recognized in net profit (loss)
|
|
|
934
|
|
|
|
1,795
|
|
|
|
|
|
|
|
|
|
|
|
|
|
332
|
|
|
|
1,333
|
|
|
|
|
|
|
|
|
|
|
Tax credits and grants receivable comprise research and
development investment tax credits receivable from the
provincial government which relate to qualifiable research and
development expenditures under the
F-19
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
applicable tax laws. The amounts recorded as receivable are
subject to a government tax audit and the final amounts received
may differ from those recorded. There are no unfulfilled
conditions or contingencies associated with the government
assistance received.
Unused federal tax credits may be used to reduce future income
tax and expire as follows:
|
|
|
|
|
|
|
$
|
|
|
2023
|
|
|
452
|
|
2024
|
|
|
1,597
|
|
2025
|
|
|
1,863
|
|
2026
|
|
|
2,178
|
|
2027
|
|
|
3,000
|
|
2028
|
|
|
3,328
|
|
2029
|
|
|
2,250
|
|
2030
|
|
|
1,167
|
|
|
|
|
|
|
|
|
|
15,835
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
DECEMBER 1,
|
|
|
|
2010
|
|
|
2009
|
|
|
2008
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Raw materials
|
|
|
3,395
|
|
|
|
2,225
|
|
|
|
|
|
Work in progress
|
|
|
922
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,317
|
|
|
|
2,225
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In 2010, $123 of raw materials, and $69 of work in progress were
written down to their net realizable value (November 30,
2009 nil and nil; December 1, 2008
nil and nil). Consequently, a write-down of $192 was recorded to
cost of sales in 2010 (2009 nil).
The write-down was due to unfavourable pricing related to raw
materials that were not originally purchased under the
conditions of the Companys current long-term procurement
agreements.
F-20
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
|
|
12.
|
Property and
Equipment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OFFICE
|
|
|
|
|
|
|
|
|
|
COMPUTER
|
|
|
LABORATORY
|
|
|
FURNITURE AND
|
|
|
LEASEHOLD
|
|
|
|
|
|
|
EQUIPMENT
|
|
|
EQUIPMENT
|
|
|
EQUIPMENT
|
|
|
IMPROVEMENTS
|
|
|
TOTAL
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Cost:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 1, 2008
|
|
|
682
|
|
|
|
1,824
|
|
|
|
1,015
|
|
|
|
1,846
|
|
|
|
5,367
|
|
Additions
|
|
|
222
|
|
|
|
125
|
|
|
|
188
|
|
|
|
8
|
|
|
|
543
|
|
Disposals
|
|
|
(30
|
)
|
|
|
(4
|
)
|
|
|
(79
|
)
|
|
|
|
|
|
|
(113
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at November 30, 2009
|
|
|
874
|
|
|
|
1,945
|
|
|
|
1,124
|
|
|
|
1,854
|
|
|
|
5,797
|
|
Additions
|
|
|
130
|
|
|
|
116
|
|
|
|
7
|
|
|
|
46
|
|
|
|
299
|
|
Disposals
|
|
|
(63
|
)
|
|
|
(43
|
)
|
|
|
(2
|
)
|
|
|
|
|
|
|
(108
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at November 30, 2010
|
|
|
941
|
|
|
|
2,018
|
|
|
|
1,129
|
|
|
|
1,900
|
|
|
|
5,988
|
|
Accumulated depreciation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 1, 2008
|
|
|
500
|
|
|
|
1,427
|
|
|
|
700
|
|
|
|
1,441
|
|
|
|
4,068
|
|
Depreciation for the year
|
|
|
147
|
|
|
|
96
|
|
|
|
79
|
|
|
|
290
|
|
|
|
612
|
|
Disposals
|
|
|
(30
|
)
|
|
|
(4
|
)
|
|
|
(78
|
)
|
|
|
|
|
|
|
(112
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at November 30, 2009
|
|
|
617
|
|
|
|
1,519
|
|
|
|
701
|
|
|
|
1,731
|
|
|
|
4,568
|
|
Depreciation for the year
|
|
|
170
|
|
|
|
88
|
|
|
|
85
|
|
|
|
123
|
|
|
|
466
|
|
Disposals
|
|
|
(63
|
)
|
|
|
(41
|
)
|
|
|
(2
|
)
|
|
|
|
|
|
|
(106
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at November 30, 2010
|
|
|
724
|
|
|
|
1,566
|
|
|
|
784
|
|
|
|
1,854
|
|
|
|
4,928
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net carrying amounts:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 1, 2008
|
|
|
182
|
|
|
|
397
|
|
|
|
315
|
|
|
|
405
|
|
|
|
1,299
|
|
November 30, 2009
|
|
|
257
|
|
|
|
426
|
|
|
|
423
|
|
|
|
123
|
|
|
|
1,229
|
|
November 30, 2010
|
|
|
217
|
|
|
|
452
|
|
|
|
345
|
|
|
|
46
|
|
|
|
1,060
|
|
Depreciation expense for the year has been recorded in the
following accounts in the consolidated statement of
comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
$
|
|
|
$
|
|
|
Cost of sales
|
|
|
8
|
|
|
|
|
|
Research and development expenses
|
|
|
231
|
|
|
|
306
|
|
Selling and market development expenses
|
|
|
10
|
|
|
|
14
|
|
General and administrative expenses
|
|
|
217
|
|
|
|
292
|
|
|
|
|
|
|
|
|
|
|
|
|
|
466
|
|
|
|
612
|
|
|
|
|
|
|
|
|
|
|
F-21
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
|
|
13.
|
Accounts Payable
and Accrued Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
DECEMBER 1,
|
|
|
|
NOTE
|
|
|
2010
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Trade payables
|
|
|
|
|
|
|
1,001
|
|
|
|
1,984
|
|
|
|
284
|
|
Accrued liabilities and other payables
|
|
|
|
|
|
|
1,440
|
|
|
|
1,768
|
|
|
|
4,692
|
|
Salaries and benefits due to related parties
|
|
|
25
|
|
|
|
565
|
|
|
|
450
|
|
|
|
504
|
|
Employee salaries and benefits payable
|
|
|
|
|
|
|
1,971
|
|
|
|
1,366
|
|
|
|
1,385
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,977
|
|
|
|
5,568
|
|
|
|
6,865
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Companys exposure to currency and liquidity risks
related to accounts payable and accrued liabilities is presented
in note 20.
Other liabilities consist of deferred lease inducements relating
to rent free periods amounting to $325 as at November 30,
2010 (November 30, 2009 and December 1,
2008 nil) (note 17).
Authorized in unlimited number and without par value:
Common shares
Preferred shares issuable in one or more series
All issued shares are fully paid, except for 33,524
(2009 90,298) issued under the share purchase plan
and for which the loan has not been repaid in full (see
note 15 (iii)).
Common shareholders are entitled to receive dividends as
declared by the Company at its discretion and are entitled to
one vote per share at the Companys annual general meeting.
No preferred shares are outstanding.
In 2010, the Company received subscriptions in the amount of $15
for the issuance of 2,880 common shares in connection with its
share purchase plan.
2009:
Under the terms of the collaboration and licensing agreement
with EMD Serono, the Company issued 2,179,837 common shares for
a cash consideration of $9,854 (see note 4).
In 2009, the Company also received subscriptions in the amount
of $96 for the issuance of 34,466 common shares in connection
with its share purchase plan.
All shares issued were for cash consideration.
|
|
(ii)
|
Shareholder
Rights Plan:
|
On February 10, 2010, the Companys Board of Directors
adopted a shareholder rights plan (the Plan),
effective as of that date. The Plan is designed to provide
adequate time for the Board of Directors and the shareholders,
to assess an unsolicited takeover bid for the Company. In
addition, the Plan provides the Board of Directors with
sufficient time to explore and develop alternatives for
maximizing shareholder value if a takeover bid is made, as well
as provide shareholders with an equal opportunity to participate
in a takeover bid to receive full and fair value for their
common shares. The Plan will expire at the close of the
Companys annual meeting of shareholders in 2013.
F-22
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
The rights issued under the Plan will initially attach to and
trade with the common shares and no separate certificates will
be issued unless a triggering event occurs. The rights will
become exercisable only when a person, including any party
related to it, acquires or attempts to acquire 20% or more of
the outstanding shares without complying with the
Permitted Bid provisions of the Plan or without
approval of the Board of Directors. Should such an acquisition
occur or be announced, each right would, upon exercise, entitle
a rights holder, other than the acquiring person and related
persons, to purchase common shares at a 50% discount to the
market price at the time.
Under the Plan, a Permitted Bid is a bid made to all holders of
the common shares and which is open for acceptance for not less
than 60 days. If at the end of 60 days at least 50% of
the outstanding common shares, other than those owned by the
offeror and certain related parties, have been tendered, the
offeror may take up and pay for the common shares, but must
extend the bid for a further 10 days to allow other
shareholders to tender.
|
|
(iii)
|
Share Purchase
Plan:
|
The Share Purchase Plan entitles full-time and part-time
employees of the Company who, on the participation date, are
residents of Canada, are not under a probationary period and do
not hold, directly or indirectly, five percent (5%) or more of
the Companys outstanding common shares, to directly
subscribe for common shares of the Company. Under the Share
Purchase Plan, a maximum of 550,000 common shares may be issued
to employees.
On May 1 and November 1 of each year (the Participation
Dates), an employee may subscribe for a number of common
shares under the Share Purchase Plan for an amount that does not
exceed 10% of that employees gross annual salary for that
year. Under the Share Purchase Plan, the Board of Directors has
the authority to suspend or defer a subscription of common
shares, or to decide that no subscription of common shares will
be allowed on a Participation Date if it is in the
Companys best interest.
The Share Purchase Plan provides that the number of common
shares that may be issued to insiders, at any time, under all
share-based compensation arrangements of the Company, cannot
exceed 10% of the Companys outstanding common shares, and
the number of common shares issued to insiders, within any
one-year period, under all security-based compensation
arrangements, cannot exceed 10% of the outstanding common shares.
The subscription price for each new common share subscribed for
under the Share Purchase Plan is equal to the weighted average
closing price of the common shares on the Toronto Stock Exchange
during a period of five days prior to the Participation Date.
Employees may not assign the rights granted under the Share
Purchase Plan.
An employee may elect to pay the subscription price for common
shares in cash or through an interest-free loan from the
Company. Loans granted by the Company under the Share Purchase
Plan are repayable through salary withholdings over a period not
exceeding two years. All loans may be repaid prior to the
scheduled repayment at any time. The loans granted to any
employee may at no time exceed 10% of that employees
current annual gross salary. All common shares purchased through
an interest-free loan are hypothecated to secure full and final
repayment of the loan and are held by a trustee until repayment
in full. Loans are immediately due and payable on the occurrence
of any of the following events: (i) termination of
employment; (ii) sale or seizure of the hypothecated common
shares; (iii) bankruptcy or insolvency of the employee; or
(iv) suspension of the payment of an employees salary
or revocation of the employees right to salary
withholdings.
At November 30, 2010, $47 (November 30,
2009 $149; December 1, 2008 $150)
was receivable under these loans (see note 9).
F-23
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
The Company has established a stock option plan under which it
can grant to its directors, officers, employees, researchers and
consultants non-transferable options for the purchase of common
shares. The exercise date of an option may not be later than
10 years after the grant date. A maximum number of
5,000,000 options can be granted under the plan. Generally, the
options vest at the date of the grant or over a period up to
5 years. As at November 30, 2010, 981,005 options
could still be granted by the Company (2009
1,244,834).
All options are to be settled by physical delivery of shares.
Changes in the number of options outstanding during the past two
years were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED
|
|
|
|
|
|
|
AVERAGE
|
|
|
|
|
|
|
EXERCISE PRICE
|
|
|
|
OPTIONS
|
|
|
PER OPTION
|
|
|
|
|
|
|
$
|
|
|
Options at December 1, 2008
|
|
|
2,161,800
|
|
|
|
6.52
|
|
Granted
|
|
|
680,500
|
|
|
|
1.83
|
|
Expired
|
|
|
(58,500
|
)
|
|
|
5.16
|
|
Forfeited
|
|
|
(118,000
|
)
|
|
|
9.92
|
|
|
|
|
|
|
|
|
|
|
Options at November 30, 2009
|
|
|
2,665,800
|
|
|
|
5.20
|
|
Granted
|
|
|
335,000
|
|
|
|
4.03
|
|
Expired
|
|
|
(32,500
|
)
|
|
|
11.15
|
|
Forfeited
|
|
|
(38,671
|
)
|
|
|
3.61
|
|
Exercised (weighted average share price: $5.14)
|
|
|
(80,491
|
)
|
|
|
1.66
|
|
|
|
|
|
|
|
|
|
|
Options at November 30, 2010
|
|
|
2,849,138
|
|
|
|
5.12
|
|
|
|
|
|
|
|
|
|
|
Exercisable at November 30, 2010
|
|
|
2,196,403
|
|
|
|
5.77
|
|
|
|
|
|
|
|
|
|
|
The following table provides stock option information as at
November 30, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPTIONS OUTSTANDING
|
|
|
|
|
|
|
WEIGHTED
|
|
|
|
|
|
|
|
|
|
AVERAGE
|
|
|
WEIGHTED
|
|
|
|
NUMBER OF
|
|
|
REMAINING
|
|
|
AVERAGE
|
|
|
|
OPTIONS
|
|
|
LIFE
|
|
|
EXERCISE
|
|
PRICE RANGE ($)
|
|
OUTSTANDING
|
|
|
(YEARS)
|
|
|
PRICE
|
|
|
|
|
|
|
|
|
|
$
|
|
|
1.20 2.00
|
|
|
1,183,015
|
|
|
|
6.54
|
|
|
|
1.71
|
|
2.01 2.75
|
|
|
141,459
|
|
|
|
3.85
|
|
|
|
2.59
|
|
2.76 3.75
|
|
|
70,000
|
|
|
|
5.51
|
|
|
|
3.37
|
|
3.76 4.60
|
|
|
265,000
|
|
|
|
9.03
|
|
|
|
3.84
|
|
4.61 6.00
|
|
|
95,000
|
|
|
|
7.69
|
|
|
|
4.93
|
|
6.01 9.00
|
|
|
570,664
|
|
|
|
4.82
|
|
|
|
8.17
|
|
9.01 13.50
|
|
|
480,000
|
|
|
|
2.86
|
|
|
|
10.72
|
|
13.51 15.30
|
|
|
44,000
|
|
|
|
0.36
|
|
|
|
15.12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,849,138
|
|
|
|
5.59
|
|
|
|
5.12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-24
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
The fair value of options granted was estimated at the grant
date using the Black-Scholes model and the following weighted
average assumptions:
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
NOVEMBER 30,
|
|
|
2010
|
|
2009
|
|
Risk-free interest rate
|
|
|
2.49
|
%
|
|
|
1.83
|
%
|
Expected volatility
|
|
|
81.13
|
%
|
|
|
79.50
|
%
|
Average option life in years
|
|
|
7.5
|
|
|
|
7.5
|
|
Expected dividends
|
|
|
nil
|
|
|
|
nil
|
|
Grant-date share price
|
|
$
|
4.03
|
|
|
$
|
1.83
|
|
Option exercise price
|
|
$
|
4.03
|
|
|
$
|
1.83
|
|
The risk-free interest rate is based on the implied yield on a
Canadian Government zero-coupon issue with a remaining term
equal to the expected term of the option. The volatility is
based solely on historical volatility equal to the expected life
of the option. The life of the options is estimated considering
the vesting period at the grant date, the life of the option and
the average length of time similar grants have remained
outstanding in the past. The dividend yield was excluded from
the calculation since it is the present policy of the Company to
retain all earnings to finance operations and future growth.
The following table summarizes the measurement date weighted
average fair value of stock options granted during the years
ended November 2010 and 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED
|
|
|
|
|
|
|
AVERAGE
|
|
|
|
NUMBER OF
|
|
|
GRANT-DATE
|
|
|
|
OPTIONS
|
|
|
FAIR VALUE
|
|
|
|
|
|
|
$
|
|
|
2010
|
|
|
335,000
|
|
|
|
3.05
|
|
2009
|
|
|
680,500
|
|
|
|
1.36
|
|
The Black-Scholes model used by the Company to calculate option
values was developed to estimate the fair value of freely
tradable, fully transferable options without vesting
restrictions, which significantly differs from the
Companys stock option awards. This model also requires
four highly subjective assumptions, including future stock price
volatility and average option life, which greatly affect the
calculated values.
The calculation of basic earnings per share at November 30,
2010 was based on the net profit (loss) attributable to common
shareholders of the Company of $8,930 (2009 -($15,156)), and a
weighted average number of common shares outstanding of
60,480,032 (2009 60,314,309), calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
Issued common shares at December 1
|
|
|
60,429,393
|
|
|
|
58,215,090
|
|
Effect of share options exercised
|
|
|
49,030
|
|
|
|
|
|
Effect of shares issued during the year
|
|
|
1,609
|
|
|
|
2,099,219
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares at November 30
|
|
|
60,480,032
|
|
|
|
60,314,309
|
|
|
|
|
|
|
|
|
|
|
F-25
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
The calculation of diluted earnings per share was based on a
weighted average number of common shares calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
Weighted average number of common shares (basic)
|
|
|
60,480,032
|
|
|
|
60,314,309
|
|
Effect of stock options on issue
|
|
|
842,959
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares (diluted) at November 30
|
|
|
61,322,991
|
|
|
|
60,314,309
|
|
|
|
|
|
|
|
|
|
|
At November 30, 2010, 1,119,664 options (2009
1,371,167) were excluded from the diluted weighted average
number of common shares calculation as their effect would have
been anti-dilutive.
The average market value of the Companys shares for
purposes of calculating the dilutive effect of share options was
based on quoted market prices for the period during which the
options were outstanding.
Current tax expense:
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
$
|
|
|
$
|
|
|
Current tax expense:
|
|
|
|
|
|
|
|
|
Current tax expense for the year
|
|
|
3,285
|
|
|
|
|
|
Recognition of previously unrecognized tax losses
|
|
|
(3,171
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Income tax expense
|
|
|
114
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax expense:
|
|
|
|
|
|
|
|
|
Recognition and reversal of temporary differences
|
|
|
|
|
|
|
(4,031
|
)
|
Change in unrecognized deductible temporary differences
|
|
|
|
|
|
|
4,031
|
|
|
|
|
|
|
|
|
|
|
Deferred income tax expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total income tax expense
|
|
|
114
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation between effective and applicable tax amounts:
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
$
|
|
|
$
|
|
|
Income taxes at domestic tax statutory rate
|
|
|
2,713
|
|
|
|
(4,683
|
)
|
Change in unrecognized deductible temporary differences
|
|
|
(3,171
|
)
|
|
|
4,031
|
|
Non-deductible expenses and other
|
|
|
572
|
|
|
|
652
|
|
|
|
|
|
|
|
|
|
|
|
|
|
114
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
tax assets:
Deferred tax asset of $114 (2009 nil) related to
share issue costs was recognized directly in equity.
F-26
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
Unrecognized
deferred tax assets:
At November 30, 2010, temporary differences for which no
deferred tax asset was recognized were as follows:
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
$
|
|
|
$
|
|
|
Long-term:
|
|
|
|
|
|
|
|
|
Research and development expenses
|
|
|
30,143
|
|
|
|
29,380
|
|
Deferred non-capital losses
|
|
|
21,013
|
|
|
|
21,490
|
|
Property and equipment
|
|
|
609
|
|
|
|
674
|
|
Intellectual property and patent fees
|
|
|
9,230
|
|
|
|
12,307
|
|
Available deductions and other
|
|
|
4,648
|
|
|
|
4,963
|
|
|
|
|
|
|
|
|
|
|
|
|
|
65,643
|
|
|
|
68,814
|
|
|
|
|
|
|
|
|
|
|
In assessing the realizability of deferred tax assets,
management considers whether it is more likely than not that
some portion or all of the deferred tax assets will not be
realized. The ultimate realization of deferred tax assets is
dependent upon the generation of future taxable income. The
generation of future taxable income is dependent on the
successful commercialization of the Companys products and
technologies.
Given the Companys past losses, management does not
believe that it is more probable than not that the Company can
realize its deferred tax assets and therefore it has not
recognized any amount in the statement of financial position.
At November 30, 2010, the amounts and expiry dates of tax
attributes to be deferred for which no deferred tax asset was
recognized were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
FEDERAL
|
|
|
PROVINCIAL
|
|
|
FEDERAL
|
|
|
PROVINCIAL
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Research and development expenses, without time limitation
|
|
|
103,324
|
|
|
|
123,062
|
|
|
|
103,346
|
|
|
|
115,686
|
|
Losses carried forward:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2014
|
|
|
1,216
|
|
|
|
|
|
|
|
9,603
|
|
|
|
|
|
2015
|
|
|
275
|
|
|
|
|
|
|
|
275
|
|
|
|
|
|
2027
|
|
|
7,638
|
|
|
|
7,628
|
|
|
|
7,638
|
|
|
|
7,628
|
|
2028
|
|
|
46,316
|
|
|
|
32,174
|
|
|
|
46,316
|
|
|
|
46,271
|
|
2029
|
|
|
19,484
|
|
|
|
16,467
|
|
|
|
21,785
|
|
|
|
18,802
|
|
2030
|
|
|
11,440
|
|
|
|
11,436
|
|
|
|
|
|
|
|
|
|
Other temporary differences, without time limitation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Excess of tax value of property and equipment over carrying value
|
|
|
2,773
|
|
|
|
1,666
|
|
|
|
3,121
|
|
|
|
1,785
|
|
Tax value of intellectual property and patent fees
|
|
|
34,301
|
|
|
|
34,289
|
|
|
|
45,735
|
|
|
|
45,718
|
|
Available deductions and other
|
|
|
57,343
|
|
|
|
1,412
|
|
|
|
58,415
|
|
|
|
2,732
|
|
F-27
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
The Company rents its headquarters and main office pursuant to
an operating lease (the Lease) expiring in
April 2021. Under the terms of the Lease, the Company has
also been granted two renewal options for periods of five years
each. Lease payments will increase by 11% beginning on
November 1, 2015.
During the year ended November 30, 2010, an amount of $628
was recognized as an expense in respect of operating leases
(2009 $805). Of the amount $133 (2009
$176) is included in General and administrative expenses and
$495 (2009 $629) is included in Research and
development expenses.
The Companys lease includes a lease of land and building.
Since the land title does not pass, and the Company does not
participate in the residual value of the building, it was
determined that substantially all the risks and rewards of the
building are with the lessor. As such, the Company determined
that the lease is an operating lease.
The Company has committed to pay the lessor for its share of
some operating expenses of the leased premises. This amount has
been set at $240 per year beginning May 1, 2010 and will be
increased by 2.5% annually for the duration of the Lease. Refer
to note 23 for the contractual commitments related to this
lease.
The lessor granted the Company a monetary allowance in the
amount of $728 to make leasehold improvements. This amount had
not been received as at November 30, 2010. Furthermore, the
Company benefits from a
25-month
rent free period which is deferred and recognized over the lease
term. As at November 30, 2010, $325 was included in Other
liability (nil November 30, 2009) in
regards to the deferred free rent inducement
(note 14 Other liabilities).
The Company had issued an irrevocable letter of credit in favour
of the lessor in the amount of $323 under the terms of the Lease
renewal, along with a first ranking movable hypothec in the
amount of $1,150 covering all the Companys tangible assets
located in the rented premises. The letter of credit and the
hypothec were cancelled on April 30, 2010.
|
|
18.
|
Contingent
Liability:
|
On July 26, 2010, the Company received a motion of
authorization to institute a class action lawsuit against the
Company, a director and a former executive officer (the
Motion). This Motion was filed in the Superior Court
of Quebec, district of Montreal. The applicant is seeking to
initiate a class action suit to represent the class of persons
who were shareholders at May 21, 2010 and who sold their
common shares of the Company on May 25 or 26, 2010. This
applicant alleges that the Company did not comply with its
continuous disclosure obligations as a reporting issuer by
failing to disclose certain alleged adverse effects relating to
the administration of
EGRIFTA®.
The Company is of the view that the allegations contained in the
Motion are entirely without merit and intends to take all
appropriate actions to vigorously defend its position.
The Motion had not yet been heard by the Superior Court of
Quebec and a date has not been set for the hearing.
The Company has subscribed to insurance covering its potential
liability and the potential liability of its directors and
officers in the performance of their duties for the Company
subject to a $200 deductible. At November 30, 2010, an
amount of $96 in legal fees has been accrued and included in
general and administrative expenses, of which $61 was paid
during the year and $35 remained in accounts payable and accrued
liabilities.
|
|
19.
|
Statement of Cash
Flows:
|
The Company entered into the following transactions which had no
impact on the cash flows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
DECEMBER 1,
|
|
|
|
2010
|
|
|
2009
|
|
|
2008
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Additions to property and equipment included in accounts payable
and accrued liabilities
|
|
|
65
|
|
|
|
183
|
|
|
|
48
|
|
Share issue costs included in accounts payable and accrued
liabilities
|
|
|
|
|
|
|
|
|
|
|
8
|
|
|
In addition, interest received totalled $2,290 (2009
$1,200).
F-28
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
|
|
20.
|
Financial
Instruments:
|
Overview:
This note provides disclosures relating to the nature and extent
of the Companys exposure to risks arising from financial
instruments, including credit risk, liquidity risk, currency
risk and interest rate risk, and how the Company manages those
risks.
Credit risk is the risk of an unexpected loss if a customer or
counterparty to a financial instrument fails to meet its
contractual obligations. The Company regularly monitors credit
risk exposure and takes steps to mitigate the likelihood of this
exposure resulting in losses.
The Companys exposure to credit risk currently relates to
accounts receivable with only one customer (see note 4).
Financial instruments other than cash and trade and other
receivables that potentially subject the Company to significant
credit risk consist principally of bonds. The Company invests
its available cash in highly liquid fixed income instruments
from governmental, paragovernmental and municipal bodies
($37,542 as at November 30, 2010) as well as from
companies with high credit ratings ($359 as at November 30,
2010). As at November 30, 2010, the Company was not exposed
to any credit risk over the carrying amount of the bonds.
Liquidity risk is the risk that the Company will not be able to
meet its financial obligations as they become due. As indicated
in the capital management section below, the Company manages
this risk through the management of its capital structure. It
also manages liquidity risk by continuously monitoring actual
and projected cash flows. The Board of Directors
and/or the
Audit Committee reviews and approves the Companys
operating and capital budgets, as well as any material
transactions out of the ordinary course of business.
The Company has adopted an investment policy in respect of the
safety and preservation of its capital to ensure the
Companys liquidity needs are met. The instruments are
selected with regard to the expected timing of expenditures and
prevailing interest rates.
The following are amounts due on the contractual maturities of
financial liabilities as at November 30, 2010 and 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30, 2010
|
|
|
|
|
|
|
CARRYING
|
|
|
LESS THAN
|
|
|
1 TO
|
|
|
MORE THAN
|
|
|
|
TOTAL
|
|
|
AMOUNT
|
|
|
1 YEAR
|
|
|
5 YEARS
|
|
|
5 YEARS
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Accounts payable and accrued liabilities
|
|
|
4,977
|
|
|
|
4,977
|
|
|
|
4,977
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30, 2009
|
|
|
|
|
|
|
CARRYING
|
|
|
LESS THAN
|
|
|
1 TO
|
|
|
MORE THAN
|
|
|
|
TOTAL
|
|
|
AMOUNT
|
|
|
1 YEAR
|
|
|
5 YEARS
|
|
|
5 YEARS
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Accounts payable and accrued liabilities
|
|
|
5,568
|
|
|
|
5,568
|
|
|
|
5,568
|
|
|
|
|
|
|
|
|
|
|
The Company is exposed to financial risk related to the
fluctuation of foreign exchange rates and the degree of
volatility of those rates. Currency risk is limited to the
portion of the Companys business transactions denominated
in currencies other than the Canadian dollar, primarily revenues
from milestone payments and expenses for research and
development incurred in US dollars, euros and
F-29
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
pounds sterling (GBP). The Company does not use
derivative financial instruments to reduce its foreign exchange
exposure.
The Company manages currency risk by maintaining cash in US
dollars on hand to support US forecasted cash budgets for a
maximum
12-month
period. The Company does not currently view its exposure to the
euro and GBP as a significant foreign exchange risk due to the
limited volume of transactions conducted by the Company in these
currencies.
Exchange rate fluctuations for foreign currency transactions can
cause cash flows as well as amounts recorded in the consolidated
statement of comprehensive income to vary from period to period
and not necessarily correspond to those forecasted in operating
budgets and projections. Additional earnings variability arises
from the translation of monetary assets and liabilities
denominated in currencies other than the Canadian dollar at the
rates of exchange at each consolidated statement of financial
position date, the impact of which is reported as foreign
exchange gain or loss in the consolidated statement of
comprehensive income. Given the Companys policy on the
management of the Companys US foreign currency risk, the
Company does not believe a sudden change in foreign exchange
rates would impair or enhance its ability to pay its US dollar
denominated obligations.
The following table presents the significant items exposed to
currency risk at the following dates:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30, 2010
|
|
|
|
$US
|
|
|
EURO
|
|
|
GBP
|
|
|
Cash
|
|
|
26,424
|
|
|
|
|
|
|
|
1
|
|
Trade and other receivables
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
|
(465
|
)
|
|
|
(26
|
)
|
|
|
(81
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Items exposed to currency risk
|
|
|
25,959
|
|
|
|
(26
|
)
|
|
|
(80
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30, 2009
|
|
|
|
$US
|
|
|
EURO
|
|
|
GBP
|
|
|
Cash
|
|
|
1,471
|
|
|
|
|
|
|
|
|
|
Trade and other receivables
|
|
|
|
|
|
|
4
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
|
(1,095
|
)
|
|
|
|
|
|
|
(25
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Items exposed to currency risk
|
|
|
376
|
|
|
|
4
|
|
|
|
(25
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 1, 2008
|
|
|
|
$US
|
|
|
EURO
|
|
|
GBP
|
|
|
Cash
|
|
|
1
|
|
|
|
|
|
|
|
|
|
Trade and other receivables
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
|
(2,589
|
)
|
|
|
(159
|
)
|
|
|
(348
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Items exposed to currency risk
|
|
|
(2,588
|
)
|
|
|
(159
|
)
|
|
|
(348
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-30
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
The following exchange rates are those applicable to the
following periods and dates:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30, 2010
|
|
|
NOVEMBER 30, 2009
|
|
|
DECEMBER 1, 2008
|
|
|
|
AVERAGE
|
|
|
REPORTING
|
|
|
AVERAGE
|
|
|
REPORTING
|
|
|
AVERAGE
|
|
|
REPORTING
|
|
|
|
RATE
|
|
|
DATE RATE
|
|
|
RATE
|
|
|
DATE RATE
|
|
|
RATE
|
|
|
DATE RATE
|
|
|
$US C$
|
|
|
1.0345
|
|
|
|
1.0266
|
|
|
|
1.0594
|
|
|
|
1.0556
|
|
|
|
1.0479
|
|
|
|
1.2370
|
|
EURO C$
|
|
|
1.3848
|
|
|
|
1.3326
|
|
|
|
1.5808
|
|
|
|
1.5852
|
|
|
|
1.5440
|
|
|
|
1.5711
|
|
GBP C$
|
|
|
1.6051
|
|
|
|
1.5969
|
|
|
|
1.7597
|
|
|
|
1.7366
|
|
|
|
1.9767
|
|
|
|
1.9060
|
|
|
Based on the Companys foreign currency exposures noted
above, varying the above foreign exchange rates to reflect a 5%
strengthening of the Canadian dollar would have increased the
net profit (loss) as follows, assuming that all other variables
remained constant:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30, 2010
|
|
NOVEMBER 30, 2009
|
|
|
$US
|
|
EURO
|
|
GBP
|
|
$US
|
|
EURO
|
|
GBP
|
|
Increase in net profit (loss)
|
|
|
1,298
|
|
|
|
(1
|
)
|
|
|
(4
|
)
|
|
|
19
|
|
|
|
|
|
|
|
(1
|
)
|
|
An assumed 5% weakening of the Canadian dollar would have had an
equal but opposite effect on the above currencies to the amounts
shown above, assuming that all other variables remain constant.
Interest rate risk is the risk that the fair value or future
cash flows of a financial instrument will fluctuate because of
changes in market interest rates.
Short-term bonds held by the Company are invested at fixed
interest rates
and/or
mature in the short-term. Long-term bonds are also instruments
that bear interest at fixed rates. The risk that the Company
will realize a loss as a result of a decline in the fair value
of its bonds is limited because these investments, although they
are classified as available for sale, are generally held to
maturity. The unrealized gains or losses on bonds are recorded
in accumulated other comprehensive income.
Based on the value of the Companys short and long-term
bonds at November 30, 2010, an assumed 0.5% decrease in
market interest rates would have increased the fair value of
these bonds and the accumulated other comprehensive income by
approximately $336; an assumed increase in interest rate of 0.5%
would have an equal but opposite effect, assuming that all other
variables remained constant.
Cash bears interest at a variable rate. Trade and other
receivables, accounts payable and accrued liabilities bear no
interest.
Based on the average value of variable interest-bearing cash
during the year ended November 30, 2010 ($3,219), an
assumed 0.5% increase in interest rates during such period would
have increased future cash flow and net profit by approximately
$16; an assumed decrease of 0.5% would have had an equal but
opposite effect.
The Companys objective in managing capital is to ensure a
sufficient liquidity position to finance its research and
development activities, general and administrative expenses,
working capital and capital spending.
To fund its activities, the Company relied primarily on public
offerings of common shares in Canada and private placements of
its common shares as well as up-front payments and milestone
payments primarily associated with EMD Serono. When possible,
the Company optimizes its liquidity position using non-dilutive
sources, including investment tax credits, grants and interest
income.
F-31
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
The Company has a $1,800 revolving credit facility for its
short-term financing needs which was unused at November 30,
2010 (see note 23 (c)).
The capital management objectives remain the same as for the
previous year.
At November 30, 2010, cash and bonds amounted to $64,550
and tax credits and grants receivable amounted to $332, for a
total of $64,882. The Company believes that its cash position
will be sufficient to finance its operations and capital needs
for the next year.
Currently, the Companys general policy on dividends is to
retain cash to keep funds available to finance the
Companys growth.
The Company is not subject to any externally imposed capital
requirements.
|
|
22.
|
Determination of
Fair Values:
|
Certain of the Companys accounting policies and
disclosures require the determination of fair value, for both
financial and non-financial assets and liabilities. Fair values
have been determined for measurement
and/or
disclosure purposes based on the following methods. When
applicable, further information about the assumptions made in
determining fair values is disclosed in the notes specific to
that asset or liability.
Financial
Assets and Liabilities:
In establishing fair value, the Company uses a fair value
hierarchy based on levels as defined below:
|
|
|
|
n
|
Level 1: defined as observable inputs such as
quoted prices in active markets.
|
|
|
n
|
Level 2: defined as inputs other than quoted
prices in active markets that are either directly or indirectly
observable.
|
|
|
n
|
Level 3: defined as inputs that are based on
little or no observable market data, therefore requiring
entities to develop its own assumptions.
|
The Company has determined that the carrying values of its
short-term financial assets and liabilities, including cash,
trade and other receivables as well as accounts payable and
accrued liabilities, approximate their fair value because of the
relatively short period to maturity of the instruments.
Bonds are stated at estimated fair value, determined by inputs
that are primarily based on broker quotes at the reporting date
(Level 2).
Share-Based
Payment Transactions:
The fair value of the employee stock options is measured based
on the Black-Scholes valuation model. Measurement inputs include
share price on measurement date, exercise price of the
instrument, expected volatility (based on weighted average
historic volatility adjusted for changes expected due to
publicly available information), weighted average expected life
of the instruments (based on historical experience and general
option holder behaviour), expected dividends, and the risk-free
interest rate (based on government bonds). Service and
non-market performance conditions attached to the transactions
are not taken into account in determining fair value.
F-32
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
At November 30, 2010 and 2009 and December 1, 2008,
the minimum payments required under the terms of the
non-cancellable lease are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
DECEMBER 1,
|
|
|
|
2010
|
|
|
2009
|
|
|
2008
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Less than one year
|
|
|
55
|
|
|
|
340
|
|
|
|
816
|
|
Between one and five years
|
|
|
2,239
|
|
|
|
2,020
|
|
|
|
340
|
|
More than five years
|
|
|
3,943
|
|
|
|
4,216
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,237
|
|
|
|
6,576
|
|
|
|
1,156
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(b)
|
Long-term
Procurement Agreements:
|
During and after the years ended November 30, 2010 and
2009, the Company entered into long-term procurement agreements
with third-party suppliers in anticipation of the
commercialization of
EGRIFTA®.
The Company has a $1,800 revolving credit facility, bearing
interest at prime plus 0.5%. Under the term of the credit
facility, the market value of investments held must always be
equivalent to 150% of amounts drawn under the facility. If the
market value falls below $7,000, the Company will provide the
bank with a first rank movable hypothec (security interest) of
$1,850 on securities judged satisfactory by the bank.
As at November 30, 2010 and 2009, the Company did not have
any borrowings outstanding under this credit facility.
The Company has a single operating segment. As described in
note 4, all of the Companys revenues are generated
from one customer, EMD Serono, which is domiciled in the United
States.
All of the Companys non-current assets are located in
Canada, the Companys headquarters.
The Company has a related party relationship with its
wholly-owned subsidiaries. There are no transactions between the
Company and its subsidiaries.
The key management personnel of the Company are the Directors.
Key management personnel compensation comprised:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
NOVEMBER 30,
|
|
|
|
NOTE
|
|
|
2010
|
|
|
2009
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
Short-term employee benefits
|
|
|
|
|
|
|
1,891
|
|
|
|
1,647
|
|
Post-employment benefits
|
|
|
|
|
|
|
61
|
|
|
|
59
|
|
Share-based compensation
|
|
|
15
|
(iv)
|
|
|
331
|
|
|
|
175
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,283
|
|
|
|
1,881
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Directors of the Company control 1.2 percent of the voting
shares of the Company.
F-33
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
On November 30, 2010, loans granted to key management
personnel under share purchase plan (note 15 (iii)) amount to
$22 as at November 30, 2010 ($75 as at November 30,
2009 and $59 as at December 1, 2008).
Distribution
and Licensing Agreement:
On December 6, 2010, the Company announced the signing of a
distribution and licensing agreement with Sanofi-aventis
(Sanofi), covering the commercial rights for
EGRIFTA®
in Latin America, Africa, and the Middle East for the treatment
of excess abdominal fat in HIV-infected patients with
lipodystrophy.
Under the terms of the agreement, the Company will sell
EGRIFTA®
to Sanofi at a transfer price equal to the higher of a
percentage of Sanofis net selling price and a
predetermined floor price. The Company has retained all future
development rights to
EGRIFTA®
and will be responsible for conducting research and development
for any additional potential indications. Sanofi will be
responsible for conducting all regulatory activities for
EGRIFTA®
in the aforementioned territories, including applications for
approval in the different countries for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy. The
Company also granted Sanofi an option to commercialize
tesamorelin for other indications in the territories mentioned
above. If such option is not exercised, or is declined, by
Sanofi, the Company may commercialize tesamorelin for such
indications on its own or with a third party.
On February 3, 2011, the Company entered into a
distribution and licensing agreement with Ferrer covering the
commercial rights for
EGRIFTA®
for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy in Europe, Russia, South Korea,
Taiwan, Thailand and certain central Asian countries.
Under the terms of the Agreement, the Company will sell
EGRIFTA®
to Ferrer at a transfer price equal to the higher of a
significant percentage of the Ferrers net selling price
and a predetermined floor price. The Company has retained all
development rights to
EGRIFTA®
for other indications and will be responsible for conducting
research and development for any additional programs. Ferrer
will be responsible for conducting all regulatory and
commercialization activities in connection with
EGRIFTA®
for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy in the territories subject to the
agreement. The Company will be responsible for the manufacture
and supply of
EGRIFTA®
to Ferrer. The Company has the option to co-promote
EGRIFTA®
for the reduction of excess abdominal fat in HIV-infected
patients with lipodystrophy in the territories. Ferrer has the
option to enter into a co-development and commercialization
agreement using tesamorelin relating to any such new
indications. The terms and conditions of such a co-development
and commercialization agreement will be negotiated based on any
additional program chosen for development.
Deferred
Share Unit Plan:
In December 2010, the Company adopted a deferred share unit plan
(Plan) to provide long-term incentive compensation
for its directors and executive officers. Under the Plan,
directors must receive their annual remuneration as a board
member in fully vested deferred share units (DSUs)
until they reach a percentage of their annual remuneration and,
once such percentage is attained, they have the option to elect
to receive part or all of this annual remuneration in DSUs.
Under the plan, executive officers have the option of receiving
all or a portion of their annual bonus in the form of
fully-vested DSUs. The units are only redeemable for cash when a
participant ceases to be an employee or member of the Board of
Directors. The Company manages the risk associated with the
issuance of the DSU by entering into a yearly forward contract
with a third party. As at February 7, 2011, all of the
99,912 DSU outstanding were covered by a prepaid forward
contract.
Stock
Option Plan:
Between December 1, 2010 and February 7, 2011, the
Company granted 250,000 options at an exercise price of $5.65
per share. Also 27,832 options were forfeited and expired at a
weighted exercise average price of $12.06 per share.
Furthermore, 3,000 options were exercised at a weighted exercise
average price of $1.80 per share for a cash consideration of $5.
F-34
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
As stated in note 2 (a), these are the Companys first
consolidated financial statements prepared in accordance with
IFRSs. The Company has applied IFRS 1 and the accounting
policies set out in note 3 in preparing the financial
statements for the year ended November 30, 2010, the
comparative information presented in these financial statements
for the year ended November 30, 2009 and in the opening
IFRS statement of financial position at December 1, 2008
(the Companys date of transition).
In preparing these consolidated financial statements in
accordance with IFRS 1, the Company has applied the mandatory
exceptions and certain of the optional exemptions from full
retrospective application of IFRSs.
The Company elected to apply the following optional exemptions
from full retrospective application:
|
|
|
|
(i)
|
Share-based payment transaction exemption:
|
The Company has elected to apply the share-based payment
exemption. It applied IFRS 2 from December 1, 2008 to those
stock options that were issued after November 7, 2002 but
that had not vested by December 1, 2008. The application of
the exemption is detailed below.
|
|
|
|
(ii)
|
Designation of financial assets and financial liabilities
exemption:
|
The Company elected to re-designate cash from the
held-for-trading
category to loans and receivables.
As required by IFRS 1, estimates made under IFRS at the date of
transition must be consistent with estimates made for the same
date under previous GAAP, unless there is evidence that those
estimates were in error.
In preparing its opening IFRS consolidated statement of
financial position, the Company has adjusted amounts reported
previously in financial statements prepared in accordance with
Canadian GAAP.
F-35
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
An explanation of how the transition from previous Canadian GAAP
to IFRS has affected the Companys financial position,
financial performance and cash flows is set out in the following
tables and accompanying notes.
Reconciliation of equity as at December 1, 2008 and
November 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 1, 2008
|
|
|
NOVEMBER 30, 2009
|
|
|
|
|
|
|
|
|
|
IFRS
|
|
|
IFRS
|
|
|
|
|
|
|
|
|
IFRS
|
|
|
IFRS
|
|
|
|
|
|
|
|
|
|
CANADIAN
|
|
|
ADJUST-
|
|
|
RECLASSI-
|
|
|
|
|
|
CANADIAN
|
|
|
ADJUST-
|
|
|
RECLASSI-
|
|
|
|
|
|
|
NOTE
|
|
|
GAAP
|
|
|
MENTS
|
|
|
FICATIONS
|
|
|
IFRS
|
|
|
GAAP
|
|
|
MENTS
|
|
|
FICATIONS
|
|
|
IFRS
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
|
|
|
|
|
|
|
133
|
|
|
|
|
|
|
|
|
|
|
|
133
|
|
|
|
1,519
|
|
|
|
|
|
|
|
|
|
|
|
1,519
|
|
Bonds
|
|
|
|
|
|
|
10,955
|
|
|
|
|
|
|
|
|
|
|
|
10,955
|
|
|
|
10,036
|
|
|
|
|
|
|
|
|
|
|
|
10,036
|
|
Trade and other receivables
|
|
|
|
|
|
|
610
|
|
|
|
|
|
|
|
|
|
|
|
610
|
|
|
|
375
|
|
|
|
|
|
|
|
|
|
|
|
375
|
|
Tax credits and grants receivable
|
|
|
(a
|
)
|
|
|
1,784
|
|
|
|
|
|
|
|
(333
|
)
|
|
|
1,451
|
|
|
|
1,666
|
|
|
|
|
|
|
|
(333
|
)
|
|
|
1,333
|
|
Inventories
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,225
|
|
|
|
|
|
|
|
|
|
|
|
2,225
|
|
Research supplies
|
|
|
(a
|
)
|
|
|
301
|
|
|
|
|
|
|
|
(301
|
)
|
|
|
|
|
|
|
287
|
|
|
|
|
|
|
|
(287
|
)
|
|
|
|
|
Prepaid expenses
|
|
|
(a
|
)
|
|
|
397
|
|
|
|
|
|
|
|
342
|
|
|
|
739
|
|
|
|
302
|
|
|
|
|
|
|
|
328
|
|
|
|
630
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
|
|
|
|
14,180
|
|
|
|
|
|
|
|
(292
|
)
|
|
|
13,888
|
|
|
|
16,410
|
|
|
|
|
|
|
|
(292
|
)
|
|
|
16,118
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bonds
|
|
|
|
|
|
|
35,249
|
|
|
|
|
|
|
|
|
|
|
|
35,249
|
|
|
|
51,807
|
|
|
|
|
|
|
|
|
|
|
|
51,807
|
|
Property and equipment
|
|
|
|
|
|
|
1,299
|
|
|
|
|
|
|
|
|
|
|
|
1,299
|
|
|
|
1,229
|
|
|
|
|
|
|
|
|
|
|
|
1,229
|
|
Other assets
|
|
|
(a
|
)
|
|
|
2,817
|
|
|
|
|
|
|
|
(41
|
)
|
|
|
2,776
|
|
|
|
41
|
|
|
|
|
|
|
|
(41
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-current assets
|
|
|
|
|
|
|
39,365
|
|
|
|
|
|
|
|
(41
|
)
|
|
|
39,324
|
|
|
|
53,077
|
|
|
|
|
|
|
|
(41
|
)
|
|
|
53,036
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
|
|
|
|
|
53,545
|
|
|
|
|
|
|
|
(333
|
)
|
|
|
53,212
|
|
|
|
69,487
|
|
|
|
|
|
|
|
(333
|
)
|
|
|
69,154
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
|
(a
|
)
|
|
|
7,198
|
|
|
|
|
|
|
|
(333
|
)
|
|
|
6,865
|
|
|
|
5,901
|
|
|
|
|
|
|
|
(333
|
)
|
|
|
5,568
|
|
Current portion of deferred revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,847
|
|
|
|
|
|
|
|
|
|
|
|
6,847
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
|
|
|
|
7,198
|
|
|
|
|
|
|
|
(333
|
)
|
|
|
6,865
|
|
|
|
12,748
|
|
|
|
|
|
|
|
(333
|
)
|
|
|
12,415
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,691
|
|
|
|
|
|
|
|
|
|
|
|
13,691
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-current liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,691
|
|
|
|
|
|
|
|
|
|
|
|
13,691
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
|
|
|
|
7,198
|
|
|
|
|
|
|
|
(333
|
)
|
|
|
6,865
|
|
|
|
26,439
|
|
|
|
|
|
|
|
(333
|
)
|
|
|
26,106
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital
|
|
|
|
|
|
|
269,219
|
|
|
|
|
|
|
|
|
|
|
|
269,219
|
|
|
|
279,169
|
|
|
|
|
|
|
|
|
|
|
|
279,169
|
|
Contributed surplus
|
|
|
(b
|
)
|
|
|
5,585
|
|
|
|
175
|
|
|
|
|
|
|
|
5,760
|
|
|
|
6,484
|
|
|
|
273
|
|
|
|
|
|
|
|
6,757
|
|
Deficit
|
|
|
(b
|
)
|
|
|
(228,829
|
)
|
|
|
(175
|
)
|
|
|
|
|
|
|
(229,004
|
)
|
|
|
(243,887
|
)
|
|
|
(273
|
)
|
|
|
|
|
|
|
(244,160
|
)
|
Accumulated other comprehensive income
|
|
|
|
|
|
|
372
|
|
|
|
|
|
|
|
|
|
|
|
372
|
|
|
|
1,282
|
|
|
|
|
|
|
|
|
|
|
|
1,282
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total equity
|
|
|
|
|
|
|
46,347
|
|
|
|
|
|
|
|
|
|
|
|
46,347
|
|
|
|
43,048
|
|
|
|
|
|
|
|
|
|
|
|
43,048
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity
|
|
|
|
|
|
|
53,545
|
|
|
|
|
|
|
|
(333
|
)
|
|
|
53,212
|
|
|
|
69,487
|
|
|
|
|
|
|
|
(333
|
)
|
|
|
69,154
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-36
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
Reconciliation of comprehensive income for the year ended
November 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IFRS
|
|
|
IFRS
|
|
|
|
|
|
|
|
|
|
CANADIAN
|
|
|
ADJUST-
|
|
|
RECLASSI-
|
|
|
|
|
|
|
NOTE
|
|
|
GAAP
|
|
|
MENTS
|
|
|
FICATION
|
|
|
IFRS
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Milestone payments
|
|
|
(c
|
)
|
|
|
|
|
|
|
|
|
|
|
10,884
|
|
|
|
10,884
|
|
Upfront payments and initial technology access fees
|
|
|
(c
|
)
|
|
|
|
|
|
|
|
|
|
|
6,560
|
|
|
|
6,560
|
|
Royalties and license fees
|
|
|
(c
|
)
|
|
|
17,468
|
|
|
|
|
|
|
|
(17,444
|
)
|
|
|
24
|
|
Interest
|
|
|
(c
|
)
|
|
|
2,252
|
|
|
|
|
|
|
|
(2,252
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
|
|
|
|
|
19,720
|
|
|
|
|
|
|
|
(2,252
|
)
|
|
|
17,468
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses, net of tax credits
|
|
|
(b
|
), (c)
|
|
|
20,431
|
|
|
|
33
|
|
|
|
346
|
|
|
|
20,810
|
|
Selling and market development expenses
|
|
|
(b
|
), (c)
|
|
|
2,583
|
|
|
|
10
|
|
|
|
4,269
|
|
|
|
6,862
|
|
General and administrative expenses
|
|
|
(b
|
), (c)
|
|
|
7,149
|
|
|
|
55
|
|
|
|
(661
|
)
|
|
|
6,543
|
|
Patents
|
|
|
(c
|
)
|
|
|
346
|
|
|
|
|
|
|
|
(346
|
)
|
|
|
|
|
Fees associated with the collaboration and licensing agreement
|
|
|
(c
|
)
|
|
|
4,269
|
|
|
|
|
|
|
|
(4,269
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
|
|
|
|
34,778
|
|
|
|
98
|
|
|
|
(661
|
)
|
|
|
34,215
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Results from operating activities
|
|
|
|
|
|
|
(15,058
|
)
|
|
|
(98
|
)
|
|
|
(1,591
|
)
|
|
|
(16,747
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income
|
|
|
(c
|
)
|
|
|
|
|
|
|
|
|
|
|
2,252
|
|
|
|
2,252
|
|
Finance costs
|
|
|
(c
|
)
|
|
|
|
|
|
|
|
|
|
|
(661
|
)
|
|
|
(661
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net finance income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,591
|
|
|
|
1,591
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
(15,058
|
)
|
|
|
(98
|
)
|
|
|
|
|
|
|
(15,156
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value of
available-for-sale
financial assets
|
|
|
|
|
|
|
1,039
|
|
|
|
|
|
|
|
|
|
|
|
1,039
|
|
Net change in fair value of
available-for-sale
financial assets transferred to net profit (loss)
|
|
|
|
|
|
|
(129
|
)
|
|
|
|
|
|
|
|
|
|
|
(129
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income for the year
|
|
|
|
|
|
|
910
|
|
|
|
|
|
|
|
|
|
|
|
910
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income for the year
|
|
|
|
|
|
|
(14,148
|
)
|
|
|
(98
|
)
|
|
|
|
|
|
|
(14,246
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Material adjustments to the consolidated statement of cash flows
for 2009:
There are no material differences between the consolidated
statement of cash flows presented under IFRS and the
consolidated statement of cash flows presented under previous
Canadian GAAP.
Notes to the reconciliations:
|
|
|
|
(a)
|
Reclassification in the consolidated statement of financial
position:
|
Certain corresponding figures as at December 1, 2008 and
November 30, 2009 have been reclassified to conform to the
new presentation under IFRS.
|
|
|
|
(b)
|
Share-based compensation:
|
In certain situations, stock options granted vest in instalments
over a specified vesting period. When the only vesting condition
is service from the grant date to the vesting date of each
tranche awarded, then each instalment should be accounted for as
a separate share-based payment arrangement under IFRS,
F-37
THERATECHNOLOGIES
INC.
NOTES TO THE
CONSOLIDATED FINANCIAL
STATEMENTS (CONTINUED)
otherwise known as graded vesting. Canadian GAAP permits an
entity the accounting policy choice with respect to graded
vesting awards. Each instalment can be considered as a separate
award, each with a different vesting period, consistent with
IFRS, or the arrangement can be treated as a single award with a
vesting period based on the average vesting period of the
instalments depending on the policy elected.
The Companys policy under Canadian GAAP was to treat
graded vesting awards under the latter method and, as a result,
an adjustment of $175 was required on the application of IFRS 2
at the transition date, and an adjustment of $98 was required
for the restated 2009 comparative balances as shown below:
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 1,
|
|
|
NOVEMBER 30,
|
|
|
|
2008
|
|
|
2009
|
|
|
|
$
|
|
|
$
|
|
|
Consolidated statement of comprehensive income:
|
|
|
|
|
|
|
|
|
Increase in research and development expenses
|
|
|
|
|
|
|
33
|
|
Increase in selling and market development expenses
|
|
|
|
|
|
|
10
|
|
Increase in general and administrative expenses
|
|
|
|
|
|
|
55
|
|
|
|
|
|
|
|
|
|
|
Adjustment to net loss and total comprehensive loss
|
|
|
|
|
|
|
98
|
|
|
|
|
|
|
|
|
|
|
Deficit
|
|
|
(175
|
)
|
|
|
(273
|
)
|
Increase in contributed surplus
|
|
|
175
|
|
|
|
273
|
|
|
|
|
|
|
(c)
|
Reclassification in the consolidated statement of comprehensive
income:
|
Under IFRS, the Company elected to present expenses using a
classification based on their function and presents net finance
income separately. The effect of these changes is summarized
below:
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
|
2009
|
|
|
|
$
|
|
|
Decrease in interest
|
|
|
(2,252
|
)
|
Increase in finance income
|
|
|
2,252
|
|
Increase in research and development expenses
|
|
|
346
|
|
Decrease in patent fees
|
|
|
(346
|
)
|
Decrease in general and administrative expenses
|
|
|
(661
|
)
|
Increase in finance costs
|
|
|
661
|
|
Increase in selling and market development expenses
|
|
|
4,269
|
|
Decrease in fees associated with the collaboration and licensing
agreement
|
|
|
(4,269
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in presentation were also made to the revenue caption in
order to conform with the new presentation under IFRS as noted
below:
|
|
|
|
|
|
|
NOVEMBER 30,
|
|
|
|
2009
|
|
|
|
$
|
|
|
Decrease in royalties and license fees
|
|
|
(17,444
|
)
|
Increase in upfront payments and initial technology access fees
|
|
|
6,560
|
|
Increase in milestone payments
|
|
|
10,884
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-38
ex-99.4
Exhibit 99.4
ANNUAL INFORMATION FORM
Financial Year Ended November 30, 2009
February 23, 2010
FORWARD-LOOKING INFORMATION
This Annual Information Form contains certain statements that are considered forward-looking
information within the meaning of applicable securities legislation. This forward-looking
information includes, but is not limited to, information regarding the approval of an NDA
(hereafter defined) from the FDA (hereafter defined), the commercialization of tesamorelin for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in the United States
and in other territories, the entering into strategic alliances with partners, the announcement of
a new clinical program for tesamorelin and the development program of Theratechnologies peptides
in AKI (hereafter defined). More specifically, paragraphs relating to the Companys perspectives,
notably Items 2.3, 3.1B and 3.2Biii are forward-looking by nature. Furthermore, the words will,
may, could, should, outlook, believe, plan, envisage, anticipate, expect and
estimate, or the negatives of these terms or variations of them and the use of the conditional
tense as well as similar expressions denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control, that could cause actual
results to differ materially from those which are disclosed in or implied by such forward-looking
information. These risks and uncertainties are described in Item 3.10 and investors are advised to
review this Section carefully.
Although the forward-looking information contained in this Annual Information Form is based upon
what the Company believes are reasonable assumptions as of the date hereof, investors are cautioned
against placing undue reliance on this information since actual results may vary from the
forward-looking information. Certain assumptions made in preparing the forward-looking information
and the Companys objectives include the assumption that the FDA will approve the NDA filed by the
Company, that tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy will be accepted by the market once commercialized and that current relationships
with the Companys third-party service or product providers will remain good.
Consequently, all of the forward-looking information contained in this Annual Information Form is
qualified by the foregoing cautionary statements, and there can be no guarantee that the results or
developments anticipated by the Company will be realized or, even if substantially realized, that
they will have the expected consequences or effects on the Company, its business, financial
condition or operating results.
TABLE OF CONTENTS
|
|
|
|
|
ITEM 1 CORPORATE STRUCTURE |
|
|
4 |
|
1.1 NAME |
|
|
4 |
|
1.2 ADDRESS |
|
|
4 |
|
1.3 INCORPORATION |
|
|
4 |
|
ITEM 2 GENERAL DEVELOPMENT OF THE BUSINESS |
|
|
5 |
|
2.1 HISTORICAL NOTES ON THE COMPANY FOR THE LAST THREE FINANCIAL YEARS |
|
|
6 |
|
2.2 RECENT DEVELOPMENTS |
|
|
9 |
|
2.3 EXPECTATIONS FOR THE PRESENT FINANCIAL YEAR |
|
|
9 |
|
ITEM 3 DESCRIPTION OF THE BUSINESS OF THE COMPANY |
|
|
11 |
|
3.1 STRATEGIC APPROACH |
|
|
11 |
|
3.2 COMPANY PRODUCTS |
|
|
13 |
|
3.3 MARKETS AND COMPETITION |
|
|
17 |
|
3.4 REGULATORY FRAMEWORK |
|
|
18 |
|
3.5 INTELLECTUAL PROPERTY |
|
|
18 |
|
3.6 COMMERCIAL AGREEMENTS |
|
|
19 |
|
3.7 HUMAN RESOURCES |
|
|
21 |
|
3.8 FACILITIES |
|
|
21 |
|
3.9 ENVIRONMENT |
|
|
22 |
|
3.10 RISKS AND UNCERTAINTIES |
|
|
22 |
|
ITEM 4 DIRECTORS AND EXECUTIVE OFFICERS |
|
|
34 |
|
4.1 DIRECTORS |
|
|
34 |
|
4.2 AUDIT COMMITTEE |
|
|
36 |
|
4.3 EXECUTIVE OFFICERS |
|
|
37 |
|
4.4 DECLARATION OF THE DIRECTORS AND OFFICERS ANTECEDENTS |
|
|
40 |
|
4.5 SECURITIES HELD BY THE DIRECTORS AND EXECUTIVE OFFICERS |
|
|
40 |
|
ITEM 5 INTERESTS OF EXPERTS |
|
|
41 |
|
ITEM 6 SECURITIES OF THE COMPANY |
|
|
42 |
|
6.1 AUTHORIZED SHARE CAPITAL |
|
|
42 |
|
6.2 DIVIDEND POLICY |
|
|
42 |
|
6.3 TRANSFER AGENT AND REGISTRAR |
|
|
42 |
|
6.4 MARKET FOR TRADING OF SECURITIES |
|
|
42 |
|
6.5 PRICE RANGE AND TRADING VOLUMES |
|
|
43 |
|
ITEM 7 MATERIAL CONTRACTS |
|
|
44 |
|
ITEM 8 ADDITIONAL INFORMATION |
|
|
46 |
|
APPENDIX A AUDIT COMMITTEE CHARTER |
|
|
47 |
|
ITEM 1 CORPORATE STRUCTURE
1.1 NAME
The Company was incorporated under the name Theratechnologies Inc. In this Annual Information Form,
the terms Company and Theratechnologies refer to Theratechnologies Inc.
1.2 ADDRESS
The head office of the Company is located at 2310 Alfred-Nobel Boulevard, in the Technoparc
Montréal, in the city of Montréal, Québec, H4S 2B4.
1.3 INCORPORATION
The Company was incorporated by Certificate of Incorporation issued under Part IA of the Companies
Act (Québec) on October 19, 1993. By a certificate of amendment dated October 20, 1993, the Company
repealed the restrictions applicable to private companies. On December 6, 1993, the articles were
amended to establish the number of directors and to amend its capital stock. Finally, on March 26,
1997, the capital stock was further amended to consist of an unlimited number of common shares and
an unlimited number of preferred shares.
|
|
|
|
|
|
Corporate Structure
|
|
Page 4 |
Annual Information Form Financial Year Ended November 30, 2009
|
|
Theratechnologies Inc. |
ITEM 2 GENERAL DEVELOPMENT OF THE BUSINESS
The Company began its activities in December 1993 with a widely diversified portfolio of research
and development projects mostly originating from the Université de Montréal. Therapeutic products
as well as projects in dentistry, veterinary medicine, medical apparatus and software development
then comprised the portfolio. The Company has also developed its own peptides such as tesamorelin,
the Companys lead compound and some analogues of peptides. Over the years, the Company proceeded
to focus its activities with the result that it is now specializing in the development of novel
therapeutic peptides that target unmet medical needs in commercially attractive specialty markets.
During this process, the Company withdrew from non-core activities by creating subsidiaries and
granting licenses to third parties. These subsidiaries were subsequently spun-off and the Company
no longer holds any significant interest in these corporate entities. Also, as part of the focusing
of its activities, the Company acquired all of the outstanding shares of Pharma-G Inc., an early
development stage company whose business was focused on the discovery of therapeutic peptides.
Pharma-Gs know-how relating to the development of therapeutic peptides was added to the discovery
tool developed internally by the Company. Pharma-G is no longer an active wholly-owned subsidiary
of the Company.
The Company has also out-licensed some of its therapeutic peptides that it considered non-core to
its business.
On October 29, 2008, the Company announced the execution of a collaboration and licensing agreement
(hereafter the Collaboration and Licensing Agreement) with EMD Serono, Inc. (hereafter EMD
Serono) granting EMD Serono the exclusive commercialization rights in the United States to
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
For a description of the Collaboration and Licensing Agreement, see Item 2.1B.
The Company concluded its Phase 3 clinical trials evaluating tesamorelin in the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy in December 2008. In May 2009, the
Company submitted a new drug application (hereafter NDA) with the Food and Drug Administration of
the United States of America (hereafter FDA) for tesamorelin for the aforementioned treatment. In
August 2009, the FDA accepted to file the NDA for review. In November 2009, the Company announced
that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA (hereafter the Advisory
Committee) was to review the Companys NDA. In January 2010, the Company announced that the
February 24, 2010 meeting date with the Advisory Committee was to be rescheduled due to an
administrative delay at the FDA.
Today, the Company is primarily focused on responding to any queries that the FDA may have
regarding the NDA submission and is in the process of preparing for the Advisory Committee. The
Company is also collaborating with EMD Serono for the preparation of the commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
in the United States if, and when, the NDA is approved by the FDA. Moreover, Theratechnologies has
begun discussions with third parties in certain territories outside of the United States with the
aim of entering into strategic alliances with those parties for the commercialization of
tesamorelin. The Company continues to develop regulatory strategies for tesamorelin for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in territories
outside of the United States and more particularly in Europe. Finally, the Company just initiated a
preclinical program on acute kidney injury (hereafter AKI).
|
|
|
|
|
|
Description of the Business of the Company
|
|
Page 5 |
Annual Information Form Financial Year Ended November 30, 2009
|
|
Theratechnologies Inc. |
2.1 HISTORICAL NOTES ON THE COMPANY FOR THE LAST THREE FINANCIAL YEARS
A. Product Development
i. Tesamorelin
During the last three financial years, the Company has advanced and concluded its Phase 3 clinical
program for tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy.
On December 19, 2006, the Company announced the top-line results for the first 26 weeks of its
first Phase 3 clinical study.
In January 2007, the Company initiated its confirmatory Phase 3 clinical study, which was conducted
in North America (Canada and United States) and Europe (United Kingdom, Belgium, France and Spain).
In July 2007, the Company announced the results related to body image, its fourth secondary
efficacy endpoint of its first Phase 3 clinical study. In October 2007, the Company announced the
52- week results of its first Phase 3 clinical study. In December 2007, the 26-week data of the
first Phase 3 clinical study were published in the New England Journal of Medicine (hereafter
NEJM). The 52 week results of the first Phase 3 clinical study were published in the September 2,
2008 issue of the
Journal of the International AIDS Society.
Certain top-line clinical results for the confirmatory Phase 3 clinical study were disclosed during
the course of 2008. In June 2008, the Company announced the 26-week results for its confirmatory
Phase 3 clinical study and, in December 2008, the Company reported the 52-week results of its
confirmatory Phase 3 clinical study. The results reported from both the 26-week confirmatory
clinical study and 52-week confirmatory clinical study were consistent with the efficacy and safety
profile observed in the first Phase 3 clinical study. This announcement concluded the Phase 3
clinical studies for tesamorelin for the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy.
Also, in May 2008, the Company entered into a material transfer agreement and a license agreement
with the Massachusetts General Hospital (hereafter MGH) and Dr. Steven Grinspoon further to Dr.
Grinspoon having received a grant from the National Institutes of Health (hereafter NIH), an
agency of the United States Department of Health and Human Services, to explore the use of
tesamorelin in relative growth hormone deficient abdominally obese subjects. The MGH, under the
direction of Dr. Grinspoon, is the sponsor and began a clinical trial with tesamorelin on obese
subjects with a moderate growth hormone deficiency. Most of those subjects have excess visceral
adipose tissue. The Company accepted to provide tesamorelin for this study and it will retain all
benefits from the results generated by this study, if any.
During the 2009 financial year, the Company met important regulatory and financial milestones. In
May 2009, the Company submitted a NDA with the FDA for tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy. The NDA was accepted for filing by the
FDA for substantive review in August 2009 which triggered a US$10 million milestone payment
pursuant to the Collaboration and Licensing Agreement. In November 2009, the Company announced that
the Advisory Committee was to hold a meeting with the Company to review the Companys NDA. In
January 2010, the Company announced that the February 24, 2010 meeting date with the Advisory
Committee was to be rescheduled due to an administrative delay at the FDA. Since the acceptance for
filing by the FDA of the NDA, the Company has assisted in the FDA review process by responding to
queries regarding the NDA as they arise and it is preparing for the review of its NDA by the
Advisory Committee.
|
|
|
|
|
|
Description of the Business of the Company
|
|
Page 6 |
Annual Information Form Financial Year Ended November 30, 2009
|
|
Theratechnologies Inc. |
Moreover, in 2009, the Company began initiating discussions with third parties in territories
outside of the United States with the aim of entering into strategic alliances with those parties
to expand the commercialization of tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy. The Company is exploring commercialization strategies in
Brazil and Europe, among other territories.
Finally, in 2009 and early 2010, the Company entered into various third-party supply agreements for
the manufacturing and commercialization in the United States of tesamorelin for the treatment of
excess abdominal fat in HIV-infected patients with lipodystrophy. For a summary of these
agreements, see Item 3.6A.
ii. Acute Kidney Injury
During the last financial years, the Company developed and did some preclinical work on a molecule
known as THG213.29 with the intent of pursuing a clinical program in AKI. AKI is the acute
deterioration of kidney function leading to increased urea waste products and electrolyte imbalance
in blood which complicates patient management in intensive care units and is highly associated with
mortality. Lack of a consensus in the definition of AKI and biomarkers, in addition to inadequate
understanding of the etiology of the disorder, have hampered drug development in this indication.
In the last few years, significant developments in this indication such as the appreciation of mild
increments of plasma creatinine as a marker of serious kidney injury, the role of inflammation in
the exacerbation and maintenance of AKI, the discovery and validation of novel early biomarkers of
AKI such as neutrophil gelatinase-associated lipocalin (hereafter NGAL), cystatin-C, N-acetyl
D-glucosaminidase and interleukin 18, have allowed the Company to devise novel peptides which could
potentially prevent the disorder or treat patients at an earlier stage.
To date, the only widely used biomarker of AKI is plasma creatinine. However, it is now known that
even small increments in serum creatinine (50% over basal levels) indicate major renal impairment.
Moreover, serum creatinine is a late stage biomarker of AKI and its increments are observed within
48-72 hours after surgery. In the last few years, new serum and urinary biomarkers have been
identified and some are undergoing clinical validation. Of these biomarkers, plasma and urinary
levels of NGAL were shown to increase as early as two to six hours after major surgery. These
developments in the diagnosis of AKI offer a unique opportunity in the selection of patients and
intervention with therapeutics to prevent or treat AKI in its early stages which may have a
significant clinical benefit on the mortality associated with AKI.
Through further research and development, the Company discovered new bifunctional peptides that
appear to have favourable properties in the preclinical animal models of AKI and, as a result
thereof, the Company decided, in its fiscal year 2008, to replaceTHG213.29 with the new
bifunctional peptide in the event the Company decides to develop a clinical program for AKI, which
is presently in preclinical development.
iii. Other Molecules
During the last financial years, the Company established a portfolio of products for the treatment
of diabetes by way of internal development, research collaboration and product acquisition.
Following a strategic analysis in the third quarter of 2005, the Company decided not to pursue its
activities in diabetes, glaucoma and pre-term labour. In September 2007, the Company announced that
it had entered into a license agreement with OctoPlus N.V., a European company, providing it with
the exclusive worldwide rights to develop and commercialize the Companys GLP-1 portfolio of
analogues. In May 2008, the Company also entered into an exclusive license agreement with PDC
Biotech GmbH for its family of antagonists of the prostaglandin F2alpha receptor for use in
pre-term labour and primary dysmenorrhea (painful menstruation).
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The Company is also conducting discovery activities in order to add peptides to its product
portfolio.
B. Strategic Alliance Agreement for Tesamorelin
EMD Serono
On October 28, 2008, the Company entered into the Collaboration and Licensing Agreement with EMD
Serono, an affiliate of Merck KGaA, Darmstadt, Germany, regarding the exclusive commercialization
rights of tesamorelin in the United States for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy. Under the terms of the agreement, the Company retained
all rights for the commercialization of tesamorelin outside of the United States and is responsible
for the development of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy up to the obtainment of marketing approval in the United States. The
Company is also responsible for the manufacturing and supply of tesamorelin and for the development
of a new formulation of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. EMD Serono is responsible for conducting product commercialization
activities. The agreement also entitles the Company to conduct research and development for
additional clinical programs. EMD Serono has the option to commercialize products resulting from
additional clinical programs with tesamorelin in the United States. If EMD Serono exercises this
option, it will pay half of the development and regulatory costs incurred and to be incurred by the
Company in connection with such clinical programs. In such cases, the Company will also have the
right, subject to EMD Seronos agreement, to participate in the promotion of the product for the
additional clinical programs. On December 15, 2008, the closing date of the transaction relating to
the Collaboration and Licensing Agreement, the Company received US$30 million, which included an
initial payment of US$22 million and US$8 million as a subscription for common shares in the
Company by Merck KGaA at a price of US$3.67 per share. In August 2009, the Company received a US$10
million milestone payment from EMD Serono associated with the acceptance to file the NDA by the
FDA. Under the terms of the Collaboration and Licensing Agreement, the Company may receive up to
US$215 million, which includes the initial payment of US$22 million with the associated equity
investment of US$8 million and the US$10 million aforementioned regulatory milestone as well as
payments based on the achievement of certain other regulatory and sales milestones. The Company
will also be entitled to receive increasing royalties on annual net sales of tesamorelin in the
United States.
C. Executive Management
In the past three financial years, the following executive officers joined the Company: Jocelyn
Lafond, Christian Marsolais and Andrea Gilpin.
D. Financing Activities
During the last three financial years, the Company completed two public financings. In February
2007, the Company completed a public offering of its common shares for gross proceeds of
$57,750,000 and, in February 2008, the Company also completed a public offering of its common
shares for gross proceeds of $29,750,000.
The Company also received proceeds of $2,391,526 in 2007, $396,871 in 2008, and $0 in 2009
following the exercise of options under its share option plan. Finally, the Company received
proceeds of $128,580 in 2007, $149,103 in 2008, and $96,172 in 2009 following the subscription of
common shares under its common share purchase plan.
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E. Investments in Other Companies
During the last three financial years, the Company sold its interests in various companies. In the
financial year ended November 30, 2009, the Company owned a 0.001% interest in Boyuan Construction
Group Inc. (formely Andromed Inc.). On January 22, 2010, the Company sold its interest in Boyuan
Construction Group Inc. on the open market. In the financial year ended November 30, 2007, the
Company sold the balance of its common shares in Thallion Pharmaceuticals Inc. (formerly Ecopia
BioSciences Inc.) on the open market.
2.2 RECENT DEVELOPMENTS
Since the fiscal year-end, the Company has continued to negotiate third-party supply agreements in
connection with its obligations to manufacture and supply tesamorelin to EMD Serono for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. Hence, on December
23, 2009, the Company entered into a manufacturing and supply agreement with Draxis Pharma General
Partnership (hereafter Draxis) in order to ensure the commercial supply of tesamorelin for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in the United States.
For a description of this agreement, see Item 3.6Aii.
On January 5, 2010, the Company also entered into a supply agreement with Gruppo Cartotecnico ABAR
Litofarma S.R.L. (hereafter ABAR) in order to ensure the commercial supply of pharmaceutical mass
market folding boxes for the sale of tesamorelin in the United States.
On January 25, 2010, the Company announced that the FDA would reschedule its meeting of the
Advisory Committee to review its NDA for tesamorelin. Originally scheduled for February 24, 2010,
the meeting will be rescheduled due to an administrative delay at the FDA. The FDA informed the
Company that this delay is entirely procedural and is not related to the tesamorelin NDA.
In addition, on February 10, 2010, the Board of Directors adopted a shareholder rights plan
(hereafter the Rights Plan) effective as of such date, by entering into a shareholder rights
agreement with Computershare Trust Company of Canada, as right agent (hereafter the Rights Plan
Agreement). The purpose of the Rights Plan is to provide adequate time for the Board of Directors
and the shareholders to assess an unsolicited takeover bid for the Company, to provide the Board of
Directors with sufficient time to explore and develop alternatives for maximizing shareholder value
if a takeover bid is made, and to provide shareholders with an equal opportunity to participate in
a takeover bid and receive full and fair value for their common shares. The Rights Plan is subject
to ratification by the shareholders of the Company at the Companys next annual and special meeting
of shareholders. If shareholders do not ratify the Rights Plan at the Companys next annual and
special meeting of shareholders, the Rights Plan will automatically terminate. For a summary of the
Plan, see Item 7.
2.3 EXPECTATIONS FOR THE PRESENT FINANCIAL YEAR
The Companys primary objective for the current financial year is obtain marketing approval of
tesamorelin in the United States for the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy. Marketing approval could result in the achievement of regulatory milestones
under the Collaboration and Licensing Agreement. Once approved, the Company expects to receive
royalties from the sale of tesamorelin in the United States. Also, the Company will continue to
collaborate with EMD Serono for the preparation of the commercialization of tesamorelin for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy if, and when, the NDA
is approved by the FDA.
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The Companys second objective is to expand into new territories where tesamorelin could be
used for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. To this
end, during the present financial year, the Company will be seeking third parties having a
regulatory expertise in obtaining marketing approval of new drugs and a commercial expertise in
launching new pharmaceutical products with the intent of entering into strategic alliance
agreements with them. Under such agreements, these third parties would be responsible for obtaining
marketing approval of tesamorelin in one or more territories and commercializing tesamorelin in
such territories.
Concurrently with the seeking of third parties with which to enter into strategic alliance
agreements, the Company will continue to pursue regulatory activities outside of the United States
to advance its application regarding the use of tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy. However, given the Companys primary objective,
the pace at which these activities will progress will depend on the FDAs decision regarding the
Companys NDA as well as on the timing of such decision.
The Companys third objective is to select and begin additional clinical programs once it has
obtained marketing approval for tesamorelin in the United States for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy.
Finally, all of the foregoing activities will be carried out in a cost-efficient manner to conserve
the Companys cash position and to manage its burn rate. The Company has sufficient liquidities to
self-finance its activities for the current financial year.
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ITEM 3 DESCRIPTION OF THE BUSINESS OF THE COMPANY
3.1 STRATEGIC APPROACH
A. Mission
Theratechnologies is a Canadian biopharmaceutical company that discovers and develops innovative
therapeutic products, with an emphasis on peptides, for commercialization. The Company targets
unmet medical needs in financially attractive speciality markets where it can retain all or some of
the commercial rights to its products. Its most advanced compound, tesamorelin, is an analogue of
the human growth hormone releasing factor.
B. Strategy
The Companys strategy for growth consists in focusing on tesamorelin. In pursuing this strategy,
the Company intends to:
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Obtain regulatory approval for the commercialization of tesamorelin for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in the United
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Enter into strategic alliance agreements with third parties for regulatory approvals
and for the commercialization of tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy in territories outside of the United States; |
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Develop additional clinical programs for tesamorelin which meet the criteria
described below other than programs in HIV-associated lipodystrophy; and |
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Manage the life cycle of tesamorelin with the development of new formulations and,
in the longer-term, develop and/or use improved drug delivery systems. |
The Company relies on the following set of criteria in building its product portfolio:
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Have the ability to be protected by one or more patents; |
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Have a potential competitive edge over products currently marketed or in
development; |
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Have a clear regulatory path and a manageable clinical program; |
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Be aimed at a specialty market where commercial rights can be retained in whole or
in part; and |
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Have the potential for attractive profit margins with a rapid return on investment. |
The Companys current product portfolio contains molecules which meet these criteria. However,
given the early development stages of these molecules, the Company may consider, at a later stage,
acquiring advanced-stage molecules from third parties which meet these criteria to grow its product
portfolio.
C. Business Plan
i. Commercialization
The first priority of the Company is to obtain marketing approval from the FDA for the
commercialization of tesamorelin in HIV-infected patients with lipodystrophy in the United States.
To that end, the Company has formed various groups within the Company who meet on a regular basis
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and work closely with EMD Seronos teams to prepare the commercialization of tesamorelin in
the United States, if and when tesamorelin is approved.
The Companys strategy is to leverage the application already created for the United States market.
Therefore, the second priority of the Company consists in expanding the territories where
tesamorelin for the treatment of excess abdominal fat for HIV-infected patients with lipodystrophy
can be commercialized. The Company currently has ongoing discussions with third parties in
territories outside of the United States with the aim of entering into strategic alliance
agreements with such third parties. Under such strategic alliance agreements, these third parties
would be responsible to obtain marketing approval of tesamorelin in one or more territories and to
commercialize the product in such territories. The Company is exploring commercialization
strategies in Brazil and Europe, among other territories.
As for the Canadian markets, the Company has the option to enter into a strategic alliance with a
third party for the commercialization of tesamorelin or to retain the commercial rights to
tesamorelin and commercialize it itself in Canada. However, as of the date hereof, the strategy for
the commercialization of tesamorelin in Canada has yet to be determined.
ii. Manufacturing
The Company only has the capacity to manufacture small quantities of peptides in its laboratories,
which may be used for preclinical studies.
In 2001, the Company entered into a manufacturing agreement with Bachem, Inc. (hereafter Bachem),
an American subsidiary of Swiss-based Bachem AG, for the manufacture of larger quantities of drug
substances to be used for clinical programs (hereafter the 2001 Bachem Agreement). On March 11,
2009, the Company and Bachem entered into a new manufacturing and supply agreement (hereafter the
API Supply Agreement) providing for the manufacture and supply of tesamorelin for clinical
programs and for commercial use. The API Supply Agreement replaces and supersedes the 2001 Bachem
Agreement. For a description of the API Supply Agreement, see Item 3.6Ai.
As part of the process of manufacturing tesamorelin, the Company entered into an agreement for the
manufacture and supply of the drug product for tesamorelin with Draxis Pharma, a division of Draxis
Specialty Pharmaceuticals, Inc. (hereafter Draxis) in 2001. This agreement provides for Draxis to
manufacture tesamorelin in its finished form as per the formulation and manufacturing process
developed by the Company. On December 23, 2009, the Company and Draxis entered into another
manufacturing and supply agreement providing for the manufacture and supply of commercial lots of
tesamorelin (hereafter the Lyophilization Agreement). Pursuant to the Companys agreements with
Draxis, Draxis must fill vials with tesamorelin, lyophilize it, label and package those vials and
deliver them to locations as directed by the Company. For a description of these agreements, see
Item 3.6Aii.
In addition, the Company has also entered into other commercial agreements to ensure the
commercialization of tesamorelin for the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy in the United States. For a description of the most salient agreements, see Item
3.6A.
iii. Development
With respect to the preclinical and clinical development of its products, Theratechnologies employs
a combination of internal resources and outside contractors. Animal toxicology studies are
conducted by contract research organizations. The Companys clinical studies are designed
internally by employees with external support when needed, but are carried out, for the most part,
by contract research
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organizations. The entry and management of clinical data, as well as the statistical analyses,
are carried out internally. In all cases where work is subcontracted, the Companys specialized
personnel is responsible for monitoring the work and ensuring that established and documented
standard operating procedures are used. These employees are responsible for preparing the
experimental protocols, following-up on the studies, interpreting the results and completing study
reports as well as other additional documents that may be required for regulatory submissions.
iv. Discovery and Preclinical
Theratechnologies has developed specific expertise in the field of therapeutic peptides.
Although natural peptides have significant therapeutic potential, they are subject to enzymatic
degradation which severely limits their effectiveness in clinical use. Theratechnologies Long
Acting Peptide Method (hereafter LAP) is a peptide stabilization method which increases the
target proteins resistance to enzymatic degradation, while maintaining its natural specificity.
This usually results in a more stable and efficient compound. The Companys tesamorelin was
developed in house using this technology.
Theratechnologies has developed know-how in peptides in the field of AKI and the Company continues
its research and development for new peptides.
3.2 COMPANY PRODUCTS
Presently, the Companys products are at different stages of development. In keeping with its
strategy, such products target unmet medical needs in commercially attractive markets.
A. Product Portfolio Overview
The following table provides an overview of the Companys products and their stages of development:
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Third-party studies evaluating tesamorelin: |
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The Company has completed its Phase 3 clinical studies and is currently under
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Independent Study sponsored by the NIH and led by Dr. Steven Grinspoon and the MGH. |
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Independent Study sponsored by the NIH and led by Dr. Michael V. Vitiello and the University of
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B. Tesamorelin
Tesamorelin, a synthetic human growth hormone releasing factor analogue, was developed in
Theratechnologies laboratories in 1995 and has been patented by the Company. This analogue was
synthesized by optimizing and stabilizing natural Growth Hormone-Releasing Factor (hereafter GRF)
using the LAP method described in Item 3.1Civ. above, thus prolonging its duration of action. This
product induces growth hormone (hereafter GH) secretion in a natural and pulsatile way. The
results obtained to date suggest a therapeutic potential in both anabolic and metabolic/lipolytic
indications.
i. Mechanism of Action
Tesamorelin induces the secretion of endogeneous GH by the pituitary gland, which plays a key role
in regulating metabolism. GH has diverse functions, including the regulation of body composition,
glucose and lipid metabolism as well as cardiac function. It exerts its lipolytic effect by
reducing the accumulation of fat in adipose tissue. GH also influences anabolism, immune function
and cognitive function. It exerts its effect on protein metabolism either directly or indirectly
through increased production of insulin-like growth factor-1 (hereafter IGF-1) in the liver or in
peripheral target tissues.
The effects of GRF (a hypothamalamic hormone) /GH on adipose tissue have led to several clinical
trials in the area of HIV-associated lipodystrophy with recombinant human (hereafter rh) GRF, rhGH
and tesamorelin. Phase 3 trials undertaken with tesamorelin have demonstrated that the lipolytic
action induced by this treatment was capable of decreasing visceral adipose tissue (hereafter
VAT) without decreasing the subcutaneous adipose tissue (hereafter SAT). The limited effect of
tesamorelin on SAT is important for the treatment of HIV-infected patients with lipodystrophy,
which is often associated with lipoatrophy, the latter being characterized by a reduction of SAT.
The safety profiles of rhGH and tesamorelin are very different. The natural synthesis of GH is
regulated by a feedback mechanism preventing its overproduction, this mechanism is short-circuited
by the administration of exogenous rhGH. This gives rise to side effects, which are particularly
frequent among older people. In addition, rhGH can cause hyperglycemia which limits its use in
patients with diabetes or pre-diabetic conditions, such patients constituting a substantial
percentage of the lipodystrophy patient population. Tesamorelin induces optimal activity of the
somatotrope function and retains the natural rhythm (pulsatility) of the physiological secretion of
GH, without interfering with the feedback mechanism mentioned above.
Tesamorelin has the characteristic of inducing secretion of GH in a natural and pulsatile fashion
and mimics the advantages of natural GRF.
ii. Development
Preclinical. In animal tests, tesamorelin has been shown to have a lasting and effective action on
the secretion of GH and, as a result, on the secretion of IGF 1. These effects are obtained with
much smaller doses when compared with natural GRF.
Phase 1. A clinical trial was designed to establish the safety of multiple doses, as well as to
measure the production of IGF 1. The results of this trial were very conclusive. In fact, in only a
few days, tesamorelin doubled IGF 1 levels in treated subjects to a level corresponding to the one
found in a young adult. In addition, the side-effect profile of tesamorelin was comparable to
placebo. It was also found that the drug was highly specific as it did not significantly affect the
secretion of other pituitary hormones. Overall, the Company completed nine Phase 1 studies to (i)
establish its safety after multiple doses, (ii) characterize its pharmacokinetic and
pharmacodynamic profile in healthy
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volunteers and also in patients, and (iii) evaluate the potential for drug-drug interactions
with other compounds likely to be administrated with tesamorelin.
Phase 2. The Phase 2 clinical development program was centered on tesamorelins effect on
anabolism, the immune system and cognitive functions as well as its lipolytic effect. The Company
completed seven Phase 2 studies through which it was able to better understand the metabolic
effects of tesamorelin and characterize its safety in various populations, including diabetic
patients.
More specifically, the Company decided to conduct a Phase 2 study on tesamorelins effect in HIV-
associated lipodystrophy. As stated above, studies have demonstrated that rhGH, by its lipolytic
action, effectively reduces excessive visceral fat in patients suffering from HIV-associated
lipodystrophy, while at the same time, increasing muscle mass and reducing non HDL cholesterol
(atherogenic or bad cholesterol). However, the administration of rhGH is not indicated for
glucose-intolerant patients, a condition often observed in HIV-infected patients with
lipodystrophy. Consequently, Theratechnologies decided to study the effect of tesamorelin in the
treatment of this condition. Highlights of the study included a good safety profile, a clear effect
on body composition and a clinically relevant reduction in visceral fat while subcutaneous fat was
preserved.
Phase 3. Based on the results of the Phase 2 clinical trials, the Company considered different
clinical programs for the late-stage development of tesamorelin. It ultimately chose HIV-associated
lipodystrophy because it provided an entry point for the commercialization of tesamorelin:
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It represented an unmet medical need, making it possible for the Company to be among
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It had a potential clinical advantage over other products in development because it
was possible to administer it safely to pre-diabetic and diabetic patients, which
represented approximately 40% of the lipodystrophic patient population; |
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The Phase 3 clinical program in this indication was manageable for a biotechnology
company the size of Theratechnologies, in terms of number of patients and duration of
treatment; and |
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The targeted commercial audience was made up of a relatively small number of HIV
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The Company designed a Phase 3 clinical program for tesamorelin in HIV-associated lipodystrophy and
had it validated by American regulatory authorities. Based on Phase 2 safety results, the Company
was able to include glucose-intolerant and diet-controlled diabetic patients in its program. The
program included two independent clinical trials to demonstrate the safety and efficacy of
tesamorelin in the treatment of HIV-infected patients with excess abdominal fat. For both Phase 3
trials, data were discussed at 26 and 52 weeks.
In June 2005, the Company began treatment of the first patient in its first Phase 3 study. The
results of the first 26-week period of the first study were announced by the Company on December
19, 2006 and were published in the NEJM on December 6, 2007. Patients treated with tesamorelin
achieved an average reduction of 15% in VAT compared to an average increase of 5% in the placebo
group (p<0.001).
The results of the extension phase (52 week data) of the Phase 3 study were announced on October
1, 2007, presented at the end of October at the 11th European AIDS Conference in Madrid and
published in AIDS on September 12, 2008. The primary objective of the extension phase of the Phase
3 study was to evaluate the safety profile of tesamorelin over a 52 week period.
The confirmatory Phase 3 clinical study began in January 2007 and the recruitment was completed by
September 2007. This study was carried out with approximately 400 patients in North America and
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Europe. The 26-week confirmatory Phase 3 clinical study was designed to evaluate the efficacy
of tesamorelin in patients with HIV-associated lipodystrophy and was powered to detect an 8%
reduction in VAT versus placebo. The results of the first 26-week period of the confirmatory study
were announced by the Company on June 18, 2008, and presented at the beginning of August 2008 at
the XVII International AIDS Conference in Mexico City. These results showed that patients treated
with tesamorelin for 26 weeks achieved an average 11% decrease in VAT versus baseline (p<0.001)
and 10% versus placebo.
On December 15, 2008, the Company announced the 52 week results of its confirmatory Phase 3
clinical study. This study was carried out to evaluate the long-term (52 weeks) safety profile of
tesamorelin in patients with HIV-associated lipodystrophy. Although the primary objective of the
Phase 3 clinical studies was to determine the long-term (52 weeks) safety profile of tesamorelin,
the data regarding the efficacy of tesamorelin in this confirmatory trial replicated what was
observed in the first Phase 3 clinical study. Those patients who were treated for 52 weeks in the
confirmatory clinical study experienced a total reduction of 18% VAT compared to baseline
(p<0.001) which is consistent with the results observed at 52 weeks in the first clinical study.
Since February 2009, the Company has made several oral and poster presentations at various
scientific meetings relating to its continuous review of the data gathered from its confirmatory
clinical study, and recently, the Company published the results of its confirmatory Phase 3 study
in the
Journal of Acquired Immune Deficiency Syndromes.
On May 29, 2009, the Company submitted a NDA to the FDA and, on August 12, 2009, the FDA accepted
to file the Companys NDA. In November 2009, the Company announced that the Advisory Committee was
to hold a meeting with the Company to review the Companys NDA. However, on January 25, 2010, the
Company announced that the February 24, 2010 meeting date with the Advisory Committee was to be
rescheduled due to an administrative delay at the FDA.
iii. Outlook
The Company is currently providing information to the FDA as part of the FDAs review of the
Companys NDA and the Company continues to prepare for the Advisory Committee. If tesamorelin for
the treatment of excess abdominal fat in HIV-infected patients is approved by the FDA, the Company
expects EMD Serono to launch the product within the next two calendar quarters following the
approval of the product.
The Company is considering two other potential groups of clinical programs for tesamorelin which
meet the criteria described in Item 3.1B, namely, a clinical program for tesamorelin using the
anabolic effects of the peptide, such as wasting or cachexia, and a clinical program for
tesamorelin using the catabolic effects of the peptide, such as GHDAO. The Company does not plan to
select and begin any additional clinical programs until marketing approval for tesamorelin in the
United States for HIV- associated lipodystrophy has been obtained.
C. Compounds for Acute Kidney Injury
By applying the criteria described in Item 3.1B, AKI has been identified as a potential clinical
program for internal development. The Company has developed novel peptides specifically tailored
for the prevention or treatment of AKI. One of these peptides (TH0673) is a bifunctional peptide
that is currently in preclinical development. For a description of AKI, see Item 2.1Aii.
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3.3 MARKETS AND COMPETITION
The Company seeks commercial approvals in specialty market indications with unmet medical needs.
Competition comes mainly from biopharmaceutical and pharmaceutical companies.
A. HIV-associated Lipodystrophy
HIV-associated lipodystrophy is a medical condition characterized by abnormalities in body shape
and composition, with multiple associated metabolic disturbances, including dyslipidemia and
insulin resistance. In HIV-infected patients, lipodystrophy may be a consequence of the viral
infection, of antiretroviral therapy, or of both. Several concerns that arise as a result of
HIV-associated lipodystrophy include a range of physiological and psychological complications,
beyond the significant health and mortality risks of the infection itself. The changes in body
composition include lipoatrophy, which is the loss of subcutaneous fat tissue, generally in the
limbs and the facial area, and/or lipohypertrophy, which is the accumulation of adipose tissue,
mainly in the abdomen (visceral fat), but also in other regions such as the neck (buffalo hump) and
the breasts. Lipohypertrophy is a risk factor for Type 2 diabetes and cardiovascular diseases. In
addition to the direct health risks, the resulting body abnormalities can stigmatize patients and
discourage compliance with their HIV treatments. To the Companys knowledge, there is currently no
approved treatment for this condition and although certain new HIV treatments tend to reduce some
of the effects regarding dyslipidemia and lipoatrophy, the lipohypertrophy component remains an
important unmet medical need. Recent estimates from the Joint United Nations Programme on HIV/AIDS
established the prevalence of HIV at 1.4 million in North America and Mexico and at 850,000 for
Western & Central Europe. In addition, the Brazilian Health Ministry has indicated that
approximately 350,000 patients are living with AIDS in Brazil. Of the patients diagnosed and
treated for HIV/AIDS, the overall prevalence of excess abdominal fat is estimated at 30% although
exact prevalence of excess abdominal fat may vary from region to region.
Theratechnologies is aware that other companies have expressed an interest in developing a product
for the treatment of lipodystrophy, but to its knowledge, such other companies are at earlier
stages of development than Theratechnologies.
B. Acute Kidney Injury
AKI is the acute deterioration of kidney function leading to increased urea waste products and
electrolyte imbalance in blood which may also affect other organs. AKI is common among hospitalized
patients and complicates the management of patients in intensive care units. It affects 3-7% of
patients admitted to hospital and approximately 25-30% of patients in the intensive care unit
within days of major surgery. The population incidence of AKI is approximately 2,000 3,000
patients per million per year. Unfortunately, despite hospitalization and renal replacement, AKI is
highly associated with mortality; of the dialyzed patients, the mortality rate is 40-60%.
Currently the only approved treatment for post-surgical AKI is hemodialysis. New developments in
the diagnosis of AKI offer a unique opportunity in the early selection of patients and intervention
with therapeutics to prevent or treat AKI in its early stages which may have significant clinical
benefit on the mortality associated with AKI. For a description of these new developments see Item
2.1Aii.
The Company believes that there exists an unmet clinical need for effective pharmacological
therapies and it has produced peptidic molecules which could be used for the potential prevention
or treatment of AKI.
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3.4 REGULATORY FRAMEWORK
The research, development, manufacture and marketing of pharmaceutical products are governed by
various governmental authorities throughout the world to ensure efficacy and safety. In Canada,
these activities are governed by the provisions of the Food and Drugs Act and its regulations, the
enforcement of which is ensured by the Therapeutic Products Directorate of the Health Products and
Food Branch of Health Canada. In the United States, it is the FDA that has jurisdiction. In order
to obtain approval for commercializing new drugs in Canada and the United States, the Company must
satisfy many regulatory conditions. The Company must complete preclinical studies in order to file
a Clinical Trial Application in Canada (hereafter a CTA) and an Investigational New Drug
Application in the United States (hereafter a IND). It then receives different clearance
authorizations to proceed with Phase 1 clinical trials, which can then lead to Phase 2 and Phase 3
clinical trials. Once these trials are completed, the Company files a registration file named New
Drug Submission in Canada (hereafter a NDS) and an NDA in the United States. If such a
registration file shows that the product was developed in accordance with the regulatory
authorities rules, regulations and guidelines and demonstrates a favourable risk/benefit analysis,
then the regulatory authorities issue a notice of compliance (Canada) or an approval action letter
(US), which allows the Company to market the product. The Company is also examining the regulatory
parameters in other territories to obtain a drug approval.
3.5 INTELLECTUAL PROPERTY
The principal intellectual property elements held by the Company consist of patents, trademarks,
license agreements and know-how.
The Companys patent portfolio is comprised of several patent families, each covering a product or
a technology. There are six families which cover therapeutic peptides under development. Presently,
the Company holds one family of patents which protect the tesamorelin peptide and a series of
tesamorelin analogues, two families which are aimed at protecting therapeutic indications of
tesamorelin, and one family which covers a new formulation thereof. In addition, there are two
families which are aimed at protecting peptides in the area of AKI.
With respect to patents, the Company generally proceeds by first filing a provisional application
with the US Patent and Trademark Office (hereafter USPTO), following which the Company
simultaneously files a utility patent application in the United States and an international
application under the Patent Cooperation Treaty (hereafter PCT). The PCT provides the option of
filing patent applications with all member states throughout the world. Countries where an
application will ultimately be filed are chosen based on a cost-to-protection analysis and on a
country-by-country basis for each individual patent application. Each product or technology
requires a separate analysis to optimize its protection. The patents, once issued, generally grant
protection for a twenty year period starting on the date of filing.
A. Tesamorelin
The Companys earliest patent applications relating to tesamorelin were filed in 1995. The patent
granted on tesamorelin will not expire before 2015 in the United States and in 2016 in Europe and
elsewhere. It is also possible for the Company to obtain from the USPTO a Patent Term Extension for
up to five years in connection with the approval of a drug. On January 8, 2008, the Company also
received from the USPTO a patent covering methods of treatment of HIV-associated lipodystrophy
using tesamorelin. This newly granted patent will not expire before 2023. On December 29, 2009, the
Company obtained patent protection for tesamorelin in Brazil. This patent will provide protection
until December 2019.
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In addition, in 2009, the Company enlarged the family of patents which protects a new
formulation of tesamorelin by filing nineteen (19) national and regional entry phases of its PCT
application.
The Company has obtained trademark registrations in Europe, Japan and Australia for several
potential commercial names for tesamorelin. In Canada and in the United States, those applications
have successfully undergone examination.
B. AKI
In 2008, the Company filed patent applications for its molecules, including the bifunctional
peptides that could be used for AKI. The Company has recently filed many national and regional
entry phases of its PCT application for AKI.
C. Others
The Company also holds patents and patent applications on its GLP 1 analogue families and on
pre-term labour related peptides which have been out licensed in September 2007 to OctoPlus N.V.
and in May 2008 to PDC Biotech GmbH, respectively.
3.6 COMMERCIAL AGREEMENTS
A. Supply Agreements
As per the Collaboration and Licensing Agreement, the Company is responsible for the manufacture
and supply of tesamorelin to satisfy commercial demands in the United States. In order to fulfill
these obligations, The Company has negotiated and entered into various third-party supply
agreements.
i. Bachem
On March 11, 2009, the Company entered into the API Supply Agreement with Bachem for the
development and validation of the manufacturing process for lots of tesamorelin which had begun
under a previous agreement, the development and validation of a manufacturing process for the
production of the active pharmaceutical ingredient for tesamorelin, and for the manufacturing and
supply of tesamorelin for clinical programs and for commercial sale in the United States. This API
Supply Agreement replaces and supersedes a previous agreement between the Company and Bachem, the
American subsidiary of Swiss-based Bachem AG pertaining to the manufacture of tesamorelin.
ii. Draxis
In 2001, the Company entered into an agreement with Draxis for the manufacture and supply of the
drug product for tesamorelin. This agreement provides for Draxis to manufacture tesamorelin in its
finished form as per the formulation and manufacturing process previously developed by the Company
for tesamorelin. As part of this agreement, Draxis must fill vials with tesamorelin, lyophilize it,
label and package those vials and deliver them to the Company. Draxis also carries out stability
studies on tesamorelin.
On December 23, 2009, the Company entered into the Lyophilization Agreement. This agreement
provides for Draxis to manufacture and supply commercial lots of tesamorelin to the Company as a
lyophilized product for the commercial sale of tesamorelin in the United States. Pursuant to this
agreement, Draxis must fill vials with tesamorelin, lyophilize it, label and package those vials
and deliver them to locations as directed by the Company.
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iii. Becton Dickinson
On November 6, 2009, the Company entered into a supply agreement with Becton Dickinson Canada Inc.
(hereafter Becton Dickinson). This agreement provides for Becton Dickinson to supply the Company
with syringes and hypodermic needles to be supplied with tesamorelin in the United States. Under
this agreement, Becton Dickinson shall also package, label and supply the needles in conformance
with the Companys specific needs for the commercial use of tesamorelin in the United States.
iv. Hospira
On March 26, 2009, the Company entered into a development and supply agreement with Hospira
Worldwide, Inc. This agreement provides for Hospira to manufacture and supply for the Company a
sterile water for injection, filled and finished in plastic vials, in connection with the sale of
tesamorelin in the United States.
v. ABAR
On January 5, 2010, the Company also entered into a supply agreement with ABAR, an Italian company,
in order to ensure the commercial supply of pharmaceutical mass market folding boxes for the sale
of tesamorelin in the United States.
B. Strategic Alliance Agreements
i. EMD Serono
In October 2008, the Company and EMD Serono entered into the Collaboration and Licensing Agreement.
For a description of the Collaboration and Licensing Agreement, see Item 2.1B.
ii. PDC Biotech GmbH
In May 2008, the Company entered into an exclusive licence agreement with PDC Biotech GmbH for its
family of antagonists of the prostaglandin F2a receptor for use in pre term labour and primary
dysmenorrhea. Under the terms of this agreement, PDC Biotech GmbH obtained all rights to the
development, use and commercialization of the family of antagonists of the prostaglandin F2a
receptor. Upon the commercialization of any product based on the technology licensed under the
agreement, the Company will be entitled to receive royalty payments. Unless earlier terminated in
accordance with certain events stated in the agreement, the agreement will expire on the later of:
(i) October 3, 2020 or (ii) the date on which all patent rights issued in connection with the
technology licensed or any improvement thereof expire.
iii. OctoPlus N.V.
On September 26, 2007, the Company entered into a license agreement with OctoPlus N.V. (hereafter
OctoPlus), a public company listed on the Euronext, which has developed drug delivery
technologies. Pursuant to the license agreement, OctoPlus was granted the exclusive worldwide
rights to develop and commercialize the Companys GLP 1 portfolio of analogues. On the date of
execution of this agreement, the Company received options entitling it to purchase ordinary shares
in the capital of OctoPlus. In addition, during the term of the agreement, the Company will be
entitled to receive additional payments which could amount to as much as 36 million based on
various milestones such as: development of the GLP 1, clinical trials, certain regulatory approvals
and commercialization of a product based on GLP 1. Royalties on the annual net sales of any
products
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developed and commercialized under the agreement could also be paid to the Company. OctoPlus
will be responsible for all future development costs for the GLP 1 portfolio of analogues.
3.7 HUMAN RESOURCES
As at November 30, 2009, the Company had 98 employees, of whom 64 were members of the research and
development team and 37 held post-graduate diplomas (MBA, M.Sc., Ph.D. and M.D.). The Companys
employees have expertise in various biotechnology sectors such as the development of peptides,
synthesis, toxicology, immunology, regulatory and the conduct of preclinical and clinical studies.
The Company also has a self-sufficient administrative department which includes legal and financial
professionals and it has a business development and marketing team. The Company maintains good
relationships with its employees, and promotes collegiality and teamwork. To that end, the Company
has created various multi-disciplinary teams to work on the Companys NDA and its filing with the
FDA and to collaborate with EMD Serono for the preparation of the commercialization of tesamorelin
in the United States.
3.8 FACILITIES
The Company carries out its activities at 2310 Alfred-Nobel Boulevard in the Technoparc Montréal.
It occupies a building of 36,400 square-feet, which houses both offices and laboratories. The
current lease has a 10 year term which expires in April 2010. In October 2009, the Company entered
into a new agreement with Société de portefeuille immobilier GE Q-Tech inc. for the renewal of its
lease which will become effective on May 1, 2010 and will expire on April 30, 2021. Under the terms
of this new lease agreement, the Company has two five (5) year renewal options. If exercised, the
first renewal option will start on May 1, 2021 and expire on April 30, 2026 and the second renewal
option, if exercised, will start on May 1, 2026 and expire on April 30, 2031.
The facilities contain laboratories which enable the Company to conduct peptide manufacturing,
discovery and preclinical research. Peptide compounds are synthesized by the pharmaceutical
development department using manual and semiautomatic methods with reactors of different sizes
(from 50 to 8000 ml) and also a 12-channel automated peptide synthesizer. The peptides are purified
using preparative high performance liquid chromatography (hereafter HPLC) comprising either the
Dynamic Axial Compression column, or a number of pre-packed columns. The final peptides are dried
to a solid form using lyophilization equipment. The analyses on the quality of the peptides are
done using a variety of equipments including HPLC instruments Agilent 1100 and 1200, UV
spectrophotometers and a water content analyzer. These tasks are accomplished by well trained
personnel. The Company has established a quality system which ensures the highest quality of
peptides which meet the requirements for research and preclinical studies.
Theratechnologies also has well-equipped discovery and preclinical research laboratories which
include two cell culture rooms and several chemical hoods. A state-of-the-art Mesoscale
chemiluminometer (Sector PR100) is used for sensitive immunological and cell-based assays. Several
HPLC instruments for preformulation and purity determinations, scintillation spectrophotometers for
radioactivity measurements, and fluorospectrophotometers and colorimetric plate readers for
cell-based screens and immunoassays enable in-house discovery and preclinical research. A
designated laboratory section is equipped to conduct studies according to Good Laboratory
Practices.
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3.9 ENVIRONMENT
To the knowledge of the Company, at its current development stage, environmental-protection
requirements do not have a significant financial or operational impact on the capital expenditures,
income or competitive position of the Company within the normal course of its operating activities.
3.10 RISKS AND UNCERTAINTIES
Investors should understand that the Company operates in a high risk industry. The Company has
identified the following risks and uncertainties that may have a material adverse effect on its
business, financial condition or operating results. Investors should carefully consider the risks
described below before purchasing securities of the Company. The risks described below are not the
only ones the Company faces. Additional risks not presently known to the Company or that the
Company currently believes are immaterial may also significantly impair its business operations.
The Companys business could be harmed by any of these risks.
The commercial success of the Company depends largely on the development and commercialization of
tesamorelin; the failure by the Company to commercialize tesamorelin would have a material adverse
effect on the Company.
The Companys focus has been to advance the development of tesamorelin in which it has invested a
significant portion of its financial resources and time. Although the Company has other peptides,
all are at earlier stages of development.
The ability of the Company to generate revenues in the future is primarily based on the
commercialization of tesamorelin for the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy. In the short-term, these revenues should be primarily derived from the
United-States market alone. Although the Company entered into the Collaboration and Licensing
Agreement for the commercialization of tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy in the United States, there can be no guarantee that
tesamorelin will be commercialized in this country, or in any other country.
The commercialization of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy will depend on several factors:
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receipt of regulatory approvals of tesamorelin for the treatment of excess abdominal fat in
HIV- infected patients with lipodystrophy from the FDA and other regulatory agencies; |
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market acceptance of the product by the medical community, patients and third-party payers
(such as governmental health administration authorities and private health coverage insurers); |
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entering into one or more strategic alliance agreements with one or more partners or building
a marketing and sales force in countries other than the United States to help with the regulatory
approval and/or the marketing and sale of tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy in those countries; |
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in the United States, the amount of resources used by the Companys commercial partner to
commercialize tesamorelin; |
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maintaining manufacturing and supply agreements to ensure the availability of commercial
quantities of tesamorelin through validated processes; the number of competitors in the market;
and |
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protecting the Companys intellectual property and avoiding patent infringement claims. |
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The Companys inability to commercialize tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy in the short term in the United States would delay its
capacity to generate revenues and would affect its financial condition and operating results.
The Company does not have the required regulatory approval to commercialize its products and cannot
guarantee that it will obtain such regulatory approval.
The commercialization of the Companys products first requires the approval of the regulatory
agencies in each of the countries where it intends to sell its products. In order to obtain the
required approvals, the Company must demonstrate, following preclinical and clinical studies, the
safety, efficacy and quality of a product. As far as tesamorelin is concerned, the Company focused
its development to treat excess abdominal fat in HIV-infected patients with lipodystrophy and the
first market the Company wishes to penetrate for this treatment is the United States. The rules and
regulations relating to the approval of a new drug are complex and stringent and although the FDA
has accepted the filing of the Companys NDA, there can be no guarantee that the FDA will approve
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
In addition, there can be no guarantee that the Company will be able to obtain the regulatory
approvals of agencies in other countries to sell tesamorelin for the treatment of excess abdominal
fat in HIV- infected patients with lipodystrophy.
All of the products of the Company are subject to preclinical and clinical studies. If the results
of such studies are not positive, the Company may not be in a position to make any filing to obtain
the mandatory regulatory approval or, even where a product has been filed for approval, it may have
to conduct additional clinical studies or testing on such product until the results support the
safety and efficacy of such product. Such studies are often costly and may also delay a filing or,
where additional studies or testing are required after a filing has been made, the approval of a
product.
While an application for a new drug is under review by a regulatory agency, it is standard for such
regulatory agency to ask questions regarding the application that was submitted. If these questions
are not answered quickly and in a satisfactory manner, the marketing approval of the product
subject to the review and its commercialization could be delayed or, if the questions are not
answered in a satisfactory manner, refused. If tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy is not approved for commercialization in the United
States by the FDA, the capacity of the Company to generate revenues in the short-term will be
hampered and this will have an adverse effect on its financial condition and its operating results.
The obtaining of regulatory approval is subject to the discretion of regulatory agencies.
Therefore, even if the Company obtains regulatory approval from one agency, or succeeds in filing
the equivalent of a NDA
in other countries, or has obtained positive results relating to the safety and efficacy of a
product, a regulatory agency may not accept the filing or the results contained therein as being
conclusive evidence of the safety and efficacy of a product in order to allow the Company to sell
the product in its country. A regulatory agency may require that additional tests on the safety and
efficacy of a product be conducted prior to granting approval of a product and such additional
tests may delay the approval of a product, can have a material adverse affect on the Companys
financial condition based on the type of additional tests to be conducted and may not necessarily
lead to the approval of a product.
Although the Company has received a Special Protocol Assessment from the FDA and the Company has
followed it and met the primary medical end-points described therein, there can be no guarantee
that the FDA will approve tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. Even if the FDA approves tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy, there can be no guarantee that other
regulatory agencies will approve tesamorelin for this treatment in their respective countries.
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Even if the Company obtains regulatory approval for any of its products, regulatory agencies have
the ability to limit the indicated use of a product. Also, the manufacture, marketing and sale of
the products will be subject to ongoing and extensive governmental regulation in the country in
which the Company intends to market its products. For instance, if the Company obtains marketing
approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in the United States, the marketing of tesamorelin will be subject to extensive
regulatory requirements administered by the FDA and other regulatory bodies, such as adverse event
reporting and compliance with all of the FDA marketing and promotional requirements. The
manufacturing facilities for the Companys tesamorelin will also be subject to continuous reviews
and periodic inspections and approval of manufacturing modifications. Manufacturing facilities are
subject to inspections by the FDA and must comply with the FDAs Good Manufacturing Practices
(hereafter GMP) regulations. The failure to comply with any of these post-approval requirements
can result in a series of sanctions, including withdrawal of the right to market a product.
The Company has no control over the timing of the review of its NDA by the FDA.
Although the FDA advised the Company that it had set a date of March 29, 2010 under the
Prescription Drug User Fee Act (United States), more commonly known as PDUFA, by which it targets
to have completed its review of the Companys NDA, there can be no guarantee that such date shall
be met. The Company has no control over the timing of the review of its NDA by the FDA and this
timing could vary based on the FDAs workload, potential review issues contained in the Companys
NDA and other similar factors over which the Company has no control.
Even if tesamorelin is ultimately approved by the FDA, any delay in completing the review of the
Companys NDA will result in a delay in the commercialization of tesamorelin for the treatment of
excess abdominal fat in HIV-infected patients with lipodystrophy and could materially adversely
affect the operating results of the Company and the development of future clinical programs.
The Company is dependent on the Collaboration and Licensing Agreement for the commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
in the United States. This agreement places the commercialization of tesamorelin outside of its
control.
Under the terms of the Collaboration and Licensing Agreement, the Company granted its commercial
partner the exclusive right to commercialize tesamorelin for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy in the United States. Although the agreement contains
provisions governing the commercialization of tesamorelin for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy in the United States, the Companys dependence on its
commercial partner for such purpose subjects it to a number of risks, including:
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the exact timing of the launch of tesamorelin in the United States, if approved by the FDA; |
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the limited control by the Company on the amount and timing of resources that its commercial
partner will be devoting to the commercialization, marketing and distribution of tesamorelin, which
could adversely affect the Companys ability to obtain or maximize its royalty payments; |
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disputes or litigation that may arise between the Company and its commercial partner, which
could adversely affect the commercialization of tesamorelin in the United States, all of which will
divert the attention of Companys management and its resources; |
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its commercial partner not properly defending the Companys intellectual property rights or
using them in such a way as to expose the Company to potential litigation, which could, in both
cases, adversely affect the value of the Companys intellectual property rights; |
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corporate reorganizations or changes in business strategies of its commercial partner, which
could adversely affect such commercial partners willingness or ability to fulfill its obligations
under the Collaboration and Licensing Agreement; |
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the termination of the Collaboration and Licensing Agreement, which would adversely affect the
commercialization of tesamorelin for the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy in the United States. |
The Company relies on third parties for the manufacture and supply of tesamorelin and such reliance
may adversely affect the Company if the third parties are unable to fulfill their obligations.
The Company does not have the resources, facilities or experience to manufacture its products in
large quantities on its own. The Company relies on third parties to manufacture and supply
tesamorelin for clinical studies and currently intends to rely on third parties to manufacture and
supply large quantities of tesamorelin for commercial sales, if approved by the FDA or other
regulatory agencies.
The Companys reliance on third-party manufacturers exposes it to a number of risks. If third-party
manufacturers become unavailable to the Company for any reason, including as a result of the
failure to comply with GMP regulations, manufacturing problems or other operational failures, such
as equipment failures or unplanned facility shutdowns required to comply with GMP or damage from
any event, including fire, flood, earthquake, business restructuring or insolvency, or, if they
fail to perform their contractual obligations under agreements with the Company, such as failing to
deliver the quantities requested on a timely basis, the Company may be subject to delays in the
manufacturing of tesamorelin and any other peptide. Any delay in the supply of a product could slow
down or interrupt the conduct of clinical trials and, if a product has reached commercialization,
could prevent the supply of the product and accordingly, adversely affect the revenues of the
Company. Under the Collaboration and Licensing Agreement, the Company agreed to act as manufacturer
and supplier of tesamorelin for its commercialization in the United States. Accordingly, any delay
in manufacturing tesamorelin by third-party service providers may have a material adverse effect on
the sales and royalties payable to the Company. In addition, any manufacturing delay or delay in
delivering tesamorelin may result in the Company being in default under the Collaboration and
Licensing Agreement. If the damage to a third-party manufacturer facility is extensive, or, for any
reason, it does not operate in compliance with GMP or is unable or refuses to perform its
obligations under its agreement with the Company, the Company will need to find an alternative
third-party manufacturer. The selection of a third-party manufacturer will be time-consuming and
costly since the Company will need to validate the manufacturing facility of such new third-party
manufacturer. The validation will include an assessment of the capacity of such third-party
manufacturer to produce the quantities that may be requested from time to time by the Company, the
manufacturing process and its compliance with GMP. In addition, the third-party manufacturer will
have to familiarize itself with the Companys technology. Any delay in finding an alternative
third-party manufacturer of a product could result in a shortage of such product, a delay in
clinical study programs and
in the filing for regulatory approval of a product and, if a product is approved for
commercialization, a shortage of such a product would result in lost revenue to the Company.
Market acceptance of the Companys products is uncertain and depends on a variety of factors, some
of which are not under the control of the Company.
The Companys ability to commercialize its products with success will depend on a variety of
factors, including the extent to which reimbursement to patients for the cost of such products and
related treatment will be available from governmental health administration authorities, private
health coverage insurers and other organizations. Obtaining reimbursement approval for a product is
time-
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Description of the Business of the Company
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Annual Information Form Financial Year Ended November 30, 2009
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Theratechnologies Inc. |
consuming and a costly process that could require the Company to provide supporting scientific,
clinical and cost effectiveness data for its use. There can be no guarantee that the Companys data
will be perceived as sufficient for third-party payers to accept to reimburse one of the Companys
products.
The Company has never made an application seeking reimbursement of a drug and must, therefore, rely
in part on third-party service providers or experienced partners to help it perform this task.
Other factors that will have an impact on the acceptance of the Companys products include:
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acceptance of a product by physicians and patients as safe and effective treatments;
product price; |
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the effectiveness of the Companys sales and marketing efforts (or those of its commercial
partners); |
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storage requirements and ease of administration; |
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dosing regimen; |
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safety and efficacy; |
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prevalence and severity of side effects; and |
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competitive products. |
The Companys financial condition could be affected by the introduction of new regulations or
amendments to existing regulations.
New regulations or changes to existing regulations affecting the Company and its potential
customers could decrease demand for the Companys products and affect its operating results and
financial condition. For example, the implementation of health care reform legislation that
regulates drug costs could limit the profits that can be made from the development of new drugs. In
addition, new laws or regulations could increase the Companys costs.
The Company must complete several preclinical and clinical studies for its products which may not
yield positive results and, consequently, could prevent it from obtaining regulatory approval.
Obtaining regulatory approval for the commercialization of drug products requires a demonstration
through preclinical and clinical studies that the drug is safe and effective. All of the Companys
molecules are in preclinical studies, except tesamorelin for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy, which is now under regulatory review at the FDA.
Tesamorelin is also being used in the Phase 2 studies conducted by the MGH and the University of
Washington. For the other molecules and for tesamorelin in Phase 2 NIH studies, there could remain
preclinical and clinical studies to be conducted prior to determining whether such molecules will
show positive results of safety and efficacy.
If any of those studies are not positively conclusive or result in adverse patient reactions, this
may require the Company to extend the term of its studies, to increase the number of patients
enrolled in a given study or to undertake ancillary testing. Any of these events could increase the
cost of conducting clinical studies, delay the filing of an application for marketing approval with
regulatory agencies or result in the termination of a study and, accordingly, abandoning the
commercialization of a molecule. In addition, the growth of the Company could be compromised since
there can be no
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Description of the Business of the Company
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Page 26 |
Annual Information Form Financial Year Ended November 30, 2009
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Theratechnologies Inc. |
guarantee that the Company will be able to develop new molecules, license or purchase compounds or
products that will result in marketed products.
The Company relies on third-party service providers to conduct its preclinical and clinical studies
and respond to the FDAs questions regarding the Companys NDA submission. The failure by one of
these third parties to comply with their obligations may delay the studies, have an adverse effect
on the Companys development program and/or delay the commercialization of tesamorelin for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
The Company has limited human resources to conduct preclinical and clinical studies and must rely
on third-party service providers to conduct its studies and carry out certain data gathering and
analyses. If the Companys third-party service providers become unavailable for any reason,
including as a result of the failure to comply with the rules and regulations governing the conduct
of preclinical and clinical studies, operational failures such as equipment failures or unplanned
facility shutdowns, or damage from any event such as fire, flood, earthquake, business
restructuring or insolvency or, if they fail to perform their contractual obligations pursuant to
the terms of the agreements entered into with the Company, such as failing to do the testing,
compute the data or complete the reports further to the testing, the Company may incur delays in
connection with the planned timing of its studies which could adversely affect the timing of the
development program of a molecule or the filing of an application for marketing approval in a
jurisdiction where the Company relies on third-party service providers to make such filing. In
addition, where the Company relies on such third-party service provider to help in answering any
question raised by a regulatory agency during its review of a Company file, the unavailability of
such third-party service provider may adversely affect the timing of the review of an application
and, could ultimately delay the approval. If the damages to any of the Companys third-party
service providers are material, or, for any reason, such providers do not operate in compliance
with GLP or are unable or refuse to perform their contractual obligations, the Company would need
to find alternative third-party service providers.
If the Company must change or select new third-party service providers, the planned working
schedule related to preclinical and/or clinical studies could be delayed since the number of
competent and reliable third-party service providers of preclinical and clinical work in compliance
with GLP is limited. In addition, if the Company must change or select new third-party service
providers to carry out work in response to a regulatory agency review of a Companys application,
there may occur delays in responding to such regulatory agency which, in turn, may lead to delays
in commercializing a product.
Any selection of new third-party service providers to carry out work related to preclinical and
clinical studies would be time-consuming and would result in additional delays in receiving data,
analysis and reports from such third-party service providers which, in turn, would delay the filing
of any new drug application with regulatory agencies for the purposes of obtaining regulatory
approval to commercialize the Companys products. Furthermore, such delays could increase the
Companys expenditures to develop a product and materially adversely affect its financial condition
and operating results.
The conduct of clinical trials requires the enrollment of patients and difficulties in enrolling
patients could delay the conduct of the Companys clinical trials or result in their
non-completion.
The conduct of clinical trials by the Company requires the enrollment of patients. Depending on the
phase of the trials and/or the type of trials which must be conducted, the number of patients may
vary. Phase 1 and Phase 2 trials generally require a smaller number of patients than Phase 3
trials.
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Description of the Business of the Company
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Page 27 |
Annual Information Form Financial Year Ended November 30, 2009
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Theratechnologies Inc. |
The Company may have difficulties enrolling patients for the conduct of its clinical trials as a
result of design protocol, the size of the patient population, the eligibility criteria to
participate in the clinical trials, the availability of competing therapies, the patient referral
practices of physicians and the availability of clinical trial sites. The Companys difficulty in
enrolling patients for its clinical trials could result in the cancellation of clinical trials or
delays in completing them. Any of these events would have adverse consequences on the timely
development of new products, the filing of an NDA, or its equivalent, with regulatory agencies and
the commercialization of the Companys products. Such events would adversely affect the business,
the financial condition and operating results of the Company.
The Companys capacity to generate revenues may be limited by governmental control over the pricing
of prescription drugs.
In some countries, the pricing of prescription drugs is subject to governmental control. In some of
these countries, pricing negotiations with governmental authorities and reimbursement structures
may delay the marketing of a product. If reimbursement of the Companys products is unavailable or
limited in scope or amount, or if pricing is set at unsatisfactory levels, the revenues of the
Company could be adversely affected.
The Company must enter into strategic alliance agreements with third parties for the sale and
marketing of its products and there is no guarantee that the Company will be able to achieve these
tasks.
Although the Company was successful in finding a third party for the commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
in the United States and although the Company has ongoing discussions with third parties with the
aim of entering into strategic alliance agreements with such third parties to commercialize
tesamorelin outside of the United States, the conclusion of an agreement with a party is a lengthy
process which includes, among other things, an analysis of the capacity of the third party, the
assessment of the services to be performed by the third party, due diligence on the Companys
products and the negotiation of the terms and conditions of the agreement. The outcome of this
process is uncertain and the Company may not be able to conclude any other strategic alliance
agreements for the commercialization of its products, including the commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
in territories other than the United States. The commercialization of the Companys products may be
delayed if it is unable to find third parties to commercialize its products and this could
adversely materially affect the financial condition and the operating results of the Company. Even
if the Company enters into strategic alliance agreements with third parties for the
commercialization of its products, those agreements often contain termination provisions which, if
exercised, could delay the commercialization of its products given that the Company has no sales
force. If the Company does not succeed in entering into a strategic alliance agreement for a
particular territory, it would then not succeed in commercializing the product in such a territory.
In such an event, the Company may decide to commercialize the product itself in that territory and
the Company has no experience in commercializing a product in any market.
The Companys intent to possibly retain the commercial rights of its products for Canada implies
that it would market and sell the product itself on the Canadian market. However, the Company
currently has limited marketing capabilities and it has limited experience in developing, training
or managing a sales force. The development of a sales force would be costly and would be
time-consuming given the limited experience the Company has in this area. To the extent the Company
develops a sales force, the Company could be competing against companies that have more experience
in managing a sales force than the Company has and that have access to more funds than the Company
with which to manage a sales force. Consequently, there can be no guarantee that a sales force
which the
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Description of the Business of the Company
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Page 28 |
Annual Information Form Financial Year Ended November 30, 2009
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Theratechnologies Inc. |
Company develops would be efficient and would maximize the revenues derived from the sale of a
Company product.
The failure by the Company to protect its intellectual property may have a material adverse effect
on its ability to develop and commercialize its products.
The Company will be able to protect its intellectual property rights from unauthorized use by third
parties only to the extent that its intellectual property rights are covered by valid and
enforceable patents or are effectively maintained as trade secrets. The Company tries to protect
its intellectual property position by filing patent applications related to its proprietary
technology, inventions and improvements that are important to the development of its business.
Because the patent position of pharmaceutical companies involves complex legal and factual
questions, the issuance, scope and enforceability of patents cannot be predicted with certainty.
Patents, if issued, may be challenged, invalidated or circumvented. If the Companys patents are
invalidated or found to be unenforceable, it would lose the ability to exclude others from making,
using or selling the inventions claimed. Moreover, an issued patent does not guarantee the Company
the right to use the patented technology or commercialize a product using that technology. Third
parties may have blocking patents that could be used to prevent the Company from developing its
product candidates, selling its products or commercializing its patented technology. Thus, patents
that the Company owns may not allow it to exploit the rights conferred by its intellectual property
protection. The Companys pending patent applications may not result in patents being issued. Even
if issued, they may not be issued with claims sufficiently broad to protect its products and
technologies or may not provide the Company with a competitive advantage against competitors with
similar products or technologies. Furthermore, others may independently develop products or
technologies similar to those that the Company has developed or discover the Companys trade
secrets. In addition, the laws of many countries do not protect intellectual property rights to the
same extent as the laws of Canada and the United States, and those countries may also lack adequate
rules and procedures for defending intellectual property rights effectively.
Although the Company has received a patent from the USPTO for the treatment of HIV-related
lipodystrophy with tesamorelin, there can be no guarantee that the Company will receive a patent in
the other countries where it filed patent applications for the treatment of HIV-related
lipodystrophy.
The Company also relies on trade secrets, know-how and technology, which are not protected by
patents, to maintain its competitive position. The Company tries to protect this information by
entering into confidentiality undertakings with parties who have access to such confidential
information, such as the Companys current and prospective suppliers, employees and consultants.
Any of these parties may breach the undertakings and disclose confidential information to the
Companys competitors.
Enforcing a claim that a third party illegally obtained and is using trade secrets is expensive and
time-consuming and the outcome is unpredictable. In addition, it could divert managements
attention from the Companys business. If any trade secret, know-how or other technology not
protected by a patent were to be disclosed to or independently developed by a competitor, the
Companys competitive position could be harmed.
The Companys ability to defend against infringement by third parties of its intellectual property
in the Unites States with respect to tesamorelin for the treatment of HIV-related lipodystrophy
depends, in part, on its commercial partners decision to bring an action against such third party.
Under the terms and conditions of the Collaboration and Licensing Agreement, the Companys
commercial partner has the first right to bring an action against a third party infringing on the
Companys intellectual property with respect to tesamorelin for the treatment of HIV-related
lipodystrophy. Any delay in pursuing such action or in advising the Company that it does not intend
to pursue the matter could decrease sales, if
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Description of the Business of the Company
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Page 29 |
Annual Information Form Financial Year Ended November 30, 2009
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Theratechnologies Inc. |
any, of tesamorelin for the treatment of HIV-related lipodystrophy and adversely affect the
Companys revenues.
The Companys commercial success depends, in part, on its ability not to infringe on third party
patents and other intellectual property rights.
The Companys capacity to commercialize its products, and more particularly tesamorelin, will
depend, in part, on the non-infringement of third parties patents and other intellectual property
rights. The biopharmaceutical and pharmaceutical industries have produced a multitude of patents
and it is not always easy for participants, including the Company, to determine which patents cover
various types of products or methods of use. The scope and breadth of patents is subject to
interpretation by the courts and such interpretation may vary depending on the jurisdiction where
the claim is filed and the court where such claim is litigated. The holding of patents by the
Company for tesamorelin and its application in HIV-related lipodystrophy does not guarantee that
the Company is not infringing on other third-party patents and there can be no guarantee that the
Company will not be in violation of third-party patents and other intellectual property rights.
Patent analysis for non-infringement is based in part on a review of publicly available databases.
Although the Company reviews from time to time certain databases to conduct patent searches, it
does not have access to all databases. It is also possible that some of the information contained
in the databases has not been reviewed by the Company or was found to be irrelevant at the time the
searches were conducted. In addition, because patents take years to be issued, there may be
currently pending applications that the Company is unaware of, which may later be issued. As a
result of the foregoing, there can be no guarantee that the Company will not violate third-party
patents.
Because of the difficulty in analyzing and interpreting patents, there can be no guarantee that a
third party will not assert that the Company infringes upon any of such third-partys patents or
any of its other intellectual property rights. Under such circumstances, there is no guarantee that
the Company would not become involved in litigation. Litigation with any third party, even if the
allegations are without merit, is expensive, time-consuming and would divert managements attention
from the daily execution of the Companys business plan. Litigation implies that a portion of the
Companys financial assets would be used to sustain the costs of litigation instead of being
allocated to further the development of its business plan.
If the Company is involved in a patent infringement litigation, it would need to demonstrate that
its products do not infringe the patent claims of the relevant patent, that the patent claims are
invalid or that the patent is unenforceable. If the Company was found liable for infringement of
third-party patents or other intellectual property rights, the Company could be required to enter
into royalty or licensing agreements on terms and conditions that may not be favourable to the
Company, and/or pay damages, including up to treble damages (but only if found liable of wilful
infringement) and/or cease the development and commercialization of its products. Any finding that
the Company is guilty of patent infringement could materially adversely affect the business,
financial condition and operating results of the Company.
The Company has not been served with any notice that it is infringing on a third-party patent, but
there may be issued patents that the Company is unaware of that its products may infringe, or
patents that the Company believes it does not infringe but could be found to be infringing. The
Company has reviewed, and is aware of, third-party patents for the reduction of accumulation of fat
tissue in HIV patients and the Company believes that it does not infringe any valid claims of these
patents.
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Description of the Business of the Company
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Page 30 |
Annual Information Form Financial Year Ended November 30, 2009
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Theratechnologies Inc. |
The Company faces competition and the development of new products by other companies could
materially adversely affect the Companys business and its products.
The biopharmaceutical and pharmaceutical industries are highly competitive and the Company must
compete with pharmaceutical companies, biotechnology companies, academic and research institutions
as well as governmental agencies for the development and commercialization of products. Although
the
Company believes that it has few direct competitors for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy, it could face indirect competition.
In the other clinical programs currently being evaluated by the Company for development, there may
exist companies that are at a more advanced stage of developing a product to treat the diseases for
which the Company is evaluating clinical programs. Some of these competitors could have access to
capital resources, research and development personnel and facilities that are superior to those of
the Company. In addition, some of these competitors could be more experienced than the Company in
the commercialization of medical products and already have a sales force in place to launch new
products. Consequently, they may be able to develop alternative forms of medical treatment which
could compete with the products of the Company and could be commercialized more rapidly and
effectively than the products of the Company.
The Companys business may be harmed if it is unable to manage its growth effectively.
The Company expects to experience rapid growth throughout its operations if tesamorelin is
commercialized. Such growth would place a strain on operational, human, and financial resources. To
manage its growth, the Company will have to further develop its operating and administrative
systems and attract and retain qualified management, professional, scientific, and technical
operating personnel.
There can be no guarantee that the Company will be successful in developing such systems and
attracting and retaining qualified personnel. Failure to manage growth effectively could have an
adverse effect on the Companys business, financial condition and operating results.
The Company depends on its key personnel to research, develop and bring new products to the market
and the loss of key personnel or the inability to attract highly qualified individuals could have a
material adverse effect on its business and growth potential.
The Companys mission is to discover or acquire novel therapeutic products targeting unmet medical
needs in financially attractive specialty markets. The achievement of this mission requires
qualified scientific and management personnel. The loss of scientific personnel or of members of
management could have a material adverse effect on the business of the Company. In addition, the
Companys growth is and will continue to be dependent, in part, on its ability to retain and hire
qualified personnel. There can be no guarantee that the Company will be able to continue to retain
its current employees or will be able to attract qualified personnel to pursue its business plan.
The Company is not profitable and may never achieve profitability.
For the financial year ended November 30, 2009, the Company reported losses of $15,058,000. The
Company has been reporting losses since its inception (except for the financial years ended
November 30, 2001 and 2000) and, as at November 30, 2009, it had an accumulated deficit of
$243,887,000. The Company does not expect to generate significant recurrent revenues in the
immediate future and will continue to experience losses as it continues its efforts to obtain
regulatory approvals for tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with
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Description of the Business of the Company
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Page 31 |
Annual Information Form Financial Year Ended November 30, 2009
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Theratechnologies Inc. |
lipodystrophy in the United States and other countries. As a result of the foregoing, the Company
will need to generate significant revenues to achieve profitability.
The Companys profitability will depend on its capacity (i) to obtain regulatory approval for the
use of tesamorelin in the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in the United States and on the capacity of its commercial partner to commercialize
tesamorelin for such indication and (ii) to expand the commercialization of tesamorelin in other
territories. However, there is no guarantee that the Company will succeed in commercializing any of
its products (including tesamorelin) and, accordingly, the Company may never become profitable.
The Company may require additional funding and may not be able to raise the capital necessary to
continue and complete the research and development of its products and their commercialization.
Although the Company has enough funding to support its current business plan, the Company does not
generate significant revenues and may need financing in order to sustain its growth, to continue
its research and development of new products and its clinical programs, to develop its marketing
and commercial capabilities and to meet its compliance obligations with various rules and
regulations to which it is subject. In the past, the Company has been financed through public
equity offerings and the Company may effect additional equity offerings to raise capital, the size
of which cannot be predicted. The issuance and sale of substantial amounts of equity, or other
securities, or the perception that such issuances and sales may occur could adversely affect the
market price of the common shares.
Moreover, the market conditions or the business performance of the Company may prevent the Company
from having access to the public market in the future. Therefore, there can be no guarantee that
the Company will be able to continue to raise capital by way of public equity offerings. In such a
case, the Company will have to use other means of financing, such as issuing debt instruments or
entering into private financing agreements, the terms and conditions of which may not be favourable
to the Company. If adequate funding is not available to the Company, it may be required to delay,
reduce, or eliminate its research and development of new products, its clinical trials or its
marketing and commercialization efforts to launch and distribute new products.
The Company may not receive the full payment of all milestones or royalty payments pursuant to the
agreements entered into with third parties and, consequently, the financial condition and operating
results of the Company could be adversely impacted.
The Company has entered into license agreements and other forms of agreements with third parties
regarding the development and commercialization of some of its products. These agreements generally
require that the third party pays to the Company certain amounts upon the attainment of various
milestones and royalties on the sales of the developed product. There can be no guarantee that the
Company will receive the payments described in those agreements since the development of products
may be cancelled if the research does not yield positive results. Under such circumstances, the
Company would also not receive royalties. Even if the development of a product yields positive
results, all of the risks described herein with respect to the obtaining of regulatory approval are
applicable. Finally, if there occurs a disagreement between the Company and the third party, the
payment relating to the attainment of milestones or of royalties may be delayed. The occurrence of
any of those circumstances could have a material adverse effect on the Companys financial
condition and operating results.
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Description of the Business of the Company
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Page 32 |
Annual Information Form Financial Year Ended November 30, 2009
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Theratechnologies Inc. |
The Company may not achieve its publicly announced milestones on time.
From time to time, the Company publicly announces the timing of certain events to occur. These
statements are forward-looking and are based on the best estimate of management relating to the
occurrence of such events. However, the actual timing of such events may differ from what has been
publicly disclosed. Events such as completion of a clinical program, discovery of a new product,
filing of an application to obtain regulatory approval, beginning of commercialization or
announcement of additional clinical programs for a product may vary from what is publicly
disclosed. These variations may occur as a result of a series of events, including the nature of
the results obtained during a clinical trial or during a research phase, problems with a supplier
or a commercial partner or any other event having the effect of delaying the publicly announced
timeline. The Companys policy on forward-looking information consists of not updating it if the
publicly disclosed timeline varies. Any variation in the timing of certain events having the effect
of postponing such events could have an adverse material effect on the business plan, financial
condition or operating results of the Company.
The outcome of scientific research is uncertain and the failure by the Company to discover new
products could slow down the growth of its portfolio of products.
The Company conducts research activities in order to increase its portfolio of products. The
outcome of scientific research is uncertain and may prove unsuccessful and, therefore, may not lead
to the discovery of new molecules and progression of existing molecules to an advanced development
stage. The inability of
the Company to develop new molecules or to further develop the existing ones could slow down the
growth of its portfolio of products.
The development and commercialization of drugs could expose the Company to liability claims which
could exceed its insurance coverage.
A risk of product liability claims is inherent in the development and commercialization of human
therapeutic products. Product liability insurance is very expensive and offers limited protection.
A product liability claim against the Company could potentially be greater than the available
coverage and, therefore, have a material adverse effect upon the Company and its financial
condition. Furthermore, a product liability claim could tarnish the Companys reputation, whether
or not such claims are covered by insurance or are with or without merit.
The Companys common share price is volatile and investors could lose money as a result of such
volatility.
The market price of the Companys common shares is subject to volatility. General market conditions
as well as differences between the Companys financial, scientific and clinical results and the
expectations of investors as well as securities analysts can have a significant impact on the
trading price of the Companys common shares. In recent years, the stocks of many biopharmaceutical
companies have experienced extreme price fluctuations, unrelated to the operating performance of
the affected companies. There can be no assurance that the market price of the common shares will
not continue to experience significant fluctuations in the future, including fluctuations that are
unrelated to the Companys performance. The occurrence of any of the above risks and uncertainties
could have a material adverse effect on the price of the common shares.
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Description of the Business of the Company
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Page 33 |
Annual Information Form Financial Year Ended November 30, 2009
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Theratechnologies Inc. |
ITEM 4 DIRECTORS AND EXECUTIVE OFFICERS
4.1 DIRECTORS
The following table lists the names of the directors of the Company, their province or state and
country of residence, their principal occupation, their position or office held in the Company (if
any), the year in which each of them first became a director of the Company and the number of
shares each of them beneficially owned, directly or indirectly, or over which they exercised
control or direction as of February 22, 2010. Each elected director remains in office until the
next annual meeting of shareholders, unless he resigns or his position becomes vacant following his
death, his destitution or for any other reason before the next annual meeting of shareholders.
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DIRECTORS |
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Number of |
Name, Province or State |
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Director |
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Common |
and Country of Residence |
|
Principal Occupation |
|
Since |
|
Shares |
Paul Pommier(1) (2) (3) (4) (5) |
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Québec, Canada
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Chairman of the Board of the Company
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1997 |
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190,100 |
|
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Gilles Cloutier(3) (5) |
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North Carolina,United States
|
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Corporate Director
|
|
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2003 |
|
|
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51,000 |
|
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A. Jean de Grandpré(2) (3) (4) (5) |
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Québec, Canada
|
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Corporate Director
|
|
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1993 |
|
|
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200,000 |
|
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Robert G. Goyer(3)
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Emeritus Professor |
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Québec, Canada
|
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Faculty of Pharmacy
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2005 |
|
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10,000 |
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Université de Montreal |
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Gérald A. Lacoste(1) (3) (5) |
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Québec, Canada
|
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Corporate Director
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|
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2006 |
|
|
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11,000 |
|
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Bernard Reculeau(2) |
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Paris, France
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Corporate Director
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|
|
2005 |
|
|
|
18,100 |
|
|
|
|
|
|
|
|
|
|
|
|
Yves Rosconi(4)
|
|
President and Chief Executive Officer
|
|
|
2004 |
|
|
|
67,093 |
|
Québec, Canada
|
|
of the Company |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jean-Denis Talon(1) (2)
|
|
Chairman of the Board |
|
|
|
|
|
|
|
|
Québec, Canada
|
|
AXA Canada
|
|
|
2001 |
|
|
|
60,000 |
|
|
|
(Insurance Company) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Luc Tanguay(4)
|
|
Senior Executive Vice President and |
|
|
|
|
|
|
|
|
Québec, Canada
|
|
Chief Financial Officer of the Company
|
|
|
1993 |
|
|
|
83,000 |
|
|
|
|
(1) |
|
Member of the Audit Committee |
|
(2) |
|
Member of the Compensation Committee |
|
(3) |
|
Member of the Nominating and Corporate Governance
Committee |
|
(4) |
|
Member of the Financing Committee |
|
(5) |
|
Member
of the Strategic Review Committee |
|
|
|
Directors
and Executive Officers
|
|
Page 34 |
Annual Information Form Financial Year Ended November 30, 2009
|
|
Theratechnologies Inc. |
Biographical Notes of the Directors
Paul Pommier, MBA. Chairman of the Board of the Company. Mr. Paul Pommier worked for more than
twenty five years at National Bank Financial Inc., his last position being Senior Executive Vice
President, Corporate and Government Finance. Throughout his career, he oversaw public and private
financings, mergers and acquisitions, as well as the marketing of investment offerings. Under his
leadership, National Bank Financial Inc. developed notable expertise in tax-shelter financings.
Retired since 1997, Mr. Pommier has acted as a director for many other companies.
Gilles Cloutier, Ph.D. Corporate Director. Dr. Gilles Cloutier has over thirty years of experience
in the pharmaceutical industry including five years with contract research organizations, providing
strategic support to the biotechnology and pharmaceutical industry. Dr. Cloutier has also held key
positions with large North-American pharmaceutical companies where he developed expertise in the
field of clinical research. His experience includes the development and approval of several drugs
in Canada, the United States and Europe. Dr. Cloutier sits on the board of directors of
Theratechnologies and is also Chairman of the Fondation André Delambre for amyotrophic lateral
sclerosis (ALS).
A. Jean de Grandpré, C.C., Q.C. Corporate Director. A. Jean de Grandpré contributed to Bell
Canadas exceptional growth as Chairman of the Board and Chief Executive Officer and went on to
become the founding Chairman of the Board and CEO of BCE. In recognition of these achievements, he
was inducted into the Canadian Business Hall of Fame. Mr. de Grandpré also served as a member of
the boards of directors of other important Canadian and US corporations, namely Northern Telecom
Limited, Chrysler Corporation, Sun Life and TD Bank, and as a member of the international advisory
boards of Chemical Bank and Goldman Sachs. He has been a member of the board of directors of
Theratechnologies since its founding in October 1993 and was appointed Chairman in 1996. He
resigned his position as Chairman in March 2007.
Robert G. Goyer, Ph.D. Emeritus professor, Faculty of Pharmacy of the Université de Montréal. Dr.
Goyer has more than forty years of experience in the pharmaceutical field. Former President of
Jouveinal Canada, Dr. Goyer is also a former dean of the Faculty of Pharmacy of Université de
Montréal. Recognized for his broad expertise in drug development, he has served on the boards of
several companies and governmental organizations. He was notably Chairman of the Advisory Committee
on drug approval procedures of Health Canadas Therapeutic Products Directorate and a member of the
board of directors of the Régie de lassurance maladie du Québec. Most recently, he was Chairman of
the Conseil du médicament du Québec.
Gérald A. Lacoste, Q.C. Corporate Director. Gérald A. Lacoste is a lawyer with extensive experience
in the fields of securities regulation, financing and corporate governance. He was previously
Chairman of the Quebec Securities Commission (now known as the Autorité des marchés financiers) and
was also President and CEO of the Montreal Stock Exchange. During his career, Mr. Lacoste acted as
legal counsel to the Canadian Standing Senate Committee on Banking, Trade and Commerce, he chaired
the Quebec Advisory Committee on Financial Institutions, and was a member of the task force on the
capitalization of life insurance companies in Quebec. Mr. Lacoste is currently a corporate
director, actively involved in the biotechnology industry, and is a member of the North American
Free Trade Agreement (NAFTA) arbitration panel.
Bernard Reculeau. Corporate Director. Mr. Bernard Reculeau brings over twenty-five years of
pharmaceutical industry experience to Theratechnologies. From September 2006 to December 2009, he
was the President of CIS Bio International, a French company specializing in nuclear medicine and
biomedical technologies. Prior to joining CIS Bio International, Mr. Reculeau was Senior Vice
President Pharmaceutical Operations of Paris-based Sanofi-Aventis for the InterContinental Region.
In his previous functions, he was responsible for product development and commercialization in
numerous countries around the world. Mr. Reculeau has extensive hands-on management experience
|
|
|
Directors
and Executive Officers
|
|
Page 35 |
Annual Information Form Financial Year Ended November 30, 2009
|
|
Theratechnologies Inc. |
in commercial activities, cumulating close to fifteen years in pharmaceutical operations,
notably in France where he very successfully ran the pharmaceutical operations for Rhône-Poulenc
and Rhône-Poulenc Rorer as well as in many other countries of the European Union. Mr. Reculeau
retired in early 2010.
Yves Rosconi, B. Sc. Pharm. MBA. President and Chief Executive Officer of the Company. Mr.
Yves Rosconi, brings more than twenty five years of global pharmaceutical experience to
Theratechnologies. He began his career with Abbott Laboratories and went on to spend twenty one
years with Rhône-Poulenc Rorer in Canada and Australia with increasing responsibilities, ultimately
becoming President and General Manager of Canadian operations. After leaving Rhône-Poulenc Rorer,
he spent the next two years as Chief Operating Officer of Æterna Laboratories before joining
Paris-based Aventis as Senior Vice President, responsible for Africa and the Middle East. Mr.
Rosconi has been acting as Chairman of the Board of Directors for BIOQuébec since September 24,
2008.
Jean-Denis Talon. Chairman of the Board, AXA Canada. Mr. Jean-Denis Talon had a successful
career with AXA Insurance over a period of more than twenty years ultimately becoming President and
Chief Executive Officer. He is currently Chairman of the Board of AXA Canada. Mr. Talon is also
former President of the Financial Affairs Committee at the Insurance Bureau of Canada.
Luc Tanguay, M.Sc., CFA. Senior Executive Vice President and Chief Financial Officer of the
Company. Mr. Luc Tanguay has been active in the biotechnology industry for over fifteen years. As a
member of senior management at Theratechnologies since 1996, he has contributed to the Companys
growth by facilitating access to public and private capital funding. A member of the Board of
Directors since 1993, he has held various management positions since joining the Company. Prior to
joining Theratechnologies, Mr. Tanguay had a career in investment banking at National Bank
Financial Inc. where he helped several organizations establish themselves as public companies.
The Board of Directors of the Company has established an Audit Committee to review its annual
financial statements prior to approval thereof by the Board of Directors and also to perform other
duties, as is described in the Audit Committees charter adopted by the Board of Directors and
attached hereto as Appendix A.
As of November 30, 2009, the Audit Committee was composed of three members: Paul Pommier, its
Chair, Jean-Denis Talon and Gérald A. Lacoste. All three are independent and financially literate.
|
C. |
|
Members Education and Experience |
The details mentioned hereunder describe the education and experience of the Audit Committee
members that is relevant to the performance of their responsibilities, in particular any experience
in preparing, auditing, analyzing and evaluating financial statements.
Paul Pommier. Mr. Pommier holds an MBA degree and has more than twenty-five years of experience in
the financial field, notably in public and private company financings, as well as in merger and
acquisition activities. While acting as a director of Royal Aviation Inc., he was also a member of
its audit committee.
|
|
|
|
|
|
Directors and Executive Officers
|
|
Page 36 |
Annual Information Form Financial Year Ended November 30, 2009
|
|
Theratechnologies Inc. |
Jean-Denis Talon. Mr. Talon has more than twenty years of experience in the insurance field as a
senior officer. Mr. Talon acted as a member of the audit committee of AXA Canada from March 1995 to
April 2008. He has been a member of the audit committee of InnovAssur since March 1999 and since
November 1999, he has been acting as Chairman of its audit committee.
Gérald A. Lacoste. Mr. Lacoste has more than thirty years of experience in the fields of securities
regulation, corporate finance and corporate governance. Mr. Lacoste was president of the audit
committee of Amisco Ltd. from 2002 to 2009 and was also a member of the audit committee of Andromed
Inc. from 2004 to 2007. Mr. Lacoste has been a member of the audit committee of Génome Québec since
2006.
Each member of the Audit Committee has acquired in-depth financial expertise giving each the
ability to read and understand a set of financial statements which presents the breadth and level
of complexity of accounting issues that are generally comparable to those that can reasonably be
expected to be raised in the issuers financial statements.
|
D. |
|
External Auditors Service Fees |
|
|
|
|
|
|
|
|
|
|
|
Financial Year Ended |
|
Financial Year Ended |
|
|
November 30, 2009 |
|
November 30, 2008 |
Audit Fees |
|
$ |
80,000 |
|
|
$ |
77,000 |
|
Audit-Related Fees (1) |
|
$ |
17,500 |
|
|
$ |
71,300 |
|
Tax Fees (2) |
|
$ |
39,626 |
|
|
$ |
40,064 |
|
All Other Fees |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Audit-related fees relate principally to services rendered in connection with the Companys
quarterly financial statements. For the financial year ended November 30, 2008, audit-related fees
paid to KPMG also included fees related to services rendered in connection with the Companys
public offering. |
|
(2) |
|
Tax fees relate to services rendered in connection with the preparation of corporate
tax returns and general tax advice. |
The following table lists the names of all executive officers, their province or state and country
of residence, their office and the number of shares beneficially owned, directly or indirectly, by
each of them or over which they exercised control or direction as at February 22, 2010.
|
|
|
|
|
|
Directors and Executive Officers
|
|
Page 37 |
Annual Information Form Financial Year Ended November 30, 2009
|
|
Theratechnologies Inc. |
EXECUTIVE OFFICERS
|
|
|
|
|
|
|
|
|
|
|
Number of Common |
Name, Province or |
|
|
|
Shares of the Company |
State and Country |
|
|
|
over which Control or |
of Residence |
|
Office |
|
Direction is Exercised |
Paul Pommier
Québec, Canada
|
|
Chairman of the Board of the Company
|
|
|
190,100 |
|
|
|
|
|
|
|
|
Yves Rosconi
Québec, Canada
|
|
President and Chief Executive Officer
|
|
|
67,093 |
|
|
|
|
|
|
|
|
Luc Tanguay
Québec, Canada
|
|
Senior Executive Vice President and Chief Financial Officer
|
|
|
83,000 |
|
|
|
|
|
|
|
|
Marie-Noël Colussi
Québec, Canada
|
|
Vice President, Finance
|
|
|
10,075 |
|
|
|
|
|
|
|
|
Chantal Desrochers
Québec, Canada
|
|
Vice President, Business Development and Commercialization
|
|
|
16,300 |
|
|
|
|
|
|
|
|
Andrea Gilpin
Québec, Canada
|
|
Vice President, Investor Relations and Communications
|
|
|
6,000 |
|
|
|
|
|
|
|
|
Jocelyn Lafond
Québec, Canada
|
|
Vice President, Legal Affairs, and Corporate Secretary
|
|
Nil |
|
|
|
|
|
|
|
|
Christian Marsolais
Québec, Canada
|
|
Vice President, Clinical Research and Medical Affairs
|
|
|
8,597 |
|
|
|
|
|
|
|
|
Martine Ortega
Québec, Canada
|
|
Vice President, Compliance and Regulatory Affairs
|
|
|
3,000 |
|
|
|
|
|
|
|
|
Pierre Perazzelli
Québec, Canada
|
|
Vice President, Pharmaceutical Development
|
|
|
1,800 |
|
|
|
|
|
|
|
|
Krishna Peri
Québec, Canada
|
|
Vice President, Research
|
|
|
35,000 |
|
Biographical Notes of the Executive Officers
For the biographical notes of Paul Pommier, Yves Rosconi and Luc Tanguay, please refer to sub-item
4.1 titled Directors of the present document.
Marie-Noël Colussi, CA. Vice President, Finance. Ms. Marie-Noël Colussi is a graduate of
Université du Québec à Montréal in business administration. Prior to joining Theratechnologies, Ms.
Colussi worked for eight years with KPMG, a major accounting firm. Ms. Colussi has acquired sound
experience in accounting, auditing, control and taxation, particularly in research and development.
She joined Theratechnologies in March 1997, and prior to her appointment as Vice President, Finance
in February 2002, she successively held the positions of Director, Accounting and Internal Control
as well as Controller.
Chantal Desrochers, B.Ph., MBA Vice President, Business Development and Commercialization.
Ms. Chantal Desrochers obtained her degrees in pharmacy and business from the Université de
Montréal. She began her career at Schering-Plough in sales and ultimately became a Product
Director. After obtaining her M.B.A., Ms. Desrochers joined Bristol-Myers Squibb Company in Canada
as Marketing Director, Pharmaceuticals and became Vice President, Institutional Business in 1995.
In 1997, Ms. Desrochers was promoted as European Franchise Marketing Director, Cardiovascular, in
France where she implemented market penetration strategies and contributed to the commercial
development of cardiovascular products. This led to her appointment as International Marketing
|
|
|
|
|
|
Directors and Executive Officers
|
|
Page 38 |
Annual Information Form Financial Year Ended November 30, 2009
|
|
Theratechnologies Inc. |
Director, Cardiovascular, at Bristol-Myers Squibb in Princeton, New Jersey. Prior to joining
Theratechnologies in 2005, Ms. Desrochers had been offering consulting services in business
development and product development strategies.
Andrea Gilpin, Ph.D., MBA Vice President, Investor Relations and Communications. Prior to
joining Theratechnologies in 2007, Dr. Gilpin was Director, Investor Relations at MethylGene Inc.
and held various positions in biotech companies. Dr Gilpin has a Ph.D. (Genetics/Biochemistry) from
the University of Toronto and an MBA from the Asper School of Business.
Jocelyn Lafond, LL.B., LL.M. Vice President, Legal Affairs, and Corporate Secretary. Mr.
Lafond has over fifteen years of experience in the fields of corporate and securities law. Mr.
Lafond holds a law degree from Université Laval and a Masters Degree in Law from the University of
Toronto. He has been a member of the Barreau du Québec since 1992. Prior to joining the Company in
2007, Mr. Lafond was a partner with the international law firm of Fasken Martineau DuMoulin, LLP.
Christian Marsolais, Ph.D. Vice President, Clinical Research and Medical Affairs. Dr.
Christian Marsolais has over fifteen years of experience in clinical research for large
pharmaceutical companies, such as Sandoz Canada and BioChem Therapeutics. Before joining
Theratechnologies in 2007, Dr. Marsolais held various positions at Pfizer Global Pharmaceuticals,
where he was appointed Director of Medical Affairs, Therapeutic Areas, in 2004. In this position,
Dr. Marsolais was responsible for the clinical program and scientific initiatives development, as
well as the integration of the Scientific Affairs and Clinical Research for the oncology and HIV
Franchise. Dr. Marsolais holds a Ph.D. in Biochemistry from the Université de Montréal.
Martine Ortega, Pharm. D. Vice President, Compliance and Regulatory Affairs. Ms. Martine
Ortega joined Theratechnologies in 2006. A graduate in pharmacy from the Université dAix-Marseille
II, she holds a postdoctoral degree in dermatology. Ms. Ortega has close to twenty years of
experience in the pharmaceutical industry where she has gained sound knowledge of the drug
development process. During her career, she has acquired broad expertise in GLP, GCP and cGMP
practices and procedures as well as in computerized systems validation. She is also experienced in
relations with US, European and Canadian regulatory agencies. Before joining Theratechnologies, she
held senior management positions at Ventana Clinical Research Corporation in Toronto, as well as
MDS Pharma Services and at the Canadian subsidiary of Sandoz in Montreal.
Pierre Perazzelli, B. Sc. Vice President, Pharmaceutical Development. A graduate of
Université Laval, Mr. Perazzelli has been working in the pharmaceutical manufacturing industry for
over twenty years. Throughout his career, he has held various positions in large pharmaceutical
companies, such as Bristol Myers Squibb and Abbott Laboratories. He was Director of the LAB
Laboratory, a research centre specializing in pharmaceutical formulation. He is also experienced in
the production of generic drugs. Mr. Perazzelli joined Theratechnologies in May 2000.
Krishna Peri, Ph.D. Vice President, Research. Co-inventor of the ExoPep technology and a
founder of Pharma-G, Dr. Krishna Peri holds a Ph.D. in biochemistry from the University of
Saskatchewan, Canada. He pursued post-doctoral research in cancer as an NCI fellow at McGill
University and at Ste. Justine Hospital Research Center. After the acquisition of Pharma-G by
Theratechnologies in 2000, he served as director of discovery research, and was subsequently
appointed Vice-President, Research, in June 2004.
|
|
|
|
|
|
Directors and Executive Officers
|
|
Page 39 |
Annual Information Form Financial Year Ended November 30, 2009
|
|
Theratechnologies Inc. |
4.4 |
|
DECLARATION OF THE DIRECTORS AND OFFICERS ANTECEDENTS |
Except as described below, to the knowledge of the Company, no director or executive officer of the
Company (a) is, as at the date of this Annual Information Form, or has been within the ten years
before the date of this Annual Information Form, a director or executive officer of any company
(including the Company) that, while that person was acting in that capacity, (i) was the subject of
a cease trade or similar order or an order that denied the relevant company access to any exemption
under securities legislation, for a period of more than thirty consecutive days; (ii) was subject
to an event that resulted, after the director or executive officer ceased to be a director or
executive officer, in the company being the subject of a cease trade or similar order or an order
that denied the relevant company access to any exemption under securities legislation, for a period
of more than thirty consecutive days; or (iii) within a year of that person ceasing to act in that
capacity, became bankrupt, made a proposal under any legislation relating to bankruptcy or
insolvency or was subject to or instituted any proceedings, arrangement or compromise with
creditors or had a receiver, receiver manager or trustee appointed to hold its assets; or (b) has,
within the ten years before the date of this Annual Information Form, become bankrupt, made a
proposal under any legislation relating to bankruptcy or insolvency, or become subject to or
instituted any proceedings, arrangement or compromise with creditors, or had a receiver, receiver
manager or trustee appointed to hold his assets.
Paul Pommier was a member of the board of directors of Royal Aviation Inc. from September 1996
until it was acquired by Canada 3000 Inc. in March 2001. Subsequently, at the end of 2001, Canada
3000 Inc. and its subsidiaries, including Royal Aviation Inc., made assignments in bankruptcy under
Item 49 of the Bankruptcy and Insolvency Act (R.S. 1985, c. B-3) (hereafter the Bankruptcy Act).
Yves Rosconi was a member of the board of directors of Mistral Pharma Inc. from September 2007
until May 2008. On June 13, 2008, Mistral Pharma Inc. filed a notice of intention to make a
proposal to its creditors under the Bankruptcy Act and, on August 19, 2008, Mistral Pharma Inc.
filed a proposal under the Bankruptcy Act.
Luc Tanguay is currently a member of the board of directors of Ambrilia Biopharma Inc. (hereafter
Ambrilia) and has been a member since August 22, 2006. On July 31, 2009, Ambrilia obtained court
protection from its creditors under the Companies Creditors Arrangement Act (Canada). The purpose
of the order issued by the court granting Ambrilia protection from its creditors is to provide
Ambrilia and its subsidiaries the opportunity to restructure its affairs. Ambrilia is still under
court protection. In addition, on July 31, 2009, the Toronto Stock Exchange halted the trading of
Ambrilias shares pending its review of Ambrilias meeting the requirements for continuous listing.
On August 5, 2009, Ambrilia announced that its shares would resume trading.
4.5 |
|
SECURITIES HELD BY THE DIRECTORS AND EXECUTIVE OFFICERS |
As at February 22, 2010, the total number of common shares (the only securities carrying a voting
right) held by the directors and executive officers of the Company amounted to 771,065, which
represented 1.28% of the outstanding common shares of the Company.
|
|
|
|
|
|
Directors and Executive Officers
|
|
Page 40 |
Annual Information Form Financial Year Ended November 30, 2009
|
|
Theratechnologies Inc. |
ITEM 5 INTERESTS OF EXPERTS
KPMG LLP, auditors of the Company, is the only person or company who is named as having prepared or
certified a statement, report or evaluation, included or mentioned in a filing under securities
regulations during the Companys most recently completed financial year.
KPMG LLP, and its partners are independent in accordance with the auditors rules of professional
conduct in the jurisdiction of Québec.
|
|
|
|
|
|
Interests of Experts
|
|
Page 41 |
Annual Information Form Financial Year Ended November 30, 2009
|
|
Theratechnologies Inc. |
ITEM 6 SECURITIES OF THE COMPANY
6.1 |
|
AUTHORIZED SHARE CAPITAL |
The Company is authorized to issue an unlimited number of common shares and an unlimited number of
preferred shares issuable in series.
Subject to the priority rights of holders of preferred shares, holders of common shares are
entitled to any dividend declared by the board of directors, to one vote per share at meetings of
shareholders of the Company and, in the event of liquidation or dissolution of the Company, to
participate in the distribution of the assets.
Preferred shares carry no voting rights. Preferred shares may be issued at any time in one or more
series. The Companys articles of incorporation give its Board of Directors the power to fix the
number of preferred shares and the consideration per share, as well as to determine the provisions
attached to the preferred shares of each series (including dividends, redemption and conversion
rights, if any). The shares of every series of preferred shares will have priority over all other
shares of the Company, including common shares, with respect to the payment of dividends and return
of capital in the event of the liquidation or dissolution of the Company.
The common shares issued represent the total voting rights pertaining to the securities of the
Company.
The Companys general policy on dividends is not to pay any in cash in order to keep funds
available to finance the Companys growth.
6.3 |
|
TRANSFER AGENT AND REGISTRAR |
The Companys transfer agent and registrar is Computershare Trust Company of Canada which holds, at
its Montreal office, the registers related to the Companys common shares, shareholders and
transfers.
6.4 |
|
MARKET FOR TRADING OF SECURITIES |
The common shares of the Company are listed and traded on the Toronto Stock Exchange under the
symbol TH.
|
|
|
|
|
|
Securities of the Company
|
|
Page 42 |
Annual Information Form Financial Year Ended November 30, 2009
|
|
Theratechnologies Inc. |
6.5 |
|
PRICE RANGE AND TRADING VOLUMES |
The following table sets forth the price of shares of the Company and the volume of shares traded
on the Toronto Stock Exchange.
|
|
|
|
|
|
|
|
|
Price |
|
|
Period |
|
$ High |
|
$ Low |
|
Volume |
February 2010 (until the 22nd)
|
|
5,03
|
|
4,72
|
|
1 789 900 |
January 2010
|
|
5,42
|
|
4,28
|
|
4 505 000 |
December 2009
|
|
4,45
|
|
3,55
|
|
5 517 800 |
November 2009
|
|
3,29
|
|
2,60
|
|
1 780 400 |
October 2009
|
|
2,88
|
|
2,57
|
|
2 885 300 |
September 2009
|
|
2,68
|
|
2,25
|
|
3 859 000 |
August 2009
|
|
2,70
|
|
2,24
|
|
3 585 000 |
July 2009
|
|
2,33
|
|
2,00
|
|
2 806 900 |
June 2009
|
|
3,00
|
|
2,35
|
|
2 530 200 |
May 2009
|
|
2,75
|
|
2,32
|
|
2 833 800 |
April 2009
|
|
3,10
|
|
1,98
|
|
4 721 300 |
March 2009
|
|
1,94
|
|
1,50
|
|
3 228 900 |
February 2009
|
|
1,56
|
|
1,20
|
|
4 642 300 |
January 2009
|
|
2,19
|
|
1,25
|
|
6 372 300 |
December 2008
|
|
2,00
|
|
1,35
|
|
4 984 900 |
|
|
|
|
|
|
Securities of the Company
|
|
Page 43 |
Annual Information Form Financial Year Ended November 30, 2009
|
|
Theratechnologies Inc. |
ITEM 7 MATERIAL CONTRACTS
On February 10, 2010, the Company entered into a Rights Plan Agreement, the terms and conditions of
which are described below.
The Rights Plan came into effect on February 10, 2010. Shareholders will be asked to approve the
Rights Plan at the Companys next annual and special meeting to be held on March 25, 2010. The
Rights Plan, if approved by the shareholders, will expire at the close of the Companys annual
meeting of shareholders in 2013. If the shareholders do not approve the Rights Plan at the next
annual and special meeting of the shareholders, the Rights Plan will terminate.
In order to implement the Rights Plan, the Board of Directors authorized the Company to issue one
right in respect of each common share (hereafter the Common Share) outstanding as of 6:00 p.m.
(Montreal time) on February 9, 2010 (hereafter the Effective Date). One Right will also be issued
and attached to each subsequently issued Common Share. The Rights will be separate from the Common
Shares to which they are attached and will become exercisable at the time (hereafter the
Separation Time) that is ten business days after the earlier of: (i) the first date of public
announcement that an Acquiring Person (as defined below) has become such; (ii) the date of
commencement of, or first public announcement in respect of, a takeover bid which will permit an
offeror to hold 20% or more of the Common Shares, other than by an acquisition pursuant to a
takeover bid permitted by the Rights Plan (hereafter a Permitted Bid as defined below); (iii) the
date upon which a Permitted Bid ceases to be a Permitted Bid; or (iv) such other date as may be
determined in good faith by the Board of Directors.
A Permitted Bid is a takeover bid that does not trigger the exercise of Rights. A Permitted Bid
is a bid that aims to acquire shares which, together with the other securities beneficially owned
by the bidder, represent not less than 20% of the outstanding Common Shares, which bid is made by
means of a takeover bid circular and satisfies the following requirements:
|
i. |
|
the bid must be made to all holders of Common Shares; |
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|
ii. |
|
the bid must include a condition without reservation providing that no share tendered
pursuant to the bid will be taken up prior to the expiry of a period of not less than 60 days
and only if at such date more than 50% in aggregate of the outstanding shares held by the
shareholders other than the bidder, its associates and affiliates, and persons acting jointly
or in concert with such persons (hereafter the Independent Shareholders) have been tendered
pursuant to the bid and not withdrawn; |
|
|
iii. |
|
if more than 50% in aggregate of the shares held by Independent Shareholders are
tendered to the bid within the 60-day period, the bidder must make a public announcement of
that fact and the bid must remain open for deposits of shares for an additional ten business
days from the date of such public announcement. |
The acquisition permitting a person (hereafter an Acquiring Person), including others acting
jointly or in concert with such person, to hold 20% or more of the outstanding Common Shares, other
than by way of a Permitted Bid, is referred to as a Flip-in Event. Any Rights held by an
Acquiring Person on or after the earlier of the Separation Time or the first date of a public
announcement (hereafter the Common Share Acquisition Date) by the Company or an Acquiring Person
that an Acquiring Person has become such, will become null and void upon the occurrence of a
Flip-in Event. Ten trading days after the occurrence of the Common Share Acquisition Date, each
Right (other than those held by the Acquiring Person) will permit the holder to purchase for the
exercise price that number of shares determined as follows: a value of twice the exercise price
divided by the average weighted market
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Material Contracts
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Annual Information Form Financial Year Ended November 30, 2009
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Theratechnologies Inc. |
price for the last 20 trading days preceding the Common Share Acquisition Date. The exercise price
is currently $25 per Right, subject to adjustment in accordance with the Rights Plan.
On January 5, 2010, the Company entered into a supply agreement with ABAR. For a description of
this Supply Agreement, see Item 3.6Av.
On December 23, 2009, the Company entered into the Lyophilization Agreement with Draxis. For a
description of the Lyophilization Agreement, see Item 3.6Aii.
In October 2009, the Company entered into a revised lease agreement with Société de Portefeuille
Immobilier GE Q Tech inc. for the renewal of the lease for its offices and laboratories located at
the same civic address as the current one. For a description of this agreement, see Item 3.8.
On November 6, 2009 the Company entered into a supply agreement with Becton Dickinson. For a
description of this agreement, see Item 3.6Aiii.
On March 26, 2009, the Company entered into a development and supply agreement with Hospira. For a
description of this agreement, see Item 3.6Aiv.
On March 11, 2009, the Company entered into the API Supply Agreement. For a description of the API
Supply Agreement, see Item 3.6Ai.
On October 29, 2008, the Company entered into the Collaboration and Licensing Agreement. For a
description of the Collaboration and Licensing Agreement, see Item 2.1B.
On January 31, 2008, the Company entered into an agreement with a syndicate of underwriters led by
BMO Nesbitt Burns Inc., including Canaccord Capital Corporation, National Bank Financial Inc.,
Desjardins Securities Inc. and Jennings Capital Inc. (collectively, the Underwriters), to issue
and sell 3,500,000 common shares of the Company at a price of $8.50 per share, representing an
offering of $29,750,000. The Company also granted the Underwriters an option to purchase an
additional 350,000 common shares ($2,975,000) at the same price, exercisable by the Underwriters
for a period of thirty days from the closing date of the offering, which occurred on February 13,
2008. The Company successfully completed its public offering of 3,500,000 common shares at a price
of $8.50 per share for gross proceeds of $29,750,000. The option was not exercised by the
Underwriters.
On February 12, 2007, the Company entered into an underwriting agreement with a syndicate of
underwriters led by BMO Nesbitt Burns Inc., including Canaccord Capital Corporation, National Bank
Financial Inc., Desjardins Securities Inc. and Jennings Capital Inc. (the Underwriters), to issue
and sell 6,250,000 common shares of the Company at a price of $8.40 per share. The Company also
granted the Underwriters an option to purchase an additional 625,000 common shares, equal to 10% of
the offering, for purposes of covering over-allotments and for market stabilization. The
Underwriters could exercise their option in whole or in part at any time over a period of 30 days
following the closing date of the offering, which occurred on February 27, 2007. On February 21,
2007, the Underwriters exercised the option in full. On February 27, 2007, the Company successfully
completed its offering of 6,875,000 common shares. Gross proceeds of this transaction, including
the proceeds from the exercise of the option, totalled $57,750,000. The proceeds of the transaction
were used primarily to finance the development of tesamorelin and for working capital purposes.
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Material Contracts
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Annual Information Form Financial Year Ended November 30, 2009
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Theratechnologies Inc. |
ITEM 8 ADDITIONAL INFORMATION
Additional information with respect to the Company, including directors and officers
compensation, principal holders of securities of the Company and securities authorized for issuance
under equity compensation plans, where applicable, is contained in the Companys Management Proxy
Circular for its most recent annual and special meeting of shareholders. The financial information
of the Company is provided in the Companys comparative financial statements and Management
Discussion & Analysis for its financial year ended November 30, 2009.
Additional information regarding the Company is available on SEDAR at www.sedar.com or upon request
addressed to Jocelyn Lafond, Corporate Secretary, at 2310 Alfred Nobel Boulevard, Montreal, Québec,
Canada H4S 2B4. Except when the securities of the Company are in the process of distribution
pursuant to a prospectus, the Company may charge reasonable fees if the request is from a person
who is not a securities holder of the Company.
AIF final
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Additional Information
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Annual Information Form Financial Year Ended November 30, 2009
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Theratechnologies Inc. |
APPENDIX A AUDIT COMMITTEE CHARTER
I. |
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Mandate |
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The Audit Committee (the Committee) is responsible for assisting the Companys Board of
Directors (the Board) in overseeing the following: |
|
A. |
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the integrity of the Companys financial statements and related information; |
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|
B. |
|
the internal control systems of the Company; |
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C. |
|
the appointment and performance of the external auditor; and |
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|
D. |
|
the supervision of the Companys Risk Management. |
II. |
|
Obligations and Duties |
|
|
|
The Committee carries out the duties usually entrusted to an audit committee and any other
duty assigned from time to time by the Board. Management has the responsibility to ensure
the integrity of the financial information and the effectiveness of the Companys internal
controls. The external auditor has the responsibility to verify and certify the accurate
presentation of the Companys financial statements; at the same time evaluating the
internal control process to determine the nature, extent and chronology of the auditing
procedures used. The Committee has the responsibility to supervise the participants
involved in the preparation process of the financial information and to report on this to
the Board. |
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|
|
Specifically, the Committee is charged with the following obligations and duties: |
|
A. |
|
Integrity of the Companys Financial Statements and Related Information |
|
1. |
|
Review annual and quarterly consolidated financial statements
and all financial information legally required to be disclosed by the Company,
i.e. financial information contained in the Management Discussion and
Analysis report, the annual information form and the press releases, as the
case may be, discuss such with management and the external auditor, and
suggest recommendations to the Board, as the case may be. |
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|
2. |
|
Approve the interim Financial Statements, the interim
Management Discussion and Analysis reports and all supplements to these
Management Discussion and Analysis reports which have to be filed with
regulatory authorities. |
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|
3. |
|
On a periodic basis, review and discuss with management and
the external auditor the following: |
|
a. |
|
major issues regarding accounting principles and financial
statement presentations, including any significant changes in the Companys
selection or application of accounting principles, and major issues as to the
adequacy of the Companys internal controls and any special audit steps
adopted in light of material control deficiencies; |
|
|
b. |
|
the effect of regulatory and accounting initiatives, as well
as off-balance sheet structures, on the financial statements of the Company;
and |
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c. |
|
the type and presentation of information to be included in
press releases dealing with financial results (paying particular attention to
any use of pro-forma information or information adjusted by means of
non-generally accepted accounting principles). |
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Appendix A Audit Committee Charter
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Annual Information Form Financial Year Ended November 30, 2009
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Theratechnologies Inc. |
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4. |
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Review and discuss reports from the external auditor on: |
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a. |
|
all critical accounting policies and practices used by the
Company; and |
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b. |
|
all material alternative treatments of financial information
within generally accepted accounting principles that have been discussed with
management, including the ramifications of the use of such alternate
treatments and disclosures and the treatment preferred by the external
auditor. |
|
B. |
|
Supervision of the Companys Internal Control Systems |
|
1. |
|
Review and discuss with management and with the external
auditor present reports and, when appropriate, provide recommendations to the
Board on the following: |
|
a. |
|
actual financial data compared with budgeted data; |
|
|
b. |
|
the Companys internal control system; |
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c. |
|
the relationship of the Committee with the management and
audit committees of the Companys consolidated subsidiaries. With respect to
the subsidiaries, the Committee must: |
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|
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obtain precisions as to the mandate of the audit committees; |
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|
enquire about internal controls and study related risks; |
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obtain the external auditors report to the audit committees
on the planning of external auditing; |
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obtain the external auditors report to the audit committees
on the auditing results; |
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obtain copy of the minutes of the audit committees meetings;
and |
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|
ensure that the critical accounting policies and practices
are identical to the Companys. |
|
2. |
|
Study the feasibility of implementing an internal auditing
system and when implemented, establish its responsibilities and supervise its
work. |
|
|
3. |
|
Establish procedures for the receipt, retention and treatment
of complaints received by the Company regarding accounting, internal
accounting controls or auditing matters, and procedures for the confidential,
anonymous submission by employees of concerns regarding questionable
accounting or auditing matters. |
|
C. |
|
Appointment and Performance Supervision of the External Auditor |
|
1. |
|
Provide recommendations to the Board on the selection of the
external auditor to be appointed by the shareholders. |
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2. |
|
Approve in advance and recommend to the Board the external
auditors remuneration and more specifically fees and terms of all audit,
review or certification services to be provided by the external auditor to the
Company and any consolidated subsidiary. |
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3. |
|
Supervise the performance of the external auditor in charge
of preparing or issuing an audit report or performing other audit services or
certification services for the Company or any consolidated subsidiary of the
Company, |
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Appendix A Audit Committee Charter
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Theratechnologies Inc. |
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where required, and review all related questions as to the terms of its mission and
the revision of its mission. |
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4. |
|
Pre-approve all engagements for permitted non-audit services provided by the
external auditor to the Company and any consolidated subsidiary, and to this effect
and at its convenience, establish policies and procedures for the engagement of the
external auditor to provide to the Company and any consolidated subsidiary permitted
non-audit services, which shall include approval in advance by the Committee of all
audit/review services and permitted non-audit services to be provided to the Company
and any consolidated subsidiary by the external auditor. |
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5. |
|
At least annually, consider, assess and report to the Board on: |
|
a. |
|
the independence of the external auditor, including whether the external
auditors performance of permitted non-audit services is compatible with the external
auditors independence; |
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b. |
|
the obtaining from the external auditor of a written statement
i) describing all relationships between the external auditor and the Company;
ii) assuring that lead audit partner rotation is carried out, as required by law;
and
iii) describing any other relationship that may adversely affect the independence
of the external auditor; and |
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c. |
|
the evaluation of the lead audit partner, taking into account the opinions of
management and the internal auditor. |
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6. |
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At least annually, obtain and review a report by the external auditor
describing: |
|
a. |
|
the external auditors internal quality-control procedures; and |
|
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b. |
|
any material issues raised by the most recent internal quality-control review
(or peer review) of the external auditors firm, or by any inquiry or investigation
by governmental or professional authorities, within the preceding five years, with
respect to one or more independent audits carried out by the external auditors
firm, and any steps taken to deal with any such issues. |
|
7. |
|
Resolve any disagreement between management and the external auditor
regarding financial reporting. |
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8. |
|
Review the audit process with the external auditor. |
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9. |
|
Review and discuss with the Chief Executive Officer and Chief Financial
Officer of the Company the process for the certifications to be provided in the
Companys public disclosure documents. |
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10. |
|
Meet periodically with the external auditor in the absence of management. |
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11. |
|
Establish procedures with respect to hiring the external auditors employees and former
employees. |
|
D. |
|
Supervision of the Companys Risk Management |
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|
Review, report and, where appropriate, provide recommendations to the Board on the
following: |
|
1. |
|
the Companys processes for identifying, assessing and managing risk; |
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|
2. |
|
the Companys major financial risk exposures and the steps the Company has taken to
monitor and control such exposures; |
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Appendix A Audit Committee Charter
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Annual Information Form Financial Year Ended November 30, 2009
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Theratechnologies Inc. |
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3. |
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the Companys insurance portfolio and the adequacy of the coverage; and |
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4. |
|
the Companys investment policy. |
III. |
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External Advisors |
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|
In discharging its duties and responsibilities, the Committee is empowered to retain
external legal counsel or other external advisors, as appropriate. The Company shall
provide the necessary funds to secure the services of such advisors. |
|
IV. |
|
Composition of the Committee |
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|
|
The Committee is composed of any number of Directors, but no less than three, as may be
determined by the Board from time to time by resolution. Each member of the Committee shall be
independent from the Company and is financially literate, as determined by the Board and in
conformity with applicable laws, rules and regulations. |
|
V. |
|
Term of the Mandate |
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|
|
Committee members are appointed by Board resolution to carry out their mandate extending
from the date of the appointment to the next annual general meeting of the shareholders or
until their successors are so appointed. |
|
VI. |
|
Vacancy |
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|
|
The Board may fill vacancies at any time by resolution. Subject to the constitution of the
quorum, the Committees members can continue to act even if there is one or many vacancies on the
Committee. |
|
VII. |
|
Chairman |
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|
|
The Board appoints the Committee Chairman who will call and chair the meetings. The
Chairman reports to the Board the deliberations of the Committee and its recommendations. |
|
VIII. |
|
Secretary |
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|
|
Unless otherwise determined by resolution of the Board, the Secretary of the Company shall
act as Committee Secretary. The Secretary must attend Committee meetings and prepare the
minutes. He/she must provide notification of meetings as directed by the Committee
Chairman. The Secretary is the guardian of the Committees records, books and archives. |
|
IX. |
|
Meeting Proceedings |
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|
|
The Committee establishes its own procedures as to how meetings are called and conducted.
Unless it is otherwise decided, the Committee shall meet privately and independently from
Management at each regularly scheduled meeting. In the absence of the regularly appointed
Chairman, the meeting shall be chaired by another Committee member selected among attending
participants and appointed accordingly. In the absence of the regularly appointed
Secretary, Committee members shall designate someone to carry out this duty. |
|
|
|
The Committee shall meet at least four times a year with management and the external auditor,
and at least once a year, separately in executive session in the absence of management and the
external auditor. At least once a year, the Committee invites the Chief |
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Appendix A Audit Committee Charter
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|
|
Theratechnologies Inc. |
|
|
Financial Officer of each subsidiary to present the financial information and internal
control systems related to such subsidiary. |
|
X. |
|
Quorum and Voting |
|
|
|
Unless the Board otherwise specifies by resolution, two Committee members shall constitute an
appropriate quorum for deliberation of items on the agenda. During meetings, decisions are reached
by a majority of votes from Committee members, unless the quorum is of two members, in which case
decisions are made by consensus of opinion. |
|
XI. |
|
Records |
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|
|
The Committee keeps records that are deemed necessary of its deliberations and reports
regularly to the Board on its activities and recommendations. |
|
XII. |
|
Effective Date |
|
|
|
This charter was adopted by the Directors at its May 3, 2004 Board meeting. It was amended by
the Directors during the April 13, 2005 and February 8, 2006 Board meetings. |
|
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Appendix A Audit Committee Charter
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Annual Information Form Financial Year Ended November 30, 2009
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Theratechnologies Inc. |
ex-99.5
Exhibit 99.5
2009 ANNUAL REPORT
CONTENTS
4 CHAIRMANS LETTER // 5 MESSAGE FROM THE PRESIDENT AND CHIEF EXECUTIVE OFFICER // 8 BOARD OF
DIRECTORS // 10 MANAGEMENTS DISCUSSION AND ANALYSIS // 38 CONSOLIDATED FINANCIAL STATEMENTS
62 CORPORATE INFORMATION
THERATECHNOLOGIES
(TSX: TH)
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company
targets unmet medical needs in financially attractive speciality markets where it can retain all or
part of the commercial rights to its products. Its most advanced compound, tesamorelin, is an
analogue of the human growth hormone releasing factor. In 2009, Theratechnologies submitted a New
Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
The Companys growth strategy is centered on the commercialization of tesamorelin in the United
States and in other markets for HIV-associated lipodystrophy, as well as the development of
clinical programs for tesamorelin in other medical conditions.
2009 HIGHLIGHTS
CONCLUSION OF A COLLABORATION AND LICENSING AGREEMENT WITH EMD SERONO, INC. granting the U.S.
commercialization rights for tesamorelin in HIV-associated lipodystrophy and receipt of a $37
million payment including a subscription for common shares in Theratechnologies.
ADOPTION OF A GROWTH STRATEGY focused on the commercialization of tesamorelin in the United States
and in other markets for HIV-associated lipodystrophy, as well as the development of clinical
programs for tesamorelin in other medical conditions.
SUBMISSION OF A NDA TO THE U.S. FDA proposing tesamorelin for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy.
RECEIPT OF A US $10 MILLION MILESTONE PAYMENT associated with the FDAs acceptance to review the
NDA for tesamorelin, in accordance with the terms of the Companys Collaboration and Licensing
Agreement with EMD Serono.
PREPARATION FOR A PUBLIC MEETING before the Endocrinologic and Metabolic Drugs Advisory Committee
of the FDA as part of the evaluation process for tesamorelins NDA.
FORWARD-LOOKING IFORMATION
This annual report contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. We caution readers not to place undue
reliance on these statements as a number of factors could cause our actual results to differ
materially from the expectations expressed in such forward-looking statements. Additional
information about forward-looking information and associated risks and uncertainties can be found
on pages 25 to 37 of this Annual Report.
FINANCIAL SUMMARY
|
|
|
|
|
|
|
|
|
|
|
|
|
(For the years ended November 30, in thousands of Canadian dollars) |
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
Revenues |
|
$ |
19,720 |
|
|
$ |
2,641 |
|
|
$ |
3,134 |
|
R&D expenditures |
|
$ |
22,226 |
|
|
$ |
35,326 |
|
|
$ |
31,866 |
|
Liquidities * |
|
$ |
65,028 |
|
|
$ |
48,121 |
|
|
$ |
61,786 |
|
Burn rate ** |
|
$ |
26,722 |
*** |
|
$ |
41,592 |
**** |
|
$ |
34,954 |
**** |
|
|
|
|
|
* |
|
Includes cash, bonds and tax credits receivable. |
|
** |
|
Represented by cash flows from operating activities and excluding changes in
operating assets and liabilities. |
|
*** |
|
Adjusted burn rate (see the Non-GAAP Measures section in the Managements
Discussion and Analysis) |
|
**** |
|
Information restated following the adoption of the Canadian Institute of Chartered
Accountants (CICA) Handbook Section 3064, Goodwill and Intangible Assets. |
2009 ANNUAL REPORT 3
CHAIRMANS LETTER
DEAR SHAREHOLDERS,
The year 2009 has been exciting for all of us at Theratechnologies with the major accomplishment of
submitting our NDA to the U.S. FDA. Theratechnologies is one of the exceptional Canadian companies
to have been entirely responsible for an NDA submission. This has been a major achievement and has
considerably de-risked the Company from a regulatory perspective. Every step that we take is one
step closer to the finish line for tesamorelin in HIV-associated lipodystrophy in the U.S.
Therefore, we continue to be optimistic with the regulatory review process and are doing everything
within our control to gain market approval as soon as possible.
At last years annual meeting of shareholders, I mentioned that I did not believe that
Theratechnologies had been recognized in the financial markets for its clinical successes despite
what I believed was a sound business plan. Over the last year, this has changed significantly. The
market has rewarded the Company for its solid fundamentals with Theratechnologies being considered
a top Canadian biotech performer in 2009. With a number of short-term catalysts on the horizon, I
can only expect this trend to continue in 2010.
One of the strategic goals that we had in 2009 was to conserve our cash position, especially in
light of what had occurred in the markets the previous year. This was achieved by focusing on our
existing pipeline and not investing in external assets. Our solid balance sheet, in combination
with a reduced cost structure, position us for growth in the coming year. For example, we wish to
use as leverage the work already done to date for the U.S. market in additional geographies, and
this, without considerably increasing our expenses. This will allow for incremental revenues to
contribute significantly to the growth of Theratechnologies. The result is, we believe, that
Theratechnologies is on its way to becoming cash flow positive, which is a major step towards
becoming a profitable biotechnology company.
In 2009, we defined our three-year business plan, which is solidly focused on tesamorelin.
Successfully gaining U.S. marketing approval, signing partnerships in additional geographies, and
expanding into additional clinical programs are all key to growing the Company as we will begin to
earn revenues. Management of this growth is an important priority for the Board of Directors, and
of course, our shareholders. Part of managing this growth is to make certain that we have
sufficient resources to select and launch additional clinical programs and to execute these
programs in order to maximize the value of Theratechnologies.
Our vision at the Board of Directors is to build a profitable Canadian biotechnology company and,
to this end, we are well on our way. We have a solid balance sheet, a well defined business plan,
and a drug in hand with great potential. Furthermore, we have a seasoned Management team that is
focused on delivering. From a Board perspective, we could not ask for more. For this, I would like
to thank the entire Management team for their commitment, motivation and enthusiasm.
On behalf of the Board of Directors, I would like to take the opportunity to thank, you, our
shareholders, and hope that you share the same excitement and optimism that I have for
Theratechnologies in the coming year.
PAUL POMMIER
CHAIRMAN OF THE BOARD
FEBRUARY 10, 2010
4 2009 ANNUAL REPORT
MESSAGE FROM THE PRESIDENT AND CHIEF EXECUTIVE OFFICER
IN THE FOLLOWING INTERVIEW, YVES ROSCONI REVIEWS THE
HIGHLIGHTS OF 2009 AND SPEAKS TO US ABOUT THE OPPORTUNITIES
FOR GROWTH IN THE YEAR AHEAD.
Q |
|
What is your assessment of 2009? |
|
A |
|
After several years of evaluating tesamorelin in the clinic, in 2009 we advanced in the
regulatory review process. This transition is another positive step that brings us closer to our
ultimate objective, which is to obtain approval for tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy. It was therefore with great enthusiasm
that we accomplished the major regulatory task of finalizing the New Drug Application (NDA) in
the early months of the year 2009, which was submitted to the U.S. Food and Drug Administration on
May 29th. The application was accepted for review in August, which triggered a US$10
million milestone payment under our Collaboration and Licensing Agreement with EMD Serono. |
|
Q |
|
Can you tell us more about what this regulatory work entailed? |
|
A |
|
In fact, the regulatory work related to the submission of our NDA to the FDA started well in
advance of 2009. Even before receiving the results of the confirmatory Phase 3 study, we
established multidisciplinary teams dedicated to preparing our regulatory filing. The assembly of
such a file totaling many thousand pages and containing all of the manufacturing, preclinical and
clinical data for tesamorelin was a colossal task requiring skill, determination and attention to
detail. |
|
|
|
The fact that our filing was accepted for review by the FDA speaks highly of the quality of the
work and I would like to thank all Theratechnologies employees who participated in its preparation
in one way or another. However, the work doesnt stop there! With our application in the process of
being evaluated, our scientific and regulatory teams are currently following up with the FDA to
advance the file and are actively preparing themselves to participate in a meeting before the
Endocrinologic and Metabolic Drugs Advisory Committee of the FDA. |
|
Q |
|
What is the role of this Advisory Committee? |
|
A |
|
The main role of the Advisory Committee is to provide the FDA with independent advice from
medical experts and other interested parties on the use of tesamorelin for treating excess
abdominal fat in HIV-infected patients with lipodystrophy. In cases where a first-in-class type of
treatment like tesamorelin is evaluated for human use, recourse to an Advisory Committee by the FDA
before taking a decision is common practice and an integral part of the review process. Personally,
I look positively upon the FDA seeking outside advice and I know that our team members, who have
been preparing themselves for several months, are looking forward to this public meeting with
confidence. I must, however, add that even in cases where advisory committees address questions
posed by the regulatory authorities, the final decision on a product approval still rests solely
with the FDA. |
2009 ANNUAL REPORT 5
Q |
|
How is the relationship between Theratechnologies and EMD Serono? |
|
A |
|
Excellent! I think its fair to say that our teams have developed a wonderful collaboration
founded upon the common objective of commercializing tesamorelin in the United States. To
facilitate interaction with our new partner, we created an alliance management position in 2009,
which coordinates all communication between Theratechnologies and EMD Serono. So far, around ten
intercompany committees have been formed and are working on various projects. Overseen by the
person managing this alliance, the teamwork in the committees is both efficient and productive. |
|
Q |
|
Virtually all of the Companys energy in recent years has been focused on tesamorelin in the United
States. Once its approved by the FDA, whats next? |
|
A |
|
The approval of tesamorelin in the United States has been our primary objective since 2005 when
we made the strategic decision to focus our efforts on HIV-associated lipodystrophy. Even though
the United States is the market offering the most potential for this medical condition, other
markets could be particularly interesting, notably Brazil, Europe and even here in Canada. Today,
the development of additional markets constitutes the second objective of our business plan, aimed
at securing Theratechnologies growth in the years to come. Following an approval for tesamorelin
to treat HIV-associated lipodystrophy, we also intend to identify clinical programs to evaluate
tesamorelin for the treatment of other diseases. Our growth strategy for the next few years is
therefore firmly fixed on tesamorelin sales of the drug in different markets, the development of
additional clinical programs, and sound product life-cycle management. |
|
Q |
|
Whats your strategy for developing HIV-associated lipodystrophy markets outside the United States? |
|
A |
|
Our strategy is to enter into agreements with strong partners in markets that are attractive and
where the investment on our part is limited. As such, we want to concentrate on markets where we
will be able to use the work already done for the NDA in the United States and on agreements where
the partners are responsible for most of the required investment. In the context where we already
have a solid agreement in the U.S., we now wish to conclude agreements elsewhere that maximize the
potential for additional royalties. |
|
Q |
|
What are your plans for Canada? |
|
A |
|
For Canada, we have two options: find a partner, as we hope to do in other markets, or hold on to
the Canadian commercial rights. We are in a position to consider the second option because we know
the Canadian market well; several of our managers have in-depth experience with the launch of
products in our home territory. The best approach has not yet been determined; its a strategic
decision that we will make by evaluating the investment and returns for each approach as well as
the long-term impact on Theratechnologies future. |
6 2009 ANNUAL REPORT
Q |
|
How will you finance these growth projects? |
|
A |
|
We ended the financial year with $65 million in available funds, which provides us with a lot of
financial flexibility. Whats more, under our agreement with EMD Serono, we can expect further
milestone payments following the approval of tesamorelin; and once it is on the market, we will be
able to count on growing royalties and milestone payments tied to the achievement of certain sales
levels in the United States. All of this should allow us to maintain an adequate cash position to
move ahead with our current business plan. |
|
Q |
|
What do you envisage for Theratechnologies in 2010? |
|
A |
|
I am approaching 2010 full of optimism and confidence, convinced that it will be a truly
exceptional year for Theratechnologies! I envisage, and this goes without saying, achieving our
number one objective, the approval of tesamorelin leading to its commercialization in the United
States by EMD Serono. In so doing, Theratechnologies would find itself among the rare Canadian
companies that have successfully taken a molecule discovered in-house through all of the steps of
the drug development process. This achievement will mark the passage of Theratechnologies from a
research company to one focused on commercial growth. |
|
Q |
|
A few words in closing? |
|
A |
|
I want to recognize the exceptional work of all of the employees of Theratechnologies, which has
carried tesamorelin to where it is today. I would also like to thank our shareholders for their
patience and support over the past year. Theratechnologies is now on solid ground and the indices
are positive! |
YVES ROSCONI
PRESIDENT AND CHIEF EXECUTIVE OFFICER
FEBRUARY 10, 2010
2009 ANNUAL REPORT 7
BOARD OF DIRECTORS
PAUL POMMIER, MBA
Chairman of the Board
PAUL POMMIERspent over 25 years at National Bank Financial, his last position being Senior
Executive Vice President, Corporate and Government Finance. Throughout his career, he oversaw
public and private financings, mergers and acquisitions, as well as the marketing of investment
offerings. Retired since 1997, Mr. Pommier was appointed Chairman of the Board of Theratechnologies
in 2007.
GILLES CLOUTIER, PH.D.
Corporate Director
DR. GILLES CLOUTIER has over 30 years of experience in the pharmaceutical industry including five
years with contract research organizations, providing strategic support to the biotechnology and
pharmaceutical industry. Dr. Cloutier has also held key positions with large North American
pharmaceutical companies where he developed expertise in clinical research. His experience includes
the development and approval of several drugs in Canada, the United States and Europe.
A. JEAN DE GRANDPRÉ,
C.C., Q.C.
Corporate Director
A. JEAN DE GRANDPRÉ contributed to Bell Canadas exceptional growth as Chairman of the Board and
Chief Executive Officer, and went on to become the founding Chairman of the Board and CEO of BCE.
In recognition of these achievements, he was inducted into the Canadian Business Hall of Fame. Mr.
de Grandpré was appointed Chairman of the Board of Theratechnologies in 1996, a position in which
he served for more than 10 years.
BERNARD RECULEAU
Corporate Director
BERNARD RECULEAU brings over 25 years of pharmaceutical industry experience to Theratechnologies.
Mr. Reculeau has extensive hands-on management experience in commercial activities, cumulating
close to 15 years in pharmaceutical operations, notably in France where he successfully ran the
operations for Rhône-Poulenc and Rhône-Poulenc Rorer. From 2006 to 2009, he was President of CIS
Bio, a French company specializing in biomedical technologies.
YVES ROSCONI,
L. PHARM., MBA President and
Chief Executive Officer
YVES ROSCONI brings over 25 years of global pharmaceutical experience to Theratechnologies. Mr.
Rosconi spent 21 years with Rhône-Poulenc Rorer in Canada and Australia with increasing
responsibilities, ultimately becoming President and General Manager of Canadian operations. Before
joining Theratechnologies in 2004, Mr. Rosconi was Senior Vice President, responsible for Africa
and the Middle East at Paris- based Aventis.
8 2009 ANNUAL REPORT
ROBERT G. GOYER, PH.D.
Professor Emeritus, Faculty of
Pharmacy, Université de Montréal
ROBERT G. GOYER has over 40 years of experience in the pharmaceutical field. Former President of
Jouveinal Canada, Dr. Goyer is also a former Dean of the Faculty of Pharmacy of Université de
Montréal. Recognized for his broad expertise in drug development, Dr. Goyer has served on the
boards of several companies and governmental organizations, such as Health Canadas Therapeutic
Products Directorate, the Régie de lassurance maladie du Québec and the Conseil du médicament du
Québec.
GÉRALD A. LACOSTE, Q.C.
Corporate Director
GÉRALD A. LACOSTE is a lawyer with extensive experience in the fields of securities regulation,
corporate finance and corporate governance. He was previously Chairman of the Quebec Securities
Commission (now known as the Autorité des marchés financiers) and was also President and CEO of the
Montreal Stock Exchange. Mr. Lacoste is a member of the North American Free Trade Agreement (NAFTA)
arbitration panel.
JEAN-DENIS TALON
Chairman of the Board,
AXA Canada
JEAN-DENIS TALON had a successful career with AXA Insurance over a period of more than 20 years
ultimately becoming President and Chief Executive Officer. He is currently Chairman of the Board of
AXA Canada. Mr. Talon is also former President of the Financial Affairs Committee at the Insurance
Bureau of Canada.
LUC TANGUAY, M.SC., CFA
Senior Executive Vice President
and Chief Financial Officer
LUC TANGUAY has been active in the biotechnology industry for over 15 years. As a member of Senior
Management at Theratechnologies since 1996, he has contributed to the Companys growth by
facilitating access to public and private capital funding. Prior to joining Theratechnologies, Mr.
Tanguay had a successful career in investment banking at National Bank Financial.
2009 ANNUAL REPORT 9
MANAGEMENTS DISCUSSION AND ANALYSIS
The following discussion and analysis provides Managements point of view on the financial position
and the results of operations of Theratechnologies Inc. (Theratechnologies or the Company), on
a consolidated basis for the twelve-month periods ended November 30, 2009 (2009) and November 30,
2008 (2008). This information is dated February 10, 2010, and should be read in conjunction with
the Audited Consolidated Financial Statements and the accompanying notes. Unless specified
otherwise, the amounts are in Canadian dollars.
The financial information contained in this Managements Discussion and Analysis and in the
Companys Audited Consolidated Financial Statements has been prepared in accordance with Canadian
generally accepted accounting principles (GAAP) except for certain information presented below
under the heading Non-GAAP Measures. The Audited Consolidated Financial Statements and
Managements Discussion and Analysis have been reviewed by the Audit Committee of Theratechnologies
and approved by its Board of Directors.
This Managements Discussion and Analysis contains forward-looking information. Additional
information about the forward-looking information as well as the associated risks and uncertainties
can be found on pages 25 to 37 of the report.
Overview
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company
targets unmet medical needs in financially attractive speciality markets where it can retain all or
some of the commercial rights to its products. Its most advanced compound, tesamorelin, is an
analogue of the human growth hormone releasing factor.
The 2009 financial year began with the closing of the Collaboration and Licensing Agreement with
EMD Serono, Inc. (EMD Serono), an affiliate of Merck KGaA, of Darmstadt, Germany. Under the terms
of this agreement, Theratechnologies received a payment of US $30,000,000 (CAD$36,951,000),
including an initial payment of US$22,000,000 (CAD$27,097,000) from EMD Serono and a subscription
for common shares of Theratechnologies totaling US$8,000,000 (CAD$9,854,000) by Merck KGaA. The
agreement, entered into between the two parties on October 28, 2008, stipulates that
Theratechnologies could receive up to US$215,000,000, including the upfront payment and milestone
payments based on attaining certain development, regulatory and sales objectives. Furthermore,
Theratechnologies will be entitled to receive increasing royalties on annual net sales of
tesamorelin in the United States.
Under the terms of this agreement, the principal responsibility of Theratechnologies was to submit
a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the United States in
order to obtain approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. In the early months of the year, Theratechnologies scientific and
regulatory teams devoted themselves to finalizing the NDA, which was submitted to the FDA on May
29, 2009. In mid-August, the FDA advised Theratechnologies that it had accepted the submission of
the tesamorelin NDA. In accordance with the Collaboration and Licensing Agreement with EMD Serono,
Theratechnologies received a milestone payment of US$10,000,000 (CAD$10,884,000) related to the
acceptance of the NDA submission by the FDA.
As part of the regulatory review currently underway, the FDA asked Theratechnologies to appear at a
public meeting before the Endocrinologic and Metabolic Drugs Advisory Committee in order to obtain
the advice of independent experts on the use of tesamorelin to treat excess abdominal fat in
HIV-infected patients with lipodystrophy. Initially scheduled for February 24, 2010, the meeting
was postponeddue to administrative delays at the FDAuntil a later date that has not yet been
determined.
In parallel with the Companys regulatory activities, Theratechnologies presented additional data
from the Phase 3 clinical program at major scientific conferences, notably the 91st
Annual Meeting of the Endocrine Society (ENDO) in Washington, D.C. and the 11th
International Workshop on Adverse Drug Reactions and Co-morbidities in HIV, in Philadelphia. By way
of background, the 52-week results from the confirmatory Phase 3 clinical trial were announced in
December 2008. As part of its effort to build awareness of the disease, Theratechnologies also
sponsored a symposium entitled Lipohypertrophy: Beyond Body Image at the 12th European
AIDS Conference (EACS) in Cologne, Germany. Finally, the Company began preclinical work in 2009
on a molecule being developed for the treatment of acute kidney failure.
10 ANNUAL REPORT 2009
With respect to the overall strategy of the Company, Management undertook a review of its business
plan in early 2009. The resulting growth strategy, which was presented at the Annual and Special
Meeting of Shareholders held on March 26, 2009, centers on the development of tesamorelin, the
Companys lead molecule, and is built around three main objectives. The first is to obtain approval
for tesamorelin in HIV-associated lipodystrophy in the United States. Once tesamorelin is approved,
the Company expects to receive increasing royalties and additional milestone payments from sales of
tesamorelin by EMD Serono in the United States. The second objective is to develop additional
markets and conclude partnership agreements outside the United States. Finally, the Companys third
objective is to select and launch clinical programs evaluating tesamorelin for the treatment of
other medical conditions. Together with sound product life-cycle management, this strategy
emphasizing the development of tesamorelin is expected to support the growth of Theratechnologies
for the next few years.
ECONOMIC ENVIRONMENT
For the past two years, the capital markets were characterized by significant stock market
volatility and a notable decline in access to capital across all sectors, particularly
biotechnology. In parallel, an economic slowdown occurred in almost all sectors.
The general decline of capital markets has had a negative effect on the cost of capital for
companies. However, the Company does not envisage raising capital in 2010 because its liquidity
level is sufficient to meet the operating needs of its current business plan.
Theratechnologies investment policy is conservative. The Company invests its funds in highly
liquid, low-risk instruments as described under the heading Liquidity and Capital Resources.
The Company relies on third parties for the manufacture and supply of tesamorelin and it is not
aware of any information suggesting that its principal suppliers will not be able to meet their
financial obligations.
Furthermore, Theratechnologies is relying on its American commercial partner, EMD Serono, to
commercialize tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy. The Company is not aware of any information suggesting that its partner will not be
able to meet its financial obligations.
EXPECTATIONS FOR THE PRESENT FINANCIAL YEAR
The Companys primary objective for the current financial year is the acceptance for marketing
approval in the United States of tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy. Marketing approval could result in the achievement of
regulatory milestones under the Collaboration and Licensing Agreement with EMD Serono. Once
approved, the Company expects to receive royalties from the sale of tesamorelin in the United
States. Furthermore, the Company will continue to collaborate with EMD Serono for the preparation
of the commercialization of tesamorelin.
The Companys second objective is to expand into new territories where tesamorelin could be used
for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. To this end,
during the present financial year, the Company will be seeking third parties having a regulatory
expertise in obtaining marketing approval of new drugs and a commercial expertise in launching new
pharmaceutical products with the intent of entering into strategic alliances with them. Under such
strategic alliance agreements, these third parties would be responsible for obtaining marketing
approval of tesamorelin in one or more territories and commercializing tesamorelin in such
territories.
Concurrently with the seeking of third parties with which to enter into strategic alliance
agreements, the Company will continue to pursue regulatory activities outside of the United States
to advance its application regarding the use of tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy. However, given the Companys primary objective,
the pace at which these activities will progress will depend on the FDAs decision regarding the
Companys NDA as well as on the timing of such decision.
ANNUAL REPORT 2009 11
The Companys third objective is to select and begin additional clinical programs once marketing
approval for tesamorelin in the United States for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy is obtained.
Finally, all of the foregoing activities will be carried out in a cost-efficient manner to conserve
the Companys cash position and to manage its burn rate. The Company has sufficient liquidities to
self-finance its activities for the current financial year.
Selected annual information
CONSOLIDATED STATEMENT OF EARNINGS
Years ended November 30
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of dollars, except per share amounts) |
|
2009 |
|
|
2008* |
|
|
2007* |
|
|
Revenues |
|
$ |
19,720 |
|
|
$ |
2,641 |
|
|
$ |
3,134 |
|
Research and development before tax credits |
|
$ |
22,226 |
|
|
$ |
35,326 |
|
|
$ |
31,866 |
|
Operating loss before realized loss on
impairment
of available-for-sale financial assets |
|
$ |
(15,058 |
) |
|
$ |
(48,033 |
) |
|
$ |
(37,611 |
) |
Net loss |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
|
$ |
(37,668 |
) |
|
Basic and diluted loss per share |
|
$ |
(0.25 |
) |
|
$ |
(0.85 |
) |
|
$ |
(0.72 |
) |
|
CONSOLIDATED BALANCE SHEET
At November 30
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of dollars) |
|
2009 |
|
|
2008* |
|
|
2007* |
|
|
Liquidities (cash and bonds) |
|
$ |
63,362 |
|
|
$ |
46,337 |
|
|
$ |
60,368 |
|
Tax credits receivable |
|
$ |
1,666 |
|
|
$ |
1,784 |
|
|
$ |
1,418 |
|
Total assets |
|
$ |
69,487 |
|
|
$ |
53,545 |
|
|
$ |
73,649 |
|
Capital stock |
|
$ |
279,169 |
|
|
$ |
269,219 |
|
|
$ |
238,842 |
|
Shareholders equity |
|
$ |
43,048 |
|
|
$ |
46,347 |
|
|
$ |
65,036 |
|
|
|
|
|
* |
|
Information restated following the adoption of the Canadian Institute of Chartered
Accountants (CICA) Handbook Section 3064, Goodwill and Intangible Assets. |
Operating results
NON-GAAP MEASURES
The Company uses measures that do not conform to GAAP to assess its operating performance.
Securities regulators require that companies caution readers that earnings and other measures
adjusted to a basis other than GAAP do not have standardized meanings and are unlikely to be
comparable to similar measures used by other companies. Accordingly, these measures should not be
considered in isolation. The Company uses non-GAAP measures such as adjusted net loss and the
adjusted burn rate from operating activities before changes in operating assets and liabilities, to
measure its performance from one period to the next without including changes caused by certain
items that could potentially distort the analysis of trends in its operating performance, and
because such measures provide meaningful information on the Companys financial condition and
operating results.
12 ANNUAL REPORT 2009
DEFINITION AND RECONCILIATION OF NON-GAAP MEASURES
In order to measure performance from one period to another, without accounting for changes related
to revenues and fees associated with the Collaboration and Licensing Agreement with EMD Serono,
Management uses adjusted net loss and adjusted burn rate before changes in operating assets and
liabilities. These items are excluded because they affect the comparability of the financial
results and could potentially distort the analysis of trends in the Companys operating
performance. The exclusion of these items does not necessarily indicate that they are
non-recurring.
Adjusted net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of dollars) |
|
Fourth quarter |
|
|
Year |
|
|
|
2009 |
|
|
2008* |
|
|
2009 |
|
|
2008* |
|
|
Net loss, per the financial statements |
|
$ |
(4,698 |
) |
|
$ |
(15,145 |
) |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues associated with a Collaboration and Licensing Agreement
(note 7 to the consolidated financial statements) |
|
|
(1,711 |
) |
|
|
|
|
|
|
(17,444 |
) |
|
|
|
|
Fees associated with a Collaboration and Licensing Agreement |
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
|
|
Adjusted net loss |
|
$ |
(6,409 |
) |
|
$ |
(15,145 |
) |
|
$ |
(28,233 |
) |
|
$ |
(48,611 |
) |
|
Adjusted burn rate from operating activities before changes in operating assets and liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of dollars) |
|
Fourth quarter |
|
|
Year |
|
|
|
2009 |
|
|
2008* |
|
|
2009 |
|
|
2008* |
|
|
Burn rate before changes in operating assets
and liabilities, per the financial statements |
|
$ |
(4,333 |
) |
|
$ |
(9,559 |
) |
|
$ |
(13,547 |
) |
|
$ |
(41,592 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues associated with a Collaboration and Licensing Agreement
(note 7 to the consolidated financial statements) |
|
|
(1,711 |
) |
|
|
|
|
|
|
(17,444 |
) |
|
|
|
|
Fees associated with a Collaboration and Licensing Agreement |
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
|
|
Adjusted burn rate before changes
in operating assets and liabilities |
|
$ |
(6,044 |
) |
|
$ |
(9,559 |
) |
|
$ |
(26,722 |
) |
|
$ |
(41,592 |
) |
|
|
|
|
* |
|
Information restated following the adoption of the CICA Handbook Section 3064,
Goodwill and Intangible Assets. |
REVENUES
Theratechnologies consolidated revenues for the year ended November 30, 2009, were $19,720,000,
compared to $2,641,000 for the same period in 2008. The increased revenues in 2009 are related to
the initial payment received on December 15, 2008, upon the closing of the Collaboration and
Licensing Agreement with EMD Serono, as well as the receipt of a milestone payment of US$10,000,000
(CAD$10,884,000) during the third quarter of 2009.
The payment of US$30,000,000 (CAD$36,951,000) received upon the closing of the agreement included
an initial payment of US$22,000,000 (CAD$27,097,000) and a subscription for common shares by Merck
KGaA at a price of US$3.67 (CAD$4.52) per share, resulting in gross proceeds of US$8,000,000
(CAD$9,854,000). The payment of $27,097,000 has been deferred and is being amortized over its
estimated service period on a straight-line basis. This period may be modified in the future based
on additional information that may be received by the Company. For the year ended November 30,
2009, an amount of $6,560,000 related to this transaction was recognized as revenue. At November
30, 2009, the deferred revenues related to this transaction recorded on the balance sheet amounted
to $20,537,000.
ANNUAL REPORT 2009 13
The milestone payment of $10,884,000, received during the third quarter, is associated with the
acceptance by the U.S. FDA to review the NDA for tesamorelin that was submitted by the Company on
May 29, 2009. Under the terms of the Collaboration and Licensing Agreement with EMD Serono, a
milestone payment of US $10,000,000 was associated with the FDAs acceptance to review the NDA for
tesamorelin. All milestone payments, including the aforementioned payment, are recorded as they are
earned, upon the achievement of predetermined milestones specified in the agreement.
For the year ended November 30, 2009, interest revenues were $2,252,000, compared to $2,427,000 for
the same period in 2008. The decrease in interest revenues over the fiscal year is associated with
lower interest rates, which translated to a lower return on investment.
R&D ACTIVITIES
For the year ended November 30, 2009, consolidated research and development (R&D) expenses,
before tax credits, amounted to $22,226,000, compared to $35,326,000 for the same period in 2008,
representing a decrease of 37.1%. The decrease in R&D expenses is due to the conclusion of the
Phase 3 clinical trials evaluating tesamorelin in HIV-associated lipodystrophy, in the first half
of 2009. The R&D expenses incurred in 2009 are mainly related to follow up on the regulatory
filing, notably managing responses to the FDAs questions, a normal part of the review process, and
the preparation for the FDA Advisory Committee meeting as well as preparation for larger-scale
production of tesamorelin. The R&D expenses for 2009 include a non-recurring charge of $1,377,000
associated with research materials produced to obtain stability data and to validate the commercial
production process, as required by the FDA.
The majority of R&D expenses in 2009 were applied to tesamorelin in HIV-associated lipodystrophy.
Based on the current business plan, R&D expenditures should decrease over the year 2010 and should
be approximately 30% lower than in 2009. During the first months of the 2010 financial year, a
large part of the R&D expenses should continue to be related to follow up on the regulatory filing,
as mentioned earlier. Several other projects are included in the R&D budget for 2010, notably
activities related to product life-cycle management for tesamorelin, regulatory activities related
to the development of additional markets outside the United States, as well as the preliminary work
related to the selection of new clinical programs. The R&D budget for 2010 also provides for the
development of an acute renal insufficiency program. The molecule developed by the Company for the
treatment of acute renal insufficiency was identified as a potential program to be developed
internally. The Company intends to complete the ongoing preclinical work before it selects and
begins a clinical program for this molecule.
TAX CREDITS
Tax credits amounted to $1,795,000 for the year ended November 30, 2009, compared to $2,111,000 in
2008. Tax credits represent refundable tax credits obtained from the Québec government. Lower R&D
expenditures in 2009 contributed to the decrease in tax credits.
GENERAL AND ADMINISTRATIVE EXPENSES
For the year ended November 30, 2009, general and administrative expenses were $7,149,000, compared
to $6,185,000 for the same period in 2008. The increased expenses for the year ended November 30,
2009, are principally due to a higher exchange loss as well as costs associated with revising the
Companys business plan in the first quarter. The exchange losses are due to the conversion of
monetary assets and liabilities denominated in foreign currencies into Canadian dollar equivalents
using rates of exchange in effect on the balance sheet date. These expenses should decrease
slightly in 2010.
14 ANNUAL REPORT 2009
SELLING AND MARKET DEVELOPMENT EXPENSES
For the year ended November 30, 2009, selling and market development expenses were $2,583,000,
compared to $3,811,000 for the same period in 2008. The decrease in selling and market development
costs is due to the signing of the agreement with EMD Serono for the U.S. commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
Following the signing of this agreement, the sales and market development expenses are principally
composed of business development expenses outside the United States and the costs of managing the
agreement with EMD Serono. These expenses should be maintained at the same level in 2010.
PATENTS, AMORTIZATION AND IMPAIRMENT OF OTHER ASSETS
For the year ended November 30, 2009, patents, amortization and impairment of other assets
amounted to $346,000, compared to $5,239,000, in 2008. In 2008, the Company conducted an impairment
test on the intellectual property of the ExoPep platform following a review of the development
strategy for new products by Management. As a consequence, the Company wrote off the carrying
amount of this intellectual property in 2008. The write-off of $4,571,000 is included in Patents,
amortization and impairment of other assets in the consolidated statement of earnings.
FEES RELATED TO THE STRATEGIC REVIEW PROCESS AND THE COLLABORATION AND LICENSING AGREEMENT WITH EMD SERONO
In 2009, an amount of $4,269,000 was recognized as a cost associated with the conclusion of the
agreement with EMD Serono described earlier. In 2008, the costs related to the strategic review
amounted to $2,224,000. These costs are essentially composed of fees paid to the various experts
retained to help Management and the Board of Directors.
REALIZED LOSS ON IMPAIRMENT OF AVAILABLE-FOR-SALE FINANCIAL ASSETS
In 2008, the Company incurred an impairment of $578,000 related to stock options held in a
publicly-traded company.
NET RESULTS
Reflecting the changes in revenues and expenses described above, the Company incurred a net
loss, in 2009, of $15,058,000 ($0.25 per share), compared to a net loss of $48,611,000 ($0.85 per
share) for the same period in 2008. For the year ended November 30, 2009, the net loss included
revenue of $17,444,000 and a non-recurring charge of $4,269,000 related to the agreement with EMD
Serono. Excluding these two items, the adjusted net loss (see Non-GAAP Measures) amounted to
$28,233,000, a decrease of 41.9% compared to the same period in 2008. The net loss in 2008 included
the previously described impairment losses totalling $5,149,000.
QUARTERLY FINANCIAL INFORMATION
The selected financial information provided below is derived from the Companys unaudited
quarterly financial statements for each of the last eight quarters. This information has been
restated following the adoption of the CICA Handbook Section 3064, Goodwill and Intangible Assets.
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of dollars, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Revenues |
|
$ |
2,246 |
|
|
$ |
13,148 |
|
|
$ |
2,317 |
|
|
$ |
2,009 |
|
|
$ |
616 |
|
|
$ |
710 |
|
|
$ |
716 |
|
|
$ |
599 |
|
Net loss (net earnings) |
|
$ |
(4,698 |
) |
|
$ |
5,824 |
|
|
$ |
(5,430 |
) |
|
$ |
(10,754 |
) |
|
$ |
(15,145 |
) |
|
$ |
(11,220 |
) |
|
$ |
(11,382 |
) |
|
$ |
(10,864 |
) |
Basic and diluted loss (earnings) per share |
|
$ |
(0.08 |
) |
|
$ |
0.10 |
|
|
$ |
(0.09 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.20 |
) |
|
As described above, the increased revenues in 2009 are related to the amortization of the initial
payment received at the closing of the agreement with EMD Serono, as well as the milestone payment
of $10,884,000 recorded in August 2009. The increase in the fourth quarter net loss in 2008 is due
to an impairment in the value of intellectual property.
ANNUAL REPORT 2009 15
Fourth quarter
Consolidated revenues for the three-month period ended November 30, 2009, amounted to
$2,246,000, compared to $616,000 for the same period in 2008. Interest revenue in the fourth
quarter of 2009 amounted to $528,000, compared to $518,000 for the same period in 2008. The
increased revenues for the three-
month period ended November 30, 2009, are related to the payment received on December 15, 2008,
upon the closing of the Collaboration and Licensing Agreement with EMD Serono. This payment of
US$30,000,000 (CAD$36,951,000) included an initial payment of US$22,000,000 (CAD$27,097,000) and a
subscription for common shares by Merck KGaA at a price of US$3.67 (CAD$4.52) per share, resulting
in gross proceeds of US$8,000,000 (CAD$9,854,000). The initial payment of $27,097,000 has been
deferred and is being amortized over its estimated service period on a straight-line basis. This
period may be modified in the future based on additional information that may be received by the
Company. For the fourth quarter of 2009, an amount of $1,711,000 related to this transaction was
recognized as revenue.
Consolidated R&D expenses, before tax credits, totalled $4,534,000 for the fourth quarter of 2009,
compared to $6,313,000 for the same period in 2008, representing a decrease of 28.2%. This decrease
in R&D expenses is due to the conclusion of the Phase 3 clinical program evaluating tesamorelin for
the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The R&D expenses
incurred in the fourth quarter of 2009 are mainly related to follow up on the regulatory filing,
notably managing responses to the FDAs questions, a normal part of the review process, and the
preparation for the FDA Advisory Committee meeting as well as preparation for larger-scale
production of tesamorelin.
General and administrative expenses were $1,634,000 in the fourth quarter of 2009, compared to
$1,874,000 for the same period in 2008. The lower expenses for the three-month period ended
November 2009 are associated with a reduction in foreign exchange loss.
Selling and market development costs amounted to $1,067,000 for the fourth quarter of 2009,
compared to $1,124,000 for the same period in 2008. The decrease in selling and market development
costs is due to the signing of the agreement with EMD Serono for the U.S. commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
Since the signing of this agreement, the sales and market development expenses are principally
composed of business development expenses outside the United States and the costs of managing the
agreement with EMD Serono.
Patents, amortization and impairment of other assets amounted to $120,000 for the three months
ended November 30, 2009, compared to $4,727,000 for the corresponding period in 2008. In the fourth
quarter of 2008, the Company conducted an impairment test on the intellectual property of the
ExoPep discovery platform following a review of the development strategy for new products by
Management. As a consequence, the Company wrote off the carrying amount of this intellectual
property in 2008. The impairment of other assets of $4,571,000 is included in Patents,
amortization and impairment of other assets in the consolidated statement of earnings.
In 2008, the Company incurred an impairment of $578,000 related to stock options held in a
publicly-traded company.
Consequently, the Company recorded a net loss for the three-month period ended November 30, 2009,
of $4,698,000 ($0.08 per share), compared to a net loss of $15,145,000 ($0.26 per share) for the
same period in 2008. The fourth quarter net loss includes revenues of $1,711,000 related to the
agreement with EMD Serono. Excluding this item, the adjusted net loss (see Non-GAAP Measures)
amounted to $6,409,000, a decrease of 57.7% compared to the same period in 2008.
In the three months ended November 30, 2009, the burn rate from operating activities, excluding
changes in operating assets and liabilities, was $4,333,000, compared to $9,559,000 for the same
period in 2008. Excluding the revenue of $1,711,000 related to the agreement with EMD Serono, the
adjusted burn rate from operating activities, excluding changes in operating assets and liabilities
(see Non-GAAP Measures), was $6,044,000, a decrease of 36.8%, compared to the corresponding
period in 2008.
16 ANNUAL REPORT 2009
Liquidity and capital resources
The Companys objective in managing capital is to ensure a sufficient liquidity position to
finance its research and development activities, general and administrative expenses, working
capital and overall capital expenditures, and patents. The Company makes every attempt to manage
its liquidity to minimize shareholder dilution.
To fund its activities, the Company has followed an approach that relies almost exclusively on the
issuance of common equity and proceeds and royalties from technologies following the closing of the
agreement with EMD Serono. Since inception, the Company has financed its liquidity needs primarily
through public offerings of common shares and private placements. When possible, the Company tries
to optimize its liquidity position through non-dilutive sources, including investment tax credits,
grants, interest income as well as proceeds and royalties from technologies.
For the year ended November 30, 2009, the burn rate, represented by cash flows from operating
activities and excluding changes in operating assets and liabilities, was $13,547,000 compared to
$41,592,000 in 2008. The decrease in the 2009 burn rate is principally related to the payments
received under the agreement with EMD Serono as well as the decline in R&D expenditures and in
selling and market
development costs. Excluding the revenue of $17,444,000 and the non-recurring charge of $4,269,000
related to the agreement with EMD Serono, the adjusted burn rate from operating activities,
excluding changes in operating assets and liabilities (see Non-GAAP Measures), was $26,722,000, a
decrease of 35.8%, compared to the corresponding period in 2008.
Based on the current business plan, the adjusted burn rate is expected to amount approximately to
$24,000,000 in 2010. Taking into consideration the liquidity level and the reduced burn rate, the
Company believes that its liquidity position is sufficient to finance its operating activities and
its capital needs over the fiscal year.
Theratechnologies maintained a good liquidity position in 2009. At November 30, 2009, cash and
bonds amounted to $63,362,000 and tax credits receivable amounted to $1,666,000, for a total of
$65,028,000.
It is the policy of the Company to minimize its level of debt. The Company has a line of credit of
$1,800,000 for its short-term financing needs. As at November 30, 2009, this line of credit was not
being used. However, $323,000 of this amount was allocated to secure an irrevocable letter of
credit related to lease commitments on its premises. This letter of credit will be cancelled on
April 30, 2010, under the terms of the lease renewal, described in Contractual obligations.
The Company invests its available cash in highly liquid fixed income instruments from governmental,
municipal and paragovernmental bodies ($60,384,000 at November 30, 2009) as well as from companies
with high credit ratings ($1,459,000 at November 30, 2009).
Under the terms of the agreement with EMD Serono, the Company issued 2,179,837 common shares for a
cash consideration of US$8,000,000 (CAD$9,854,000) during the first quarter. The Company also
received share subscriptions amounting to $96,000 for the issuance of 34,466 common shares in
connection with its share purchase plan.
During the first quarter of 2008, the Company completed a public offering for the sale and issuance
of 3,500,000 common shares for cash proceeds of $29,750,000. Issue costs totalled $1,938,000,
resulting in net proceeds of $27,812,000. In the year ended November 30, 2008, the Company issued
119,666 common shares following the exercise of stock options, for cash proceeds of $397,000. The
Company also received share subscriptions amounting to $149,000 for the issuance of 64,291 common
shares to employees in connection with its share purchase plan.
ANNUAL REPORT 2009 17
Contractual obligations
The Company rents premises under an operating lease expiring in April 2010. The lease was
renewed by the Company and the lessor during the 2009 financial year for a period of 11 years
ending April 30, 2021. Under the terms of the lease, the Company has also been granted two renewal
options for periods of five years each. The minimum payments required under the terms of the lease
are as follows:
PAYMENTS REQUIRED BY DUE DATE
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|
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|
|
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|
|
|
Less than |
|
|
1 to 5 |
|
|
Over |
|
(in thousands of dollars) |
|
Total |
|
|
1 year |
|
|
years |
|
|
5 years |
|
|
Operating lease |
|
$ |
6,576 |
|
|
$ |
340 |
|
|
$ |
2,020 |
|
|
$ |
4,216 |
|
|
The Company has committed to pay the lessor for its share of some operating expenses of the leased
premises. This amount has been set at $240,000 for the year beginning May 1, 2010, and will be
increased by 2.5% annually for the duration of the lease.
The lessor will provide the Company an amount of $728,000 to allow it to undertake leasehold
improvements.
The Company has issued an irrevocable letter of credit in favour of the lessor in the amount of
$323,000 which will be cancelled on April 30, 2010, under the terms of the lease renewal, along
with a first rank movable mortgage in the amount of $1,150,000 covering all of the Companys
tangible assets located in the rented premises. This mortgage, however, can be subordinated to
those of lending institutions.
Furthermore, during and after the year ended November 30, 2009, the Company entered into long-term
procurement agreements with third-party suppliers in anticipation of the commercialization of
tesamorelin. Some of these agreements stipulate an obligation to purchase minimum quantities of
product, subject to certain conditions.
Off-balance sheet arrangements
The Company was not involved in any off-balance sheet arrangements as at November 30, 2009,
with the exception of the lease renewal as described above and an irrevocable letter of credit
issued in the amount of $323,000 related to lease commitments.
Subsequent events
A) |
|
SHAREHOLDER RIGHTS PLAN |
|
|
|
On February 10, 2010, the Companys Board of Directors adopted a shareholder rights plan
(the Plan), effective as of such date. The Plan is designed to provide adequate time for the
Board of Directors, and the shareholders, to assess an unsolicited takeover bid for
Theratechnologies. In addition, the Plan provides the Board of Directors with sufficient time
to explore and develop alternatives for maximizing shareholder value if a takeover bid is made,
as well as provide shareholders with an equal opportunity to participate in a takeover bid to
receive full and fair value for their common shares (the Common Shares). The Plan, if
approved by the shareholders, will expire at the close of the Companys annual meeting of
shareholders in 2013. |
|
|
|
The rights issued under the Plan will initially attach to and trade with the Common Shares and
no separate certificates will be issued unless an event triggering these rights occurs. The
rights will become exercisable only when a person, including any party related to it, acquires
or attempts to acquire 20% or more of the outstanding Common Shares without complying with the
Permitted Bid provisions of the Plan or without approval of the Board of Directors. Should
such an acquisition occur or be announced, each right would, upon exercise, entitle a rights
holder, other than the acquiring person and related persons, to purchase Common Shares at a 50%
discount to the market price at the time. |
18 ANNUAL REPORT 2009
|
|
Under the Plan, a Permitted Bid is a bid made to all holders of the Common Shares and which is
open for acceptance for not less than 60 days. If at the end of 60 days at least 50% of the
outstanding Common Shares, other than those owned by the offeror and certain related parties
have been tendered, the offeror may take up and pay for the Common Shares but must extend the
bid for a further 10 days to allow other shareholders to tender. |
|
B) |
|
GRANTING OF STOCK OPTIONS |
|
|
|
On December 8, 2009, the Company granted 265,000 options at an exercise price of $3.84 per
share and cancelled 19,167 options at a weighted exercise price of $2.38 per share in
connection with its stock option plan. |
Financial risk management
This note provides disclosures relating to the nature and extent of the Companys exposure to
risks arising from financial instruments, including credit risk, liquidity risk, foreign currency
risk and interest rate risk, and how the Company manages those risks.
CREDIT RISK
Credit risk is the risk of an unexpected loss if a customer or counterparty to a financial
instrument fails to meet its contractual obligations. The Company regularly monitors the credit
risk exposure and takes steps to mitigate the likelihood of these exposures resulting in losses.
Financial instruments other than cash that potentially subject the Company to significant credit
risk consist principally of bonds. The Company invests its available cash in fixed income
instruments from governmental, paragovernmental and municipal bonds
($60,384,000 as at November 30, 2009) as well as from companies with high credit ratings
($1,459,000 as at November 30, 2009).
As at November 30, 2009, the Company was not exposed to any credit risk over the carrying amount of
the bonds.
LIQUIDITY RISK
Liquidity risk is the risk that the Company will not be able to meet its financial obligations
as they fall due. The Company manages liquidity risk through the management of its capital
structure, as outlined in the section Liquidity and Capital Ressources. It also manages liquidity
risk by continuously monitoring actual and projected cash flows. The Board of Directors and/or the
Audit Committee reviews and approves the Companys operating and capital budgets, as well as any
material transactions out of the ordinary course of business.
The Company has adopted an investment policy in respect of the safety and preservation of its
capital to ensure the Companys liquidity needs are met. The instruments are selected with regard
to the expected timing of expenditures and prevailing interest rates. Bonds mature on November 30
during the following fiscal years: $10,036,000 in 2010, $15,446,000 in 2011, $19,716,000 in 2012,
$13,791,000 in 2013 and $2,854,000 in 2014. The required payments on the contractual maturities of
financial liabilities, as well as the
payments required under the terms of the operating lease, as at November 30, 2009, are presented in
note 13B) of the Consolidated Financial Statements.
FOREIGN CURRENCY RISK
The Company is exposed to the financial risk related to the fluctuation of foreign exchange
rates and the degree of volatility of those rates. Foreign currency risk is limited to the portion
of the Companys business transactions denominated in currencies other than the Canadian dollar,
primarily revenues from royalties, technologies and other expenses for research and development
incurred in US dollars, euros and pounds sterling (GBP). The Company does not use derivative
financial instruments to reduce its foreign exchange exposure.
The Company manages foreign exchange risk by maintaining U.S. cash on hand to support U.S.
forecasted cash outflows for a maximum 12-month period. The Company does not currently view its
exposure to the euro and GBP as a significant foreign exchange risk, due to the limited volume of
transactions conducted by the Company in these currencies.
ANNUAL REPORT 2009 19
Exchange rate fluctuations for foreign currency transactions can cause cash flow as well as amounts
recorded in the consolidated statement of earnings to vary from period to period and not
necessarily correspond to those forecasted in operating budgets and projections. Additional
earnings variability arises from the conversion of monetary assets and liabilities denominated in
currencies other than the Canadian dollar at the rates of exchange at each balance sheet date, the
impact of which is reported as foreign exchange gain or loss in the consolidated statement of
earnings. Given the Companys policy on the management of foreign currencies, a sudden change in
foreign exchange rates would not impair or enhance its ability to pay its U.S. dollar denominated
obligations.
The following table provides significant items exposed to foreign exchange as at November 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of Canadian dollars) |
|
November 30, 2009 |
|
|
|
$US |
|
|
EUR |
|
|
GBP |
|
|
Cash |
|
|
1,471 |
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
|
|
|
|
4 |
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
(1,095 |
) |
|
|
|
|
|
|
(25 |
) |
|
Balance sheet elements exposed to foreign currency risk |
|
|
376 |
|
|
|
4 |
|
|
|
(25 |
) |
|
The following exchange rates applied during the year ended November 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Reporting |
|
|
|
rate |
|
|
date |
|
|
$US $CAN |
|
|
1.0594 |
|
|
|
1.0556 |
|
EUR $CAN |
|
|
1.5808 |
|
|
|
1.5852 |
|
GBP $CAN |
|
|
1.7597 |
|
|
|
1.7366 |
|
Based on the Companys foreign currency exposures noted above, varying the foreign exchange rates
in the preceding table to reflect a 5% strengthening of the Canadian dollar would have increased
the net loss as follows, assuming that all other variables remained constant:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of Canadian dollars) |
|
$US |
|
|
EURO |
|
|
GBP |
|
|
Increase net loss |
|
|
19 |
|
|
|
|
|
|
|
(1 |
) |
|
An assumed 5% weakening of the Canadian dollar would have had an equal but opposite effect on the
foreign currency amounts shown above, on the basis that all other variables remain constant.
INTEREST RATE RISK
Interest rate risk is the risk that the fair value or future cash flows of a financial
instrument will fluctuate because of changes in market interest rates.
Short-term bonds of the Company are invested at fixed interest rates and mature in the short-term.
Long-term bonds are also instruments that bear interest at fixed rates. The risk that the Company
will realize a loss as a result of a decline in the fair value of its bonds is limited because
these investments, although they are available for sale, are generally held to maturity. The
unrealized gains or losses on bonds are recorded in the accumulated other comprehensive income
(loss).
Based on the value of the Companys short and long-term bonds at November 30, 2009, an assumed 0.5%
decrease in market interest rates would have increased the fair value of these bonds and the
accumulated other comprehensive loss by $620,000; an assumed increase in interest rate of 0.5%
would have an equal but opposite effect, assuming that all other variables remained constant.
20 ANNUAL REPORT 2009
Cash bears interest at a variable rate. Accounts receivable, accounts payable and accrued
liabilities bear no interest.
Based on the value of variable interest-bearing cash during year ended November 30, 2009
($5,800,000), an assumed 0.5% increase in interest rates during such period would have increased
the future cash flow and decreased the net loss by $29,000; an assumed decrease of 0.5% would have
had an equal but opposite effect.
Financial instruments
The Company has determined that the carrying values of its short-term financial assets and
liabilities, including cash, accounts receivable, as well as accounts payable and accrued
liabilities, approximate their fair value because of the relatively short period to maturity of the
instruments.
Bonds and investments in public companies are stated at estimated fair value, determined by prices
quoted on active markets (level 2 inputs see New accounting policies Financial instruments
Disclosures).
Critical accounting estimates
The preparation of financial statements in conformity with GAAP requires Management to make
estimates and assumptions, which affect the reported amounts of assets and liabilities, and
disclosure of contingent assets and liabilities at the date of the financial statements, and the
reported amounts of revenues and expenses during the reporting period. The amounts presented and
the information provided in the notes reflect the range of economic conditions that are most
susceptible to occur and the measures Management intends to take. Actual results could differ from
these estimates. Discussed below are those policies that are judged to be critical and require the
use of judgment in their application.
INVENTORY VALUATION
Our inventory is carried at the lower of First-In-First-Out cost or net realizable value. We
regularly review inventory quantities on hand and record a provision for those inventories no
longer deemed to be fully recoverable. The cost of inventories may no longer be recoverable if
those inventories are slow moving, damaged, if they have become obsolete, or if their selling
prices or estimated forecast of product demand decline. If actual market conditions are less
favorable than previously projected, or if liquidation of the inventory no longer deemed to be
fully recoverable is more difficult than anticipated, additional provisions may be required.
PROPERTY AND EQUIPMENT AND OTHER ASSETS
Property and equipment and other assets are stated at cost. Amortization is provided using
methods and annual rates which are expected to reflect their economic and useful life. On a regular
basis, the Company reviews the estimated useful lives of its property and equipment. Assessing the
reasonableness of the estimated useful lives of property and equipment requires judgement and is
based on currently available information.
IMPAIRMENT OF LONG-TERM ASSETS
The Company reviews its property and equipment and other assets for impairment whenever events
or changes in circumstances indicate that the carrying value of an asset may not be recoverable.
Recoverability of assets to be used is measured by the comparison of the carrying amount of an
asset to estimated undiscounted future cash flows expected to be generated from the asset. If the
carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is
recognized in the amount by which the carrying value of the asset exceeds the fair value of the
asset. Managements judgment regarding the existence of impairment indicators is based on legal
factors, market conditions and operating performance. The fair value against which the asset is
measured may be established based on comparable
information or transactions, discounted cash flows or other methods of assessment depending on the
nature of the asset. In estimating future cash flows, the Company uses its best estimates based on
internal plans, which take Management judgment into consideration. Changes in circumstances, such
as technological advances and changes in business strategy can result in useful lives and future
cash flows differing significantly from estimates. Revisions to the estimated useful lives of
property and equipment or future cash flows constitute a change in accounting estimate and are
applied prospectively.
ANNUAL REPORT 2009 21
INCOME TAXES
Income taxes are accounted for using the asset and liability method. Future income tax assets
and liabilities are recognized in the balance sheet to account for the future tax consequences
attributable to temporary differences between the respective accounting and taxable value of
balance sheet assets and liabilities. Future income tax assets and income tax liabilities are
measured using the income tax rates that are most likely to apply when the asset is realized or the
liability is settled. The effect of changes in income tax rates is recognized in the year during
which these rates change. As appropriate, a valuation allowance is recognized to decrease the value
of tax assets to an amount that is more likely than not to be realized. In estimating the
realization of future income tax assets, Management considers whether a portion or all future tax
assets is more likely than not to be realized. Realization is subject to future taxable income. As
at November 30, 2009, the Company determined that a tax valuation allowance for the full amount of
future tax assets was necessary. In the event the Company determines that it can realize its tax
assets, it will readjust them for the amount and adjust the income in the period for which such
determination is made.
RESEARCH AND DEVELOPMENT
Research and development expenditures consist of direct and indirect expenses. They are
expensed as they are incurred. The Company accounts for clinical trial expenses on the basis of
work completed which relies on estimates of total costs incurred based on completion of studies, on
the number of patients and other factors. The expenses that are recorded with respect to clinical
trials are reviewed as the trial advances up until its final phase.
STOCK-BASED COMPENSATION AND OTHER STOCK-BASED PAYMENTS
The Company accounts for employee stock options using the fair value based method estimated
using the Black-Scholes model, which requires the use of certain assumptions, including future
stock price volatility and the time interval until the options are exercised. Under this method,
compensation cost is measured at fair value at the date of grant and is expensed over the vesting
period.
GOVERNMENT ASSISTANCE
Government assistance consists of research tax credits and grants and is applied against
related expenses and the cost of the asset acquired. Tax credits are available based on eligible
research and development expenses consisting of direct and indirect expenditures and including a
reasonable allocation of overhead expenses. Grants are subject to compliance with terms and
conditions of the related agreements. Government assistance is recognized when there is reasonable
assurance that the Company has met the requirements of the approved grant program or, with regard
to tax credits, when there is reasonable assurance that they will be realized.
New accounting policies
ADOPTION OF NEW ACCOUNTING STANDARDS
Goodwill and intangible assets
Effective with the commencement of its 2009 fiscal year, the Company adopted the CICA Handbook
Section 3064, Goodwill and Intangible Assets, which will replace Section 3062, Goodwill and Other
Intangible Assets, and Section 3450, Research and Development Costs. The standard provides guidance
on the recognition of intangible assets in accordance with the definition of an asset and the
criteria for asset recognition, whether these assets are separately acquired or internally
developed. The impact of adopting this standard has been to increase the opening deficit and to
reduce other assets at December 1, 2007 and 2008 by $941,000 and $599,000, respectively, which is
the amount of patent costs related to periods prior to these dates. Furthermore, following the
adoption of this standard, patents and amortization of other assets presented in the consolidated
statements of earnings were reduced by $342,000 for the year ended November 30, 2008.
22 ANNUAL REPORT 2009
Inventories
Effective with the commencement of its 2009 fiscal year, the Company adopted CICA Section 3031,
Inventories, which replaces Section 3030 and harmonizes the Canadian standards related to
inventories with International Financial Reporting Standards (IFRS). This Section provides
changes to the
measurement and more extensive guidance on the determination of cost, including allocation of
overhead; narrows the permitted cost formulas; requires impairment testing; and expands the
disclosure requirements to increase transparency. As the Company had no inventories on November 30,
2008, the adoption of this section had no impact on the Companys consolidated financial
statements.
Credit risk and fair value of financial assets and financial liabilities
On January 20, 2009, the Emerging Issues Committee (EIC) of the Accounting Standards Board
(AcSB) issued EIC Abstract 173,
Credit Risk and Fair Value of Financial Assets and Financial Liabilities, which establishes that an
entitys own credit risk and the credit risk of the counterparty should be taken into account in
determining the fair value of financial assets and financial liabilities, including derivative
instruments. EIC 173 is applied retrospectively without restatement of prior years to all financial
assets and liabilities measured at fair value in interim and annual financial statements for
periods ending on or after January 20, 2009. The adoption of EIC 173 did not have an impact on the
consolidated financial statements of the Company.
Financial instruments Disclosures
In June 2009, the AcSB issued amendments to CICA Handbook Section 3862, Financial Instruments
Disclosures, in order to align with IFRS 7, Financial Instruments: Disclosures. This Section has
been amended to include additional disclosure requirements about fair value measurements of
financial instruments and to enhance liquidity risk disclosure. The amendments establish a
three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These
tiers include: Level 1, defined as observable inputs such as quoted prices in active markets; Level
2, defined as inputs other than quoted prices in active markets that are either directly or
indirectly observable; and Level 3, defined as unobservable inputs in which little or no market
data exists, therefore requiring an entity to develop its own assumptions. The amendments apply to
annual financial statements relating to fiscal years ended after September 30, 2009 and are
applicable to the Company as at November 30, 2009. The amended section relates to disclosure only
and did not impact the financial results of the Company.
FUTURE ACCOUNTING CHANGES
Business combinations, consolidated financial statements and non-controlling interests
The CICA issued three new accounting standards in January 2009: Section 1582, Business
Combinations, Section 1601, Consolidated Financial Statements, and Section 1602, Non-controlling
Interests. The Company is in the process of evaluating the requirements of the new standards.
Section 1582 establishes standards for the accounting for a business combination. It provides the
Canadian equivalent to International Financial Reporting Standard IFRS 3 Business Combinations.
The section applies prospectively to business combinations for which the acquisition date is on or
after the beginning of the first annual reporting period beginning on or after January 1, 2011 and
early application is permitted.
Section 1601 establishes standards for the preparation of consolidated financial statements.
Section 1602 establishes standards for accounting for a non-controlling interest in a subsidiary in
consolidated financial statements. It is equivalent to the corresponding provisions of IFRS IAS 27
- Consolidated and Separate Financial Statements, Sections 1601 and 1602, and applies to interim
and annual consolidated financial statements relating to fiscal years beginning on or after January
1, 2011 and early application is permitted.
ANNUAL REPORT 2009 23
International Financial Reporting Standards
In February 2008, Canadas AcSB confirmed that Canadian GAAP, as used by publicly accountable
enterprises, would be fully converged into IFRS, as issued by the International Accounting
Standards Board (IASB). The changeover date is for interim and annual financial statements
relating to fiscal years beginning on or after January 1, 2011. As a result, the Company will be
required to report under IFRS for its 2012 interim and annual financial statements. The Company
will convert to these new standards according to the timetable set within these new rules. The
Company will determine at a future date the impact of adopting the standards on its consolidated
financial statements.
Outstanding share data
At February 9, 2010, the number of shares issued and outstanding was 60,449,225 while outstanding options granted under the stock option plan were 2,891,801.
Disclosure controls and procedures and internal control over financial reporting
As at November 30, 2009, an evaluation of the effectiveness of disclosure controls and
procedures, as defined in the rules of the
Canadian Securities Administrators, was carried out. Based on that evaluation, the President and
Chief Executive Officer and the Senior Executive Vice-President and Chief Financial Officer
certified that the design and operating effectiveness of those disclosure controls and procedures
were effective.
Also at November 30, 2009, an evaluation of the effectiveness of internal controls over financial
reporting, as defined in the rules of the Canadian Securities Administrators, was carried out to
provide reasonable assurance regarding the reliability of financial reporting and financial
statement compliance with GAAP. Based on that evaluation, the President and Chief Executive Officer
and the Senior Executive Vice-President and Chief Financial Officer will certify that the design
and operating effectiveness of internal controls over financial reporting were effective.
These evaluations were based on the criteria outlined in the document entitled Internal Control
over Financial Reporting Guidance for Smaller Public Companies published by the Committee of
Sponsoring Organizations of the Treadway Commission, a recognized model, and as per Regulation
52-109 of the Canadian Securities Administrators. A disclosure committee comprised of members of
Senior Management assists the President and Chief Executive Officer and the Senior Executive
Vice-President and Chief Financial Officer in their responsibilities.
All internal control systems, no matter how well designed, have inherent limitations, including the
possibility of human error and the circumvention or overriding of the controls or procedures. As a
result, there is no certainty that disclosure controls and procedures or internal control over
financial reporting will prevent all errors or all fraud. There were no changes in internal
controls over financial reporting that occurred during the year ended November 30, 2009 that have
materially affected, or are reasonably likely to materially affect, internal controls over
financial reporting.
There were no changes in our internal controls over financial reporting that occurred during the
year ended November 30, 2009 that have materially affected, or are reasonably likely to materially
affect, the Companys internal controls over financial reporting.
24 ANNUAL REPORT 2009
Risks and uncertainties
Investors should understand that the Company operates in a high risk industry. The Company has
identified the following risks and uncertainties that may have a material adverse effect on its
business, financial condition or operating results. Investors should carefully consider the risks
described below before purchasing securities of the Company. The risks described below are not the
only ones the Company faces. Additional risks not presently known to the Company or that the
Company currently believes are immaterial may also significantly impair its business operations.
The Companys business could be harmed by any of these risks.
The commercial success of the Company depends largely on the development and commercialization of
tesamorelin; the failure by the Company to commercialize tesamorelin would have a material adverse
effect on the Company.
The Companys focus has been to advance the development of tesamorelin in which it has invested a
significant portion of its financial resources and time. Although the Company has other peptides,
all are at earlier stages of development.
The ability of the Company to generate revenues in the future is primarily based on the
commercialization of tesamorelin for the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy. In the short-term, these revenues should be primarily derived from the United
States market alone. Although the Company entered into the Collaboration and Licensing Agreement
for the commercialization of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy in the United States, there can be no guarantee that tesamorelin will
be commercialized in this country, or in any other country.
The commercialization of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy will depend on several factors:
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receipt of regulatory approvals of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
from the FDA and other regulatory agencies; |
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market acceptance of the product by the medical
community, patients and third-party payers (such as governmental health administration
authorities and private health coverage insurers); |
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entering into one or more strategic alliance
agreements with one or more partners or building a marketing and sales force in countries other
than the United States to help with the regulatory approval and/or the marketing and sale of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
in those countries; |
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in the United States, the amount of resources used by the Companys
commercial partner to commercialize tesamorelin; |
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maintaining manufacturing and supply agreements
to ensure the availability of commercial quantities of tesamorelin through validated processes; |
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the number of competitors in the market; and |
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protecting the Companys intellectual property
and avoiding patent infringement claims. |
The Companys inability to commercialize tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy in the short term in the United States would delay its
capacity to generate revenues and would affect its financial condition and operating results.
ANNUAL REPORT 2009 25
The Company does not have the required regulatory approval to commercialize its products and cannot
guarantee that it will obtain such regulatory approval.
The commercialization of the Companys products first requires the approval of the regulatory
agencies in each of the countries where it intends to sell its products. In order to obtain the
required approvals, the Company must demonstrate, following preclinical and clinical studies, the
safety, efficacy and quality of a product. As far as tesamorelin is concerned, the Company focused
its development to treat excess abdominal fat in HIV-infected patients with lipodystrophy and the
first market the Company wishes to penetrate for this treatment is the United States. The rules and
regulations relating to the approval of a new drug are complex and stringent and although the FDA
has accepted the filing of the Companys NDA, there can be no guarantee that the FDA will approve
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
In addition, there can be no guarantee that the Company will be able to obtain the regulatory
approvals of agencies in other countries to sell tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy.
All of the products of the Company are subject to preclinical and clinical studies. If the results
of such studies are not positive, the Company may not be in a position to make any filing to obtain
the mandatory regulatory approval or, even where a product has been filed for approval, it may have
to conduct additional clinical studies or testing on such product until the results support the
safety and efficacy of such product. Such studies are often costly and may also delay a filing or,
where additional studies or testing are required after a filing has been made, the approval of a
product.
While an application for a new drug is under review by a regulatory agency, it is standard for such
regulatory agency to ask questions regarding the application that was submitted. If these questions
are not answered quickly and in a satisfactory manner, the marketing approval of the product
subject to the review and its commercialization could be delayed or, if the questions are not
answered in a satisfactory manner, refused. If tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy is not approved for commercialization in the United
States by the FDA, the capacity of the Company to generate revenues in the short-term will be
hampered and this will have an adverse effect on its financial condition and its operating results.
The obtaining of regulatory approval is subject to the discretion of regulatory agencies.
Therefore, even if the Company obtains regulatory approval from one agency, or succeeds in filing
the equivalent of a NDA in other countries, or has obtained positive results relating to the safety
and efficacy of a product, a regulatory agency may not accept the filing or the results contained
therein as being conclusive evidence of the safety and efficacy of a product in order to allow the
Company to sell the product in its country. A regulatory agency may require that additional tests
on the safety and efficacy of a product be conducted prior to granting approval of a product and
such additional tests may delay the approval of a product, can have a material adverse affect on
the Companys financial condition based on the type of additional tests to be conducted and may not
necessarily lead to the approval of a product.
Although the Company has received a Special Protocol Assessment from the FDA and the Company has
followed it and met the primary medical end-points described therein, there can be no guarantee
that the FDA will approve tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. Even if the FDA approves tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy, there can be no guarantee that other
regulatory agencies will approve tesamorelin for this treatment in their respective countries.
26 ANNUAL REPORT 2009
Even if the Company obtains regulatory approval for any of its products, regulatory agencies have
the ability to limit the indicated use of a product. Also, the manufacture, marketing and sale of
the products will be subject to ongoing and extensive governmental regulation in the country in
which the Company intends to market its products. For instance, if the Company obtains marketing
approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in the United States, the marketing of tesamorelin will be subject to extensive
regulatory requirements administered by the FDA and other regulatory bodies, such as adverse event
reporting and compliance with all of the FDA marketing and promotional requirements. The
manufacturing facilities for the Companys tesamorelin will also be subject to continuous reviews
and periodic inspections and approval of manufacturing modifications. Manufacturing facilities are
subject to inspections by the FDA and must comply with the FDAs Good Manufacturing Practices
(hereafter GMP) regulations. The failure to comply with any of these post-approval requirements
can result in a series of sanctions, including withdrawal of the right to market a product.
The Company has no control over the timing of the review of its NDA by the FDA.
Although the FDA advised the Company that it had set a date of March 29, 2010 under the
Prescription Drug User Fee Act (United States), more commonly known as PDUFA, by which it targets
to have completed its review of the Companys NDA, there can be no guarantee that such date shall
be met. The Company has no control over the timing of the review of its NDA by the FDA and this
timing could vary based on the FDAs workload, potential review issues contained in the Companys
NDA and other similar factors over which the Company has no control.
Even if tesamorelin is ultimately approved by the FDA, any delay in completing the review of the
Companys NDA will result in a delay in the commercialization of tesamorelin for the treatment of
excess abdominal fat in HIV-infected patients with lipodystrophy and could materially adversely
affect the operating results of the Company and the development of future clinical programs.
The Company is dependent on the Collaboration and Licensing Agreement for the commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
in the United States. This agreement places the commercialization of tesamorelin outside of its
control.
Under the terms of the Collaboration and Licensing Agreement, the Company granted its commercial
partner the exclusive right to commercialize tesamorelin for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy in the United States. Although the agreement contains
provisions governing the commercialization of tesamorelin for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy in the United States, the Companys dependence on its
commercial partner for such purpose subjects it to a number of risks, including:
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the exact timing of the launch of tesamorelin in the United States, if approved by the FDA; |
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the limited
control by the Company on the amount and timing of resources that its commercial partner will be
devoting to the commercialization, marketing and distribution of tesamorelin, which could
adversely affect the Companys ability to obtain or maximize its royalty payments; |
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disputes or
litigation that may arise between the Company and its commercial partner, which could adversely
affect the commercialization of tesamorelin in the United States, all of which will divert the
attention of Companys Management and its resources; |
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its commercial partner not properly
defending the Companys intellectual property rights or using them in such a way as to expose the
Company to potential litigation, which could, in both cases, adversely affect the value of the
Companys intellectual property rights; |
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corporate reorganizations or changes in business
strategies of its commercial partner, which could adversely affect such commercial partners
willingness or ability to fulfill its obligations under the Collaboration and Licensing Agreement; |
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the termination of the Collaboration and Licensing Agreement, which would adversely affect the
commercialization of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy in the United States. |
ANNUAL REPORT 2009 27
The Company relies on third parties for the manufacture and supply of tesamorelin and such reliance
may adversely affect the Company if the third parties are unable to fulfill their obligations.
The Company does not have the resources, facilities or experience to manufacture its products in
large quantities on its own. The Company relies on third parties to manufacture and supply
tesamorelin for clinical studies and currently intends to rely on third parties to manufacture and
supply large quantities of tesamorelin for commercial sales, if approved by the FDA or other
regulatory agencies.
The Companys reliance on third-party manufacturers exposes it to a number of risks. If third-party
manufacturers become unavailable to the Company for any reason, including as a result of the
failure to comply with GMP regulations, manufacturing problems or other operational failures, such
as equipment failures or unplanned facility shutdowns required to comply with GMP or damage from
any event, including fire, flood, earthquake, business restructuring or insolvency, or, if they
fail to perform their contractual obligations under agreements with the Company, such as failing to
deliver the quantities requested on a timely basis, the Company may be subject to delays in the
manufacturing of tesamorelin and any other peptide. Any delay in the supply of a product could slow
down or interrupt the conduct of clinical trials and, if a product has reached commercialization,
could prevent the supply of the product and accordingly, adversely affect the revenues of the
Company. Under the Collaboration and Licensing Agreement, the Company agreed to act as manufacturer
and supplier of tesamorelin for its commercialization in the United States. Accordingly, any delay
in manufacturing tesamorelin by third-party service providers may have a material adverse effect on
the sales and royalties payable to the Company. In addition, any manufacturing delay or delay in
delivering tesamorelin may result in the Company being in default under the Collaboration and
Licensing Agreement. If the damage to a third-party manufacturer facility is extensive, or, for any
reason, it does not operate in compliance with GMP or is unable or refuses to perform its
obligations under its agreement with the Company, the Company will need to find an alternative
third-party manufacturer. The selection of a third-party manufacturer will be time-consuming and
costly since the Company will need to validate the manufacturing facility of such new third-party
manufacturer. The validation will include an
assessment of the capacity of such third-party manufacturer to produce the quantities that may be
requested from time to time by the Company, the manufacturing process and its compliance with GMP.
In addition, the third-party manufacturer will have to familiarize itself with the Companys
technology. Any delay in finding an alternative third-party manufacturer of a product could result
in a shortage of such product, a delay in clinical study programs and in the filing for regulatory
approval of a product and, if a product is approved for commercialization, a shortage of such a
product would result in lost revenue to the Company.
Market acceptance of the Companys products is uncertain and depends on a variety of factors, some
of which are not under the control of the Company.
The Companys ability to commercialize its products with success will depend on a variety of
factors, including the extent to which reimbursement to patients for the cost of such products and
related treatment will be available from governmental health administration authorities, private
health coverage insurers and other organizations. Obtaining reimbursement approval for a product is
time-consuming and a costly process that could require the Company to provide supporting
scientific, clinical and cost effectiveness data for its use. There can be no guarantee that the
Companys data will be perceived as sufficient for third-party payers to accept to reimburse one of
the Companys products.
The Company has never made an application seeking reimbursement of a drug and must, therefore, rely
in part on third-party service providers or experienced partners to help it perform this task.
28 ANNUAL REPORT 2009
Other factors that will have an impact on the acceptance of the Companys products
include:
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acceptance of a product by physicians and patients as safe and effective
treatments; |
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product price; |
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the effectiveness of the Companys sales and marketing efforts (or those of its
commercial partners); |
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storage requirements and ease of administration; |
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dosing regimen; |
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safety and efficacy; |
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prevalence and severity of side effects; and |
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competitive products. |
The Companys financial condition could be affected by the introduction of new regulations or
amendments to existing regulations.
New regulations or changes to existing regulations affecting the Company and its potential
customers could decrease demand for the Companys products and affect its operating results and
financial condition. For example, the implementation of health care reform legislation that
regulates drug costs could limit the profits that can be made from the development of new drugs. In
addition, new laws or regulations could increase the Companys costs.
The Company must complete several preclinical and clinical studies for its products which may not
yield positive results and, consequently, could prevent it from obtaining regulatory approval.
Obtaining regulatory approval for the commercialization of drug products requires a demonstration
through preclinical and clinical studies that the drug is safe and effective. All of the Companys
molecules are in preclinical studies, except tesamorelin for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy, which is now under regulatory review at the FDA.
Tesamorelin is also being used in the Phase 2 studies conducted by the MGH and the University of
Washington. For the other molecules, and for tesamorelin in Phase 2 NIH studies, there could remain
preclinical and clinical studies to be conducted prior to determining whether such molecules will
show positive results of safety and efficacy.
If any of those studies are not positively conclusive or result in adverse patient reactions, this
may require the Company to extend the term of its studies, to increase the number of patients
enrolled in a given study or to undertake ancillary testing. Any of these events could increase the
cost of conducting clinical studies, delay the filing of an application for marketing approval with
regulatory agencies or result in the termination of a study and, accordingly, abandoning the
commercialization of a molecule. In addition, the growth of the Company could be compromised since
there can be no guarantee that the Company will be able to develop new molecules, license or
purchase compounds or products that will result in marketed products.
ANNUAL REPORT 2009 29
The Company relies on third-party service providers to conduct its preclinical and clinical
studies and respond to the FDAs questions regarding the Companys NDA submission. The failure by
one of these third parties to comply with their obligations may delay the studies, have an adverse
effect on the Companys development program and/or delay the commercialization of tesamorelin for
the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
The Company has limited human resources to conduct preclinical and clinical studies and must rely
on third-party service providers to conduct its studies and carry out certain data gathering and
analyses. If the Companys third-party service providers become unavailable for any reason,
including as a result of the failure to comply with the rules and regulations governing the conduct
of preclinical and clinical studies, operational failures such as equipment failures or unplanned
facility shutdowns, or damage from any event such as fire, flood, earthquake, business
restructuring or insolvency or, if they fail to perform their contractual obligations pursuant to
the terms of the agreements entered into with the Company, such as failing to do the testing,
compute the data or complete the reports further to the testing, the Company may incur delays in
connection with the planned timing of its studies which could adversely affect the timing of the
development program of a molecule or the filing of an application for marketing approval in a
jurisdiction where the Company relies on third-party service provider to make such filing. In
addition, where the Company relies on such third-party service provider to help in answering any
question raised by a regulatory agency during its review of a Company file, the unavailability of
such third-party service provider may adversely affect the timing of the review of an application
and, could ultimately delay the approval. If the damages to any of the Companys third-party
service providers are material, or, for any reason, such providers do not operate in compliance
with GLP or are unable or refuse to perform their contractual obligations, the Company would need
to find alternative third-party service providers.
If the Company must change or select new third-party service providers, the planned working
schedule related to preclinical and/or clinical studies could be delayed since the number of
competent and reliable third-party service providers of preclinical and clinical work in compliance
with GLP is limited. In addition, if the Company must change or select new third-party service
providers to carry out work in response to a regulatory agency review of a Companys application,
there may occur delays in responding to such regulatory agency which, in turn, may lead to delays
in commercializing a product.
Any selection of new third-party service providers to carry out work related to preclinical and
clinical studies would be time-consuming and would result in additional delays in receiving data,
analysis and reports from such third-party service providers which, in turn, would delay the filing
of any new drug application with regulatory agencies for the purposes of obtaining regulatory
approval to commercialize the Companys products. Furthermore, such delays could increase the
Companys expenditures to develop a product and materially adversely affect its financial condition
and operating results.
The conduct of clinical trials requires the enrollment of patients and difficulties in enrolling
patients could delay the conduct of the Companys clinical trials or result in their
non-completion.
The conduct of clinical trials by the Company requires the enrollment of patients. Depending on the
phase of the trials and/or the type of trials which must be conducted, the number of patients may
vary. Phase 1 and Phase 2 trials generally require a smaller number of patients than Phase 3
trials.
The Company may have difficulties enrolling patients for the conduct of its clinical trials as a
result of design protocol, the size of the patient population, the eligibility criteria to
participate in the clinical trials, the availability of competing therapies, the patient referral
practices of physicians and the availability of clinical trial sites. The Companys difficulty in
enrolling patients for its clinical trials could result in the cancellation of clinical trials or
delays in completing them. Any of these events would have adverse consequences on the timely
development of new products, the filing of an NDA, or its equivalent, with regulatory agencies and
the commercialization of the Companys products. Such events would adversely affect the business,
the financial condition and operating results of the Company.
30 ANNUAL REPORT 2009
The Companys capacity to generate revenues may be limited by governmental control over the pricing
of prescription drugs.
In some countries, the pricing of prescription drugs is subject to governmental control. In some of
these countries, pricing negotiations with governmental authorities and reimbursement structures
may delay the marketing of a product. If reimbursement of the Companys products is unavailable or
limited in scope or amount, or if pricing is set at unsatisfactory levels, the revenues of the
Company could be adversely affected.
The Company must enter into strategic alliance agreements with third parties for the sale and
marketing of its products and there is no guarantee that the Company will be able to achieve these
tasks.
Although the Company was successful in finding a third party for the commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
in the United States and although the Company has ongoing discussions with third parties with the
aim of entering into strategic alliance agreements with such third parties to commercialize
tesamorelin outside of the United States, the conclusion of an agreement with a party is a lengthy
process which includes, among other things, an analysis of the capacity of the third party, the
assessment of the services to be performed by the third party, due diligence on the Companys
products and the negotiation of the terms and conditions of the agreement. The outcome of this
process is uncertain and the Company may not be able to conclude any other strategic alliance
agreements for the commercialization of its products, including the commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
in territories other than the United States. The commercialization of the Companys products may be
delayed if it is unable to find third parties to commercialize its products and this could
adversely materially affect the financial condition and the operating results of the Company. Even
if the Company enters into strategic alliance agreements with third parties for the
commercialization of its products, those agreements often contain termination provisions which, if
exercised, could delay the commercialization of its products given that the Company has no sales
force. If the Company does not succeed in entering into a strategic alliance agreement for a
particular territory, it would then not succeed in commercializing the product in such a territory.
In such an event, the Company may decide to commercialize the product itself in that territory and
the Company has no experience in commercializing a product in any market.
The Companys intent to possibly retain the commercial rights of its products for Canada implies
that it would market and sell the product itself on the Canadian market. However, the Company
currently has limited marketing capabilities and it has limited experience in developing, training
or managing a sales force. The development of a sales force would be costly and would be
time-consuming given the limited experience the Company has in this area. To the extent the Company
develops a sales force, the Company could be competing against companies that have more experience
in managing a sales force than the Company has and that have access to more funds than the Company
with which to manage a sales force. Consequently, there can be no guarantee that a sales force
which the Company develops would be efficient and would maximize the revenues derived from the sale
of a Company product.
ANNUAL REPORT 2009 31
The failure by the Company to protect its intellectual property may have a material adverse effect
on its ability to develop and commercialize its products.
The Company will be able to protect its intellectual property rights from unauthorized use by third
parties only to the extent that its intellectual property rights are covered by valid and
enforceable patents or are effectively maintained as trade secrets. The Company tries to protect
its intellectual property position by filing patent applications related to its proprietary
technology, inventions and improvements that are important to the development of its business.
Because the patent position of pharmaceutical companies involves complex legal and factual
questions, the issuance, scope and enforceability of patents cannot be predicted with certainty.
Patents, if issued, may be challenged, invalidated or circumvented. If the Companys patents are
invalidated or found to be unenforceable, it would lose the ability to exclude others from making,
using or selling the inventions claimed. Moreover, an issued patent does not guarantee the Company
the right to use the patented technology or commercialize a product using that technology. Third
parties may have blocking patents that could be used to prevent the Company from developing its
product candidates, selling its products or commercializing its patented technology. Thus, patents
that the Company owns may not allow it to exploit the rights conferred by its intellectual property
protection. The Companys pending patent applications may not result in patents being issued. Even
if issued, they may not be issued with claims sufficiently broad to protect its products and
technologies or may not provide the Company with a competitive advantage against competitors with
similar products or technologies. Furthermore, others may independently develop products or
technologies similar to those that the Company has developed or discover the Companys trade
secrets. In addition, the laws of many countries do not protect intellectual property rights to the
same extent as the laws of Canada and the United States, and those countries may also lack adequate
rules and procedures for defending intellectual property rights effectively.
Although the Company has received a patent from the USPTO for the treatment of HIV-related
lipodystrophy with tesamorelin, there can be no guarantee that the Company will receive a patent in
the other countries where it filed patent applications for the treatment of HIV-related
lipodystrophy.
The Company also relies on trade secrets, know-how and technology, which are not protected by
patents, to maintain its competitive position. The Company tries to protect this information by
entering into confidentiality undertakings with parties who have access to such confidential
information, such as the Companys current and prospective suppliers, employees and consultants.
Any of these parties may breach the undertakings and disclose confidential information to the
Companys competitors.
Enforcing a claim that a third party illegally obtained and is using trade secrets is expensive and
time-consuming and the outcome is unpredictable. In addition, it could divert Managements
attention from the Companys business. If any trade secret, know-how or other technology not
protected by a patent were to be disclosed to or independently developed by a competitor, the
Companys competitive position could be harmed.
The Companys ability to defend against infringement by third parties of its intellectual property
in the Unites States with respect to tesamorelin for the treatment of HIV-related lipodystrophy
depends, in part, on its commercial partners decision to bring an action against such third party.
Under the terms and conditions of the Collaboration and Licensing Agreement, the Companys
commercial partner has the first right to bring an action against a third party infringing on the
Companys intellectual property with respect to tesamorelin for the treatment of HIV-related
lipodystrophy. Any delay in pursuing such action or in advising the Company that it does not intend
to pursue the matter could decrease sales, if any, of tesamorelin for the treatment of HIV-related
lipodystrophy and adversely affect the Companys revenues.
32 ANNUAL REPORT 2009
The Companys commercial success depends, in part, on its ability not to infringe on third parties
patents and other intellectual property rights.
The Companys capacity to commercialize its products, and more particularly tesamorelin, will
depend, in part, on the non-infringement of third parties patents and other intellectual property
rights. The biopharmaceutical and pharmaceutical industries have produced a multitude of patents
and it is not always easy for participants, including the Company, to determine which patents cover
various types of products or methods of use. The scope and breadth of patents is subject to
interpretation by the courts and such interpretation may vary depending on the jurisdiction where
the claim is filed and the court where such claim is litigated. The holding of patents by the
Company for tesamorelin and its application in HIV-related lipodystrophy does not guarantee that
the Company is not infringing on other third-party patents and there can be no guarantee that the
Company will not be in violation of third-party patents and other intellectual property rights.
Patent analysis for non-infringement is based in part on a review of publicly available databases.
Although the Company reviews from time to time certain databases to conduct patent searches, it
does not have access to all databases. It is also possible that some of the information contained
in the databases has not been reviewed by the Company or was found to be irrelevant at the time the
searches were conducted. In addition, because patents take years to be issued, there may be
currently pending applications that the Company is unaware of, which may later be issued. As a
result of the foregoing, there can be no guarantee that the Company will not violate third-party
patents.
Because of the difficulty in analyzing and interpreting patents, there can be no guarantee that a
third party will not assert that the Company infringes upon any of such third-partys patents or
any of its other intellectual property rights. Under such circumstances, there is no guarantee that
the Company would not become involved in litigation. Litigation with any third party, even if the
allegations are without merit, is expensive, time-consuming and would divert Managements attention
from the daily execution of the Companys business plan. Litigation implies that a portion of the
Companys financial assets would be used to sustain the costs of litigation instead of being
allocated to further the development of its business plan.
If the Company is involved in a patent infringement litigation, it would need to demonstrate that
its products do not infringe the patent claims of the relevant patent, that the patent claims are
invalid or that the patent is unenforceable. If the Company was to be found liable for infringement
of third-party patents or other intellectual property rights, the Company could be required to
enter into royalty or licensing agreements on terms and conditions that may not be favourable to
the Company, and/or pay damages, including up to treble damages (but only if found liable of wilful
infringement) and/or cease the development and commercialization of its products. Any finding that
the Company is guilty of patent infringement could materially adversely affect the business,
financial condition and operating results of the Company.
The Company has not been served with any notice that it is infringing on a third-party patent, but
there may be issued patents that the Company is unaware of that its products may infringe, or
patents that the Company believes it does not infringe but could be found to be infringing. The
Company has reviewed, and is aware of, third-party patents for the reduction of accumulation of
abdominal fat tissue in HIV patients and the Company believes that it does not infringe any valid
claims of these patents.
The Company faces competition and the development of new products by other companies could
materially adversely affect the Companys business and its products.
The biopharmaceutical and pharmaceutical industries are highly competitive and the Company must
compete with pharmaceutical companies, biotechnology companies, academic and research institutions
as well as governmental agencies for the development and commercialization of products. Although
the Company believes that it has few direct competitors for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy, it could face indirect competition.
ANNUAL REPORT 2009 33
In the other clinical programs currently being evaluated by the Company for development, there may
exist companies that are at a more advanced stage of developing a product to treat the diseases for
which the Company is evaluating clinical programs. Some of these competitors could have access to
capital resources, research and development personnel and facilities that are superior to those of
the Company. In addition, some of these competitors could be more experienced than the Company in
the commercialization of medical products and already have a sales force in place to launch new
products. Consequently, they may be able to develop alternative forms of medical treatment which
could compete with the products of the Company and could be commercialized more rapidly and
effectively than the products of the Company.
The Companys business may be harmed if it is unable to manage its growth effectively.
The Company expects to experience rapid growth throughout its operations if tesamorelin is
commercialized. Such growth would place a strain on operational, human, and financial resources. To
manage its growth, the Company will have to further develop its operating and administrative
systems and attract and retain qualified Management, professional, scientific, and technical
operating personnel.
There can be no guarantee that the Company will be successful in developing such systems and
attracting and retaining qualified personnel. Failure to manage growth effectively could have an
adverse effect on the Companys business, financial condition and operating results.
The Company depends on its key personnel to research, develop and bring new products to the market
and the loss of key personnel or the inability to attract highly qualified individuals could have a
material adverse effect on its business and growth potential.
The Companys mission is to discover or acquire novel therapeutic products targeting unmet medical
needs in financially attractive specialty markets. The achievement of this mission requires
qualified scientific and management personnel. The loss of scientific personnel or of members of
Management could have a material adverse effect on the business of the Company. In addition, the
Companys growth is and will continue to be dependent, in part, on its ability to retain and hire
qualified personnel. There can be no guarantee that the Company will be able to continue to retain
its current employees or will be able to attract qualified personnel to pursue its business plan.
The Company is not profitable and may never achieve profitability.
For the financial year ended November 30, 2009, the Company reported losses of $15,058,000. The
Company has been reporting losses since its inception (except for the financial years ended
November 30, 2001 and 2000) and, as at November 30, 2009, it had an accumulated deficit of
$243,887,000. The Company does not expect to generate significant recurrent revenues in the
immediate future and will continue to experience losses as it continues its efforts to obtain
regulatory approvals for tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy in the United States and other countries. As a result of the foregoing,
the Company will need to generate significant revenues to achieve profitability.
The Companys profitability will depend on its capacity (i) to obtain regulatory approval for the
use of tesamorelin in the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in the United States and on the capacity of its commercial partner to commercialize
tesamorelin for such indication and (ii) to expand the commercialization of tesamorelin in other
territories. However, there is no guarantee that the Company will succeed in commercializing any of
its products (including tesamorelin) and, accordingly, the Company may never become profitable.
34 ANNUAL REPORT 2009
The Company may require additional funding and may not be able to raise the capital necessary to
continue and complete the research and development of its products and their commercialization.
Although the Company has enough funding to support its current business plan, the Company does not
generate significant revenues and may need financing in order to sustain its growth, to continue
its research and development of new products and clinical programs, to develop its marketing and
commercial capabilities and to meet its compliance obligations with various rules and regulations
to which it is subject. In the past, the Company has been financed through public equity offerings
and the Company may effect additional equity offerings to raise capital, the size of which cannot
be predicted. The issuance and sale of substantial amounts of equity, or other securities, or the
perception that such issuances and sales may occur could adversely affect the market price of the
common shares.
Moreover, the market conditions or the business performance of the Company may prevent the Company
from having access to the public market in the future. Therefore, there can be no guarantee that
the Company will be able to continue to raise capital by way of public equity offerings. In such a
case, the Company will have to use other means of financing, such as issuing debt instruments or
entering into private financing agreements, the terms and conditions of which may not be favourable
to the Company. If adequate funding is not available to the Company, it may be required to delay,
reduce, or eliminate its research and development of new products, its clinical trials or its
marketing and commercialization efforts to launch and distribute new products.
The Company may not receive the full payment of all milestones or royalty payments pursuant to the
agreements entered into with third parties and, consequently, the financial condition and operating
results of the Company could be adversely impacted.
The Company has entered into license agreements and other forms of agreements with third parties
regarding the development and commercialization of some of its products. These agreements generally
require that the third party pays to the Company certain amounts upon the attainment of various
milestones and royalties on the sales of the developed product. There can be no guarantee that the
Company will receive the payments described in those agreements since the development of products
may be cancelled if the research does not yield positive results. Under such circumstances, the
Company would also not receive royalties. Even if the development of a product yields positive
results, all of the risks described herein with respect to the obtaining of regulatory approval are
applicable. Finally, if there occurs a disagreement between the Company and the third party, the
payment relating to the attainment of milestones or of royalties may be delayed. The occurrence of
any of those circumstances could have a material adverse effect on the Companys financial
condition and operating results.
The Company may not achieve its publicly announced milestones on time.
From time to time, the Company publicly announces the timing of certain events to occur. These
statements are forward-looking and are based on the best estimate of Management relating to the
occurrence of such events. However, the actual timing of such events may differ from what has been
publicly disclosed. Events such as completion of a clinical program, discovery of a new product,
filing of an application to obtain regulatory approval, beginning of commercialization or
announcement of additional clinical programs for a product may vary from what is publicly
disclosed. These variations may occur as a result of a series of events, including the nature of
the results obtained during a clinical trial or during a research phase, problems with a supplier
or a commercial partner or any other event having the effect of delaying the publicly announced
timeline. The Companys policy on forward-looking information consists of not updating it if the
publicly disclosed timeline varies. Any variation in the timing of certain events having the effect
of postponing such events could have an adverse material effect on the business plan, financial
condition or operating results of the Company.
ANNUAL REPORT 2009 35
The outcome of scientific research is uncertain and the failure by the Company to discover new
products could slow down the growth of its portfolio of products.
The Company conducts research activities in order to increase its portfolio of products. The
outcome of scientific research is uncertain and may prove unsuccessful and, therefore, may not lead
to the discovery of new molecules and progression of existing molecules to an advanced development
stage. The inability of the Company to develop new molecules or to further develop the existing
ones could slow down the growth of its portfolio of products.
The development and commercialization of drugs could expose the Company to liability claims which
could exceed its insurance coverage.
A risk of product liability claims is inherent in the development and commercialization of human
therapeutic products. Product liability insurance is very expensive and offers limited protection.
A product liability claim against the Company could potentially be greater than the available
coverage and, therefore, have a material adverse effect upon the Company and its financial
condition. Furthermore, a product liability claim could tarnish the Companys reputation, whether
or not such claims are covered by insurance or are with or without merit.
The Companys common share price is volatile and investors could lose money as a result of such
volatility.
The market price of the Companys common shares is subject to volatility. General market conditions
as well as differences between the Companys financial, scientific and clinical results and the
expectations of investors as well as securities analysts can have a significant impact on the
trading price of the Companys common shares. In recent years, the stocks of many biopharmaceutical
companies have experienced extreme price fluctuations, unrelated to the operating performance of
the affected companies. There can be no assurance that the market price of the common shares will
not continue to experience significant fluctuations in the future, including fluctuations that are
unrelated to the Companys performance. The occurrence of any of the above risks and uncertainties
could have a material adverse effect on the price of the common shares.
36 ANNUAL REPORT 2009
Forward-looking information
This annual report and the MD&A contained herein, include certain statements that are considered
forward-looking information within the meaning of applicable securities legislation. This
forward-looking information includes, but is not limited to, information regarding the
commercialization of tesamorelin in the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy, the receipt of royalties related to sales of tesamorelin, the development of
tesamorelin in additional markets, the conclusion of strategic partnerships, and the liquidity
needs to finance the Companys operations. Furthermore, the words will, may, could, should,
outlook, believe, plan, envisage, anticipate, expect and estimate, or the negatives
of these terms or variations of them and the use of the conditional tense as well as similar
expressions denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control, that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties are described under the section Risks and
Uncertainties above.
Although the forward-looking information contained in this MD&A is based upon what the Company
believes are reasonable assumptions, investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking information. Certain assumptions
made in preparing the forward-looking information and the Companys objectives include the
assumption that the FDA will approve tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy, that the Companys business plan will not be
substantially modified and that current relationships with the Companys third-party suppliers of
services and products will remain good.
Consequently, all of the forward-looking information contained in this MD&A are qualified by the
foregoing cautionary statements, and there can be no guarantee that the results or developments
anticipated by the Company will be realized or, even if substantially realized, that they will have
the expected consequences or effects on the Company, its business, financial condition or results
of operation.
Further information on Theratechnologies
Further information on Theratechnologies, including the Companys Annual Information Form, is
available on the SEDAR site at www.sedar.com.
ANNUAL REPORT 2009 37
MANAGEMENTS
REPORT
The consolidated financial statements of Theratechnologies Inc. presented in the following pages
and all information in this annual report are the responsibility of Management and have been
approved by the Board of Directors of the Company.
These financial statements have been prepared by Management in accordance with accounting
principles generally accepted in Canada. They include amounts based on exercise of judgment and on
estimates. Management has established these amounts reasonably to ensure that financial results are
presented accurately in all material respects. The other financial information included in the
annual report is consistent with that of the financial statements.
In order to ensure accuracy and objectiveness of information included in the financial statements,
the Companys Management maintains internal accounting and administrative control systems.
Management is of the opinion that these controls provide reasonable assurance regarding the
adequacy of the accounting records for the preparation of the financial statements and the adequacy
of the recording and safeguarding of assets.
The Board of Directors is responsible for ensuring that Management fulfills its responsibilities
for financial reporting and internal control. The Board carries out this responsibility principally
through its Audit Committee. The Audit Committee is appointed by the Board, and none of its members
is involved in the daily operations of the Company. All the members of this Committee are
financially literate. The Committee meets periodically with Management and the external auditors to
discuss internal controls over the financial reporting process, auditing matters and financial
reporting issues, to satisfy itself that everyone is properly discharging their responsibilities,
and to review the financial statements with the external auditors.
The Committee reports its findings to the Board for consideration when approving the financial
statements for issuance to the shareholders. The Committee also considers, for review by the Board
and approval by the shareholders, the re-appointment of the external auditors.
The financial statements have been audited on behalf of the shareholders by KPMG LLP, the external
auditors, in accordance with Canadian generally accepted auditing standards. The external auditors
have full and free access to the Audit Committee with respect to their findings concerning the
fairness of the financial reporting and the adequacy of internal controls.
|
|
|
|
|
|
YVES ROSCONI
|
|
LUC TANGUAY |
PRESIDENT AND
|
|
SENIOR EXECUTIVE VICE PRESIDENT |
CHIEF EXECUTIVE OFFICER
|
|
AND CHIEF FINANCIAL OFFICER |
|
|
|
MONTRÉAL, CANADA |
|
|
FEBRUARY 10, 2010 |
|
|
38 2009 ANNUAL REPORT
AUDITORS REPORT
TO THE SHAREHOLDERS
We have audited the consolidated balance sheets of Theratechnologies Inc. as at November 30, 2009
and 2008 and the consolidated statements of earnings, comprehensive loss, shareholders equity and
cash flows for the years then ended. These financial statements are the responsibility of the
Companys Management. Our responsibility is to express an opinion on these financial statements
based on our audits.
We conducted our audits in accordance with Canadian generally accepted auditing standards. Those
standards require that we plan and perform an audit to obtain reasonable assurance whether the
financial statements are free of material misstatement. An audit includes examining, on a test
basis, evidence supporting the amounts and disclosures in the financial statements. An audit also
includes assessing the accounting principles used and significant estimates made by Management, as
well as evaluating the overall financial statement presentation.
In our opinion, these consolidated financial statements present fairly, in all material respects,
the financial position of the Company as at November 30, 2009 and 2008 and the results of its
operations and its cash flows for the years then ended in accordance with Canadian generally
accepted accounting principles.
CHARTERED ACCOUNTANTS
MONTRÉAL, CANADA
JANUARY 22, 2010
(EXCEPT FOR NOTE 15 A),
WHICH IS AS OF FEBRUARY 10, 2010)
|
|
|
* |
|
CA Auditor permit no. 14114 |
2009 ANNUAL REPORT 39
CONSOLIDATED
BALANCE SHEETS
NOVEMBER 30, 2009 AND 2008
|
|
|
|
|
|
|
|
|
(in thousands of dollars) |
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
(restated note 2A)) |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
1,519 |
|
|
$ |
133 |
|
Bonds |
|
|
10,036 |
|
|
|
10,955 |
|
Accounts receivable |
|
|
375 |
|
|
|
610 |
|
Tax credits receivable |
|
|
1,666 |
|
|
|
1,784 |
|
Inventories |
|
|
2,225 |
|
|
|
|
|
Research supplies |
|
|
287 |
|
|
|
301 |
|
Prepaid expenses |
|
|
302 |
|
|
|
397 |
|
|
|
|
|
16,410 |
|
|
|
14,180 |
|
|
|
|
|
|
|
|
|
|
Bonds |
|
|
51,807 |
|
|
|
35,249 |
|
Property and equipment (note 4) |
|
|
1,229 |
|
|
|
1,299 |
|
Other assets (note 5) |
|
|
41 |
|
|
|
2,817 |
|
|
|
|
$ |
69,487 |
|
|
$ |
53,545 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
5,901 |
|
|
$ |
7,198 |
|
Current portion of deferred revenues (note 7) |
|
|
6,847 |
|
|
|
|
|
|
|
|
|
12,748 |
|
|
|
7,198 |
|
|
|
|
|
|
|
|
|
|
Deferred revenues (note 7) |
|
|
13,691 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Capital stock (note 6) |
|
|
279,169 |
|
|
|
269,219 |
|
Contributed surplus |
|
|
6,484 |
|
|
|
5,585 |
|
|
|
|
|
|
|
|
|
|
Accumulated other comprehensive income |
|
|
1,282 |
|
|
|
372 |
|
Deficit |
|
|
(243,887 |
) |
|
|
(228,829 |
) |
|
|
|
|
(242,605 |
) |
|
|
(228,457 |
) |
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
43,048 |
|
|
|
46,347 |
|
|
|
|
|
|
|
|
|
|
Commitments (note 9) |
|
|
|
|
|
|
|
|
Subsequent events (note 15) |
|
|
|
|
|
|
|
|
|
|
|
$ |
69,487 |
|
|
$ |
53,545 |
|
|
See accompanying notes to consolidated financial statements.
On behalf of the Board:
|
|
|
|
|
|
|
PAUL POMMIER
|
|
JEAN-DENIS TALON |
DIRECTOR
|
|
DIRECTOR |
40 2009 ANNUAL REPORT
CONSOLIDATED STATEMENTS
OF EARNINGS
YEARS ENDED NOVEMBER 30, 2009 AND 2008
|
|
|
|
|
|
|
|
|
(in thousands of dollars, except per share amounts) |
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
(restated note 2 A)) |
|
Revenues: |
|
|
|
|
|
|
|
|
Royalties, technologies and other (note 7) |
|
$ |
17,468 |
|
|
$ |
214 |
|
Interest |
|
|
2,252 |
|
|
|
2,427 |
|
|
|
|
|
19,720 |
|
|
|
2,641 |
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
22,226 |
|
|
|
35,326 |
|
Tax credits |
|
|
(1,795 |
) |
|
|
(2,111 |
) |
|
|
|
|
20,431 |
|
|
|
33,215 |
|
General and administrative |
|
|
7,149 |
|
|
|
6,185 |
|
Selling and market development |
|
|
2,583 |
|
|
|
3,811 |
|
Patents, amortization and impairment of other assets (note 5) |
|
|
346 |
|
|
|
5,239 |
|
Fees associated with the strategic review process |
|
|
|
|
|
|
2,224 |
|
Fees associated with the Collaboration and Licensing Agreement (note 7) |
|
|
4,269 |
|
|
|
|
|
|
|
|
|
34,778 |
|
|
|
50,674 |
|
|
Operating loss before undernoted item |
|
|
(15,058 |
) |
|
|
(48,033 |
) |
Realized loss on impairment of available-for-sale financial assets (note 11 B)) |
|
|
|
|
|
|
(578 |
) |
|
Net loss |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
|
Basic and diluted loss per share (note 6 C)) |
|
$ |
(0.25 |
) |
|
$ |
(0.85 |
) |
|
Weighted average number of common shares outstanding |
|
|
60,314,309 |
|
|
|
57,415,468 |
|
|
See accompanying notes to consolidated financial statements.
CONSOLIDATED STATEMENTS
OF COMPREHENSIVE LOSS
YEARS ENDED NOVEMBER 30, 2009 AND 2008
|
|
|
|
|
|
|
|
|
(in thousands of dollars) |
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
(restated note 2A))
|
|
Net loss |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
Unrealized gains on available-for-sale financial assets |
|
|
1,039 |
|
|
|
133 |
|
Reclassification adjustment for gains and losses
on available-for-sale financial assets (note 11 B)) |
|
|
(129 |
) |
|
|
572 |
|
|
Comprehensive loss |
|
$ |
(14,148 |
) |
|
$ |
(47,906 |
) |
|
See accompanying notes to consolidated financial statements.
2009 ANNUAL REPORT 41
CONSOLIDATED STATEMENTS
OF SHAREHOLDERS EQUITY
YEARS ENDED NOVEMBER 30, 2009 AND 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
comprehensive |
|
|
|
|
|
|
|
|
|
Capital stock |
|
|
Contributed |
|
|
income |
|
|
|
|
|
|
|
(in thousands of dollars) |
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
(loss) |
|
|
Deficit |
|
|
Total |
|
|
Balance, November 30, 2007 |
|
|
54,531,133 |
|
|
$ |
238,842 |
|
|
$ |
4,807 |
|
|
$ |
(333 |
) |
|
$ |
(177,339 |
) |
|
$ |
65,977 |
|
Changes in accounting policies (note 2 A)) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(941 |
) |
|
|
(941 |
) |
Issuance of share capital (note 6) |
|
|
3,564,291 |
|
|
|
29,899 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,899 |
|
Share issue costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,938 |
) |
|
|
(1,938 |
) |
Exercise of stock options: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash proceeds |
|
|
119,666 |
|
|
|
397 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
397 |
|
Ascribed value |
|
|
|
|
|
|
81 |
|
|
|
(81 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
859 |
|
|
|
|
|
|
|
|
|
|
|
859 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(48,611 |
) |
|
|
(48,611 |
) |
Change in unrealized gains and losses
on available-for-sale financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
705 |
|
|
|
|
|
|
|
705 |
|
|
Balance, November 30, 2008 |
|
|
58,215,090 |
|
|
|
269,219 |
|
|
|
5,585 |
|
|
|
372 |
|
|
|
(228,829 |
) |
|
|
46,347 |
|
Issuance of share capital (note 6) |
|
|
2,214,303 |
|
|
|
9,950 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,950 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
899 |
|
|
|
|
|
|
|
|
|
|
|
899 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(15,058 |
) |
|
|
(15,058 |
) |
Change in unrealized gains and losses
on available-for-sale financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
910 |
|
|
|
|
|
|
|
910 |
|
|
Balance, November 30, 2009 |
|
|
60,429,393 |
|
|
$ |
279,169 |
|
|
$ |
6,484 |
|
|
$ |
1,282 |
|
|
$ |
(243,887 |
) |
|
$ |
43,048 |
|
|
See accompanying notes to consolidated financial statements.
42 2009 ANNUAL REPORT
CONSOLIDATED STATEMENTS
OF CASH FLOW
YEARS ENDED NOVEMBER 30, 2009 AND 2008
|
|
|
|
|
|
|
|
|
(in thousands of dollars) |
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
(restated note 2A))
|
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
Adjustments for: |
|
|
|
|
|
|
|
|
Amortization of property and equipment |
|
|
612 |
|
|
|
625 |
|
Amortization and impairment of other assets |
|
|
|
|
|
|
4,957 |
|
Stock-based compensation |
|
|
899 |
|
|
|
859 |
|
Realized loss on impairment of available-for-sale financial assets |
|
|
|
|
|
|
578 |
|
|
|
|
|
(13,547 |
) |
|
|
(41,592 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Interest receivable on bonds |
|
|
(923 |
) |
|
|
405 |
|
Accounts receivable |
|
|
260 |
|
|
|
(134 |
) |
Tax credits receivable |
|
|
118 |
|
|
|
(366 |
) |
Inventories |
|
|
(2,225 |
) |
|
|
|
|
Research supplies |
|
|
2,765 |
|
|
|
582 |
|
Prepaid expenses |
|
|
95 |
|
|
|
17 |
|
Accounts payable and accrued liabilities |
|
|
(1,424 |
) |
|
|
(1,324 |
) |
Deferred revenues |
|
|
20,538 |
|
|
|
|
|
|
|
|
|
19,204 |
|
|
|
(820 |
) |
|
|
|
|
5,657 |
|
|
|
(42,412 |
) |
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Share issuance |
|
|
9,950 |
|
|
|
30,296 |
|
Share issue costs |
|
|
(8 |
) |
|
|
(1,930 |
) |
|
|
|
|
9,942 |
|
|
|
28,366 |
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Additions to property and equipment |
|
|
(407 |
) |
|
|
(301 |
) |
Acquisition of bonds |
|
|
(29,111 |
) |
|
|
(17,987 |
) |
Disposal of bonds |
|
|
15,305 |
|
|
|
29,889 |
|
|
|
|
|
(14,213 |
) |
|
|
11,601 |
|
|
Net change in cash |
|
|
1,386 |
|
|
|
(2,445 |
) |
Cash, beginning of year |
|
|
133 |
|
|
|
2,578 |
|
|
Cash, end of year |
|
$ |
1,519 |
|
|
$ |
133 |
|
|
See note 11 for supplemental cash flow information.
See accompanying notes to consolidated financial statements.
2009 ANNUAL REPORT 43
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
1. |
|
Organization and business activities |
|
|
The Company, incorporated under Part 1A of the Québec Companies Act, is a Canadian
biopharmaceutical company that discovers and develops novel therapeutic products, with an
emphasis on peptides, for commercialization. The Company targets unmet medical needs in
financially attractive speciality markets where it can retain all or some of the whole or a
part of the commercial rights for its products. |
2. |
|
New accounting policies |
|
A) |
|
ADOPTION OF NEW ACCOUNTING STANDARDS |
|
|
|
Goodwill and intangible assets |
|
|
|
Effective with the commencement of its 2009 fiscal year, the Company adopted the Canadian
Institute of Chartered Accountants (CICA) Handbook Section 3064, Goodwill and
Intangible Assets, which will replace Section 3062, Goodwill and Other Intangible Assets,
and Section 3450, Research and Development Costs. The standard provides guidance on the
recognition of intangible assets in accordance with the definition of an asset and the
criteria for asset recognition, whether these assets are separately acquired or
internally developed. The impact of adopting this standard has been to increase the
opening deficit and to reduce other assets at December 1, 2007 and 2008 by $941 and $599,
respectively, which is the amount of patent costs related to periods prior to these
dates. Furthermore, following the adoption of this standard, patents and amortization of
other assets presented on the consolidated statements of earnings were reduced by $342
for the year ended November 30, 2008. |
|
|
|
|
Inventories |
|
|
|
|
Effective with the commencement of its 2009 fiscal year, the Company adopted CICA Section
3031, Inventories, which replaces Section 3030 and harmonizes the Canadian standards
related to inventories with International Financial Reporting Standards (IFRS). This
Section provides changes to the measurement and more extensive guidance on the
determination of cost, including allocation of overhead; narrows the permitted cost
formulas; requires impairment testing; and expands the disclosure requirements to
increase transparency. As the Company had no inventories on November 30, 2008, the
adoption of this section had no impact on the Companys consolidated financial
statements. |
|
|
|
|
Credit risk and fair value of financial assets and financial liabilities |
|
|
|
|
On January 20, 2009, the Emerging Issues Committee (EIC) of the Accounting Standards
Board (AcSB) issued EIC Abstract 173, Credit Risk and Fair Value of Financial Assets
and Financial Liabilities, which establishes that an entitys own credit risk and the
credit risk of the counterparty should be taken into account in determining the fair
value of financial assets and financial liabilities, including derivative instruments.
EIC 173 is applied retrospectively, without restatement of prior years, to all financial
assets and liabilities measured at fair value in the interim and annual financial
statements for periods ending on or after January 20, 2009. The adoption of EIC 173 did
not have an impact on the consolidated financial statements of the Company. |
44 2009 ANNUAL REPORT
2. |
|
New accounting policies (continued) |
|
A) |
|
ADOPTION OF NEW ACCOUNTING STANDARDS (CONTINUED) |
|
|
|
Financial instruments Disclosures |
|
|
|
In June 2009, the AcSB issued amendments to CICA Handbook Section 3862, Financial
Instruments Disclosures, in order to align with IFRS 7, Financial Instruments:
Disclosures. This Section has been amended to include additional disclosure requirements
about fair value measurements of financial instruments and to enhance liquidity risk
disclosure. The amendments establish a three-tier fair value hierarchy, which prioritizes
the inputs used in measuring fair value. These tiers include: Level 1, defined as
observable inputs such as quoted prices in active markets; Level 2, defined as inputs
other than quoted prices in active markets that are either directly or indirectly
observable; and Level 3, defined as unobservable inputs in which little or no market data
exists, therefore requiring an entity to develop its own assumptions. The amendments apply
to annual financial statements relating to fiscal years ended after September 30, 2009 and
are applicable to the Company as at November 30, 2009. The amended section relates to
disclosure only and did not impact the financial results of the Company. |
|
B) |
|
FUTURE ACCOUNTING CHANGES |
|
|
|
|
Business combinations, consolidated financial statements and non-controlling interests |
|
|
|
The CICA issued three new accounting standards in January 2009: Section 1582, Business
Combinations, Section 1601, Consolidated Financial Statements, and Section 1602,
Non-controlling Interests. The Company is in the process of evaluating the requirements of
the new standards. |
|
|
|
Section 1582 establishes standards for the accounting for a business combination. It
provides the Canadian equivalent to IFRS 3 Business Combinations. The section applies
prospectively to business combinations for which the acquisition date is on or after the
beginning of the first annual reporting period beginning on or after January 1, 2011 and
early application is permitted. |
|
|
|
Section 1601 establishes standards for the preparation of consolidated financial
statements. Section 1602 establishes standards for accounting for a non-controlling
interest in a subsidiary in consolidated financial statements. It is equivalent to the
corresponding provisions of IFRS IAS 27 Consolidated and Separate Financial Statements,
Sections 1601 and 1602, and applies to interim and annual consolidated financial
statements relating to fiscal years beginning on or after January 1, 2011 and early
application is permitted. |
|
|
|
|
International Financial Reporting Standards |
|
|
|
In February 2008, Canadas AcSB confirmed that Canadian generally accepted accounting
principles, as used by publicly accountable enterprises, would be fully converged into
IFRS, as issued by the International Accounting Standards Board (IASB). The changeover
date is for interim and annual financial statements relating to fiscal years beginning on
or after January 1, 2011. As a result, the Company will be required to report under IFRS
for its 2012 interim and annual financial statements. The Company will convert to these
new standards according to the timetable set within these new rules. The Company will
determine at a future date the impact of adopting the standards on its consolidated
financial statements. |
2009 ANNUAL REPORT 45
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
3. |
|
Significant accounting policies |
|
|
|
The consolidated financial statements include the accounts of the Company and its
subsidiaries. All significant intercompany transactions and balances have been eliminated. |
|
|
|
Cash equivalents are restricted to investments that are readily convertible into cash,
having a term to initial maturity not exceeding three months and whose value is not likely
to change significantly. As at November 30, 2009 and 2008, there were no cash equivalents. |
|
|
|
Inventories are stated at the lower of first-in first-out cost or net realizable value.
Inventory costs include the purchase price and other costs directly related to the
acquisition of materials. Inventory costs also include the costs directly related to the
conversion of materials to finished goods, such as direct labour, and a systematic
allocation of fixed and variable production overhead, including manufacturing depreciation
expense. The allocation of fixed production overheads to the cost of inventories is based
on the normal capacity of the production facilities. Normal capacity is the average
production expected to be achieved over a number of periods under normal circumstances. |
|
D) |
|
FINANCIAL ASSETS AND LIABILITIES |
|
|
|
All financial instruments are classified into one of the following five categories: held
for trading, held-to-maturity investments, loans and receivables, available-for-sale
financial assets or other financial liabilities. All financial instruments, including
derivatives, are included in the consolidated balance sheets and are measured at fair
market value, with the exception of loans and receivables, investments held-to-maturity
and other financial liabilities, which are measured at amortized cost. Subsequent
measurement and recognition of changes in fair value of financial instruments depend on
their initial classification. Held-for-trading financial investments are measured at fair
value and all gains and losses are included in net income in the period in which they
arise. Available-for-sale financial instruments are measured at fair value with
revaluation gains and losses included in other comprehensive income until the assets are
removed from the balance sheet or if there is an impairment in fair value of these assets
that is other than temporary. |
|
|
|
Derivative instruments are recorded as either assets or liabilities measured at their fair
value unless exempted from derivative treatment as a normal purchase and sale. Certain
derivatives embedded in other contracts must also be measured at fair value. All changes
in the fair value of derivatives are recognized in earnings unless specific hedge criteria
are met, which requires that a company must formally document, designate and assess the
effectiveness of transactions that receive hedge accounting. |
|
|
|
The Company has classified its bonds and investments in public companies as
available-for-sale financial assets and are measured at fair market value. The Company has
also classified accounts receivable as loans and receivables, and accounts payable and
accrued liabilities as other financial liabilities, and they are measured at amortized
cost. |
46 2009 ANNUAL REPORT
3. |
|
Significant accounting policies (continued) |
|
E) |
|
PROPERTY AND EQUIPMENT |
|
|
|
Property and equipment are stated at cost. Amortization is provided using the following
methods and annual rates/periods: |
|
|
|
|
|
|
|
|
|
Asset |
|
Method |
|
|
Rate/period |
|
|
Computer equipment |
|
Declining balance |
|
|
50 |
% |
Laboratory equipment |
|
Declining balance and straight-line |
|
|
20 5 years |
% |
|
Office equipment and furniture |
|
Declining balance |
|
|
20 |
% |
Leasehold improvements |
|
Straight-line |
|
Term of lease |
|
|
|
|
|
Other assets consist namely of intellectual property and research supplies. |
|
|
|
Intellectual property is amortized over a period of 20 years using the straight-line method. |
|
|
|
Research supplies are purchased in advance in accordance with regulatory requirements to be
used in connection with the Companys clinical trials. Research supplies that are not expected
to be used within one year from the date of the balance sheet are classified as long-term. |
|
G) |
|
IMPAIRMENT OF LONG-LIVED ASSETS |
|
|
|
The Company reviews property and equipment and other long-term assets for impairment whenever
events or changes in circumstances indicate that the carrying value of property and equipment
or assets may not be recoverable. Recoverability of assets to be used is measured by the
comparison of the carrying amount of an asset to estimated undiscounted future cash flows
expected to be generated from the assets. If the carrying amount of an asset exceeds its
estimated future cash flows, an impairment charge is recognized by the amount by which the
carrying value of the asset exceeds its fair value. The fair value against which the asset is
measured may be established based on comparable information or transactions, or any other
method of assessment. |
|
|
|
Revenues from research contracts are recognized when services to be provided are rendered and
all conditions under the terms of the underlying agreement are met. Revenues subject to the
achievement of milestones are recorded only when the specified events have occurred and
collectibility is assured. |
|
|
|
Upfront payments and initial technology access fees are deferred and recognized as revenue on a
systematic basis over the period during which the related products or services are delivered
and all obligations are performed. |
|
|
|
License fees are recorded when conditions and events under the license agreement have occurred
and collectibility is reasonably assured. |
|
|
|
Revenues from a collaboration agreement that includes multiple elements are considered to be a
revenue arrangement with multiple deliverables. Under this type of arrangement, the
identification of separate units of accounting is required and revenue is allocated among the
separate units based on their relative fair values. Payments received under the collaboration
agreement may include upfront payments, milestone payments, research contracts, license fees
and royalties. Revenues for each unit of accounting are recorded as described above. |
|
|
|
Interest income is recognized as earned using the effective interest method. |
2009 ANNUAL REPORT 47
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
3. |
|
Significant accounting policies (continued) |
|
I) |
|
RESEARCH AND DEVELOPMENT |
|
|
|
Research expenditures, net of related research tax credits and grants, are charged to
earnings in the year in which they are incurred. Development expenditures, net of tax
credits, if any, are capitalized when they meet the appropriate criteria for
capitalization in accordance with generally accepted accounting principles. During the
years ended November 30, 2009 and 2008, no development expenditures were capitalized. |
|
J) |
|
STOCK-BASED COMPENSATION AND OTHER STOCK-BASED PAYMENTS |
|
|
|
The Company records stock-based compensation related to employee stock options granted
using the fair value based method estimated using the Black-Scholes model. Under this
method, compensation cost is measured at fair value at the date of grant and is expensed
over the awards vesting period. Stock-based compensation related to non-employee stock
options is based on the fair value of the consideration received, or the fair value of the
equity instrument issued, whichever is more reliably measured. |
|
|
|
Government assistance, consisting of research tax credits and grants, is recorded as a
reduction of the related expense or cost of the asset acquired. Government grants are
recognized when there is reasonable assurance that the Company has met the requirements of
the approved grant program. Research tax credits are recorded when there is reasonable
assurance that they will be realized. |
|
|
|
Foreign denominated monetary assets and liabilities are converted to Canadian dollars at
the rates of exchange prevailing at the balance sheet dates. Other assets and liabilities
are converted to the exchange rates prevailing when the assets were acquired or the
liabilities incurred. Revenues and expenses are converted at the rates prevailing at the
respective transaction date, except for depreciation and amortization which are converted
at the same rates as those used in the translation of the corresponding assets. Foreign
exchange gains and losses are included in the determination of net earnings or net loss. |
|
|
|
The Company uses the asset and liability method of accounting for income taxes. Future
income tax assets and liabilities are recognized in the balance sheet to account for the
future tax consequences attributable to temporary differences between the respective
accounting and taxable value of balance sheet assets and liabilities. As appropriate, a
valuation allowance is recognized to decrease the value of tax assets to an amount that is
more likely than not to be realized. Future income tax assets and income tax liabilities
are measured using income tax rates that are enacted or substantively enacted when the
asset is realized or the liability is settled. The effect of changes in income tax rates
is recognized in the year during which these rates change. |
|
|
|
The earnings per share are determined using the weighted average number of outstanding
shares during the year. |
|
|
|
The treasury stock method is used for the computation of the diluted earnings per share.
Under this method, a number of additional shares, if they are dilutive, are calculated
assuming that the outstanding stock options are exercised, and that the proceeds from the
transactions are used to purchase common shares at the average market price during the
period. |
48 2009 ANNUAL REPORT
3. |
|
Significant accounting policies (continued) |
|
|
|
The preparation of the financial statements in conformity with generally accepted
accounting principles requires Management to make estimates and assumptions that affect the reported amounts of assets
and liabilities and disclosure of contingent assets and liabilities at the date of the
financial statements and the reported amounts of revenues and expenses during the
reporting period. Significant areas requiring the use of Management estimates include
estimating the useful lives and recoverability of long-lived assets, including property
and equipment and other assets, estimating accruals for clinical trial expenses,
estimating stock-based compensation and revenue, as well as assessing the recoverability
of inventories, research tax credits and grants, investments and future income taxes.
Reported amounts and note disclosure reflect the overall economic conditions that are most
likely to occur and anticipated measures to be taken by Management. Actual results could
differ from those estimates. |
4. |
|
Property and equipment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
|
|
|
|
|
|
Accumulated |
|
|
Net book |
|
|
|
Cost |
|
|
amortization |
|
|
value |
|
|
Computer equipment |
|
$ |
874 |
|
|
$ |
617 |
|
|
$ |
257 |
|
Laboratory equipment |
|
|
1,945 |
|
|
|
1,519 |
|
|
|
426 |
|
Office equipment and furniture |
|
|
1,124 |
|
|
|
701 |
|
|
|
423 |
|
Leasehold improvements |
|
|
1,854 |
|
|
|
1,731 |
|
|
|
123 |
|
|
|
|
$ |
5,797 |
|
|
$ |
4,568 |
|
|
$ |
1,229 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
|
|
|
|
|
Accumulated |
|
|
Net book |
|
|
|
Cost |
|
|
amortization |
|
|
value |
|
|
Computer equipment |
|
$ |
682 |
|
|
$ |
500 |
|
|
$ |
182 |
|
Laboratory equipment |
|
|
1,824 |
|
|
|
1,427 |
|
|
|
397 |
|
Office equipment and furniture |
|
|
1,015 |
|
|
|
700 |
|
|
|
315 |
|
Leasehold improvements |
|
|
1,846 |
|
|
|
1,441 |
|
|
|
405 |
|
|
|
|
$ |
5,367 |
|
|
$ |
4,068 |
|
|
$ |
1,299 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
|
|
|
|
|
|
Accumulated |
|
|
Net book |
|
|
|
Cost |
|
|
amortization |
|
|
value |
|
|
Other assets |
|
$ |
41 |
|
|
$ |
|
|
|
$ |
41 |
|
|
2009 ANNUAL REPORT 49
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
5. |
|
Other assets (continued) |
|
|
For the year ended November 30, 2009, research and development expenses include a charge of
$1,377 related to research supplies that were produced in order to obtain stability data and
to validate the production process as required by the U.S. Food and Drug Administration
(FDA). |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
(Restated note 2A)) |
|
|
|
|
|
|
|
|
Accumulated |
|
|
Net book |
|
|
|
Cost |
|
|
amortization |
|
|
value |
|
|
Intellectual property |
|
$ |
7,670 |
|
|
$ |
7,670 |
|
|
$ |
|
|
Research supplies |
|
|
2,751 |
|
|
|
|
|
|
|
2,751 |
|
Other assets |
|
|
66 |
|
|
|
|
|
|
|
66 |
|
|
|
|
$ |
10,487 |
|
|
$ |
7,670 |
|
|
$ |
2,817 |
|
|
|
|
In 2008, the Company conducted an impairment test on the intellectual property included in Other
assets following a review of the development strategy by Management for new products. As a
consequence, the Company wrote off the carrying amount of this intellectual property. The write-off
of $4,571 is included in Patents, amortization and impairment of other assets in the consolidated
statements of earnings. |
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
Authorized in unlimited number and without par value: |
|
|
|
|
|
|
|
|
Common shares |
|
|
|
|
|
|
|
|
Preferred shares issuable in one or more series |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued: |
|
|
|
|
|
|
|
|
60,429,393 common shares (58,215,090 in 2008) |
|
$ |
279,169 |
|
|
$ |
269,219 |
|
|
|
|
2009 |
|
|
|
Under the terms of the agreement with EMD Serono Inc. (EMD Serono), the Company issued 2,179,837
common shares for a cash consideration of $9,854 (see note 7). |
|
|
|
In 2009, the Company received subscriptions in the amount of $96 for the issuance of 34,466 common
shares in connection with its share purchase plan. |
|
|
|
2008 |
|
|
|
On February 13, 2008, the Company completed a public offering for the sale and issue of 3,500,000
common shares for cash proceeds of $29,750. The issuance costs amounted to $1,938. |
|
|
|
In 2008, the Company received subscriptions in the amount of $149 for the issuance of 64,291 common
shares in connection with its share purchase plan. |
|
|
|
All shares were issued for a cash consideration. |
50 2009 ANNUAL REPORT
6. |
|
Capital stock (continued) |
|
|
|
The Company has established a stock option plan under which it can grant to its Directors,
Officers, Employees, Researchers and Consultants non-transferable options for the purchase
of common shares. The exercise date of an option may not be later than 10 years after the
date it is granted. A maximum number of 5,000,000 options can be granted under the plan.
Generally, the options vest at the date of the grant or over a period of 0 to 5 years. On
November 30, 2009, 1,244,834 additional options could be granted by the Company. |
|
|
|
Changes in the number of options outstanding during the past two fiscal years were as
follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average |
|
|
|
|
|
|
|
exercise price |
|
|
|
Options |
|
|
per share |
|
|
Options as at November 30, 2007 |
|
|
2,207,633 |
|
|
$ |
6.32 |
|
Granted |
|
|
111,000 |
|
|
|
7.98 |
|
Exercised |
|
|
(119,666 |
) |
|
|
3.32 |
|
Cancelled |
|
|
(37,167 |
) |
|
|
9.57 |
|
|
Options as at November 30, 2008 |
|
|
2,161,800 |
|
|
|
6.52 |
|
Granted |
|
|
680,500 |
|
|
|
1.83 |
|
Cancelled and expired |
|
|
(176,500 |
) |
|
|
8.34 |
|
|
Options as at November 30, 2009 |
|
|
2,665,800 |
|
|
$ |
5.20 |
|
|
The following table provides stock option information as at November 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding |
|
|
|
Exercisable options |
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
average |
|
|
Weighted |
|
|
|
|
|
|
Weighted |
|
|
|
Number of |
|
|
remaining |
|
|
average |
|
|
Number of |
|
|
average |
|
|
|
options |
|
|
life |
|
|
exercise |
|
|
exercisable |
|
|
exercise |
|
Price range |
|
outstanding |
|
|
(years) |
|
|
price |
|
|
options |
|
|
price |
|
|
$1.20 - $2.00 |
|
|
1,291,508 |
|
|
|
7.57 |
|
|
$ |
1.71 |
|
|
|
742,508 |
|
|
$ |
1.63 |
|
2.01 - 2.75 |
|
|
141,459 |
|
|
|
4.85 |
|
|
|
2.59 |
|
|
|
141,459 |
|
|
|
2.59 |
|
2.76 - 3.75 |
|
|
70,000 |
|
|
|
6.51 |
|
|
|
3.37 |
|
|
|
43,333 |
|
|
|
3.64 |
|
4.61 - 6.00 |
|
|
25,000 |
|
|
|
3.53 |
|
|
|
5.43 |
|
|
|
25,000 |
|
|
|
5.43 |
|
6.01 - 9.00 |
|
|
591,333 |
|
|
|
5.76 |
|
|
|
8.18 |
|
|
|
526,977 |
|
|
|
8.16 |
|
9.01 - 13.50 |
|
|
495,000 |
|
|
|
3.76 |
|
|
|
10.72 |
|
|
|
441,662 |
|
|
|
10.68 |
|
13.51 - 15.30 |
|
|
51,500 |
|
|
|
1.28 |
|
|
|
15.15 |
|
|
|
51,500 |
|
|
|
15.15 |
|
|
|
|
|
2,665,800 |
|
|
|
6.13 |
|
|
$ |
5.20 |
|
|
|
1,972,439 |
|
|
$ |
5.92 |
|
|
|
B) |
|
STOCK-BASED COMPENSATION AND OTHER STOCK-BASED PAYMENTS |
|
|
|
The estimated fair value of the options granted was estimated at the date of grant using the
Black-Scholes option pricing model with the following weighted average assumptions: |
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
Risk-free interest rate |
|
|
1.83 |
% |
|
|
3.36 |
% |
Volatility |
|
|
79.5 |
% |
|
|
70.4 |
% |
Average option life in years |
|
|
6 |
|
|
|
6 |
|
Dividend yield |
|
nil |
|
|
nil |
|
2009 ANNUAL REPORT 51
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
6. |
|
Capital stock (continued) |
|
B) |
|
STOCK-BASED COMPENSATION AND OTHER STOCK-BASED PAYMENTS (CONTINUED) |
|
|
|
The risk-free interest rate is based on the implied yield on a Canadian Treasury
zero-coupon issue with a remaining term equal to the expected term of the option. The
volatility is based solely on historical volatility equal to the expected term of the
option. The average life of the options is estimated considering the vesting period, the
term of the option and the length of time similar grants have remained outstanding in the
past. Dividend yield was excluded from the calculation, since it is the present policy of
the Company to retain all earnings to finance operations and future growth. |
|
|
|
The following table summarizes the weighted average fair value of stock options granted
during the years ended November 30, 2009 and 2008: |
|
|
|
|
|
|
|
|
|
|
|
Number |
|
|
Weighted average |
|
|
|
of options |
|
|
grant-date fair value |
|
|
2009 |
|
|
680,500 |
|
|
$ |
1.26 |
|
2008 |
|
|
111,000 |
|
|
$ |
5.16 |
|
|
|
|
|
The Black-Scholes model, used by the Company to calculate option values, as well as other
accepted option valuation models, were developed to estimate the fair value of freely
tradable, fully transferable options without vesting restrictions, which significantly
differs from the Companys stock option awards. These models also require four highly
subjective assumptions, including future stock price volatility and expected time until
exercise, which greatly affect the calculated values. |
|
C) |
|
DILUTED LOSS PER SHARE |
|
|
|
Diluted loss per share was not presented as the effect of options would have been
anti-dilutive. All options outstanding at the end of the year could potentially dilute
basic earnings per share in the future. |
7. |
|
Collaboration and Licensing Agreement |
|
|
On October 28, 2008, the Company entered into a Collaboration and Licensing Agreement with EMD
Serono, an affiliate of Merck KGaA, of Darmstadt, Germany, regarding the exclusive
commercialization rights of tesamorelin in the United States for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy (the Initial Product).
Theratechnologies retains all tesamorelin commercialization rights outside of the United
States. |
|
|
|
Under the terms of the agreement, the Company is responsible for the development of the
Initial Product up to obtaining marketing approval in the United States. The Company is also
responsible for product production and for the development of a new formulation of the Initial
Product. EMD Serono is responsible for conducting product commercialization activities. |
|
|
|
At the closing of the agreement, on December 15, 2008, the Company received US$30,000
(CAD$36,951) which, includes an initial payment of US$22,000 (CAD$27,097) and US$8,000
(CAD$9,854) as a subscription for common shares in the Company by Merck KGaA at a price of
US$3.67 (CAD$4.52) per share. The Company may receive up to US$215,000, which amount includes
the initial payment of US$22,000, the equity investment of US$8,000, as well as payments based
on the achievement of certain development, regulatory and sales milestones. The Company will
also be entitled to receive increasing royalties on annual net sales of tesamorelin in the
United States, if applicable. |
|
|
|
The initial payment of $27,097 has been deferred and is being amortized over its estimated
service period on a straight-line basis. This period may be modified in the future based on
additional information that may be received by the Company. For the year ended November 30,
2009, an amount of $6,560 related to this transaction was recognized as revenue. At November
30, 2009, the deferred revenues related to this transaction amounted to $20,537. |
52 2009 ANNUAL REPORT
7. |
|
Collaboration and Licensing Agreement (continued) |
|
|
On August 12, 2009, the FDA accepted the New Drug Application (NDA) made by the Company for
tesamorelin. Under the terms of the Companys Collaboration and Licensing Agreement with EMD
Serono, the acceptance of the tesamorelin NDA resulted in a milestone payment of US$10,000
(CAD$10,884). This milestone payment has been recorded in the third quarter of 2009. |
|
|
The Company may conduct research and development for additional indications. Under the
Collaboration and Licensing Agreement, EMD Serono will have the option to commercialize
additional indications for tesamorelin in the United States. If it exercises this option, EMD
Serono will pay half of the development costs related to such additional indications. In such
cases, the Company will also have the right, subject to EMD Seronos agreement, to participate
in the promotion of the additional indications. |
|
|
Details of the components of income taxes are as follows: |
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
Net loss before income taxes |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
Basic income tax rate |
|
|
30.9 |
% |
|
|
31.0 |
% |
|
Computed income tax provision |
|
|
(4,652 |
) |
|
|
(15,069 |
) |
|
|
|
|
|
|
|
|
|
Adjustments to income tax provision resulting from: |
|
|
|
|
|
|
|
|
Impact of decrease in federal tax rates: |
|
|
|
|
|
|
|
|
Decrease in value of future tax assets |
|
|
|
|
|
|
5,910 |
|
Change in valuation allowance |
|
|
|
|
|
|
(5,910 |
) |
Unrecorded potential tax benefit of current year
losses and other deductions |
|
|
4,029 |
|
|
|
17,201 |
|
Non-deductible items and others |
|
|
623 |
|
|
|
(2,132 |
) |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
The tax incidence of temporary differences resulting in significant portions of future income tax assets is as follows: |
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
Future income tax assets: |
|
|
|
|
|
|
|
|
Losses carried forward |
|
$ |
21,490 |
|
|
$ |
16,045 |
|
Unused research and development expenses |
|
|
29,380 |
|
|
|
26,591 |
|
Property and equipment |
|
|
674 |
|
|
|
544 |
|
Share issue costs |
|
|
776 |
|
|
|
1,174 |
|
Intellectual property and patent fees |
|
|
12,307 |
|
|
|
16,248 |
|
Available deductions and other |
|
|
4,187 |
|
|
|
4,183 |
|
|
|
|
|
68,814 |
|
|
|
64,785 |
|
|
|
|
|
|
|
|
|
|
Less valuation allowance |
|
|
(68,814 |
) |
|
|
(64,785 |
) |
|
Net future income tax asset |
|
$ |
|
|
|
$ |
|
|
|
|
|
In estimating the realization of future income tax assets, Management considers whether a portion
or all future tax assets are more likely than not to be realized. Realization of future tax assets
is subject to the generation of future taxable income. |
2009 ANNUAL REPORT 53
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
8. |
|
Future income taxes (continued) |
|
|
As at November 30, 2009, the Company had available the following deductions, losses and
credits: |
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
Provincial |
|
|
Research and development expenses, without time limitation |
|
$ |
103,346 |
|
|
$ |
115,686 |
|
|
|
|
|
|
|
|
|
|
|
Losses carried forward, until: |
|
|
|
|
|
|
|
|
2014 |
|
$ |
9,603 |
|
|
$ |
|
|
2015 |
|
|
275 |
|
|
|
|
|
2027 |
|
|
7,638 |
|
|
|
7,628 |
|
2028 |
|
|
46,316 |
|
|
|
46,271 |
|
2029 |
|
|
21,785 |
|
|
|
18,802 |
|
|
|
|
$ |
85,617 |
|
|
$ |
72,701 |
|
|
|
|
|
|
|
|
|
|
|
Unused tax credits expiring in: |
|
|
|
|
|
|
|
|
|
2023 |
|
$ |
559 |
|
|
|
|
|
2024 |
|
|
1,597 |
|
|
|
|
|
2025 |
|
|
1,863 |
|
|
|
|
|
2026 |
|
|
2,178 |
|
|
|
|
|
2027 |
|
|
3,000 |
|
|
|
|
|
2028 |
|
|
3,328 |
|
|
|
|
|
2029 |
|
|
2,250 |
|
|
|
|
|
|
|
|
$ |
14,775 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
Provincial |
|
|
Share issue costs |
|
$ |
2,732 |
|
|
$ |
2,732 |
|
Excess of tax value of intellectual property
and patent fees over carrying value |
|
|
45,735 |
|
|
|
45,718 |
|
Excess of tax value of property and equipment over carrying value |
|
|
3,121 |
|
|
|
1,785 |
|
|
54 2009 ANNUAL REPORT
|
|
|
The Company rents premises under an operating lease (the Lease) expiring in April 2010.
The Lease was renewed by the Company and the lessor during the 2009 financial year for a
period of 11 years ending April 30, 2021. Under the terms of the Lease, the Company has
also been granted two renewal options for periods of five years each. The minimum payments
required under the terms of the Lease are as follows: |
|
|
|
|
|
2010 |
|
$ |
340 |
|
2011 |
|
|
55 |
|
2012 |
|
|
655 |
|
2013 |
|
|
655 |
|
2014 |
|
|
655 |
|
2015 |
|
|
273 |
|
Thereafter |
|
|
3,943 |
|
|
|
|
$ |
6,576 |
|
|
|
|
|
The Company has committed to pay the lessor for its share of some operating expenses of the
leased premises. This amount has been set at $240 for the year beginning May 1, 2010 and will
be increased by 2.5% annually for the duration of the Lease. |
|
|
|
The lessor will provide the Company an amount of $728 to allow it to undertake leasehold
improvements. |
|
|
|
The Company has issued an irrevocable letter of credit in favour of the lessor in the amount of
$323 which will be cancelled April 30, 2010 under the terms of the Lease renewal, along with a
first rank movable mortgage in the amount of $1,150 covering all the Companys tangible assets
located in the rented premises. This mortgage, however, can be subordinated to those of lending
institutions. |
|
|
B) |
|
LONG-TERM SUPPLY AGREEMENTS |
|
|
|
During and after the year ended November 30, 2009, the Company entered into long-term
procurement agreements with third-party suppliers in anticipation of the commercialization of
tesamorelin. Some of these agreements stipulate an obligation to purchase minimum quantities of
product, subject to certain conditions. |
|
|
C) |
|
CREDIT FACILITY |
|
|
|
The Company has a credit facility available in the amount of $1,800, bearing interest at prime
plus 0.5% and secured by bonds. Under the credit facility, the market value of investments held
must always be equivalent to 150% of amounts drawn under the facility. If the market value
falls below $7,000, the Company will provide the bank with a first rank movable hypothec of
$1,850 on securities judged satisfactory by the bank. |
|
|
|
As at November 30, 2009 and 2008, with the exception of the letter of credit mentioned in A)
above, the credit facility available to the Company was not utilized. |
2009 ANNUAL REPORT 55
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
|
|
In addition to the exclusively held products, the Company has certain exclusive licenses to
market or commercialize intellectual property from research activities assigned to certain
research institutions. Under these licenses, the Company is committed to pay royalties on the
net sales of the products commercialized by the Company, or, if applicable, on the amounts
received from sub-license, subject to the application of the clauses of such agreements. |
11. |
|
Supplemental information |
|
A) |
|
STATEMENT OF CASH FLOWS |
|
|
|
The following transactions were conducted by the Company and did not impact cash flows: |
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
(Restated note 2A)) |
|
|
Additions to property and equipment included in accounts payable and accrued liabilities |
|
$ |
183 |
|
|
$ |
48 |
|
Share issue costs included in accounts payable and accrued liabilities |
|
|
|
|
|
|
8 |
|
|
|
B) |
|
In 2009, the Company reclassified under net earnings an amount of $129 in realized gains on available-for-sale financial
assets previously recorded in accumulated other comprehensive income. |
|
|
|
|
In 2008, the Company reclassified under net earnings an amount of $572 in realized losses on available-for-sale financial
assets previously recorded in accumulated other comprehensive income. The realized loss includes an impairment loss of
$578 related to a decline in value that is other than temporary for stock options held in a publicly-traded company. |
|
|
|
|
On November 30, 2009, the accumulated other comprehensive income was composed of unrealized gains on available-for-sale financial assets of $1,282 (gain of $372 on November 30, 2008). |
|
|
C) |
|
The Company received tax credits of $
1,912 in 2009 ($1,746 in 2008). |
|
|
D) |
|
The following items were included in the determination of the Companys net loss: |
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
(Restated note 2A)) |
|
|
Amortization of property and equipment |
|
$ |
612 |
|
|
$ |
625 |
|
Amortization and impairment of other assets (note 5) |
|
|
|
|
|
|
4,957 |
|
Stock-based compensation |
|
|
899 |
|
|
|
859 |
|
|
56 2009 ANNUAL REPORT
|
|
The Companys objective in managing capital is to ensure a sufficient liquidity position to
finance its research and development activities, general and administrative expenses, working
capital and overall capital expenditures, including those associated with patents. The Company
makes every attempt to manage its liquidity to minimize shareholder dilution. |
|
|
|
To fund its activities, the Company has followed an approach that relies almost exclusively on
the issuance of common equity, as well as proceeds and royalties from technologies following
the closing of the transaction disclosed in note 7. Since inception, the Company has financed
its liquidity needs primarily through public offerings of common shares and private
placements. When possible, the Company tries to optimize its liquidity position by
non-dilutive sources, including investment tax credits, grants, interest income as well as
proceeds and royalties from technologies. |
|
|
|
The Companys policy is to maintain a minimum level of debt. The Company has a line of credit
of $1,800 for its short-term financing needs. As at November 30, 2009, this line of credit has
not been used, with the exception of the letter of credit mentioned in note 9A). |
|
|
|
The capital management objectives remain the same as for the previous fiscal year. |
|
|
|
At November 30, 2009, cash and bonds amounted to $63,362 and tax credits receivable amounted
to $1,666, for a total of $65,028. The Company believes that its cash position will be
sufficient to finance its operations and capital needs for the next year. |
|
|
|
The Companys general policy on dividends is to retain cash to keep funds available to finance
the Companys growth. |
|
|
|
The Company is not subject to any externally imposed capital requirements. |
2009 ANNUAL REPORT 57
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
13. |
|
Financial risk management |
|
|
This note provides disclosures relating to the nature and extent of the Companys exposure to
risks arising from financial instruments, including credit risk, liquidity risk, foreign
currency risk and interest rate risk, and how the Company manages those risks. |
|
|
|
Credit risk is the risk of an unexpected loss if a customer or counterparty to a
financial instrument fails to meet its contractual obligations. The Company regularly
monitors the credit risk exposure and takes steps to mitigate the likelihood of these
exposures resulting in losses. |
|
|
|
Financial instruments other than cash that potentially subject the Company to significant
credit risk consist principally of bonds. The Company invests its available cash in fixed
income instruments from governmental, paragovernmental and municipal bonds ($60,384 as at
November 30, 2009) as well as from corporations with high credit ratings ($1,459 as at
November 30, 2009). As at November 30, 2009, the Company was not exposed to any credit
risk over the carrying amount of the bonds. |
|
|
|
Liquidity risk is the risk that the Company will not be able to meet its financial
obligations as they fall due. The Company manages liquidity risk through the management
of its capital structure and financial leverage, as outlined in note 12. It also manages
liquidity risk by continuously monitoring actual and projected cash flows. The Board of
Directors and/or the Audit Committee reviews and approves the Companys operating and
capital budgets, as well as any material transactions out of the ordinary course of
business. |
|
|
|
The Company has adopted an investment policy in respect of the safety and preservation of
its capital to ensure the Companys liquidity needs are met. |
|
|
|
The instruments are selected with regard to the expected timing of expenditures and
prevailing interest rates. Bonds mature during the following fiscal years: $10,036 in
2010, $15,446 in 2011, $19,716 in 2012, $13,791 in 2013 and $2,854 in 2014. |
|
|
|
The following are the contractual maturities of financial liabilities, as well as the
payments required under the terms of the operating lease, as at November 30, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Carrying |
|
|
Less than |
|
|
1 to |
|
|
More than |
|
|
|
Total |
|
|
amount |
|
|
1 year |
|
|
5 years |
|
|
5 years |
|
|
Accounts payable and accrued liabilities |
|
$ |
5,901 |
|
|
$ |
5,901 |
|
|
$ |
5,901 |
|
|
$ |
|
|
|
$ |
|
|
Operating lease |
|
|
6,576 |
|
|
|
|
|
|
|
340 |
|
|
|
2,020 |
|
|
|
4,216 |
|
|
|
|
$ |
12,477 |
|
|
$ |
5,901 |
|
|
$ |
6,241 |
|
|
$ |
2,020 |
|
|
$ |
4,216 |
|
|
58 2009 ANNUAL REPORT
13. |
|
Financial risk management (continued) |
|
|
|
The Company is exposed to the financial risk related to the fluctuation of foreign
exchange rates and the degree of volatility of those rates. Foreign currency risk is
limited to the portion of the Companys business transactions denominated in currencies
other than the Canadian dollar, primarily revenues from royalties, technologies and other
expenses for research and development incurred in US dollars, euros and pounds sterling
(GBP). The Company does not use derivative financial instruments to reduce its foreign
exchange exposure. |
|
|
|
The Company manages foreign exchange risk by maintaining US cash on hand to support US
forecasted cash outflows for a maximum 12-month period. The Company does not currently
view its exposure to the euro and GBP as a significant foreign exchange risk due to the
limited volume of transactions conducted by the Company in these currencies. |
|
|
|
Exchange rate fluctuations for foreign currency transactions can cause cash flow as well
as amounts recorded in the consolidated statement of earnings to vary from period to
period and not necessarily correspond to those forecasted in operating budgets and
projections. Additional earnings variability arises from the translation of monetary
assets and liabilities denominated in currencies other than the Canadian dollar at the
rates of exchange at each balance sheet date, the impact of which is reported as foreign
exchange gain or loss in the consolidated statement of earnings. Given the Companys
policy on the management of foreign currencies, a sudden change in foreign exchange rates
would not impair or enhance its ability to pay its US dollar denominated obligations. |
|
|
|
The following table provides significant items exposed to foreign exchange as at November
30, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November 30, 2009 |
|
|
(in thousands of Canadian dollars) |
|
US$ |
|
|
EURO |
|
|
GBP |
|
|
Cash |
|
|
1,471 |
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
|
|
|
|
4 |
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
(1,095 |
) |
|
|
|
|
|
|
(25 |
) |
|
Balance sheets elements exposed
to foreign currency risk |
|
|
376 |
|
|
|
4 |
|
|
|
(25 |
) |
|
The following exchange rates applied during the year ended November 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reporting |
|
|
|
Average rate |
|
|
date rate |
|
|
|
November 30, 2009 |
|
|
November 30, 2009 |
|
|
US$ CAD$ |
|
|
1.0594 |
|
|
|
1.0556 |
|
EUR CAD$ |
|
|
1.5808 |
|
|
|
1.5852 |
|
GBP CAD$ |
|
|
1.7597 |
|
|
|
1.7366 |
|
Based on the Companys foreign currency exposures noted above, varying the above foreign exchange
rates to reflect a 5% strengthening of the Canadian dollar would have increased the net loss as
follows, assuming that all other variables remained constant:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of Canadian dollars) |
|
US$ |
|
|
EURO |
|
|
GBP |
|
|
Increased in net loss |
|
|
19 |
|
|
|
|
|
|
|
(1 |
) |
|
An assumed 5% weakening of the Canadian dollar would have had an equal but opposite effect on the
above currencies to the amounts shown above, on the basis that all other variables remain constant.
2009 ANNUAL REPORT 59
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
13. |
|
Financial risk management (continued) |
|
|
|
Interest rate risk is the risk that the fair value or future cash flows of a financial
instrument will fluctuate because of changes in market interest rates. |
|
|
|
Short-term bonds of the Company are invested at fixed interest rates and mature in the
short-term. Long-term bonds are also instruments that bear interest at fixed rates. The
risk that the Company will realize a loss as a result of a decline in the fair value of
its bonds is limited because these investments, although they are available for sale, are
generally held to maturity. The unrealized gains or losses on bonds are recorded in the
accumulated other comprehensive income (loss). |
|
|
|
Based on the value of the Companys short and long-term bonds at November 30, 2009, an
assumed 0.5% decrease in market interest rates would have increased the fair value of
these bonds and the accumulated other comprehensive loss by $620; an assumed increase in
interest rate of 0.5% would have an equal but opposite effect, assuming that all other
variables remained constant. |
|
|
|
Cash bears interest at a variable rate. Accounts receivable, accounts payable and accrued
liabilities bear no interest. |
|
|
|
Based on the value of variable interest-bearing cash during the year ended November 30,
2009 ($5,800), an assumed 0.5% increase in interest rates during such period would have
increased the future cash flow and decreased the net loss by $29; an assumed decrease of
0.5% would have had an equal but opposite effect. |
14. |
|
Financial instruments |
|
A) |
|
CARRYING VALUE AND FAIR VALUE |
|
|
|
The Company has determined that the carrying values of its short-term financial assets and
liabilities, including cash, accounts receivable, as well as accounts payable and accrued
liabilities, approximate their fair value because of the relatively short period to
maturity of the instruments. |
|
|
|
Bonds and investments in public companies are stated at estimated fair value, determined
by inputs that are directly observable (Level 2 inputs). |
|
B) |
|
INTEREST INCOME AND EXPENSES |
|
|
|
Interest income consists of interest earned on cash and bonds. |
|
|
|
General and administrative expenses include a loss on foreign exchange of $635 for the
year ended November 30, 2009 (loss of $247 in 2008). |
60 2009 ANNUAL REPORT
|
A) |
|
SHAREHOLDER RIGHTS PLAN |
|
|
|
On February 10, 2010, the Board of Directors of the Company adopted a shareholder rights
plan (the Plan), effective as of such date. The Plan is designed to provide adequate
time for the Board of Directors, and the shareholders, to assess an unsolicited takeover
bid for Theratechnologies. In addition, the Plan provides the Board of Directors with
sufficient time to explore and develop alternatives for maximizing shareholder value if a
takeover bid is made, as well as provide shareholders with an equal opportunity to
participate in a takeover bid to receive full and fair value for their common shares (the
Common Shares). The Plan, if approved by the shareholders, will expire at the close of
the Companys annual meeting of shareholders in 2013. |
|
|
|
The rights issued under the Plan will initially attach to and trade with the Common Shares
and no separate certificates will be issued unless an event triggering these rights
occurs. The rights will become exercisable only when a person, including any party related
to it, acquires or attempts to acquire 20% or more of the outstanding Common Shares
without complying with the Permitted Bid provisions of the Plan or without approval of
the Board of Directors. Should such an acquisition occur or be announced, each right
would, upon exercise, entitle a rights holder, other than the acquiring person and related
persons, to purchase Common Shares at a 50% discount to the market price at the time. |
|
|
|
Under the Plan, a Permitted Bid is a bid made to all holders of the Common Shares and
which is open for acceptance for not less than 60 days. If at the end of 60 days at least
50% of the outstanding Common Shares, other than those owned by the offeror and certain
related parties have been tendered, the offeror may take up and pay for the Common Shares
but must extend the bid for a further 10 days to allow other shareholders to tender. |
|
B) |
|
GRANTING OF STOCK OPTIONS |
|
|
|
On December 8, 2009, the Company granted 265,000 options at an exercise price of $3.84 per
share and cancelled 19,167 options at a weighted exercise price of $2.38 per share in
connection with its stock option plan. |
|
|
Certain of the 2008 comparative figures have been reclassified to conform with the financial
statement presentation adopted in 2009. |
2009 ANNUAL REPORT 61
MANAGEMENT
YVES ROSCONI, L. PHARM., MBA
President and Chief Executive Officer
LUC TANGUAY, M.SC., CFA
Senior Executive Vice President and Chief Financial Officer
MARIE-NOËL COLUSSI, CA
Vice President, Finance
CHANTAL DESROCHERS, B. PH., MBA
Vice President, Business Development and Commercialization
ANDREA GILPIN, PH.D., MBA
Vice President, Investor Relations and Communications
JOCELYN LAFOND, LL.B., LL.M.
Vice President, Legal Affairs, and Corporate Secretary
CHRISTIAN MARSOLAIS, PH.D.
Vice President, Clinical Research and Medical Affairs
MARTINE ORTEGA, PHARM. D.
Vice President, Compliance and Regulatory Affairs
PIERRE PERAZZELLI, B.SC.
Vice President, Pharmaceutical Development
KRISHNA PERI, PH.D.
Vice President, Research
CORPORATE
INFORMATION
LISTING: Toronto Stock Exchange
SYMBOL: TH
TRANSFER AGENT AND REGISTRAR
Computershare Trust Company of Canada
1500 University Street
Suite 700
Montréal, Québec H3A 3S8
Telephone: 1 800 564-6253
www.computershare.com
AUDITORS
KPMG LLP
BANK
National Bank of Canada
ANNUAL AND SPECIAL MEETING OF SHAREHOLDERS
Thursday, March 25, 2010, at 10:00 a.m.
Centre Mont-Royal
2200 Mansfield Street
Montréal, Québec H3A 3R8
INVESTOR RELATIONS
Andrea Gilpin
Telephone: 514 336-7800, ext. 205
Email: communications@theratech.com
62 2009 ANNUAL REPORT
Design : Cabana Séguin inc.
|
|
|
2310 ALFRED-NOBEL BLVD
MONTRÉAL, QUÉBEC, CANADA H4S 2B4
Telephone: 514 336-7800
Fax: 514 336-7242
www.theratech.com
|
|
|
ex-99.6
Exhibit 99.6
Corrected as at March 8, 2010 ////
MANAGEMENTS DISCUSSION
AND ANALYSIS
The following discussion and analysis provides Managements point of view on the financial
position and the results of operations of Theratechnologies Inc. (Theratechnologies or the
Company), on a consolidated basis for the twelve-month periods ended November 30, 2009 (2009)
and November 30, 2008 (2008). This information is dated February 10, 2010, and should be read in
conjunction with the Audited Consolidated Financial Statements and the accompanying notes. Unless
specified otherwise, the amounts are in Canadian dollars.
The financial information contained in this Managements Discussion and Analysis and in the
Companys Audited Consolidated Financial Statements has been prepared in accordance with Canadian
generally accepted accounting principles (GAAP) except for certain information presented below
under the heading Non-GAAP Measures. The Audited Consolidated Financial Statements and
Managements Discussion and Analysis have been reviewed by the Audit Committee of Theratechnologies
and approved by its Board of Directors.
This Managements Discussion and Analysis contains forward-looking information. Additional
information about the forward-looking information as well as the associated risks and uncertainties
can be found on pages 25 to 37 of the report.
Overview
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company
targets unmet medical needs in financially attractive speciality markets where it can retain all or
some of the commercial rights to its products. Its most advanced compound, tesamorelin, is an
analogue of the human growth hormone releasing factor.
The 2009 financial year began with the closing of the Collaboration and Licensing Agreement with
EMD Serono, Inc. (EMD Serono), an affiliate of Merck KGaA, of Darmstadt, Germany. Under the terms
of this agreement, Theratechnologies received a payment of US $30,000,000 (CAD$36,951,000),
including an initial payment of US$22,000,000 (CAD$27,097,000) from EMD Serono and a subscription
for common shares of Theratechnologies totaling US$8,000,000 (CAD$9,854,000) by Merck KGaA. The
agreement, entered into between the two parties on October 28, 2008, stipulates that
Theratechnologies could receive up to US$215,000,000, including the upfront payment and milestone
payments based on attaining certain development, regulatory and sales objectives. Furthermore,
Theratechnologies will be entitled to receive increasing royalties on annual net sales of
tesamorelin in the United States.
Under the terms of this agreement, the principal responsibility of Theratechnologies was to submit
a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the United States in
order to obtain approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. In the early months of the year, Theratechnologies scientific and
regulatory teams devoted themselves to finalizing the NDA, which was submitted to the FDA on May
29, 2009. In mid-August, the FDA advised Theratechnologies that it had accepted the submission of
the tesamorelin NDA. In accordance with the Collaboration and Licensing Agreement with EMD Serono,
Theratechnologies received a milestone payment of US$10,000,000 (CAD$10,884,000) related to the
acceptance of the NDA submission by the FDA.
As part of the regulatory review currently underway, the FDA asked Theratechnologies to appear at a
public meeting before the Endocrinologic and Metabolic Drugs Advisory Committee in order to obtain
the advice of independent experts on the use of tesamorelin to treat excess abdominal fat in
HIV-infected patients with lipodystrophy. Initially scheduled for February 24, 2010, the meeting
was postponeddue to administrative delays at the FDAuntil a later date that has not yet been
determined.
In parallel with the Companys regulatory activities, Theratechnologies presented additional data
from the Phase 3 clinical program at major scientific conferences, notably the 91st
Annual Meeting of the Endocrine Society (ENDO) in Washington, D.C. and the 11th
International Workshop on Adverse Drug Reactions and Co-morbidities in HIV, in Philadelphia. By way
of background, the 52-week results from the confirmatory Phase 3 clinical trial were announced in
December 2008. As part of its effort to build awareness of the disease, Theratechnologies also
sponsored a symposium entitled Lipohypertrophy: Beyond Body Image at the 12th European
AIDS Conference (EACS) in Cologne, Germany. Finally, the Company began preclinical work in 2009
on a molecule being developed for the treatment of acute kidney failure.
10 //// ANNUAL REPORT 2009
Corrected as at March 8, 2010 ////
With respect to the overall strategy of the Company, Management undertook a review of its
business plan in early 2009. The resulting growth strategy, which was presented at the Annual and
Special Meeting of Shareholders held on March 26, 2009, centers on the development of tesamorelin,
the Companys lead molecule, and is built around three main objectives. The first is to obtain
approval for tesamorelin in HIV-associated lipodystrophy in the United States. Once tesamorelin is
approved, the Company expects to receive increasing royalties and additional milestone payments
from sales of tesamorelin by EMD Serono in the United States. The second objective is to develop
additional markets and conclude partnership agreements outside the United States. Finally, the
Companys third objective is to select and launch clinical programs evaluating tesamorelin for the
treatment of other medical conditions. Together with sound product life-cycle management, this
strategy emphasizing the development of tesamorelin is expected to support the growth of
Theratechnologies for the next few years.
ECONOMIC ENVIRONMENT
For the past two years, the capital markets were characterized by significant stock market
volatility and a notable decline in access to capital across all sectors, particularly
biotechnology. In parallel, an economic slowdown occurred in almost all sectors.
The general decline of capital markets has had a negative effect on the cost of capital for
companies. However, the Company does not envisage raising capital in 2010 because its liquidity
level is sufficient to meet the operating needs of its current business plan.
Theratechnologies investment policy is conservative. The Company invests its funds in highly
liquid, low-risk instruments as described under the heading Liquidity and Capital Resources.
The Company relies on third parties for the manufacture and supply of tesamorelin and it is not
aware of any information suggesting that its principal suppliers will not be able to meet their
financial obligations.
Furthermore, Theratechnologies is relying on its American commercial partner, EMD Serono, to
commercialize tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy. The Company is not aware of any information suggesting that its partner will not be
able to meet its financial obligations.
EXPECTATIONS FOR THE PRESENT FINANCIAL YEAR
The Companys primary objective for the current financial year is the acceptance for marketing
approval in the United States of tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy. Marketing approval could result in the achievement of
regulatory milestones under the Collaboration and Licensing Agreement with EMD Serono. Once
approved, the Company expects to receive royalties from the sale of tesamorelin in the United
States. Furthermore, the Company will continue to collaborate with EMD Serono for the preparation
of the commercialization of tesamorelin.
The Companys second objective is to expand into new territories where tesamorelin could be used
for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. To this end,
during the present financial year, the Company will be seeking third parties having a regulatory
expertise in obtaining marketing approval of new drugs and a commercial expertise in launching new
pharmaceutical products with the intent of entering into strategic alliances with them. Under such
strategic alliance agreements, these third parties would be responsible for obtaining marketing
approval of tesamorelin in one or more territories and commercializing tesamorelin in such
territories.
Concurrently with the seeking of third parties with which to enter into strategic alliance
agreements, the Company will continue to pursue regulatory activities outside of the United States
to advance its application regarding the use of tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy. However, given the Companys primary objective,
the pace at which these activities will progress will depend on the FDAs decision regarding the
Companys NDA as well as on the timing of such decision.
ANNUAL REPORT 2009 //// 11
Corrected as at March 8, 2010 ////
The Companys third objective is to select and begin additional clinical programs once
marketing approval for tesamorelin in the United States for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy is obtained.
Finally, all of the foregoing activities will be carried out in a cost-efficient manner to conserve
the Companys cash position and to manage its burn rate. The Company has sufficient liquidities to
self-finance its activities for the current financial year.
Selected annual information
CONSOLIDATED STATEMENT OF EARNINGS
Years ended November 30
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of dollars, except per share amounts) |
|
2009 |
|
|
2008* |
|
|
2007* |
|
|
Revenues |
|
$ |
19,720 |
|
|
$ |
2,641 |
|
|
$ |
3,134 |
|
Research and development before tax credits |
|
$ |
22,226 |
|
|
$ |
35,326 |
|
|
$ |
31,866 |
|
Operating
loss before realized loss on impairment of available-for-sale financial assets |
|
$ |
(15,058 |
) |
|
$ |
(48,033 |
) |
|
$ |
(37,611 |
) |
Net loss |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
|
$ |
(37,668 |
) |
|
Basic and diluted loss per share |
|
$ |
(0.25 |
) |
|
$ |
(0.85 |
) |
|
$ |
(0.72 |
) |
|
CONSOLIDATED BALANCE SHEET
At November 30
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of dollars) |
|
2009 |
|
|
2008* |
|
|
2007* |
|
|
Liquidities (cash and bonds) |
|
$ |
63,362 |
|
|
$ |
46,337 |
|
|
$ |
60,368 |
|
Tax credits receivable |
|
$ |
1,666 |
|
|
$ |
1,784 |
|
|
$ |
1,418 |
|
Total assets |
|
$ |
69,487 |
|
|
$ |
53,545 |
|
|
$ |
73,649 |
|
Capital stock |
|
$ |
279,169 |
|
|
$ |
269,219 |
|
|
$ |
238,842 |
|
Shareholders equity |
|
$ |
43,048 |
|
|
$ |
46,347 |
|
|
$ |
65,036 |
|
|
|
|
|
* |
|
Information restated following the adoption of the Canadian Institute of
Chartered Accountants (CICA) Handbook Section 3064, Goodwill and Intangible Assets. |
Operating results
NON-GAAP MEASURES
The Company uses measures that do not conform to GAAP to assess its operating performance.
Securities regulators require that companies caution readers that earnings and other measures
adjusted to a basis other than GAAP do not have standardized meanings and are unlikely to be
comparable to similar measures used by other companies. Accordingly, these measures should not be
considered in isolation. The Company uses non-GAAP measures such as adjusted net loss and the
adjusted burn rate from operating activities before changes in operating assets and liabilities, to
measure its performance from one period to the next without including changes caused by certain
items that could potentially distort the analysis of trends in its operating performance, and
because such measures provide meaningful information on the Companys financial condition and
operating results.
12 //// ANNUAL REPORT 2009
Corrected as at March 8, 2010 ////
DEFINITION AND RECONCILIATION OF NON-GAAP MEASURES
In order to measure performance from one period to another, without accounting for changes
related to revenues and fees associated with the Collaboration and Licensing Agreement with EMD
Serono, Management uses adjusted net loss and adjusted burn rate before changes in operating assets
and liabilities. These items are excluded because they affect the comparability of the financial
results and could potentially distort the analysis of trends in the Companys operating
performance. The exclusion of these items does not necessarily indicate that they are
non-recurring.
Adjusted net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of dollars) |
|
Fourth quarter |
|
|
Year |
|
|
|
2009 |
|
|
2008* |
|
|
2009 |
|
|
2008* |
|
|
Net loss, per the financial statements |
|
$ |
(4,698 |
) |
|
$ |
(15,145 |
) |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues associated with a Collaboration and Licensing Agreement
(note 7 to the consolidated financial statements) |
|
|
(1,711 |
) |
|
|
|
|
|
|
(17,444 |
) |
|
|
|
|
Fees associated with a Collaboration and Licensing Agreement |
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
|
|
Adjusted net loss |
|
$ |
(6,409 |
) |
|
$ |
(15,145 |
) |
|
$ |
(28,233 |
) |
|
$ |
(48,611 |
) |
|
Adjusted burn rate from operating activities before changes in operating assets and liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of dollars) |
|
Fourth quarter |
|
|
Year |
|
|
|
2009 |
|
|
2008* |
|
|
2009 |
|
|
2008* |
|
|
Burn rate before changes in operating assets
and liabilities, per the financial statements |
|
$ |
(4,333 |
) |
|
$ |
(9,559 |
) |
|
$ |
(13,547 |
) |
|
$ |
(41,592 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues associated with a Collaboration and Licensing Agreement
(note 7 to the consolidated financial statements) |
|
|
(1,711 |
) |
|
|
|
|
|
|
(17,444 |
) |
|
|
|
|
Fees associated with a Collaboration and Licensing Agreement |
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
|
|
Adjusted burn rate before changes
in operating assets and liabilities |
|
$ |
(6,044 |
) |
|
$ |
(9,559 |
) |
|
$ |
(26,722 |
) |
|
$ |
(41,592 |
) |
|
|
|
|
* |
|
Information restated following the adoption of the CICA Handbook Section 3064,
Goodwill and Intangible Assets. |
REVENUES
Theratechnologies consolidated revenues for the year ended November 30, 2009, were
$19,720,000, compared to $2,641,000 for the same period in 2008. The increased revenues in 2009 are
related to the initial payment received on December 15, 2008, upon the closing of the Collaboration
and Licensing Agreement with EMD Serono, as well as the receipt of a milestone payment of
US$10,000,000 (CAD$10,884,000) during the third quarter of 2009.
The payment of US$30,000,000 (CAD$36,951,000) received upon the closing of the agreement included
an initial payment of
US$22,000,000 (CAD$27,097,000) and a subscription for common shares by Merck KGaA at a price of
US$3.67 (CAD$4.52) per share, resulting in gross proceeds of US$8,000,000 (CAD$9,854,000). The
payment of $27,097,000 has been deferred and is being amortized over its estimated service period
on a straight-line basis. This period may be modified in the future based on additional information
that may be received by the Company. For the year ended November 30, 2009, an amount of $6,560,000
related to this transaction was recognized as revenue. At November 30, 2009, the deferred revenues
related to this transaction recorded on the balance sheet amounted to $20,537,000.
ANNUAL REPORT 2009 //// 13
Corrected as at March 8, 2010 ////
The milestone payment of $10,884,000, received during the third quarter, is associated with the
acceptance by the U.S. FDA to review the NDA for tesamorelin that was submitted by the Company on
May 29, 2009. Under the terms of the Collaboration and Licensing Agreement with EMD Serono, a
milestone payment of US $10,000,000 was associated with the FDAs acceptance to review the NDA for
tesamorelin. All milestone payments, including the aforementioned payment, are recorded as they are
earned, upon the achievement of predetermined milestones specified in the agreement.
For the year ended November 30, 2009, interest revenues were $2,252,000, compared to $2,427,000 for
the same period in 2008. The decrease in interest revenues over the fiscal year is associated with
lower interest rates, which translated to a lower return on investment.
R&D ACTIVITIES
For the year ended November 30, 2009, consolidated research and development (R&D) expenses,
before tax credits, amounted to $22,226,000, compared to $35,326,000 for the same period in 2008,
representing a decrease of 37.1%. The decrease in R&D expenses is due to the conclusion of the
Phase 3 clinical trials evaluating tesamorelin in HIV-associated lipodystrophy, in the first half
of 2009. The R&D expenses incurred in 2009 are mainly related to follow up on the regulatory
filing, notably managing responses to the FDAs questions, a normal part of the review process, and
the preparation for the FDA Advisory Committee meeting as well as preparation for larger-scale
production of tesamorelin. The R&D expenses for 2009 include a non-recurring charge of $1,377,000
associated with research materials produced to obtain stability data and to validate the commercial
production process, as required by the FDA.
The majority of R&D expenses in 2009 were applied to tesamorelin in HIV-associated lipodystrophy.
Based on the current business plan, R&D expenditures should decrease over the year 2010 and should
be approximately 30% lower than in 2009. During the first months of the 2010 financial year, a
large part of the R&D expenses should continue to be related to follow up on the regulatory filing,
as mentioned earlier. Several other projects are included in the R&D budget for 2010, notably
activities related to product life-cycle management for tesamorelin, regulatory activities related
to the development of additional markets outside the United States, as well as the preliminary work
related to the selection of new clinical programs. The R&D budget for 2010 also provides for the
development of an acute renal insufficiency program. The molecule developed by the Company for the
treatment of acute renal insufficiency was identified as a potential program to be developed
internally. The Company intends to complete the ongoing preclinical work before it selects and
begins a clinical program for this molecule.
TAX CREDITS
Tax credits amounted to $1,795,000 for the year ended November 30, 2009, compared to $2,111,000
in 2008. Tax credits represent refundable tax credits obtained from the Québec government. Lower
R&D expenditures in 2009 contributed to the decrease in tax credits.
GENERAL AND ADMINISTRATIVE EXPENSES
For the year ended November 30, 2009, general and administrative expenses were $7,149,000,
compared to $6,185,000 for the same period in 2008. The increased expenses for the year ended
November 30, 2009, are principally due to a higher exchange loss as well as costs associated with
revising the Companys business plan in the first quarter. The exchange losses are due to the
conversion of monetary assets and liabilities denominated in foreign currencies into Canadian
dollar equivalents using rates of exchange in effect on the balance sheet date. These expenses
should decrease slightly in 2010.
14 //// ANNUAL REPORT 2009
Corrected as at March 8, 2010 ////
SELLING AND MARKET DEVELOPMENT EXPENSES
For the year ended November 30, 2009, selling and market development expenses were $2,583,000,
compared to $3,811,000 for the same period in 2008. The decrease in selling and market development
costs is due to the signing of the agreement with EMD Serono for the U.S. commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
Following the signing of this agreement, the sales and market development expenses are principally
composed of business development expenses outside the United States and the costs of managing the
agreement with EMD Serono. These expenses should be maintained at the same level in 2010.
PATENTS, AMORTIZATION AND IMPAIRMENT OF OTHER ASSETS
For the year ended November 30, 2009, patents, amortization and impairment of other assets
amounted to $346,000, compared to $5,239,000, in 2008. In 2008, the Company conducted an impairment
test on the intellectual property of the ExoPep platform following a review of the development
strategy for new products by Management. As a consequence, the Company wrote off the carrying
amount of this intellectual property in 2008. The write-off of $4,571,000 is included in Patents,
amortization and impairment of other assets in the consolidated statement of earnings.
FEES RELATED TO THE STRATEGIC REVIEW PROCESS AND THE COLLABORATION AND LICENSING AGREEMENT
WITH EMD SERONO
In 2009, an amount of $4,269,000 was recognized as a cost associated with the conclusion of the
agreement with EMD Serono described earlier. In 2008, the costs related to the strategic review
amounted to $2,224,000. These costs are essentially composed of fees paid to the various experts
retained to help Management and the Board of Directors.
REALIZED LOSS ON IMPAIRMENT OF AVAILABLE-FOR-SALE FINANCIAL ASSETS
In 2008, the Company incurred an impairment of $578,000 related to stock options held in a
publicly-traded company.
NET RESULTS
Reflecting the changes in revenues and expenses described above, the Company incurred a net
loss, in 2009, of $15,058,000 ($0.25 per share), compared to a net loss of $48,611,000 ($0.85 per
share) for the same period in 2008. For the year ended November 30, 2009, the net loss included
revenue of $17,444,000 and a non-recurring charge of $4,269,000 related to the agreement with EMD
Serono. Excluding these two items, the adjusted net loss (see Non-GAAP Measures) amounted to
$28,233,000, a decrease of 41.9% compared to the same period in 2008. The net loss in 2008 included
the previously described impairment losses totalling $5,149,000.
QUARTERLY FINANCIAL INFORMATION
The selected financial information provided below is derived from the Companys unaudited
quarterly financial statements for each of the last eight quarters. This information has been
restated following the adoption of the CICA Handbook Section 3064, Goodwill and Intangible Assets.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of dollars, except per share amounts) |
|
|
|
|
|
|
2009 |
|
2008 |
|
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Revenues |
|
$ |
2,246 |
|
|
$ |
13,148 |
|
|
$ |
2,317 |
|
|
$ |
2,009 |
|
|
$ |
616 |
|
|
$ |
710 |
|
|
$ |
716 |
|
|
$ |
599 |
|
Net loss
(net earnings) |
|
$ |
(4,698 |
) |
|
$ |
5,824 |
|
|
$ |
(5,430 |
) |
|
$ |
(10,754 |
) |
|
$ |
(15,145 |
) |
|
$ |
(11,220 |
) |
|
$ |
(11,382 |
) |
|
$ |
(10,864 |
) |
Basic and diluted
loss (earnings)
per share |
|
$ |
(0.08 |
) |
|
$ |
0.10 |
|
|
$ |
(0.09 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.20 |
) |
|
As described above, the increased revenues in 2009 are related to the amortization of the
initial payment received at the closing of the agreement with EMD Serono, as well as the milestone
payment of $10,884,000 recorded in August 2009. The increase in the fourth quarter net loss in 2008
is due to an impairment in the value of intellectual property.
ANNUAL REPORT 2009 //// 15
Corrected as at March 8, 2010 ////
Fourth quarter
Consolidated revenues for the three-month period ended November 30, 2009, amounted to
$2,246,000, compared to $616,000 for the same period in 2008. Interest revenue in the fourth
quarter of 2009 amounted to $528,000, compared to $518,000 for the same period in 2008. The
increased revenues for the three-month period ended November 30, 2009, are related to the payment
received on December 15, 2008, upon the closing of the Collaboration and Licensing Agreement with
EMD Serono. This payment of US$30,000,000 (CAD$36,951,000) included an initial payment of
US$22,000,000 (CAD$27,097,000) and a subscription for common shares by Merck KGaA at a price of
US$3.67 (CAD$4.52) per share, resulting in gross proceeds of US$8,000,000 (CAD$9,854,000). The
initial payment of $27,097,000 has been deferred and is being amortized over its estimated service
period on a straight-line basis. This period may be modified in the future based on additional
information that may be received by the Company. For the fourth quarter of 2009, an amount of
$1,711,000 related to this transaction was recognized as revenue.
Consolidated R&D expenses, before tax credits, totalled $4,534,000 for the fourth quarter of 2009,
compared to $6,313,000 for the same period in 2008, representing a decrease of 28.2%. This decrease
in R&D expenses is due to the conclusion of the Phase 3 clinical program evaluating tesamorelin for
the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The R&D expenses
incurred in the fourth quarter of 2009 are mainly related to follow up on the regulatory filing,
notably managing responses to the FDAs questions, a normal part of the review process, and the
preparation for the FDA Advisory Committee meeting as well as preparation for larger-scale
production of tesamorelin.
General and administrative expenses were $1,634,000 in the fourth quarter of 2009, compared to
$1,874,000 for the same period in 2008. The lower expenses for the three-month period ended
November 2009 are associated with a reduction in foreign exchange loss.
Selling and market development costs amounted to $1,067,000 for the fourth quarter of 2009,
compared to $1,124,000 for the same period in 2008. The decrease in selling and market development
costs is due to the signing of the agreement with EMD Serono for the U.S. commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
Since the signing of this agreement, the sales and market development expenses are principally
composed of business development expenses outside the United States and the costs of managing the
agreement with EMD Serono.
Patents, amortization and impairment of other assets amounted to $120,000 for the three months
ended November 30, 2009, compared to $4,727,000 for the corresponding period in 2008. In the fourth
quarter of 2008, the Company conducted an impairment test on the intellectual property of the
ExoPep discovery platform following a review of the development strategy for new products by
Management. As a consequence, the Company wrote off the carrying amount of this intellectual
property in 2008. The impairment of other assets of $4,571,000 is included in Patents,
amortization and impairment of other assets in the consolidated statement of earnings.
In 2008, the Company incurred an impairment of $578,000 related to stock options held in a
publicly-traded company.
Consequently, the Company recorded a net loss for the three-month period ended November 30, 2009,
of $4,698,000 ($0.08 per share), compared to a net loss of $15,145,000 ($0.26 per share) for the
same period in 2008. The fourth quarter net loss includes revenues of $1,711,000 related to the
agreement with EMD Serono. Excluding this item, the adjusted net loss (see Non-GAAP Measures)
amounted to $6,409,000, a decrease of 57.7% compared to the same period in 2008.
In the three months ended November 30, 2009, the burn rate from operating activities, excluding
changes in operating assets and liabilities, was $4,333,000, compared to $9,559,000 for the same
period in 2008. Excluding the revenue of $1,711,000 related to the agreement with EMD Serono, the
adjusted burn rate from operating activities, excluding changes in operating assets and liabilities
(see Non-GAAP Measures), was $6,044,000, a decrease of 36.8%, compared to the corresponding
period in 2008.
16 //// ANNUAL REPORT 2009
Corrected as at March 8, 2010 ////
Liquidity and capital resources
The Companys objective in managing capital is to ensure a sufficient liquidity position to
finance its research and development activities, general and administrative expenses, working
capital and overall capital expenditures, and patents. The Company makes every attempt to manage
its liquidity to minimize shareholder dilution.
To fund its activities, the Company has followed an approach that relies almost exclusively on the
issuance of common equity and proceeds and royalties from technologies following the closing of the
agreement with EMD Serono. Since inception, the Company has financed its liquidity needs primarily
through public offerings of common shares and private placements. When possible, the Company tries
to optimize its liquidity position through non-dilutive sources, including investment tax credits,
grants, interest income as well as proceeds and royalties from technologies.
For the year ended November 30, 2009, the burn rate, represented by cash flows from operating
activities and excluding changes in operating assets and liabilities, was $13,547,000 compared to
$41,592,000 in 2008. The decrease in the 2009 burn rate is principally related to the payments
received under the agreement with EMD Serono as well as the decline in R&D expenditures and in
selling and market development costs. Excluding the revenue of $17,444,000 and the non-recurring
charge of $4,269,000 related to the agreement with EMD Serono, the adjusted burn rate from
operating activities, excluding changes in operating assets and liabilities (see Non-GAAP
Measures), was $26,722,000, a decrease of 35.8%, compared to the corresponding period in 2008.
Based on the current business plan, the adjusted burn rate is expected to amount approximately to
$24,000,000 in 2010. Taking into consideration the liquidity level and the reduced burn rate, the
Company believes that its liquidity position is sufficient to finance its operating activities and
its capital needs over the fiscal year.
Theratechnologies maintained a good liquidity position in 2009. At November 30, 2009, cash and
bonds amounted to $63,362,000 and tax credits receivable amounted to $1,666,000, for a total of
$65,028,000.
It is the policy of the Company to minimize its level of debt. The Company has a line of credit of
$1,800,000 for its short-term financing needs. As at November 30, 2009, this line of credit was not
being used. However, $323,000 of this amount was allocated to secure an irrevocable letter of
credit related to lease commitments on its premises. This letter of credit will be cancelled on
April 30, 2010, under the terms of the lease renewal, described in Contractual obligations.
The Company invests its available cash in highly liquid fixed income instruments from governmental,
municipal and paragovernmental bodies ($60,384,000 at November 30, 2009) as well as from companies
with high credit ratings ($1,459,000 at November 30, 2009).
Under the terms of the agreement with EMD Serono, the Company issued 2,179,837 common shares for a
cash consideration of US$8,000,000 (CAD$9,854,000) during the first quarter. The Company also
received share subscriptions amounting to $96,000 for the issuance of 34,466 common shares in
connection with its share purchase plan.
During the first quarter of 2008, the Company completed a public offering for the sale and issuance
of 3,500,000 common shares for cash proceeds of $29,750,000. Issue costs totalled $1,938,000,
resulting in net proceeds of $27,812,000. In the year ended November 30, 2008, the Company issued
119,666 common shares following the exercise of stock options, for cash proceeds of $397,000. The
Company also received share subscriptions amounting to $149,000 for the issuance of 64,291 common
shares to employees in connection with its share purchase plan.
ANNUAL REPORT 2009 //// 17
Corrected as at March 8, 2010 ////
Contractual obligations
The Company rents premises under an operating lease expiring in April 2010. The lease was
renewed by the Company and the lessor during the 2009 financial year for a period of 11 years
ending April 30, 2021. Under the terms of the lease, the Company has also been granted two renewal
options for periods of five years each. The minimum payments required under the terms of the lease
are as follows:
PAYMENTS REQUIRED BY DUE DATE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than |
|
|
1 to 5 |
|
|
Over |
|
(in thousands of dollars) |
|
Total |
|
|
1 year |
|
|
years |
|
|
5 years |
|
|
Operating lease |
|
$ |
6,576 |
|
|
$ |
340 |
|
|
$ |
2,020 |
|
|
$ |
4,216 |
|
|
The Company has committed to pay the lessor for its share of some operating expenses of the leased
premises. This amount has been set at $240,000 for the year beginning May 1, 2010, and will be
increased by 2.5% annually for the duration of the lease.
The lessor will provide the Company an amount of $728,000 to allow it to undertake leasehold
improvements.
The Company has issued an irrevocable letter of credit in favour of the lessor in the amount of
$323,000 which will be cancelled on April 30, 2010, under the terms of the lease renewal, along
with a first rank movable mortgage in the amount of $1,150,000 covering all of the Companys
tangible assets located in the rented premises. This mortgage, however, can be subordinated to
those of lending institutions.
Furthermore, during and after the year ended November 30, 2009, the Company entered into long-term
procurement agreements with third-party suppliers in anticipation of the commercialization of
tesamorelin. Some of these agreements stipulate an obligation to purchase minimum quantities of
product, subject to certain conditions.
Off-balance sheet arrangements
The Company was not involved in any off-balance sheet arrangements as at November 30, 2009,
with the exception of the lease renewal as described above and an irrevocable letter of credit
issued in the amount of $323,000 related to lease commitments.
Subsequent events
A) |
|
SHAREHOLDER RIGHTS PLAN |
|
|
On February 10, 2010, the Companys Board of Directors adopted a shareholder rights plan
(the Plan), effective as of such date. The Plan is designed to provide adequate time for the
Board of Directors, and the shareholders, to assess an unsolicited takeover bid for
Theratechnologies. In addition, the Plan provides the Board of Directors with sufficient time to
explore and develop alternatives for maximizing shareholder value if a takeover bid is made, as
well as provide shareholders with an equal opportunity to participate in a takeover bid to
receive full and fair value for their common shares (the Common Shares). The Plan, if approved
by the shareholders, will expire at the close of the Companys annual meeting of shareholders in
2013. |
|
|
|
The rights issued under the Plan will initially attach to and trade with the Common Shares and
no separate certificates will be issued unless an event triggering these rights occurs. The
rights will become exercisable only when a person, including any party related to it, acquires
or attempts to acquire 20% or more of the outstanding Common Shares without complying with the
Permitted Bid provisions of the Plan or without approval of the Board of Directors. Should
such an acquisition occur or be announced, each right would, upon exercise, entitle a rights
holder, other than the acquiring person and related persons, to purchase Common Shares at a 50%
discount to the market price at the time. |
18 //// ANNUAL REPORT 2009
Corrected as at March 8, 2010 ////
|
|
Under the Plan, a Permitted Bid is a bid made to all holders of the Common Shares and which
is open for acceptance for not less than 60 days. If at the end of 60 days at least 50% of the
outstanding Common Shares, other than those owned by the offeror and certain related parties
have been tendered, the offeror may take up and pay for the Common Shares but must extend the
bid for a further 10 days to allow other shareholders to tender. |
B) |
|
GRANTING OF STOCK OPTIONS |
|
|
|
On December 8, 2009, the Company granted 265,000 options at an exercise price of $3.84 per
share and cancelled 19,167 options at a weighted exercise price of $2.38 per share in connection
with its stock option plan. |
Financial risk management
This note provides disclosures relating to the nature and extent of the Companys exposure to
risks arising from financial instruments, including credit risk, liquidity risk, foreign currency
risk and interest rate risk, and how the Company manages those risks.
CREDIT RISK
Credit risk is the risk of an unexpected loss if a customer or counterparty to a financial
instrument fails to meet its contractual obligations. The Company regularly monitors the credit
risk exposure and takes steps to mitigate the likelihood of these exposures resulting in losses.
Financial instruments other than cash that potentially subject the Company to significant credit
risk consist principally of bonds. The Company invests its available cash in fixed income
instruments from governmental, paragovernmental and municipal bonds
($60,384,000 as at November 30, 2009) as well as from companies with high credit ratings
($1,459,000 as at November 30, 2009).
As at November 30, 2009, the Company was not exposed to any credit risk over the carrying amount of
the bonds.
LIQUIDITY RISK
Liquidity risk is the risk that the Company will not be able to meet its financial obligations
as they fall due. The Company manages liquidity risk through the management of its capital
structure, as outlined in the section Liquidity and Capital Ressources. It also manages liquidity
risk by continuously monitoring actual and projected cash flows. The Board of Directors and/or the
Audit Committee reviews and approves the Companys operating and capital budgets, as well as any
material transactions out of the ordinary course of business.
The Company has adopted an investment policy in respect of the safety and preservation of its
capital to ensure the Companys liquidity needs are met. The instruments are selected with regard
to the expected timing of expenditures and prevailing interest rates. Bonds mature on November 30
during the following fiscal years: $10,036,000 in 2010, $15,446,000 in 2011, $19,716,000 in 2012,
$13,791,000 in 2013 and $2,854,000 in 2014. The required payments on the contractual maturities of
financial liabilities, as well as the payments required under the terms of the operating lease, as
at November 30, 2009, are presented in note 13B) of the Consolidated Financial Statements.
FOREIGN CURRENCY RISK
The Company is exposed to the financial risk related to the fluctuation of foreign exchange
rates and the degree of volatility of those rates. Foreign currency risk is limited to the portion
of the Companys business transactions denominated in currencies other than the Canadian dollar,
primarily revenues from royalties, technologies and other expenses for research and development
incurred in US dollars, euros and pounds sterling (GBP). The Company does not use derivative
financial instruments to reduce its foreign exchange exposure.
The Company manages foreign exchange risk by maintaining U.S. cash on hand to support U.S.
forecasted cash outflows for a maximum 12-month period. The Company does not currently view its
exposure to the euro and GBP as a significant foreign exchange risk, due to the limited volume of
transactions conducted by the Company in these currencies.
ANNUAL REPORT 2009 //// 19
Corrected as at March 8, 2010 ////
Exchange rate fluctuations for foreign currency transactions can cause cash flow as well as
amounts recorded in the consolidated statement of earnings to vary from period to period and not
necessarily correspond to those forecasted in operating budgets and projections. Additional
earnings variability arises from the conversion of monetary assets and liabilities denominated in
currencies other than the Canadian dollar at the rates of exchange at each balance sheet date, the
impact of which is reported as foreign exchange gain or loss in the consolidated statement of
earnings. Given the Companys policy on the management of foreign currencies, a sudden change in
foreign exchange rates would not impair or enhance its ability to pay its U.S. dollar denominated
obligations.
The following table provides significant items exposed to foreign exchange as at November 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of Canadian dollars) |
|
|
|
|
|
|
|
|
|
November 30, 2009 |
|
|
|
|
$US |
|
|
EUR |
|
|
GBP |
|
|
Cash |
|
|
1,471 |
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
|
|
|
|
4 |
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
(1,095 |
) |
|
|
|
|
|
|
(25 |
) |
|
Balance sheet elements exposed to foreign currency risk |
|
|
376 |
|
|
|
4 |
|
|
|
(25 |
) |
|
The following exchange rates applied during the year ended November 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Reporting |
|
|
|
rate |
|
|
date |
|
|
$US $CAN |
|
|
1.0594 |
|
|
|
1.0556 |
|
EUR $CAN |
|
|
1.5808 |
|
|
|
1.5852 |
|
GBP $CAN |
|
|
1.7597 |
|
|
|
1.7366 |
|
|
Based on the Companys foreign currency exposures noted above, varying the foreign exchange rates
in the preceding table to reflect a 5% strengthening of the Canadian dollar would have increased
the net loss as follows, assuming that all other variables remained constant:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of Canadian dollars) |
|
$US |
|
|
EURO |
|
|
GBP |
|
|
Increase net loss |
|
|
19 |
|
|
|
|
|
|
|
(1 |
) |
|
An assumed 5% weakening of the Canadian dollar would have had an equal but opposite effect on the
foreign currency amounts shown above, on the basis that all other variables remain constant.
INTEREST RATE RISK
Interest rate risk is the risk that the fair value or future cash flows of a financial
instrument will fluctuate because of changes in market interest rates.
Short-term bonds of the Company are invested at fixed interest rates and mature in the short-term.
Long-term bonds are also instruments that bear interest at fixed rates. The risk that the Company
will realize a loss as a result of a decline in the fair value of its bonds is limited because
these investments, although they are available for sale, are generally held to maturity. The
unrealized gains or losses on bonds are recorded in the accumulated other comprehensive income
(loss).
Based on the value of the Companys short and long-term bonds at November 30, 2009, an assumed 0.5%
decrease in market interest rates would have increased the fair value of these bonds and the
accumulated other comprehensive loss by $620,000; an assumed increase in interest rate of 0.5%
would have an equal but opposite effect, assuming that all other variables remained constant.
20 //// ANNUAL REPORT 2009
Corrected as at March 8, 2010 ////
Cash bears interest at a variable rate. Accounts receivable, accounts payable and accrued
liabilities bear no interest.
Based on the value of variable interest-bearing cash during year ended November 30, 2009
($5,800,000), an assumed 0.5% increase in interest rates during such period would have increased
the future cash flow and decreased the net loss by $29,000; an assumed decrease of 0.5% would have
had an equal but opposite effect.
Financial instruments
The Company has determined that the carrying values of its short-term financial assets and
liabilities, including cash, accounts receivable, as well as accounts payable and accrued
liabilities, approximate their fair value because of the relatively short period to maturity of the
instruments.
Bonds and investments in public companies are stated at estimated fair value, determined by prices
quoted on active markets (level 2 inputs see New accounting policies Financial instruments
Disclosures).
Critical accounting estimates
The preparation of financial statements in conformity with GAAP requires Management to make
estimates and assumptions, which affect the reported amounts of assets and liabilities, and
disclosure of contingent assets and liabilities at the date of the financial statements, and the
reported amounts of revenues and expenses during the reporting period. The amounts presented and
the information provided in the notes reflect the range of economic conditions that are most
susceptible to occur and the measures Management intends to take. Actual results could differ from
these estimates. Discussed below are those policies that are judged to be critical and require the
use of judgment in their application.
INVENTORY VALUATION
Our inventory is carried at the lower of First-In-First-Out cost or net realizable value. We
regularly review inventory quantities on hand and record a provision for those inventories no
longer deemed to be fully recoverable. The cost of inventories may no longer be recoverable if
those inventories are slow moving, damaged, if they have become obsolete, or if their selling
prices or estimated forecast of product demand decline. If actual market conditions are less
favorable than previously projected, or if liquidation of the inventory no longer deemed to be
fully recoverable is more difficult than anticipated, additional provisions may be required.
PROPERTY AND EQUIPMENT AND OTHER ASSETS
Property and equipment and other assets are stated at cost. Amortization is provided using
methods and annual rates which are expected to reflect their economic and useful life. On a regular
basis, the Company reviews the estimated useful lives of its property and equipment. Assessing the
reasonableness of the estimated useful lives of property and equipment requires judgement and is
based on currently available information.
IMPAIRMENT OF LONG-TERM ASSETS
The Company reviews its property and equipment and other assets for impairment whenever events
or changes in circumstances indicate that the carrying value of an asset may not be recoverable.
Recoverability of assets to be used is measured by the comparison of the carrying amount of an
asset to estimated undiscounted future cash flows expected to be generated from the asset. If the
carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is
recognized in the amount by which the carrying value of the asset exceeds the fair value of the
asset. Managements judgment regarding the existence of impairment indicators is based on legal
factors, market conditions and operating performance. The fair value against which the asset is
measured may be established based on comparable information or transactions, discounted cash flows
or other methods of assessment depending on the nature of the asset. In estimating future cash
flows, the Company uses its best estimates based on internal plans, which take Management judgment
into consideration. Changes in circumstances, such as technological advances and changes in
business strategy can result in useful lives and future cash flows differing significantly from
estimates. Revisions to the estimated useful lives of property and equipment or future cash flows
constitute a change in accounting estimate and are applied prospectively.
ANNUAL REPORT 2009 //// 21
Corrected as at March 8, 2010 ////
INCOME TAXES
Income taxes are accounted for using the asset and liability method. Future income tax assets
and liabilities are recognized in the balance sheet to account for the future tax consequences
attributable to temporary differences between the respective accounting and taxable value of
balance sheet assets and liabilities. Future income tax assets and income tax liabilities are
measured using the income tax rates that are most likely to apply when the asset is realized or the
liability is settled. The effect of changes in income tax rates is recognized in the year during
which these rates change. As appropriate, a valuation allowance is recognized to decrease the value
of tax assets to an amount that is more likely than not to be realized. In estimating the
realization of future income tax assets, Management considers whether a portion or all future tax
assets is more likely than not to be realized. Realization is subject to future taxable income. As
at November 30, 2009, the Company determined that a tax valuation allowance for the full amount of
future tax assets was necessary. In the event the Company determines that it can realize its tax
assets, it will readjust them for the amount and adjust the income in the period for which such
determination is made.
RESEARCH AND DEVELOPMENT
Research and development expenditures consist of direct and indirect expenses. They are
expensed as they are incurred. The Company accounts for clinical trial expenses on the basis of
work completed which relies on estimates of total costs incurred based on completion of studies, on
the number of patients and other factors. The expenses that are recorded with respect to clinical
trials are reviewed as the trial advances up until its final phase.
STOCK-BASED COMPENSATION AND OTHER STOCK-BASED PAYMENTS
The Company accounts for employee stock options using the fair value based method estimated
using the Black-Scholes model, which requires the use of certain assumptions, including future
stock price volatility and the time interval until the options are exercised. Under this method,
compensation cost is measured at fair value at the date of grant and is expensed over the vesting
period.
GOVERNMENT ASSISTANCE
Government assistance consists of research tax credits and grants and is applied against
related expenses and the cost of the asset acquired. Tax credits are available based on eligible
research and development expenses consisting of direct and indirect expenditures and including a
reasonable allocation of overhead expenses. Grants are subject to compliance with terms and
conditions of the related agreements. Government assistance is recognized when there is reasonable
assurance that the Company has met the requirements of the approved grant program or, with regard
to tax credits, when there is reasonable assurance that they will be realized.
New accounting policies
ADOPTION OF NEW ACCOUNTING STANDARDS
Goodwill and intangible assets
Effective with the commencement of its 2009 fiscal year, the Company adopted the CICA Handbook
Section 3064, Goodwill and Intangible Assets, which will replace Section 3062, Goodwill and Other
Intangible Assets, and Section 3450, Research and Development Costs. The standard provides guidance
on the recognition of intangible assets in accordance with the definition of an asset and the
criteria for asset recognition, whether these assets are separately acquired or internally
developed. The impact of adopting this standard has been to increase the opening deficit and to
reduce other assets at December 1, 2007 and 2008 by $941,000 and $599,000, respectively, which is
the amount of patent costs related to periods prior to these dates. Furthermore, following the
adoption of this standard, patents and amortization of other assets presented in the consolidated
statements of earnings were reduced by $342,000 for the year ended November 30, 2008.
22 //// ANNUAL REPORT 2009
Corrected as at March 8, 2010 ////
Inventories
Effective with the commencement of its 2009 fiscal year, the Company adopted CICA Section 3031,
Inventories, which replaces Section 3030 and harmonizes the Canadian standards related to
inventories with International Financial Reporting Standards (IFRS). This Section provides
changes to the measurement and more extensive guidance on the determination of cost, including
allocation of overhead; narrows the permitted cost formulas; requires impairment testing; and
expands the disclosure requirements to increase transparency. As the Company had no inventories on
November 30, 2008, the adoption of this section had no impact on the Companys consolidated
financial statements.
Credit risk and fair value of financial assets and financial liabilities
On January 20, 2009, the Emerging Issues Committee (EIC) of the Accounting Standards Board
(AcSB) issued EIC Abstract 173,
Credit Risk and Fair Value of Financial Assets and Financial Liabilities, which establishes that an
entitys own credit risk and the credit risk of the counterparty should be taken into account in
determining the fair value of financial assets and financial liabilities, including derivative
instruments. EIC 173 is applied retrospectively without restatement of prior years to all financial
assets and liabilities measured at fair value in interim and annual financial statements for
periods ending on or after January 20, 2009. The adoption of EIC 173 did not have an impact on the
consolidated financial statements of the Company.
Financial instruments Disclosures
In June 2009, the AcSB issued amendments to CICA Handbook Section 3862, Financial Instruments
Disclosures, in order to align with IFRS 7, Financial Instruments: Disclosures. This Section has
been amended to include additional disclosure requirements about fair value measurements of
financial instruments and to enhance liquidity risk disclosure. The amendments establish a
three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These
tiers include: Level 1, defined as observable inputs such as quoted prices in active markets; Level
2, defined as inputs other than quoted prices in active markets that are either directly or
indirectly observable; and Level 3, defined as unobservable inputs in which little or no market
data exists, therefore requiring an entity to develop its own assumptions. The amendments apply to
annual financial statements relating to fiscal years ended after September 30, 2009 and are
applicable to the Company as at November 30, 2009. The amended section relates to disclosure only
and did not impact the financial results of the Company.
FUTURE ACCOUNTING CHANGES
Business combinations, consolidated financial statements and non-controlling interests
The CICA issued three new accounting standards in January 2009: Section 1582, Business
Combinations, Section 1601, Consolidated Financial Statements, and Section 1602, Non-controlling
Interests. The Company is in the process of evaluating the requirements of the new standards.
Section 1582 establishes standards for the accounting for a business combination. It provides the
Canadian equivalent to International Financial Reporting Standard IFRS 3 Business Combinations.
The section applies prospectively to business combinations for which the acquisition date is on or
after the beginning of the first annual reporting period beginning on or after January 1, 2011 and
early application is permitted.
Section 1601 establishes standards for the preparation of consolidated financial statements.
Section 1602 establishes standards for accounting for a non-controlling interest in a subsidiary in
consolidated financial statements. It is equivalent to the corresponding provisions of IFRS IAS 27
- Consolidated and Separate Financial Statements, Sections 1601 and 1602, and applies to interim
and annual consolidated financial statements relating to fiscal years beginning on or after January
1, 2011 and early application is permitted.
ANNUAL REPORT 2009 //// 23
Corrected as at March 8, 2010 ////
International Financial Reporting Standards
In February 2008, Canadas AcSB confirmed that Canadian GAAP, as used by publicly accountable
enterprises, would be fully converged into IFRS, as issued by the International Accounting
Standards Board (IASB). The changeover date is for interim and annual financial statements
relating to fiscal years beginning on or after January 1, 2011. As a result, the Company will be
required to report under IFRS for its 2012 interim and annual financial statements. The Company
will convert to these new standards according to the timetable set within these new rules. The
Company will determine at a future date the impact of adopting the standards on its consolidated
financial statements.
Outstanding share data
At February 9, 2010, the number of shares issued and outstanding was 60,449,225 while
outstanding options granted under the stock option plan were 2,891,801.
Disclosure controls and procedures and internal control over financial
reporting
As at November 30, 2009, an evaluation of the effectiveness of disclosure controls and
procedures, as defined in the rules of the Canadian Securities Administrators, was carried out.
Based on that evaluation, the President and Chief Executive Officer and the Senior Executive
Vice-President and Chief Financial Officer concluded that the design and operating effectiveness of
those disclosure controls and procedures were effective.
Also at November 30, 2009, an evaluation of the effectiveness of internal controls over financial
reporting, as defined in the rules of the Canadian Securities Administrators, was carried out to
provide reasonable assurance regarding the reliability of financial reporting and financial
statement compliance with GAAP. Based on that evaluation, the President and Chief Executive Officer
and the Senior Executive Vice-President and Chief Financial Officer concluded that the design and
operating effectiveness of internal controls over financial reporting were effective.
These evaluations were based on the criteria outlined in the document entitled Internal Control
over Financial Reporting Guidance for Smaller Public Companies published by the Committee of
Sponsoring Organizations of the Treadway Commission, a recognized model, and as per Regulation
52-109 of the Canadian Securities Administrators. A disclosure committee comprised of members of
Senior Management assists the President and Chief Executive Officer and the Senior Executive
Vice-President and Chief Financial Officer in their responsibilities.
All internal control systems, no matter how well designed, have inherent limitations, including the
possibility of human error and the circumvention or overriding of the controls or procedures. As a
result, there is no certainty that disclosure controls and procedures or internal control over
financial reporting will prevent all errors or all fraud. There were no changes in internal
controls over financial reporting that occurred during the year ended November 30, 2009 that have
materially affected, or are reasonably likely to materially affect, internal controls over
financial reporting.
There were no changes in our internal controls over financial reporting that occurred during the
year ended November 30, 2009 that have materially affected, or are reasonably likely to materially
affect, the Companys internal controls over financial reporting.
24 //// ANNUAL REPORT 2009
Corrected as at March 8, 2010 ////
Risks and uncertainties
Investors should understand that the Company operates in a high risk industry. The Company has
identified the following risks and uncertainties that may have a material adverse effect on its
business, financial condition or operating results. Investors should carefully consider the risks
described below before purchasing securities of the Company. The risks described below are not the
only ones the Company faces. Additional risks not presently known to the Company or that the
Company currently believes are immaterial may also significantly impair its business operations.
The Companys business could be harmed by any of these risks.
The commercial success of the Company depends largely on the development and commercialization of
tesamorelin; the failure by the Company to commercialize tesamorelin would have a material adverse
effect on the Company.
The Companys focus has been to advance the development of tesamorelin in which it has invested a
significant portion of its financial resources and time. Although the Company has other peptides,
all are at earlier stages of development.
The ability of the Company to generate revenues in the future is primarily based on the
commercialization of tesamorelin for the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy. In the short-term, these revenues should be primarily derived from the United
States market alone. Although the Company entered into the Collaboration and Licensing Agreement
for the commercialization of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy in the United States, there can be no guarantee that tesamorelin will
be commercialized in this country, or in any other country.
The commercialization of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy will depend on several factors:
|
|
|
receipt of regulatory approvals of tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy from the FDA and other regulatory agencies; |
|
|
|
|
market acceptance of the product by the medical community, patients and third-party payers (such
as governmental health administration authorities and private health coverage insurers); |
|
|
|
|
entering into one or more strategic alliance agreements with one or more partners or
building a marketing and sales force in countries other than the United States to help with the
regulatory approval and/or the marketing and sale of tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy in those countries; |
|
|
|
|
in the United States, the amount of resources used by the Companys commercial partner to
commercialize tesamorelin; |
|
|
|
|
maintaining manufacturing and supply agreements to ensure the availability of commercial
quantities of tesamorelin through validated processes; |
|
|
|
|
the number of competitors in the market; and |
|
|
|
|
protecting the Companys intellectual property and avoiding patent infringement claims. |
The Companys inability to commercialize tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy in the short term in the United States would delay its
capacity to generate revenues and would affect its financial condition and operating results.
ANNUAL REPORT 2009 //// 25
Corrected as at March 8, 2010 ////
The Company does not have the required regulatory approval to commercialize its products and
cannot guarantee that it will obtain such regulatory approval.
The commercialization of the Companys products first requires the approval of the regulatory
agencies in each of the countries where it intends to sell its products. In order to obtain the
required approvals, the Company must demonstrate, following preclinical and clinical studies, the
safety, efficacy and quality of a product. As far as tesamorelin is concerned, the Company focused
its development to treat excess abdominal fat in HIV-infected patients with lipodystrophy and the
first market the Company wishes to penetrate for this treatment is the United States. The rules and
regulations relating to the approval of a new drug are complex and stringent and although the FDA
has accepted the filing of the Companys NDA, there can be no guarantee that the FDA will approve
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
In addition, there can be no guarantee that the Company will be able to obtain the regulatory
approvals of agencies in other countries to sell tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy.
All of the products of the Company are subject to preclinical and clinical studies. If the results
of such studies are not positive, the Company may not be in a position to make any filing to obtain
the mandatory regulatory approval or, even where a product has been filed for approval, it may have
to conduct additional clinical studies or testing on such product until the results support the
safety and efficacy of such product. Such studies are often costly and may also delay a filing or,
where additional studies or testing are required after a filing has been made, the approval of a
product.
While an application for a new drug is under review by a regulatory agency, it is standard for such
regulatory agency to ask questions regarding the application that was submitted. If these questions
are not answered quickly and in a satisfactory manner, the marketing approval of the product
subject to the review and its commercialization could be delayed or, if the questions are not
answered in a satisfactory manner, refused. If tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy is not approved for commercialization in the United
States by the FDA, the capacity of the Company to generate revenues in the short-term will be
hampered and this will have an adverse effect on its financial condition and its operating results.
The obtaining of regulatory approval is subject to the discretion of regulatory agencies.
Therefore, even if the Company obtains regulatory approval from one agency, or succeeds in filing
the equivalent of a NDA in other countries, or has obtained positive results relating to the safety
and efficacy of a product, a regulatory agency may not accept the filing or the results contained
therein as being conclusive evidence of the safety and efficacy of a product in order to allow the
Company to sell the product in its country. A regulatory agency may require that additional tests
on the safety and efficacy of a product be conducted prior to granting approval of a product and
such additional tests may delay the approval of a product, can have a material adverse affect on
the Companys financial condition based on the type of additional tests to be conducted and may not
necessarily lead to the approval of a product.
Although the Company has received a Special Protocol Assessment from the FDA and the Company has
followed it and met the primary medical end-points described therein, there can be no guarantee
that the FDA will approve tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. Even if the FDA approves tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy, there can be no guarantee that other
regulatory agencies will approve tesamorelin for this treatment in their respective countries.
26 //// ANNUAL REPORT 2009
Corrected as at March 8, 2010 ////
Even if the Company obtains regulatory approval for any of its products, regulatory agencies
have the ability to limit the indicated use of a product. Also, the manufacture, marketing and sale
of the products will be subject to ongoing and extensive governmental regulation in the country in
which the Company intends to market its products. For instance, if the Company obtains marketing
approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in the United States, the marketing of tesamorelin will be subject to extensive
regulatory requirements administered by the FDA and other regulatory bodies, such as adverse event
reporting and compliance with all of the FDA marketing and promotional requirements. The
manufacturing facilities for the Companys tesamorelin will also be subject to continuous reviews
and periodic inspections and approval of manufacturing modifications. Manufacturing facilities are
subject to inspections by the FDA and must comply with the FDAs Good Manufacturing Practices
(hereafter GMP) regulations. The failure to comply with any of these post-approval requirements
can result in a series of sanctions, including withdrawal of the right to market a product.
The Company has no control over the timing of the review of its NDA by the FDA.
Although the FDA advised the Company that it had set a date of March 29, 2010 under the
Prescription Drug User Fee Act (United States), more commonly known as PDUFA, by which it targets
to have completed its review of the Companys NDA, there can be no guarantee that such date shall
be met. The Company has no control over the timing of the review of its NDA by the FDA and this
timing could vary based on the FDAs workload, potential review issues contained in the Companys
NDA and other similar factors over which the Company has no control.
Even if tesamorelin is ultimately approved by the FDA, any delay in completing the review of the
Companys NDA will result in a delay in the commercialization of tesamorelin for the treatment of
excess abdominal fat in HIV-infected patients with lipodystrophy and could materially adversely
affect the operating results of the Company and the development of future clinical programs.
The Company is dependent on the Collaboration and Licensing Agreement for the commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
in the United States. This agreement places the commercialization of tesamorelin outside of its
control.
Under the terms of the Collaboration and Licensing Agreement, the Company granted its commercial
partner the exclusive right to commercialize tesamorelin for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy in the United States. Although the agreement contains
provisions governing the commercialization of tesamorelin for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy in the United States, the Companys dependence on its
commercial partner for such purpose subjects it to a number of risks, including:
|
|
|
the exact timing of the launch of tesamorelin in the United States, if approved by the FDA; |
|
|
|
|
the limited control by the Company on the amount and timing of resources that its commercial
partner will be devoting to the commercialization, marketing and distribution of tesamorelin,
which could adversely affect the Companys ability to obtain or maximize its royalty payments; |
|
|
|
|
disputes or litigation that may arise between the Company and its commercial partner, which could
adversely affect the commercialization of tesamorelin in the United States, all of which will
divert the attention of Companys Management and its resources; |
|
|
|
|
its commercial partner not properly defending the Companys intellectual property rights or using
them in such a way as to expose the Company to potential litigation, which could, in both cases,
adversely affect the value of the Companys intellectual property rights; |
|
|
|
|
corporate reorganizations or changes in business strategies of its commercial partner, which
could adversely affect such commercial partners willingness or ability to fulfill its
obligations under the Collaboration and Licensing Agreement; |
|
|
|
|
the termination of the Collaboration and Licensing Agreement, which would adversely affect the
commercialization of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy in the United States. |
ANNUAL REPORT 2009 //// 27
Corrected as at March 8, 2010 ////
The Company relies on third parties for the manufacture and supply of tesamorelin and such
reliance may adversely affect the Company if the third parties are unable to fulfill their
obligations.
The Company does not have the resources, facilities or experience to manufacture its products in
large quantities on its own. The Company relies on third parties to manufacture and supply
tesamorelin for clinical studies and currently intends to rely on third parties to manufacture and
supply large quantities of tesamorelin for commercial sales, if approved by the FDA or other
regulatory agencies.
The Companys reliance on third-party manufacturers exposes it to a number of risks. If third-party
manufacturers become unavailable to the Company for any reason, including as a result of the
failure to comply with GMP regulations, manufacturing problems or other operational failures, such
as equipment failures or unplanned facility shutdowns required to comply with GMP or damage from
any event, including fire, flood, earthquake, business restructuring or insolvency, or, if they
fail to perform their contractual obligations under agreements with the Company, such as failing to
deliver the quantities requested on a timely basis, the Company may be subject to delays in the
manufacturing of tesamorelin and any other peptide. Any delay in the supply of a product could slow
down or interrupt the conduct of clinical trials and, if a product has reached commercialization,
could prevent the supply of the product and accordingly, adversely affect the revenues of the
Company. Under the Collaboration and Licensing Agreement, the Company agreed to act as manufacturer
and supplier of tesamorelin for its commercialization in the United States. Accordingly, any delay
in manufacturing tesamorelin by third-party service providers may have a material adverse effect on
the sales and royalties payable to the Company. In addition, any manufacturing delay or delay in
delivering tesamorelin may result in the Company being in default under the Collaboration and
Licensing Agreement. If the damage to a third-party manufacturer facility is extensive, or, for any
reason, it does not operate in compliance with GMP or is unable or refuses to perform its
obligations under its agreement with the Company, the Company will need to find an alternative
third-party manufacturer. The selection of a third-party manufacturer will be time-consuming and
costly since the Company will need to validate the manufacturing facility of such new third-party
manufacturer. The validation will include an assessment of the capacity of such third-party
manufacturer to produce the quantities that may be requested from time to time by the Company, the
manufacturing process and its compliance with GMP. In addition, the third-party manufacturer will
have to familiarize itself with the Companys technology. Any delay in finding an alternative
third-party manufacturer of a product could result in a shortage of such product, a delay in
clinical study programs and in the filing for regulatory approval of a product and, if a product is
approved for commercialization, a shortage of such a product would result in lost revenue to the
Company.
Market acceptance of the Companys products is uncertain and depends on a variety of factors, some
of which are not under the control of the Company.
The Companys ability to commercialize its products with success will depend on a variety of
factors, including the extent to which reimbursement to patients for the cost of such products and
related treatment will be available from governmental health administration authorities, private
health coverage insurers and other organizations. Obtaining reimbursement approval for a product is
time-consuming and a costly process that could require the Company to provide supporting
scientific, clinical and cost effectiveness data for its use. There can be no guarantee that the
Companys data will be perceived as sufficient for third-party payers to accept to reimburse one of
the Companys products.
The Company has never made an application seeking reimbursement of a drug and must, therefore, rely
in part on third-party service providers or experienced partners to help it perform this task.
28 //// ANNUAL REPORT 2009
Corrected as at March 8, 2010 ////
Other factors that will have an impact on the acceptance of the Companys products
include:
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acceptance of a product by physicians and patients as safe and effective
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product price; |
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the effectiveness of the Companys sales and marketing efforts (or those of its commercial
partners); |
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storage requirements and ease of administration; |
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dosing regimen; |
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safety and
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prevalence and severity of side effects; and |
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competitive products. |
The Companys financial condition could be affected by the introduction of new regulations or
amendments to existing regulations.
New regulations or changes to existing regulations affecting the Company and its potential
customers could decrease demand for the Companys products and affect its operating results and
financial condition. For example, the implementation of health care reform legislation that
regulates drug costs could limit the profits that can be made from the development of new drugs. In
addition, new laws or regulations could increase the Companys costs.
The Company must complete several preclinical and clinical studies for its products which may not
yield positive results and, consequently, could prevent it from obtaining regulatory approval.
Obtaining regulatory approval for the commercialization of drug products requires a demonstration
through preclinical and clinical studies that the drug is safe and effective. All of the Companys
molecules are in preclinical studies, except tesamorelin for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy, which is now under regulatory review at the FDA.
Tesamorelin is also being used in the Phase 2 studies conducted by the MGH and the University of
Washington. For the other molecules, and for tesamorelin in Phase 2 NIH studies, there could remain
preclinical and clinical studies to be conducted prior to determining whether such molecules will
show positive results of safety and efficacy.
If any of those studies are not positively conclusive or result in adverse patient reactions, this
may require the Company to extend the term of its studies, to increase the number of patients
enrolled in a given study or to undertake ancillary testing. Any of these events could increase the
cost of conducting clinical studies, delay the filing of an application for marketing approval with
regulatory agencies or result in the termination of a study and, accordingly, abandoning the
commercialization of a molecule. In addition, the growth of the Company could be compromised since
there can be no guarantee that the Company will be able to develop new molecules, license or
purchase compounds or products that will result in marketed products.
ANNUAL REPORT 2009 //// 29
Corrected as at March 8, 2010 ////
The Company relies on third-party service providers to conduct its preclinical and clinical
studies and respond to the FDAs questions regarding the Companys NDA submission. The failure by
one of these third parties to comply with their obligations may delay the studies, have an adverse
effect on the Companys development program and/or delay the commercialization of tesamorelin for
the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
The Company has limited human resources to conduct preclinical and clinical studies and must rely
on third-party service providers to conduct its studies and carry out certain data gathering and
analyses. If the Companys third-party service providers become unavailable for any reason,
including as a result of the failure to comply with the rules and regulations governing the conduct
of preclinical and clinical studies, operational failures such as equipment failures or unplanned
facility shutdowns, or damage from any event such as fire, flood, earthquake, business
restructuring or insolvency or, if they fail to perform their contractual obligations pursuant to
the terms of the agreements entered into with the Company, such as failing to do the testing,
compute the data or complete the reports further to the testing, the Company may incur delays in
connection with the planned timing of its studies which could adversely affect the timing of the
development program of a molecule or the filing of an application for marketing approval in a
jurisdiction where the Company relies on third-party service provider to make such filing. In
addition, where the Company relies on such third-party service provider to help in answering any
question raised by a regulatory agency during its review of a Company file, the unavailability of
such third-party service provider may adversely affect the timing of the review of an application
and, could ultimately delay the approval. If the damages to any of the Companys third-party
service providers are material, or, for any reason, such providers do not operate in compliance
with GLP or are unable or refuse to perform their contractual obligations, the Company would need
to find alternative third-party service providers.
If the Company must change or select new third-party service providers, the planned working
schedule related to preclinical and/or clinical studies could be delayed since the number of
competent and reliable third-party service providers of preclinical and clinical work in compliance
with GLP is limited. In addition, if the Company must change or select new third-party service
providers to carry out work in response to a regulatory agency review of a Companys application,
there may occur delays in responding to such regulatory agency which, in turn, may lead to delays
in commercializing a product.
Any selection of new third-party service providers to carry out work related to preclinical and
clinical studies would be time-consuming and would result in additional delays in receiving data,
analysis and reports from such third-party service providers which, in turn, would delay the filing
of any new drug application with regulatory agencies for the purposes of obtaining regulatory
approval to commercialize the Companys products. Furthermore, such delays could increase the
Companys expenditures to develop a product and materially adversely affect its financial condition
and operating results.
The conduct of clinical trials requires the enrollment of patients and difficulties in enrolling
patients could delay the conduct of the Companys clinical trials or result in their
non-completion.
The conduct of clinical trials by the Company requires the enrollment of patients. Depending on the
phase of the trials and/or the type of trials which must be conducted, the number of patients may
vary. Phase 1 and Phase 2 trials generally require a smaller number of patients than Phase 3
trials.
The Company may have difficulties enrolling patients for the conduct of its clinical trials as a
result of design protocol, the size of the patient population, the eligibility criteria to
participate in the clinical trials, the availability of competing therapies, the patient referral
practices of physicians and the availability of clinical trial sites. The Companys difficulty in
enrolling patients for its clinical trials could result in the cancellation of clinical trials or
delays in completing them. Any of these events would have adverse consequences on the timely
development of new products, the filing of an NDA, or its equivalent, with regulatory agencies and
the commercialization of the Companys products. Such events would adversely affect the business,
the financial condition and operating results of the Company.
30 //// ANNUAL REPORT 2009
Corrected as at March 8, 2010 ////
The Companys capacity to generate revenues may be limited by governmental control over the
pricing of prescription drugs.
In some countries, the pricing of prescription drugs is subject to governmental control. In some of
these countries, pricing negotiations with governmental authorities and reimbursement structures
may delay the marketing of a product. If reimbursement of the Companys products is unavailable or
limited in scope or amount, or if pricing is set at unsatisfactory levels, the revenues of the
Company could be adversely affected.
The Company must enter into strategic alliance agreements with third parties for the sale and
marketing of its products and there is no guarantee that the Company will be able to achieve these
tasks.
Although the Company was successful in finding a third party for the commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
in the United States and although the Company has ongoing discussions with third parties with the
aim of entering into strategic alliance agreements with such third parties to commercialize
tesamorelin outside of the United States, the conclusion of an agreement with a party is a lengthy
process which includes, among other things, an analysis of the capacity of the third party, the
assessment of the services to be performed by the third party, due diligence on the Companys
products and the negotiation of the terms and conditions of the agreement. The outcome of this
process is uncertain and the Company may not be able to conclude any other strategic alliance
agreements for the commercialization of its products, including the commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
in territories other than the United States. The commercialization of the Companys products may be
delayed if it is unable to find third parties to commercialize its products and this could
adversely materially affect the financial condition and the operating results of the Company. Even
if the Company enters into strategic alliance agreements with third parties for the
commercialization of its products, those agreements often contain termination provisions which, if
exercised, could delay the commercialization of its products given that the Company has no sales
force. If the Company does not succeed in entering into a strategic alliance agreement for a
particular territory, it would then not succeed in commercializing the product in such a territory.
In such an event, the Company may decide to commercialize the product itself in that territory and
the Company has no experience in commercializing a product in any market.
The Companys intent to possibly retain the commercial rights of its products for Canada implies
that it would market and sell the product itself on the Canadian market. However, the Company
currently has limited marketing capabilities and it has limited experience in developing, training
or managing a sales force. The development of a sales force would be costly and would be
time-consuming given the limited experience the Company has in this area. To the extent the Company
develops a sales force, the Company could be competing against companies that have more experience
in managing a sales force than the Company has and that have access to more funds than the Company
with which to manage a sales force. Consequently, there can be no guarantee that a sales force
which the Company develops would be efficient and would maximize the revenues derived from the sale
of a Company product.
ANNUAL REPORT 2009 //// 31
Corrected as at March 8, 2010 ////
The failure by the Company to protect its intellectual property may have a material adverse
effect on its ability to develop and commercialize its products.
The Company will be able to protect its intellectual property rights from unauthorized use by third
parties only to the extent that its intellectual property rights are covered by valid and
enforceable patents or are effectively maintained as trade secrets. The Company tries to protect
its intellectual property position by filing patent applications related to its proprietary
technology, inventions and improvements that are important to the development of its business.
Because the patent position of pharmaceutical companies involves complex legal and factual
questions, the issuance, scope and enforceability of patents cannot be predicted with certainty.
Patents, if issued, may be challenged, invalidated or circumvented. If the Companys patents are
invalidated or found to be unenforceable, it would lose the ability to exclude others from making,
using or selling the inventions claimed. Moreover, an issued patent does not guarantee the Company
the right to use the patented technology or commercialize a product using that technology. Third
parties may have blocking patents that could be used to prevent the Company from developing its
product candidates, selling its products or commercializing its patented technology. Thus, patents
that the Company owns may not allow it to exploit the rights conferred by its intellectual property
protection. The Companys pending patent applications may not result in patents being issued. Even
if issued, they may not be issued with claims sufficiently broad to protect its products and
technologies or may not provide the Company with a competitive advantage against competitors with
similar products or technologies. Furthermore, others may independently develop products or
technologies similar to those that the Company has developed or discover the Companys trade
secrets. In addition, the laws of many countries do not protect intellectual property rights to the
same extent as the laws of Canada and the United States, and those countries may also lack adequate
rules and procedures for defending intellectual property rights effectively.
Although the Company has received a patent from the USPTO for the treatment of HIV-related
lipodystrophy with tesamorelin, there can be no guarantee that the Company will receive a patent in
the other countries where it filed patent applications for the treatment of HIV-related
lipodystrophy.
The Company also relies on trade secrets, know-how and technology, which are not protected by
patents, to maintain its competitive position. The Company tries to protect this information by
entering into confidentiality undertakings with parties who have access to such confidential
information, such as the Companys current and prospective suppliers, employees and consultants.
Any of these parties may breach the undertakings and disclose confidential information to the
Companys competitors.
Enforcing a claim that a third party illegally obtained and is using trade secrets is expensive and
time-consuming and the outcome is unpredictable. In addition, it could divert Managements
attention from the Companys business. If any trade secret, know-how or other technology not
protected by a patent were to be disclosed to or independently developed by a competitor, the
Companys competitive position could be harmed.
The Companys ability to defend against infringement by third parties of its intellectual property
in the Unites States with respect to tesamorelin for the treatment of HIV-related lipodystrophy
depends, in part, on its commercial partners decision to bring an action against such third party.
Under the terms and conditions of the Collaboration and Licensing Agreement, the Companys
commercial partner has the first right to bring an action against a third party infringing on the
Companys intellectual property with respect to tesamorelin for the treatment of HIV-related
lipodystrophy. Any delay in pursuing such action or in advising the Company that it does not intend
to pursue the matter could decrease sales, if any, of tesamorelin for the treatment of HIV-related
lipodystrophy and adversely affect the Companys revenues.
32 //// ANNUAL REPORT 2009
Corrected as at March 8, 2010 ////
The Companys commercial success depends, in part, on its ability not to infringe on third
parties patents and other intellectual property rights.
The Companys capacity to commercialize its products, and more particularly tesamorelin, will
depend, in part, on the non-infringement of third parties patents and other intellectual property
rights. The biopharmaceutical and pharmaceutical industries have produced a multitude of patents
and it is not always easy for participants, including the Company, to determine which patents cover
various types of products or methods of use. The scope and breadth of patents is subject to
interpretation by the courts and such interpretation may vary depending on the jurisdiction where
the claim is filed and the court where such claim is litigated. The holding of patents by the
Company for tesamorelin and its application in HIV-related lipodystrophy does not guarantee that
the Company is not infringing on other third-party patents and there can be no guarantee that the
Company will not be in violation of third-party patents and other intellectual property rights.
Patent analysis for non-infringement is based in part on a review of publicly available databases.
Although the Company reviews from time to time certain databases to conduct patent searches, it
does not have access to all databases. It is also possible that some of the information contained
in the databases has not been reviewed by the Company or was found to be irrelevant at the time the
searches were conducted. In addition, because patents take years to be issued, there may be
currently pending applications that the Company is unaware of, which may later be issued. As a
result of the foregoing, there can be no guarantee that the Company will not violate third-party
patents.
Because of the difficulty in analyzing and interpreting patents, there can be no guarantee that a
third party will not assert that the Company infringes upon any of such third-partys patents or
any of its other intellectual property rights. Under such circumstances, there is no guarantee that
the Company would not become involved in litigation. Litigation with any third party, even if the
allegations are without merit, is expensive, time-consuming and would divert Managements attention
from the daily execution of the Companys business plan. Litigation implies that a portion of the
Companys financial assets would be used to sustain the costs of litigation instead of being
allocated to further the development of its business plan.
If the Company is involved in a patent infringement litigation, it would need to demonstrate that
its products do not infringe the patent claims of the relevant patent, that the patent claims are
invalid or that the patent is unenforceable. If the Company was to be found liable for infringement
of third-party patents or other intellectual property rights, the Company could be required to
enter into royalty or licensing agreements on terms and conditions that may not be favourable to
the Company, and/or pay damages, including up to treble damages (but only if found liable of wilful
infringement) and/or cease the development and commercialization of its products. Any finding that
the Company is guilty of patent infringement could materially adversely affect the business,
financial condition and operating results of the Company.
The Company has not been served with any notice that it is infringing on a third-party patent, but
there may be issued patents that the Company is unaware of that its products may infringe, or
patents that the Company believes it does not infringe but could be found to be infringing. The
Company has reviewed, and is aware of, third-party patents for the reduction of accumulation of
abdominal fat tissue in HIV patients and the Company believes that it does not infringe any valid
claims of these patents.
The Company faces competition and the development of new products by other companies could
materially adversely affect the Companys business and its products.
The biopharmaceutical and pharmaceutical industries are highly competitive and the Company must
compete with pharmaceutical companies, biotechnology companies, academic and research institutions
as well as governmental agencies for the development and commercialization of products. Although
the Company believes that it has few direct competitors for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy, it could face indirect competition.
ANNUAL REPORT 2009 //// 33
Corrected as at March 8, 2010 ////
In the other clinical programs currently being evaluated by the Company for development, there
may exist companies that are at a more advanced stage of developing a product to treat the diseases
for which the Company is evaluating clinical programs. Some of these competitors could have access
to capital resources, research and development personnel and facilities that are superior to those
of the Company. In addition, some of these competitors could be more experienced than the Company
in the commercialization of medical products and already have a sales force in place to launch new
products. Consequently, they may be able to develop alternative forms of medical treatment which
could compete with the products of the Company and could be commercialized more rapidly and
effectively than the products of the Company.
The Companys business may be harmed if it is unable to manage its growth effectively.
The Company expects to experience rapid growth throughout its operations if tesamorelin is
commercialized. Such growth would place a strain on operational, human, and financial resources. To
manage its growth, the Company will have to further develop its operating and administrative
systems and attract and retain qualified Management, professional, scientific, and technical
operating personnel.
There can be no guarantee that the Company will be successful in developing such systems and
attracting and retaining qualified personnel. Failure to manage growth effectively could have an
adverse effect on the Companys business, financial condition and operating results.
The Company depends on its key personnel to research, develop and bring new products to the market
and the loss of key personnel or the inability to attract highly qualified individuals could have a
material adverse effect on its business and growth potential.
The Companys mission is to discover or acquire novel therapeutic products targeting unmet medical
needs in financially attractive specialty markets. The achievement of this mission requires
qualified scientific and management personnel. The loss of scientific personnel or of members of
Management could have a material adverse effect on the business of the Company. In addition, the
Companys growth is and will continue to be dependent, in part, on its ability to retain and hire
qualified personnel. There can be no guarantee that the Company will be able to continue to retain
its current employees or will be able to attract qualified personnel to pursue its business plan.
The Company is not profitable and may never achieve profitability.
For the financial year ended November 30, 2009, the Company reported losses of $15,058,000. The
Company has been reporting losses since its inception (except for the financial years ended
November 30, 2001 and 2000) and, as at November 30, 2009, it had an accumulated deficit of
$243,887,000. The Company does not expect to generate significant recurrent revenues in the
immediate future and will continue to experience losses as it continues its efforts to obtain
regulatory approvals for tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy in the United States and other countries. As a result of the foregoing,
the Company will need to generate significant revenues to achieve profitability.
The Companys profitability will depend on its capacity (i) to obtain regulatory approval for the
use of tesamorelin in the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in the United States and on the capacity of its commercial partner to commercialize
tesamorelin for such indication and (ii) to expand the commercialization of tesamorelin in other
territories. However, there is no guarantee that the Company will succeed in commercializing any of
its products (including tesamorelin) and, accordingly, the Company may never become profitable.
34 //// ANNUAL REPORT 2009
Corrected as at March 8, 2010 ////
The Company may require additional funding and may not be able to raise the capital necessary
to continue and complete the research and development of its products and their commercialization.
Although the Company has enough funding to support its current business plan, the Company does not
generate significant revenues and may need financing in order to sustain its growth, to continue
its research and development of new products and clinical programs, to develop its marketing and
commercial capabilities and to meet its compliance obligations with various rules and regulations
to which it is subject. In the past, the Company has been financed through public equity offerings
and the Company may effect additional equity offerings to raise capital, the size of which cannot
be predicted. The issuance and sale of substantial amounts of equity, or other securities, or the
perception that such issuances and sales may occur could adversely affect the market price of the
common shares.
Moreover, the market conditions or the business performance of the Company may prevent the Company
from having access to the public market in the future. Therefore, there can be no guarantee that
the Company will be able to continue to raise capital by way of public equity offerings. In such a
case, the Company will have to use other means of financing, such as issuing debt instruments or
entering into private financing agreements, the terms and conditions of which may not be favourable
to the Company. If adequate funding is not available to the Company, it may be required to delay,
reduce, or eliminate its research and development of new products, its clinical trials or its
marketing and commercialization efforts to launch and distribute new products.
The Company may not receive the full payment of all milestones or royalty payments pursuant to the
agreements entered into with third parties and, consequently, the financial condition and operating
results of the Company could be adversely impacted.
The Company has entered into license agreements and other forms of agreements with third parties
regarding the development and commercialization of some of its products. These agreements generally
require that the third party pays to the Company certain amounts upon the attainment of various
milestones and royalties on the sales of the developed product. There can be no guarantee that the
Company will receive the payments described in those agreements since the development of products
may be cancelled if the research does not yield positive results. Under such circumstances, the
Company would also not receive royalties. Even if the development of a product yields positive
results, all of the risks described herein with respect to the obtaining of regulatory approval are
applicable. Finally, if there occurs a disagreement between the Company and the third party, the
payment relating to the attainment of milestones or of royalties may be delayed. The occurrence of
any of those circumstances could have a material adverse effect on the Companys financial
condition and operating results.
The Company may not achieve its publicly announced milestones on time.
From time to time, the Company publicly announces the timing of certain events to occur. These
statements are forward-looking and are based on the best estimate of Management relating to the
occurrence of such events. However, the actual timing of such events may differ from what has been
publicly disclosed. Events such as completion of a clinical program, discovery of a new product,
filing of an application to obtain regulatory approval, beginning of commercialization or
announcement of additional clinical programs for a product may vary from what is publicly
disclosed. These variations may occur as a result of a series of events, including the nature of
the results obtained during a clinical trial or during a research phase, problems with a supplier
or a commercial partner or any other event having the effect of delaying the publicly announced
timeline. The Companys policy on forward-looking information consists of not updating it if the
publicly disclosed timeline varies. Any variation in the timing of certain events having the effect
of postponing such events could have an adverse material effect on the business plan, financial
condition or operating results of the Company.
ANNUAL REPORT 2009 //// 35
Corrected as at March 8, 2010 ////
The outcome of scientific research is uncertain and the failure by the Company to discover new
products could slow down the growth of its portfolio of products.
The Company conducts research activities in order to increase its portfolio of products. The
outcome of scientific research is uncertain and may prove unsuccessful and, therefore, may not lead
to the discovery of new molecules and progression of existing molecules to an advanced development
stage. The inability of the Company to develop new molecules or to further develop the existing
ones could slow down the growth of its portfolio of products.
The development and commercialization of drugs could expose the Company to liability claims which
could exceed its insurance coverage.
A risk of product liability claims is inherent in the development and commercialization of human
therapeutic products. Product liability insurance is very expensive and offers limited protection.
A product liability claim against the Company could potentially be greater than the available
coverage and, therefore, have a material adverse effect upon the Company and its financial
condition. Furthermore, a product liability claim could tarnish the Companys reputation, whether
or not such claims are covered by insurance or are with or without merit.
The Companys common share price is volatile and investors could lose money as a result of such
volatility.
The market price of the Companys common shares is subject to volatility. General market conditions
as well as differences between the Companys financial, scientific and clinical results and the
expectations of investors as well as securities analysts can have a significant impact on the
trading price of the Companys common shares. In recent years, the stocks of many biopharmaceutical
companies have experienced extreme price fluctuations, unrelated to the operating performance of
the affected companies. There can be no assurance that the market price of the common shares will
not continue to experience significant fluctuations in the future, including fluctuations that are
unrelated to the Companys performance. The occurrence of any of the above risks and uncertainties
could have a material adverse effect on the price of the common shares.
36 //// ANNUAL REPORT 2009
Corrected as at March 8, 2010 ////
Forward-looking information
This annual report and the MD&A contained herein, include certain statements that are
considered forward-looking information within the meaning of applicable securities legislation.
This forward-looking information includes, but is not limited to, information regarding the
commercialization of tesamorelin in the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy, the receipt of royalties related to sales of tesamorelin, the development of
tesamorelin in additional markets, the conclusion of strategic partnerships, and the liquidity
needs to finance the Companys operations. Furthermore, the words will, may, could, should,
outlook, believe, plan, envisage, anticipate, expect and estimate, or the negatives
of these terms or variations of them and the use of the conditional tense as well as similar
expressions denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control, that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties are described under the section Risks and
Uncertainties above.
Although the forward-looking information contained in this MD&A is based upon what the Company
believes are reasonable assumptions, investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking information. Certain assumptions
made in preparing the forward-looking information and the Companys objectives include the
assumption that the FDA will approve tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy, that the Companys business plan will not be
substantially modified and that current relationships with the Companys third-party suppliers of
services and products will remain good.
Consequently, all of the forward-looking information contained in this MD&A are qualified by the
foregoing cautionary statements, and there can be no guarantee that the results or developments
anticipated by the Company will be realized or, even if substantially realized, that they will have
the expected consequences or effects on the Company, its business, financial condition or results
of operation.
Further information on Theratechnologies
Further information on Theratechnologies, including the Companys Annual Information Form, is
available on the SEDAR site at www.sedar.com.
ANNUAL REPORT 2009 //// 37
ex-99.7
Exhibit 99.7
MANAGEMENTS
DISCUSSION
AND ANALYSIS
The following discussion and analysis provides Managements point of view on the financial
position and the results of operations of Theratechnologies Inc. (Theratechnologies or the
Company), on a consolidated basis for the twelve-month periods ended November 30, 2009 (2009)
and November 30, 2008 (2008). This information is dated February 10, 2010, and should be read in
conjunction with the Audited Consolidated Financial Statements and the accompanying notes. Unless
specified otherwise, the amounts are in Canadian dollars.
The financial information contained in this Managements Discussion and Analysis and in the
Companys Audited Consolidated Financial Statements has been prepared in accordance with Canadian
generally accepted accounting principles (GAAP) except for certain information presented below
under the heading Non-GAAP Measures. The Audited Consolidated Financial Statements and
Managements Discussion and Analysis have been reviewed by the Audit Committee of Theratechnologies
and approved by its Board of Directors.
This Managements Discussion and Analysis contains forward-looking information. Additional
information about the forward-looking information as well as the associated risks and uncertainties
can be found on pages 25 to 37 of the report.
Overview
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company
targets unmet medical needs in financially attractive speciality markets where it can retain all or
some of the commercial rights to its products. Its most advanced compound, tesamorelin, is an
analogue of the human growth hormone releasing factor.
The 2009 financial year began with the closing of the Collaboration and Licensing Agreement with
EMD Serono, Inc. (EMD Serono), an affiliate of Merck KGaA, of Darmstadt, Germany. Under the terms
of this agreement, Theratechnologies received a payment of US $30,000,000 (CAD$36,951,000),
including an initial payment of US$22,000,000 (CAD$27,097,000) from EMD Serono and a subscription
for common shares of Theratechnologies totaling US$8,000,000 (CAD$9,854,000) by Merck KGaA. The
agreement, entered into between the two parties on October 28, 2008, stipulates that
Theratechnologies could receive up to US$215,000,000, including the upfront payment and milestone
payments based on attaining certain development, regulatory and sales objectives. Furthermore,
Theratechnologies will be entitled to receive increasing royalties on annual net sales of
tesamorelin in the United States.
Under the terms of this agreement, the principal responsibility of Theratechnologies was to submit
a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the United States in
order to obtain approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. In the early months of the year, Theratechnologies scientific and
regulatory teams devoted themselves to finalizing the NDA, which was submitted to the FDA on May
29, 2009. In mid-August, the FDA advised Theratechnologies that it had accepted the submission of
the tesamorelin NDA. In accordance with the Collaboration and Licensing Agreement with EMD Serono,
Theratechnologies received a milestone payment of US$10,000,000 (CAD$10,884,000) related to the
acceptance of the NDA submission by the FDA.
As part of the regulatory review currently underway, the FDA asked Theratechnologies to appear at a
public meeting before the Endocrinologic and Metabolic Drugs Advisory Committee in order to obtain
the advice of independent experts on the use of tesamorelin to treat excess abdominal fat in
HIV-infected patients with lipodystrophy. Initially scheduled for February 24, 2010, the meeting
was postponeddue to administrative delays at the FDAuntil a later date that has not yet been
determined.
In parallel with the Companys regulatory activities, Theratechnologies presented additional data
from the Phase 3 clinical program at major scientific conferences, notably the 91st
Annual Meeting of the Endocrine Society (ENDO) in Washington, D.C. and the 11th
International Workshop on Adverse Drug Reactions and Co-morbidities in HIV, in Philadelphia. By way
of background, the 52-week results from the confirmatory Phase 3 clinical trial were announced in
December 2008. As part of its effort to build awareness of the disease, Theratechnologies also
sponsored a symposium entitled Lipohypertrophy: Beyond Body Image at the 12th European
AIDS Conference (EACS) in Cologne, Germany. Finally, the Company began preclinical work in 2009
on a molecule being developed for the treatment of acute kidney failure.
10 //// ANNUAL REPORT 2009
With respect to the overall strategy of the Company, Management undertook a review of its
business plan in early 2009. The resulting growth strategy, which was presented at the Annual and
Special Meeting of Shareholders held on March 26, 2009, centers on the development of tesamorelin,
the Companys lead molecule, and is built around three main objectives. The first is to obtain
approval for tesamorelin in HIV-associated lipodystrophy in the United States. Once tesamorelin is
approved, the Company expects to receive increasing royalties and additional milestone payments
from sales of tesamorelin by EMD Serono in the United States. The second objective is to develop
additional markets and conclude partnership agreements outside the United States. Finally, the
Companys third objective is to select and launch clinical programs evaluating tesamorelin for the
treatment of other medical conditions. Together with sound product life-cycle management, this
strategy emphasizing the development of tesamorelin is expected to support the growth of
Theratechnologies for the next few years.
ECONOMIC ENVIRONMENT
For the past two years, the capital markets were characterized by significant stock market
volatility and a notable decline in access to capital across all sectors, particularly
biotechnology. In parallel, an economic slowdown occurred in almost all sectors.
The general decline of capital markets has had a negative effect on the cost of capital for
companies. However, the Company does not envisage raising capital in 2010 because its liquidity
level is sufficient to meet the operating needs of its current business plan.
Theratechnologies investment policy is conservative. The Company invests its funds in highly
liquid, low-risk instruments as described under the heading Liquidity and Capital Resources.
The Company relies on third parties for the manufacture and supply of tesamorelin and it is not
aware of any information suggesting that its principal suppliers will not be able to meet their
financial obligations.
Furthermore, Theratechnologies is relying on its American commercial partner, EMD Serono, to
commercialize tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy. The Company is not aware of any information suggesting that its partner will not be
able to meet its financial obligations.
EXPECTATIONS FOR THE PRESENT FINANCIAL YEAR
The Companys primary objective for the current financial year is the acceptance for marketing
approval in the United States of tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy. Marketing approval could result in the achievement of
regulatory milestones under the Collaboration and Licensing Agreement with EMD Serono. Once
approved, the Company expects to receive royalties from the sale of tesamorelin in the United
States. Furthermore, the Company will continue to collaborate with EMD Serono for the preparation
of the commercialization of tesamorelin.
The Companys second objective is to expand into new territories where tesamorelin could be used
for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. To this end,
during the present financial year, the Company will be seeking third parties having a regulatory
expertise in obtaining marketing approval of new drugs and a commercial expertise in launching new
pharmaceutical products with the intent of entering into strategic alliances with them. Under such
strategic alliance agreements, these third parties would be responsible for obtaining marketing
approval of tesamorelin in one or more territories and commercializing tesamorelin in such
territories.
Concurrently with the seeking of third parties with which to enter into strategic alliance
agreements, the Company will continue to pursue regulatory activities outside of the United States
to advance its application regarding the use of tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy. However, given the Companys primary objective,
the pace at which these activities will progress will depend on the FDAs decision regarding the
Companys NDA as well as on the timing of such decision.
ANNUAL REPORT 2009 //// 11
The Companys third objective is to select and begin additional clinical programs once
marketing approval for tesamorelin in the United States for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy is obtained.
Finally, all of the foregoing activities will be carried out in a cost-efficient manner to conserve
the Companys cash position and to manage its burn rate. The Company has sufficient liquidities to
self-finance its activities for the current financial year.
Selected annual information
CONSOLIDATED STATEMENT OF EARNINGS
Years ended November 30
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of dollars, except per share amounts) |
|
2009 |
|
|
2008* |
|
|
2007* |
|
|
Revenues |
|
$ |
19,720 |
|
|
$ |
2,641 |
|
|
$ |
3,134 |
|
Research and development before tax credits |
|
$ |
22,226 |
|
|
$ |
35,326 |
|
|
$ |
31,866 |
|
Operating loss before realized loss on impairment
of available-for-sale financial assets |
|
$ |
(15,058 |
) |
|
$ |
(48,033 |
) |
|
$ |
(37,611 |
) |
Net loss |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
|
$ |
(37,668 |
) |
|
Basic and diluted loss per share |
|
$ |
(0.25 |
) |
|
$ |
(0.85 |
) |
|
$ |
(0.72 |
) |
|
CONSOLIDATED BALANCE SHEET
At November 30
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of dollars) |
|
2009 |
|
|
2008* |
|
|
2007* |
|
|
Liquidities (cash and bonds) |
|
$ |
63,362 |
|
|
$ |
46,337 |
|
|
$ |
60,368 |
|
Tax credits receivable |
|
$ |
1,666 |
|
|
$ |
1,784 |
|
|
$ |
1,418 |
|
Total assets |
|
$ |
69,487 |
|
|
$ |
53,545 |
|
|
$ |
73,649 |
|
Capital stock |
|
$ |
279,169 |
|
|
$ |
269,219 |
|
|
$ |
238,842 |
|
Shareholders equity |
|
$ |
43,048 |
|
|
$ |
46,347 |
|
|
$ |
65,036 |
|
|
|
|
|
* |
|
Information restated following the adoption of the Canadian Institute of
Chartered Accountants (CICA) Handbook Section 3064, Goodwill and Intangible Assets. |
Operating
results
NON-GAAP MEASURES
The Company uses measures that do not conform to GAAP to assess its operating performance.
Securities regulators require that companies caution readers that earnings and other measures
adjusted to a basis other than GAAP do not have standardized meanings and are unlikely to be
comparable to similar measures used by other companies. Accordingly, these measures should not be
considered in isolation. The Company uses non-GAAP measures such as adjusted net loss and the
adjusted burn rate from operating activities before changes in operating assets and liabilities, to
measure its performance from one period to the next without including changes caused by certain
items that could potentially distort the analysis of trends in its operating performance, and
because such measures provide meaningful information on the Companys financial condition and
operating results.
12 //// ANNUAL REPORT 2009
DEFINITION AND RECONCILIATION OF NON-GAAP MEASURES
In order to measure performance from one period to another, without accounting for changes
related to revenues and fees associated with the Collaboration and Licensing Agreement with EMD
Serono, Management uses adjusted net loss and adjusted burn rate before changes in operating assets
and liabilities. These items are excluded because they affect the comparability of the financial
results and could potentially distort the analysis of trends in the Companys operating
performance. The exclusion of these items does not necessarily indicate that they are
non-recurring.
Adjusted net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of dollars) |
|
Fourth quarter |
|
|
|
|
|
|
Year |
|
|
|
2009 |
|
|
2008* |
|
|
2009 |
|
|
2008* |
|
|
Net loss, per the financial statements |
|
$ |
(4,698 |
) |
|
$ |
(15,145 |
) |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues associated with a Collaboration and Licensing Agreement
(note 7 to the consolidated financial statements) |
|
|
(1,711 |
) |
|
|
|
|
|
|
(17,444 |
) |
|
|
|
|
Fees associated with a Collaboration and Licensing Agreement |
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
|
|
Adjusted net loss |
|
$ |
(6,409 |
) |
|
$ |
(15,145 |
) |
|
$ |
(28,233 |
) |
|
$ |
(48,611 |
) |
|
Adjusted burn rate from operating activities before changes in operating assets and liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of dollars) |
|
Fourth quarter |
|
|
|
|
|
|
Year |
|
|
|
2009 |
|
|
2008* |
|
|
2009 |
|
|
2008* |
|
|
Burn rate before changes in operating assets
and liabilities, per the financial statements |
|
$ |
(4,333 |
) |
|
$ |
(9,559 |
) |
|
$ |
(13,547 |
) |
|
$ |
(41,592 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues associated with a Collaboration and Licensing Agreement
(note 7 to the consolidated financial statements) |
|
|
(1,711 |
) |
|
|
|
|
|
|
(17,444 |
) |
|
|
|
|
Fees associated with a Collaboration and Licensing Agreement |
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
|
|
Adjusted burn rate before changes
in operating assets and liabilities |
|
$ |
(6,044 |
) |
|
$ |
(9,559 |
) |
|
$ |
(26,722 |
) |
|
$ |
(41,592 |
) |
|
|
|
|
* |
|
Information restated following the adoption of the CICA Handbook Section 3064,
Goodwill and Intangible Assets. |
REVENUES
Theratechnologies consolidated revenues for the year ended November 30, 2009, were
$19,720,000, compared to $2,641,000 for the same period in 2008. The increased revenues in 2009 are
related to the initial payment received on December 15, 2008, upon the closing of the Collaboration
and Licensing Agreement with EMD Serono, as well as the receipt of a milestone payment of
US$10,000,000 (CAD$10,884,000) during the third quarter of 2009.
The payment of US$30,000,000 (CAD$36,951,000) received upon the closing of the agreement included
an initial payment of US$22,000,000 (CAD$27,097,000) and a subscription for common shares by Merck
KGaA at a price of US$3.67 (CAD$4.52) per share, resulting in gross proceeds of US$8,000,000
(CAD$9,854,000). The payment of $27,097,000 has been deferred and is being amortized over its
estimated service period on a straight-line basis. This period may be modified in the future based
on additional information that may be received by the Company. For the year ended November 30,
2009, an amount of $6,560,000 related to this transaction was recognized as revenue. At November
30, 2009, the deferred revenues related to this transaction recorded on the balance sheet amounted
to $20,537,000.
ANNUAL REPORT 2009 //// 13
The milestone payment of $10,884,000, received during the third quarter, is associated with the
acceptance by the U.S. FDA to review the NDA for tesamorelin that was submitted by the Company on
May 29, 2009. Under the terms of the Collaboration and Licensing Agreement with EMD Serono, a
milestone payment of US $10,000,000 was associated with the FDAs acceptance to review the NDA for
tesamorelin. All milestone payments, including the aforementioned payment, are recorded as they are
earned, upon the achievement of predetermined milestones specified in the agreement.
For the year ended November 30, 2009, interest revenues were $2,252,000, compared to $2,427,000 for
the same period in 2008. The decrease in interest revenues over the fiscal year is associated with
lower interest rates, which translated to a lower return on investment.
R&D ACTIVITIES
For the year ended November 30, 2009, consolidated research and development (R&D) expenses,
before tax credits, amounted to $22,226,000, compared to $35,326,000 for the same period in 2008,
representing a decrease of 37.1%. The decrease in R&D expenses is due to the conclusion of the
Phase 3 clinical trials evaluating tesamorelin in HIV-associated lipodystrophy, in the first half
of 2009. The R&D expenses incurred in 2009 are mainly related to follow up on the regulatory
filing, notably managing responses to the FDAs questions, a normal part of the review process, and
the preparation for the FDA Advisory Committee meeting as well as preparation for larger-scale
production of tesamorelin. The R&D expenses for 2009 include a non-recurring charge of $1,377,000
associated with research materials produced to obtain stability data and to validate the commercial
production process, as required by the FDA.
The majority of R&D expenses in 2009 were applied to tesamorelin in HIV-associated lipodystrophy.
Based on the current business plan, R&D expenditures should decrease over the year 2010 and should
be approximately 30% lower than in 2009. During the first months of the 2010 financial year, a
large part of the R&D expenses should continue to be related to follow up on the regulatory filing,
as mentioned earlier. Several other projects are included in the R&D budget for 2010, notably
activities related to product life-cycle management for tesamorelin, regulatory activities related
to the development of additional markets outside the United States, as well as the preliminary work
related to the selection of new clinical programs. The R&D budget for 2010 also provides for the
development of an acute renal insufficiency program. The molecule developed by the Company for the
treatment of acute renal insufficiency was identified as a potential program to be developed
internally. The Company intends to complete the ongoing preclinical work before it selects and
begins a clinical program for this molecule.
TAX CREDITS
Tax credits amounted to $1,795,000 for the year ended November 30, 2009, compared to $2,111,000
in 2008. Tax credits represent refundable tax credits obtained from the Québec government. Lower
R&D expenditures in 2009 contributed to the decrease in tax credits.
GENERAL AND ADMINISTRATIVE EXPENSES
For the year ended November 30, 2009, general and administrative expenses were $7,149,000,
compared to $6,185,000 for the same period in 2008. The increased expenses for the year ended
November 30, 2009, are principally due to a higher exchange loss as well as costs associated with
revising the Companys business plan in the first quarter. The exchange losses are due to the
conversion of monetary assets and liabilities denominated in foreign currencies into Canadian
dollar equivalents using rates of exchange in effect on the balance sheet date. These expenses
should decrease slightly in 2010.
14 //// ANNUAL REPORT 2009
SELLING AND MARKET DEVELOPMENT EXPENSES
For the year ended November 30, 2009, selling and market development expenses were $2,583,000,
compared to $3,811,000 for the same period in 2008. The decrease in selling and market development
costs is due to the signing of the agreement with EMD Serono for the U.S. commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
Following the signing of this agreement, the sales and market development expenses are principally
composed of business development expenses outside the United States and the costs of managing the
agreement with EMD Serono. These expenses should be maintained at the same level in 2010.
PATENTS, AMORTIZATION AND IMPAIRMENT OF OTHER ASSETS
For the year ended November 30, 2009, patents, amortization and impairment of other assets
amounted to $346,000, compared to $5,239,000, in 2008. In 2008, the Company conducted an impairment
test on the intellectual property of the ExoPep platform following a review of the development
strategy for new products by Management. As a consequence, the Company wrote off the carrying
amount of this intellectual property in 2008. The write-off of $4,571,000 is included in Patents,
amortization and impairment of other assets in the consolidated statement of earnings.
FEES RELATED TO THE STRATEGIC REVIEW PROCESS AND THE COLLABORATION AND LICENSING AGREEMENT
WITH EMD SERONO
In 2009, an amount of $4,269,000 was recognized as a cost associated with the conclusion of the
agreement with EMD Serono described earlier. In 2008, the costs related to the strategic review
amounted to $2,224,000. These costs are essentially composed of fees paid to the various experts
retained to help Management and the Board of Directors.
REALIZED LOSS ON IMPAIRMENT OF AVAILABLE-FOR-SALE FINANCIAL ASSETS
In 2008, the Company incurred an impairment of $578,000 related to stock options held in a
publicly-traded company.
NET RESULTS
Reflecting the changes in revenues and expenses described above, the Company incurred a net
loss, in 2009, of $15,058,000 ($0.25 per share), compared to a net loss of $48,611,000 ($0.85 per
share) for the same period in 2008. For the year ended November 30, 2009, the net loss included
revenue of $17,444,000 and a non-recurring charge of $4,269,000 related to the agreement with EMD
Serono. Excluding these two items, the adjusted net loss (see Non-GAAP Measures) amounted to
$28,233,000, a decrease of 41.9% compared to the same period in 2008. The net loss in 2008 included
the previously described impairment losses totalling $5,149,000.
QUARTERLY FINANCIAL INFORMATION
The selected financial information provided below is derived from the Companys unaudited
quarterly financial statements for each of the last eight quarters. This information has been
restated following the adoption of the CICA Handbook Section 3064, Goodwill and Intangible Assets.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of dollars, except per share amounts) |
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Revenues |
|
$ |
2,246 |
|
|
$ |
13,148 |
|
|
$ |
2,317 |
|
|
$ |
2,009 |
|
|
$ |
616 |
|
|
$ |
710 |
|
|
$ |
716 |
|
|
$ |
599 |
|
Net loss
(net earnings) |
|
$ |
(4,698 |
) |
|
$ |
5,824 |
|
|
$ |
(5,430 |
) |
|
$ |
(10,754 |
) |
|
$ |
(15,145 |
) |
|
$ |
(11,220 |
) |
|
$ |
(11,382 |
) |
|
$ |
(10,864 |
) |
Basic and diluted
loss (earnings)
per share |
|
$ |
(0.08 |
) |
|
$ |
0.10 |
|
|
$ |
(0.09 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.20 |
) |
|
As described above, the increased revenues in 2009 are related to the amortization of the initial
payment received at the closing of the agreement with EMD Serono, as well as the milestone payment
of $10,884,000 recorded in August 2009. The increase in the fourth quarter net loss in 2008 is due
to an impairment in the value of intellectual property.
ANNUAL REPORT 2009 //// 15
Fourth quarter
Consolidated revenues for the three-month period ended November 30, 2009, amounted to
$2,246,000, compared to $616,000 for the same period in 2008. Interest revenue in the fourth
quarter of 2009 amounted to $528,000, compared to $518,000 for the same period in 2008. The
increased revenues for the three-month period ended November 30, 2009, are related to the payment
received on December 15, 2008, upon the closing of the Collaboration and Licensing Agreement with
EMD Serono. This payment of US$30,000,000 (CAD$36,951,000) included an initial payment of
US$22,000,000 (CAD$27,097,000) and a subscription for common shares by Merck KGaA at a price of
US$3.67 (CAD$4.52) per share, resulting in gross proceeds of US$8,000,000 (CAD$9,854,000). The
initial payment of $27,097,000 has been deferred and is being amortized over its estimated service
period on a straight-line basis. This period may be modified in the future based on additional
information that may be received by the Company. For the fourth quarter of 2009, an amount of
$1,711,000 related to this transaction was recognized as revenue.
Consolidated R&D expenses, before tax credits, totalled $4,534,000 for the fourth quarter of 2009,
compared to $6,313,000 for the same period in 2008, representing a decrease of 28.2%. This decrease
in R&D expenses is due to the conclusion of the Phase 3 clinical program evaluating tesamorelin for
the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The R&D expenses
incurred in the fourth quarter of 2009 are mainly related to follow up on the regulatory filing,
notably managing responses to the FDAs questions, a normal part of the review process, and the
preparation for the FDA Advisory Committee meeting as well as preparation for larger-scale
production of tesamorelin.
General and administrative expenses were $1,634,000 in the fourth quarter of 2009, compared to
$1,874,000 for the same period in 2008. The lower expenses for the three-month period ended
November 2009 are associated with a reduction in foreign exchange loss.
Selling and market development costs amounted to $1,067,000 for the fourth quarter of 2009,
compared to $1,124,000 for the same period in 2008. The decrease in selling and market development
costs is due to the signing of the agreement with EMD Serono for the U.S. commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
Since the signing of this agreement, the sales and market development expenses are principally
composed of business development expenses outside the United States and the costs of managing the
agreement with EMD Serono.
Patents, amortization and impairment of other assets amounted to $120,000 for the three months
ended November 30, 2009, compared to $4,727,000 for the corresponding period in 2008. In the fourth
quarter of 2008, the Company conducted an impairment test on the intellectual property of the
ExoPep discovery platform following a review of the development strategy for new products by
Management. As a consequence, the Company wrote off the carrying amount of this intellectual
property in 2008. The impairment of other assets of $4,571,000 is included in Patents,
amortization and impairment of other assets in the consolidated statement of earnings.
In 2008, the Company incurred an impairment of $578,000 related to stock options held in a
publicly-traded company.
Consequently, the Company recorded a net loss for the three-month period ended November 30, 2009,
of $4,698,000 ($0.08 per share), compared to a net loss of $15,145,000 ($0.26 per share) for the
same period in 2008. The fourth quarter net loss includes revenues of $1,711,000 related to the
agreement with EMD Serono. Excluding this item, the adjusted net loss (see Non-GAAP Measures)
amounted to $6,409,000, a decrease of 57.7% compared to the same period in 2008.
In the three months ended November 30, 2009, the burn rate from operating activities, excluding
changes in operating assets and liabilities, was $4,333,000, compared to $9,559,000 for the same
period in 2008. Excluding the revenue of $1,711,000 related to the agreement with EMD Serono, the
adjusted burn rate from operating activities, excluding changes in operating assets and liabilities
(see Non-GAAP Measures), was $6,044,000, a decrease of 36.8%, compared to the corresponding
period in 2008.
16 //// ANNUAL REPORT 2009
Liquidity and capital resources
The Companys objective in managing capital is to ensure a sufficient liquidity position to
finance its research and development activities, general and administrative expenses, working
capital and overall capital expenditures, and patents. The Company makes every attempt to manage
its liquidity to minimize shareholder dilution.
To fund its activities, the Company has followed an approach that relies almost exclusively on the
issuance of common equity and proceeds and royalties from technologies following the closing of the
agreement with EMD Serono. Since inception, the Company has financed its liquidity needs primarily
through public offerings of common shares and private placements. When possible, the Company tries
to optimize its liquidity position through non-dilutive sources, including investment tax credits,
grants, interest income as well as proceeds and royalties from technologies.
For the year ended November 30, 2009, the burn rate, represented by cash flows from operating
activities and excluding changes in operating assets and liabilities, was $13,547,000 compared to
$41,592,000 in 2008. The decrease in the 2009 burn rate is principally related to the payments
received under the agreement with EMD Serono as well as the decline in R&D expenditures and in
selling and market development costs. Excluding the revenue of $17,444,000 and the non-recurring
charge of $4,269,000 related to the agreement with EMD Serono, the adjusted burn rate from
operating activities, excluding changes in operating assets and liabilities (see Non-GAAP
Measures), was $26,722,000, a decrease of 35.8%, compared to the corresponding period in 2008.
Based on the current business plan, the adjusted burn rate is expected to amount approximately to
$24,000,000 in 2010. Taking into consideration the liquidity level and the reduced burn rate, the
Company believes that its liquidity position is sufficient to finance its operating activities and
its capital needs over the fiscal year.
Theratechnologies maintained a good liquidity position in 2009. At November 30, 2009, cash and
bonds amounted to $63,362,000 and tax credits receivable amounted to $1,666,000, for a total of
$65,028,000.
It is the policy of the Company to minimize its level of debt. The Company has a line of credit of
$1,800,000 for its short-term financing needs. As at November 30, 2009, this line of credit was not
being used. However, $323,000 of this amount was allocated to secure an irrevocable letter of
credit related to lease commitments on its premises. This letter of credit will be cancelled on
April 30, 2010, under the terms of the lease renewal, described in Contractual obligations.
The Company invests its available cash in highly liquid fixed income instruments from governmental,
municipal and paragovernmental bodies ($60,384,000 at November 30, 2009) as well as from companies
with high credit ratings ($1,459,000 at November 30, 2009).
Under the terms of the agreement with EMD Serono, the Company issued 2,179,837 common shares for a
cash consideration of US$8,000,000 (CAD$9,854,000) during the first quarter. The Company also
received share subscriptions amounting to $96,000 for the issuance of 34,466 common shares in
connection with its share purchase plan.
During the first quarter of 2008, the Company completed a public offering for the sale and issuance
of 3,500,000 common shares for cash proceeds of $29,750,000. Issue costs totalled $1,938,000,
resulting in net proceeds of $27,812,000. In the year ended November 30, 2008, the Company issued
119,666 common shares following the exercise of stock options, for cash proceeds of $397,000. The
Company also received share subscriptions amounting to $149,000 for the issuance of 64,291 common
shares to employees in connection with its share purchase plan.
ANNUAL REPORT 2009 //// 17
Contractual obligations
The Company rents premises under an operating lease expiring in April 2010. The lease was
renewed by the Company and the lessor during the 2009 financial year for a period of 11 years
ending April 30, 2021. Under the terms of the lease, the Company has also been granted two renewal
options for periods of five years each. The minimum payments required under the terms of the lease
are as follows:
PAYMENTS REQUIRED BY DUE DATE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than |
|
|
1 to 5 |
|
|
Over |
|
(in thousands of dollars) |
|
Total |
|
|
1 year |
|
|
years |
|
|
5 years |
|
|
Operating lease |
|
$ |
6,576 |
|
|
$ |
340 |
|
|
$ |
2,020 |
|
|
$ |
4,216 |
|
|
The Company has committed to pay the lessor for its share of some operating expenses of the leased
premises. This amount has been set at $240,000 for the year beginning May 1, 2010, and will be
increased by 2.5% annually for the duration of the lease.
The lessor will provide the Company an amount of $728,000 to allow it to undertake leasehold
improvements.
The Company has issued an irrevocable letter of credit in favour of the lessor in the amount of
$323,000 which will be cancelled on April 30, 2010, under the terms of the lease renewal, along
with a first rank movable mortgage in the amount of $1,150,000 covering all of the Companys
tangible assets located in the rented premises. This mortgage, however, can be subordinated to
those of lending institutions.
Furthermore, during and after the year ended November 30, 2009, the Company entered into long-term
procurement agreements with third-party suppliers in anticipation of the commercialization of
tesamorelin. Some of these agreements stipulate an obligation to purchase minimum quantities of
product, subject to certain conditions.
Off-balance sheet arrangements
The Company was not involved in any off-balance sheet arrangements as at November 30, 2009,
with the exception of the lease renewal as described above and an irrevocable letter of credit
issued in the amount of $323,000 related to lease commitments.
Subsequent events
A) |
|
SHAREHOLDER RIGHTS PLAN |
|
|
|
On February 10, 2010, the Companys Board of Directors adopted a shareholder rights plan
(the Plan), effective as of such date. The Plan is designed to provide adequate time for the
Board of Directors, and the shareholders, to assess an unsolicited takeover bid for
Theratechnologies. In addition, the Plan provides the Board of Directors with sufficient time to
explore and develop alternatives for maximizing shareholder value if a takeover bid is made, as
well as provide shareholders with an equal opportunity to participate in a takeover bid to
receive full and fair value for their common shares (the Common Shares). The Plan, if approved
by the shareholders, will expire at the close of the Companys annual meeting of shareholders in
2013. |
|
|
|
The rights issued under the Plan will initially attach to and trade with the Common Shares and
no separate certificates will be issued unless an event triggering these rights occurs. The
rights will become exercisable only when a person, including any party related to it, acquires
or attempts to acquire 20% or more of the outstanding Common Shares without complying with the
Permitted Bid provisions of the Plan or without approval of the Board of Directors. Should
such an acquisition occur or be announced, each right would, upon exercise, entitle a rights
holder, other than the acquiring person and related persons, to purchase Common Shares at a 50%
discount to the market price at the time. |
18 //// ANNUAL REPORT 2009
|
|
Under the Plan, a Permitted Bid is a bid made to all holders of the Common Shares and which
is open for acceptance for not less than 60 days. If at the end of 60 days at least 50% of the
outstanding Common Shares, other than those owned by the offeror and certain related parties
have been tendered, the offeror may take up and pay for the Common Shares but must extend the
bid for a further 10 days to allow other shareholders to tender. |
|
B) |
|
GRANTING OF STOCK OPTIONS |
|
|
|
On December 8, 2009, the Company granted 265,000 options at an exercise price of $3.84 per
share and cancelled 19,167 options at a weighted exercise price of $2.38 per share in connection
with its stock option plan. |
Financial risk management
This note provides disclosures relating to the nature and extent of the Companys exposure to
risks arising from financial instruments, including credit risk, liquidity risk, foreign currency
risk and interest rate risk, and how the Company manages those risks.
CREDIT RISK
Credit risk is the risk of an unexpected loss if a customer or counterparty to a financial
instrument fails to meet its contractual obligations. The Company regularly monitors the credit
risk exposure and takes steps to mitigate the likelihood of these exposures resulting in losses.
Financial instruments other than cash that potentially subject the Company to significant credit
risk consist principally of bonds. The Company invests its available cash in fixed income
instruments from governmental, paragovernmental and municipal bonds
($60,384,000 as at November 30, 2009) as well as from companies with high credit ratings
($1,459,000 as at November 30, 2009).
As at November 30, 2009, the Company was not exposed to any credit risk over the carrying amount of
the bonds.
LIQUIDITY RISK
Liquidity risk is the risk that the Company will not be able to meet its financial obligations
as they fall due. The Company manages liquidity risk through the management of its capital
structure, as outlined in the section Liquidity and Capital Ressources. It also manages liquidity
risk by continuously monitoring actual and projected cash flows. The Board of Directors and/or the
Audit Committee reviews and approves the Companys operating and capital budgets, as well as any
material transactions out of the ordinary course of business.
The Company has adopted an investment policy in respect of the safety and preservation of its
capital to ensure the Companys liquidity needs are met. The instruments are selected with regard
to the expected timing of expenditures and prevailing interest rates. Bonds mature on November 30
during the following fiscal years: $10,036,000 in 2010, $15,446,000 in 2011, $19,716,000 in 2012,
$13,791,000 in 2013 and $2,854,000 in 2014. The required payments on the contractual maturities of
financial liabilities, as well as the payments required under the terms of the operating lease, as
at November 30, 2009, are presented in note 13B) of the Consolidated Financial Statements.
FOREIGN CURRENCY RISK
The Company is exposed to the financial risk related to the fluctuation of foreign exchange
rates and the degree of volatility of those rates. Foreign currency risk is limited to the portion
of the Companys business transactions denominated in currencies other than the Canadian dollar,
primarily revenues from royalties, technologies and other expenses for research and development
incurred in US dollars, euros and pounds sterling (GBP). The Company does not use derivative
financial instruments to reduce its foreign exchange exposure.
The Company manages foreign exchange risk by maintaining U.S. cash on hand to support U.S.
forecasted cash outflows for a maximum 12-month period. The Company does not currently view its
exposure to the euro and GBP as a significant foreign exchange risk, due to the limited volume of
transactions conducted by the Company in these currencies.
ANNUAL REPORT 2009 //// 19
Exchange rate fluctuations for foreign currency transactions can cause cash flow as well as
amounts recorded in the consolidated statement of earnings to vary from period to period and not
necessarily correspond to those forecasted in operating budgets and projections. Additional
earnings variability arises from the conversion of monetary assets and liabilities denominated in
currencies other than the Canadian dollar at the rates of exchange at each balance sheet date, the
impact of which is reported as foreign exchange gain or loss in the consolidated statement of
earnings. Given the Companys policy on the management of foreign currencies, a sudden change in
foreign exchange rates would not impair or enhance its ability to pay its U.S. dollar denominated
obligations.
The following table provides significant items exposed to foreign exchange as at November 30, 2009:
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|
|
|
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|
|
|
|
(in thousands of Canadian dollars) |
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|
|
|
|
|
|
|
|
November 30, 2009 |
|
|
|
$US |
|
|
EUR |
|
|
GBP |
|
|
Cash |
|
|
1,471 |
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
|
|
|
|
4 |
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
(1,095 |
) |
|
|
|
|
|
|
(25 |
) |
|
Balance sheet elements exposed to foreign currency risk |
|
|
376 |
|
|
|
4 |
|
|
|
(25 |
) |
|
The following exchange rates applied during the year ended November 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Reporting |
|
|
|
rate |
|
|
date |
|
|
$US $CAN |
|
|
1.0594 |
|
|
|
1.0556 |
|
EUR $CAN |
|
|
1.5808 |
|
|
|
1.5852 |
|
GBP $CAN |
|
|
1.7597 |
|
|
|
1.7366 |
|
Based on the Companys foreign currency exposures noted above, varying the foreign exchange rates
in the preceding table to reflect a 5% strengthening of the Canadian dollar would have increased
the net loss as follows, assuming that all other variables remained constant:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of Canadian dollars) |
|
$US |
|
|
EURO |
|
|
GBP |
|
|
Increase net loss |
|
|
19 |
|
|
|
|
|
|
|
(1 |
) |
|
An assumed 5% weakening of the Canadian dollar would have had an equal but opposite effect on the
foreign currency amounts shown above, on the basis that all other variables remain constant.
INTEREST RATE RISK
Interest rate risk is the risk that the fair value or future cash flows of a financial
instrument will fluctuate because of changes in market interest rates.
Short-term bonds of the Company are invested at fixed interest rates and mature in the short-term.
Long-term bonds are also instruments that bear interest at fixed rates. The risk that the Company
will realize a loss as a result of a decline in the fair value of its bonds is limited because
these investments, although they are available for sale, are generally held to maturity. The
unrealized gains or losses on bonds are recorded in the accumulated other comprehensive income
(loss).
Based on the value of the Companys short and long-term bonds at November 30, 2009, an assumed 0.5%
decrease in market interest rates would have increased the fair value of these bonds and the
accumulated other comprehensive loss by $620,000; an assumed increase in interest rate of 0.5%
would have an equal but opposite effect, assuming that all other variables remained constant.
20 //// ANNUAL REPORT 2009
Cash bears interest at a variable rate. Accounts receivable, accounts payable and accrued
liabilities bear no interest.
Based on the value of variable interest-bearing cash during year ended November 30, 2009
($5,800,000), an assumed 0.5% increase in interest rates during such period would have increased
the future cash flow and decreased the net loss by $29,000; an assumed decrease of 0.5% would have
had an equal but opposite effect.
Financial instruments
The Company has determined that the carrying values of its short-term financial assets and
liabilities, including cash, accounts receivable, as well as accounts payable and accrued
liabilities, approximate their fair value because of the relatively short period to maturity of the
instruments.
Bonds and investments in public companies are stated at estimated fair value, determined by prices
quoted on active markets (level 2 inputs see New accounting policies Financial instruments
Disclosures).
Critical accounting estimates
The preparation of financial statements in conformity with GAAP requires Management to make
estimates and assumptions, which affect the reported amounts of assets and liabilities, and
disclosure of contingent assets and liabilities at the date of the financial statements, and the
reported amounts of revenues and expenses during the reporting period. The amounts presented and
the information provided in the notes reflect the range of economic conditions that are most
susceptible to occur and the measures Management intends to take. Actual results could differ from
these estimates. Discussed below are those policies that are judged to be critical and require the
use of judgment in their application.
INVENTORY VALUATION
Our inventory is carried at the lower of First-In-First-Out cost or net realizable value. We
regularly review inventory quantities on hand and record a provision for those inventories no
longer deemed to be fully recoverable. The cost of inventories may no longer be recoverable if
those inventories are slow moving, damaged, if they have become obsolete, or if their selling
prices or estimated forecast of product demand decline. If actual market conditions are less
favorable than previously projected, or if liquidation of the inventory no longer deemed to be
fully recoverable is more difficult than anticipated, additional provisions may be required.
PROPERTY AND EQUIPMENT AND OTHER ASSETS
Property and equipment and other assets are stated at cost. Amortization is provided using
methods and annual rates which are expected to reflect their economic and useful life. On a regular
basis, the Company reviews the estimated useful lives of its property and equipment. Assessing the
reasonableness of the estimated useful lives of property and equipment requires judgement and is
based on currently available information.
IMPAIRMENT OF LONG-TERM ASSETS
The Company reviews its property and equipment and other assets for impairment whenever events
or changes in circumstances indicate that the carrying value of an asset may not be recoverable.
Recoverability of assets to be used is measured by the comparison of the carrying amount of an
asset to estimated undiscounted future cash flows expected to be generated from the asset. If the
carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is
recognized in the amount by which the carrying value of the asset exceeds the fair value of the
asset. Managements judgment regarding the existence of impairment indicators is based on legal
factors, market conditions and operating performance. The fair value against which the asset is
measured may be established based on comparable information or transactions, discounted cash flows
or other methods of assessment depending on the nature of the asset. In estimating future cash
flows, the Company uses its best estimates based on internal plans, which take Management judgment
into consideration. Changes in circumstances, such as technological advances and changes in
business strategy can result in useful lives and future cash flows differing significantly from
estimates. Revisions to the estimated useful lives of property and equipment or future cash flows
constitute a change in accounting estimate and are applied prospectively.
ANNUAL REPORT 2009 //// 21
INCOME TAXES
Income taxes are accounted for using the asset and liability method. Future income tax assets
and liabilities are recognized in the balance sheet to account for the future tax consequences
attributable to temporary differences between the respective accounting and taxable value of
balance sheet assets and liabilities. Future income tax assets and income tax liabilities are
measured using the income tax rates that are most likely to apply when the asset is realized or the
liability is settled. The effect of changes in income tax rates is recognized in the year during
which these rates change. As appropriate, a valuation allowance is recognized to decrease the value
of tax assets to an amount that is more likely than not to be realized. In estimating the
realization of future income tax assets, Management considers whether a portion or all future tax
assets is more likely than not to be realized. Realization is subject to future taxable income. As
at November 30, 2009, the Company determined that a tax valuation allowance for the full amount of
future tax assets was necessary. In the event the Company determines that it can realize its tax
assets, it will readjust them for the amount and adjust the income in the period for which such
determination is made.
RESEARCH AND DEVELOPMENT
Research and development expenditures consist of direct and indirect expenses. They are
expensed as they are incurred. The Company accounts for clinical trial expenses on the basis of
work completed which relies on estimates of total costs incurred based on completion of studies, on
the number of patients and other factors. The expenses that are recorded with respect to clinical
trials are reviewed as the trial advances up until its final phase.
STOCK-BASED COMPENSATION AND OTHER STOCK-BASED PAYMENTS
The Company accounts for employee stock options using the fair value based method estimated
using the Black-Scholes model, which requires the use of certain assumptions, including future
stock price volatility and the time interval until the options are exercised. Under this method,
compensation cost is measured at fair value at the date of grant and is expensed over the vesting
period.
GOVERNMENT ASSISTANCE
Government assistance consists of research tax credits and grants and is applied against
related expenses and the cost of the asset acquired. Tax credits are available based on eligible
research and development expenses consisting of direct and indirect expenditures and including a
reasonable allocation of overhead expenses. Grants are subject to compliance with terms and
conditions of the related agreements. Government assistance is recognized when there is reasonable
assurance that the Company has met the requirements of the approved grant program or, with regard
to tax credits, when there is reasonable assurance that they will be realized.
New accounting policies
ADOPTION OF NEW ACCOUNTING STANDARDS
Goodwill and intangible assets
Effective with the commencement of its 2009 fiscal year, the Company adopted the CICA Handbook
Section 3064, Goodwill and Intangible Assets, which will replace Section 3062, Goodwill and Other
Intangible Assets, and Section 3450, Research and Development Costs. The standard provides guidance
on the recognition of intangible assets in accordance with the definition of an asset and the
criteria for asset recognition, whether these assets are separately acquired or internally
developed. The impact of adopting this standard has been to increase the opening deficit and to
reduce other assets at December 1, 2007 and 2008 by $941,000 and $599,000, respectively, which is
the amount of patent costs related to periods prior to these dates. Furthermore, following the
adoption of this standard, patents and amortization of other assets presented in the consolidated
statements of earnings were reduced by $342,000 for the year ended November 30, 2008.
22 //// ANNUAL REPORT 2009
Inventories
Effective with the commencement of its 2009 fiscal year, the Company adopted CICA Section 3031,
Inventories, which replaces Section 3030 and harmonizes the Canadian standards related to
inventories with International Financial Reporting Standards (IFRS). This Section provides
changes to the measurement and more extensive guidance on the determination of cost, including
allocation of overhead; narrows the permitted cost formulas; requires impairment testing; and
expands the disclosure requirements to increase transparency. As the Company had no inventories on
November 30, 2008, the adoption of this section had no impact on the Companys consolidated
financial statements.
Credit risk and fair value of financial assets and financial liabilities
On January 20, 2009, the Emerging Issues Committee (EIC) of the Accounting Standards Board
(AcSB) issued EIC Abstract 173,
Credit Risk and Fair Value of Financial Assets and Financial Liabilities, which establishes that an
entitys own credit risk and the credit risk of the counterparty should be taken into account in
determining the fair value of financial assets and financial liabilities, including derivative
instruments. EIC 173 is applied retrospectively without restatement of prior years to all financial
assets and liabilities measured at fair value in interim and annual financial statements for
periods ending on or after January 20, 2009. The adoption of EIC 173 did not have an impact on the
consolidated financial statements of the Company.
Financial instruments Disclosures
In June 2009, the AcSB issued amendments to CICA Handbook Section 3862, Financial Instruments
Disclosures, in order to align with IFRS 7, Financial Instruments: Disclosures. This Section has
been amended to include additional disclosure requirements about fair value measurements of
financial instruments and to enhance liquidity risk disclosure. The amendments establish a
three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These
tiers include: Level 1, defined as observable inputs such as quoted prices in active markets; Level
2, defined as inputs other than quoted prices in active markets that are either directly or
indirectly observable; and Level 3, defined as unobservable inputs in which little or no market
data exists, therefore requiring an entity to develop its own assumptions. The amendments apply to
annual financial statements relating to fiscal years ended after September 30, 2009 and are
applicable to the Company as at November 30, 2009. The amended section relates to disclosure only
and did not impact the financial results of the Company.
FUTURE ACCOUNTING CHANGES
Business combinations, consolidated financial statements and non-controlling interests
The CICA issued three new accounting standards in January 2009: Section 1582, Business
Combinations, Section 1601, Consolidated Financial Statements, and Section 1602, Non-controlling
Interests. The Company is in the process of evaluating the requirements of the new standards.
Section 1582 establishes standards for the accounting for a business combination. It provides the
Canadian equivalent to International Financial Reporting Standard IFRS 3 Business Combinations.
The section applies prospectively to business combinations for which the acquisition date is on or
after the beginning of the first annual reporting period beginning on or after January 1, 2011 and
early application is permitted.
Section 1601 establishes standards for the preparation of consolidated financial statements.
Section 1602 establishes standards for accounting for a non-controlling interest in a subsidiary in
consolidated financial statements. It is equivalent to the corresponding provisions of IFRS IAS 27
- Consolidated and Separate Financial Statements, Sections 1601 and 1602, and applies to interim
and annual consolidated financial statements relating to fiscal years beginning on or after January
1, 2011 and early application is permitted.
ANNUAL REPORT 2009 //// 23
International Financial Reporting Standards
In February 2008, Canadas AcSB confirmed that Canadian GAAP, as used by publicly accountable
enterprises, would be fully converged into IFRS, as issued by the International Accounting
Standards Board (IASB). The changeover date is for interim and annual financial statements
relating to fiscal years beginning on or after January 1, 2011. As a result, the Company will be
required to report under IFRS for its 2012 interim and annual financial statements. The Company
will convert to these new standards according to the timetable set within these new rules. The
Company will determine at a future date the impact of adopting the standards on its consolidated
financial statements.
Outstanding share data
At February 9, 2010, the number of shares issued and outstanding was 60,449,225 while
outstanding options granted under the stock option plan were 2,891,801.
Disclosure
controls and procedures
and internal control over financial reporting
As at November 30, 2009, an evaluation of the effectiveness of disclosure controls and
procedures, as defined in the rules of the Canadian Securities Administrators, was carried out.
Based on that evaluation, the President and Chief Executive Officer and the Senior Executive
Vice-President and Chief Financial Officer certified that the design and operating effectiveness of
those disclosure controls and procedures were effective.
Also at November 30, 2009, an evaluation of the effectiveness of internal controls over financial
reporting, as defined in the rules of the Canadian Securities Administrators, was carried out to
provide reasonable assurance regarding the reliability of financial reporting and financial
statement compliance with GAAP. Based on that evaluation, the President and Chief Executive Officer
and the Senior Executive Vice-President and Chief Financial Officer will certify that the design
and operating effectiveness of internal controls over financial reporting were effective.
These evaluations were based on the criteria outlined in the document entitled Internal Control
over Financial Reporting Guidance for Smaller Public Companies published by the Committee of
Sponsoring Organizations of the Treadway Commission, a recognized model, and as per Regulation
52-109 of the Canadian Securities Administrators. A disclosure committee comprised of members of
Senior Management assists the President and Chief Executive Officer and the Senior Executive
Vice-President and Chief Financial Officer in their responsibilities.
All internal control systems, no matter how well designed, have inherent limitations, including the
possibility of human error and the circumvention or overriding of the controls or procedures. As a
result, there is no certainty that disclosure controls and procedures or internal control over
financial reporting will prevent all errors or all fraud. There were no changes in internal
controls over financial reporting that occurred during the year ended November 30, 2009 that have
materially affected, or are reasonably likely to materially affect, internal controls over
financial reporting.
There were no changes in our internal controls over financial reporting that occurred during the
year ended November 30, 2009 that have materially affected, or are reasonably likely to materially
affect, the Companys internal controls over financial reporting.
24 //// ANNUAL REPORT 2009
Risks and uncertainties
Investors should understand that the Company operates in a high risk industry. The Company has
identified the following risks and uncertainties that may have a material adverse effect on its
business, financial condition or operating results. Investors should carefully consider the risks
described below before purchasing securities of the Company. The risks described below are not the
only ones the Company faces. Additional risks not presently known to the Company or that the
Company currently believes are immaterial may also significantly impair its business operations.
The Companys business could be harmed by any of these risks.
The commercial success of the Company depends largely on the development and commercialization of
tesamorelin; the failure by the Company to commercialize tesamorelin would have a material adverse
effect on the Company.
The Companys focus has been to advance the development of tesamorelin in which it has invested a
significant portion of its financial resources and time. Although the Company has other peptides,
all are at earlier stages of development.
The ability of the Company to generate revenues in the future is primarily based on the
commercialization of tesamorelin for the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy. In the short-term, these revenues should be primarily derived from the United
States market alone. Although the Company entered into the Collaboration and Licensing Agreement
for the commercialization of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy in the United States, there can be no guarantee that tesamorelin will
be commercialized in this country, or in any other country.
The commercialization of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy will depend on several factors:
|
|
|
receipt of regulatory approvals of tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy from the FDA and other regulatory
agencies; |
|
|
|
|
market acceptance of the product by the medical community, patients and third-party
payers (such as governmental health administration authorities and private health
coverage insurers); |
|
|
|
|
entering into one or more strategic alliance agreements with one or more partners or
building a marketing and sales force in countries other than the United States to help
with the regulatory approval and/or the marketing and sale of tesamorelin for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in those
countries; |
|
|
|
|
in the United States, the amount of resources used by the Companys commercial partner
to commercialize tesamorelin; |
|
|
|
|
maintaining manufacturing and supply agreements to ensure the availability of
commercial quantities of tesamorelin through validated processes; |
|
|
|
|
the number of competitors in the market; and |
|
|
|
|
protecting the Companys intellectual property and avoiding patent infringement claims. |
The Companys inability to commercialize tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy in the short term in the United States would delay its
capacity to generate revenues and would affect its financial condition and operating results.
ANNUAL REPORT 2009 //// 25
The Company does not have the required regulatory approval to commercialize its products and
cannot guarantee that it will obtain such regulatory approval.
The commercialization of the Companys products first requires the approval of the regulatory
agencies in each of the countries where it intends to sell its products. In order to obtain the
required approvals, the Company must demonstrate, following preclinical and clinical studies, the
safety, efficacy and quality of a product. As far as tesamorelin is concerned, the Company focused
its development to treat excess abdominal fat in HIV-infected patients with lipodystrophy and the
first market the Company wishes to penetrate for this treatment is the United States. The rules and
regulations relating to the approval of a new drug are complex and stringent and although the FDA
has accepted the filing of the Companys NDA, there can be no guarantee that the FDA will approve
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
In addition, there can be no guarantee that the Company will be able to obtain the regulatory
approvals of agencies in other countries to sell tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy.
All of the products of the Company are subject to preclinical and clinical studies. If the results
of such studies are not positive, the Company may not be in a position to make any filing to obtain
the mandatory regulatory approval or, even where a product has been filed for approval, it may have
to conduct additional clinical studies or testing on such product until the results support the
safety and efficacy of such product. Such studies are often costly and may also delay a filing or,
where additional studies or testing are required after a filing has been made, the approval of a
product.
While an application for a new drug is under review by a regulatory agency, it is standard for such
regulatory agency to ask questions regarding the application that was submitted. If these questions
are not answered quickly and in a satisfactory manner, the marketing approval of the product
subject to the review and its commercialization could be delayed or, if the questions are not
answered in a satisfactory manner, refused. If tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy is not approved for commercialization in the United
States by the FDA, the capacity of the Company to generate revenues in the short-term will be
hampered and this will have an adverse effect on its financial condition and its operating results.
The obtaining of regulatory approval is subject to the discretion of regulatory agencies.
Therefore, even if the Company obtains regulatory approval from one agency, or succeeds in filing
the equivalent of a NDA in other countries, or has obtained positive results relating to the safety
and efficacy of a product, a regulatory agency may not accept the filing or the results contained
therein as being conclusive evidence of the safety and efficacy of a product in order to allow the
Company to sell the product in its country. A regulatory agency may require that additional tests
on the safety and efficacy of a product be conducted prior to granting approval of a product and
such additional tests may delay the approval of a product, can have a material adverse affect on
the Companys financial condition based on the type of additional tests to be conducted and may not
necessarily lead to the approval of a product.
Although the Company has received a Special Protocol Assessment from the FDA and the Company has
followed it and met the primary medical end-points described therein, there can be no guarantee
that the FDA will approve tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. Even if the FDA approves tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy, there can be no guarantee that other
regulatory agencies will approve tesamorelin for this treatment in their respective countries.
26 //// ANNUAL REPORT 2009
Even if the Company obtains regulatory approval for any of its products, regulatory agencies
have the ability to limit the indicated use of a product. Also, the manufacture, marketing and sale
of the products will be subject to ongoing and extensive governmental regulation in the country in
which the Company intends to market its products. For instance, if the Company obtains marketing
approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in the United States, the marketing of tesamorelin will be subject to extensive
regulatory requirements administered by the FDA and other regulatory bodies, such as adverse event
reporting and compliance with all of the FDA marketing and promotional requirements. The
manufacturing facilities for the Companys tesamorelin will also be subject to continuous reviews
and periodic inspections and approval of manufacturing modifications. Manufacturing facilities are
subject to inspections by the FDA and must comply with the FDAs Good Manufacturing Practices
(hereafter GMP) regulations. The failure to comply with any of these post-approval requirements
can result in a series of sanctions, including withdrawal of the right to market a product.
The Company has no control over the timing of the review of its NDA by the FDA.
Although the FDA advised the Company that it had set a date of March 29, 2010 under the
Prescription Drug User Fee Act (United States), more commonly known as PDUFA, by which it targets
to have completed its review of the Companys NDA, there can be no guarantee that such date shall
be met. The Company has no control over the timing of the review of its NDA by the FDA and this
timing could vary based on the FDAs workload, potential review issues contained in the Companys
NDA and other similar factors over which the Company has no control.
Even if tesamorelin is ultimately approved by the FDA, any delay in completing the review of the
Companys NDA will result in a delay in the commercialization of tesamorelin for the treatment of
excess abdominal fat in HIV-infected patients with lipodystrophy and could materially adversely
affect the operating results of the Company and the development of future clinical programs.
The Company is dependent on the Collaboration and Licensing Agreement for the commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
in the United States. This agreement places the commercialization of tesamorelin outside of its
control.
Under the terms of the Collaboration and Licensing Agreement, the Company granted its commercial
partner the exclusive right to commercialize tesamorelin for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy in the United States. Although the agreement contains
provisions governing the commercialization of tesamorelin for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy in the United States, the Companys dependence on its
commercial partner for such purpose subjects it to a number of risks, including:
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the exact timing of the launch of tesamorelin in the United States, if approved by the
FDA; |
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the limited control by the Company on the amount and timing of resources that its
commercial partner will be devoting to the commercialization, marketing and distribution
of tesamorelin, which could adversely affect the Companys ability to obtain or maximize
its royalty payments; |
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disputes or litigation that may arise between the Company and its commercial partner,
which could adversely affect the commercialization of tesamorelin in the United States,
all of which will divert the attention of Companys Management and its resources; |
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its commercial partner not properly defending the Companys intellectual property
rights or using them in such a way as to expose the Company to potential litigation,
which could, in both cases, adversely affect the value of the Companys intellectual
property rights; |
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corporate reorganizations or changes in business strategies of its
commercial partner, which could adversely affect such commercial partners willingness or
ability to fulfill its obligations under the Collaboration and Licensing Agreement; |
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the termination of the Collaboration and Licensing Agreement, which would adversely
affect the commercialization of tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy in the United States. |
ANNUAL REPORT 2009 //// 27
The Company relies on third parties for the manufacture and supply of tesamorelin and such
reliance may adversely affect the Company if the third parties are unable to fulfill their
obligations.
The Company does not have the resources, facilities or experience to manufacture its products in
large quantities on its own. The Company relies on third parties to manufacture and supply
tesamorelin for clinical studies and currently intends to rely on third parties to manufacture and
supply large quantities of tesamorelin for commercial sales, if approved by the FDA or other
regulatory agencies.
The Companys reliance on third-party manufacturers exposes it to a number of risks. If third-party
manufacturers become unavailable to the Company for any reason, including as a result of the
failure to comply with GMP regulations, manufacturing problems or other operational failures, such
as equipment failures or unplanned facility shutdowns required to comply with GMP or damage from
any event, including fire, flood, earthquake, business restructuring or insolvency, or, if they
fail to perform their contractual obligations under agreements with the Company, such as failing to
deliver the quantities requested on a timely basis, the Company may be subject to delays in the
manufacturing of tesamorelin and any other peptide. Any delay in the supply of a product could slow
down or interrupt the conduct of clinical trials and, if a product has reached commercialization,
could prevent the supply of the product and accordingly, adversely affect the revenues of the
Company. Under the Collaboration and Licensing Agreement, the Company agreed to act as manufacturer
and supplier of tesamorelin for its commercialization in the United States. Accordingly, any delay
in manufacturing tesamorelin by third-party service providers may have a material adverse effect on
the sales and royalties payable to the Company. In addition, any manufacturing delay or delay in
delivering tesamorelin may result in the Company being in default under the Collaboration and
Licensing Agreement. If the damage to a third-party manufacturer facility is extensive, or, for any
reason, it does not operate in compliance with GMP or is unable or refuses to perform its
obligations under its agreement with the Company, the Company will need to find an alternative
third-party manufacturer. The selection of a third-party manufacturer will be time-consuming and
costly since the Company will need to validate the manufacturing facility of such new third-party
manufacturer. The validation will include an assessment of the capacity of such third-party
manufacturer to produce the quantities that may be requested from time to time by the Company, the
manufacturing process and its compliance with GMP. In addition, the third-party manufacturer will
have to familiarize itself with the Companys technology. Any delay in finding an alternative
third-party manufacturer of a product could result in a shortage of such product, a delay in
clinical study programs and in the filing for regulatory approval of a product and, if a product is
approved for commercialization, a shortage of such a product would result in lost revenue to the
Company.
Market acceptance of the Companys products is uncertain and depends on a variety of factors, some
of which are not under the control of the Company.
The Companys ability to commercialize its products with success will depend on a variety of
factors, including the extent to which reimbursement to patients for the cost of such products and
related treatment will be available from governmental health administration authorities, private
health coverage insurers and other organizations. Obtaining reimbursement approval for a product is
time-consuming and a costly process that could require the Company to provide supporting
scientific, clinical and cost effectiveness data for its use. There can be no guarantee that the
Companys data will be perceived as sufficient for third-party payers to accept to reimburse one of
the Companys products.
The Company has never made an application seeking reimbursement of a drug and must, therefore, rely
in part on third-party service providers or experienced partners to help it perform this task.
28//// ANNUAL REPORT 2009
Other factors that will have an impact on the acceptance of the Companys products include:
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acceptance of a product by physicians and patients as safe and effective treatments; |
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product price; |
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the effectiveness of the Companys sales and marketing efforts (or those of its commercial partners); |
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storage requirements and ease of administration; |
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dosing regimen; |
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safety and efficacy; |
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prevalence and severity of side effects; and |
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competitive products. |
The Companys financial condition could be affected by the introduction of new regulations or
amendments to existing regulations.
New regulations or changes to existing regulations affecting the Company and its potential
customers could decrease demand for the Companys products and affect its operating results and
financial condition. For example, the implementation of health care reform legislation that
regulates drug costs could limit the profits that can be made from the development of new drugs. In
addition, new laws or regulations could increase the Companys costs.
The Company must complete several preclinical and clinical studies for its products which may not
yield positive results and, consequently, could prevent it from obtaining regulatory approval.
Obtaining regulatory approval for the commercialization of drug products requires a demonstration
through preclinical and clinical studies that the drug is safe and effective. All of the Companys
molecules are in preclinical studies, except tesamorelin for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy, which is now under regulatory review at the FDA.
Tesamorelin is also being used in the Phase 2 studies conducted by the MGH and the University of
Washington. For the other molecules, and for tesamorelin in Phase 2 NIH studies, there could remain
preclinical and clinical studies to be conducted prior to determining whether such molecules will
show positive results of safety and efficacy.
If any of those studies are not positively conclusive or result in adverse patient reactions, this
may require the Company to extend the term of its studies, to increase the number of patients
enrolled in a given study or to undertake ancillary testing. Any of these events could increase the
cost of conducting clinical studies, delay the filing of an application for marketing approval with
regulatory agencies or result in the termination of a study and, accordingly, abandoning the
commercialization of a molecule. In addition, the growth of the Company could be compromised since
there can be no guarantee that the Company will be able to develop new molecules, license or
purchase compounds or products that will result in marketed products.
ANNUAL REPORT 2009 //// 29
The Company relies on third-party service providers to conduct its preclinical and clinical
studies and respond to the FDAs questions regarding the Companys NDA submission. The failure by
one of these third parties to comply with their obligations may delay the studies, have an adverse
effect on the Companys development program and/or delay the commercialization of tesamorelin for
the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
The Company has limited human resources to conduct preclinical and clinical studies and must rely
on third-party service providers to conduct its studies and carry out certain data gathering and
analyses. If the Companys third-party service providers become unavailable for any reason,
including as a result of the failure to comply with the rules and regulations governing the conduct
of preclinical and clinical studies, operational failures such as equipment failures or unplanned
facility shutdowns, or damage from any event such as fire, flood, earthquake, business
restructuring or insolvency or, if they fail to perform their contractual obligations pursuant to
the terms of the agreements entered into with the Company, such as failing to do the testing,
compute the data or complete the reports further to the testing, the Company may incur delays in
connection with the planned timing of its studies which could adversely affect the timing of the
development program of a molecule or the filing of an application for marketing approval in a
jurisdiction where the Company relies on third-party service provider to make such filing. In
addition, where the Company relies on such third-party service provider to help in answering any
question raised by a regulatory agency during its review of a Company file, the unavailability of
such third-party service provider may adversely affect the timing of the review of an application
and, could ultimately delay the approval. If the damages to any of the Companys third-party
service providers are material, or, for any reason, such providers do not operate in compliance
with GLP or are unable or refuse to perform their contractual obligations, the Company would need
to find alternative third-party service providers.
If the Company must change or select new third-party service providers, the planned working
schedule related to preclinical and/or clinical studies could be delayed since the number of
competent and reliable third-party service providers of preclinical and clinical work in compliance
with GLP is limited. In addition, if the Company must change or select new third-party service
providers to carry out work in response to a regulatory agency review of a Companys application,
there may occur delays in responding to such regulatory agency which, in turn, may lead to delays
in commercializing a product.
Any selection of new third-party service providers to carry out work related to preclinical and
clinical studies would be time-consuming and would result in additional delays in receiving data,
analysis and reports from such third-party service providers which, in turn, would delay the filing
of any new drug application with regulatory agencies for the purposes of obtaining regulatory
approval to commercialize the Companys products. Furthermore, such delays could increase the
Companys expenditures to develop a product and materially adversely affect its financial condition
and operating results.
The conduct of clinical trials requires the enrollment of patients and difficulties in enrolling
patients could delay the conduct of the Companys clinical trials or result in their
non-completion.
The conduct of clinical trials by the Company requires the enrollment of patients. Depending on the
phase of the trials and/or the type of trials which must be conducted, the number of patients may
vary. Phase 1 and Phase 2 trials generally require a smaller number of patients than Phase 3
trials.
The Company may have difficulties enrolling patients for the conduct of its clinical trials as a
result of design protocol, the size of the patient population, the eligibility criteria to
participate in the clinical trials, the availability of competing therapies, the patient referral
practices of physicians and the availability of clinical trial sites. The Companys difficulty in
enrolling patients for its clinical trials could result in the cancellation of clinical trials or
delays in completing them. Any of these events would have adverse consequences on the timely
development of new products, the filing of an NDA, or its equivalent, with regulatory agencies and
the commercialization of the Companys products. Such events would adversely affect the business,
the financial condition and operating results of the Company.
30 //// ANNUAL REPORT 2009
The Companys capacity to generate revenues may be limited by governmental control over the
pricing of prescription drugs.
In some countries, the pricing of prescription drugs is subject to governmental control. In some of
these countries, pricing negotiations with governmental authorities and reimbursement structures
may delay the marketing of a product. If reimbursement of the Companys products is unavailable or
limited in scope or amount, or if pricing is set at unsatisfactory levels, the revenues of the
Company could be adversely affected.
The Company must enter into strategic alliance agreements with third parties for the sale and
marketing of its products and there is no guarantee that the Company will be able to achieve these
tasks.
Although the Company was successful in finding a third party for the commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
in the United States and although the Company has ongoing discussions with third parties with the
aim of entering into strategic alliance agreements with such third parties to commercialize
tesamorelin outside of the United States, the conclusion of an agreement with a party is a lengthy
process which includes, among other things, an analysis of the capacity of the third party, the
assessment of the services to be performed by the third party, due diligence on the Companys
products and the negotiation of the terms and conditions of the agreement. The outcome of this
process is uncertain and the Company may not be able to conclude any other strategic alliance
agreements for the commercialization of its products, including the commercialization of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
in territories other than the United States. The commercialization of the Companys products may be
delayed if it is unable to find third parties to commercialize its products and this could
adversely materially affect the financial condition and the operating results of the Company. Even
if the Company enters into strategic alliance agreements with third parties for the
commercialization of its products, those agreements often contain termination provisions which, if
exercised, could delay the commercialization of its products given that the Company has no sales
force. If the Company does not succeed in entering into a strategic alliance agreement for a
particular territory, it would then not succeed in commercializing the product in such a territory.
In such an event, the Company may decide to commercialize the product itself in that territory and
the Company has no experience in commercializing a product in any market.
The Companys intent to possibly retain the commercial rights of its products for Canada implies
that it would market and sell the product itself on the Canadian market. However, the Company
currently has limited marketing capabilities and it has limited experience in developing, training
or managing a sales force. The development of a sales force would be costly and would be
time-consuming given the limited experience the Company has in this area. To the extent the Company
develops a sales force, the Company could be competing against companies that have more experience
in managing a sales force than the Company has and that have access to more funds than the Company
with which to manage a sales force. Consequently, there can be no guarantee that a sales force
which the Company develops would be efficient and would maximize the revenues derived from the sale
of a Company product.
ANNUAL REPORT 2009 //// 31
The failure by the Company to protect its intellectual property may have a material adverse
effect on its ability to develop and commercialize its products.
The Company will be able to protect its intellectual property rights from unauthorized use by third
parties only to the extent that its intellectual property rights are covered by valid and
enforceable patents or are effectively maintained as trade secrets. The Company tries to protect
its intellectual property position by filing patent applications related to its proprietary
technology, inventions and improvements that are important to the development of its business.
Because the patent position of pharmaceutical companies involves complex legal and factual
questions, the issuance, scope and enforceability of patents cannot be predicted with certainty.
Patents, if issued, may be challenged, invalidated or circumvented. If the Companys patents are
invalidated or found to be unenforceable, it would lose the ability to exclude others from making,
using or selling the inventions claimed. Moreover, an issued patent does not guarantee the Company
the right to use the patented technology or commercialize a product using that technology. Third
parties may have blocking patents that could be used to prevent the Company from developing its
product candidates, selling its products or commercializing its patented technology. Thus, patents
that the Company owns may not allow it to exploit the rights conferred by its intellectual property
protection. The Companys pending patent applications may not result in patents being issued. Even
if issued, they may not be issued with claims sufficiently broad to protect its products and
technologies or may not provide the Company with a competitive advantage against competitors with
similar products or technologies. Furthermore, others may independently develop products or
technologies similar to those that the Company has developed or discover the Companys trade
secrets. In addition, the laws of many countries do not protect intellectual property rights to the
same extent as the laws of Canada and the United States, and those countries may also lack adequate
rules and procedures for defending intellectual property rights effectively.
Although the Company has received a patent from the USPTO for the treatment of HIV-related
lipodystrophy with tesamorelin, there can be no guarantee that the Company will receive a patent in
the other countries where it filed patent applications for the treatment of HIV-related
lipodystrophy.
The Company also relies on trade secrets, know-how and technology, which are not protected by
patents, to maintain its competitive position. The Company tries to protect this information by
entering into confidentiality undertakings with parties who have access to such confidential
information, such as the Companys current and prospective suppliers, employees and consultants.
Any of these parties may breach the undertakings and disclose confidential information to the
Companys competitors.
Enforcing a claim that a third party illegally obtained and is using trade secrets is expensive and
time-consuming and the outcome is unpredictable. In addition, it could divert Managements
attention from the Companys business. If any trade secret, know-how or other technology not
protected by a patent were to be disclosed to or independently developed by a competitor, the
Companys competitive position could be harmed.
The Companys ability to defend against infringement by third parties of its intellectual property
in the Unites States with respect to tesamorelin for the treatment of HIV-related lipodystrophy
depends, in part, on its commercial partners decision to bring an action against such third party.
Under the terms and conditions of the Collaboration and Licensing Agreement, the Companys
commercial partner has the first right to bring an action against a third party infringing on the
Companys intellectual property with respect to tesamorelin for the treatment of HIV-related
lipodystrophy. Any delay in pursuing such action or in advising the Company that it does not intend
to pursue the matter could decrease sales, if any, of tesamorelin for the treatment of HIV-related
lipodystrophy and adversely affect the Companys revenues.
32 //// ANNUAL REPORT 2009
The Companys commercial success depends, in part, on its ability not to infringe on third
parties patents and other intellectual property rights.
The Companys capacity to commercialize its products, and more particularly tesamorelin, will
depend, in part, on the non-infringement of third parties patents and other intellectual property
rights. The biopharmaceutical and pharmaceutical industries have produced a multitude of patents
and it is not always easy for participants, including the Company, to determine which patents cover
various types of products or methods of use. The scope and breadth of patents is subject to
interpretation by the courts and such interpretation may vary depending on the jurisdiction where
the claim is filed and the court where such claim is litigated. The holding of patents by the
Company for tesamorelin and its application in HIV-related lipodystrophy does not guarantee that
the Company is not infringing on other third-party patents and there can be no guarantee that the
Company will not be in violation of third-party patents and other intellectual property rights.
Patent analysis for non-infringement is based in part on a review of publicly available databases.
Although the Company reviews from time to time certain databases to conduct patent searches, it
does not have access to all databases. It is also possible that some of the information contained
in the databases has not been reviewed by the Company or was found to be irrelevant at the time the
searches were conducted. In addition, because patents take years to be issued, there may be
currently pending applications that the Company is unaware of, which may later be issued. As a
result of the foregoing, there can be no guarantee that the Company will not violate third-party
patents.
Because of the difficulty in analyzing and interpreting patents, there can be no guarantee that a
third party will not assert that the Company infringes upon any of such third-partys patents or
any of its other intellectual property rights. Under such circumstances, there is no guarantee that
the Company would not become involved in litigation. Litigation with any third party, even if the
allegations are without merit, is expensive, time-consuming and would divert Managements attention
from the daily execution of the Companys business plan. Litigation implies that a portion of the
Companys financial assets would be used to sustain the costs of litigation instead of being
allocated to further the development of its business plan.
If the Company is involved in a patent infringement litigation, it would need to demonstrate that
its products do not infringe the patent claims of the relevant patent, that the patent claims are
invalid or that the patent is unenforceable. If the Company was to be found liable for infringement
of third-party patents or other intellectual property rights, the Company could be required to
enter into royalty or licensing agreements on terms and conditions that may not be favourable to
the Company, and/or pay damages, including up to treble damages (but only if found liable of wilful
infringement) and/or cease the development and commercialization of its products. Any finding that
the Company is guilty of patent infringement could materially adversely affect the business,
financial condition and operating results of the Company.
The Company has not been served with any notice that it is infringing on a third-party patent, but
there may be issued patents that the Company is unaware of that its products may infringe, or
patents that the Company believes it does not infringe but could be found to be infringing. The
Company has reviewed, and is aware of, third-party patents for the reduction of accumulation of
abdominal fat tissue in HIV patients and the Company believes that it does not infringe any valid
claims of these patents.
The Company faces competition and the development of new products by other companies could
materially adversely affect the Companys business and its products.
The biopharmaceutical and pharmaceutical industries are highly competitive and the Company must
compete with pharmaceutical companies, biotechnology companies, academic and research institutions
as well as governmental agencies for the development and commercialization of products. Although
the Company believes that it has few direct competitors for the treatment of excess abdominal fat
in HIV-infected patients with lipodystrophy, it could face indirect competition.
ANNUAL REPORT 2009 //// 33
In the other clinical programs currently being evaluated by the Company for development, there
may exist companies that are at a more advanced stage of developing a product to treat the diseases
for which the Company is evaluating clinical programs. Some of these competitors could have access
to capital resources, research and development personnel and facilities that are superior to those
of the Company. In addition, some of these competitors could be more experienced than the Company
in the commercialization of medical products and already have a sales force in place to launch new
products. Consequently, they may be able to develop alternative forms of medical treatment which
could compete with the products of the Company and could be commercialized more rapidly and
effectively than the products of the Company.
The Companys business may be harmed if it is unable to manage its growth effectively.
The Company expects to experience rapid growth throughout its operations if tesamorelin is
commercialized. Such growth would place a strain on operational, human, and financial resources. To
manage its growth, the Company will have to further develop its operating and administrative
systems and attract and retain qualified Management, professional, scientific, and technical
operating personnel.
There can be no guarantee that the Company will be successful in developing such systems and
attracting and retaining qualified personnel. Failure to manage growth effectively could have an
adverse effect on the Companys business, financial condition and operating results.
The Company depends on its key personnel to research, develop and bring new products to the market
and the loss of key personnel or the inability to attract highly qualified individuals could have a
material adverse effect on its business and growth potential.
The Companys mission is to discover or acquire novel therapeutic products targeting unmet medical
needs in financially attractive specialty markets. The achievement of this mission requires
qualified scientific and management personnel. The loss of scientific personnel or of members of
Management could have a material adverse effect on the business of the Company. In addition, the
Companys growth is and will continue to be dependent, in part, on its ability to retain and hire
qualified personnel. There can be no guarantee that the Company will be able to continue to retain
its current employees or will be able to attract qualified personnel to pursue its business plan.
The Company is not profitable and may never achieve profitability.
For the financial year ended November 30, 2009, the Company reported losses of $15,058,000. The
Company has been reporting losses since its inception (except for the financial years ended
November 30, 2001 and 2000) and, as at November 30, 2009, it had an accumulated deficit of
$243,887,000. The Company does not expect to generate significant recurrent revenues in the
immediate future and will continue to experience losses as it continues its efforts to obtain
regulatory approvals for tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy in the United States and other countries. As a result of the foregoing,
the Company will need to generate significant revenues to achieve profitability.
The Companys profitability will depend on its capacity (i) to obtain regulatory approval for the
use of tesamorelin in the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in the United States and on the capacity of its commercial partner to commercialize
tesamorelin for such indication and (ii) to expand the commercialization of tesamorelin in other
territories. However, there is no guarantee that the Company will succeed in commercializing any of
its products (including tesamorelin) and, accordingly, the Company may never become profitable.
34 //// ANNUAL REPORT 2009
The Company may require additional funding and may not be able to raise the capital necessary
to continue and complete the research and development of its products and their commercialization.
Although the Company has enough funding to support its current business plan, the Company does not
generate significant revenues and may need financing in order to sustain its growth, to continue
its research and development of new products and clinical programs, to develop its marketing and
commercial capabilities and to meet its compliance obligations with various rules and regulations
to which it is subject. In the past, the Company has been financed through public equity offerings
and the Company may effect additional equity offerings to raise capital, the size of which cannot
be predicted. The issuance and sale of substantial amounts of equity, or other securities, or the
perception that such issuances and sales may occur could adversely affect the market price of the
common shares.
Moreover, the market conditions or the business performance of the Company may prevent the Company
from having access to the public market in the future. Therefore, there can be no guarantee that
the Company will be able to continue to raise capital by way of public equity offerings. In such a
case, the Company will have to use other means of financing, such as issuing debt instruments or
entering into private financing agreements, the terms and conditions of which may not be favourable
to the Company. If adequate funding is not available to the Company, it may be required to delay,
reduce, or eliminate its research and development of new products, its clinical trials or its
marketing and commercialization efforts to launch and distribute new products.
The Company may not receive the full payment of all milestones or royalty payments pursuant to the
agreements entered into with third parties and, consequently, the financial condition and operating
results of the Company could be adversely impacted.
The Company has entered into license agreements and other forms of agreements with third parties
regarding the development and commercialization of some of its products. These agreements generally
require that the third party pays to the Company certain amounts upon the attainment of various
milestones and royalties on the sales of the developed product. There can be no guarantee that the
Company will receive the payments described in those agreements since the development of products
may be cancelled if the research does not yield positive results. Under such circumstances, the
Company would also not receive royalties. Even if the development of a product yields positive
results, all of the risks described herein with respect to the obtaining of regulatory approval are
applicable. Finally, if there occurs a disagreement between the Company and the third party, the
payment relating to the attainment of milestones or of royalties may be delayed. The occurrence of
any of those circumstances could have a material adverse effect on the Companys financial
condition and operating results.
The Company may not achieve its publicly announced milestones on time.
From time to time, the Company publicly announces the timing of certain events to occur. These
statements are forward-looking and are based on the best estimate of Management relating to the
occurrence of such events. However, the actual timing of such events may differ from what has been
publicly disclosed. Events such as completion of a clinical program, discovery of a new product,
filing of an application to obtain regulatory approval, beginning of commercialization or
announcement of additional clinical programs for a product may vary from what is publicly
disclosed. These variations may occur as a result of a series of events, including the nature of
the results obtained during a clinical trial or during a research phase, problems with a supplier
or a commercial partner or any other event having the effect of delaying the publicly announced
timeline. The Companys policy on forward-looking information consists of not updating it if the
publicly disclosed timeline varies. Any variation in the timing of certain events having the effect
of postponing such events could have an adverse material effect on the business plan, financial
condition or operating results of the Company.
ANNUAL REPORT 2009 //// 35
The outcome of scientific research is uncertain and the failure by the Company to discover new
products could slow down the growth of its portfolio of products.
The Company conducts research activities in order to increase its portfolio of products. The
outcome of scientific research is uncertain and may prove unsuccessful and, therefore, may not lead
to the discovery of new molecules and progression of existing molecules to an advanced development
stage. The inability of the Company to develop new molecules or to further develop the existing
ones could slow down the growth of its portfolio of products.
The development and commercialization of drugs could expose the Company to liability claims which
could exceed its insurance coverage.
A risk of product liability claims is inherent in the development and commercialization of human
therapeutic products. Product liability insurance is very expensive and offers limited protection.
A product liability claim against the Company could potentially be greater than the available
coverage and, therefore, have a material adverse effect upon the Company and its financial
condition. Furthermore, a product liability claim could tarnish the Companys reputation, whether
or not such claims are covered by insurance or are with or without merit.
The Companys common share price is volatile and investors could lose money as a result of such
volatility.
The market price of the Companys common shares is subject to volatility. General market conditions
as well as differences between the Companys financial, scientific and clinical results and the
expectations of investors as well as securities analysts can have a significant impact on the
trading price of the Companys common shares. In recent years, the stocks of many biopharmaceutical
companies have experienced extreme price fluctuations, unrelated to the operating performance of
the affected companies. There can be no assurance that the market price of the common shares will
not continue to experience significant fluctuations in the future, including fluctuations that are
unrelated to the Companys performance. The occurrence of any of the above risks and uncertainties
could have a material adverse effect on the price of the common shares.
36 //// ANNUAL REPORT 2009
Forward-looking information
This annual report and the MD&A contained herein, include certain statements that are
considered forward-looking information within the meaning of applicable securities legislation.
This forward-looking information includes, but is not limited to, information regarding the
commercialization of tesamorelin in the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy, the receipt of royalties related to sales of tesamorelin, the development of
tesamorelin in additional markets, the conclusion of strategic partnerships, and the liquidity
needs to finance the Companys operations. Furthermore, the words will, may, could, should,
outlook, believe, plan, envisage, anticipate, expect and estimate, or the negatives
of these terms or variations of them and the use of the conditional tense as well as similar
expressions denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control, that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties are described under the section Risks and
Uncertainties above.
Although the forward-looking information contained in this MD&A is based upon what the Company
believes are reasonable assumptions, investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking information. Certain assumptions
made in preparing the forward-looking information and the Companys objectives include the
assumption that the FDA will approve tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy, that the Companys business plan will not be
substantially modified and that current relationships with the Companys third-party suppliers of
services and products will remain good.
Consequently, all of the forward-looking information contained in this MD&A are qualified by the
foregoing cautionary statements, and there can be no guarantee that the results or developments
anticipated by the Company will be realized or, even if substantially realized, that they will have
the expected consequences or effects on the Company, its business, financial condition or results
of operation.
Further information on Theratechnologies
Further information on Theratechnologies, including the Companys Annual Information Form, is
available on the SEDAR site at www.sedar.com.
ANNUAL REPORT 2009 //// 37
ex-99.8
Exhibit 99.8
MANAGEMENTS
REPORT
The consolidated financial statements of Theratechnologies Inc. presented in the following
pages and all information in this annual report are the responsibility of Management and have been
approved by the Board of Directors of the Company.
These financial statements have been prepared by Management in accordance with accounting
principles generally accepted in Canada. They include amounts based on exercise of judgment and on
estimates. Management has established these amounts reasonably to ensure that financial results are
presented accurately in all material respects. The other financial information included in the
annual report is consistent with that of the financial statements.
In order to ensure accuracy and objectiveness of information included in the financial statements,
the Companys Management maintains internal accounting and administrative control systems.
Management is of the opinion that these controls provide reasonable assurance regarding the
adequacy of the accounting records for the preparation of the financial statements and the adequacy
of the recording and safeguarding of assets.
The Board of Directors is responsible for ensuring that Management fulfills its responsibilities
for financial reporting and internal control. The Board carries out this responsibility principally
through its Audit Committee. The Audit Committee is appointed by the Board, and none of its members
is involved in the daily operations of the Company. All the members of this Committee are
financially literate. The Committee meets periodically with Management and the external auditors to
discuss internal controls over the financial reporting process, auditing matters and financial
reporting issues, to satisfy itself that everyone is properly discharging their responsibilities,
and to review the financial statements with the external auditors.
The Committee reports its findings to the Board for consideration when approving the financial
statements for issuance to the shareholders. The Committee also considers, for review by the Board
and approval by the shareholders, the re-appointment of the external auditors.
The financial statements have been audited on behalf of the shareholders by KPMG LLP, the external
auditors, in accordance with Canadian generally accepted auditing standards. The external auditors
have full and free access to the Audit Committee with respect to their findings concerning the
fairness of the financial reporting and the adequacy of internal controls.
|
|
|
|
|
|
YVES ROSCONI
|
|
LUC TANGUAY |
PRESIDENT AND
|
|
SENIOR EXECUTIVE VICE PRESIDENT |
CHIEF EXECUTIVE OFFICER
|
|
AND CHIEF FINANCIAL OFFICER |
MONTRÉAL,
CANADA
FEBRUARY 10, 2010
38 //// 2009 ANNUAL REPORT
AUDITORS REPORT
TO THE SHAREHOLDERS
We have audited the consolidated balance sheets of Theratechnologies Inc. as at November 30,
2009 and 2008 and the consolidated statements of earnings, comprehensive loss, shareholders equity
and cash flows for the years then ended. These financial statements are the responsibility of the
Companys Management. Our responsibility is to express an opinion on these financial statements
based on our audits.
We conducted our audits in accordance with Canadian generally accepted auditing standards. Those
standards require that we plan and perform an audit to obtain reasonable assurance whether the
financial statements are free of material misstatement. An audit includes examining, on a test
basis, evidence supporting the amounts and disclosures in the financial statements. An audit also
includes assessing the accounting principles used and significant estimates made by Management, as
well as evaluating the overall financial statement presentation.
In our opinion, these consolidated financial statements present fairly, in all material respects,
the financial position of the Company as at November 30, 2009 and 2008 and the results of its
operations and its cash flows for the years then ended in accordance with Canadian generally
accepted accounting principles.
CHARTERED ACCOUNTANTS
MONTRÉAL, CANADA
JANUARY 22, 2010
(EXCEPT FOR NOTE 15 A),
WHICH IS AS OF FEBRUARY 10, 2010)
* CA Auditor permit no. 14114
2009 ANNUAL REPORT //// 39
CONSOLIDATED
BALANCE SHEETS
NOVEMBER 30, 2009 AND 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
|
|
|
|
(restated |
|
(in thousands of dollars) |
|
2009 |
|
|
note 2A)) |
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
1,519 |
|
|
$ |
133 |
|
Bonds |
|
|
10,036 |
|
|
|
10,955 |
|
Accounts receivable |
|
|
375 |
|
|
|
610 |
|
Tax credits receivable |
|
|
1,666 |
|
|
|
1,784 |
|
Inventories |
|
|
2,225 |
|
|
|
|
|
Research supplies |
|
|
287 |
|
|
|
301 |
|
Prepaid expenses |
|
|
302 |
|
|
|
397 |
|
|
|
|
|
16,410 |
|
|
|
14,180 |
|
|
|
|
|
|
|
|
|
|
Bonds |
|
|
51,807 |
|
|
|
35,249 |
|
Property and equipment (note 4) |
|
|
1,229 |
|
|
|
1,299 |
|
Other assets (note 5) |
|
|
41 |
|
|
|
2,817 |
|
|
|
|
$ |
69,487 |
|
|
$ |
53,545 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
5,901 |
|
|
$ |
7,198 |
|
Current portion of deferred revenues (note 7) |
|
|
6,847 |
|
|
|
|
|
|
|
|
|
12,748 |
|
|
|
7,198 |
|
Deferred revenues (note 7) |
|
|
13,691 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Capital stock (note 6) |
|
|
279,169 |
|
|
|
269,219 |
|
Contributed surplus |
|
|
6,484 |
|
|
|
5,585 |
|
|
|
|
|
|
|
|
|
|
Accumulated other comprehensive income |
|
|
1,282 |
|
|
|
372 |
|
Deficit |
|
|
(243,887 |
) |
|
|
(228,829 |
) |
|
|
|
|
(242,605 |
) |
|
|
(228,457 |
) |
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
43,048 |
|
|
|
46,347 |
|
|
|
|
|
|
|
|
|
|
Commitments (note 9) |
|
|
|
|
|
|
|
|
Subsequent events (note 15) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
69,487 |
|
|
$ |
53,545 |
|
|
See accompanying notes to consolidated financial statements.
On behalf of the Board:
|
|
|
|
|
|
PAUL POMMIER
|
|
JEAN-DENIS TALON |
DIRECTOR
|
|
DIRECTOR |
40 //// 2009 ANNUAL REPORT
CONSOLIDATED STATEMENTS
OF EARNINGS
YEARS ENDED NOVEMBER 30, 2009 AND 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
|
|
|
|
(restated |
|
(in thousands of dollars, except per share amounts) |
|
2009 |
|
|
note 2 A)) |
|
|
Revenues: |
|
|
|
|
|
|
|
|
Royalties, technologies and other (note 7) |
|
$ |
17,468 |
|
|
$ |
214 |
|
Interest |
|
|
2,252 |
|
|
|
2,427 |
|
|
|
|
|
19,720 |
|
|
|
2,641 |
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
22,226 |
|
|
|
35,326 |
|
Tax credits |
|
|
(1,795 |
) |
|
|
(2,111 |
) |
|
|
|
|
20,431 |
|
|
|
33,215 |
|
General and administrative |
|
|
7,149 |
|
|
|
6,185 |
|
Selling and market development |
|
|
2,583 |
|
|
|
3,811 |
|
Patents, amortization and impairment of other assets (note 5) |
|
|
346 |
|
|
|
5,239 |
|
Fees associated with the strategic review process |
|
|
|
|
|
|
2,224 |
|
Fees associated with the Collaboration and Licensing
Agreement (note 7) |
|
|
4,269 |
|
|
|
|
|
|
|
|
|
34,778 |
|
|
|
50,674 |
|
|
Operating loss before undernoted item |
|
|
(15,058 |
) |
|
|
(48,033 |
) |
Realized loss on impairment of available-for-sale financial
assets (note 11 B)) |
|
|
|
|
|
|
(578 |
) |
|
Net loss |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
|
Basic and diluted loss per share (note 6 C)) |
|
$ |
(0.25 |
) |
|
$ |
(0.85 |
) |
|
Weighted average number of common shares outstanding |
|
|
60,314,309 |
|
|
|
57,415,468 |
|
|
|
See accompanying notes to consolidated financial statements. |
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENTS
OF COMPREHENSIVE LOSS
YEARS ENDED NOVEMBER 30, 2009 AND 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
|
|
|
|
(restated |
|
(in thousands of dollars) |
|
2009 |
|
|
note 2A)) |
|
|
Net loss |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
Unrealized gains on available-for-sale financial assets |
|
|
1,039 |
|
|
|
133 |
|
Reclassification adjustment for gains and losses
on available-for-sale financial assets (note 11 B)) |
|
|
(129 |
) |
|
|
572 |
|
|
Comprehensive loss |
|
$ |
(14,148 |
) |
|
$ |
(47,906 |
) |
|
See accompanying notes to consolidated financial statements.
2009 ANNUAL REPORT //// 41
CONSOLIDATED STATEMENTS
OF SHAREHOLDERS EQUITY
YEARS ENDED NOVEMBER 30, 2009 AND 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
comprehensive |
|
|
|
|
|
|
|
|
|
Capital stock |
|
|
Contributed |
|
|
income |
|
|
|
|
|
|
|
(in thousands of dollars) |
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
(loss) |
|
|
Deficit |
|
|
Total |
|
|
Balance, November 30, 2007 |
|
|
54,531,133 |
|
|
$ |
238,842 |
|
|
$ |
4,807 |
|
|
$ |
(333 |
) |
|
$ |
(177,339 |
) |
|
$ |
65,977 |
|
Changes in accounting policies (note 2 A)) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(941 |
) |
|
|
(941 |
) |
Issuance of share capital (note 6) |
|
|
3,564,291 |
|
|
|
29,899 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,899 |
|
Share issue costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,938 |
) |
|
|
(1,938 |
) |
Exercise of stock options: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash proceeds |
|
|
119,666 |
|
|
|
397 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
397 |
|
Ascribed value |
|
|
|
|
|
|
81 |
|
|
|
(81 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
859 |
|
|
|
|
|
|
|
|
|
|
|
859 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(48,611 |
) |
|
|
(48,611 |
) |
Change in unrealized gains and losses
on available-for-sale financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
705 |
|
|
|
|
|
|
|
705 |
|
|
Balance, November 30, 2008 |
|
|
58,215,090 |
|
|
|
269,219 |
|
|
|
5,585 |
|
|
|
372 |
|
|
|
(228,829 |
) |
|
|
46,347 |
|
Issuance of share capital (note 6) |
|
|
2,214,303 |
|
|
|
9,950 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,950 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
899 |
|
|
|
|
|
|
|
|
|
|
|
899 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(15,058 |
) |
|
|
(15,058 |
) |
Change in unrealized gains and losses
on available-for-sale financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
910 |
|
|
|
|
|
|
|
910 |
|
|
Balance, November 30, 2009 |
|
|
60,429,393 |
|
|
$ |
279,169 |
|
|
$ |
6,484 |
|
|
$ |
1,282 |
|
|
$ |
(243,887 |
) |
|
$ |
43,048 |
|
|
See accompanying notes to consolidated financial statements.
42 //// 2009 ANNUAL REPORT
CONSOLIDATED STATEMENTS
OF CASH FLOW
YEARS ENDED NOVEMBER 30, 2009 AND 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
|
|
|
|
(restated |
|
(in thousands of dollars) |
|
2009 |
|
|
note 2A)) |
|
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
Adjustments for: |
|
|
|
|
|
|
|
|
Amortization of property and equipment |
|
|
612 |
|
|
|
625 |
|
Amortization and impairment of other assets |
|
|
|
|
|
|
4,957 |
|
Stock-based compensation |
|
|
899 |
|
|
|
859 |
|
Realized loss on impairment of available-for-sale financial assets |
|
|
|
|
|
|
578 |
|
|
|
|
|
(13,547 |
) |
|
|
(41,592 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Interest receivable on bonds |
|
|
(923 |
) |
|
|
405 |
|
Accounts receivable |
|
|
260 |
|
|
|
(134 |
) |
Tax credits receivable |
|
|
118 |
|
|
|
(366 |
) |
Inventories |
|
|
(2,225 |
) |
|
|
|
|
Research supplies |
|
|
2,765 |
|
|
|
582 |
|
Prepaid expenses |
|
|
95 |
|
|
|
17 |
|
Accounts payable and accrued liabilities |
|
|
(1,424 |
) |
|
|
(1,324 |
) |
Deferred revenues |
|
|
20,538 |
|
|
|
|
|
|
|
|
|
19,204 |
|
|
|
(820 |
) |
|
|
|
|
5,657 |
|
|
|
(42,412 |
) |
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Share issuance |
|
|
9,950 |
|
|
|
30,296 |
|
Share issue costs |
|
|
(8 |
) |
|
|
(1,930 |
) |
|
|
|
|
9,942 |
|
|
|
28,366 |
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Additions to property and equipment |
|
|
(407 |
) |
|
|
(301 |
) |
Acquisition of bonds |
|
|
(29,111 |
) |
|
|
(17,987 |
) |
Disposal of bonds |
|
|
15,305 |
|
|
|
29,889 |
|
|
|
|
|
(14,213 |
) |
|
|
11,601 |
|
|
Net change in cash |
|
|
1,386 |
|
|
|
(2,445 |
) |
Cash, beginning of year |
|
|
133 |
|
|
|
2,578 |
|
|
Cash, end of year |
|
$ |
1,519 |
|
|
$ |
133 |
|
|
See note 11 for supplemental cash flow information.
See accompanying notes to consolidated financial statements.
2009 ANNUAL REPORT //// 43
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
1. |
|
Organization and business activities |
|
|
The Company, incorporated under Part 1A of the Québec Companies Act, is a Canadian
biopharmaceutical company that discovers and develops novel therapeutic products, with an
emphasis on peptides, for commercialization. The Company targets unmet medical needs in
financially attractive speciality markets where it can retain all or some of the whole or a
part of the commercial rights for its products. |
2. |
|
New accounting policies |
|
A) |
|
ADOPTION OF NEW ACCOUNTING STANDARDS |
|
|
|
Goodwill and intangible assets |
|
|
|
Effective with the commencement of its 2009 fiscal year, the Company adopted the Canadian
Institute of Chartered Accountants (CICA) Handbook Section 3064, Goodwill and
Intangible Assets, which will replace Section 3062, Goodwill and Other Intangible Assets,
and Section 3450, Research and Development Costs. The standard provides guidance on the
recognition of intangible assets in accordance with the definition of an asset and the
criteria for asset recognition, whether these assets are separately acquired or
internally developed. The impact of adopting this standard has been to increase the
opening deficit and to reduce other assets at December 1, 2007 and 2008 by $941 and $599,
respectively, which is the amount of patent costs related to periods prior to these
dates. Furthermore, following the adoption of this standard, patents and amortization of
other assets presented on the consolidated statements of earnings were reduced by $342
for the year ended November 30, 2008. |
|
|
|
Effective with the commencement of its 2009 fiscal year, the Company adopted CICA Section
3031, Inventories, which replaces Section 3030 and harmonizes the Canadian standards
related to inventories with International Financial Reporting Standards (IFRS). This
Section provides changes to the measurement and more extensive guidance on the
determination of cost, including allocation of overhead; narrows the permitted cost
formulas; requires impairment testing; and expands the disclosure requirements to
increase transparency. As the Company had no inventories on November 30, 2008, the
adoption of this section had no impact on the Companys consolidated financial
statements. |
|
|
|
Credit risk and fair value of financial assets and financial liabilities |
|
|
|
On January 20, 2009, the Emerging Issues Committee (EIC) of the Accounting Standards
Board (AcSB) issued EIC Abstract 173, Credit Risk and Fair Value of Financial Assets
and Financial Liabilities, which establishes that an entitys own credit risk and the
credit risk of the counterparty should be taken into account in determining the fair
value of financial assets and financial liabilities, including derivative instruments.
EIC 173 is applied retrospectively, without restatement of prior years, to all financial
assets and liabilities measured at fair value in the interim and annual financial
statements for periods ending on or after January 20, 2009. The adoption of EIC 173 did
not have an impact on the consolidated financial statements of the Company. |
44 //// 2009 ANNUAL REPORT
2. |
|
New accounting policies (continued) |
|
A) |
|
ADOPTION OF NEW ACCOUNTING STANDARDS (CONTINUED) |
|
|
|
Financial instruments Disclosures |
|
|
|
In June 2009, the AcSB issued amendments to CICA Handbook Section 3862, Financial
Instruments Disclosures, in order to align with IFRS 7, Financial Instruments:
Disclosures. This Section has been amended to include additional disclosure requirements
about fair value measurements of financial instruments and to enhance liquidity risk
disclosure. The amendments establish a three-tier fair value hierarchy, which prioritizes
the inputs used in measuring fair value. These tiers include: Level 1, defined as
observable inputs such as quoted prices in active markets; Level 2, defined as inputs
other than quoted prices in active markets that are either directly or indirectly
observable; and Level 3, defined as unobservable inputs in which little or no market data
exists, therefore requiring an entity to develop its own assumptions. The amendments apply
to annual financial statements relating to fiscal years ended after September 30, 2009 and
are applicable to the Company as at November 30, 2009. The amended section relates to
disclosure only and did not impact the financial results of the Company. |
|
B) |
|
FUTURE ACCOUNTING CHANGES |
|
|
|
Business combinations, consolidated financial statements and non-controlling interests |
|
|
|
The CICA issued three new accounting standards in January 2009: Section 1582, Business
Combinations, Section 1601, Consolidated Financial Statements, and Section 1602,
Non-controlling Interests. The Company is in the process of evaluating the requirements of
the new standards. |
|
|
|
Section 1582 establishes standards for the accounting for a business combination. It
provides the Canadian equivalent to IFRS 3 Business Combinations. The section applies
prospectively to business combinations for which the acquisition date is on or after the
beginning of the first annual reporting period beginning on or after January 1, 2011 and
early application is permitted. |
|
|
|
Section 1601 establishes standards for the preparation of consolidated financial
statements. Section 1602 establishes standards for accounting for a non-controlling
interest in a subsidiary in consolidated financial statements. It is equivalent to the
corresponding provisions of IFRS IAS 27 Consolidated and Separate Financial Statements,
Sections 1601 and 1602, and applies to interim and annual consolidated financial
statements relating to fiscal years beginning on or after January 1, 2011 and early
application is permitted. |
|
|
|
International Financial Reporting Standards |
|
|
|
In February 2008, Canadas AcSB confirmed that Canadian generally accepted accounting
principles, as used by publicly accountable enterprises, would be fully converged into
IFRS, as issued by the International Accounting Standards Board (IASB). The changeover
date is for interim and annual financial statements relating to fiscal years beginning on
or after January 1, 2011. As a result, the Company will be required to report under IFRS
for its 2012 interim and annual financial statements. The Company will convert to these
new standards according to the timetable set within these new rules. The Company will
determine at a future date the impact of adopting the standards on its consolidated
financial statements. |
2009 ANNUAL REPORT //// 45
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
3. |
|
Significant accounting policies |
|
A) |
|
CONSOLIDATION |
|
|
|
|
The consolidated financial statements include the accounts of the Company and its
subsidiaries. All significant intercompany transactions and balances have been eliminated. |
|
|
B) |
|
CASH EQUIVALENTS |
|
|
|
|
Cash equivalents are restricted to investments that are readily convertible into cash,
having a term to initial maturity not exceeding three months and whose value is not likely
to change significantly. As at November 30, 2009 and 2008, there were no cash equivalents. |
|
|
C) |
|
INVENTORIES |
|
|
|
|
Inventories are stated at the lower of first-in first-out cost or net realizable
value. Inventory costs include the purchase price and other costs directly related to the
acquisition of materials. Inventory costs also include the costs directly related to the
conversion of materials to finished goods, such as direct labour, and a systematic
allocation of fixed and variable production overhead, including manufacturing depreciation
expense. The allocation of fixed production overheads to the cost of inventories is based
on the normal capacity of the production facilities. Normal capacity is the average
production expected to be achieved over a number of periods under normal circumstances. |
|
|
D) |
|
FINANCIAL ASSETS AND LIABILITIES |
|
|
|
|
All financial instruments are classified into one of the following five categories:
held for trading, held-to-maturity investments, loans and receivables, available-for-sale
financial assets or other financial liabilities. All financial instruments, including
derivatives, are included in the consolidated balance sheets and are measured at fair
market value, with the exception of loans and receivables, investments held-to-maturity
and other financial liabilities, which are measured at amortized cost. Subsequent
measurement and recognition of changes in fair value of financial instruments depend on
their initial classification. Held-for-trading financial investments are measured at fair
value and all gains and losses are included in net income in the period in which they
arise. Available-for-sale financial instruments are measured at fair value with
revaluation gains and losses included in other comprehensive income until the assets are
removed from the balance sheet or if there is an impairment in fair value of these assets
that is other than temporary. |
|
|
|
|
Derivative instruments are recorded as either assets or liabilities measured at their fair
value unless exempted from derivative treatment as a normal purchase and sale. Certain
derivatives embedded in other contracts must also be measured at fair value. All changes
in the fair value of derivatives are recognized in earnings unless specific hedge criteria
are met, which requires that a company must formally document, designate and assess the
effectiveness of transactions that receive hedge accounting. |
|
|
|
|
The Company has classified its bonds and investments in public companies as
available-for-sale financial assets and are measured at fair market value. The Company has
also classified accounts receivable as loans and receivables, and accounts payable and
accrued liabilities as other financial liabilities, and they are measured at amortized
cost. |
46 //// 2009 ANNUAL REPORT
3. |
|
Significant accounting policies (continued) |
|
E) |
|
PROPERTY AND EQUIPMENT |
|
|
|
|
Property and equipment are stated at cost. Amortization is provided using the
following methods and annual rates/periods: |
|
|
|
|
|
|
|
|
|
Asset |
|
Method |
|
Rate/period |
|
Computer equipment |
|
Declining balance |
|
|
50% |
Laboratory equipment |
|
Declining balance and straight-line |
|
|
20% 5 years |
Office equipment and furniture |
|
Declining balance |
|
|
20% |
Leasehold improvements |
|
Straight-line |
|
Term of lease |
|
|
F) |
|
OTHER ASSETS |
|
|
|
|
Other assets consist namely of intellectual property and research supplies. |
|
|
|
|
Intellectual property is amortized over a period of 20 years using the straight-line method. |
|
|
|
|
Research supplies are purchased in advance in accordance with regulatory requirements to be
used in connection with the Companys clinical trials. Research supplies that are not expected
to be used within one year from the date of the balance sheet are classified as long-term. |
|
|
G) |
|
IMPAIRMENT OF LONG-LIVED ASSETS |
|
|
|
|
The Company reviews property and equipment and other long-term assets for impairment
whenever events or changes in circumstances indicate that the carrying value of property and
equipment or assets may not be recoverable. Recoverability of assets to be used is measured by
the comparison of the carrying amount of an asset to estimated undiscounted future cash flows
expected to be generated from the assets. If the carrying amount of an asset exceeds its
estimated future cash flows, an impairment charge is recognized by the amount by which the
carrying value of the asset exceeds its fair value. The fair value against which the asset is
measured may be established based on comparable information or transactions, or any other
method of assessment. |
|
|
H) |
|
REVENUE RECOGNITION |
|
|
|
|
Revenues from research contracts are recognized when services to be provided are rendered
and all conditions under the terms of the underlying agreement are met. Revenues subject to the
achievement of milestones are recorded only when the specified events have occurred and
collectibility is assured. |
|
|
|
|
Upfront payments and initial technology access fees are deferred and recognized as revenue on a
systematic basis over the period during which the related products or services are delivered
and all obligations are performed. |
|
|
|
|
License fees are recorded when conditions and events under the license agreement have occurred
and collectibility is reasonably assured. |
|
|
|
|
Revenues from a collaboration agreement that includes multiple elements are considered to be a
revenue arrangement with multiple deliverables. Under this type of arrangement, the
identification of separate units of accounting is required and revenue is allocated among the
separate units based on their relative fair values. Payments received under the collaboration
agreement may include upfront payments, milestone payments, research contracts, license fees
and royalties. Revenues for each unit of accounting are recorded as described above. |
|
|
|
|
Interest income is recognized as earned using the effective interest method. |
2009 ANNUAL REPORT //// 47
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
3. |
|
Significant accounting policies (continued) |
|
I) |
|
RESEARCH AND DEVELOPMENT |
|
|
|
|
Research expenditures, net of related research tax credits and grants, are charged to
earnings in the year in which they are incurred. Development expenditures, net of tax
credits, if any, are capitalized when they meet the appropriate criteria for
capitalization in accordance with generally accepted accounting principles. During the
years ended November 30, 2009 and 2008, no development expenditures were capitalized. |
|
|
J) |
|
STOCK-BASED COMPENSATION AND OTHER STOCK-BASED PAYMENTS |
|
|
|
|
The Company records stock-based compensation related to employee stock options granted
using the fair value based method estimated using the Black-Scholes model. Under this
method, compensation cost is measured at fair value at the date of grant and is expensed
over the awards vesting period. Stock-based compensation related to non-employee stock
options is based on the fair value of the consideration received, or the fair value of the
equity instrument issued, whichever is more reliably measured. |
|
|
K) |
|
GOVERNMENT ASSISTANCE |
|
|
|
|
Government assistance, consisting of research tax credits and grants, is recorded as a
reduction of the related expense or cost of the asset acquired. Government grants are
recognized when there is reasonable assurance that the Company has met the requirements of
the approved grant program. Research tax credits are recorded when there is reasonable
assurance that they will be realized. |
|
|
L) |
|
FOREIGN EXCHANGE |
|
|
|
|
Foreign denominated monetary assets and liabilities are converted to Canadian dollars
at the rates of exchange prevailing at the balance sheet dates. Other assets and
liabilities are converted to the exchange rates prevailing when the assets were acquired
or the liabilities incurred. Revenues and expenses are converted at the rates prevailing
at the respective transaction date, except for depreciation and amortization which are
converted at the same rates as those used in the translation of the corresponding assets.
Foreign exchange gains and losses are included in the determination of net earnings or net
loss. |
|
|
M) |
|
INCOME TAXES |
|
|
|
|
The Company uses the asset and liability method of accounting for income taxes. Future
income tax assets and liabilities are recognized in the balance sheet to account for the
future tax consequences attributable to temporary differences between the respective
accounting and taxable value of balance sheet assets and liabilities. As appropriate, a
valuation allowance is recognized to decrease the value of tax assets to an amount that is
more likely than not to be realized. Future income tax assets and income tax liabilities
are measured using income tax rates that are enacted or substantively enacted when the
asset is realized or the liability is settled. The effect of changes in income tax rates
is recognized in the year during which these rates change. |
|
|
N) |
|
EARNINGS PER SHARE |
|
|
|
|
The earnings per share are determined using the weighted average number of outstanding shares during the year. |
|
|
|
|
The treasury stock method is used for the computation of the diluted earnings per share.
Under this method, a number of additional shares, if they are dilutive, are calculated
assuming that the outstanding stock options are exercised, and that the proceeds from the
transactions are used to purchase common shares at the average market price during the
period. |
48 //// 2009 ANNUAL REPORT
3. |
|
Significant accounting policies (continued) |
|
O) |
|
USE OF ESTIMATES |
|
|
|
|
The preparation of the financial statements in conformity with generally accepted
accounting principles requires Management to make estimates and assumptions that affect the reported amounts of assets
and liabilities and disclosure of contingent assets and liabilities at the date of the
financial statements and the reported amounts of revenues and expenses during the
reporting period. Significant areas requiring the use of Management estimates include
estimating the useful lives and recoverability of long-lived assets, including property
and equipment and other assets, estimating accruals for clinical trial expenses,
estimating stock-based compensation and revenue, as well as assessing the recoverability
of inventories, research tax credits and grants, investments and future income taxes.
Reported amounts and note disclosure reflect the overall economic conditions that are most
likely to occur and anticipated measures to be taken by Management. Actual results could
differ from those estimates. |
4. |
|
Property and equipment |
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
|
|
|
|
|
Accumulated |
|
|
Net book |
|
|
|
Cost |
|
|
amortization |
|
|
value |
|
|
Computer equipment |
|
$ |
874 |
|
|
$ |
617 |
|
|
$ |
257 |
|
Laboratory equipment |
|
|
1,945 |
|
|
|
1,519 |
|
|
|
426 |
|
Office equipment and furniture |
|
|
1,124 |
|
|
|
701 |
|
|
|
423 |
|
Leasehold improvements |
|
|
1,854 |
|
|
|
1,731 |
|
|
|
123 |
|
|
|
|
$ |
5,797 |
|
|
$ |
4,568 |
|
|
$ |
1,229 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
|
|
|
|
Accumulated |
|
|
Net book |
|
|
|
Cost |
|
|
amortization |
|
|
value |
|
|
Computer equipment |
|
$ |
682 |
|
|
$ |
500 |
|
|
$ |
182 |
|
Laboratory equipment |
|
|
1,824 |
|
|
|
1,427 |
|
|
|
397 |
|
Office equipment and furniture |
|
|
1,015 |
|
|
|
700 |
|
|
|
315 |
|
Leasehold improvements |
|
|
1,846 |
|
|
|
1,441 |
|
|
|
405 |
|
|
|
|
$ |
5,367 |
|
|
$ |
4,068 |
|
|
$ |
1,299 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
|
|
|
|
|
Accumulated |
|
|
Net book |
|
|
|
Cost |
|
|
amortization |
|
|
value |
|
|
Other assets |
|
$ |
41 |
|
|
$ |
|
|
|
$ |
41 |
|
|
2009 ANNUAL REPORT //// 49
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
5. |
|
Other assets (continued) |
|
|
|
For the year ended November 30, 2009, research and development expenses include a charge
of $1,377 related to research supplies that were produced in order to obtain stability data
and to validate the production process as required by the U.S. Food and Drug Administration
(FDA). |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
(Restated note 2A)) |
|
|
|
|
|
|
|
Accumulated |
|
|
Net book |
|
|
|
Cost |
|
|
amortization |
|
|
value |
|
|
Intellectual property |
|
$ |
7,670 |
|
|
$ |
7,670 |
|
|
$ |
|
|
Research supplies |
|
|
2,751 |
|
|
|
|
|
|
|
2,751 |
|
Other assets |
|
|
66 |
|
|
|
|
|
|
|
66 |
|
|
|
|
$ |
10,487 |
|
|
$ |
7,670 |
|
|
$ |
2,817 |
|
|
|
|
In 2008, the Company conducted an impairment test on the intellectual property included in
Other assets following a review of the development strategy by Management for new products.
As a consequence, the Company wrote off the carrying amount of this intellectual property. The
write-off of $4,571 is included in Patents, amortization and impairment of other assets in
the consolidated statements of earnings. |
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
Authorized in unlimited number and without par value: |
|
|
|
|
|
|
|
|
Common shares |
|
|
|
|
|
|
|
|
Preferred shares issuable in one or more series |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued: |
|
|
|
|
|
|
|
|
60,429,393 common shares (58,215,090 in 2008) |
|
$ |
279,169 |
|
|
$ |
269,219 |
|
|
|
|
2009 |
|
|
|
Under the terms of the agreement with EMD Serono Inc. (EMD Serono), the Company issued
2,179,837 common shares for a cash consideration of $9,854 (see note 7). |
|
|
|
In 2009, the Company received subscriptions in the amount of $96 for the issuance of 34,466
common shares in connection with its share purchase plan. |
|
|
|
2008 |
|
|
|
On February 13, 2008, the Company completed a public offering for the sale and issue of
3,500,000 common shares for cash proceeds of $29,750. The issuance costs amounted to $1,938. |
|
|
|
In 2008, the Company received subscriptions in the amount of $149 for the issuance of 64,291
common shares in connection with its share purchase plan. |
|
|
|
All shares were issued for a cash consideration. |
50 //// 2009 ANNUAL REPORT
6. |
|
Capital stock (continued) |
|
A) |
|
STOCK OPTION PLAN |
|
|
|
|
The Company has established a stock option plan under which it can grant to its
Directors, Officers, Employees, Researchers and Consultants non-transferable options for
the purchase of common shares. The exercise date of an option may not be later than 10
years after the date it is granted. A maximum number of 5,000,000 options can be granted
under the plan. Generally, the options vest at the date of the grant or over a period of 0
to 5 years. On November 30, 2009, 1,244,834 additional options could be granted by the
Company. |
|
|
|
|
Changes in the number of options outstanding during the past two fiscal years were as
follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average |
|
|
|
|
|
|
|
exercise price |
|
|
|
Options |
|
|
per share |
|
|
Options as at November 30, 2007 |
|
|
2,207,633 |
|
|
$ |
6.32 |
|
Granted |
|
|
111,000 |
|
|
|
7.98 |
|
Exercised |
|
|
(119,666 |
) |
|
|
3.32 |
|
Cancelled |
|
|
(37,167 |
) |
|
|
9.57 |
|
|
Options as at November 30, 2008 |
|
|
2,161,800 |
|
|
|
6.52 |
|
Granted |
|
|
680,500 |
|
|
|
1.83 |
|
Cancelled and expired |
|
|
(176,500 |
) |
|
|
8.34 |
|
|
Options as at November 30, 2009 |
|
|
2,665,800 |
|
|
$ |
5.20 |
|
|
The following table provides stock option information as at November 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding |
|
|
Exercisable options |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
average |
|
|
Weighted |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Number of |
|
|
remaining |
|
|
average |
|
|
Number of |
|
|
average |
|
|
|
|
|
|
|
|
options |
|
|
life |
|
|
exercise |
|
|
exercisable |
|
|
exercise |
|
Price range |
|
|
outstanding |
|
|
(years) |
|
|
price |
|
|
options |
|
|
price |
|
|
$ |
1.20 - |
|
$ |
2.00 |
|
|
|
1,291,508 |
|
|
|
7.57 |
|
|
$ |
1.71 |
|
|
|
742,508 |
|
|
$ |
1.63 |
|
|
2.01 - |
|
|
2.75 |
|
|
|
141,459 |
|
|
|
4.85 |
|
|
|
2.59 |
|
|
|
141,459 |
|
|
|
2.59 |
|
|
2.76 - |
|
|
3.75 |
|
|
|
70,000 |
|
|
|
6.51 |
|
|
|
3.37 |
|
|
|
43,333 |
|
|
|
3.64 |
|
|
4.61 - |
|
|
6.00 |
|
|
|
25,000 |
|
|
|
3.53 |
|
|
|
5.43 |
|
|
|
25,000 |
|
|
|
5.43 |
|
|
6.01 - |
|
|
9.00 |
|
|
|
591,333 |
|
|
|
5.76 |
|
|
|
8.18 |
|
|
|
526,977 |
|
|
|
8.16 |
|
|
9.01 - |
|
|
13.50 |
|
|
|
495,000 |
|
|
|
3.76 |
|
|
|
10.72 |
|
|
|
441,662 |
|
|
|
10.68 |
|
|
13.51 - |
|
|
15.30 |
|
|
|
51,500 |
|
|
|
1.28 |
|
|
|
15.15 |
|
|
|
51,500 |
|
|
|
15.15 |
|
|
|
|
|
|
|
|
|
|
2,665,800 |
|
|
|
6.13 |
|
|
$ |
5.20 |
|
|
|
1,972,439 |
|
|
$ |
5.92 |
|
|
|
B) |
|
STOCK-BASED COMPENSATION AND OTHER STOCK-BASED PAYMENTS |
|
|
|
|
The estimated fair value of the options granted was estimated at the date of grant using
the Black-Scholes option pricing model with the following weighted average assumptions: |
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
Risk-free interest rate |
|
|
1.83 |
% |
|
|
3.36 |
% |
Volatility |
|
|
79.5 |
% |
|
|
70.4 |
% |
Average option life in years |
|
|
6 |
|
|
|
6 |
|
Dividend yield |
|
nil |
|
|
nil |
|
|
2009 ANNUAL REPORT //// 51
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
6. |
|
Capital stock (continued) |
|
B) |
|
STOCK-BASED COMPENSATION AND OTHER STOCK-BASED PAYMENTS (CONTINUED) |
|
|
|
|
The risk-free interest rate is based on the implied yield on a Canadian Treasury zero-coupon
issue with a remaining term equal to the expected term of the option. The volatility is based
solely on historical volatility equal to the expected term of the option. The average life of the
options is estimated considering the vesting period, the term of the option and the length of time
similar grants have remained outstanding in the past. Dividend yield was excluded from the
calculation, since it is the present policy of the Company to retain all earnings to finance
operations and future growth. |
|
|
|
|
The following table summarizes the weighted average fair value of stock options granted during the
years ended November 30, 2009 and 2008: |
|
|
|
|
|
|
|
|
|
|
|
Number |
|
|
Weighted average |
|
|
|
of options |
|
|
grant-date fair value |
|
|
2009 |
|
|
680,500 |
|
|
$ |
1.26 |
|
2008 |
|
|
111,000 |
|
|
$ |
5.16 |
|
|
|
|
|
The Black-Scholes model, used by the Company to calculate option values, as well as other accepted
option valuation models, were developed to estimate the fair value of freely tradable, fully
transferable options without vesting restrictions, which significantly differs from the Companys
stock option awards. These models also require four highly subjective assumptions, including future
stock price volatility and expected time until exercise, which greatly affect the calculated
values. |
|
|
C) |
|
DILUTED LOSS PER SHARE
|
|
|
|
|
Diluted loss per share was not presented as the effect of options would have been
anti-dilutive. All options outstanding at the end of the year could potentially dilute basic
earnings per share in the future. |
7. |
|
Collaboration and Licensing Agreement |
|
|
|
On October 28, 2008, the Company entered into a Collaboration and Licensing Agreement with EMD
Serono, an affiliate of Merck KGaA, of Darmstadt, Germany, regarding the exclusive
commercialization rights of tesamorelin in the United States for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy (the Initial Product). Theratechnologies retains
all tesamorelin commercialization rights outside of the United States. |
|
|
|
Under the terms of the agreement, the Company is responsible for the development of the Initial
Product up to obtaining marketing approval in the United States. The Company is also responsible
for product production and for the development of a new formulation of the Initial Product. EMD
Serono is responsible for conducting product commercialization activities. |
|
|
|
At the closing of the agreement, on December 15, 2008, the Company received US$30,000 (CAD$36,951)
which, includes an initial payment of US$22,000 (CAD$27,097) and US$8,000 (CAD$9,854) as a
subscription for common shares in the Company by Merck KGaA at a price of US$3.67 (CAD$4.52) per
share. The Company may receive up to US$215,000, which amount includes the initial payment of
US$22,000, the equity investment of US$8,000, as well as payments based on the achievement of
certain development, regulatory and sales milestones. The Company will also be entitled to receive
increasing royalties on annual net sales of tesamorelin in the United States, if applicable. |
|
|
|
The initial payment of $27,097 has been deferred and is being amortized over its estimated service
period on a straight-line basis. This period may be modified in the future based on additional
information that may be received by the Company. For the year ended November 30, 2009, an amount of
$6,560 related to this transaction was recognized as revenue. At November 30, 2009, the deferred
revenues related to this transaction amounted to $20,537. |
52 //// 2009 ANNUAL REPORT
7. |
|
Collaboration and Licensing Agreement (continued) |
|
|
|
On August 12, 2009, the FDA accepted the New Drug Application (NDA) made by the Company
for tesamorelin. Under the terms of the Companys Collaboration and Licensing Agreement with
EMD Serono, the acceptance of the tesamorelin NDA resulted in a milestone payment of US$10,000
(CAD$10,884). This milestone payment has been recorded in the third quarter of 2009. |
|
|
|
The Company may conduct research and development for additional indications. Under the
Collaboration and Licensing Agreement, EMD Serono will have the option to commercialize
additional indications for tesamorelin in the United States. If it exercises this option, EMD
Serono will pay half of the development costs related to such additional indications. In such
cases, the Company will also have the right, subject to EMD Seronos agreement, to participate
in the promotion of the additional indications. |
|
8. |
|
Future income taxes |
|
|
|
Details of the components of income taxes are as follows: |
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
Net loss before income taxes |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
Basic income tax rate |
|
|
30.9 |
% |
|
|
31.0 |
% |
|
Computed income tax provision |
|
|
(4,652 |
) |
|
|
(15,069 |
) |
|
|
|
|
|
|
|
|
|
Adjustments to income tax provision resulting from: |
|
|
|
|
|
|
|
|
Impact of decrease in federal tax rates: |
|
|
|
|
|
|
|
|
Decrease in value of future tax assets |
|
|
|
|
|
|
5,910 |
|
Change in valuation allowance |
|
|
|
|
|
|
(5,910 |
) |
Unrecorded potential tax benefit of current year
losses and other deductions |
|
|
4,029 |
|
|
|
17,201 |
|
Non-deductible items and others |
|
|
623 |
|
|
|
(2,132 |
) |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
The tax incidence of temporary differences resulting in significant portions of future income tax
assets is as follows: |
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
Future income tax assets: |
|
|
|
|
|
|
|
|
Losses carried forward |
|
$ |
21,490 |
|
|
$ |
16,045 |
|
Unused research and development expenses |
|
|
29,380 |
|
|
|
26,591 |
|
Property and equipment |
|
|
674 |
|
|
|
544 |
|
Share issue costs |
|
|
776 |
|
|
|
1,174 |
|
Intellectual property and patent fees |
|
|
12,307 |
|
|
|
16,248 |
|
Available deductions and other |
|
|
4,187 |
|
|
|
4,183 |
|
|
|
|
|
68,814 |
|
|
|
64,785 |
|
Less valuation allowance |
|
|
(68,814 |
) |
|
|
(64,785 |
) |
|
Net future income tax asset |
|
$ |
|
|
|
$ |
|
|
|
|
|
In estimating the realization of future income tax assets, Management considers whether a portion
or all future tax assets are more likely than not to be realized. Realization of future tax assets
is subject to the generation of future taxable income. |
2009 ANNUAL REPORT //// 53
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
8. |
|
Future income taxes (continued) |
|
|
|
As at November 30, 2009, the Company had available the following deductions, losses
and credits: |
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
Provincial |
|
|
Research and development expenses, without time limitation |
|
$ |
103,346 |
|
|
$ |
115,686 |
|
|
Losses carried forward, until: |
|
|
|
|
|
|
|
|
2014 |
|
$ |
9,603 |
|
|
$ |
|
|
2015 |
|
|
275 |
|
|
|
|
|
2027 |
|
|
7,638 |
|
|
|
7,628 |
|
2028 |
|
|
46,316 |
|
|
|
46,271 |
|
2029 |
|
|
21,785 |
|
|
|
18,802 |
|
|
|
|
$ |
85,617 |
|
|
$ |
72,701 |
|
|
Unused tax credits expiring in: |
|
|
|
|
|
|
|
|
|
2023 |
|
$ |
559 |
|
|
|
|
|
2024 |
|
|
1,597 |
|
|
|
|
|
2025 |
|
|
1,863 |
|
|
|
|
|
2026 |
|
|
2,178 |
|
|
|
|
|
2027 |
|
|
3,000 |
|
|
|
|
|
2028 |
|
|
3,328 |
|
|
|
|
|
2029 |
|
|
2,250 |
|
|
|
|
|
|
|
|
$ |
14,775 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
Provincial |
|
|
Share issue costs |
|
$ |
2,732 |
|
|
$ |
2,732 |
|
Excess of tax value of intellectual property
and patent fees over carrying value |
|
|
45,735 |
|
|
|
45,718 |
|
Excess of tax value of property and equipment over carrying value |
|
|
3,121 |
|
|
|
1,785 |
|
|
54 |
|
//// 2009 ANNUAL REPORT |
|
A) |
|
RENTAL OF PREMISES |
|
|
|
|
The Company rents premises under an operating lease (the Lease) expiring in April
2010. The Lease was renewed by the Company and the lessor during the 2009 financial year for
a period of 11 years ending April 30, 2021. Under the terms of the Lease, the Company has
also been granted two renewal options for periods of five years each. The minimum payments
required under the terms of the Lease are as follows: |
|
|
|
|
|
2010 |
|
$ |
340 |
|
2011 |
|
|
55 |
|
2012 |
|
|
655 |
|
2013 |
|
|
655 |
|
2014 |
|
|
655 |
|
2015 |
|
|
273 |
|
Thereafter |
|
|
3,943 |
|
|
|
|
$ |
6,576 |
|
|
|
|
|
The Company has committed to pay the lessor for its share of some operating expenses of the
leased premises. This amount has been set at $240 for the year beginning May 1, 2010 and
will be increased by 2.5% annually for the duration of the Lease. |
|
|
|
|
The lessor will provide the Company an amount of $728 to allow it to undertake leasehold
improvements. |
|
|
|
|
The Company has issued an irrevocable letter of credit in favour of the lessor in the amount
of $323 which will be cancelled April 30, 2010 under the terms of the Lease renewal, along
with a first rank movable mortgage in the amount of $1,150 covering all the Companys
tangible assets located in the rented premises. This mortgage, however, can be subordinated
to those of lending institutions. |
|
|
B) |
|
LONG-TERM SUPPLY AGREEMENTS |
|
|
|
|
During and after the year ended November 30, 2009, the Company entered into long-term
procurement agreements with third-party suppliers in anticipation of the commercialization
of tesamorelin. Some of these agreements stipulate an obligation to purchase minimum
quantities of product, subject to certain conditions. |
|
|
C) |
|
CREDIT FACILITY |
|
|
|
|
The Company has a credit facility available in the amount of $1,800, bearing interest at
prime plus 0.5% and secured by bonds. Under the credit facility, the market value of
investments held must always be equivalent to 150% of amounts drawn under the facility. If
the market value falls below $7,000, the Company will provide the bank with a first rank
movable hypothec of $1,850 on securities judged satisfactory by the bank. |
|
|
|
|
As at November 30, 2009 and 2008, with the exception of the letter of credit mentioned
in A) above, the credit facility available to the Company was not utilized. |
2009 ANNUAL REPORT //// 55
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
10. |
|
Licenses |
|
|
|
In addition to the exclusively held products, the Company has certain exclusive licenses
to market or commercialize intellectual property from research activities assigned to certain
research institutions. Under these licenses, the Company is committed to pay royalties on the
net sales of the products commercialized by the Company, or, if applicable, on the amounts
received from sub-license, subject to the application of the clauses of such agreements. |
|
11. |
|
Supplemental information |
|
A) |
|
STATEMENT OF CASH FLOWS |
|
|
|
|
The following transactions were conducted by the Company and did not impact cash flows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
2009 |
|
|
(Restated note 2A)) |
|
|
Additions to property and equipment included
in accounts payable and accrued liabilities |
|
$ |
183 |
|
|
|
$48 |
|
Share issue costs included in accounts payable and accrued liabilities |
|
|
|
|
|
|
8 |
|
|
|
B) |
|
In 2009, the Company reclassified under net earnings an amount of $129 in realized
gains on available-for-sale financial assets previously recorded in accumulated other
comprehensive income. |
|
|
|
|
In 2008, the Company reclassified under net earnings an amount of $572 in realized
losses on available-for-sale financial assets previously recorded in accumulated other
comprehensive income. The realized loss includes an impairment loss of $578 related to
a decline in value that is other than temporary for stock options held in a
publicly-traded company. |
|
|
|
|
On November 30, 2009, the accumulated other comprehensive income was composed of
unrealized gains on available-for-sale financial assets of $1,282 (gain of $372 on
November 30, 2008). |
|
|
C) |
|
The Company received tax credits of $1,912 in 2009 ($1,746 in 2008). |
|
|
D) |
|
The following items were included in the determination of the Companys net loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
2009 |
|
|
(Restated note 2A)) |
|
|
Amortization of property and equipment |
|
$ |
612 |
|
|
$ |
625 |
|
Amortization and impairment of other assets (note 5) |
|
|
|
|
|
|
4,957 |
|
Stock-based compensation |
|
|
899 |
|
|
|
859 |
|
|
56 //// 2009 ANNUAL REPORT
12. |
|
Capital disclosures |
|
|
|
The Companys objective in managing capital is to ensure a sufficient liquidity position
to finance its research and development activities, general and administrative expenses,
working capital and overall capital expenditures, including those associated with patents. The
Company makes every attempt to manage its liquidity to minimize shareholder dilution. |
|
|
|
To fund its activities, the Company has followed an approach that relies almost exclusively on
the issuance of common equity, as well as proceeds and royalties from technologies following
the closing of the transaction disclosed in note 7. Since inception, the Company has financed
its liquidity needs primarily through public offerings of common shares and private
placements. When possible, the Company tries to optimize its liquidity position by
non-dilutive sources, including investment tax credits, grants, interest income as well as
proceeds and royalties from technologies. |
|
|
|
The Companys policy is to maintain a minimum level of debt. The Company has a line of credit
of $1,800 for its short-term financing needs. As at November 30, 2009, this line of credit has
not been used, with the exception of the letter of credit mentioned in note 9A). |
|
|
|
The capital management objectives remain the same as for the previous fiscal year. |
|
|
|
At November 30, 2009, cash and bonds amounted to $63,362 and tax credits receivable amounted
to $1,666, for a total of $65,028. The Company believes that its cash position will be
sufficient to finance its operations and capital needs for the next year. |
|
|
|
The Companys general policy on dividends is to retain cash to keep funds available to finance
the Companys growth. |
|
|
|
The Company is not subject to any externally imposed capital requirements. |
2009 ANNUAL REPORT //// 57
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
13. |
|
Financial risk management |
|
|
|
This note provides disclosures relating to the nature and extent of the Companys exposure
to risks arising from financial instruments, including credit risk, liquidity risk, foreign
currency risk and interest rate risk, and how the Company manages those risks. |
|
A) |
|
CREDIT RISK |
|
|
|
|
Credit risk is the risk of an unexpected loss if a customer or counterparty to a
financial instrument fails to meet its contractual obligations. The Company regularly
monitors the credit risk exposure and takes steps to mitigate the likelihood of these
exposures resulting in losses. |
|
|
|
|
Financial instruments other than cash that potentially subject the Company to significant
credit risk consist principally of bonds. The Company invests its available cash in fixed
income instruments from governmental, paragovernmental and municipal bonds ($60,384 as at
November 30, 2009) as well as from corporations with high credit ratings ($1,459 as at
November 30, 2009). As at November 30, 2009, the Company was not exposed to any credit risk
over the carrying amount of the bonds. |
|
|
B) |
|
LIQUIDITY RISK |
|
|
|
|
Liquidity risk is the risk that the Company will not be able to meet its financial
obligations as they fall due. The Company manages liquidity risk through the management of
its capital structure and financial leverage, as outlined in note 12. It also manages
liquidity risk by continuously monitoring actual and projected cash flows. The Board of
Directors and/or the Audit Committee reviews and approves the Companys operating and
capital budgets, as well as any material transactions out of the ordinary course of
business. |
|
|
|
|
The Company has adopted an investment policy in respect of the safety and preservation of
its capital to ensure the Companys liquidity needs are met. |
|
|
|
|
The instruments are selected with regard to the expected timing of expenditures and
prevailing interest rates. Bonds mature during the following fiscal years: $10,036 in 2010,
$15,446 in 2011, $19,716 in 2012, $13,791 in 2013 and $2,854 in 2014. |
|
|
|
|
The following are the contractual maturities of financial liabilities, as well as the
payments required under the terms of the operating lease, as at November 30, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Carrying |
|
|
Less than |
|
|
1 to |
|
|
More than |
|
|
|
Total |
|
|
amount |
|
|
1 year |
|
|
5 years |
|
|
5 years |
|
|
Accounts payable and accrued liabilities |
|
$ |
5,901 |
|
|
$ |
5,901 |
|
|
$ |
5,901 |
|
|
$ |
|
|
|
$ |
|
|
Operating lease |
|
|
6,576 |
|
|
|
|
|
|
|
340 |
|
|
|
2,020 |
|
|
|
4,216 |
|
|
|
|
$ |
12,477 |
|
|
$ |
5,901 |
|
|
$ |
6,241 |
|
|
$ |
2,020 |
|
|
$ |
4,216 |
|
|
58 //// 2009 ANNUAL REPORT
13. |
|
Financial risk management (continued) |
|
C) |
|
FOREIGN CURRENCY RISK |
|
|
|
|
The Company is exposed to the financial risk related to the fluctuation of foreign
exchange rates and the degree of volatility of those rates. Foreign currency risk is limited
to the portion of the Companys business transactions denominated in currencies other than
the Canadian dollar, primarily revenues from royalties, technologies and other expenses for
research and development incurred in US dollars, euros and pounds sterling (GBP). The
Company does not use derivative financial instruments to reduce its foreign exchange
exposure. |
|
|
|
|
The Company manages foreign exchange risk by maintaining US cash on hand to support US
forecasted cash outflows for a maximum 12-month period. The Company does not currently view
its exposure to the euro and GBP as a significant foreign exchange risk due to the limited
volume of transactions conducted by the Company in these currencies. |
|
|
|
|
Exchange rate fluctuations for foreign currency transactions can cause cash flow as well as
amounts recorded in the consolidated statement of earnings to vary from period to period and
not necessarily correspond to those forecasted in operating budgets and projections.
Additional earnings variability arises from the translation of monetary assets and
liabilities denominated in currencies other than the Canadian dollar at the rates of
exchange at each balance sheet date, the impact of which is reported as foreign exchange
gain or loss in the consolidated statement of earnings. Given the Companys policy on the
management of foreign currencies, a sudden change in foreign exchange rates would not impair
or enhance its ability to pay its US dollar denominated obligations. |
|
|
|
|
The following table provides significant items exposed to foreign exchange as at November
30, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November 30, 2009 |
|
(in thousands of Canadian dollars) |
|
US$ |
|
|
EURO |
|
|
GBP |
|
|
Cash |
|
|
1,471 |
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
|
|
|
|
4 |
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
(1,095 |
) |
|
|
|
|
|
|
(25 |
) |
|
Balance sheets elements exposed
to foreign currency risk |
|
|
376 |
|
|
|
4 |
|
|
|
(25 |
) |
|
|
|
|
The following exchange rates applied during the year ended November 30, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reporting |
|
|
|
Average rate |
|
|
date rate |
|
|
|
November 30, 2009 |
|
|
November 30, 2009 |
|
|
US$ CAD $ |
|
|
1.0594 |
|
|
|
1.0556 |
|
EUR CAD$ |
|
|
1.5808 |
|
|
|
1.5852 |
|
GBP CAD$ |
|
|
1.7597 |
|
|
|
1.7366 |
|
|
|
|
|
Based on the Companys foreign currency exposures noted above, varying the above foreign
exchange rates to reflect a 5% strengthening of the Canadian dollar would have increased the
net loss as follows, assuming that all other variables remained constant: |
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of Canadian dollars) |
|
US$ |
|
|
EURO |
|
|
GBP |
|
|
Increased in net loss |
|
|
19 |
|
|
|
|
|
|
|
(1 |
) |
|
|
|
|
An assumed 5% weakening of the Canadian dollar would have had an equal but opposite effect
on the above currencies to the amounts shown above, on the basis that all other variables
remain constant. |
2009 ANNUAL REPORT //// 59
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
YEARS ENDED NOVEMBER 30, 2009 AND 2008 (in thousands of dollars, except per share amounts)
13. |
|
Financial risk management (continued) |
|
D) |
|
INTEREST RATE RISK |
|
|
|
|
Interest rate risk is the risk that the fair value or future cash flows of a financial
instrument will fluctuate because of changes in market interest rates. |
|
|
|
|
Short-term bonds of the Company are invested at fixed interest rates and mature in the
short-term. Long-term bonds are also instruments that bear interest at fixed rates. The
risk that the Company will realize a loss as a result of a decline in the fair value of its
bonds is limited because these investments, although they are available for sale, are
generally held to maturity. The unrealized gains or losses on bonds are recorded in the
accumulated other comprehensive income (loss). |
|
|
|
|
Based on the value of the Companys short and long-term bonds at November 30, 2009, an
assumed 0.5% decrease in market interest rates would have increased the fair value of these
bonds and the accumulated other comprehensive loss by $620; an assumed increase in interest
rate of 0.5% would have an equal but opposite effect, assuming that all other variables
remained constant. |
|
|
|
|
Cash bears interest at a variable rate. Accounts receivable, accounts payable and accrued
liabilities bear no interest. |
|
|
|
|
Based on the value of variable interest-bearing cash during the year ended November 30,
2009 ($5,800), an assumed 0.5% increase in interest rates during such period would have
increased the future cash flow and decreased the net loss by $29; an assumed decrease of
0.5% would have had an equal but opposite effect. |
14. |
|
Financial instruments |
|
A) |
|
CARRYING VALUE AND FAIR VALUE |
|
|
|
|
The Company has determined that the carrying values of its short-term financial assets
and liabilities, including cash, accounts receivable, as well as accounts payable and
accrued liabilities, approximate their fair value because of the relatively short period to
maturity of the instruments. |
|
|
|
|
Bonds and investments in public companies are stated at estimated fair value, determined by
inputs that are directly observable (Level 2 inputs). |
|
|
B) |
|
INTEREST INCOME AND EXPENSES |
|
|
|
|
Interest income consists of interest earned on cash and bonds. |
|
|
C) |
|
LOSS ON EXCHANGE |
|
|
|
|
General and administrative expenses include a loss on foreign exchange of $635 for the
year ended November 30, 2009 (loss of $247 in 2008). |
60 //// 2009 ANNUAL REPORT
|
A) |
|
SHAREHOLDER RIGHTS PLAN |
|
|
|
|
On February 10, 2010, the Board of Directors of the Company adopted a shareholder
rights plan (the Plan), effective as of such date. The Plan is designed to provide
adequate time for the Board of Directors, and the shareholders, to assess an unsolicited
takeover bid for Theratechnologies. In addition, the Plan provides the Board of Directors
with sufficient time to explore and develop alternatives for maximizing shareholder value
if a takeover bid is made, as well as provide shareholders with an equal opportunity to
participate in a takeover bid to receive full and fair value for their common shares (the
Common Shares). The Plan, if approved by the shareholders, will expire at the close of
the Companys annual meeting of shareholders in 2013. |
|
|
|
|
The rights issued under the Plan will initially attach to and trade with the Common Shares
and no separate certificates will be issued unless an event triggering these rights occurs.
The rights will become exercisable only when a person, including any party related to it,
acquires or attempts to acquire 20% or more of the outstanding Common Shares without
complying with the Permitted Bid provisions of the Plan or without approval of the Board
of Directors. Should such an acquisition occur or be announced, each right would, upon
exercise, entitle a rights holder, other than the acquiring person and related persons, to
purchase Common Shares at a 50% discount to the market price at the time. |
|
|
|
|
Under the Plan, a Permitted Bid is a bid made to all holders of the Common Shares and which
is open for acceptance for not less than 60 days. If at the end of 60 days at least 50% of
the outstanding Common Shares, other than those owned by the offeror and certain related
parties have been tendered, the offeror may take up and pay for the Common Shares but must
extend the bid for a further 10 days to allow other shareholders to tender. |
|
|
B) |
|
GRANTING OF STOCK OPTIONS |
|
|
|
|
On December 8, 2009, the Company granted 265,000 options at an exercise price of $3.84
per share and cancelled 19,167 options at a weighted exercise price of $2.38 per share in
connection with its stock option plan. |
16. |
|
Comparative figures |
|
|
|
Certain of the 2008 comparative figures have been reclassified to conform with the
financial statement presentation adopted in 2009. |
2009 ANNUAL REPORT //// 61
ex-99.9
Exhibit 99.9
MANAGEMENTS DISCUSSION AND ANALYSIS
FOR THE THREE-MONTH PERIOD ENDED FEBRUARY 28, 2011
The following Managements Discussion and Analysis (MD&A) provides Managements point of view on
the financial position and the results of operations of Theratechnologies Inc. for the three-month
period ended February 28, 2011, as compared to the three-month period ended February 28, 2010.
Unless otherwise indicated or unless the context requires otherwise, all references in this MD&A to
Theratechnologies, the Company, the Corporation, we, us, our or similar terms refer to
Theratechnologies Inc. and its consolidated subsidiaries. This view contains information that we
believe may affect our prospective financial condition, cash flows and results of operations. The
unaudited interim consolidated financial statements have been prepared in accordance with
International Financial Reporting Standards (IFRS) as issued by the International Accounting
Standards Board (IASB). This MD&A should be read in conjunction with our unaudited interim
consolidated financial statements and the notes thereto as at February 28, 2011, as well as the
MD&A and audited consolidated financial statements including the related notes thereto as at
November 30, 2010. Unless specified otherwise, all amounts are in Canadian dollars.
Financial Overview
Theratechnologies (TSX: TH) is a specialty pharmaceutical company that discovers and develops
innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor
peptides. We are leveraging our expertise in the field of metabolism to discover and develop
products in specialty markets. Our commercialization strategy is to retain all or a significant
portion of the commercial rights to our products.
Our first product, EGRIFTA® (tesamorelin for injection), was approved by the United
States Food and Drug Administration (FDA) in November 2010 and is, to date, the only approved
therapy for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
EGRIFTA® is currently marketed in the United States by EMD Serono pursuant to a
collaboration and licensing agreement executed in October 2008.
During the first quarter of 2011, we concluded two distribution and licensing agreements for
EGRIFTA® outside of the United States. We signed a distribution and licensing agreement
with a subsidiary of Sanofi-aventis (collectively, Sanofi), on December 6, 2010, granting them
the exclusive commercialization rights for EGRIFTA® for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy in Latin America, Africa and the Middle
East, and with Ferrer Internacional S.A. (Ferrer), on February 3, 2011, granting them the
exclusive commercialization rights for EGRIFTA® for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy in Europe, Russia, South Korea, Taiwan, Thailand
and certain central Asian countries.
On February 22, 2011, we announced a new clinical program evaluating tesamorelin in muscle wasting
associated with chronic obstructive pulmonary disease (COPD). The Phase 2 study will evaluate two
different doses using a new formulation and we expect the first patient to be enrolled in the fall
of 2011.
In addition, we announced the filing of a preliminary prospectus in order to raise funds with the
intention of listing our common shares on the NASDAQ stock exchange in the United States. The
offering was subsequently withdrawn due to an offering price that was not acceptable to us.
Following the FDA approval of EGRIFTA® on November 10, 2010, our third-party suppliers increased
manufacturing activities in order to support the sales of EGRIFTA® in the United States by EMD
Serono. EMD Serono launched EGRIFTA® on January 10, 2011 and we will start receiving royalties from
sales in the United States in the second quarter of this year.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
Our principal objectives are: to maximize the global commercial value of EGRIFTA® by working
closely with our partners in order to submit regulatory filings in Europe and selected Latin
American markets in the second and third quarters, to launch a Phase 2 clinical program evaluating
the potential of tesamorelin for the treatment of muscle wasting associated with COPD, and to
solidify our position as a leader in the field of novel GRF products.
Revenues
Consolidated revenues for the three-month period ended February 28, 2011 amounted to $3,518,000,
compared to $1,717,000 for the same period in 2010, an increase of 104.9%. The higher revenues in
2011 include $1,798,000 revenues generated from the sales of EGRIFTA® to EMD Serono.
The first product shipment of EGRIFTA® took place in December 2010, shortly after its FDA approval
as the first treatment in the United States for the reduction of excess abdominal fat in
HIV-infected patients with lipodystrophy.
We will receive royalties on sales of EGRIFTA® in the United States by EMD
Serono beginning in the second quarter of fiscal 2011 upon receipt and confirmation of the sales
report relating to the previous quarter.
Revenues for the first quarter of 2011 are also associated with the amortization of the initial
payment of $27,097,000 received upon the closing of the agreement with EMD Serono. For the
three-month period ended February 28, 2011, an amount of $1,711,000 ($1,711,000 for the same period
in 2010) was recognized as revenue related to this transaction. At February 28, 2011, the deferred
revenues related to this transaction recorded on the balance sheet amounted to $11,981,000.
Cost of Sales
For the first quarter of 2011, the cost of sales of EGRIFTA® totaled $2,595,000. Cost
of sales exceeded sales revenue principally due to raw materials purchased prior to negotiating our
current long-term procurement agreements, an inventory write-down of $375,000 related to an
unfavorable foreign currency difference and costs associated with validating a second
EGRIFTA® supplier. There were no costs related to the production of
EGRIFTA® in the first quarter of 2010, as we only began producing inventories through
our third-party suppliers during the second half of 2010, in anticipation of the launch of
EGRIFTA® in the United States.
R&D Activities
Research and development (R&D) expenses, net of tax credits, totaled $2,993,000 for the first
quarter of 2011, compared to $4,123,000 for the same period in 2010, a decrease of 27.4%. The R&D
expenses incurred in the first quarter are related to the preparation for the Phase 2 clinical
trial evaluating tesamorelin in muscle wasting associated with COPD, to the work on a new
formulation and a new presentation of EGRIFTA®, as well as to the development of novel
growth hormone releasing factor peptides. R&D expenses also include all regulatory, manufacturing
and clinical activities to support our three commercial partners, as well as follow up on the
post-approval commitments. The R&D expenses incurred in the first quarter of 2010 were mainly
related to the regulatory activities connected with the preparation for the FDA Advisory Committee
meeting which took place on May 26, 2010.
Selling and Market Development Expenses
Selling and market development expenses amounted to $477,000 for the first quarter of 2011,
compared to $620,000 for the same period in 2010, a decrease of 23.1%. The decrease is principally
due first-quarter signings of distribution and licensing agreements with Sanofi and Ferrer which
transferred responsibility for all marketing expenses to the licensees. Selling and market
development expenses continue to include activities associated with the management of the
agreements with our three partners.
2
General and Administrative Expenses
For the first quarter of 2011, general and administrative expenses amounted to $3,215,000, compared
to $1,745,000 for the same period in 2010. The higher expenses were principally due to costs
associated with the change in leadership of the Company, many of which were entirely expensed in
the first quarter of 2011. Additional expenses were also incurred in relation to deferred stock
units granted to the members of the Board of Directors during the first quarter. Although the
deferred stock units replace a part of their annual compensation, the deferred stock units were
entirely expensed in the three-month period.
Net Financial Charges
Interest revenues for the first quarter 2011 amounted to $372,000 compared to $578,000 for the same
period in 2010. Lower interest revenues for 2011 were due to a lower yield on the portfolio during
the period.
As at November 30, 2010, the foreign currency difference arising from the conversion of the
US$25,000,000 milestone payment from EMD Serono into the functional currency of the Company
resulted in a net foreign exchange gain of $635,000 as of November 30, 2010. However, in the first
quarter, when this amount was converted to Canadian dollars, a foreign exchange loss of $550,000
was incurred. The foreign exchange loss for the same period in 2010 was $44,000.
Net Results
Taking into account the revenues and expenses described above, we recorded a first quarter net loss
of $5,932,000, or $0.10 per share, compared to a net loss of $4,241,000, or $0.07 per share for the
same period in 2010.
Financial Position
At February 28, 2011, liquidities, which include cash and bonds, amounted to $55,842,000, and tax
credits and grants receivable amounted to $485,000, for a total of $56,327,000.
Taking into account the revenues and expenses described above, for the three-month period ended
February 28, 2011, use of cash from operating activities, was $7,764,000, compared to f $7,676,000
for the same period in 2010. Use of cash includes changes in trade and other receivables, related
to product sales to EMD Serono.
Quarterly Financial Information
The following table is a summary of our unaudited consolidated operating results presented in
accordance with IFRS for the last eight quarters.
(in thousands of Canadian dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Revenue |
|
$ |
3,518 |
|
|
$ |
26,717 |
|
|
$ |
1,717 |
|
|
$ |
1,717 |
|
|
$ |
1,717 |
|
|
$ |
1,718 |
|
|
$ |
12,601 |
|
|
$ |
1,717 |
|
Net (loss) profit |
|
$ |
(5,932 |
) |
|
$ |
21,299 |
|
|
$ |
(3,357 |
) |
|
$ |
(4,771 |
) |
|
$ |
(4,241 |
) |
|
$ |
(4,654 |
) |
|
$ |
5,779 |
|
|
$ |
(5,454 |
) |
Basic and diluted
(loss ) earnings per
share |
|
$ |
(0.10 |
) |
|
$ |
0.35 |
|
|
$ |
(0.06 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.08 |
) |
|
$ |
0.10 |
|
|
$ |
(0.09 |
) |
|
As described above, the higher revenues in 2011 include $1,798,000 of revenues generated from
the sales of EGRIFTA® to EMD Serono. The higher revenue in the fourth quarter of 2010
is related to the receipt from EMD Serono of a milestone payment of $25,000,000 following marketing
approval of EGRIFTA® by the FDA. The higher revenue in the third quarter of 2009 is
related to the milestone payment of $10,884,000 received from EMD Serono following the FDAs
granting acceptance to file our New Drug Application for EGRIFTA®.
3
Subsequent Events
On March 8, 2011, the Board of Directors decided not to pursue our public offering in Canada and
the United States due to an expected offering price which was not acceptable. We had previously
announced our intention to proceed to an initial public offering in the United States on February
22, 2011, with the filing of a preliminary short form base prospectus. The decision to withdraw the
offering does not affect the corporate strategy, as we intend to pursue our business plan with our
existing financial resources. The costs associated with the withdrawn public offering amount to
approximately $2,000,000, and were not included in the forecasted expenses previously disclosed for
2011.
Between March 1, 2011 and April 11, 2011, 284,168 options were exercised at a weighted exercise
average price of $1.92 per share for a cash consideration of $545,000.
Upcoming changes in accounting policies
(a) |
|
Amendments to existing standards: |
|
|
|
Annual improvements to IFRS: |
|
|
|
The IASBs improvements to IFRS contain seven amendments that result in accounting changes
for presentation, recognition or measurement purposes. The most significant features of the
IASBs annual improvements project published in May 2010 which are applicable for annual
periods beginning on or after January 1, 2011 (with partial adoption permitted) are
included under the specific revisions to standards discussed below. |
|
(i) |
|
IFRS 7: |
|
|
|
|
Amendment to IFRS 7, Financial Instruments: Disclosures: |
|
|
|
|
Multiple clarifications related to the disclosure of financial instruments and in
particular in regards to transfers of financial assets. |
|
|
(ii) |
|
IAS 1: |
|
|
|
|
Amendment to IAS 1, Presentation of Financial Statements: |
|
|
|
|
Entities may present the analysis of the components of other comprehensive income
either in the statement of changes in equity or within the notes to the financial
statements. |
|
|
(iii) |
|
IAS 27: |
|
|
|
|
Amendment to IAS 27, Consolidated and Separate Financial Statements: |
|
|
|
|
The 2008 revisions to this standard resulted in consequential amendments to IAS 21, The
Effects of Changes in Foreign Exchange Rates, IAS 28, Investments in Associates, and
IAS 31, Interests in Joint Ventures. IAS 27 now provides that these amendments are to
be applied prospectively. |
|
|
(iv) |
|
IAS 34: |
|
|
|
|
Amendment to IAS 34, Interim Financial Reporting: |
|
|
|
|
The amendments place greater emphasis on the disclosure principles for interim
financial reporting involving significant events and transactions, including changes to
fair value measurements and the need to update relevant information from the most
recent annual report. |
|
|
In addition, the following new or revised standards and interpretations have been issued
but are not yet applicable to us: |
|
(i) |
|
IFRS 9 Financial instruments: |
4
|
|
|
Effective for annual periods beginning on or after January 1, 2013, with earlier
adoption permitted. |
|
|
|
|
As part of the project to replace IAS 39, Financial Instruments: Recognition and
Measurement, this standard retains but simplifies the mixed measurement model and
establishes two primary measurement categories for financial assets. More specifically,
the standard: |
|
|
|
deals with classification and measurement of financial assets |
|
|
|
|
establishes two primary measurement categories for financial assets:
amortized cost and fair value |
|
|
|
|
prescribes that classification depends on entitys business model and
the contractual cash flow characteristics of the financial asset |
|
|
|
|
eliminates the existing categories: held to maturity, available for
sale, and loans and receivables. |
|
|
|
Certain changes were also made regarding the fair value option for financial
liabilities and accounting for certain derivatives linked to unquoted equity
instruments. |
Outstanding Share Data
On April 11, 2011, the number of shares issued and outstanding was 60,799,932 while outstanding
options granted under the stock option plan were 2,754,803.
Contractual Obligations
Except as described herein, there were no material changes in contractual obligations during the
quarter, other than in the ordinary course of business.
Economic and Industry Factors
Economic and industry factors were substantially unchanged from those reported in our 2010 Annual
Report.
Forward-Looking Information
This MD&A for the first quarter contains certain statements that are considered forward-looking
information within the meaning of applicable securities legislation. This forward-looking
information includes, but is not limited to, information regarding the preparation and filing of
applications seeking regulatory approval of EGRIFTA® in the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy in various territories outside of the United States, the
revenue to be generated as a result of sales of EGRIFTA® to EMD Serono and the receipt of royalties
from EMD Serono in connection with the sale of EGRIFTA® in the United States. Furthermore, the
words will, may, could, should, outlook, believe, plan, envisage, anticipate,
expect and estimate, or the negatives of these terms, or variations of them and the use of the
future and conditional tenses as well as similar expressions denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties include, but are not limited to, the risk that EGRIFTA®
is
not approved in all or some of the territories referred to in this MD&A, the revenue and royalties
we expect to generate from sales of EGRIFTA® are lower than anticipated, the supply of EGRIFTA® to
our commercial partners is delayed or suspended as a result of problems with our suppliers,
EGRIFTA® is withdrawn from the market as a result of defects or recalls, our intellectual property
is not adequately protected and our liquidity level decreases based on unexpected activities that
must be carried out in order to achieve our business plan.
5
Although the forward-looking information contained in this MD&A is based upon what the Company
believes are reasonable assumptions, investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking information. Certain assumptions
made in preparing the forward-looking information and the Companys objectives include the
assumption that EGRIFTA® for the reduction of excess abdominal fat in HIV-infected patients with
lipodystrophy will receive approvals in the territories referred to in this MD&A, no additional
clinical studies will be required to obtain these regulatory approvals, EGRIFTA® will be accepted
by the marketplace in the United States and will be on the list of reimbursed drugs by third-party
payers, relations with third-party suppliers of EGRIFTA® will be conflict-free and that such
third-party suppliers will have enough capacity to manufacture and supply EGRIFTA® to meet its
demand and will manufacture on a timely-basis and that the Companys business plan will not be
substantially modified.
Consequently, the forward-looking information is qualified by the foregoing cautionary statements,
and there can be no guarantee that the results or developments anticipated by the Company will be
realized or, even if substantially realized, that they will have the expected consequences or
effects on the Company, its business, its financial condition or its results of operations.
Furthermore, the forward-looking information reflects current expectations regarding future events
only as of the date of this MD&A.
Investors are referred to the Companys public filings available at www.sedar.com. In particular,
further details on the risks and descriptions of the risks are disclosed in the Risks and
Uncertainties section of the Companys Annual Information Form, dated February 22, 2011, for the
year ended November 30, 2010. This MD&A is dated April 12, 2011, and has been approved by the Audit
Committee.
6
ex-99.10
Exhibit 99.10
Consolidated Financial Statements of
(Unaudited)
THERATECHNOLOGIES INC.
Three-month periods ended February 28, 2011 and 2010
THERATECHNOLOGIES INC.
Consolidated Financial Statements
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
|
|
|
|
|
Financial Statements |
|
|
|
|
Consolidated Statement of Financial Position |
|
|
1 |
|
Consolidated Statement of Comprehensive Income |
|
|
2 |
|
Consolidated Statement of Changes in Equity |
|
|
3 |
|
Consolidated Statement of Cash Flows |
|
|
5 |
|
Notes to the Consolidated Financial Statements |
|
|
6 |
|
THERATECHNOLOGIES INC.
Consolidated Statement of Financial Position
(Unaudited)
As at February 28, 2011, November 30, 2010
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
February 28, |
|
|
November 30, |
|
|
|
Note |
|
|
2011 |
|
|
2010 |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
|
|
|
|
|
532 |
|
|
|
26,649 |
|
Bonds |
|
|
|
|
|
|
9,605 |
|
|
|
1,860 |
|
Trade and other receivables |
|
|
6 |
|
|
|
1,393 |
|
|
|
161 |
|
Tax credits and grants receivable |
|
|
|
|
|
|
485 |
|
|
|
332 |
|
Inventories |
|
|
7 |
|
|
|
4,614 |
|
|
|
4,317 |
|
Prepaid expenses |
|
|
|
|
|
|
909 |
|
|
|
1,231 |
|
Derivative financial assets |
|
|
9 a |
) |
|
|
721 |
|
|
|
|
|
|
Total current assets |
|
|
|
|
|
|
18,259 |
|
|
|
34,550 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Bonds |
|
|
|
|
|
|
45,705 |
|
|
|
36,041 |
|
Property and equipment |
|
|
|
|
|
|
1,012 |
|
|
|
1,060 |
|
|
Total non-current assets |
|
|
|
|
|
|
46,717 |
|
|
|
37,101 |
|
|
Total assets |
|
|
|
|
|
|
64,976 |
|
|
|
71,651 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
|
|
|
|
5,026 |
|
|
|
4,977 |
|
Current portion of deferred revenue |
|
|
5 |
|
|
|
6,846 |
|
|
|
6,847 |
|
|
Total current liabilities |
|
|
|
|
|
|
11,872 |
|
|
|
11,824 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Other liabilities |
|
|
8 |
|
|
|
1,153 |
|
|
|
325 |
|
Deferred revenue |
|
|
5 |
|
|
|
5,135 |
|
|
|
6,846 |
|
|
Total non-current liabilities |
|
|
|
|
|
|
6,288 |
|
|
|
7,171 |
|
|
Total liabilities |
|
|
|
|
|
|
18,160 |
|
|
|
18,995 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
|
|
|
|
279,407 |
|
|
|
279,398 |
|
Contributed surplus |
|
|
|
|
|
|
8,231 |
|
|
|
7,808 |
|
Deficit |
|
|
|
|
|
|
(241,048 |
) |
|
|
(235,116 |
) |
Accumulated other comprehensive income |
|
|
|
|
|
|
226 |
|
|
|
566 |
|
|
Total equity |
|
|
|
|
|
|
46,816 |
|
|
|
52,656 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent liability |
|
|
11 |
|
|
|
|
|
|
|
|
|
Subsequent events |
|
|
12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity |
|
|
|
|
|
|
64,976 |
|
|
|
71,651 |
|
|
See accompanying notes to unaudited consolidated financial statements.
1
THERATECHNOLOGIES INC.
Consolidated Statement of Comprehensive Income
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
(in thousands of Canadian dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note |
|
|
2011 |
|
|
2010 |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
(Restated - |
|
|
|
|
|
|
|
|
|
|
|
note 2 (a)) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Sale of goods |
|
|
|
|
|
|
1,798 |
|
|
|
|
|
Research services: |
|
|
|
|
|
|
|
|
|
|
|
|
Upfront payments and initial technology access fees |
|
|
5 |
|
|
|
1,711 |
|
|
|
1,711 |
|
Royalties and license fees |
|
|
|
|
|
|
9 |
|
|
|
6 |
|
|
Total revenue |
|
|
|
|
|
|
3,518 |
|
|
|
1,717 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
|
|
|
|
2,595 |
|
|
|
|
|
Research and development expenses, net of tax credits of $153 (2010 - $168) |
|
|
|
|
|
|
2,993 |
|
|
|
4,123 |
|
Selling and market development expenses |
|
|
|
|
|
|
477 |
|
|
|
620 |
|
General and administrative expenses |
|
|
|
|
|
|
3,215 |
|
|
|
1,745 |
|
|
Total operating expenses |
|
|
|
|
|
|
9,280 |
|
|
|
6,488 |
|
|
Results from operating activities |
|
|
|
|
|
|
(5,762 |
) |
|
|
(4,771 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income |
|
|
|
|
|
|
372 |
|
|
|
578 |
|
Finance costs |
|
|
|
|
|
|
(577 |
) |
|
|
(48 |
) |
|
Total (finance costs) net finance income |
|
|
|
|
|
|
(205 |
) |
|
|
530 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before income taxes |
|
|
|
|
|
|
(5,967 |
) |
|
|
(4,241 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax recovery |
|
|
|
|
|
|
35 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
(5,932 |
) |
|
|
(4,241 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss, net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value available-for-sale financial assets, net of tax |
|
|
|
|
|
|
(324 |
) |
|
|
3 |
|
Net change in fair value available-for-sale financial assets transferred to net loss, net of tax |
|
|
|
|
|
|
(16 |
) |
|
|
(100 |
) |
|
|
|
|
|
|
|
|
(340 |
) |
|
|
(97 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the period |
|
|
|
|
|
|
(6,272 |
) |
|
|
(4,338 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share |
|
|
9 |
(c) |
|
|
(0.10 |
) |
|
|
(0.07 |
) |
|
See accompanying notes to unaudited consolidated financial statements.
2
THERATECHNOLOGIES INC.
Consolidated Statement of Changes in Equity
(Unaudited)
Three-month period ended February 28, 2011
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
or losses on |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
available-for-sale |
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
Contributed |
|
|
financial |
|
|
|
|
|
|
|
|
|
Note |
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
assets (i) |
|
|
Deficit |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Balance as at November 30, 2010 |
|
|
|
|
|
|
60,512,764 |
|
|
|
279,398 |
|
|
|
7,808 |
|
|
|
566 |
|
|
|
(235,116 |
) |
|
|
52,656 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the period: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,932 |
) |
|
|
(5,932 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value of available-for-sale financial assets, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(324 |
) |
|
|
|
|
|
|
(324 |
) |
Net change in fair value of available-for-sale financial assets transferred to net loss,
net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16 |
) |
|
|
|
|
|
|
(16 |
) |
|
Total comprehensive loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(340 |
) |
|
|
(5,932 |
) |
|
|
(6,272 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transactions with owners, recorded directly in equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation plan: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation for stock option plan |
|
|
9 |
(b) |
|
|
|
|
|
|
|
|
|
|
427 |
|
|
|
|
|
|
|
|
|
|
|
427 |
|
Exercise of stock options: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Monetary consideration |
|
|
9 |
(b) |
|
|
3,000 |
|
|
|
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5 |
|
Attributed value |
|
|
9 |
(b) |
|
|
|
|
|
|
4 |
|
|
|
(4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contributions by owners |
|
|
|
|
|
|
3,000 |
|
|
|
9 |
|
|
|
423 |
|
|
|
|
|
|
|
|
|
|
|
432 |
|
|
Balance as at February 28, 2011 |
|
|
|
|
|
|
60,515,764 |
|
|
|
279,407 |
|
|
|
8,231 |
|
|
|
226 |
|
|
|
(241,048 |
) |
|
|
46,816 |
|
|
|
|
|
(i) |
|
Accumulated other comprehensive income. |
See accompanying notes to unaudited consolidated financial statements.
3
THERATECHNOLOGIES INC.
Consolidated Statement of Changes in Equity, Continued
(Unaudited)
Three-month period ended February 28, 2010
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
or losses on |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
available-for-sale |
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
Contributed |
|
|
financial |
|
|
|
|
|
|
|
|
|
Note |
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
assets (i) |
|
|
Deficit |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Restated - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
note 2 (a)) |
|
Balance as at November 30, 2009 |
|
|
|
|
|
|
60,429,393 |
|
|
|
279,169 |
|
|
|
6,757 |
|
|
|
1,282 |
|
|
|
(244,160 |
) |
|
|
43,048 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the period: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,241 |
) |
|
|
(4,241 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value of available-for-sale financial assets, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
3 |
|
Net change in fair value of available-for-sale financial assets transferred to net loss,
net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(100 |
) |
|
|
|
|
|
|
(100 |
) |
|
Total comprehensive loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(97 |
) |
|
|
(4,241 |
) |
|
|
(4,338 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transactions with owners, recorded directly in equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation plan: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation for stock option plan |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
233 |
|
|
|
|
|
|
|
|
|
|
|
233 |
|
Exercise of stock options: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Monetary consideration |
|
|
|
|
|
|
21,164 |
|
|
|
38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38 |
|
Attributed value |
|
|
|
|
|
|
|
|
|
|
23 |
|
|
|
(23 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contributions by owners |
|
|
|
|
|
|
21,164 |
|
|
|
61 |
|
|
|
210 |
|
|
|
|
|
|
|
|
|
|
|
271 |
|
|
Balance as at February 28, 2010 |
|
|
|
|
|
|
60,450,557 |
|
|
|
279,230 |
|
|
|
6,967 |
|
|
|
1,185 |
|
|
|
(248,401 |
) |
|
|
38,981 |
|
|
|
|
|
(i) |
|
Accumulated other comprehensive income. |
See accompanying notes to unaudited consolidated financial statements.
4
THERATECHNOLOGIES INC.
Consolidated Statement of Cash Flows
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note |
|
|
2011 |
|
|
2010 |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
|
|
|
(Restated - |
|
|
|
|
|
|
|
|
|
|
|
note 2 (a)) |
|
Operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
(5,932 |
) |
|
|
(4,241 |
) |
Adjustments for: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation of property and equipment |
|
|
|
|
|
|
67 |
|
|
|
147 |
|
Share-based compensation |
|
|
|
|
|
|
921 |
|
|
|
233 |
|
Write-down of inventories |
|
|
7 |
|
|
|
375 |
|
|
|
|
|
Lease inducements and amortization |
|
|
|
|
|
|
126 |
|
|
|
|
|
Change in fair value of derivative financial assets |
|
|
9 |
(a) |
|
|
116 |
|
|
|
|
|
Change in fair value of liability related to the deferred stock unit plan |
|
|
9 |
(a) |
|
|
(93 |
) |
|
|
|
|
Tax recovery |
|
|
|
|
|
|
(35 |
) |
|
|
|
|
|
Operating activities before changes in operating assets and liabilities |
|
|
|
|
|
|
(4,455 |
) |
|
|
(3,861 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in accrued interest income on bonds |
|
|
|
|
|
|
(234 |
) |
|
|
163 |
|
Change in trade and other receivables |
|
|
|
|
|
|
(1,232 |
) |
|
|
94 |
|
Change in tax credits and grants receivable |
|
|
|
|
|
|
(153 |
) |
|
|
165 |
|
Change in inventories |
|
|
|
|
|
|
(672 |
) |
|
|
(26 |
) |
Change in prepaid expenses |
|
|
|
|
|
|
322 |
|
|
|
(395 |
) |
Change in accounts payable and accrued liabilities |
|
|
|
|
|
|
372 |
|
|
|
(2,113 |
) |
Change in deferred revenue |
|
|
|
|
|
|
(1,712 |
) |
|
|
(1,703 |
) |
|
|
|
|
|
|
|
|
(3,309 |
) |
|
|
(3,815 |
) |
|
Cash flows used in operating activities |
|
|
|
|
|
|
(7,764 |
) |
|
|
(7,676 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options |
|
|
|
|
|
|
5 |
|
|
|
38 |
|
|
Cash flows from financing activities |
|
|
|
|
|
|
5 |
|
|
|
38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition of property and equipment |
|
|
|
|
|
|
(41 |
) |
|
|
(175 |
) |
Proceeds from sale of bonds |
|
|
|
|
|
|
8,579 |
|
|
|
9,626 |
|
Acquisition of bonds |
|
|
|
|
|
|
(26,059 |
) |
|
|
|
|
Acquisition of derivative financial assets |
|
|
9 |
(a) |
|
|
(837 |
) |
|
|
|
|
|
Cash flows (used in) from investing activities |
|
|
|
|
|
|
(18,358 |
) |
|
|
9,451 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in cash |
|
|
|
|
|
|
(26,117 |
) |
|
|
1,813 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash as at December 1 |
|
|
|
|
|
|
26,649 |
|
|
|
1,519 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash as at February 28 |
|
|
|
|
|
|
532 |
|
|
|
3,332 |
|
|
See note 10 for supplemental cash flow information.
See accompanying notes to unaudited consolidated financial statements.
5
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
(in thousands of Canadian dollars, except per share amounts)
|
|
Theratechnologies Inc. is a specialty pharmaceutical company that discovers and develops
innovative therapeutic peptide products with an emphasis on growth hormone releasing factor
peptides. Its first product, EGRIFTA® (tesamorelin for injection), was approved by
the United States Food and Drug Administration (''FDA) in November 2010. To date,
EGRIFTA® is the only approved therapy for the reduction of excess abdominal fat in
HIV-infected patients with lipodystrophy. |
|
|
The consolidated financial statements include the accounts of Theratechnologies Inc. and its
wholly-owned subsidiaries (together referred to as the ''Company and individually as ''the
subsidiaries of the Company). |
|
|
Theratechnologies Inc. is governed by the Business Corporations Act (Québec) and is domiciled
in Québec, Canada. The Company is located at 2310 boul. Alfred-Nobel, Montréal, Québec, H4S
2B4. |
|
(a) |
|
Accounting framework: |
|
|
|
|
These unaudited consolidated interim financial statements (interim financial statements),
including comparative figures, have been prepared using accounting policies consistent with
International Financial Reporting Standards (IFRS) as prescribed by the International
Accounting Standards Board (IASB) and in accordance with International Accounting
Standard (IAS) 34 Interim Financial Reporting (IAS 34). |
|
|
|
|
Certain information, in particular the accompanying notes normally included in the annual
financial statements prepared in accordance with IFRS have been omitted or condensed. These
interim financial statements do not include all disclosures required under IFRS and
accordingly should be read in conjunction with the annual financial statements for the year
ended November 30, 2010 and the notes thereto. These interim financial statements have not
been reviewed by the Companys auditors. |
|
|
|
|
The interim financial statements of the Company for the three-month period ended February
28, 2010 were restated to reflect changes related to the Companys adoption of IFRS. In the
fourth quarter of 2010, the Company filed a request to adopt IFRS two years in advance of
the date required for canadian public companies. The request was approved by the Canadian
Securities authorities. The Company filed restated interim financial statements to comply
with this approval. |
6
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
(in thousands of Canadian dollars, except per share amounts)
2. |
|
Basis of preparation (continued): |
|
(b) |
|
Summary of accounting policies: |
|
|
|
|
The preparation of financial data is based on accounting principles and practices
consistent with those used in the preparation of the audited annual financial statements as
at November 30, 2010 except as noted below: |
|
|
|
|
Effective December 1, 2010, The Company adopted a new accounting standard, IFRS 8 Operating
Segments, that was issued by the IASB. IFRS 8 was revised and now requires disclosure of
information about segment assets. This accounting policy change was adopted on a
prospective basis with no restatement of prior period financial statements and had no
impact on the Companys operating segments disclosure. |
|
|
|
|
Other new or amended accounting standards also had no impact on the Companys accounting
methods. |
|
|
(c) |
|
Basis of measurement: |
|
|
|
|
The Companys consolidated financial statements have been prepared on a going concern and
historical cost basis, except for available-for-sale financial assets and derivative
financial assets which are measured at fair value. |
|
|
(d) |
|
Use of estimates and judgements: |
|
|
|
|
The preparation of the Companys interim financial statements in conformity with IFRSs
requires management to make estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues and expenses during the
reporting period. |
|
|
|
|
Information about critical judgements in applying accounting policies that have the most
significant effect on the amounts recognized in the interim financial statements relate to
the timing of revenue recognition, the valuation of share-based compensation; the
realizability of deferred tax assets, and the recognition and measurement of contingent
liabilities. |
|
|
|
|
Other areas of judgement and uncertainty relate to the estimation of accruals for clinical
trial expenses, the recoverability of inventories, the measurement of the amount and
assessment of the recoverability of tax credits and grants receivable and the
capitalization of development expenditures. |
|
|
|
|
Reported amounts and note disclosure reflect the overall economic conditions that are most
likely to occur and anticipated measures management intends to take. Actual results could
differ from those estimates. |
7
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
(in thousands of Canadian dollars, except per share amounts)
2. |
|
Basis of preparation (continued): |
|
(d) |
|
Use of estimates and judgements (continued): |
|
|
|
|
The above estimates and assumptions are reviewed regularly. All revisions to accounting
estimates are recognized in the period in which the estimates are revised and in any future
periods affected. |
|
|
(e) |
|
Functional and presentation currency: |
|
|
|
|
These interim consolidated financial statements are presented in Canadian dollars, which is
the Companys functional currency. All financial information presented in Canadian dollars
has been rounded to the nearest thousand. |
3. |
|
Significant accounting policies: |
|
|
Derivative financial instruments |
|
|
|
Derivative financial instruments are recorded as either assets or liabilities measured at their
fair value unless exempted from derivative treatment as a normal purchase and sale. Certain
derivatives embedded in other contracts must also be measured at fair value. The changes in the
fair value of derivatives are recognized in the statement of comprehensive income. |
4. |
|
Upcoming changes in accounting policies: |
|
(a) |
|
Amendments to existing standards: |
|
|
|
|
Annual improvements to IFRS: |
|
|
|
|
The IASBs improvements to IFRS contain seven amendments that result in accounting changes
for presentation, recognition or measurement purposes. The most significant features of the
IASBs annual improvements project published in May 2010 which are applicable for annual
period beginning on or after January 1, 2011 with partial adoption permitted are included
under the specific revisions to standards discussed below. |
|
(i) |
|
IFRS 7: |
|
|
|
|
Amendment to IFRS 7, Financial Instruments: Disclosures: |
|
|
|
|
Multiple clarifications related to the disclosure of financial instruments and in
particular in regards to transfers of financial assets. |
8
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
(in thousands of Canadian dollars, except per share amounts)
4. |
|
Upcoming changes in accounting policies (continued): |
|
(a) |
|
Amendments to existing standards (continued): |
|
|
|
|
Annual improvements to IFRS (continued): |
|
(ii) |
|
IAS 1: |
|
|
|
|
Amendment to IAS 1, Presentation of Financial Statements: |
|
|
|
|
Entities may present the analysis of the components of other comprehensive income
either in the statement of changes in equity or within the notes to the financial
statements. |
|
|
(iii) |
|
IAS 27: |
|
|
|
|
Amendment to IAS 27, Consolidated and Separate Financial Statements: |
|
|
|
|
The 2008 revisions to this standard resulted in consequential amendments to IAS 21, The
Effects of Changes in Foreign Exchange Rates, IAS 28, Investments in Associates, and
IAS 31, Interests in Joint Ventures. IAS 27 now provides that these amendments are to
be applied prospectively. |
|
|
(iv) |
|
IAS 34: |
|
|
|
|
Amendment to IAS 34, Interim Financial Reporting: |
|
|
|
|
The amendments place greater emphasis on the disclosure principles for interim
financial reporting involving significant events and transactions, including changes to
fair value measurements and the need to update relevant information from the most
recent annual report. |
|
|
|
In addition, the following new or revised standards and interpretations have been issued
but are not yet applicable to the Company: |
|
(i) |
|
IFRS 9 Financial instruments: |
|
|
|
|
Effective for annual periods beginning on or after January 1, 2013, with earlier
adoption permitted. |
9
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
(in thousands of Canadian dollars, except per share amounts)
4. |
|
Upcoming changes in accounting policies (continued): |
|
(a) |
|
Amendments to existing standards (continued): |
|
|
|
|
Annual improvements to IFRS (continued): |
|
(i) |
|
IFRS 9 Financial instruments (continued): |
|
|
|
|
As part of the project to replace IAS 39, Financial Instruments: Recognition and
Measurement, this standard retains but simplifies the mixed measurement model and
establishes two primary measurement categories for financial assets. More specifically,
the standard: |
|
|
|
deals with classification and measurement of financial assets |
|
|
|
|
establishes two primary measurement categories for financial assets:
amortized cost and fair value |
|
|
|
|
prescribes that classification depends on entitys business model and
the contractual cash flow characteristics of the financial asset |
|
|
|
|
eliminates the existing categories: held to maturity, available for
sale, and loans and receivables. |
|
|
|
Certain changes were also made regarding the fair value option for financial
liabilities and accounting for certain derivatives linked to unquoted equity
instruments. |
5. |
|
Revenue and deferred revenue: |
|
a) |
|
EMD Serono Inc. |
|
|
|
|
On October 28, 2008, the Company entered into a collaboration and licensing agreement with
EMD Serono Inc. (EMD Serono), an affiliate of Merck KGaA, of Darmstadt, Germany,
regarding the exclusive commercialization rights of EGRIFTA® in the United
States for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy (the Initial Product). |
|
|
|
|
Under the terms of the agreement, the Company is responsible for the development of the
Initial Product up to obtaining marketing approval in the United States, which was obtained
on November 10, 2010. The Company is also responsible for production and for the
development of a new formulation of the initial product. EMD Serono is responsible for
conducting product commercialization activities. |
10
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Revenue and deferred revenue (continued): |
|
a) |
|
EMD Serono Inc. (continued) |
|
|
|
|
At the closing of the agreement, on December 15, 2008, the Company received US$30,000
(CAD$36,951), which included an initial payment of US$22,000 (CAD$27,097) and US$8,000
(CAD$9,854) as a subscription for common shares in the Company by Merck KGaA at a price of
US$3.67 (CAD$4.52) per share. The Company may receive up to US$215,000, which amount
includes the initial payment of US$22,000, the equity investment of US$8,000, as well as
payments based on the achievement of certain development, regulatory and sales milestones.
The Company will also be entitled to receive increasing royalties on annual net sales of
EGRIFTA® in the United States, if applicable. |
|
|
|
|
The initial payment of $27,097 has been deferred and is being amortized on a straight-line
basis over the estimated period for developing a new formulation of the Initial Product.
This period may be modified in the future based on additional information that may be
received by the Company. For the three-month period ended February 28, 2011, an amount of
$1,711 (2010 $1,711) was recognized as revenue. As at February 28, 2011, the deferred
revenue related to this transaction amounted to $11,981 (November 30, 2010 $13,692). |
|
|
|
|
The Company may conduct research and development for additional indications. Under the
collaboration and licensing agreement, EMD Serono will have the option to commercialize
additional indications for tesamorelin in the United States. If it exercises this option,
EMD Serono will pay half of the development costs related to such additional indications.
In such cases, the Company will also have the right, subject to an agreement with EMD
Serono, to participate in the promotion of the additional indications. |
|
|
b) |
|
Sanofi-aventis |
|
|
|
|
On December 6, 2010, the Company announced the signing of a distribution and licensing
agreement with Sanofi-aventis (Sanofi), covering the commercial rights for
EGRIFTA® in Latin America, Africa, and the Middle East for the treatment of
excess abdominal fat in HIV-infected patients with lipodystrophy. |
11
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Revenue and deferred revenue (continued): |
|
b) |
|
Sanofi-aventis (continued) |
|
|
|
|
Under the terms of the agreement, the Company will sell EGRIFTA® to Sanofi at a
transfer price equal to the higher of a percentage of Sanofis net selling price and a
predetermined floor price. The Company has retained all future development rights to
EGRIFTA® and will be responsible for conducting research and development for
any additional clinical programs. Sanofi will be responsible for conducting all regulatory
activities for EGRIFTA® in the aforementioned territories, including
applications for approval in the different countries for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy. The Company also granted Sanofi an option
to commercialize tesamorelin for other indications in the territories mentioned above. If
such option is not exercised, or is declined, by Sanofi, the Company may commercialize
tesamorelin for such indications on its own or with a third party. |
|
|
c) |
|
Ferrer Internacional S.A. |
|
|
|
|
On February 3, 2011, the Company entered into a distribution and licensing agreement with
Ferrer Internacional S.A. (''Ferrer) covering the commercial rights for
EGRIFTA® for the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy in Europe, Russia, South Korea, Taiwan, Thailand and certain central
Asian countries. |
|
|
|
|
Under the terms of the Agreement, the Company will sell EGRIFTA® to Ferrer at a
transfer price equal to the higher of a significant percentage of the Ferrers net selling
price and a predetermined floor price. The Company has retained all development rights to
EGRIFTA® for other indications and will be responsible for conducting research
and development for any additional programs. Ferrer will be responsible for conducting all
regulatory and commercialization activities in connection with EGRIFTA® for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in the
territories mentioned above. The Company will be responsible for the manufacture and supply
of EGRIFTA® to Ferrer. The Company has the option to co-promote
EGRIFTA® for the reduction of excess abdominal fat in HIV-infected patients
with lipodystrophy in the territories. Ferrer has the option to enter into a co-development
and commercialization agreement using tesamorelin relating to any such new indications. The
terms and conditions of such a co-development and commercialization agreement will be
negotiated based on any additional program chosen for development. |
12
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
(in thousands of Canadian dollars, except per share amounts)
6. |
|
Trade and other receivables: |
|
|
|
|
|
|
|
|
|
|
|
February 28, |
|
|
November 30, |
|
|
|
2011 |
|
|
2010 |
|
|
|
$ |
|
|
$ |
|
Trade receivables |
|
|
1,342 |
|
|
|
6 |
|
Sales tax receivable |
|
|
28 |
|
|
|
100 |
|
Loans granted to employees under the share purchase plan |
|
|
14 |
|
|
|
25 |
|
Loans granted to related parties under the share purchase plan |
|
|
|
|
|
|
22 |
|
Other receivables |
|
|
9 |
|
|
|
8 |
|
|
|
|
|
1,393 |
|
|
|
161 |
|
|
|
|
As at February 28, 2011, $109 of raw materials, $132 of work in progress and $134 of finished
products were written down to their net realizable value (2010 nil). Consequently, a
write-down of $375 was recorded to cost of sales in 2011 (2010 nil). |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
February 28, |
|
|
November 30, |
|
|
|
Note |
|
|
2011 |
|
|
2010 |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
Deferred lease inducements |
|
|
|
|
|
|
451 |
|
|
|
325 |
|
Liability related to the deferred stock unit plan |
|
|
9 (a) |
|
|
|
702 |
|
|
|
|
|
|
|
|
|
|
|
|
|
1,153 |
|
|
|
325 |
|
|
13
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
(in thousands of Canadian dollars, except per share amounts)
|
(a) |
|
Deferred stock unit plan: |
|
|
|
|
On December 10, 2010, the Board of Directors adopted a deferred stock unit plan (the DSU
Plan) for the benefit of its directors and officers (the Beneficiaries). The goal of the
DSU Plan is to increase the Companys ability to attract and retain high-quality
individuals to act as directors or officers and better align their interests with those of
the shareholders of the Company in the creation of long-term value. Under the terms of the
DSU Plan, Beneficiaries who are directors are entitled to elect to receive all or part of
their annual retainer to act as directors in deferred stock units (DSU). In addition to
his annual retainer, the Chairman of the Board is also entitled to elect to receive all or
part of his annual retainer in DSU. Beneficiaries who act as officers are entitled to elect
to receive all or part of their annual bonus, if any, in DSU. The value of a DSU (the DSU
Value) is equal to the average closing price of the common shares on The Toronto Stock
Exchange on the date on which a Beneficiary determines that he desires to receive or redeem
DSU and during the four (4) previous trading days. Beneficiaries who act as directors must
elect to receive DSU before December 23 of a calendar year for the ensuing calendar year
whereas Beneficiaries who act as officers must make that election within 48 hours after
having been notified of their annual bonus. For the purposes of granting DSU, the DSU Value
for directors is determined as at December 31 of a calendar year and the DSU Value for
officers is determined on the second business day after they have been notified of their
annual bonus. |
|
|
|
|
DSU may only be redeemed when a Beneficiary ceases to act as a director or an officer of
the Company. Upon redemption, the Company must provide a Beneficiary with an amount in cash
equal to the DSU Value on the Redemption Date. Beneficiaries may not sell, transfer or
otherwise assign their DSU or any rights associated therewith other than by will or in
accordance with legislation regarding the vesting and partition of successions. |
|
|
|
|
The DSU are totally vested at the grant date. In the case of the DSU granted to officers
for annual bonuses, a DSU liability is recorded at the grant date in place of the liability
for the bonuses payments. In the case of the directors, the expense related to DSU and
their liabilities are recognized at the grant date. During the quarter $494 (2010 -
nil) was recorded as an expense and is included in general and administrative expenses. The
liability is adjusted periodically to reflect any change in market value of common shares.
During the three-month period ended February 28, 2011, a gain of $93 due to the change in
the fair value of the liability related to the DSU was recognized. As at February 28, 2011,
the Company has a total of 145 658 DSU outstanding (2010 nil) and a liability related to
the DSU of $702 (2010 nil) recognised in other non-current liabilities. There were no
stock units that were redeemed. |
14
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
(in thousands of Canadian dollars, except per share amounts)
9. |
|
Share capital (continued): |
|
(a) |
|
Deferred stock unit plan (continued): |
|
|
|
|
To protect against fluctuations in the value of the DSUs, the Company signed two futures
stock contracts in the first quarter of 2011. The Company paid $837 as advance payments on
the contracts, $580 for the first and $257 for the second, these amounts correspond to 146
875 common shares of the Company at a price of $5.69 and $5.72 respectively. The contracts
expire in December 2011. They were not designated as hedging instruments for accounting
purposes. Changes in fair value of these contracts are, therefore, included in gain (loss)
on financial instruments carried at fair value in the period in which they occur. During
the three-month period ended February 28, 2011, a loss of $116 related to the change in the
fair value of derivative financial assets was recognized. As at February 28, 2011, the fair
value of future stock contracts was $721 (2010 nil) and is recorded in derivative
financial assets. |
|
|
(b) |
|
Stock option plan: |
|
|
|
|
The risk-free interest rate is based on the implied yield on a Canadian Government
zero-coupon issue with a remaining term equal to the expected term of the option. The
volatility is based solely on historical volatility equal to the expected life of the
option. The life of the options is estimated considering the vesting period at the grant
date, the life of the option and the average length of time of similar grants have remained
outstanding in the past. The dividend yield was excluded from the calculation, since it is
the present policy of the Company to retain in all earnings to finance operations and
future growth. |
|
|
|
|
The following table summarizes the measurement date weighted average fair value of stock
options granted during the periods ended February 28, 2011 and 2010: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
Number of |
|
|
grant-date |
|
|
|
options |
|
|
fair value |
|
|
|
|
|
|
|
$ |
|
2011 |
|
|
250,000 |
|
|
|
4.08 |
|
2010 |
|
|
265,000 |
|
|
|
2.90 |
|
|
15
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
(in thousands of Canadian dollars, except per share amounts)
9. |
|
Share capital (continued): |
|
(b) |
|
Stock option plan (continued): |
|
|
|
|
The Black-Scholes model used by the Company to calculate option values was developed to
estimate the fair value of freely tradable, fully transferable options without vesting
restrictions, which significantly differs from the Companys stock option awards. This
model also requires four highly subjective assumptions, including future stock price
volatility and average option life, which greatly affect the calculated values. |
|
|
|
|
Changes in outstanding options granted under the Companys stock option plan for the year
ended November 30, 2010 and the three-month period ended February 28, 2011 were as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
|
|
|
|
exercise price |
|
|
|
Options |
|
|
per option |
|
|
|
|
|
|
|
$ |
|
Options at November 30, 2009 |
|
|
2,665,800 |
|
|
|
5.20 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
335,000 |
|
|
|
4.03 |
|
Expired |
|
|
(32,500 |
) |
|
|
11.15 |
|
Forfeited |
|
|
(38,671 |
) |
|
|
3.61 |
|
Exercised |
|
|
(80,491 |
) |
|
|
1.66 |
|
|
|
|
|
|
|
|
|
|
|
Options at November 30, 2010 |
|
|
2,849,138 |
|
|
|
5.12 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
250,000 |
|
|
|
5.65 |
|
Expired |
|
|
(18,000 |
) |
|
|
15.30 |
|
Forfeited |
|
|
(39,167 |
) |
|
|
3.96 |
|
Exercised |
|
|
(3,000 |
) |
|
|
1.80 |
|
|
|
|
|
|
|
|
|
|
|
Options at February 28, 2011 |
|
|
3,038,971 |
|
|
|
5.12 |
|
|
16
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
(in thousands of Canadian dollars, except per share amounts)
9. |
|
Share capital (continued): |
|
(b) |
|
Stock option plan (continued): |
|
|
|
|
The fair value of the options granted was estimated at the grant date using the
Black-Scholes model and the following weighted average assumptions: |
|
|
|
|
|
|
|
|
|
|
|
February 28, |
|
|
February 28, |
|
|
|
2011 |
|
|
2010 |
|
|
Risk-free interest rate |
|
|
2.72 |
% |
|
|
2.46 |
% |
Volatility |
|
|
74.46 |
% |
|
|
81 |
% |
Average option life in years |
|
|
7.5 |
|
|
|
7.5 |
|
Dividend yield |
|
Nil |
|
|
Nil |
|
Grant-date share price |
|
$ |
5.65 |
|
|
$ |
3.84 |
|
Option exercise price |
|
$ |
5.65 |
|
|
$ |
3.84 |
|
|
|
(c) |
|
Earnings per share: |
|
|
|
|
The calculation of basic earnings per share at February 28, 2011 was based on the net loss
attributable to common shareholders of the Company of $5,932 (2010 $4,241), and a
weighted average number of common shares outstanding of 60,514,420 (2010 60,438,098). The
weighted average number of common shares is calculated as follows: |
|
|
|
|
|
|
|
|
|
|
|
February 28, |
|
|
February 28, |
|
|
|
2011 |
|
|
2010 |
|
|
Issued common shares at December 1 |
|
|
60,512,764 |
|
|
|
60,429,393 |
|
Effect of share options exercised |
|
|
1,656 |
|
|
|
8,705 |
|
|
Weighted average number of common shares at February 28 |
|
|
60,514,420 |
|
|
|
60,438,098 |
|
|
|
|
|
At February 28, 2011, 1,324,832 options (2010 1,157,166) were excluded from the
diluted weighted average number of common shares calculation as their effect would have
been anti-dilutive. |
17
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
(in thousands of Canadian dollars, except per share amounts)
10. |
|
Supplemental cash flow information: |
|
|
The Company entered into the following transactions which had no impact on the cash flows: |
|
|
|
|
|
|
|
|
|
|
|
February 28, |
|
|
February 28, |
|
|
|
2011 |
|
|
2010 |
|
|
|
$ |
|
|
$ |
|
Additions to property and equipment included in accounts payable and accrued liabilities |
|
|
43 |
|
|
|
135 |
|
DSU issue related to bonus included in accounts payable and accrued liabilities |
|
|
301 |
|
|
|
|
|
|
|
|
In addition, interest received totaled $122 (2010 $641). |
11. |
|
Contingent liability: |
|
|
On July 26, 2010, the Company received a motion of authorization to institute a class action
lawsuit against the Company, a director and a former executive officer (the Motion). This
Motion was filed in the Superior Court of Quebec, district of Montreal. The applicant is
seeking to initiate a class action suit to represent the class of persons who were shareholders
at May 21, 2010 and who sold their common shares of the Company on May 25 or 26, 2010. This
applicant alleges that the Company did not comply with its continuous disclosure obligations as
a reporting issuer by failing to disclose certain alleged adverse effects relating to the
administration of EGRIFTA®. The Company is of the view that the allegations
contained in the Motion are entirely without merit and intends to take all appropriate actions
to vigorously defend its position. |
|
|
|
The Motion had not yet been heard by the Superior Court of Quebec. |
|
|
|
The Company has subscribed to insurance covering its potential liability and the potential
liability of its directors and officers in the performance of their duties for the Company
subject to a $200 deductible. |
18
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2011 and 2010
(in thousands of Canadian dollars, except per share amounts)
|
|
On March 8, 2011, the Board of Directors decided not to pursue our public offering in Canada
and the United States, the expected offering price was not acceptable. The Company had
previously announced its intention to proceed to an initial public offering in the United
States on February 22, 2011, with the filing of a preliminary short form base prospectus. The
decision to withdraw the offering does not affect the Companys strategy, because it intends to
pursue its business plan with existing financial resources. The costs associated with the
withdrawn public offering amount to approximately $2,000. |
|
|
|
Between March 1, 2011 and April 11, 2011, 284,168 options were exercised at a weighted exercise
average price of $1.92 per share for a cash consideration of 545 $. |
19
ex-99.11
Exhibit 99.11
MANAGEMENTS DISCUSSION AND ANALYSIS
FOR THE THREE-MONTH AND NINE-MONTH PERIODS ENDED AUGUST 31, 2010
The following Managements Discussion and Analysis (MD&A) provides Managements point of view on
the financial position and the results of operations of Theratechnologies Inc. (Theratechnologies
or the Company), for the three-month and nine-month periods ended August 31, 2010, as compared to
the three-month and nine-month periods ended August 31, 2009. This view contains information that
the Company believes may affect its prospective financial condition, cash flows and results of
operations. The unaudited interim consolidated financial statements have been prepared in
accordance with Canadian Generally Accepted Accounting Principles (GAAP). This MD&A should be
read in conjunction with the unaudited interim consolidated financial statements of the Company and
the notes thereto as at August 31, 2010, as well as the MD&A and audited consolidated financial
statements including the related notes thereto as at November 30, 2009. Unless specified otherwise,
all amounts are in Canadian dollars.
Financial Overview
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company
targets unmet medical needs in specialty markets where it can retain all or some of the commercial
rights to its products. Its most advanced compound, tesamorelin, is an analogue of the human growth
hormone releasing factor.
The Companys growth strategy is centered upon the development of tesamorelin. In late 2008,
Theratechnologies entered into a collaboration and licensing agreement with EMD Serono, Inc. (EMD
Serono), an affiliate of Merck KGaA, Darmstadt, Germany, for the exclusive commercialization
rights to tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in the United States. The principal strategic objective of Theratechnologies is to
obtain regulatory approval for tesamorelin in the United States in this indication and good
progress was made by participating in the U.S. Food and Drug Administration (FDA or the Agency)
Endocrinologic and Metabolic Drugs Advisory Committee. On May 27, 2010, the Committee recommended
by a 16 to 0 unanimous vote that tesamorelin be granted marketing approval by the FDA for this
indication. Although advisory committees provide their recommendations, the decision on marketing
approval is made by the Agency. Theratechnologies expects a final decision from the Agency on the
approval of tesamorelin in the United States during the fourth quarter 2010. Should tesamorelin be
approved, the Company expects to receive regulatory milestone payments, royalties and additional
milestone payments from sales of tesamorelin by EMD Serono in the United States.
Concurrent with advancing the regulatory process, Theratechnologies has begun building inventory in
preparation for the launch of tesamorelin in the United States by EMD Serono, upon its approval by
the FDA. In the coming months, the Company will continue building inventory.
In light of a lower expense level and cost control measures, the Company anticipates that the
adjusted burn rate for 2010 will be between $22,000,000 and $23,000,000, and thus will be less than
the initially forecasted adjusted burn rate of $24,000,000.
Revenues
Consolidated revenues for the three-month period ended August 31, 2010, amounted to $2,152,000,
compared to $13,148,000 for 2009. For the nine-month period ended August 31, 2010, consolidated
revenues were $6,673,000, compared to $17,474,000 for the same period in 2009. The higher revenues
in 2009 are due to the receipt in the third quarter of a milestone payment of $10,884,000
associated with the FDAs agreement to review the New Drug Application (NDA) for tesamorelin,
pursuant to the collaboration and licensing agreement with EMD Serono.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
The initial payment received upon the closing of the agreement with EMD Serono of $27,097,000 has
been deferred and is being amortized over its estimated service period on a straight-line basis.
This period may be modified in the future based on additional information. For the three-month
period ended August 31, 2010, an amount of $1,711,000 ($1,712,000 for the same period in 2009) was
recognized as revenue related to this transaction, while an amount of $5,134,000 was recognized as
revenue related to this transaction for the nine-month period ($4,849,000 for the same period in
2009). At August 31, 2010, the deferred revenues related to this transaction recorded on the
balance sheet amounted to $15,403,000.
R&D Activities
Research and development (R&D) expenses, before tax credits, totaled $2,930,000 for the third
quarter of 2010, compared to $5,681,000 in 2009. For the nine-month period ended August 31, 2010,
R&D expenses were $11,298,000 compared to $17,692,000 for the same period in 2009, a decrease of
36.1%. The R&D expenses incurred in the third quarter of 2010 are mainly related to the pursuit of
the regulatory filing for tesamorelin with the FDA. The expenses incurred in the third quarter of
2009, in addition to expenses related to the pursuit of the regulatory filing described above,
included a non-recurring charge of $1,395,000 related to a write-down of research supplies produced
in order to obtain stability data and to validate the manufacturing process for commercial
purposes, as required by the FDA. The expenses incurred in the nine-month period ended August 31,
2009, also included costs associated with completing the Phase 3 clinical trials evaluating
tesamorelin in HIV-associated lipodystrophy.
Other Expenses
For the third quarter of 2010, general and administrative expenses amounted to $2,225,000, compared
to $1,337,000 for the same period in 2009. For the nine-month period ended August 31, 2010, general
and administrative expenses amounted to $6,083,000, compared to $5,515,000 for the same period in
2009. The higher expenses in the third quarter of 2010 are principally due to professional fees
associated with the recruitment of the new President and Chief Executive Officer, variations in
stock-based compensation expenses, and foreign exchange rate fluctuations. The higher expenses in
the nine-month period are principally due to heightened communication activities related to the FDA
Advisory Committee meeting as well as an increase in other administrative expenses partially offset
by a reduction in the loss on foreign exchange. The expenses for the nine-month period ending
August 31, 2009, include the costs associated with revising the Companys business plan.
For the third quarter of 2010, the cost of sales, an amount related to the production of
tesamorelin, totaled $120,000. There were no costs related to the production of tesamorelin for the
corresponding period in 2009.
Selling and market development expenses amounted to $521,000 for the third quarter of 2010,
compared to $495,000 for the same period in 2009. For the nine-month period ended August 31, 2010,
selling and market development expenses amounted to $1,901,000, compared to $1,516,000 for the same
period in 2009. The increase in the selling and market development expenses is principally due to
business development and market research studies for countries other than the United States. These
expenses also include activities associated with the management of the agreement with EMD Serono.
Net Results
Taking into account the revenues and expenses described above, the Company recorded a third quarter
net loss of $3,277,000, representing $0.05 per share, compared to a net earning of
$5,824,000, representing $0.10 per share for the same period in 2009. For the nine-month period
ended August 31, 2010, the net loss was $12,367,000, representing $0.20 per share, compared to a
net loss of $10,360,000, representing $0.17 per share for the same period in 2009.
2
The net loss in the third quarter of 2010 includes revenue of $1,711,000 related to the agreement
with EMD Serono. Excluding this item, the adjusted net loss amounted to $4,988,000 in 2010, a
decrease of 26.3% compared to the same period in 2009. For the nine-month period, the net loss
includes revenue and costs related to the agreement with EMD Serono. Excluding those items, the
adjusted net loss amounted to $17,501,000, compared to $21,824,000 for the same period in 2009, a
decrease of 19.8%.
Financial Position
At August 31, 2010, liquidities, which include cash and bonds, amounted to $43,419,000, and tax
credits receivable amounted to $514,000, for a total of $43,933,000.
Taking into account the revenues and expenses described above, for the three-month period ended
August 31, 2010, the burn rate from operating activities, excluding changes in operating assets and
liabilities, was $2,629,000, compared to a cash flow of $6,186,000 in 2009. Excluding the revenue
and costs related to the agreement with EMD Serono, the adjusted burn rate from operating
activities, excluding changes in operating assets and liabilities, was $4,340,000 for the quarter
ended August 31, 2010, compared to $6,410,000 for the third quarter of 2009, a decrease of 32.3%.
For the nine-month period ending August 31, 2010, the burn rate from operating activities,
excluding changes in operating assets and liabilities, was $10,877,000 compared to $9,214,000 for
the same period in 2009. Excluding the revenue and costs associated with the agreement with EMD
Serono, the adjusted burn rate from operating activities, excluding changes in operating assets and
liabilities, was $16,011,000, compared to $20,678,000 for the corresponding period in 2009,
representing a decrease of 22.6%.
Quarterly Financial Information
The selected financial information provided below is derived from the Companys unaudited quarterly
financial statements for each of the last eight quarters. This information has been restated
following the adoption of the Canadian Institute of Chartered Accountants (CICA) Handbook Section
3064, Goodwill and Intangible Assets.
(in thousands of Canadian dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Q4 |
|
|
Revenues |
|
$ |
2,152 |
|
|
$ |
2,226 |
|
|
$ |
2,295 |
|
|
$ |
2,246 |
|
|
$ |
13,148 |
|
|
$ |
2,317 |
|
|
$ |
2,009 |
|
|
$ |
616 |
|
Net (loss) earnings |
|
$ |
(3,277 |
) |
|
$ |
(4,823 |
) |
|
$ |
(4,267 |
) |
|
$ |
(4,698 |
) |
|
$ |
5,824 |
|
|
$ |
(5,430 |
) |
|
$ |
(10,754 |
) |
|
$ |
(15,145 |
) |
Basic and diluted
(loss) earnings per
share |
|
$ |
(0.05 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.08 |
) |
|
$ |
0.10 |
|
|
$ |
(0.09 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.26 |
) |
|
As described above, the increased revenues in 2010 and 2009 are related to the amortization of
the initial payment received at the closing of the agreement with EMD Serono, as well as the
milestone payment of $10,884,000 recorded in August 2009. The increase in the fourth quarter net
loss in 2008 is due to impairment charges for intellectual property.
Non-GAAP Measures
The Company uses measures that do not conform to Canadian GAAP to assess its operating performance.
Securities regulators require that companies caution readers that earnings and other measures
adjusted to a basis other than GAAP do not have standardized meanings and are unlikely to be
comparable to similar measures used by other companies. Accordingly, these measures should not be
considered in isolation. The Company uses non-GAAP measures such as adjusted net loss and the
adjusted burn rate from operating activities before changes in operating
assets and liabilities, to measure its performance from one period to the next without including
changes caused by certain items that could potentially distort the analysis of trends in its
operating performance, and because such measures provide meaningful information on the Companys
financial condition and operating results.
3
Definition and Reconciliation of Non-GAAP Measures
In order to measure performance from one period to another, without accounting for changes related
to the impact of revenues and costs associated with the collaboration and licensing agreement with
EMD Serono, Management uses adjusted net loss and adjusted burn rate from operating activities
before changes in operating assets and liabilities. These items are excluded because they affect
the comparability of the financial results and could potentially distort the analysis of trends in
the Companys operating performance. The exclusion of these items does not necessarily indicate
that they are non-recurring.
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 31st |
|
|
August 31st |
|
|
|
(3 months) |
|
|
(9 months) |
|
Adjusted net loss |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
(Net loss) net earnings per the financial statements |
|
$ |
(3,277 |
) |
|
$ |
5,824 |
|
|
$ |
(12,367 |
) |
|
$ |
(10,360 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue associated with a collaboration and
licensing agreement (note 7 to the consolidated
financial statements) |
|
|
(1,711 |
) |
|
|
(12,596 |
) |
|
|
(5,134 |
) |
|
|
(15,733 |
) |
Costs associated with collaboration and licensing
agreement |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
Adjusted net loss |
|
$ |
(4,988 |
) |
|
$ |
(6,772 |
) |
|
$ |
(17,501 |
) |
|
$ |
(21,824 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 31st |
|
|
August 31st |
|
|
|
(3 months) |
|
|
(9 months) |
|
Adjusted burn rate before changes in operating assets and liabilities |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
(Burn rate) cash
flow before changes
in operating assets
and liabilities,
per the financial
statements |
|
$ |
(2,629 |
) |
|
$ |
6,186 |
|
|
$ |
(10,877 |
) |
|
$ |
(9,214 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue associated
with a
collaboration and
licensing agreement
(note 7 to the
consolidated
financial
statements) |
|
|
(1,711 |
) |
|
|
(12,596 |
) |
|
|
(5,134 |
) |
|
|
(15,733 |
) |
Costs associated
with collaboration
and licensing
agreement |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
Adjusted burn rate
before changes in
operating assets
and liabilities |
|
$ |
(4,340 |
) |
|
$ |
(6,410 |
) |
|
$ |
(16,011 |
) |
|
$ |
(20,678 |
) |
|
|
|
Contingency
On July 26, 2010, the Company received a motion of authorization to institute a class action
against the Company and certain of its executive officers (the Motion). The Motion was filed in
the Superior Court of Quebec, district of Montreal. The applicant is seeking to initiate a class
action suit to represent the class of persons who were shareholders at May 21, 2010 and who sold
their common shares of the Company on May 25 or 26, 2010. This applicant alleges that the Company
did not comply with its continuous disclosure obligations as a reporting issuer by failing to
disclose a material change. The Company is of the view that the allegations contained in the motion
are entirely without merit and intends to take all appropriate actions to vigorously defend its
position. As of October 11, 2010, the motion has not yet been heard by the Superior Court of
Quebec.
New Accounting Policies
In February 2008, the Accounting Standards Board of Canada (AcSB) announced that accounting
standards in Canada, as used by public companies, will converge with International Financial
Reporting Standards (IFRS), for financial periods beginning on and after January 1, 2011 with the
option to early adopt IFRS upon receipt of approval from the Canadian Securities regulatory
authorities.
4
The Companys mandatory changeover from current Canadian GAAP to IFRS applies to the fiscal year
beginning December 1, 2011. However, the Company plans to file an exemption with the Canadian
securities regulatory authorities to early adopt IFRS beginning December 1, 2009, the change over
date. The Company intends to file its November 30, 2010 financial statements under IFRS with
December 1, 2008 being the proposed transition date. Should the exemption be granted, the
comparative annual period for fiscal 2009 will be restated under IFRS as will all quarterly filings
for 2009 and 2010. The following discussion provides further information about the Companys IFRS
convergence activities.
Management of IFRS Convergence Project
Management has evaluated its overall readiness for transition from GAAP to IFRS, including the
readiness of its staff, Board of Directors and Audit Committee and has determined that the Company
is adequately prepared for the conversion to IFRS.
The Company has established a formal project plan and a detailed timetable to manage the
transition. It has also allocated substantial internal resources and is working with its auditors
to ensure a timely and accurate conversion. The conversion project is being monitored by senior
members of the finance team which report regularly to the Audit Committee and the Board of
Directors on the progress of the convergence project through meetings and communication. The
Company is currently on schedule with its plan.
Conversion Plan
The Companys IFRS convergence project includes four steps: diagnostic and planning, detailed
analysis, design, and implementation, which in certain cases will occur concurrently as IFRS is
applied to specific areas.
Phase One: Diagnostic and Planning This phase involves establishing a transition plan to
IFRS and the initial identification of differences between Canadian GAAP and IFRS.
Phase Two: Detailed Analysis This phase involves a comprehensive assessment of the
differences between the Companys current accounting policies and the requirements of IFRS
in order to evaluate the impact on the Company. In addition, as part of the detailed
analysis, the Company identifies training requirements, and determines eventual changes to
business processes and information systems.
Phase Three: Design This phase consists of an analysis of the available accounting
options under IFRS, notably the exceptions, exemptions and actual accounting policy choices
available for the transition and the preparation of draft IFRS financial statements and
accompanying notes. In addition, it is during this phase that changes to the business
processes and the information systems are designed.
Phase Four: Implementation This phase involves implementing changes to systems, business
processes and internal controls, determining the opening IFRS transition balance sheet and
the impact on taxation, parallel accounting under Canadian GAAP and IFRS and preparing
detailed reconciliations between Canadian GAAP and IFRS financial statements.
Conversion Progress
At the date of preparing this MD&A, the Company has met the key milestones of the project plan,
including the completion of the diagnostic and detailed analysis phases, and has made significant
progress in the completion of the design phase.
Though IFRS uses a conceptual framework similar to Canadian GAAP, there are still significant
differences in recognition, measurement and the disclosure of information. Based on the comparative
analysis of the current IFRS with Canadian GAAP, upon which the Companys accounting practices are
now based, the Company has identified a number of differences and impacts which are discussed
below. The list should not be interpreted as a comprehensive list of
5
changes, it highlights those
areas of accounting differences that the Company currently believes are to be the most significant
upon conversion to IFRS.
IFRS 1, First-time Adoption of International Financial Reporting Standards (IFRS 1)
The adoption of IFRS requires application of IFRS 1, which provides guidance for an entitys
initial adoption of IFRS and outlines that, in general, an entity applies the principles under IFRS
retrospectively with adjustments arising on conversion from Canadian GAAP to IFRS being directly
recognized in retained earnings as of the beginning of the first comparative financial statements
presented. In this case, the Company will restate its comparative 2009 financial statements for
annual and interim periods to be in accordance with IFRS and will reconcile equity and net earnings
from the previously reported fiscal 2009 GAAP amounts to the restated 2009 IFRS amounts.
IFRS also provides certain optional exemptions from retrospective application of certain IFRS
requirements as well as mandatory exceptions which prohibit retrospective application of standards.
The Company elected to take the following IFRS 1 optional exemptions:
Fair value or revaluation as deemed cost IFRS 1 provides a choice between measuring
property, plant and equipment at its fair value at the date of transition and using those
amounts as deemed cost or using the historical valuation under the prior GAAP. The Company
plans to retain the historical basis as cost and forego of the option to use fair value as
deemed cost.
Share-based payments IFRS 1 encourages application of IFRS 2, Share-based payment
provisions to equity instruments granted on or before November 7, 2002, but permits the
application only to equity instruments granted after November 7, 2002 that were not vested
by the transition date. The Company will apply IFRS 2 only to equity instruments granted
after November 7, 2002 that were not vested by December 1, 2008.
Changes in existing decommissioning, restoration and similar liabilities included in the
cost of property, plant and equipment IFRS 1 allows for either the retroactive adoption
or prospective adoption from the transition date of IFRIC 1, Changes in existing
decommissioning, restoration and similar liabilities. The Company plans to prospectively
apply this standard, as the case may be.
Further optional exemptions are provided under IFRS 1. However, the Company does not believe these
exemptions will impact its adoption of IFRS. Hindsight is not permitted to create or revise
estimates. Estimates previously made by the Company under Canadian GAAP cannot be revised for
application of IFRS except where necessary to reflect any difference in accounting policies.
IFRS 2, Share-based Payments (IFRS 2)
Under IFRS, when stock option awards vest gradually, each tranche is to be considered as a separate
award, while under Canadian GAAP, companies can make a policy choice to consider gradually vested
tranches as a single award. Similarly, the IFRS standard requires that forfeiture estimates be
established at the time of the initial fair value assessment of share-based payments rather than to
account for the forfeitures as they occur. Therefore, the compensation expense will have to be
recognized over the expected term of each tranche and take into account the impact of the
differences in accounting for forfeitures. The Company has performed its preliminary calculation
and concluded that an adjustment of approximately $200,000 will be recorded at the proposed
transition date.
IAS 36, Impairment (IAS 36)
Under Canadian GAAP standards for impairment of non-financial assets, for assets other than
financial assets, a write-down to estimated fair value is recognized if the estimated undiscounted
future cash flows from an asset or group of assets are less than their carrying value. IAS 36
requires a write-down to be recognized if the recoverable amount, determined as the higher of the
6
estimated fair value less costs to sell or value in use is less than carrying value. The Company
will assess as of the transition date whether there are any indicators of impairment at that date.
In the event of a possible early adoption, the Company has performed impairment testing as of
December 1, 2008 and November 30, 2009 and has concluded that there is no impairment charge under
IFRS as of December 1, 2008. No impairment indicators were identified for the period between the
transition date and November 30, 2009. IAS 36 also permits the reversal of certain impairment
charges where conditions have changed. The Company reviewed past impairment charges and concluded
that there was no justification for reversal of past impairment charges.
IAS 1, Presentation of Financial Statement (IAS 1)
Financial statement presentation is addressed in conjunction with the related IFRS standards.
Certain additional disclosures will be required in the notes to the financial statements and the
statement of operations will be modified to reflect either a presentation by nature or by function.
The Company is currently working on preliminary IFRS financial statements in accordance with IAS 1,
Presentation of Financial Statements which will be completed in the last quarter of 2010.
Other Standards
Based on the results of the comparative analysis of the current IFRS with Canadian GAAP, the
Company has also completed its assessment of the following standards and determined that, other
than enhanced disclosures, no material adjustments would result regarding:
|
|
|
Property plant and equipment |
|
|
|
|
Leases |
|
|
|
|
Revenue recognition |
|
|
|
|
Provisions, contingent assets and contingent liabilities |
|
|
|
|
Foreign exchange |
|
|
|
|
Intangible assets |
|
|
|
|
Inventories |
|
|
|
|
Employee benefits |
The Company is in the process of completing its analysis of the few remaining potential differences
identified, but does not expect material adjustments to be required.
The Company continues to assess the aggregate effect of adopting IFRS, and the relevant changes in
accounting policies. Key milestones for the remainder of the year which are in line with the
Companys plan include:
|
|
|
Completion of the analysis of relevant accounting policies and standards |
|
|
|
|
Completion of the opening transition balance sheet |
|
|
|
|
Identifying, documenting and embedding changes to systems, business processes and
internal controls, as required |
|
|
|
|
Parallel accounting under Canadian GAAP and IFRS |
|
|
|
|
Preparation of detailed reconciliations of Canadian GAAP to IFRS financial statements |
|
|
|
|
Training programs for the Companys finance team and other affected parties, as
necessary |
|
|
|
|
Audit Committee approval of IFRS financial statements |
Impact on the Business
The impact of the conversion to IFRS on the Company has been minimal and will therefore result in a
limited number of adjustments. The Companys systems can easily accommodate the required changes.
The Companys internal and disclosure control processes, as currently designed, will likely not
require significant modification as a result of its conversion to IFRS. The Company is
assessing the impacts of adopting IFRS on its contractual arrangements, and has not identified any
material compliance issues to date. The Company is considering the impacts that the transition will
have on its internal planning process and compensation arrangements and continues to evaluate the
impact of transitioning to IFRS on the communication of its financial results.
7
Impact on Information Systems and Technology
The transition is expected to have minimal impact on information systems used by the Company. The
areas where information systems are most impacted to date are minor modifications to certain
general ledger accounts, sub-ledgers and end-user reports to accommodate IFRS accounting
adjustments, recording, and heightened disclosures.
Impact on Internal Controls and Disclosure Controls and Procedures
The Companys internal controls will not be materially affected by the transition to IFRS. The IFRS
differences require presentation and process changes to report more detailed information in the
notes to the financial statements, but it is not currently expected to lead to many differences in
the accounting treatments used by the Company. Disclosure controls and procedures may change due to
the transition to IFRS, but the impact is expected to be minimal as well.
Impact on Financial Reporting Expertise
Training and education has been provided to all members of the finance team who are directly
affected by the transition to IFRS. IFRS training to other financial staff will be performed as
deemed necessary. This training will focus mainly around the process changes required and an
overview of the reasons behind the changes from a standards perspective. Considering the minor
impact on the Companys operating results and financial situation, investors and other parties will
not be significantly affected by its conversion to IFRS.
Outstanding Share Data
On October 8, 2010, the number of shares issued and outstanding was 60 511 598 while outstanding
options granted under the stock option plan were 2 853 638.
Contractual Obligations
There were no material changes in contractual obligations during the quarter, other than in the
ordinary course of business.
Economic and Industry Factors
Economic and industry factors were substantially unchanged from those reported in the Companys
2009 Annual Report.
Forward-Looking Information
This MD&A for the third quarter contains certain statements that are considered forward-looking
information within the meaning of applicable securities legislation. This forward-looking
information includes, but is not limited to, information regarding the approval of tesamorelin for
the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy by the FDA, the
receipt of milestone payments and/or royalties under the agreement entered into with EMD Serono,
the potential decrease in the adjusted burn rate, and the completion of a conversion plan to IFRS.
Furthermore, the words will, may, could, should, outlook, believe, plan, envisage,
anticipate, expect and estimate, or variations of them denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties include, but are not limited to, the risk that the FDA
does not approve tesamorelin for the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy, the risk that the payment of milestones is delayed or not received or that the
royalties from the sale of tesamorelin are not received, the risk that unexpected expenses increase
the adjusted burn rate, and the risk that the timeline for preparing a conversion plan to IFRS is
not met.
Although the forward-looking information contained herein is based upon what the Company believes
are reasonable assumptions, investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking information. Certain assumptions
made in preparing the forward-looking information and the Companys objectives
8
include the
assumption, among others, that the FDA will approve tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy, sales of tesamorelin in the United
States will be successful, unexpected expenses will not result in an adjusted burn rate increase,
and the Company will not experience any difficulties in preparing a conversion plan to IFRS.
Consequently, the forward-looking information is qualified by the foregoing cautionary statements,
and there can be no guarantee that the results or developments anticipated by the Company will be
realized or, even if substantially realized, that they will have the expected consequences or
effects on the Company, its business, its financial condition or its results of operations.
Furthermore, the forward-looking information reflects current expectations regarding future events
only as of the date of release of this MD&A.
Investors are referred to the Companys public filings available at www.sedar.com. In particular,
further details on the risks and descriptions of the risks are disclosed in the Risks and
Uncertainties section of the Companys Annual Information Form, dated February 23, 2010, for the
year ended November 30, 2009. This MD&A is dated October 12, 2010, and has been approved by the
Audit Committee.
9
ex-99.12
Exhibit 99.12
Amended Consolidated Financial Statements of
(Unaudited)
THERATECHNOLOGIES INC.
Nine-month periods ended August 31, 2010 and 2009
THERATECHNOLOGIES INC.
Amended Consolidated Financial Statements
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
Amended Financial Statements
|
|
|
|
|
Consolidated Statement of Financial Position |
|
|
1 |
|
|
Consolidated Statement of Comprehensive Income |
|
|
2 |
|
|
Consolidated Statement of Changes in Equity |
|
|
3 |
|
|
Consolidated Statement of Cash Flows |
|
|
5 |
|
|
Notes to the Consolidated Financial Statements |
|
|
6 |
|
EXPLANATORY NOTE
These amended unaudited consolidated financial statements of Theratechnologies Inc. (the
Company) for the nine-month periods ended August 31, 2010 and 2009 reflect the Companys adoption
of International Financial Reporting Standards (''IFRS), as issued by the International
Accounting Standards Board (''IASB). In the fourth quarter of 2010, The Company filed a request
to adopt IFRS two years in advance of the date required by the Accounting Standards Board. The
request was approved by the regulatory authorities. The Company is filing these amended
consolidated financial statements to comply with this approval.
The Companys Audit Committee originally approved the unaudited consolidated financial statements
for the nine-month periods ended August 31, 2010 and 2009 on October 12, 2010 and those financial
statements were filed on October 12, 2010. Those financial statements were prepared in accordance
with generally accepted accounting principles in Canada (Canadian GAAP). Except for the changes
related to the Companys adoption of IFRS, these amended unaudited consolidated financial
statements do not reflect events occurring after October 12, 2010. These amended unaudited
consolidated financial statements supersede the Companys original filing and should be read in
connection with the consolidated financial statements as at November 30, 2010 and 2009 prepared in
accordance with IFRS.
THERATECHNOLOGIES INC.
Consolidated Statement of Financial Position
(Unaudited)
As at August 31, 2010, November 30, 2009 and December 1, 2008
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 31, |
|
|
November 30, |
|
|
December 1, |
|
|
|
Note |
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
|
|
|
|
|
2,370 |
|
|
|
1,519 |
|
|
|
133 |
|
Bonds |
|
|
|
|
|
|
1,694 |
|
|
|
10,036 |
|
|
|
10,955 |
|
Trade and other receivables |
|
|
|
|
|
|
131 |
|
|
|
375 |
|
|
|
610 |
|
Tax credits and grants receivable |
|
|
|
|
|
|
181 |
|
|
|
1,333 |
|
|
|
1,451 |
|
Inventories |
|
|
|
|
|
|
4,585 |
|
|
|
2,225 |
|
|
|
|
|
Prepaid expenses |
|
|
|
|
|
|
1,004 |
|
|
|
630 |
|
|
|
739 |
|
|
Total current assets |
|
|
|
|
|
|
9,965 |
|
|
|
16,118 |
|
|
|
13,888 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bonds |
|
|
|
|
|
|
39,355 |
|
|
|
51,807 |
|
|
|
35,249 |
|
Property and equipment |
|
|
|
|
|
|
1,106 |
|
|
|
1,229 |
|
|
|
1,299 |
|
Other assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,776 |
|
|
Total non-current assets |
|
|
|
|
|
|
40,461 |
|
|
|
53,036 |
|
|
|
39,324 |
|
|
Total assets |
|
|
|
|
|
|
50,426 |
|
|
|
69,154 |
|
|
|
53,212 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
|
|
|
|
3,490 |
|
|
|
5,568 |
|
|
|
6,865 |
|
Current portion of deferred revenue |
|
|
4 |
|
|
|
6,849 |
|
|
|
6,847 |
|
|
|
|
|
|
Total current liabilities |
|
|
|
|
|
|
10,339 |
|
|
|
12,415 |
|
|
|
6,865 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other liabilities |
|
|
|
|
|
|
167 |
|
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
4 |
|
|
|
8,557 |
|
|
|
13,691 |
|
|
|
|
|
|
Total non-current liabilities |
|
|
|
|
|
|
8,724 |
|
|
|
13,691 |
|
|
|
|
|
|
Total liabilities |
|
|
|
|
|
|
19,063 |
|
|
|
26,106 |
|
|
|
6,865 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
5 |
|
|
|
279,389 |
|
|
|
279,169 |
|
|
|
269,219 |
|
Contributed surplus |
|
|
|
|
|
|
7,631 |
|
|
|
6,757 |
|
|
|
5,760 |
|
Deficit |
|
|
|
|
|
|
(256,529 |
) |
|
|
(244,160 |
) |
|
|
(229,004 |
) |
Accumulated other comprehensive income |
|
|
|
|
|
|
872 |
|
|
|
1,282 |
|
|
|
372 |
|
|
Total equity |
|
|
|
|
|
|
31,363 |
|
|
|
43,048 |
|
|
|
46,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent events |
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity |
|
|
|
|
|
|
50,426 |
|
|
|
69,154 |
|
|
|
53,212 |
|
|
See accompanying notes to unaudited consolidated financial statements.
1
THERATECHNOLOGIES INC.
Consolidated Statement of Comprehensive Income
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 31, |
|
|
August 31, |
|
|
Note |
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
(3 months) |
|
|
(9 months) |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Milestone payment |
|
|
4 |
|
|
|
|
|
|
|
10,884 |
|
|
|
|
|
|
|
10,884 |
|
Upfront payments and initial technology
access fees |
|
|
4 |
|
|
|
1,711 |
|
|
|
1,711 |
|
|
|
5,134 |
|
|
|
4,848 |
|
Royalties and license fees |
|
|
|
|
|
|
6 |
|
|
|
6 |
|
|
|
17 |
|
|
|
18 |
|
|
Total revenue |
|
|
|
|
|
|
1,717 |
|
|
|
12,601 |
|
|
|
5,151 |
|
|
|
15,750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
|
|
|
|
120 |
|
|
|
|
|
|
|
120 |
|
|
|
|
|
Research and development expenses, net of tax
credits of $448 (2009 - $294) for the three-month
period and $783 (2009 - $1,384) for the nine-month
period |
|
|
|
|
|
|
2,591 |
|
|
|
5,523 |
|
|
|
10,892 |
|
|
|
16,598 |
|
Selling and market development expenses |
|
|
|
|
|
|
524 |
|
|
|
498 |
|
|
|
1,909 |
|
|
|
5,793 |
|
General and administrative expenses |
|
|
|
|
|
|
2,262 |
|
|
|
1,488 |
|
|
|
5,966 |
|
|
|
4,980 |
|
|
Total operating expenses |
|
|
|
|
|
|
5,497 |
|
|
|
7,509 |
|
|
|
18,887 |
|
|
|
27,371 |
|
|
Results from operating activities |
|
|
|
|
|
|
(3,780 |
) |
|
|
5,092 |
|
|
|
(13,736 |
) |
|
|
(11,621 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income |
|
|
|
|
|
|
435 |
|
|
|
547 |
|
|
|
1,522 |
|
|
|
1,724 |
|
Finance costs |
|
|
|
|
|
|
(12 |
) |
|
|
140 |
|
|
|
(155 |
) |
|
|
(605 |
) |
|
Total net financial income |
|
|
|
|
|
|
423 |
|
|
|
687 |
|
|
|
1,367 |
|
|
|
1,119 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) profit |
|
|
|
|
|
|
(3,357 |
) |
|
|
5,779 |
|
|
|
(12,369 |
) |
|
|
(10,502 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss, net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value available-for-sale
financial assets, net of tax |
|
|
|
|
|
|
586 |
|
|
|
342 |
|
|
|
(151 |
) |
|
|
1,327 |
|
Net change in fair value available-for-sale
financial assets transferred to net loss, net of tax |
|
|
|
|
|
|
(65 |
) |
|
|
(48 |
) |
|
|
(259 |
) |
|
|
(118 |
) |
|
|
|
|
|
|
|
|
521 |
|
|
|
294 |
|
|
|
(410 |
) |
|
|
1,209 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive (loss) income for the period |
|
|
|
|
|
|
(2,836 |
) |
|
|
6,073 |
|
|
|
(12,779 |
) |
|
|
(9,293 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted (loss) earnings per share |
|
|
5 |
|
|
|
(0.06 |
) |
|
|
0.10 |
|
|
|
(0.20 |
) |
|
|
(0.17 |
) |
|
See accompanying notes to unaudited consolidated financial statements.
2
THERATECHNOLOGIES INC.
Consolidated Statement of Changes in Equity
(Unaudited)
Nine-month period ended August 31, 2010
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
or losses on |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
available-for-sale |
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
Contributed |
|
|
financial |
|
|
|
|
|
|
|
|
|
Note |
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
assets (i) |
|
|
Deficit |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Balance as at November 30, 2009 |
|
|
|
|
|
|
60,429,393 |
|
|
|
279,169 |
|
|
|
6,757 |
|
|
|
1,282 |
|
|
|
(244,160 |
) |
|
|
43,048 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the period: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,369 |
) |
|
|
(12,369 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value of available-for-sale financial assets, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(151 |
) |
|
|
|
|
|
|
(151 |
) |
Net change in fair value of available-for-sale financial assets transferred to net loss,
net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(259 |
) |
|
|
|
|
|
|
(259 |
) |
|
Total comprehensive loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(410 |
) |
|
|
(12,369 |
) |
|
|
(12,779 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transactions with owners, recorded directly in equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue of common shares |
|
|
|
|
|
|
2,880 |
|
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15 |
|
Share-based compensation for stock option plan |
|
|
5 |
(c) |
|
|
|
|
|
|
|
|
|
|
951 |
|
|
|
|
|
|
|
|
|
|
|
951 |
|
Exercise of stock option: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Monetary consideration |
|
|
5 |
(c) |
|
|
77,493 |
|
|
|
128 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
128 |
|
Attributed value |
|
|
5 |
(c) |
|
|
|
|
|
|
77 |
|
|
|
(77 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contributions by owners |
|
|
|
|
|
|
80,373 |
|
|
|
220 |
|
|
|
874 |
|
|
|
|
|
|
|
|
|
|
|
1,094 |
|
|
Balance as at August 31, 2010 |
|
|
|
|
|
|
60,509,766 |
|
|
|
279,389 |
|
|
|
7,631 |
|
|
|
872 |
|
|
|
(256,529 |
) |
|
|
31,363 |
|
|
|
|
|
(i) |
|
Accumulated other comprehensive income. |
3
THERATECHNOLOGIES INC.
Consolidated Statement of Changes in Equity, Continued
(Unaudited)
Nine-month period ended August 31, 2009
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
or losses on |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
available-for-sale |
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
Contributed |
|
|
financial |
|
|
|
|
|
|
|
|
|
Note |
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
assets (i) |
|
|
Deficit |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Balance as at November 30, 2008 |
|
|
|
|
|
|
58,215,090 |
|
|
|
269,219 |
|
|
|
5,760 |
|
|
|
372 |
|
|
|
(229,004 |
) |
|
|
46,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the period: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,502 |
) |
|
|
(10,502 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value of available-for-sale financial assets, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,327 |
|
|
|
|
|
|
|
1,327 |
|
Net change in fair value of available-for-sale financial assets transferred to net loss,
net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(118 |
) |
|
|
|
|
|
|
(118 |
) |
|
Total comprehensive loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,209 |
|
|
|
(10,502 |
) |
|
|
(9,293 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transactions with owners, recorded directly in equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue of common shares |
|
|
4 |
|
|
|
2,182,387 |
|
|
|
9,861 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,861 |
|
Share-based compensation plan: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation for stock option plan |
|
|
5 |
(c) |
|
|
|
|
|
|
|
|
|
|
847 |
|
|
|
|
|
|
|
|
|
|
|
847 |
|
|
Total contributions by owners |
|
|
|
|
|
|
2,182,387 |
|
|
|
9,861 |
|
|
|
847 |
|
|
|
|
|
|
|
|
|
|
|
10,708 |
|
|
Balance as at August 31, 2009 |
|
|
|
|
|
|
60,397,477 |
|
|
|
279,080 |
|
|
|
6,607 |
|
|
|
1,581 |
|
|
|
(239,506 |
) |
|
|
47,762 |
|
|
|
|
|
(i) |
|
Accumulated other comprehensive income. |
See accompanying notes to unaudited consolidated financial statements.
4
THERATECHNOLOGIES INC.
Consolidated Statement of Cash Flows
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 31, |
|
|
August 31, |
|
|
|
Note |
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
(3 months) |
|
|
(9 months) |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
(3,357 |
) |
|
|
5,779 |
|
|
|
(12,369 |
) |
|
|
(10,502 |
) |
Adjustments for: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation of property and equipment |
|
|
|
|
|
|
92 |
|
|
|
157 |
|
|
|
374 |
|
|
|
441 |
|
Share-based compensation |
|
|
|
|
|
|
511 |
|
|
|
249 |
|
|
|
951 |
|
|
|
847 |
|
Lease inducements and amortization |
|
|
|
|
|
|
125 |
|
|
|
|
|
|
|
167 |
|
|
|
|
|
|
Operating activities before changes in operating
assets and liabilities |
|
|
|
|
|
|
(2,629 |
) |
|
|
6,185 |
|
|
|
(10,877 |
) |
|
|
(9,214 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in accrued interest income on bonds |
|
|
|
|
|
|
317 |
|
|
|
74 |
|
|
|
696 |
|
|
|
(728 |
) |
Change in trade and other receivables |
|
|
|
|
|
|
45 |
|
|
|
57 |
|
|
|
244 |
|
|
|
391 |
|
Change in tax credits and grants receivable |
|
|
|
|
|
|
1,487 |
|
|
|
(294 |
) |
|
|
1,485 |
|
|
|
(1,050 |
) |
Change in inventories |
|
|
|
|
|
|
(89 |
) |
|
|
|
|
|
|
(2,360 |
) |
|
|
(1,594 |
) |
Change in prepaid expenses |
|
|
|
|
|
|
(30 |
) |
|
|
(532 |
) |
|
|
(375 |
) |
|
|
(1,055 |
) |
Change in other assets |
|
|
|
|
|
|
|
|
|
|
2,129 |
|
|
|
|
|
|
|
2,776 |
|
Change in accounts payable and accrued liabilities |
|
|
|
|
|
|
(3,214 |
) |
|
|
(921 |
) |
|
|
(2,282 |
) |
|
|
(2,923 |
) |
Change in deferred revenue |
|
|
|
|
|
|
(1,714 |
) |
|
|
(1,715 |
) |
|
|
(5,132 |
) |
|
|
22,252 |
|
|
|
|
|
|
|
|
|
(3,198 |
) |
|
|
(1,202 |
) |
|
|
(7,724 |
) |
|
|
18,069 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from operating activities |
|
|
|
|
|
|
(5,827 |
) |
|
|
4,983 |
|
|
|
(18,601 |
) |
|
|
8,855 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issue of share capital |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15 |
|
|
|
9,861 |
|
Proceeds from exercise of stock options |
|
|
|
|
|
|
37 |
|
|
|
|
|
|
|
128 |
|
|
|
|
|
Share issue costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8 |
) |
|
Cash flows from financing activities |
|
|
|
|
|
|
37 |
|
|
|
|
|
|
|
143 |
|
|
|
9,853 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition of property and equipment |
|
|
|
|
|
|
(43 |
) |
|
|
(55 |
) |
|
|
(379 |
) |
|
|
(290 |
) |
Proceeds from sale of bonds |
|
|
|
|
|
|
4,706 |
|
|
|
3,963 |
|
|
|
19,688 |
|
|
|
13,805 |
|
Acquisition of bonds |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(19,631 |
) |
|
Cash flows from (used in) investing activities |
|
|
|
|
|
|
4,663 |
|
|
|
3,908 |
|
|
|
19,309 |
|
|
|
(6,116 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in cash |
|
|
|
|
|
|
(1,127 |
) |
|
|
8,891 |
|
|
|
851 |
|
|
|
12,592 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash as at December 1 |
|
|
|
|
|
|
3,497 |
|
|
|
3,834 |
|
|
|
1,519 |
|
|
|
133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash as at August 31 |
|
|
|
|
|
|
2,370 |
|
|
|
12,725 |
|
|
|
2,370 |
|
|
|
12,725 |
|
|
See note 6 for supplemental cash flow information.
See accompanying notes to unaudited consolidated financial statements.
5
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
|
|
Theratechnologies Inc. is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The
Company targets unmet medical needs in specialty markets where it can retain all or some of the
commercial rights to its products. Its most advanced compound, tesamorelin, is an analogue of
the human growth hormone releasing factor. |
|
|
The consolidated financial statements include the accounts of Theratechnologies Inc. and its
wholly-owned subsidiaries (together referred to as the ''Company and individually as ''the
subsidiaries of the Company). |
|
|
Theratechnologies Inc. is incorporated under Part 1A of the Québec Companies Act and is
domiciled in Quebec, Canada. The Company is located at 2310 boul. Alfred-Nobel, Montreal,
Quebec, H4S 2B4. |
|
(a) |
|
Statement of compliance: |
|
|
|
|
These amended interim consolidated financial statements of the Company have been prepared
in accordance with International Financial Reporting Standards (''IFRSs) as issued by the
International Accounting Standards Board (''IASB). The Companys first IFRS financial
statements were for the annual period ended November 30, 2010 and were prepared using
December 1, 2008 as the date of transition. In preparing the accompanying amended interim
financial statements, the Company applied IFRS 1, First-time Adoption of International
Financial Reporting Standards as disclosed in note 8. |
|
|
|
|
These amended interim consolidated financial statements have been prepared in accordance
with IAS 34, Interim Financial Reporting. However, they should not be read in conjunction
with the notes to the Companys audited consolidated financial statements for the year
ended November 30, 2009 as those were prepared in accordance with Canadian GAAP. The
Companys interim consolidated financial statements as previously filed were also prepared
in accordance with Canadian GAAP. Canadian GAAP differs in some areas from IFRS. In
preparing these amended interim consolidated financial statements, management amended the
accounting and valuation methods previously applied in the Canadian GAAP financial
statements to comply with IFRS. The Companys annual consolidated financial statements as
at November 30, 2010 and 2009 and for the years then ended have been concurrently filed
with these amended unaudited interim consolidated financial statements. The same accounting
policies as described in note 3 of these amended interim consolidated financial statements
were used. The comparative figures for 2009 were also restated to reflect these
adjustments. |
6
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
2. |
|
Basis of preparation (continued): |
|
(a) |
|
Statement of compliance (continued): |
|
|
|
|
Certain information and footnote disclosures which are considered material to the
understanding of the Companys amended interim consolidated financial statements and which
are normally included in annual financial statements prepared in accordance with IFRS are
presented in note 3 along with reconciliations and descriptions of the effect of the
transition from Canadian GAAP to IFRS on equity, earnings and comprehensive income
presented in note 8. These amended interim consolidated financial statements do not include
all disclosures required under IFRS and accordingly should be read in connection with the
aforementioned annual financial statements and the notes thereto. These amended interim
consolidated financial statements have not been reviewed by the Companys auditors. |
|
|
|
|
These amended unaudited interim consolidated financial statements were authorized for issue
by the Audit Committee on February 8, 2011. |
|
|
(b) |
|
Basis of measurement: |
|
|
|
|
The Companys consolidated financial statements have been prepared on a going concern and
historical cost basis, except for available-for-sale financial assets which are measured at
fair value. |
|
|
|
|
The methods used to measure fair value are discussed in note 22 included in the Companys
annual financial statements dated February 8, 2011. |
|
|
(c) |
|
Functional and presentation currency: |
|
|
|
|
These amended interim consolidated financial statements are presented in Canadian dollars,
which is the Companys functional currency. All financial information presented in Canadian
dollars has been rounded to the nearest thousand. |
|
|
(d) |
|
Use of estimates and judgements: |
|
|
|
|
The preparation of the Companys amended interim consolidated financial statements in
conformity with IFRSs requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and the reported amounts of revenues
and expenses during the reporting period. |
|
|
|
|
Information about critical judgements in applying accounting policies and assumption and
estimation uncertainties that have the most significant effect on the amounts recognized in
the amended interim consolidated financial statements relate to the timing of revenue
recognition, the valuation of share-based compensation; the realizability of deferred
income tax assets, and the recognition and measurement of contingent liabilities. |
7
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
2. |
|
Basis of preparation (continued): |
|
(d) |
|
Use of estimates and judgements (continued): |
|
|
|
|
Other areas of judgement and uncertainty relate to the estimation of accruals for clinical
trial expenses, the recoverability of inventories, the measurement of the amount and
assessment of the recoverability of tax credits and grants receivable and the
capitalization of development expenditures. |
|
|
|
|
Reported amounts and note disclosure reflect the overall economic conditions that are most
likely to occur and anticipated measures management intends to take. Actual results could
differ from those estimates. |
|
|
|
|
The above estimates and assumptions are reviewed regularly. Revisions to accounting
estimates are recognized in the period in which the estimates are revised and in any future
periods affected. |
3. |
|
Significant accounting policies: |
|
|
|
The accounting policies set out below have been applied consistently to all periods presented
in these amended interim consolidated financial statements and in preparing the opening IFRS
statement of financial position at December 1, 2008, the date of transition to IFRSs. |
|
|
|
The accounting policies have been applied consistently by the subsidiaries of the Company. |
|
(a) |
|
Basis of consolidation: |
|
|
|
|
The financial statements of subsidiaries are included in the consolidated financial
statements from the date on which control commences until the date on which control ceases.
Subsidiaries are entities controlled by the Company. Control is present where the Company
has the power to govern the financial and operating policies of the entity so as to obtain
benefits from its activities. In assessing control, potential voting rights that are
exercisable currently are taken into consideration. The accounting policies of subsidiaries
are changed when necessary to align them with the policies adopted by the Company. |
|
|
|
|
Reciprocal balances and transactions, revenues and expenses resulting from transactions
between subsidiaries and with the Company are eliminated in preparing the consolidated
financial statements. |
8
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(b) |
|
Foreign currency: |
|
|
|
|
Transactions in foreign currencies are translated to the respective functional currencies
of the subsidiaries of the Company at exchange rates at the dates of the transactions.
Monetary assets and liabilities denominated in foreign currencies at the reporting date are
retranslated to the functional currency at the exchange rate at that date. The foreign
currency gain or loss on monetary items is the difference between amortized cost in the
functional currency at the beginning of the period, adjusted for effective interest and
payments during the period, and the amortized cost in foreign currency translated at the
exchange rate at the end of the reporting period. |
|
|
|
|
Foreign currency differences arising on translation are recognized in net profit (loss),
except for differences arising on the translation of available-for-sale equity instruments,
which are recognized in other comprehensive income. Non-monetary assets and liabilities
denominated in foreign currencies that are measured at fair value are translated to the
functional currency at the exchange rate at the date that the fair value was determined.
Non-monetary items that are measured at historical cost in a foreign currency are
translated using the exchange rate at the date of the transaction. |
|
|
(c) |
|
Revenue recognition: |
|
|
|
|
Collaboration agreements that include multiple deliverables are considered to be
multi-element arrangements. Under this type of arrangement, the identification of separate
units of accounting is required and revenue is allocated among the separate units based on
their relative fair values. |
|
|
|
|
Payments received under the collaboration agreement may include upfront payments, milestone
payments, research services, royalties and license fees. Revenues for each unit of
accounting are recorded as described below: |
|
(i) |
|
Sale of goods: |
|
|
|
|
Revenues from the sale of goods are recognized when the Company has transferred to the
buyer the significant risks and rewards of ownership of the goods, there is no
continuing management involvement with the goods, and the amount of revenue can be
measured reliably. |
|
|
(ii) |
|
Royalties and license fees: |
|
|
|
|
Royalties and license fees are recognized when conditions and events under the license
agreement have occurred and collectibility is reasonably assured. |
9
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(c) |
|
Revenue recognition (continued): |
|
(iii) |
|
Research services: |
|
|
|
|
Revenues from research contracts are recognized when services to be provided are
rendered and all conditions under the terms of the underlying agreement are met. |
|
(a) |
|
Upfront payments and initial technology access fees: |
|
|
|
|
Upfront payments and initial technology access fees are deferred and recognized as
revenue on a systematic basis over the period during which the related products or
services are delivered and all obligations are performed. |
|
|
(b) |
|
Milestone payments: |
|
|
|
|
Revenues subject to the achievement of milestones are recognized only when the
specified events have occurred and collectibility is reasonably assured. |
|
(d) |
|
Cost of sales: |
|
|
|
|
Cost of sales represents the cost of goods sold and includes the cost of raw materials,
supplies, direct overhead charges, unallocated indirect costs related to production as well
as write-down of inventories. Other direct costs such as manufacturing start-up costs
between validation and the achievement of normal production are expensed as incurred. |
|
|
(e) |
|
Employee benefits: |
|
|
|
|
Salaries and short-term employee benefits: |
|
|
|
|
Salaries and short-term employee benefit obligations are measured on an undiscounted basis
and are expensed as the related service is provided. A liability is recognized for the
amount expected to be paid under short-term profit-sharing or cash bonus plans if the
Company has a legal or constructive obligation to pay an amount as a result of past
services rendered by an employee and the obligation can be estimated reliably. |
|
|
|
|
Post-employment benefits: |
|
|
|
|
Post-employment benefits include a defined contribution plan under which an entity pays
fixed contributions into a separate entity and will have no legal or constructive
obligation to pay further amounts. Obligations for contributions to defined contribution
plans are recognized as an employee benefit expense when due. Prepaid contributions are
recognized as an asset to the extent that a cash refund or a reduction in future payments
is available. The Companys defined contribution plan comprises the registered retirement
savings plan, the Quebec Pension Plan and unemployment insurance. |
10
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(e) |
|
Employee benefits (continued): |
|
|
|
|
Termination benefits: |
|
|
|
|
Termination benefits are recognized as an expense when the Company is committed
demonstrably, without realistic possibility of withdrawal, to a formal detailed plan to
either terminate employment before the normal retirement date, or to provide termination
benefits as a result of an offer made to encourage voluntary redundancy. |
|
|
(f) |
|
Finance income and finance costs: |
|
|
|
|
Finance income comprises interest income on available-for-sale financial assets and gains
(losses) on the disposal of available-for-sale financial assets. Interest income is
recognized as it accrues in profit (loss), using the effective interest method. |
|
|
|
|
Finance costs are comprised of bank charges, impairment losses on financial assets
recognized in profit (loss) and foreign currency gains and losses which are reported on a
net basis. |
|
|
(g) |
|
Inventories: |
|
|
|
|
Inventories are presented at the lower of cost, determined using the first-in first-out
method, or net realizable value. Inventory costs include the purchase price and other costs
directly related to the acquisition of materials, and other costs incurred in bringing the
inventories to their present location and condition. Inventory costs also include the
costs directly related to the conversion of materials to finished goods, such as direct
labour, and a systematic allocation of fixed and variable production overhead, including
manufacturing depreciation expense. The allocation of fixed production overheads to the
cost of inventories is based on the normal capacity of the production facilities. Normal
capacity is the average production expected to be achieved over a number of periods under
normal circumstances. |
|
|
|
|
Net realizable value is the estimated selling price in the Companys ordinary course of
business, less the estimated costs of completion and selling expenses. |
|
|
(h) |
|
Property and equipment: |
|
|
|
|
Recognition and measurement: |
|
|
|
|
Items of property and equipment are recognized at cost less accumulated depreciation and
accumulated impairment losses. Cost includes expenditure that is directly attributable to
the acquisition of the asset and the costs of dismantling and removing the item and
restoring the site on which it is located, if any. |
11
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(h) |
|
Property and equipment (continued): |
|
|
|
|
Recognition and measurement (continued): |
|
|
|
|
When parts of an item of property and equipment have different useful lives, they are
accounted for as separate items (major components) of property and equipment. |
|
|
|
|
Gains and losses on disposal of an item of property and equipment are determined by
comparing the proceeds from disposal with the carrying amount of property and equipment,
and are recognized in net profit (loss). |
|
|
|
|
Subsequent costs: |
|
|
|
|
The cost of replacing a part of an item of property and equipment is recognized in the
carrying amount of the item if it is probable that the future economic benefits embodied
within the part will flow to the Company, and its cost can be measured reliably. The
carrying amount of the replaced part is derecognized. The costs of the day-to-day servicing
of property and equipment are recognized in profit (loss) as incurred. |
|
|
|
|
Depreciation: |
|
|
|
|
The estimated useful lives and the methods of depreciation for the current and comparative
periods are as follows: |
|
|
|
|
|
|
|
|
|
Asset |
|
Method |
|
|
Rate/Period |
|
|
Computer equipment |
|
Declining balance |
|
|
50 |
% |
Laboratory equipment |
|
Declining balance |
|
|
20 |
% |
|
|
and straight-line |
|
5 years |
Office furniture and equipment |
|
Declining balance |
|
|
20 |
% |
Leasehold improvements |
|
Straight-line |
|
Lower of term of lease |
|
|
|
|
|
|
or economic life |
|
|
|
|
This most closely reflects the expected pattern of consumption of the future economic
benefits embodied in the asset. |
|
|
|
|
Estimates for depreciation methods, useful lives and residual values are reviewed at each
reporting period-end and adjusted, if appropriate. |
12
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(i) |
|
Intangible assets: |
|
|
|
|
Research and development: |
|
|
|
|
Expenditure on research activities, undertaken with the prospect of gaining new scientific
or technical knowledge and understanding, is expensed as incurred. |
|
|
|
|
Development activities involve a plan or design for the production of new or substantially
improved products and processes. Development expenditure is capitalized only if development
costs can be measured reliably, the product or process is technically and commercially
feasible, future economic benefits are probable, and the Company intends to and has
sufficient resources to complete development and to use or sell the asset. These criteria
are usually met when a regulatory filing has been made in a major market and approval is
considered highly probable. The expenditure capitalized includes the cost of materials,
direct labour, and overhead costs that are directly attributable to preparing the asset for
its intended use. Other development expenditures are expensed as incurred. Capitalized
development expenditures are measured at cost less accumulated amortization and accumulated
impairment losses. |
|
|
|
|
During the periods ended August 31, 2010 and 2009, November 30, 2009 and as at December 1,
2008, no development expenditures were capitalized. |
|
|
(j) |
|
Financial instruments: |
|
|
|
|
The Companys financial instruments are classified into one of three categories: loans and
receivables, available-for-sale financial assets and other financial liabilities. Loans and
receivables and other financial liabilities are measured at amortized cost. |
|
|
|
|
The Company has classified its bonds as available-for-sale financial assets. The Company
has classified cash, and trade and other receivables as loans and receivables, and accounts
payable and accrued liabilities as other financial liabilities. |
|
|
|
|
Available-for-sale financial assets are non-derivative financial assets that are designated
as available-for-sale and that are not classified in any of the other categories.
Subsequent to initial recognition, they are measured at fair value and changes therein,
other than impairment losses and foreign currency differences on available-for-sale debt
instruments, are recognized in other comprehensive income and presented within equity. When
an investment is derecognized, the cumulative gain or loss in other comprehensive income is
transferred to profit (loss). |
13
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(k) |
|
Other assets: |
|
|
|
|
Other assets consist of prepaid expenses for research supplies that are not expected to be
used within one year from the date of the consolidated statement of financial position. |
|
|
|
|
Research supplies are purchased in advance, in accordance with specific regulatory
requirements, to be used in connection with the Companys clinical trials. |
|
|
(l) |
|
Leases: |
|
|
|
|
Operating lease payments are recognized in net profit (loss) on a straight-line basis over
the term of the lease. |
|
|
|
|
Lease inducements arising from leasehold improvements allowances and rent-free periods form
an integral part of the total lease cost and are deferred and recognized in net profit
(loss) over the term of the lease on a straight-line basis. |
|
|
(m) |
|
Impairment: |
|
|
|
|
Financial assets: |
|
|
|
|
A financial asset not carried at fair value through profit or loss is assessed at each
consolidated financial statement reporting date to determine whether there is objective
evidence that it is impaired. The Company considers that a financial asset is impaired if
objective evidence indicates that one or more loss events had a negative effect on the
estimated future cash flows of that asset that can be estimated reliably. |
|
|
|
|
An impairment test is performed, on an individual basis, for each material financial asset.
Other individually non-material financial assets are tested as groups of financial assets
with similar risk characteristics. Impairment losses are recognized in net profit (loss). |
|
|
|
|
An impairment loss in respect of a financial asset measured at amortized cost is calculated
as the difference between its carrying amount and the present value of the estimated future
cash flows discounted at the assets original effective interest rate. Losses are
recognized in net profit (loss) and reflected in an allowance account against the
respective financial asset. Interest on the impaired asset continues to be recognized
through the unwinding of the discount. When a subsequent event causes the amount of
impairment loss to decrease, the decrease in impairment loss is reversed through net profit
(loss). |
14
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(m) |
|
Impairment (continued): |
|
|
|
|
Financial assets (continued): |
|
|
|
|
Impairment losses on available-for-sale investment securities are recognized by
transferring the cumulative loss that has been recognized in other comprehensive income,
and presented in unrealized gains/losses on available-for-sale financial assets in equity,
to net profit (loss). The cumulative loss that is removed from other comprehensive income
and recognized in net profit (loss) is the difference between the acquisition cost, net of
any principal repayment and amortization, and the current fair value, less any impairment
loss previously recognized in net profit (loss). Changes in impairment provisions
attributable to time value are reflected as a separate component of interest income. |
|
|
|
|
If, in a subsequent period, the fair value of an impaired available-for-sale debt security
increases and the increase can be related objectively to an event occurring after the
impairment loss was recognized in net profit (loss), then the impairment loss is reversed,
with the amount of the reversal recognized in net profit (loss). However, any subsequent
recovery in the fair value of an impaired available-for-sale equity security is recognized
in other comprehensive income. |
|
|
|
|
Non-financial assets: |
|
|
|
|
The carrying amounts of the Companys non-financial assets, other than inventories and
deferred tax assets, are reviewed at each reporting date to determine whether there is any
indication of impairment. If such an indication exists, the recoverable amount is
estimated. |
|
|
|
|
The recoverable amount of an asset or a cash-generating unit is the greater of its value in
use and its fair value less costs to sell. In assessing value in use, the estimated future
cash flows are discounted to their present value using a pre-tax discount rate that
reflects current market assessments of the time value of money and the risks specific to
the asset. For the purpose of impairment testing, assets are grouped together into the
smallest group of assets that generates cash inflows from continuing use that are largely
independent of cash inflows from other assets or groups of assets (''cash-generating
unit). Impairment losses recognized in prior periods are determined at each reporting
date for any indications that the loss has decreased or no longer exists. An impairment
loss is reversed if there has been a change in the estimates used to determine the
recoverable amount. An assets carrying amount, increased through reversal of an impairment
loss, must not exceed the carrying amount that would have been determined, net of
depreciation or amortization, if no impairment loss had been recognized. |
15
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(n) |
|
Provisions: |
|
|
|
|
A provision is recognized if, as a result of a past event, the Company has a present legal
or constructive obligation that can be estimated reliably, and it is probable that an
outflow of economic benefits will be required to settle the obligation. Provisions are
assessed by discounting the expected future cash flows at a pre-tax rate that reflects
current market assessments of the time value of money and the risks specific to the
liability. The unwinding of the discount on provisions is recognized in finance costs. |
|
|
|
|
Onerous contracts: |
|
|
|
|
A provision for onerous contracts is recognized when the expected benefits to be derived by
the Company from a contract are lower than the unavoidable cost of meeting its obligations
under the contract. The provision is measured at the present value of the lower of the
expected cost of terminating the contract and the expected net cost of continuing with the
contract. Before a provision is established, the Company recognizes any impairment loss on
the assets associated with that contract. There were no onerous contracts as at August 31,
2010 and 2009, November 30, 2009 and December 1, 2008. |
|
|
|
|
Site restoration: |
|
|
|
|
Where there is a legal or constructive obligation to restore leased premises to good
condition, except for normal aging on expiry or early termination of the lease, the
resulting costs are provisioned up to the discounted value of estimated future costs and
increase the carrying amount of the corresponding item of property and equipment. The
Company amortizes the cost of restoring leased premises and recognizes an unwinding of
discount expense on the liability related to the term of the lease. |
|
|
|
|
Contingent liability: |
|
|
|
|
A contingent liability is a possible obligation that arises from past events and of which
the existence will be confirmed only by the occurrence or non-occurrence of one or more
uncertain future events not wholly within the control of the Company; or a present
obligation that arises from past events (and therefore exists), but is not recognized
because it is not probable that a transfer or use of assets, provision of services or any
other transfer of economic benefits will be required to settle the obligation, or the
amount of the obligation cannot be estimated reliably. |
16
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(o) |
|
Income taxes: |
|
|
|
|
Income tax expense comprises current and deferred tax. Current tax and deferred tax are
recognized in net profit (loss), except to the extent that they relate to items recognized
directly in other comprehensive income or in equity. |
|
|
|
|
Current tax: |
|
|
|
|
Current tax is the expected tax payable or receivable on the taxable income or loss for the
year, using tax rates enacted or substantively enacted at the reporting date, and any
adjustment to tax payable in respect of previous years. The Company establishes provisions
where appropriate on the basis of amounts expected to be paid to the tax authorities. |
|
|
|
|
Deferred tax: |
|
|
|
|
Deferred tax is recognized in respect of temporary differences between the carrying amounts
of assets and liabilities for financial reporting purposes and the amounts used for
taxation purposes. Deferred tax is measured at the tax rates that are expected to be
applied to temporary differences when they reverse, based on the laws that have been
enacted or substantively enacted by the reporting date. |
|
|
|
|
A deferred tax liability is generally recognized for all taxable temporary differences. |
|
|
|
|
A deferred tax asset is recognized for unused tax losses and deductible temporary
differences, to the extent that it is probable that future taxable profits will be
available against which they can be utilized. Deferred tax assets are reviewed at each
reporting date and are reduced to the extent that it is no longer probable that the related
tax benefit will be realized. |
|
(p) |
|
Share-based compensation: |
|
|
|
|
The Company records share-based compensation related to employee stock options granted
using the fair value-based method estimated using the Black-Scholes model. Under this
method, compensation cost is measured at fair value at the date of grant and expensed, as
employee benefits, over the period in which employees unconditionally become entitled to
the award. The amount recognized as an expense is adjusted to reflect the number of awards
for which the related service conditions are expected to be met, such that the amount
ultimately recognized as an expense is based on the number of awards that do meet the
related service and non-market performance conditions at the vesting date. |
|
|
|
|
Share-based payment arrangements in which the Company receives goods or services as
consideration for its own equity instruments are accounted for as equity-settled
share-based payment transactions, regardless of how the equity instruments are obtained by
the Company. |
17
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(p) |
|
Share-based compensation (continued): |
|
|
|
|
As permitted by IFRS 1, the Company elected not to restate options that were granted before
November 7, 2002 and those granted after November 7, 2002 that were fully vested prior to
the date of transition to IFRS. |
|
|
(q) |
|
Government grants: |
|
|
|
|
Government grants, consisting of grants and research investment tax credits, are recorded
as a reduction of the related expense or cost of the asset acquired. Government grants are
recognized when there is reasonable assurance that the Company has met the requirements of
the approved grant program and there is reasonable assurance that the grant will be
received. |
|
|
(r) |
|
Share capital: |
|
|
|
|
Common shares: |
|
|
|
|
Common shares are classified as equity. Incremental costs directly attributable to the
issue of common shares and share options are recognized as a deduction from equity, net of
any tax effects. |
|
|
(s) |
|
Earnings per share: |
|
|
|
|
The Company presents basic and diluted earnings per share (''EPS) data for its common
shares. Basic EPS is calculated by dividing the net profit or loss attributable to common
shareholders of the Company by the weighted average number of common shares outstanding
during the period, adjusted for own shares held, if applicable. Diluted EPS is determined
by adjusting the profit or loss attributable to common shareholders and the weighted
average number of common shares outstanding, adjusted for own shares held, if applicable,
for the effects of all dilutive potential common shares, which consist of the stock options
granted to employees. |
|
|
(t) |
|
New standards and interpretations not yet applied: |
|
|
|
|
Certain pronouncements were issued by the IASB or International Financial Reporting
Interpretations Committee that are mandatory for accounting periods beginning on or after
January 1, 2010 or later periods. Many of these updates are not applicable or are
inconsequential to the Company and have been excluded from the discussion below. The
remaining pronouncements are being assessed to determine their impact on the Companys
results and financial position: |
18
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(t) |
|
New standards and interpretations not yet applied (continued): |
|
|
|
|
Annual improvements to IFRS: |
|
|
|
|
The IASBs improvements to IFRS published in April 2009 contain fifteen amendments to
twelve standards that result in accounting changes for presentation, recognition or
measurement purposes largely for annual periods beginning on or after January 1, 2010, with
early adoption permitted. These amendments were considered by the Company and deemed to be
not applicable to the Company other than for the amendment to IAS 17 Leases relating to
leases which include both land and buildings elements. In this case, the Company early
adopted this amendment. |
|
|
|
|
The IASBs improvements to IFRS contain seven amendments that result in accounting changes
for presentation, recognition or measurement purposes. The most significant features of the
IASBs annual improvements project published in May 2010 are included under the specific
revisions to standards discussed below. |
|
(i) |
|
IFRS 3: |
|
|
|
|
Revision to IFRS 3, Business Combinations: |
|
|
|
|
Effective for annual periods beginning on or after July 1, 2010, with earlier adoption
permitted. |
|
|
|
|
Clarification on the following areas: |
|
|
|
the choice of measuring non-controlling interests at fair value or at
the proportionate share of the acquirees net assets applies only to instruments
that represent present ownership interests and entitle their holders to a
proportionate share of the net assets in the event of liquidation. All other
components of non-controlling interest are measured at fair value unless another
measurement basis is required by IFRS. |
|
|
|
|
application guidance relating to the accounting for share-based
payments in IFRS 3 applies to all share-based payment transactions that are part
of a business combination, including unreplaced awards (i.e., unexpired awards
over the acquiree shares that remain outstanding rather than being replaced by the
acquirer) and voluntarily replaced share-based payment awards. |
19
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(t) |
|
New standards and interpretations not yet applied (continued): |
|
|
|
|
Annual improvements to IFRS (continued): |
|
(ii) |
|
IFRS 7: |
|
|
|
|
Amendment to IFRS 7, Financial Instruments: Disclosures: |
|
|
|
|
Effective for annual periods beginning on or after January 1, 2011, with earlier
adoption permitted. |
|
|
|
|
Multiple clarifications related to the disclosure of financial instruments and in
particular in regards to transfers of financial assets. |
|
(iii) |
|
IAS 1: |
|
|
|
|
Amendment to IAS 1, Presentation of Financial Statements: |
|
|
|
|
Effective for annual periods beginning on or after January 1, 2011, with earlier
adoption permitted. |
|
|
|
|
Entities may present the analysis of the components of other comprehensive income
either in the statement of changes in equity or within the notes to the financial
statements. |
|
|
(iv) |
|
IAS 27: |
|
|
|
|
Amendment to IAS 27, Consolidated and Separate Financial Statements: |
|
|
|
|
Effective for annual periods beginning on or after January 1, 2011, with earlier
adoption permitted. |
|
|
|
|
The 2008 revisions to this standard resulted in consequential amendments to IAS 21, The
Effects of Changes in Foreign Exchange Rates, IAS 28, Investments in Associates, and
IAS 31, Interests in Joint Ventures. IAS 27 now provides that these amendments are to
be applied prospectively. |
20
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(t) |
|
New standards and interpretations not yet applied (continued): |
|
|
|
|
Annual improvements to IFRS (continued): |
|
(v) |
|
IAS 34: |
|
|
|
|
Amendment to IAS 34, Interim Financial Reporting: |
|
|
|
|
Effective for annual periods beginning on or after January 1, 2011, with earlier
adoption permitted. |
|
|
|
|
The amendments place greater emphasis on the disclosure principles for interim
financial reporting involving significant events and transactions, including changes to
fair value measurements and the need to update relevant information from the most
recent annual report. |
|
|
|
New or revised standards and interpretations: |
|
|
|
|
In addition, the following new or revised standards and interpretations have been issued
but are not yet applicable to the Company: |
|
(i) |
|
IFRS 8: |
|
|
|
|
IFRS 8, Operating Segments (revised): |
|
|
|
|
Effective for annual periods beginning on or after January 1, 2010. |
|
|
|
|
Requires purchase information about segment assets. |
|
|
(ii) |
|
IFRS 9: |
|
|
|
|
New standard IFRS 9, Financial Instruments: |
|
|
|
|
Effective for annual periods beginning on or after January 1, 2013, with earlier
adoption permitted. |
|
|
|
|
As part of the project to replace IAS 39, Financial Instruments: Recognition and
Measurement, this standard retains but simplifies the mixed measurement model and
establishes two primary measurement categories for financial assets. More specifically,
the standard: |
|
|
|
deals with classification and measurement of financial assets |
|
|
|
|
establishes two primary measurement categories for financial assets:
amortized cost and fair value |
21
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(t) |
|
New standards and interpretations not yet applied (continued): |
|
|
|
|
New or revised standards and interpretations (continued): |
|
(ii) |
|
IFRS 9 (continued): |
|
|
|
|
New standard IFRS 9, Financial Instruments (continued): |
|
|
|
classification depends on entitys business model and the contractual
cash flow characteristics of the financial asset |
|
|
|
|
eliminates the existing categories: held to maturity, available for
sale, and loans and receivables. |
|
|
|
Certain changes were also made regarding the fair value option for financial
liabilities and accounting for certain derivatives linked to unquoted equity
instruments. |
4. |
|
Revenue and deferred revenue: |
|
|
|
On October 28, 2008, the Company entered into a collaboration and licensing agreement with EMD
Serono, Inc. (EMD Serono), an affiliate of Merck KGaA, of Darmstadt, Germany, regarding the
exclusive commercialization rights of tesamorelin in the United States for the treatment of
excess abdominal fat in HIV-infected patients with lipodystrophy (the Initial Product). The
Company retains all tesamorelin commercialization rights outside of the United States. |
|
|
|
Under the terms of the agreement, the Company is responsible for the development of the Initial
Product up to obtaining marketing approval in the United States. The Company is also
responsible for product production and for the development of a new formulation of the initial
product. EMD Serono is responsible for conducting product commercialization activities. |
|
|
|
At the closing of the agreement, on December 15, 2008, the Company received US$30,000
(CAD$36,951), which includes an initial payment of US$22,000 (CAD$27,097) and US$8,000
(CAD$9,854) as a subscription for common shares in the Company by Merck KGaA at a price of
US$3.67 (CAD$4.52) per share. The Company may receive up to US$215,000, which amount includes
the initial payment of US$22,000, the equity investment of US$8,000, as well as payments based
on the achievement of certain development, regulatory and sales milestones. The Company will
also be entitled to receive increasing royalties on annual net sales of tesamorelin in the
United States, if applicable. |
22
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
4. |
|
Revenue and deferred revenue (continued): |
|
|
|
The initial payment of $27,097 has been deferred and is being amortized over its estimated
service period for developing a new formulation of the Initial Product. This period may be
modified in the future based on additional information that may be received by the Company. For
the nine-month period ended August 31, 2010, an amount of $5,134 related to this transaction
was recognized as revenue. As at August 31, 2010, the deferred revenues related to this
transaction amounted to $15,403 (November 30, 2009 $20,537). |
|
|
|
On August 12, 2009, the US Food and Drug Administration accepted the New Drug Application
(NDA) made by the Company for tesamorelin. Under the terms of the Companys Collaboration and
Licensing Agreement with EMD Serono, the acceptance of the tesamorelin NDA resulted in a
milestone payment of US$10,000 (CAD$10,884). This milestone payment has been recorded in the
third quarter of 2009. |
|
|
|
The Company may conduct research and development for additional indications. Under the
collaboration and licensing agreement, EMD Serono will have the option to commercialize
additional indications for tesamorelin in the United States. If it exercises this option, EMD
Serono will pay half of the development costs related to such additional indications. In such
cases, the Company will also have the right, subject to an agreement with EMD Serono, to
participate in the promotion of the additional indications. |
5. |
|
Share capital: |
|
|
|
During the second quarter of 2010, the Company received subscriptions in the amount of $15 ($7
for the same period in 2009) for the issue of 2,880 common shares (2,550 for the same period in
2009) in connection with its share purchase plan. |
|
(a) |
|
Shareholder rights plan: |
|
|
|
|
On February 10, 2010, the Board of Directors of the Company adopted a shareholder rights
plan (the ''Plan), effective as of that date. The Plan is designed to provide adequate
time for the Board of Directors and the shareholders, to assess an unsolicited takeover bid
for the Company. In addition, the Plan provides the Board of Directors with sufficient time
to explore and develop alternatives for maximizing shareholder value if a takeover bid is
made, as well as provide shareholders with an equal opportunity to participate if a
takeover bid is made, as well as provide shareholders with an equal opportunity to
participate in a takeover bid to receive full and fair value for their common shares. The
Plan will expire at the close of the Companys annual meeting of shareholders in 2013. |
23
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Share capital (continued): |
|
(a) |
|
Shareholder rights plan (continued): |
|
|
|
|
The rights issued under the Plan will initially attach to and trade with the common shares
and no separate certificates will be issued unless a triggering occurs. The rights will
become exercisable only when a person, including any party related to it, acquires or
attempts to acquire 20% or more of the outstanding shares without complying with the
''Permitted Bid provisions of the Plan or without approval of the Board of Directors.
Should such an acquisition occur or be announced, each right would, upon exercise, entitle
a rights holder, other than the acquiring person and related persons, to purchase common
shares at a 50% discount to the market price at the time. |
|
|
|
|
Under the Plan, a Permitted Bid is a bid made to all holders of the common shares and which
is open for acceptance for no less than 60 days. If, at the end of 60 days, at least 50% of
the outstanding common shares, other than those owned by the offeror and certain related
parties, have been tendered, the offeror may take up and pay for the common shares, but
must extend the bid for a further 10 days to allow other shareholders to tender. |
|
|
(b) |
|
Share purchase plan: |
|
|
|
|
The Share Purchase Plan entitles full-time and part-time employees of the Company who, on
the participation date, are residents of Canada, are not under a probationary period and do
not hold, directly or indirectly, five percent (5%) or more of the Companys outstanding
common shares, to directly subscribe for common shares of the Company. Under the Share
Purchase Plan, a maximum of 550,000 common shares may be issued to employees. |
|
|
|
|
On May 1 and November 1 of each year (the ''Participation Dates), an employee may
subscribe for a number of common shares under the Share Purchase Plan for an amount that
does not exceed 10% of that employees gross annual salary for that year. Under the Share
Purchase Plan, the Board of Directors has the authority to suspend or defer a subscription
of common shares, or to decide that no subscription of common shares will be allowed on a
Participation Date if it is in the Companys best interest. |
|
|
|
|
The Share Purchase Plan provides that the number of common shares that may be issued to
insiders, at any time, under all share-based compensation arrangements of the Company,
cannot exceed 10% of the Companys outstanding common shares, and the number of common
shares issued to insiders, within any one-year period, under all security-based
compensation arrangements, cannot exceed 10% of the outstanding common shares. |
24
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Share capital (continued): |
|
(b) |
|
Share purchase plan (continued): |
|
|
|
|
The subscription price for each new common share subscribed for under the Share Purchase
Plan is equal to the weighted average closing price of the common shares on the Toronto
Stock Exchange during a period of five days prior to the Participation Date. Employees may
not assign the rights granted under the Share Purchase Plan. |
|
|
|
|
An employee may elect to pay the subscription price for common shares in cash or through an
interest-free loan from the Company. Loans granted by the Company under the Share Purchase
Plan are repayable through salary withholdings over a period not exceeding two years. All
loans may be repaid prior to the scheduled repayment at any time. The loans granted to any
employee may at no time exceed 10% of that employees current annual gross salary. All
common shares purchased through an interest-free loan are hypothecated to secure full and
final repayment of the loan and are held by a trustee until repayment in full. Loans are
immediately due and payable on the occurrence of any of the following events: (i)
termination of employment; (ii) sale or seizure of the hypothecated common shares; (iii)
bankruptcy or insolvency of the employee; or (iv) suspension of the payment of an
employees salary or revocation of the employees right to salary withholdings. |
|
|
|
|
At August 31, 2010, $72 (November 30, 2009 $149; December 1, 2008 $150) was receivable
under these loans. |
|
|
(c) |
|
Stock option plan: |
|
|
|
|
The Company has established a stock option plan under which it can grant to its directors,
officers, employees, researchers and consultants non-transferable options for the purchase
of common shares. The exercise date of an option may not be later than 10 years after the
grant date. A maximum number of 5,000,000 options can be granted under the plan. Generally,
the options vest at the date of the grant or over a period up to 5 years. As at August 31,
2010, 970,171 options could still be granted by the Company (August 31 1,236,168). |
|
|
|
|
All options are to be settled by physical delivery of shares. |
25
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Share capital (continued): |
|
(c) |
|
Stock option plan (continued): |
|
|
|
|
Changes in outstanding options granted under the Companys stock option plan for the year
ended November 30, 2009 and the nine-month period ended August 31, 2010 were as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
|
|
|
|
exercise price |
|
|
|
Options |
|
|
per option |
|
|
|
|
|
|
|
$ |
|
Options at December 1, 2008 |
|
|
2,161,800 |
|
|
|
6.52 |
|
Granted |
|
|
680,500 |
|
|
|
1.83 |
|
Expired |
|
|
(58,500 |
) |
|
|
5.16 |
|
Forfeited |
|
|
(118,000 |
) |
|
|
9.92 |
|
|
|
|
|
|
|
|
|
|
|
Options at November 30, 2009 |
|
|
2,665,800 |
|
|
|
5.20 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
335,000 |
|
|
|
4.03 |
|
Expired |
|
|
(25,000 |
) |
|
|
9.91 |
|
Forfeited |
|
|
(35,337 |
) |
|
|
3.78 |
|
Exercised |
|
|
(77,493 |
) |
|
|
1.65 |
|
|
|
|
|
|
|
|
|
|
|
Options at August 31, 2010 |
|
|
2,862,970 |
|
|
|
5.14 |
|
|
|
|
|
The fair value of the options granted was estimated at the grant date using the
Black-Scholes model and the following weighted average assumptions: |
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
Risk-free interest rate |
|
|
2.46 |
% |
|
|
1.79 |
% |
Volatility |
|
|
81 |
% |
|
|
79 |
% |
Average option life in years |
|
|
7.5 |
|
|
|
7.5 |
|
Dividend yield |
|
Nil |
|
|
Nil |
|
Grant-date share price |
|
$ |
4.03 |
|
|
$ |
1.83 |
|
Option exercise price |
|
$ |
4.03 |
|
|
$ |
1.83 |
|
|
26
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Share capital (continued): |
|
(c) |
|
Stock option plan (continued): |
|
|
|
|
The risk-free interest rate is based on the implied yield on a Canadian Treasury
zero-coupon issue with a remaining term equal to the expected term of the option. The
volatility is based solely on historical volatility equal to the expected term of the
option. The average life of the options is estimated considering the vesting period, the
term of the option and the length of time that similar grants have remained outstanding in
the past. Dividend yield was excluded from the calculation, since it is the present policy
of the Company not to retain in cash in order to keep funds available to finance the
Companys growth. |
|
|
|
|
The following table summarizes the measurement date weighted average fair value of stock
options granted during the periods ended August 31, 2010 and 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
Number of |
|
|
grant-date |
|
Periods ended August 31 (9 months) |
|
options |
|
|
fair value |
|
|
|
|
|
|
|
$ |
|
2010 |
|
|
335,000 |
|
|
|
3.05 |
|
2009 |
|
|
660,500 |
|
|
|
1.34 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
Number of |
|
|
grant-date |
|
Periods ended August 31 (3 months) |
|
options |
|
|
fair value |
|
|
|
|
|
|
|
$ |
|
2010 |
|
|
70,000 |
|
|
|
3.62 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
The Black-Scholes model used by the Company to calculate option values was developed
to estimate the fair value of freely tradable, fully transferable options without vesting
restrictions, which significantly differs from the Companys stock option awards. This
model also requires four highly subjective assumptions, including future stock price
volatility and average option life, which greatly affect the calculated values. |
27
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Share capital (continued): |
|
(d) |
|
Earnings per share: |
|
|
|
|
The calculation of basic earnings per share at August 31, 2010 was based on the net loss
attributable to common shareholders of the Company of ($12,369) (2009 ($10,502)), and a
weighted average number of common shares outstanding of 60,469,621 (2009 60,284,591),
calculated as follows: |
|
|
|
|
|
|
|
|
|
|
|
August 31, |
|
|
August 31, |
|
|
|
2010 |
|
|
2009 |
|
|
Issued common shares at December 1 |
|
|
60,429,393 |
|
|
|
58,215,090 |
|
Effect of share options exercised |
|
|
39,040 |
|
|
|
|
|
Effect of shares issued during the period |
|
|
1,188 |
|
|
|
2,069,501 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares at August 31 |
|
|
60,469,621 |
|
|
|
60,284,591 |
|
|
|
|
|
The calculation of diluted earnings per share was based on a weighted average number
of common shares calculated as follows: |
|
|
|
|
|
|
|
|
|
|
|
August 31, |
|
|
August 31, |
|
|
|
2010 |
|
|
2009 |
|
|
Weighted average number of common shares (basic) |
|
|
60,469,621 |
|
|
|
60,284,591 |
|
Effect of stock options on issue |
|
|
|
|
|
|
165,420 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares (diluted) at August 31 |
|
|
60,469,621 |
|
|
|
60,450,011 |
|
|
|
|
|
At August 2010, 1,127,164 options (2009 1,385,833) were excluded from the diluted
weighted average number of common shares calculation as their effect would have been
anti-dilutive. |
|
|
|
|
The average market value of the Companys shares for purposes of calculating the dilutive
effect of share options was based on quoted market prices for the period during which the
options were outstanding. |
28
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
6. |
|
Supplemental information: |
|
|
|
The following transactions were conducted by the Company and did not impact cash flows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 31, |
|
|
August 31, |
|
|
November 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2009 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
Additions to property and equipment included in accounts payable and
accrued liabilities |
|
|
55 |
|
|
|
28 |
|
|
|
183 |
|
|
|
(a) |
|
Except for changes related to the Companys adoption of IFRS, these amended unaudited
interim consolidated financial statements do not reflect events occurring after October
12, 2010, the date of the filing of the consolidated financial statements prepared in
accordance with Canadian GAAP. The annual audited consolidated financial statements of the
Company prepared in accordance with IFRS have been filed concurrently with these amended
unaudited interim consolidated financial statements. These amended unaudited interim
consolidated financial statements should be read in connection with the annual financial
statements for additional disclosures with respect to subsequent events. |
|
|
(b) |
|
On July 26, 2010, the Company received a motion of authorization to institute a class
action against the Company and certain of its executive officers (the Motion). This
Motion was filed in the Superior Court of Quebec, district of Montreal. The applicant is
seeking to initiate a class action suit to represent the class of persons who were
shareholders at May 21, 2010 and who sold their common shares of the Company on May 25 or
26, 2010. This applicant alleges that the Company did not comply with its continuous
disclosure obligations as a reporting issuer by failing to disclose a material change. The
Company is of the view that the allegations contained in the Motion are frivolous and
entirely without merit and intends to take all appropriate actions to vigorously defend
its position. |
|
|
|
|
As of October 11, 2010, the Motion has not yet been heard by the Superior Court of Quebec. |
|
|
|
|
The Company subscribed insurances covering the responsibility of its administrators and
officers in the exercise of their functions. |
29
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
|
|
|
As stated in note 2 (a), the Company has applied IFRS 1 and the accounting policies set out in
note 3 in preparing the financial statements for the period ended August 31, 2010, the
comparative period ended August 31, 2009, for the year ended November 30, 2009, and for the
opening IFRS statement of financial position as at December 1, 2008 (the Companys date of
transition). |
|
|
|
|
In preparing these consolidated financial statements in accordance with IFRS 1, the Company has
applied the mandatory exceptions and certain of the optional exemptions from full retrospective
application of IFRS. |
|
|
|
|
The Company elected to apply the following optional exemptions from full retrospective
application: |
|
(i) |
|
Share-based payment transaction exemption: |
|
|
|
|
The Company has elected to apply the share-based payment exemption. It applied IFRS 2 from
December 1, 2008 to those stock options that were issued after November 7, 2002 but that
had not vested by December 1, 2008. The application of the exemption is detailed below. |
|
|
(ii) |
|
Designation of financial assets and financial liabilities exemption: |
|
|
|
|
The Company elected to re-designate cash from the held for trading category to loans and
receivables. |
|
|
|
As required by IFRS 1, estimates made under IFRS at the date of transition must be consistent
with estimates made for the same date under previous GAAP, unless there is evidence that those
estimates were in error. |
|
|
|
|
In preparing its opening IFRS consolidated statement of financial position, the Company has
adjusted amounts reported previously in financial statements prepared in accordance with
Canadian GAAP. |
|
|
|
|
An explanation of how the transition from previous Canadian GAAP to IFRS has affected the
Companys financial position, financial performance and cash flows is set out in the following
tables and accompanying notes. |
30
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
|
Reconciliation of equity as at December 1, 2008 and November 30, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 1, 2008 |
|
November 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Note |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
|
|
|
|
|
133 |
|
|
|
|
|
|
|
|
|
|
|
133 |
|
|
|
1,519 |
|
|
|
|
|
|
|
|
|
|
|
1,519 |
|
Bonds |
|
|
|
|
|
|
10,955 |
|
|
|
|
|
|
|
|
|
|
|
10,955 |
|
|
|
10,036 |
|
|
|
|
|
|
|
|
|
|
|
10,036 |
|
Trade and other
receivables |
|
|
|
|
|
|
610 |
|
|
|
|
|
|
|
|
|
|
|
610 |
|
|
|
375 |
|
|
|
|
|
|
|
|
|
|
|
375 |
|
Tax credits and
grants receivable |
|
|
(a |
) |
|
|
1,784 |
|
|
|
|
|
|
|
(333 |
) |
|
|
1,451 |
|
|
|
1,666 |
|
|
|
|
|
|
|
(333 |
) |
|
|
1,333 |
|
Inventories |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,225 |
|
|
|
|
|
|
|
|
|
|
|
2,225 |
|
Research supplies |
|
|
(a |
) |
|
|
301 |
|
|
|
|
|
|
|
(301 |
) |
|
|
|
|
|
|
287 |
|
|
|
|
|
|
|
(287 |
) |
|
|
|
|
Prepaid expenses |
|
|
(a |
) |
|
|
397 |
|
|
|
|
|
|
|
342 |
|
|
|
739 |
|
|
|
302 |
|
|
|
|
|
|
|
328 |
|
|
|
630 |
|
|
Total current assets |
|
|
|
|
|
|
14,180 |
|
|
|
|
|
|
|
(292 |
) |
|
|
13,888 |
|
|
|
16,410 |
|
|
|
|
|
|
|
(292 |
) |
|
|
16,118 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bonds |
|
|
|
|
|
|
35,249 |
|
|
|
|
|
|
|
|
|
|
|
35,249 |
|
|
|
51,807 |
|
|
|
|
|
|
|
|
|
|
|
51,807 |
|
Property and equipment |
|
|
|
|
|
|
1,299 |
|
|
|
|
|
|
|
|
|
|
|
1,299 |
|
|
|
1,229 |
|
|
|
|
|
|
|
|
|
|
|
1,229 |
|
Other assets |
|
|
(a |
) |
|
|
2,817 |
|
|
|
|
|
|
|
(41 |
) |
|
|
2,776 |
|
|
|
41 |
|
|
|
|
|
|
|
(41 |
) |
|
|
|
|
|
Total non-current assets |
|
|
|
|
|
|
39,365 |
|
|
|
|
|
|
|
(41 |
) |
|
|
39,324 |
|
|
|
53,077 |
|
|
|
|
|
|
|
(41 |
) |
|
|
53,036 |
|
|
Total assets |
|
|
|
|
|
|
53,545 |
|
|
|
|
|
|
|
(333 |
) |
|
|
53,212 |
|
|
|
69,487 |
|
|
|
|
|
|
|
(333 |
) |
|
|
69,154 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
and accrued liabilities |
|
|
(a |
) |
|
|
7,198 |
|
|
|
|
|
|
|
(333 |
) |
|
|
6,865 |
|
|
|
5,901 |
|
|
|
|
|
|
|
(333 |
) |
|
|
5,568 |
|
Current portion of
deferred revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,847 |
|
|
|
|
|
|
|
|
|
|
|
6,847 |
|
|
Total current liabilities |
|
|
|
|
|
|
7,198 |
|
|
|
|
|
|
|
(333 |
) |
|
|
6,865 |
|
|
|
12,748 |
|
|
|
|
|
|
|
(333 |
) |
|
|
12,415 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,691 |
|
|
|
|
|
|
|
|
|
|
|
13,691 |
|
|
Total non-current liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,691 |
|
|
|
|
|
|
|
|
|
|
|
13,691 |
|
|
Total liabilities |
|
|
|
|
|
|
7,198 |
|
|
|
|
|
|
|
(333 |
) |
|
|
6,865 |
|
|
|
26,439 |
|
|
|
|
|
|
|
(333 |
) |
|
|
26,106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
|
|
|
|
269,219 |
|
|
|
|
|
|
|
|
|
|
|
269,219 |
|
|
|
279,169 |
|
|
|
|
|
|
|
|
|
|
|
279,169 |
|
Contributed surplus |
|
|
(b |
) |
|
|
5,585 |
|
|
|
175 |
|
|
|
|
|
|
|
5,760 |
|
|
|
6,484 |
|
|
|
273 |
|
|
|
|
|
|
|
6,757 |
|
Deficit |
|
|
(b |
) |
|
|
(228,829 |
) |
|
|
(175 |
) |
|
|
|
|
|
|
(229,004 |
) |
|
|
(243,887 |
) |
|
|
(273 |
) |
|
|
|
|
|
|
(244,160 |
) |
Accumulated other
comprehensive income |
|
|
|
|
|
|
372 |
|
|
|
|
|
|
|
|
|
|
|
372 |
|
|
|
1,282 |
|
|
|
|
|
|
|
|
|
|
|
1,282 |
|
|
Total equity |
|
|
|
|
|
|
46,347 |
|
|
|
|
|
|
|
|
|
|
|
46,347 |
|
|
|
43,048 |
|
|
|
|
|
|
|
|
|
|
|
43,048 |
|
|
Total liabilities and equity |
|
|
|
|
|
|
53,545 |
|
|
|
|
|
|
|
(333 |
) |
|
|
53,212 |
|
|
|
69,487 |
|
|
|
|
|
|
|
(333 |
) |
|
|
69,154 |
|
|
31
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
|
Reconciliation of equity as at August 31, 2010 and 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 31, 2010 |
|
August 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Note |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
|
|
|
|
|
2,370 |
|
|
|
|
|
|
|
|
|
|
|
2,370 |
|
|
|
12,725 |
|
|
|
|
|
|
|
|
|
|
|
12,725 |
|
Bonds |
|
|
|
|
|
|
1,694 |
|
|
|
|
|
|
|
|
|
|
|
1,694 |
|
|
|
9,562 |
|
|
|
|
|
|
|
|
|
|
|
9,562 |
|
Trade and other
receivables |
|
|
|
|
|
|
131 |
|
|
|
|
|
|
|
|
|
|
|
131 |
|
|
|
220 |
|
|
|
|
|
|
|
|
|
|
|
220 |
|
Tax credits and
grants receivable |
|
|
(a |
) |
|
|
514 |
|
|
|
|
|
|
|
(333 |
) |
|
|
181 |
|
|
|
3,167 |
|
|
|
|
|
|
|
(333 |
) |
|
|
2,834 |
|
Inventories |
|
|
|
|
|
|
4,585 |
|
|
|
|
|
|
|
|
|
|
|
4,585 |
|
|
|
1,594 |
|
|
|
|
|
|
|
|
|
|
|
1,594 |
|
Research supplies |
|
|
(a |
) |
|
|
283 |
|
|
|
|
|
|
|
(283 |
) |
|
|
|
|
|
|
1,029 |
|
|
|
|
|
|
|
(1,029 |
) |
|
|
|
|
Prepaid expenses |
|
|
(a |
) |
|
|
680 |
|
|
|
|
|
|
|
324 |
|
|
|
1,004 |
|
|
|
723 |
|
|
|
|
|
|
|
1,372 |
|
|
|
2,095 |
|
|
Total current assets |
|
|
|
|
|
|
10,257 |
|
|
|
|
|
|
|
(292 |
) |
|
|
9,965 |
|
|
|
29,020 |
|
|
|
|
|
|
|
10 |
|
|
|
29,030 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bonds |
|
|
|
|
|
|
39,355 |
|
|
|
|
|
|
|
|
|
|
|
39,355 |
|
|
|
44,103 |
|
|
|
|
|
|
|
|
|
|
|
44,103 |
|
Property and equipment |
|
|
|
|
|
|
1,106 |
|
|
|
|
|
|
|
|
|
|
|
1,106 |
|
|
|
1,128 |
|
|
|
|
|
|
|
|
|
|
|
1,128 |
|
Other assets |
|
|
(a |
) |
|
|
41 |
|
|
|
|
|
|
|
(41 |
) |
|
|
|
|
|
|
343 |
|
|
|
|
|
|
|
(343 |
) |
|
|
|
|
|
Total non-current assets |
|
|
|
|
|
|
40,502 |
|
|
|
|
|
|
|
(41 |
) |
|
|
40,461 |
|
|
|
45,574 |
|
|
|
|
|
|
|
(343 |
) |
|
|
45,231 |
|
|
Total assets |
|
|
|
|
|
|
50,759 |
|
|
|
|
|
|
|
(333 |
) |
|
|
50,426 |
|
|
|
74,594 |
|
|
|
|
|
|
|
(333 |
) |
|
|
74,261 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
and accrued liabilities |
|
|
(a |
) |
|
|
3,823 |
|
|
|
|
|
|
|
(333 |
) |
|
|
3,490 |
|
|
|
4,580 |
|
|
|
|
|
|
|
(333 |
) |
|
|
4,247 |
|
Current portion of
deferred revenue |
|
|
|
|
|
|
6,849 |
|
|
|
|
|
|
|
|
|
|
|
6,849 |
|
|
|
6,850 |
|
|
|
|
|
|
|
|
|
|
|
6,850 |
|
|
Total current liabilities |
|
|
|
|
|
|
10,672 |
|
|
|
|
|
|
|
(333 |
) |
|
|
10,339 |
|
|
|
11,430 |
|
|
|
|
|
|
|
(333 |
) |
|
|
11,097 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other liabilities |
|
|
|
|
|
|
167 |
|
|
|
|
|
|
|
|
|
|
|
167 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
|
|
|
|
8,557 |
|
|
|
|
|
|
|
|
|
|
|
8,557 |
|
|
|
15,402 |
|
|
|
|
|
|
|
|
|
|
|
15,402 |
|
|
Total non-current liabilities |
|
|
|
|
|
|
8,724 |
|
|
|
|
|
|
|
|
|
|
|
8,724 |
|
|
|
15,402 |
|
|
|
|
|
|
|
|
|
|
|
15,402 |
|
|
Total liabilities |
|
|
|
|
|
|
19,396 |
|
|
|
|
|
|
|
(333 |
) |
|
|
19,063 |
|
|
|
26,832 |
|
|
|
|
|
|
|
(333 |
) |
|
|
26,499 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
|
|
|
|
279,389 |
|
|
|
|
|
|
|
|
|
|
|
279,389 |
|
|
|
279,080 |
|
|
|
|
|
|
|
|
|
|
|
279,080 |
|
Contributed surplus |
|
|
(b |
) |
|
|
7,356 |
|
|
|
275 |
|
|
|
|
|
|
|
7,631 |
|
|
|
6,290 |
|
|
|
317 |
|
|
|
|
|
|
|
6,607 |
|
Deficit |
|
|
(b |
) |
|
|
(256,254 |
) |
|
|
(275 |
) |
|
|
|
|
|
|
(256,529 |
) |
|
|
(239,189 |
) |
|
|
(317 |
) |
|
|
|
|
|
|
(239,506 |
) |
Accumulated other
comprehensive income |
|
|
|
|
|
|
872 |
|
|
|
|
|
|
|
|
|
|
|
872 |
|
|
|
1,581 |
|
|
|
|
|
|
|
|
|
|
|
1,581 |
|
|
Total equity |
|
|
|
|
|
|
31,363 |
|
|
|
|
|
|
|
|
|
|
|
31,363 |
|
|
|
47,762 |
|
|
|
|
|
|
|
|
|
|
|
47,762 |
|
|
Total liabilities and equity |
|
|
|
|
|
|
50,759 |
|
|
|
|
|
|
|
(333 |
) |
|
|
50,426 |
|
|
|
74,594 |
|
|
|
|
|
|
|
(333 |
) |
|
|
74,261 |
|
|
32
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
|
Reconciliation of comprehensive income for the year ended November 30, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Note |
|
|
GAAP |
|
|
ments |
|
|
fication |
|
|
IFRS |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
10,884 |
|
|
|
10,884 |
|
Upfront payments and initial technology access fees |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
6,560 |
|
|
|
6,560 |
|
Royalties and license fees |
|
|
(c |
) |
|
|
17,468 |
|
|
|
|
|
|
|
(17,444 |
) |
|
|
24 |
|
Interest |
|
|
(c |
) |
|
|
2,252 |
|
|
|
|
|
|
|
(2,252 |
) |
|
|
|
|
|
Total revenue |
|
|
|
|
|
|
19,720 |
|
|
|
|
|
|
|
(2,252 |
) |
|
|
17,468 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses, net of tax credits |
|
|
(b), |
(c) |
|
|
20,431 |
|
|
|
33 |
|
|
|
346 |
|
|
|
20,810 |
|
Selling and market development expenses |
|
|
(b), |
(c) |
|
|
2,583 |
|
|
|
10 |
|
|
|
4,269 |
|
|
|
6,862 |
|
General and administrative expenses |
|
|
(b), |
(c) |
|
|
7,149 |
|
|
|
55 |
|
|
|
(661 |
) |
|
|
6,543 |
|
Patents |
|
|
(c |
) |
|
|
346 |
|
|
|
|
|
|
|
(346 |
) |
|
|
|
|
Fees associated with the collaboration and licensing
agreement |
|
|
(c |
) |
|
|
4,269 |
|
|
|
|
|
|
|
(4,269 |
) |
|
|
|
|
|
Total operating expenses |
|
|
|
|
|
|
34,778 |
|
|
|
98 |
|
|
|
(661 |
) |
|
|
34,215 |
|
|
Results from operating activities |
|
|
|
|
|
|
(15,058 |
) |
|
|
(98 |
) |
|
|
(1,591 |
) |
|
|
(16,747 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
2,252 |
|
|
|
2,252 |
|
Finance costs |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
(661 |
) |
|
|
(661 |
) |
|
Total net finance income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,591 |
|
|
|
1,591 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
(15,058 |
) |
|
|
(98 |
) |
|
|
|
|
|
|
(15,156 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income, net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value of available-for-sale financial assets,
net of tax |
|
|
|
|
|
|
1,039 |
|
|
|
|
|
|
|
|
|
|
|
1,039 |
|
Net change in fair value of available-for-sale financial assets
transferred to net loss, net of tax |
|
|
|
|
|
|
(129 |
) |
|
|
|
|
|
|
|
|
|
|
(129 |
) |
|
Other comprehensive income for the year |
|
|
|
|
|
|
910 |
|
|
|
|
|
|
|
|
|
|
|
910 |
|
|
Total comprehensive income for the year |
|
|
|
|
|
|
(14,148 |
) |
|
|
(98 |
) |
|
|
|
|
|
|
(14,246 |
) |
|
33
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
|
Reconciliation of comprehensive income for the three-month periods ended August 31, 2010 and
2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 31, 2010 |
|
August 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Note |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,884 |
|
|
|
10,884 |
|
Upfront payments
and initial
technology
access fees |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
1,711 |
|
|
|
1,711 |
|
|
|
|
|
|
|
|
|
|
|
1,711 |
|
|
|
1,711 |
|
Royalties and license
fees |
|
|
(c |
) |
|
|
1,717 |
|
|
|
|
|
|
|
(1,711 |
) |
|
|
6 |
|
|
|
12,601 |
|
|
|
|
|
|
|
(12,595 |
) |
|
|
6 |
|
Interest |
|
|
(c |
) |
|
|
435 |
|
|
|
|
|
|
|
(435 |
) |
|
|
|
|
|
|
547 |
|
|
|
|
|
|
|
(547 |
) |
|
|
|
|
|
Total revenue |
|
|
|
|
|
|
2,152 |
|
|
|
|
|
|
|
(435 |
) |
|
|
1,717 |
|
|
|
13,148 |
|
|
|
|
|
|
|
(547 |
) |
|
|
12,601 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
|
|
|
|
120 |
|
|
|
|
|
|
|
|
|
|
|
120 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
expenses, net of
tax credits |
|
|
(b),(c |
) |
|
|
2,482 |
|
|
|
28 |
|
|
|
81 |
|
|
|
2,591 |
|
|
|
5,387 |
|
|
|
31 |
|
|
|
105 |
|
|
|
5,523 |
|
Selling and market
development
expenses |
|
|
(b),(c |
) |
|
|
521 |
|
|
|
3 |
|
|
|
|
|
|
|
524 |
|
|
|
495 |
|
|
|
3 |
|
|
|
|
|
|
|
498 |
|
General and
administrative
expenses |
|
|
(b),(c |
) |
|
|
2,225 |
|
|
|
49 |
|
|
|
(12 |
) |
|
|
2,262 |
|
|
|
1,337 |
|
|
|
11 |
|
|
|
140 |
|
|
|
1,488 |
|
Patents |
|
|
(c |
) |
|
|
81 |
|
|
|
|
|
|
|
(81 |
) |
|
|
|
|
|
|
105 |
|
|
|
|
|
|
|
(105 |
) |
|
|
|
|
|
Total operating expenses |
|
|
|
|
|
|
5,429 |
|
|
|
80 |
|
|
|
(12 |
) |
|
|
5,497 |
|
|
|
7,324 |
|
|
|
45 |
|
|
|
140 |
|
|
|
7,509 |
|
|
Results from operating
activities |
|
|
|
|
|
|
(3,277 |
) |
|
|
(80 |
) |
|
|
(423 |
) |
|
|
(3,780 |
) |
|
|
5,824 |
|
|
|
(45 |
) |
|
|
(687 |
) |
|
|
5,092 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
435 |
|
|
|
435 |
|
|
|
|
|
|
|
|
|
|
|
547 |
|
|
|
547 |
|
Finance costs |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
(12 |
) |
|
|
(12 |
) |
|
|
|
|
|
|
|
|
|
|
140 |
|
|
|
140 |
|
|
Total net finance income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
423 |
|
|
|
423 |
|
|
|
|
|
|
|
|
|
|
|
687 |
|
|
|
687 |
|
|
Net loss |
|
|
|
|
|
|
(3,277 |
) |
|
|
(80 |
) |
|
|
|
|
|
|
(3,357 |
) |
|
|
5,824 |
|
|
|
(45 |
) |
|
|
|
|
|
|
5,779 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income,
net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value
of available-for-sale
financial assets, net of tax |
|
|
|
|
|
|
586 |
|
|
|
|
|
|
|
|
|
|
|
586 |
|
|
|
342 |
|
|
|
|
|
|
|
|
|
|
|
342 |
|
Net change in fair value
of available-for-sale
financial assets
transferred to net loss,
net of tax |
|
|
|
|
|
|
(65 |
) |
|
|
|
|
|
|
|
|
|
|
(65 |
) |
|
|
(48 |
) |
|
|
|
|
|
|
|
|
|
|
(48 |
) |
|
Other comprehensive income
for the period |
|
|
|
|
|
|
521 |
|
|
|
|
|
|
|
|
|
|
|
521 |
|
|
|
294 |
|
|
|
|
|
|
|
|
|
|
|
294 |
|
|
Total comprehensive income
for the period |
|
|
|
|
|
|
(2,756 |
) |
|
|
(80 |
) |
|
|
|
|
|
|
(2,836 |
) |
|
|
6,118 |
|
|
|
(45 |
) |
|
|
|
|
|
|
6,073 |
|
|
34
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
|
Reconciliation of comprehensive income for the nine-month periods ended August 31, 2010 and
2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 31, 2010 |
|
|
August 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Note |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,884 |
|
|
|
10,884 |
|
Upfront payments
and initial
technology
access fees |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
5,134 |
|
|
|
5,134 |
|
|
|
|
|
|
|
|
|
|
|
4,848 |
|
|
|
4,848 |
|
Royalties and license
fees |
|
|
(c |
) |
|
|
5,151 |
|
|
|
|
|
|
|
(5,134 |
) |
|
|
17 |
|
|
|
15,750 |
|
|
|
|
|
|
|
(15,732 |
) |
|
|
18 |
|
Interest |
|
|
(c |
) |
|
|
1,522 |
|
|
|
|
|
|
|
(1,522 |
) |
|
|
|
|
|
|
1,724 |
|
|
|
|
|
|
|
(1,724 |
) |
|
|
|
|
|
Total revenue |
|
|
|
|
|
|
6,673 |
|
|
|
|
|
|
|
(1,522 |
) |
|
|
5,151 |
|
|
|
17,474 |
|
|
|
|
|
|
|
(1,724 |
) |
|
|
15,750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
|
|
|
|
120 |
|
|
|
|
|
|
|
|
|
|
|
120 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
expenses, net of
tax credits |
|
|
(b),(c |
) |
|
|
10,515 |
|
|
|
(44 |
) |
|
|
421 |
|
|
|
10,892 |
|
|
|
16,308 |
|
|
|
64 |
|
|
|
226 |
|
|
|
16,598 |
|
Selling and market
development
expenses |
|
|
(b),(c |
) |
|
|
1,901 |
|
|
|
8 |
|
|
|
|
|
|
|
1,909 |
|
|
|
1,516 |
|
|
|
8 |
|
|
|
4,269 |
|
|
|
5,793 |
|
General and
administrative
expenses |
|
|
(b),(c |
) |
|
|
6,083 |
|
|
|
38 |
|
|
|
(155 |
) |
|
|
5,966 |
|
|
|
5,515 |
|
|
|
70 |
|
|
|
(605 |
) |
|
|
4,980 |
|
Patents |
|
|
(c |
) |
|
|
421 |
|
|
|
|
|
|
|
(421 |
) |
|
|
|
|
|
|
226 |
|
|
|
|
|
|
|
(226 |
) |
|
|
|
|
Other expenses |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
|
|
|
(4,269 |
) |
|
|
|
|
|
Total operating expenses |
|
|
|
|
|
|
19,040 |
|
|
|
2 |
|
|
|
(155 |
) |
|
|
18,887 |
|
|
|
27,834 |
|
|
|
142 |
|
|
|
(605 |
) |
|
|
27,371 |
|
|
Results from operating
activities |
|
|
|
|
|
|
(12,367 |
) |
|
|
(2 |
) |
|
|
(1,367 |
) |
|
|
(13,736 |
) |
|
|
(10,360 |
) |
|
|
(142 |
) |
|
|
(1,120 |
) |
|
|
(11,621 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
1,522 |
|
|
|
1,522 |
|
|
|
|
|
|
|
|
|
|
|
1,724 |
|
|
|
1,724 |
|
Finance costs |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
(155 |
) |
|
|
(155 |
) |
|
|
|
|
|
|
|
|
|
|
(605 |
) |
|
|
(605 |
) |
|
Total net finance income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,367 |
|
|
|
1,367 |
|
|
|
|
|
|
|
|
|
|
|
1,119 |
|
|
|
1,119 |
|
|
Net loss |
|
|
|
|
|
|
(12,367 |
) |
|
|
(2 |
) |
|
|
|
|
|
|
(12,369 |
) |
|
|
(10,360 |
) |
|
|
(142 |
) |
|
|
|
|
|
|
(10,502 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income,
net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value
of available-for-sale
financial assets, net of tax |
|
|
|
|
|
|
(151 |
) |
|
|
|
|
|
|
|
|
|
|
(151 |
) |
|
|
1,327 |
|
|
|
|
|
|
|
|
|
|
|
1,327 |
|
Net change in fair value
of available-for-sale
financial assets transferred
to net loss, net of tax |
|
|
|
|
|
|
(259 |
) |
|
|
|
|
|
|
|
|
|
|
(259 |
) |
|
|
(118 |
) |
|
|
|
|
|
|
|
|
|
|
(118 |
) |
|
Other comprehensive income
for the period |
|
|
|
|
|
|
(410 |
) |
|
|
|
|
|
|
|
|
|
|
(410 |
) |
|
|
1,209 |
|
|
|
|
|
|
|
|
|
|
|
1,209 |
|
|
Total comprehensive income
for the period |
|
|
|
|
|
|
(12,777 |
) |
|
|
(2 |
) |
|
|
|
|
|
|
(12,779 |
) |
|
|
(9,151 |
) |
|
|
(142 |
) |
|
|
|
|
|
|
(9,293 |
) |
|
35
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
|
Material adjustments to the consolidated statement of cash flows for 2010 and 2009: |
|
|
|
There are no material differences between the consolidated statement of cash flows presented
under IFRS and the consolidated statement of cash flows presented under previous Canadian GAAP. |
|
|
|
Notes to the reconciliations: |
|
(a) |
|
Reclassification in the consolidated statement of financial position: |
|
|
|
|
Certain corresponding figures as at December 1, 2008, November 30, 2009, August 31, 2009
and 2010 have been reclassified to conform to the new presentation under IFRS. |
|
|
(b) |
|
Share-based compensation: |
|
|
|
|
In certain situations, stock options granted vest in installments over a specified vesting
period. When the only vesting condition is service from the grant date to the vesting date
of each tranche awarded, then each installment should be accounted for as a separate
share-based payment arrangement under IFRS, otherwise known as graded vesting. Canadian
GAAP permits an entity the accounting policy choice with respect to graded vesting awards.
Each installment can be considered as a separate award, each with a different vesting
period, consistent with IFRS, or the arrangement can be treated as a single award with a
vesting period based on the average vesting period of the installments depending on the
policy elected. |
36
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
(b) |
|
Share-based compensation (continued): |
|
|
|
|
The Companys policy under Canadian GAAP was to treat graded vesting awards under the
latter method and, as a result, an adjustment of $175 was required on the application of
IFRS 2 at the transition date and an adjustment of $98 was required for the restated
November 30, 2009, $142 for August 31, 2009 and ($2) for August 31, 2010 comparative
balances as shown below: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 1, |
|
|
November 30, |
|
|
August 31, |
|
|
August 31, |
|
|
|
2008 |
|
|
2009 |
|
|
2009 |
|
|
2010 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Consolidated statement of comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase in research and development expenses |
|
|
|
|
|
|
33 |
|
|
|
64 |
|
|
|
(44 |
) |
Increase in selling and market development expenses |
|
|
|
|
|
|
10 |
|
|
|
8 |
|
|
|
8 |
|
Increase in general and administrative expenses |
|
|
|
|
|
|
55 |
|
|
|
70 |
|
|
|
38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustment to net loss and total comprehensive loss |
|
|
|
|
|
|
98 |
|
|
|
142 |
|
|
|
2 |
|
|
|
Deficit |
|
|
(175 |
) |
|
|
(273 |
) |
|
|
(317 |
) |
|
|
(275 |
) |
Increase in contributed surplus |
|
|
175 |
|
|
|
273 |
|
|
|
317 |
|
|
|
275 |
|
(c) |
|
Reclassification in the consolidated statement of comprehensive income: |
|
|
|
Under IFRS, the Company elected to present expenses using a classification based on their
function and presents net finance income separately. The effect of these changes is
summarized below: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November 30, |
|
|
August 31, |
|
|
August 31, |
|
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
Decrease in interest |
|
|
(2,252 |
) |
|
|
(1,522 |
) |
|
|
(1,724 |
) |
Increase in finance income |
|
|
2,252 |
|
|
|
1,522 |
|
|
|
1,724 |
|
Increase in research and development expenses |
|
|
346 |
|
|
|
421 |
|
|
|
226 |
|
Decrease in patent fees |
|
|
(346 |
) |
|
|
(421 |
) |
|
|
(226 |
) |
Decrease in general and administrative expenses |
|
|
(661 |
) |
|
|
(155 |
) |
|
|
(605 |
) |
Increase in finance costs |
|
|
661 |
|
|
|
155 |
|
|
|
605 |
|
Increase in selling and market development activities |
|
|
4,269 |
|
|
|
|
|
|
|
4,269 |
|
Decrease in other expenses |
|
|
(4,269 |
) |
|
|
|
|
|
|
(4,269 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Nine-month periods ended August 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
(c) |
|
Reclassification in the consolidated statement of comprehensive income (continued): |
|
|
|
|
Changes in presentation were also made to the revenue caption in order to conform with the
new presentation under IFRS as noted below: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November 30, |
|
|
August 31, |
|
|
August 31, |
|
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
Decrease in royalties and license fees |
|
|
(17,444 |
) |
|
|
(5,134 |
) |
|
|
(15,732 |
) |
Increase in upfront payments and initial technology access fees |
|
|
6,560 |
|
|
|
5,134 |
|
|
|
4,848 |
|
Increase in milestone payments |
|
|
10,884 |
|
|
|
|
|
|
|
10,884 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38
ex-99.13
Exhibit 99.13
EXPLANATORY NOTE
This amended Managements Discussion and Analysis (MD&A) for the three-month and nine-month
periods ended August 31, 2010 and August 31, 2009 reflects the Companys adoption of International
Financial Reporting Standards (''IFRS), as issued by the International Accounting Standards Board
(''IASB). The Company originally filed a MD&A for the three-month and nine-month periods ended
August 31, 2010 and August 31, 2009 on October 12, 2010. That MD&A was based on financial
statements prepared in accordance with generally accepted accounting principles in Canada
(''Canadian GAAP). In the fourth quarter of 2010, the Company filed a request to adopt IFRS two
years in advance of the date required by the Accounting Standards Board. The request was approved
by the regulatory authorities. The Company is filing the amended interim consolidated financial
statements and this amended MD&A to comply with this approval.
This amended MD&A continues to describe conditions, trends results and outlook as of October
12, 2010, which was the date of the original MD&A. Except for the changes related to the Companys
adoption of IFRS, this amended MD&A does not reflect events occurring after October 12, 2010 and
the Company has not modified or updated the discussion and analysis from its original filing.
This amended MD&A and the amended interim consolidated financial statements for the three-month and
nine-month periods periods ended August 31, 2010 and 2009 supersede the Companys original filings
and should be read in conjunction with the consolidated financial statements as at November 30,
2010 and 2009 prepared in accordance with IFRS.
AMENDED MANAGEMENTS DISCUSSION AND ANALYSIS
For the three-month and nine-month periods ended August 31, 2010
The following amended MD&A provides Managements point of view on the financial position and the
results of operations of Theratechnologies Inc. (Theratechnologies or the Company), for the
three-month and nine-month periods ended August 31, 2010, as compared to the three-month and
nine-month periods ended August 31, 2009. This view contains certain factors that the Company
believes may affect its prospective financial condition, cash flows and results of operations. The
amended unaudited interim consolidated financial statements have been prepared in accordance with
International Financial Reporting Standards (IFRS). This amended MD&A should be read in
conjunction with the amended unaudited interim consolidated financial statements of the Company and
the notes thereto as at August 31, 2010, as well as the MD&A and audited consolidated financial
statements including the related notes thereto as at November 30, 2010. Unless specified otherwise,
all amounts are in Canadian dollars.
Financial Overview
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company
targets unmet medical needs in specialty markets where it can retain all or some of the commercial
rights to its products. Its most advanced compound, tesamorelin, is an analogue of the human growth
hormone releasing factor.
The Companys growth strategy is centered upon the development of tesamorelin. In late 2008,
Theratechnologies entered into a collaboration and licensing agreement with EMD Serono, Inc. (EMD
Serono), an affiliate of Merck KGaA, Darmstadt, Germany, for the exclusive commercialization
rights to tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in the United States.
The principal strategic objective of Theratechnologies is to obtain regulatory approval for
tesamorelin in the United States in this indication and good progress was made by participating
in
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
the U.S. Food and Drug Administration (FDA or the Agency) Endocrinologic and Metabolic
Drugs Advisory Committee. On May 27, 2010, the Committee recommended by a 16 to 0 unanimous vote
that tesamorelin be granted marketing approval by the FDA for this indication. Although advisory
committees provide their recommendations, the decision on marketing approval is made by the Agency.
Theratechnologies expects a final decision from the Agency on the approval of tesamorelin in the
United States during the fourth quarter 2010. Should tesamorelin be approved, the Company expects
to receive regulatory milestone payments, royalties and additional milestone payments from sales of
tesamorelin by EMD Serono in the United States.
Concurrent with advancing the regulatory process, Theratechnologies has begun building inventory in
preparation for the launch of tesamorelin in the United States by EMD Serono, upon its approval by
the FDA. In the coming months, the Company will continue building inventory.
Revenues
Consolidated revenues for the three-month period ended August 31, 2010, amounted to $1,717,000
compared to $12,601,000 in 2009. For the nine-month period ended August 31, 2010, consolidated
revenues were $5,151,000 compared to $15,750,000 in 2009. The higher revenues in 2009 are due to
the receipt in the third quarter of a milestone payment of $10,884,000 associated with the FDAs
agreement to review the New Drug Application (NDA) for tesamorelin, pursuant to the collaboration
and licensing agreement with EMD Serono.
The initial payment received upon the closing of the agreement with EMD Serono of $27,097,000 has
been deferred and is being amortized over its estimated service period on a straight-line basis.
This period may be modified in the future based on additional information that the Company may
receive. For the three-month period ended August 31, 2010, an amount of $1,711,000 ($1,711,000 in
2009) was recognized as revenue related to this transaction, while an amount of $5,134,000 was
recognized as revenue related to this transaction for the nine-month period ($4,848,000 in 2009).
At August 31, 2010, the deferred revenues related to this transaction recorded on the balance sheet
amounted to $15,403,000.
Cost of Sales
In the third quarter of 2010, the company began producing inventories in anticipation of the launch
of tesamorelin in the United States. The cost of sales related to this production totaled $120,000.
There were no costs related to the production of tesamorelin in the corresponding period of 2009.
R&D Activities
Research and development (R&D) expenses net of tax credits, totaled $2,591,000 for the third
quarter of 2010, compared to $5,523,000 in 2009. For the nine-month period ended August 31, 2010,
R&D expenses were $10,892,000 compared to $16,598,000 in 2009, a decrease of 34.4%. The R&D
expenses incurred in the third quarter of 2010 are mainly related to the pursuit of the regulatory
filing for tesamorelin with the FDA. The expenses incurred in the third quarter of 2009, in
addition to expenses related to the pursuit of the regulatory filing described above, included a
non-recurring charge of $1,395,000 related to a write-down of research supplies produced in order
to obtain stability data and to validate the manufacturing process for commercial purposes, as
required by the FDA. The expenses incurred in the nine-month period ended August 31, 2009, also
included costs associated with completing the Phase 3 clinical trials evaluating tesamorelin in
HIV-associated lipodystrophy.
Selling and Market Development Expenses
Selling and market development expenses amounted to $524,000 for the third quarter of 2010,
compared to $498,000 in 2009. For the nine-month period ended August 31, 2010, selling and market
development expenses amounted to $1,909,000, compared to $5,793,000 in 2009. The 2010 selling and
market development expenses are principally composed of business development and market research
outside the United States and the costs of managing the agreement with EMD Serono. In 2009, the
Company incurred first-quarter expenses totalling $4,269,000 in connection with professional fees
related to the transaction with EMD Serono.
2
General and Administrative Expenses
For the third quarter of 2010, general and administrative expenses amounted to $2,262,000 compared
to $1,488,000 in 2009. For the nine-month period ended August 31, 2010, general and administrative
expenses amounted to $5,966,000 compared to $4,980,000 in 2009. The higher expenses in the third
quarter of 2010 are principally due to professional fees associated with the recruitment of the new
President and Chief Executive Officer and variations in stock-based compensation expenses. In
addition, higher expenses in the nine-month period reflect increased corporate communication
activities associated with the FDA Advisory Committee meeting as well as an increase in other
administrative expenses. The expenses for the nine-month period in 2009 include costs associated
with revising the Companys business plan.
Net Financial Income
Finance income in the third quarter of 2010 amounted to $435,000 compared to $547,000 in 2009.
Finance income in the nine-months ended August 31, 2010 was $1,522,000 compared to $1,724,000 in
2009. The year-over-year declines are due to lower average cash positions and a decrease in yield
on our bond portfolio. Finance costs are largely a function of exchange rate fluctuations. In the
third quarter of 2010 finance costs were $12,000 compared to a gain of $140,000 in 2009. Finance
costs in the nine-month period ended August 31, 2010 were $155,000 compared to $605,000 in 2009.
The higher finance costs in 2009 include a first-quarter exchange loss of $416,000 incurred upon
the conversion of the initial payment from EMD Serono to Canadian dollars.
Net Results
Reflecting the changes in revenues and expenses described above, the Company recorded a third
quarter net loss of $3,357,000 ($0.06per share) compared to net earnings of $5,779,000 ($0.10 per
share) in 2009. For the nine-month period ended August 31, 2010, the net loss was $12,369,000
($0.20 per share) compared to a net loss of $10,502,000 (0.17 per share) in 2009.
Quarterly Financial Information
The selected financial information provided below is derived from the Companys unaudited quarterly
financial statements for each of the last eight quarters.
(in thousands of Canadian dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
2008(1) |
|
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
|
|
|
|
amended |
|
|
amended |
|
|
amended |
|
|
amended |
|
|
amended |
|
|
amended |
|
|
amended |
|
|
Q4 |
|
|
Revenues |
|
$ |
1,717 |
|
|
$ |
1,717 |
|
|
$ |
1,717 |
|
|
$ |
1,718 |
|
|
$ |
12,601 |
|
|
$ |
1,717 |
|
|
$ |
1,432 |
|
|
$ |
616 |
|
Net (loss) earnings |
|
$ |
(3,357 |
) |
|
$ |
(4,771 |
) |
|
$ |
(4,241 |
) |
|
$ |
(4,654 |
) |
|
$ |
5,779 |
|
|
$ |
(5,454 |
) |
|
$ |
(10,827 |
) |
|
$ |
(15,145 |
) |
Basic and diluted
(loss) earnings per
share |
|
$ |
(0.06 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.08 |
) |
|
$ |
0.10 |
|
|
$ |
(0.09 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.26 |
) |
|
|
|
|
(1) |
|
Theratechnologies adopted IFRS in fiscal 2010 with a transition date of
December 1, 2008. Consequently, the selected financial information for the year ended
November 30, 2008, as presented in our 2009 Audited Consolidated Financial Statements, which were
presented in conformity with Canadian GAAP, was not restated in accordance with IFRS and
accordingly, is not comparable with the information for fiscal 2010 and 2009. |
As described above, the increased revenues in 2010 and 2009 are related to the amortization of the
initial payment received at the closing of the agreement with EMD Serono, as well as the milestone
payment of $10,884,000 recorded in August 2009. The increase in the fourth quarter net loss in 2008
is due to impairment charges for intellectual property.
Financial Position
At August 31, 2010, cash and bonds amounted to $43,419,000, and tax credits and grants receivable
amounted to $181,000, for a total of $43,600,000.
3
For the three-month period ended August 31, 2010, cash used for operating activities, excluding
changes in operating assets and liabilities, was $2,629,000, compared to a cash flow of $6,185,000
in 2009. For the nine-month period ending August 31, 2010, cash used for operating activities,
excluding changes in operating assets and liabilities, was $10,877,000 compared to $9,214,000 in
2009.
Contingency
On July 26, 2010, the Company received a motion of authorization to institute a class action
against the Company and certain of its executive officers (the Motion). The Motion was filed in
the Superior Court of Quebec, district of Montreal. The applicant is seeking to initiate a class
action suit to represent the class of persons who were shareholders at May 21, 2010 and who sold
their common shares of the Company on May 25 or 26, 2010. This applicant alleges that the Company
did not comply with its continuous disclosure obligations as a reporting issuer by failing to
disclose a material change. The Company is of the view that the allegations contained in the motion
are entirely without merit and intends to take all appropriate actions to vigorously defend its
position. As of October 11, 2010, the motion has not yet been heard by the Superior Court of
Quebec.
Subsequent events
Except for changes related to the Companys adoption of IFRS, this amended MD&A does not reflect
events occurring after October 12, 2010, the date of the filing of the MD&A prepared in accordance
with Canadian GAAP. The annual MD&A of the Company prepared in accordance with IFRS has been filed
concurrently with this amended MD&A. This amended MD&A should be read in conjunction with the
November 30, 2010 annual financial statements and the related MD&A for additional disclosures with
respect to subsequent events.
Transition to IFRS
The Company has applied IFRS 1 and the accounting policies set out in note 3 in preparing the
financial statements for the period ended August 31, 2010, the comparative information for the
period ended August 31, 2009, for the year ended November 30, 2009, and for the opening IFRS
statement of financial position as at December 1, 2008 (the Companys date of transition).
In preparing these interim consolidated financial statements in accordance with IFRS 1, the Company
has applied the mandatory exceptions and certain of the optional exemptions from full retrospective
application of IFRS.
The Company elected to apply the following optional exemptions from full retrospective application:
(i) |
|
Share-based payment transaction exemption: |
|
|
|
The Company has elected to apply the share-based payment exemption. It applied IFRS 2 from
December 1, 2008 to those stock options that were issued after November 7, 2002 but that
had not vested by December 1, 2008. The application of the exemption is detailed below. |
|
(ii) |
|
Designation of financial assets and financial liabilities exemption: |
|
|
|
The Company elected to re-designate cash from the held for trading category to loans and
receivables. |
As required by IFRS 1, estimates made under IFRS at the date of transition must be consistent with
estimates made for the same date under previous GAAP, unless there is evidence that those estimates
were in error.
4
In preparing its opening IFRS consolidated statement of financial position, the Company has
adjusted amounts reported previously in financial statements prepared in accordance with Canadian
GAAP.
An explanation of how the transition from previous Canadian GAAP to IFRS has affected the Companys
financial position, financial performance and cash flows is set out in note 8 of the amended
unaudited interim consolidated financial statements for the periods ended August 31, 2010 and 2009.
Outstanding Share Data
On October 8, 2010, the number of shares issued and outstanding was 60 511 598 while outstanding
options granted under the stock option plan were 2 853 638.
Contractual Obligations
There were no material changes in contractual obligations during the quarter, other than in the
ordinary course of business.
Economic and Industry Factors
Economic and industry factors were substantially unchanged from those reported in the Companys
2009 Annual Report.
Forward-Looking Information
This MD&A for the third quarter contains certain statements that are considered forward-looking
information within the meaning of applicable securities legislation. This forward-looking
information includes, but is not limited to, information regarding the approval of tesamorelin for
the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy by the FDA, the
receipt of milestone payments and/or royalties under the agreement entered into with EMD Serono,
the potential decrease in the adjusted burn rate, and the completion of a conversion plan to IFRS.
Furthermore, the words will, may, could, should, outlook, believe, plan, envisage,
anticipate, expect and estimate, or variations of them denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties include, but are not limited to, the risk that the FDA
does not approve tesamorelin for the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy, the risk that the payment of milestones is delayed or not received or that the
royalties from the sale of tesamorelin are not received, and the risk that unexpected expenses
increase the adjusted burn rate.
Although the forward-looking information contained herein is based upon what the Company believes
are reasonable assumptions, investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking information. Certain assumptions
made in preparing the forward-looking information and the Companys objectives include the
assumption, among others, that the FDA will approve tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy, sales of tesamorelin in the United
States will be successful, and unexpected expenses will not result in an adjusted burn rate
increase.
Consequently, the forward-looking information is qualified by the foregoing cautionary statements,
and there can be no guarantee that the results or developments anticipated by the Company will be
realized or, even if substantially realized, that they will have the expected consequences or
effects on the Company, its business, its financial condition or its results of operations.
Furthermore, the forward-looking information reflects current expectations regarding future events
only as of the date of release of this MD&A.
5
Investors are referred to the Companys public filings available at www.sedar.com. In particular,
further details on the risks and descriptions of the risks are disclosed in the Risks and
Uncertainties section of the Companys Annual Information Form, dated February 23, 2010, for the
year ended November 30, 2009. This MD&A is dated October 12, 2010, and has been approved by the
Audit Committee.
6
ex-99.14
Exhibit 99.14
Consolidated Financial Statements of
(Unaudited)
THERATECHNOLOGIES INC.
Nine-month periods ended August 31, 2010 and 2009
THERATECHNOLOGIES INC.
Consolidated Financial Statements
(Unaudited)
Periods ended August 31, 2010 and 2009
|
|
|
|
|
Financial Statements |
|
|
|
|
Consolidated Balance Sheets |
|
|
1 |
|
Consolidated Statements of Operations |
|
|
2 |
|
Consolidated Statements of Comprehensive Loss |
|
|
3 |
|
Consolidated Statements of Shareholders Equity |
|
|
4-5 |
|
Consolidated Statements of Cash Flows |
|
|
6 |
|
Notes to Consolidated Financial Statements |
|
|
7 |
|
THERATECHNOLOGIES INC.
Consolidated Balance Sheets
(Unaudited)
August 31, 2010 and November 30, 2009
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
August 31, |
|
|
November 30, |
|
|
|
2010 |
|
|
2009 |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
2,370 |
|
|
$ |
1,519 |
|
Bonds |
|
|
1,694 |
|
|
|
10,036 |
|
Accounts receivable |
|
|
131 |
|
|
|
375 |
|
Tax credits receivable |
|
|
514 |
|
|
|
1,666 |
|
Inventories |
|
|
4,585 |
|
|
|
2,225 |
|
Research supplies |
|
|
283 |
|
|
|
287 |
|
Prepaid expenses |
|
|
680 |
|
|
|
302 |
|
|
|
|
|
10,257 |
|
|
|
16,410 |
|
|
Bonds |
|
|
39,355 |
|
|
|
51,807 |
|
Property and equipment |
|
|
1,106 |
|
|
|
1,229 |
|
Other assets |
|
|
41 |
|
|
|
41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
50,759 |
|
|
$ |
69,487 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
3,823 |
|
|
$ |
5,901 |
|
Current portion of deferred revenues (note 7) |
|
|
6,849 |
|
|
|
6,847 |
|
|
|
|
|
10,672 |
|
|
|
12,748 |
|
|
Deferred revenues (note 7) |
|
|
8,557 |
|
|
|
13,691 |
|
Deferred lease inducements |
|
|
167 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Capital stock (note 3) |
|
|
279,389 |
|
|
|
279,169 |
|
Contributed surplus |
|
|
7,356 |
|
|
|
6,484 |
|
|
|
|
|
|
|
|
|
|
Accumulated other comprehensive income |
|
|
872 |
|
|
|
1,282 |
|
Deficit |
|
|
(256,254 |
) |
|
|
(243,887 |
) |
|
|
|
|
(255,382 |
) |
|
|
(242,605 |
) |
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
31,363 |
|
|
|
43,048 |
|
|
|
|
|
|
|
|
|
|
Contingency (note 4) |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
50,759 |
|
|
$ |
69,487 |
|
|
See accompanying notes to unaudited consolidated financial statements.
1
THERATECHNOLOGIES INC.
Consolidated Statement of Operations
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 31, |
|
|
August 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
(3 months) |
|
|
(9 months) |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalties, technologies
and other (note 7) |
|
$ |
1,717 |
|
|
$ |
12,601 |
|
|
$ |
5,151 |
|
|
$ |
15,750 |
|
Interest |
|
|
435 |
|
|
|
547 |
|
|
|
1,522 |
|
|
|
1,724 |
|
|
|
|
|
2,152 |
|
|
|
13,148 |
|
|
|
6,673 |
|
|
|
17,474 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
2,930 |
|
|
|
5,681 |
|
|
|
11,298 |
|
|
|
17,692 |
|
Tax credits |
|
|
(448 |
) |
|
|
(294 |
) |
|
|
(783 |
) |
|
|
(1,384 |
) |
|
|
|
|
2,482 |
|
|
|
5,387 |
|
|
|
10,515 |
|
|
|
16,308 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
2,225 |
|
|
|
1,337 |
|
|
|
6,083 |
|
|
|
5,515 |
|
Cost of Sales |
|
|
120 |
|
|
|
|
|
|
|
120 |
|
|
|
|
|
Selling and market
development |
|
|
521 |
|
|
|
495 |
|
|
|
1,901 |
|
|
|
1,516 |
|
Patents |
|
|
81 |
|
|
|
105 |
|
|
|
421 |
|
|
|
226 |
|
Fees associated with
collaboration and
licensing agreement
(note 7) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
|
5,429 |
|
|
|
7,324 |
|
|
|
19,040 |
|
|
|
27,834 |
|
|
|
(Net loss) net earnings |
|
$ |
(3,277 |
) |
|
$ |
5,824 |
|
|
$ |
(12,367 |
) |
|
$ |
(10,360 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted (loss)
earnings per share
(note 3 (d)) |
|
$ |
(0.05 |
) |
|
$ |
0.10 |
|
|
$ |
(0.20 |
) |
|
$ |
(0.17 |
) |
|
See accompanying notes to unaudited consolidated financial statements.
2
THERATECHNOLOGIES INC.
Consolidated Statements of Comprehensive Loss
(Unaudited)
Periods ended August 31, 2010 and 2009
(In thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 31, |
|
|
August 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
(3 months) |
|
|
(9 months) |
|
(Net loss) net earnings |
|
$ |
(3,277 |
) |
|
$ |
5,824 |
|
|
$ |
(12,367 |
) |
|
$ |
(10,360 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains (losses) on
available-for-sale financial
assets |
|
|
586 |
|
|
|
342 |
|
|
|
(151 |
) |
|
|
1,327 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification adjustment
for gains and losses on
available-for-sale financial
assets |
|
|
(65 |
) |
|
|
(48 |
) |
|
|
(259 |
) |
|
|
(118 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive (loss)
earnings |
|
$ |
(2,756 |
) |
|
$ |
6,118 |
|
|
$ |
(12,777 |
) |
|
$ |
(9,151 |
) |
|
See accompanying notes to unaudited consolidated financial statements.
3
THERATECHNOLOGIES INC.
Consolidated Statements of Shareholders Equity
(Unaudited)
Nine-month period ended August 31, 2010
(In thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
compre- |
|
|
|
|
|
|
|
|
|
Capital stock |
|
|
Contributed |
|
|
hensive |
|
|
|
|
|
|
|
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
income |
|
|
Deficit |
|
|
Total |
|
|
Balance, November 30, 2009 |
|
|
60,429,393 |
|
|
$ |
279,169 |
|
|
$ |
6,484 |
|
|
$ |
1,282 |
|
|
$ |
(243,887 |
) |
|
$ |
43,048 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of share capital (note 3) |
|
|
2,880 |
|
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash proceeds |
|
|
77,493 |
|
|
|
128 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
128 |
|
Ascribed value |
|
|
|
|
|
|
77 |
|
|
|
(77 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
949 |
|
|
|
|
|
|
|
|
|
|
|
949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,367 |
) |
|
|
(12,367 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains on available-for-
sale financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(410 |
) |
|
|
|
|
|
|
(410 |
) |
|
|
Balance, August 31, 2010 |
|
|
60,509,766 |
|
|
$ |
279,389 |
|
|
$ |
7,356 |
|
|
$ |
872 |
|
|
$ |
(256,254 |
) |
|
$ |
31,363 |
|
|
See accompanying notes to unaudited consolidated financial statements.
4
THERATECHNOLOGIES INC.
Consolidated Statements of Shareholders Equity, Continued
(Unaudited)
Nine-month period ended August 31, 2009
(In thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
compre- |
|
|
|
|
|
|
|
|
|
Capital stock |
|
|
Contributed |
|
|
hensive |
|
|
|
|
|
|
|
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
income |
|
|
Deficit |
|
|
Total |
|
|
Balance, November 30, 2008 |
|
|
58,215,090 |
|
|
$ |
269,219 |
|
|
$ |
5,585 |
|
|
$ |
372 |
|
|
$ |
(228,230 |
) |
|
$ |
46,946 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of share capital
(note 2 (a)) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(599 |
) |
|
|
(599 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share issue costs
(notes 3 and 7) |
|
|
2,182,387 |
|
|
|
9,861 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,861 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
705 |
|
|
|
|
|
|
|
|
|
|
|
705 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,360 |
) |
|
|
(10,360 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains on available-
for-sale financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,209 |
|
|
|
|
|
|
|
1,209 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, August 31, 2009 |
|
|
60,397,477 |
|
|
$ |
279,080 |
|
|
$ |
6,290 |
|
|
$ |
1,581 |
|
|
$ |
(239,189 |
) |
|
$ |
47,762 |
|
|
See accompanying notes to unaudited consolidated financial statements.
5
THERATECHNOLOGIES INC.
Consolidated Statements of Cash Flows
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 31, |
|
|
August 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
(3 months) |
|
|
(9 months) |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,277 |
) |
|
$ |
5,824 |
|
|
$ |
(12,367 |
) |
|
$ |
(10,360 |
) |
Adjustments for: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of property
and equipment |
|
|
92 |
|
|
|
157 |
|
|
|
374 |
|
|
|
441 |
|
Lease inducements
and amortization |
|
|
125 |
|
|
|
|
|
|
|
167 |
|
|
|
|
|
Stock-based compensation |
|
|
431 |
|
|
|
205 |
|
|
|
949 |
|
|
|
705 |
|
|
|
|
|
(2,629 |
) |
|
|
6,186 |
|
|
|
(10,877 |
) |
|
|
(9,214 |
) |
Changes in operating assets
and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest receivable on bonds |
|
|
317 |
|
|
|
74 |
|
|
|
696 |
|
|
|
(728 |
) |
Accounts receivable |
|
|
45 |
|
|
|
56 |
|
|
|
244 |
|
|
|
415 |
|
Tax credits receivable |
|
|
1,488 |
|
|
|
(293 |
) |
|
|
1,152 |
|
|
|
(1,383 |
) |
Inventories |
|
|
(89 |
) |
|
|
|
|
|
|
(2,360 |
) |
|
|
(1,594 |
) |
Research supplies |
|
|
(12 |
) |
|
|
1,797 |
|
|
|
4 |
|
|
|
2,023 |
|
Prepaid expenses |
|
|
(17 |
) |
|
|
(200 |
) |
|
|
(378 |
) |
|
|
(326 |
) |
Accounts payable and
accrued liabilities |
|
|
(3,216 |
) |
|
|
(922 |
) |
|
|
(1,950 |
) |
|
|
(2,590 |
) |
Deferred revenues |
|
|
(1,714 |
) |
|
|
(1,715 |
) |
|
|
(5,132 |
) |
|
|
22,252 |
|
|
|
|
|
(3,198 |
) |
|
|
(1,203 |
) |
|
|
(7,724 |
) |
|
|
18,069 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,827 |
) |
|
|
4,983 |
|
|
|
(18,601 |
) |
|
|
8,855 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share issuance |
|
|
37 |
|
|
|
|
|
|
|
143 |
|
|
|
9,861 |
|
Share issue costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8 |
) |
|
|
|
|
37 |
|
|
|
|
|
|
|
143 |
|
|
|
9,853 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions to property and
equipment |
|
|
(43 |
) |
|
|
(55 |
) |
|
|
(379 |
) |
|
|
(290 |
) |
Acquisition of bonds |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(19,631 |
) |
Disposal of bonds |
|
|
4,706 |
|
|
|
3,963 |
|
|
|
19,688 |
|
|
|
13,805 |
|
|
|
|
|
4,663 |
|
|
|
3,908 |
|
|
|
19,309 |
|
|
|
(6,116 |
) |
|
|
Net (decrease) increase in cash |
|
|
(1,127 |
) |
|
|
8,891 |
|
|
|
851 |
|
|
|
12,592 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, beginning of period |
|
|
3,497 |
|
|
|
3,834 |
|
|
|
1,519 |
|
|
|
133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, end of period |
|
$ |
2,370 |
|
|
$ |
12,725 |
|
|
$ |
2,370 |
|
|
$ |
12,725 |
|
|
See note 5 (a) for supplemental cash flow information.
See accompanying notes to unaudited consolidated financial statements.
6
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
1. |
|
Basis of presentation: |
|
|
The financial statements included in this report are unaudited and reflect normal and recurring
adjustments which are, in the opinion of the Company, considered necessary for a fair
presentation of its results. These financial statements have been prepared in conformity with
Canadian generally accepted accounting principles (GAAP). The same accounting policies as
described in the Companys latest annual report have been used. However, these financial
statements do not include all disclosures required under GAAP and, accordingly, should be read
in connection with the financial statements and the notes thereto included in the Companys
latest annual report. These interim financial statements have not been reviewed by the
auditors. |
2. |
|
New accounting policies: |
|
(a) |
|
Adoption of new accounting standards: |
|
|
|
Goodwill and intangible assets |
|
|
|
|
Effective with the commencement of its 2009 fiscal year, the Company adopted the Canadian
Institute of Chartered Accountants (CICA) Handbook Section 3064, Goodwill and
Intangible Assets, which will replace Section 3062, Goodwill and Other Intangible Assets,
and Section 3450, Research and Development Costs. The standard provides guidance on the
recognition of intangible assets in accordance with the definition of an asset and the
criteria for asset recognition, whether these assets are separately acquired or internally
developed. The impact of adopting this standard has been to increase the opening deficit
and to reduce other assets as at December 1, 2008 by $599, which is the amount of patent
costs related to periods prior to these dates. |
|
|
|
|
Lease inducements |
|
|
|
|
Lease inducements arising from leasehold improvements allowance and rent-free inducements
received are deferred and amortized over the term of the lease on a straight-line basis. |
7
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
2. |
|
New accounting policies (continued): |
|
(b) |
|
Future accounting changes: |
|
|
|
|
International Financial Reporting Standards |
|
|
|
|
In February 2008, the Accounting Standards Board of Canada (AcSB) announced that
accounting standards in Canada, as used by public companies, will converge with
International Financial Reporting Standards (IFRS), for financial periods beginning on
and after January 1, 2011 with the option to early adopt IFRS upon receipt of approval from
the Canadian Securities regulatory authorities. |
|
|
|
|
The Companys mandatory changeover from current Canadian GAAP to IFRS applies to the fiscal
year beginning December 1, 2011. However, the Company plans to file an exemption with the
Canadian securities regulatory authorities to early adopt IFRS beginning December 1, 2009,
the change over date. The Company intends to file its November 30, 2010 financial
statements under IFRS with December 1, 2008 being the proposed transition date. Should the
exemption be granted, the comparative annual period for fiscal 2009 will be restated under
IFRS as will all quarterly filings for 2009 and 2010. |
|
|
During the second quarter of 2010, the Company received subscriptions in the amount of $15 ($7
for the same period in 2009) for the issue of 2,880 common shares (2,550 for the same period in
2009) in connection with its share purchase plan. |
|
(a) |
|
Shareholder rights plan: |
|
|
|
|
On February 10, 2010, the Board of Directors of the Company adopted a shareholder rights
plan (the Plan), effective as of such date. The Plan is designed to provide adequate
time for the Board of Directors, and the shareholders, to assess an unsolicited takeover
bid for the Company. In addition, the Plan provides the Board of Directors with sufficient
time to explore and develop alternatives for maximizing shareholder value if a takeover bid
is made, as well as provide shareholders with an equal opportunity to participate in a
takeover bid and receive full and fair value for their common shares (the Common Shares).
The Plan, if approved by the shareholders, will expire at the close of the Companys annual
meeting of shareholders in 2013. |
8
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
3. |
|
Capital stock (continued): |
|
(a) |
|
Shareholder rights plan (continued): |
|
|
|
|
The rights issued under the Plan will initially attach to and trade with the Common Shares
and no separate certificates will be issued unless an event triggering these rights occurs.
The rights will become exercisable only when a person, including any party related to it,
acquires or attempts to acquire 20% or more of the outstanding Common Shares without
complying with the Permitted Bid provisions of the Plan or without approval of the
Board of Directors. Should such an acquisition occur or be announced, each right would,
upon exercise, entitle a rights holder, other than the acquiring person and related
persons, to purchase Common Shares at a 50% discount to the market price at the time. |
|
|
|
|
Under the Plan, a Permitted Bid is a bid made to all holders of the Common Shares and which
is open for acceptance for no less than 60 days. If, at the end of the 60-day period, at
least 50% of the outstanding Common Shares, other than those owned by the offeror and
certain related parties, have been tendered, the offeror may take up and pay for the Common
Shares but must extend the bid for a further 10 days to allow other shareholders to tender. |
|
|
(b) |
|
Stock option plan: |
|
|
|
|
Changes in outstanding options granted under the Companys stock option plan for the year
ended November 30, 2009 and the nine-month period ended August 31, 2010 were as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
|
|
|
|
exercise price |
|
|
|
Number |
|
|
per share |
|
|
Options as at November 30, 2008 |
|
|
2,161,800 |
|
|
$ |
6.52 |
|
|
Granted |
|
|
680,500 |
|
|
|
1.83 |
|
Cancelled and expired |
|
|
(176,500 |
) |
|
|
8.34 |
|
|
|
Options as at November 30, 2009 |
|
|
2,665,800 |
|
|
|
5.20 |
|
|
Granted |
|
|
335,000 |
|
|
|
4.03 |
|
Cancelled and expired |
|
|
(60,337 |
) |
|
|
6.32 |
|
Exercised |
|
|
(77,493 |
) |
|
|
1.65 |
|
|
|
Options as at August 31, 2010 |
|
|
2,862,970 |
|
|
$ |
5.14 |
|
|
9
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
3. |
|
Capital stock (continued): |
|
(c) |
|
Stock-based compensation and other stock-based payments: |
|
|
|
|
The estimated fair value of the options granted was estimated at the date of grant using
the Black-Scholes option pricing model with the following weighted average assumptions: |
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
Risk-free interest rate |
|
|
2.49 |
% |
|
|
1.80 |
% |
Volatility |
|
|
81 |
% |
|
|
79 |
% |
Average option life in years |
|
|
6 |
|
|
|
6 |
|
Dividend yield |
|
Nil |
|
|
Nil |
|
|
|
|
|
The risk-free interest rate is based on the implied yield on a Canadian Treasury
zero-coupon issue with a remaining term equal to the expected term of the option. The
volatility is based solely on historical volatility equal to the expected term of the
option. The average life of the options is estimated considering the vesting period, the
term of the option and the length of time that similar grants have remained outstanding in
the past. Dividend yield was excluded from the calculation, since it is the present policy
of the Company not to retain in cash in order to keep funds available to finance the
Companys growth. |
|
|
|
|
The following table summarizes the weighted average fair value of stock options granted
during the periods ended August 31, 2010 and 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average |
|
|
|
Number of |
|
|
grant-date |
|
Periods ended August 31 (9 months) |
|
options |
|
|
fair value |
|
|
2010 |
|
|
335,000 |
|
|
$ |
2.83 |
|
2009 |
|
|
660,500 |
|
|
|
1.24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average |
|
|
|
Number of |
|
|
grant-date |
|
Periods ended August 31 (3 months) |
|
options |
|
|
fair value |
|
|
2010 |
|
|
70,000 |
|
|
$ |
3.36 |
|
2009 |
|
|
|
|
|
|
|
|
|
10
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
3. |
|
Capital stock (continued): |
|
(d) |
|
Diluted (loss) earnings per share: |
|
|
|
|
The following table presents a reconciliation between basic and diluted (loss) earnings per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 31, |
|
|
August 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
(3 months) |
|
|
(9 months) |
|
Basic (loss) earnings per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted
average number of common
shares outstanding |
|
|
60,502,515 |
|
|
|
60,397,477 |
|
|
|
60,469,621 |
|
|
|
60,284,591 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic (loss) earnings
per share |
|
$ |
(0.05 |
) |
|
$ |
0.10 |
|
|
$ |
(0.20 |
) |
|
$ |
(0.17 |
) |
|
Diluted (loss) earnings
per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted
average number of
common shares
outstanding |
|
|
60,502,515 |
|
|
|
60,397,477 |
|
|
|
60,469,621 |
|
|
|
60,284,591 |
|
Plus impact of
stock options |
|
|
|
|
|
|
237,498 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted weighted
average number
of common shares
outstanding |
|
|
60,502,515 |
|
|
|
60,634,975 |
|
|
|
60,469,621 |
|
|
|
60,284,591 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted (loss) earnings
per share |
|
$ |
(0.05 |
) |
|
$ |
0.10 |
|
|
$ |
(0.20 |
) |
|
$ |
(0.17 |
) |
|
11
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
|
|
On July 26, 2010, the Company received a motion of authorization to institute a class action
against the Company and certain of its executive officers (the Motion). This Motion was filed
in the Superior Court of Quebec, district of Montreal. The applicant is seeking to initiate a
class action suit to represent the class of persons who were shareholders at May 21, 2010 and
who sold their common shares of the Company on May 25 or 26, 2010. This applicant alleges that
the Company did not comply with its continuous disclosure obligations as a reporting issuer by
failing to disclose a material change. The Company is of the view that the allegations
contained in the Motion are frivolous and entirely without merit and intends to take all
appropriate actions to vigorously defend its position. |
|
|
As of October 11, 2010, the Motion has not yet been heard by the Superior Court of Quebec. |
|
|
The Company subscribed insurances covering the responsibility of its administrators and
officers in the exercise of their functions. |
5. |
|
Supplemental information: |
|
(a) |
|
The following transactions were conducted by the Company and did not impact cash
flows: |
|
|
|
|
|
|
|
|
|
|
|
August 31, |
|
|
November 30, |
|
|
|
2010 |
|
|
2009 |
|
|
Additions to property and equipment included in
accounts payable and accrued liabilities |
|
$ |
55 |
|
|
$ |
183 |
|
|
|
(b) |
|
For the nine-month period ended August 31, 2010, the Company has reclassified in net
loss $259 of realized gains on available-for-sale financial assets previously recorded in
accumulated other comprehensive income ($118 in 2009). |
|
|
|
|
On August 31, 2010, the accumulated other comprehensive loss was composed of unrealized
gains on available-for-sale financial assets of $872 (gains of $1,282 on November 30,
2009). |
12
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
5. |
|
Supplemental information (continued): |
|
(c) |
|
For the periods ended August 31, 2010 and 2009, the following items were included in
the determination of the Companys net loss: |
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
Amortization of property and equipment |
|
$ |
374 |
|
|
$ |
441 |
|
Stock-based compensation |
|
|
949 |
|
|
|
705 |
|
|
6. |
|
Financial instruments: |
|
(a) |
|
Carrying value and fair value: |
|
|
|
|
The Company has determined that the carrying values of its short-term financial assets and
liabilities, including cash, accounts receivable, as well as accounts payable and accrued
liabilities, approximate their fair value because of the relatively short period to
maturity of these instruments. |
|
|
|
|
Bonds and investments in public companies are stated at estimated fair value, determined by
inputs that are directly observable. |
|
|
(b) |
|
Interest income and expenses: |
|
|
|
|
Interest income consists of interest earned on cash and
bonds.
|
|
|
(c) |
|
Loss on exchange: |
|
|
|
|
General and administrative expenses include a loss on foreign exchange of $144 ($580 in
2009) for the nine-month period ended August 31, 2010. |
7. |
|
Collaboration and licensing agreement: |
|
|
On October 28, 2008, the Company entered into a collaboration and licensing agreement with EMD
Serono, Inc. (EMD Serono), an affiliate of Merck KGaA, of Darmstadt, Germany,
regarding the exclusive commercialization rights of tesamorelin in the United States for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy (the Initial
Product). The Company retains all tesamorelin commercialization rights outside of the United
States. |
13
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
7. |
|
Collaboration and licensing agreement (continued): |
|
|
Under the terms of the agreement, the Company is responsible for the development of the Initial
Product up to obtaining marketing approval in the United States. The Company is also
responsible for product production and for the development of a new formulation of the initial
product. EMD Serono is responsible for conducting product commercialization activities. |
|
|
At the closing of the agreement, on December 15, 2008, the Company received US$30,000
(CAD$36,951), which includes an initial payment of US$22,000 (CAD$27,097) and US$8,000
(CAD$9,854) as a subscription for common shares in the Company by Merck KGaA at a price of
US$3.67 (CAD$4.52) per share. The Company may receive up to US$215,000, which amount includes
the initial payment of US$22,000, the equity investment of US$8,000, as well as payments based
on the achievement of certain development, regulatory and sales milestones. The Company will
also be entitled to receive increasing royalties on annual net sales of tesamorelin in the
United States, if applicable. |
|
|
The initial payment of $27,097 has been deferred and is being amortized over its estimated
service period on a straight-line basis. This period may be modified in the future based on
additional information that may be received by the Company. For the nine-month period ended
August 31, 2010, an amount of $5,134 related to this transaction was recognized as revenue. At
August 31, 2010, the deferred revenues related to this transaction amounted to $15,403. |
|
|
On August 12, 2009, the US Food and Drug Administration accepted the New Drug Application
(NDA) made by the Company for tesamorelin. Under the terms of the Companys Collaboration and
Licensing Agreement with EMD Serono, the acceptance of the tesamorelin NDA resulted in a
milestone payment of US$10,000 (CAD$10,884). This milestone payment has been recorded in the
third quarter of 2009. |
|
|
The Company may conduct research and development for additional indications. Under the
Collaboration and Licensing Agreement, EMD Serono will have the option to commercialize
additional indications for tesamorelin in the United States. If it exercises this option, EMD
Serono will pay half of the development costs related to such additional indications. In such
cases, the Company will also have the right, subject to EMD Seronos agreement, to participate
in the promotion of the additional indications. |
14
ex-99.15
Exhibit 99.15
EXPLANATORY NOTE
This amended Managements Discussion and Analysis (''MD&A) for the three-month and six-month
periods ended May 31, 2010 and May 31, 2009 reflects the Companys adoption of International
Financial Reporting Standards (''IFRS), as issued by the International Accounting Standards Board
(''IASB). The Company originally filed a MD&A for the three-month and six-month periods ended May
31, 2010 and May 31, 2009 on July 7, 2010. That MD&A was based on financial statements prepared in
accordance with generally accepted accounting principles in Canada (''Canadian GAAP). In the
fourth quarter of 2010, the Company filed a request to adopt IFRS two years in advance of the date
required by the Accounting Standards Board. The request was approved by the regulatory authorities.
The Company is filing amended interim consolidated financial statements and this amended MD&A to
comply with this approval.
This amended MD&A continues to describe conditions, trends results and outlook as of July 7, 2010,
which was the date of the original MD&A. Except for the changes related to the Companys adoption
of IFRS, this amended MD&A does not reflect events occurring after July 7, 2010 and the Company has
not modified or updated the discussion and analysis from its original filing.
This amended MD&A and the amended interim consolidated financial statements for the three-month and
six-month periods ended May 31, 2010 and 2009 supersede the Companys original filings and should
be read in conjunction with the consolidated financial statements as at November 30, 2010 and 2009
prepared in accordance with IFRS.
AMENDED MANAGEMENTS DISCUSSION AND ANALYSIS
For the three-month and six-month periods ended May 31, 2010
The following amended MD&A provides Managements point of view on the financial position and the
results of operations of Theratechnologies Inc. (Theratechnologies or the Company), for the
three-month and six-month periods ended May 31, 2010, as compared to the three-month and six-month
periods ended May 31, 2009. This view contains certain factors that the Company believes may affect
its prospective financial condition, cash flows and results of operations. The amended unaudited
interim consolidated financial statements have been prepared in accordance with International
Financial Reporting Standards (IFRS). This amended MD&A should be read in conjunction with the
amended unaudited interim consolidated financial statements of the Company and the notes thereto as
at May 31, 2010, as well as the MD&A and audited consolidated financial statements including the
related notes thereto as at November 30, 2010. Unless specified otherwise, all amounts are in
Canadian dollars.
Financial Overview
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company
targets unmet medical needs in financially attractive specialty markets where it can retain all or
some of the commercial rights to its products. Its most advanced compound, tesamorelin, is an
analogue of the human growth hormone releasing factor.
The Companys growth strategy is centered upon the development of tesamorelin. In late 2008,
Theratechnologies entered into a collaboration and licensing agreement with EMD Serono, Inc. (EMD
Serono) (an affiliate of Merck KGaA, Darmstadt, Germany), for the exclusive commercialization
rights to tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in the United States.
The principal strategic objective of Theratechnologies is to obtain regulatory approval for
tesamorelin in this indication and good progress was made in the second quarter by participating in
the U.S. Food and Drug Administration (FDA or the Agency) Endocrinologic and Metabolic Drugs
Advisory Committee. On May 27, 2010, the Committee recommended by a 16 to 0 unanimous vote that
tesamorelin be granted marketing approval by the FDA for this treatment.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
Although advisory
committees provide their recommendations to the FDA, the final decisions on marketing approvals are
made by the Agency. The FDA has indicated that the action goal date, which is the target date for
the FDA to complete its review of the tesamorelin New Drug Application (NDA), will be July 27,
2010. If tesamorelin is approved, the Company expects to receive regulatory milestone payments,
royalties and additional milestone payments from sales of tesamorelin by EMD Serono in the U.S.
In addition, Theratechnologies has begun building inventory in preparation for the launch of
tesamorelin in the U.S., in the event of FDA approval. In the coming months, the Company will
continue building inventory.
Revenues
Consolidated revenues for the three-month period ended May 31, 2010, amounted to $1,717,000,
compared to $1,717,000 in 2009. For the six-month period ended May 31, 2010, consolidated revenues
were $3,434,000, compared to $3,149,000 in 2009. The increased revenues for the six-month period in
2010 are related to a longer amortization period (6 months in 2010 versus 5.5 months in 2009) for
the initial payment received within the collaboration and licensing agreement with EMD Serono.
The initial payment received upon the closing of the agreement with EMD Serono of $27,097,000 has
been deferred and is being amortized over its estimated service period on a straight-line basis.
This period may be modified in the future based on additional information that the Company may
receive. For the three-month period ended May 31, 2010, an amount of $1,712,000 ($1,711,000 in
2009) was recognized as revenue related to this transaction, while an amount of $3,423,000 was
recognized as revenue for the six-month period related to this transaction ($3,137,000 in 2009). At
May 31, 2010, the deferred revenues related to this transaction recorded on the balance sheet
amounted to $17,114,000.
R&D Activities
Research and development (R&D) expenses net of tax credits totaled $4,178,000 for the second
quarter of 2010, compared to $5,355,000 in 2009. For the six-month period ended May 31, 2010, R&D
expenses net of tax credits were $8,301,000 compared to $11,075,000 in 2009, representing a
decrease of 25.0%. The R&D expenses incurred in the second quarter of 2010 are mainly related to
regulatory activities connected with the preparation for the FDA Advisory Committee meeting,
whereas the expenses incurred in the second quarter of 2009 were principally related to the end of
the Phase 3 clinical trials evaluating tesamorelin in HIV-associated lipodystrophy and the
preparation of the NDA which was submitted to the FDA in May 2009. This explains the significant
reduction in R&D expenses in accordance with the Companys plans.
Selling and Market Development Expenses
Selling and market development expenses amounted to $765,000 for the second quarter of 2010,
compared to $545,000 in 2009. For the six-month period ended May 31, 2010, selling and market
development expenses amounted to $1,385,000, compared to $5,295,000 in 2009. The 2010 selling and
market development expenses are principally composed of business development and market research
outside the United States and the costs of managing the agreement with EMD Serono. In 2009, the
Company incurred first-quarter expenses totalling $4,269,000 in connection with professional fees
related to the transaction with EMD Serono.
General and Administrative Expenses
For the second quarter of 2010, general and administrative expenses amounted to $1,959,000,
compared to $1,555,000 in 2009. For the six-month period ended May 31, 2010, general and
administrative expenses amounted to $3,704,000, compared to $3,492,000 in 2009. The increase in the
second quarter of 2010 is due to increased corporate communication activities associated with the
FDA Advisory Committee meeting. Expenses in the six-month period in 2009 include costs associated
with revising the Companys business plan.
2
Net Financial Income
Finance income in the second quarter of 2010 amounted to $509,000 compared to $600,000 in 2009.
Finance income in the six-month period ended May 31, 2010 was $1,087,000 compared to $1,177,000 in
2009. The year-over-year declines are due to lower average cash positions and a decrease in yield
on our bond portfolio. Finance costs in the second quarter of 2010 were $95,000 compared to
$316,000 in 2009. Finance costs in the six-month period ended May 31, 2010 were $143,000 compared
to $745,000 in 2009. The higher finance costs in 2009 are due to foreign exchanges fluctuations and
include a first-quarter exchange loss of $416,000 incurred upon the conversion of the initial
payment from EMD Serono to Canadian dollars.
Net Loss
Reflecting the changes in revenues and expenses described above, the Company recorded a second
quarter net loss of $4,771,000 ($0.08 per share), compared to a net loss of $5,454,000 ($0.09 per
share) in 2009. For the six-month period ended May 31, 2010, the net loss was $9,012,000 ($0.15 per
share), compared to a net loss of $16,281,000 ($0.27 per share) in 2009.
Quarterly Financial Information
The selected financial information provided below is derived from the Companys unaudited quarterly
financial statements for each of the last eight quarters.
(in thousands of Canadian dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
|
|
|
|
2009 |
|
|
2008 (1) |
|
|
|
Q2 |
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
|
|
|
|
|
|
|
amended |
|
|
amended |
|
|
amended |
|
|
amended |
|
|
amended |
|
|
amended |
|
|
Q4 |
|
|
Q3 |
|
|
Revenues |
|
$ |
1,717 |
|
|
$ |
1,717 |
|
|
$ |
1,718 |
|
|
$ |
12,601 |
|
|
$ |
1,717 |
|
|
$ |
1,432 |
|
|
$ |
616 |
|
|
$ |
710 |
|
Net (loss) earnings |
|
$ |
(4,771 |
) |
|
$ |
(4,241 |
) |
|
$ |
(4,654 |
) |
|
$ |
5,779 |
|
|
$ |
(5,454 |
) |
|
$ |
(10,827 |
) |
|
$ |
(15,145 |
) |
|
$ |
(11,220 |
) |
Basic and diluted (loss) earnings per share |
|
$ |
(0.08 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.08 |
) |
|
$ |
0.10 |
|
|
$ |
(0.09 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.19 |
) |
|
|
|
|
(1) |
|
Theratechnologies adopted IFRS in fiscal 2010 with a transition date of
December 1, 2008. Consequently, the selected financial information for the year ended
November 30, 2008, as presented in our 2009 Audited Consolidated Financial Statements, which were
presented in conformity with Canadian GAAP, was not restated in accordance with IFRS and
accordingly, is not comparable with the information for fiscal 2010 and 2009. |
As described above, the increased revenues in 2010 and 2009 are related to the amortization of the
initial payment received at the closing of the agreement with EMD Serono, as well as the milestone
payment of $10,884,000 recorded in August 2009. The increase in the fourth quarter net loss in
2008 is due to impairment charges for intellectual property.
Financial Position
At May 31, 2010, cash and bonds amounted to $49,048,000, and tax credits and grants receivable
amounted to $1,669,000, for a total of $50,717,000.
For the three-month period ended May 31, 2010, cash used for operating activities, excluding
changes in operating assets and liabilities, was $4,387,000, compared to $4,987,000 in 2009. For
the six-month period ending May 31, 2010, cash used for operating activities, excluding changes in
operating assets and liabilities, was $8,248,000, compared to $15,399,000 in 2009.
Subsequent events
Except for changes related to the Companys adoption of IFRS, this amended MD&A does not reflect
events occurring after July 7, 2010, the date of the filing of the MD&A prepared in accordance with
Canadian GAAP. The annual MD&A of the Company prepared in accordance with IFRS has been filed
concurrently with this amended MD&A. This amended MD&A should be read in
3
conjunction with the
November 30, 2010 annual financial statements and the related MD&A for additional disclosures with
respect to subsequent events.
Transition to IFRS
The Company has applied IFRS 1 and the accounting policies set out in note 3 in preparing the
financial statements for the period ended May 31, 2010, the comparative information for the period
ended May 31, 2009, for the year ended November 30, 2009, and for the opening IFRS statement of
financial position as at December 1, 2008 (the Companys date of transition).
In preparing these interim consolidated financial statements in accordance with IFRS 1, the Company
has applied the mandatory exceptions and certain of the optional exemptions from full retrospective
application of IFRS.
The Company elected to apply the following optional exemptions from full retrospective application:
(i) |
|
Share-based payment transaction exemption: |
|
|
|
The Company has elected to apply the share-based payment exemption. It applied IFRS 2 from
December 1, 2008 to those stock options that were issued after November 7, 2002 but that had
not vested by December 1, 2008. The application of the exemption is detailed below. |
|
(ii) |
|
Designation of financial assets and financial liabilities exemption: |
|
|
|
The Company elected to re-designate cash from the held for trading category to loans and
receivables. |
As required by IFRS 1, estimates made under IFRS at the date of transition must be consistent with
estimates made for the same date under previous GAAP, unless there is evidence that those estimates
were in error.
In preparing its opening IFRS consolidated statement of financial position, the Company has
adjusted amounts reported previously in financial statements prepared in accordance with Canadian
GAAP.
An explanation of how the transition from previous Canadian GAAP to IFRS has affected the Companys
financial position, financial performance and cash flows is set out in note 8 of the amended
unaudited interim consolidated financial statements for the periods ended May 31, 2010 and 2009
Outstanding Share Data
On July 6, 2010, the number of shares issued and outstanding was 60,497,934, while outstanding
options granted under the stock option plan were 2,897,472.
Contractual Obligations
There were no material changes in contractual obligations during the first six months of the year,
other than in the ordinary course of business.
Economic and Industry Factors
Economic and industry factors were substantially unchanged from those reported in the Companys
2009 Annual Report.
Forward-Looking Information
This MD&A for the second quarter of 2010 contains certain statements that are considered
forward-looking information within the meaning of applicable securities legislation. This
forward-looking
4
information includes, but is not limited to, information regarding the approval of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
by the FDA, the receipt of milestone payments and/or royalties under the agreement entered into
with EMD Serono, the filing of a New Drug Submission in Canada, the potential increase in the
adjusted burn rate, and the completion of a conversion plan to IFRS. Furthermore, the words will,
may, could, should, outlook, believe, plan, envisage, anticipate, expect and
estimate, or variations of them denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties include, but are not limited to, the risk that the FDA
does not approve tesamorelin for the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy, the risk that the payment of milestones is delayed or not received or that the
royalties from the sale of tesamorelin are not received, the risk that the preparation of a New
Drug Submission in Canada is delayed or is not completed, and the risk that the Company is unable
to enter into commercial agreements with third parties to qualify back-up suppliers of tesamorelin
Although the forward-looking information contained herein is based upon what the Company believes
are reasonable assumptions, investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking information. Certain assumptions
made in preparing the forward-looking information and the Companys objectives include the
assumption, among others, that the FDA will approve tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy, sales of tesamorelin in the United
States will be successful, no issue will occur in the preparation of a New Drug Submission in
Canada, and the Company is able to enter into commercial agreements with third parties to qualify
back-up suppliers of tesamorelin.
Consequently, all of the forward-looking information is qualified by the foregoing cautionary
statements, and there can be no guarantee that the results or developments anticipated by the
Company will be realized or, even if substantially realized, that they will have the expected
consequences or effects on the Company, its business, its financial condition or its results of
operation. Furthermore, the forward-looking information reflects current expectations regarding
future events only as of the date of release of this MD&A.
Investors are referred to the Companys public filings available at www.sedar.com. In particular,
further details on the risks and descriptions of the risks are disclosed in the Risk and
Uncertainties section of the Companys Annual Information Form, dated February 23, 2010, for the
year ended November 30, 2009. This MD&A is dated July 7, 2010, and has been approved by the Audit
Committee.
###
5
ex-99.16
Exhibit 99.16
Amended Consolidated Financial Statements of
(Unaudited)
THERATECHNOLOGIES INC.
Six-month periods ended May 31, 2010 and 2009
THERATECHNOLOGIES INC.
Amended Consolidated Financial Statements
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
|
|
|
|
|
Amended Financial Statements |
|
|
|
|
|
|
|
|
|
Consolidated Statement of Financial Position |
|
|
1 |
|
|
|
|
|
|
Consolidated Statement of Comprehensive Income |
|
|
2 |
|
|
|
|
|
|
Consolidated Statement of Changes in Equity |
|
|
3 |
|
|
|
|
|
|
Consolidated Statement of Cash Flows |
|
|
5 |
|
|
|
|
|
|
Notes to the Consolidated Financial Statements |
|
|
6 |
|
EXPLANATORY NOTE
These amended unaudited consolidated financial statements of Theratechnologies Inc. (the
Company) for the six-month periods ended May 31, 2010 and 2009 reflect the Companys adoption of
International Financial Reporting Standards (''IFRS), as issued by the International Accounting
Standards Board (''IASB). In the fourth quarter of 2010, The Company filed a request to adopt
IFRS two years in advance of the date required by the Accounting Standards Board. The request was
approved by the regulatory authorities. The Company is filing these amended consolidated financial
statements to comply with this approval.
The Companys Audit Committee originally approved the unaudited consolidated financial statements
for the six-month periods ended May 31, 2010 and 2009 on July 6, 2010 and those financial
statements were filed on July 7, 2010. Those financial statements were prepared in accordance with
generally accepted accounting principles in Canada (Canadian GAAP). Except for the changes
related to the Companys adoption of IFRS, these amended unaudited consolidated financial
statements do not reflect events occurring after July 7, 2010. These amended unaudited consolidated
financial statements supersede the Companys original filing and should be read in connection with
the consolidated financial statements as at November 30, 2010 and 2009 prepared in accordance with
IFRS.
THERATECHNOLOGIES INC.
Consolidated Statement of Financial Position
(Unaudited)
May 31, 2010, November 30, 2009 and December 1, 2008
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 31, |
|
|
November 30, |
|
|
December 1, |
|
|
|
Note |
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
|
|
|
|
|
3,497 |
|
|
|
1,519 |
|
|
|
133 |
|
Bonds |
|
|
|
|
|
|
5,292 |
|
|
|
10,036 |
|
|
|
10,955 |
|
Trade and other receivables |
|
|
|
|
|
|
176 |
|
|
|
375 |
|
|
|
610 |
|
Tax credits and grants receivable |
|
|
|
|
|
|
1,669 |
|
|
|
1,333 |
|
|
|
1,451 |
|
Inventories |
|
|
|
|
|
|
4,496 |
|
|
|
2,225 |
|
|
|
|
|
Prepaid expenses |
|
|
|
|
|
|
975 |
|
|
|
630 |
|
|
|
739 |
|
|
Total current assets |
|
|
|
|
|
|
16,105 |
|
|
|
16,118 |
|
|
|
13,888 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bonds |
|
|
|
|
|
|
40,259 |
|
|
|
51,807 |
|
|
|
35,249 |
|
Property and equipment |
|
|
|
|
|
|
1,161 |
|
|
|
1,229 |
|
|
|
1,299 |
|
Other assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,776 |
|
|
Total non-current assets |
|
|
|
|
|
|
41,420 |
|
|
|
53,036 |
|
|
|
39,324 |
|
|
Total assets |
|
|
|
|
|
|
57,525 |
|
|
|
69,154 |
|
|
|
53,212 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
|
|
|
|
6,712 |
|
|
|
5,568 |
|
|
|
6,865 |
|
Current portion of deferred revenue |
|
|
4 |
|
|
|
6,852 |
|
|
|
6,847 |
|
|
|
|
|
|
Total current liabilities |
|
|
|
|
|
|
13,564 |
|
|
|
12,415 |
|
|
|
6,865 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other liabilities |
|
|
|
|
|
|
42 |
|
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
4 |
|
|
|
10,268 |
|
|
|
13,691 |
|
|
|
|
|
|
Total non-current liabilities |
|
|
|
|
|
|
10,310 |
|
|
|
13,691 |
|
|
|
|
|
|
Total liabilities |
|
|
|
|
|
|
23,874 |
|
|
|
26,106 |
|
|
|
6,865 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
5 |
|
|
|
279,329 |
|
|
|
279,169 |
|
|
|
269,219 |
|
Contributed surplus |
|
|
|
|
|
|
7,143 |
|
|
|
6,757 |
|
|
|
5,760 |
|
Deficit |
|
|
|
|
|
|
(253,172 |
) |
|
|
(244,160 |
) |
|
|
(229,004 |
) |
Accumulated other comprehensive income |
|
|
|
|
|
|
351 |
|
|
|
1,282 |
|
|
|
372 |
|
|
Total equity |
|
|
|
|
|
|
33,651 |
|
|
|
43,048 |
|
|
|
46,347 |
|
|
Subsequent events |
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity |
|
|
|
|
|
|
57,525 |
|
|
|
69,154 |
|
|
|
53,212 |
|
|
See accompanying notes to unaudited consolidated financial statements.
1
THERATECHNOLOGIES INC.
Consolidated Statement of Comprehensive Income
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 31, |
|
|
May 31, |
|
|
|
Note |
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
(3 months) |
|
|
(6 months) |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Upfront payments and initial technology access fees |
|
|
4 |
|
|
|
1,712 |
|
|
|
1,711 |
|
|
|
3,423 |
|
|
|
3,137 |
|
Royalties and license fees |
|
|
|
|
|
|
5 |
|
|
|
6 |
|
|
|
11 |
|
|
|
12 |
|
|
Total revenue |
|
|
|
|
|
|
1,717 |
|
|
|
1,717 |
|
|
|
3,434 |
|
|
|
3,149 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses, net of tax
credits of $167 (2009 - $422) for the three-month
period and $335 (2009 - $1,090) for the six-month period |
|
|
|
|
|
|
4,178 |
|
|
|
5,355 |
|
|
|
8,301 |
|
|
|
11,075 |
|
Selling and market development expenses |
|
|
|
|
|
|
765 |
|
|
|
545 |
|
|
|
1,385 |
|
|
|
5,295 |
|
General and administrative expenses |
|
|
|
|
|
|
1,959 |
|
|
|
1,555 |
|
|
|
3,704 |
|
|
|
3,492 |
|
|
Total operating expenses |
|
|
|
|
|
|
6,902 |
|
|
|
7,455 |
|
|
|
13,390 |
|
|
|
19,862 |
|
|
Results from operating activities |
|
|
|
|
|
|
(5,185 |
) |
|
|
(5,738 |
) |
|
|
(9,956 |
) |
|
|
(16,713 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income |
|
|
|
|
|
|
509 |
|
|
|
600 |
|
|
|
1,087 |
|
|
|
1,177 |
|
Finance costs |
|
|
|
|
|
|
(95 |
) |
|
|
(316 |
) |
|
|
(143 |
) |
|
|
(745 |
) |
|
Total net financial income |
|
|
|
|
|
|
414 |
|
|
|
284 |
|
|
|
944 |
|
|
|
432 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
(4,771 |
) |
|
|
(5,454 |
) |
|
|
(9,012 |
) |
|
|
(16,281 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss, net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value available-for-sale financial
assets, net of tax |
|
|
|
|
|
|
(740 |
) |
|
|
668 |
|
|
|
(737 |
) |
|
|
985 |
|
Net change in fair value available-for-sale financial
assets transferred to net loss, net of tax |
|
|
|
|
|
|
(94 |
) |
|
|
(47 |
) |
|
|
(194 |
) |
|
|
(70 |
) |
|
|
|
|
|
|
|
|
(834 |
) |
|
|
621 |
|
|
|
(931 |
) |
|
|
915 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the period |
|
|
|
|
|
|
(5,605 |
) |
|
|
(4,833 |
) |
|
|
(9,943 |
) |
|
|
(15,366 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share |
|
|
5 |
|
|
|
(0.08 |
) |
|
|
(0.09 |
) |
|
|
(0.15 |
) |
|
|
(0.27 |
) |
|
See accompanying notes to unaudited consolidated financial statements.
2
THERATECHNOLOGIES INC.
Consolidated Statement of Changes in Equity
(Unaudited)
Six-month period ended May 31, 2010
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
or losses on |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
available-for-sale |
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
Contributed |
|
|
financial |
|
|
|
|
|
|
|
|
|
Note |
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
assets (i) |
|
|
Deficit |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Balance as at November 30, 2009 |
|
|
|
|
|
|
60,429,393 |
|
|
|
279,169 |
|
|
|
6,757 |
|
|
|
1,282 |
|
|
|
(244,160 |
) |
|
|
43,048 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the period: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,012 |
) |
|
|
(9,012 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value of available-for-sale financial assets, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(737 |
) |
|
|
|
|
|
|
(737 |
) |
Net change in fair value of available-for-sale financial assets transferred to net loss,
net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(194 |
) |
|
|
|
|
|
|
(194 |
) |
|
Total comprehensive loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(931 |
) |
|
|
(9,012 |
) |
|
|
(9,943 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transactions with owners, recorded directly in equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue of common shares |
|
|
|
|
|
|
2,880 |
|
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15 |
|
Share-based compensation for stock option plan |
|
|
5 |
(c) |
|
|
|
|
|
|
|
|
|
|
440 |
|
|
|
|
|
|
|
|
|
|
|
440 |
|
Exercise of stock option: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Monetary consideration |
|
|
5 |
(c) |
|
|
55,161 |
|
|
|
91 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
91 |
|
Attributed value |
|
|
5 |
(c) |
|
|
|
|
|
|
54 |
|
|
|
(54 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contributions by owners |
|
|
|
|
|
|
58,041 |
|
|
|
160 |
|
|
|
386 |
|
|
|
|
|
|
|
|
|
|
|
546 |
|
|
Balance as at May 31, 2010 |
|
|
|
|
|
|
60,487,434 |
|
|
|
279,329 |
|
|
|
7,143 |
|
|
|
351 |
|
|
|
(253,172 |
) |
|
|
33,651 |
|
|
|
|
|
(i) |
|
Accumulated other comprehensive income. |
3
THERATECHNOLOGIES INC.
Consolidated Statement of Changes in Equity, Continued
(Unaudited)
Six-month period ended May 31, 2009
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
or losses on |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
available-for-sale |
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
Contributed |
|
|
financial |
|
|
|
|
|
|
|
|
|
Note |
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
assets (i) |
|
|
Deficit |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Balance as at November 30, 2008 |
|
|
|
|
|
|
58,215,090 |
|
|
|
269,219 |
|
|
|
5,760 |
|
|
|
372 |
|
|
|
(229,004 |
) |
|
|
46,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the period: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,281 |
) |
|
|
(16,281 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value of available-for-sale financial assets, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
985 |
|
|
|
|
|
|
|
985 |
|
Net change in fair value of available-for-sale financial assets transferred to net loss,
net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(70 |
) |
|
|
|
|
|
|
(70 |
) |
|
Total comprehensive loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
915 |
|
|
|
(16,281 |
) |
|
|
(15,366 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transactions with owners, recorded directly in equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue of common shares |
|
|
4 |
|
|
|
2,182,387 |
|
|
|
9,861 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,861 |
|
Share-based compensation plan: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation for stock option plan |
|
|
5 |
(c) |
|
|
|
|
|
|
|
|
|
|
598 |
|
|
|
|
|
|
|
|
|
|
|
598 |
|
|
Total contributions by owners |
|
|
|
|
|
|
2,182,387 |
|
|
|
9,861 |
|
|
|
598 |
|
|
|
|
|
|
|
|
|
|
|
10,459 |
|
|
Balance as at May 31, 2009 |
|
|
|
|
|
|
60,397,477 |
|
|
|
279,080 |
|
|
|
6,358 |
|
|
|
1,287 |
|
|
|
(245,285 |
) |
|
|
41,440 |
|
|
|
|
|
(i) |
|
Accumulated other comprehensive income. |
See accompanying notes to unaudited consolidated financial statements.
4
THERATECHNOLOGIES INC.
Consolidated Statement of Cash Flows
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 31, |
|
|
May 31, |
|
|
|
Note |
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
(3 months) |
|
|
(6 months) |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
(4,771 |
) |
|
|
(5,454 |
) |
|
|
(9,012 |
) |
|
|
(16,281 |
) |
Adjustments for: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation of property and equipment |
|
|
|
|
|
|
135 |
|
|
|
147 |
|
|
|
282 |
|
|
|
284 |
|
Share-based compensation |
|
|
|
|
|
|
207 |
|
|
|
320 |
|
|
|
440 |
|
|
|
598 |
|
Lease inducements and amortization |
|
|
|
|
|
|
42 |
|
|
|
|
|
|
|
42 |
|
|
|
|
|
|
Operating activities before changes in operating
assets and liabilities |
|
|
|
|
|
|
(4,387 |
) |
|
|
(4,987 |
) |
|
|
(8,248 |
) |
|
|
(15,399 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in accrued interest income on bonds |
|
|
|
|
|
|
216 |
|
|
|
167 |
|
|
|
379 |
|
|
|
(802 |
) |
Change in trade and other receivables |
|
|
|
|
|
|
105 |
|
|
|
283 |
|
|
|
199 |
|
|
|
334 |
|
Change in tax credits and grants receivable |
|
|
|
|
|
|
(167 |
) |
|
|
(421 |
) |
|
|
(2 |
) |
|
|
(756 |
) |
Change in inventories |
|
|
|
|
|
|
(2,245 |
) |
|
|
|
|
|
|
(2,271 |
) |
|
|
(1,594 |
) |
Change in prepaid expenses |
|
|
|
|
|
|
50 |
|
|
|
(53 |
) |
|
|
(345 |
) |
|
|
(523 |
) |
Change in other assets |
|
|
|
|
|
|
|
|
|
|
79 |
|
|
|
|
|
|
|
647 |
|
Change in accounts payable and accrued liabilities |
|
|
|
|
|
|
3,045 |
|
|
|
(1,542 |
) |
|
|
932 |
|
|
|
(2,002 |
) |
Change in deferred revenue |
|
|
|
|
|
|
(1,715 |
) |
|
|
(1,714 |
) |
|
|
(3,418 |
) |
|
|
23,967 |
|
|
|
|
|
|
|
|
|
(711 |
) |
|
|
(3,201 |
) |
|
|
(4,526 |
) |
|
|
19,271 |
|
|
Cash flows from operating activities |
|
|
|
|
|
|
(5,098 |
) |
|
|
(8,188 |
) |
|
|
(12,774 |
) |
|
|
3,872 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issue of share capital |
|
|
|
|
|
|
15 |
|
|
|
7 |
|
|
|
15 |
|
|
|
9,861 |
|
Proceeds from exercise of stock options |
|
|
|
|
|
|
53 |
|
|
|
|
|
|
|
91 |
|
|
|
|
|
Share issue costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8 |
) |
|
Cash flows from financing activities |
|
|
|
|
|
|
68 |
|
|
|
7 |
|
|
|
106 |
|
|
|
9,853 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition of property and equipment |
|
|
|
|
|
|
(161 |
) |
|
|
(133 |
) |
|
|
(336 |
) |
|
|
(235 |
) |
Proceeds from sale of bonds |
|
|
|
|
|
|
5,356 |
|
|
|
5,257 |
|
|
|
14,982 |
|
|
|
9,842 |
|
Acquisition of bonds |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(19,631 |
) |
|
Cash flows from (used in) investing activities |
|
|
|
|
|
|
5,195 |
|
|
|
5,124 |
|
|
|
14,646 |
|
|
|
(10,024 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in cash |
|
|
|
|
|
|
165 |
|
|
|
(3,057 |
) |
|
|
1,978 |
|
|
|
3,701 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash as at December 1 |
|
|
|
|
|
|
3,332 |
|
|
|
6,891 |
|
|
|
1,519 |
|
|
|
133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash as at May 31 |
|
|
|
|
|
|
3,497 |
|
|
|
3,834 |
|
|
|
3,497 |
|
|
|
3,834 |
|
|
See note 6 for supplemental cash flow information.
See accompanying notes to unaudited consolidated financial statements.
5
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
Theratechnologies Inc. is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The
Company targets unmet medical needs in financially attractive specialty markets where it can
retain all or some of the commercial rights to its products. Its most advanced compound,
tesamorelin, is an analogue of the human growth hormone releasing factor.
The consolidated financial statements include the accounts of Theratechnologies Inc. and its
wholly-owned subsidiaries (together referred to as the ''Company and individually as ''the
subsidiaries of the Company).
Theratechnologies Inc. is incorporated under Part 1A of the Québec Companies Act and is
domiciled in Quebec, Canada. The Company is located at 2310 boul. Alfred-Nobel, Montreal,
Quebec, H4S 2B4.
|
(a) |
|
Statement of compliance: |
These amended interim consolidated financial statements of the Company have been prepared
in accordance with International Financial Reporting Standards (''IFRSs) as issued by the
International Accounting Standards Board (''IASB). The Companys first IFRS financial
statements were for the annual period ended November 30, 2010 and were prepared using
December 1, 2008 as the date of transition. In preparing the accompanying amended interim
financial statements, the Company applied IFRS 1, First-time Adoption of International
Financial Reporting Standards as disclosed in note 8.
These amended interim consolidated financial statements have been prepared in accordance
with IAS 34, Interim Financial Reporting. However, they should not be read in conjunction
with the notes to the Companys audited consolidated financial statements for the year
ended November 30, 2009 as those were prepared in accordance with Canadian GAAP. The
Companys interim consolidated financial statements as previously filed were also prepared
in accordance with Canadian GAAP. Canadian GAAP differs in some areas from IFRS. In
preparing these amended interim consolidated financial statements, management amended the
accounting and valuation methods previously applied in the Canadian GAAP financial
statements to comply with IFRS. The Companys annual consolidated financial statements as
at November 30, 2010 and 2009 and for the years then ended have been concurrently filed
with these amended unaudited interim consolidated financial statements. The same accounting
policies as described in note 3 of these amended interim consolidated financial statements
were used. The comparative figures for 2009 were also restated to reflect these
adjustments.
6
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
2. |
|
Basis of preparation (continued): |
|
(a) |
|
Statement of compliance (continued): |
|
|
|
|
Certain information and footnote disclosures which are considered material to the
understanding of the Companys amended interim consolidated financial statements and which
are normally included in annual financial statements prepared in accordance with IFRS are
presented in note 3 along with reconciliations and descriptions of the effect of the
transition from Canadian GAAP to IFRS on equity, earnings and comprehensive income
presented in note 8. These amended interim consolidated financial statements do not include
all disclosures required under IFRS and accordingly should be read in connection with the
aforementioned annual financial statements and the notes thereto. These amended interim
consolidated financial statements have not been reviewed by the Companys auditors. |
|
|
|
|
These amended unaudited interim consolidated financial statements were authorized for issue
by the Audit Committee on February 8, 2011. |
|
|
(b) |
|
Basis of measurement: |
|
|
|
|
The Companys consolidated financial statements have been prepared on a going concern and
historical cost basis, except for available-for-sale financial assets which are measured at
fair value. |
|
|
|
|
The methods used to measure fair value are discussed in note 22 included in the Companys
annual financial statements dated February 8, 2011. |
|
|
(c) |
|
Functional and presentation currency: |
|
|
|
|
These amended interim consolidated financial statements are presented in Canadian dollars,
which is the Companys functional currency. All financial information presented in Canadian
dollars has been rounded to the nearest thousand. |
|
|
(d) |
|
Use of estimates and judgements: |
|
|
|
|
The preparation of the Companys amended interim consolidated financial statements in
conformity with IFRSs requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and the reported amounts of revenues
and expenses during the reporting period. |
|
|
|
|
Information about critical judgements in applying accounting policies and assumption and
estimation uncertainties that have the most significant effect on the amounts recognized in
the amended interim consolidated financial statements relate to the timing of revenue
recognition, the valuation of share-based compensation and the realizability of deferred
income tax assets. |
7
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
2. |
|
Basis of preparation (continued): |
|
(d) |
|
Use of estimates and judgements (continued): |
|
|
|
|
Other areas of judgement and uncertainty relate to the estimation of accruals for clinical
trial expenses, the recoverability of inventories, the measurement of the amount and
assessment of the recoverability of tax credits and grants receivable and the
capitalization of development expenditures. |
|
|
|
|
Reported amounts and note disclosure reflect the overall economic conditions that are most
likely to occur and anticipated measures management intends to take. Actual results could
differ from those estimates. |
|
|
|
|
The above estimates and assumptions are reviewed regularly. Revisions to accounting
estimates are recognized in the period in which the estimates are revised and in any future
periods affected. |
3. |
|
Significant accounting policies: |
The accounting policies set out below have been applied consistently to all periods presented
in these amended interim consolidated financial statements and in preparing the opening IFRS
statement of financial position at December 1, 2008, the date of transition to IFRSs.
The accounting policies have been applied consistently by the subsidiaries of the Company.
|
(a) |
|
Basis of consolidation: |
|
|
|
|
The financial statements of subsidiaries are included in the consolidated financial
statements from the date on which control commences until the date on which control ceases.
Subsidiaries are entities controlled by the Company. Control is present where the Company
has the power to govern the financial and operating policies of the entity so as to obtain
benefits from its activities. In assessing control, potential voting rights that are
exercisable currently are taken into consideration. The accounting policies of subsidiaries
are changed when necessary to align them with the policies adopted by the Company. |
|
|
|
|
Reciprocal balances and transactions, revenues and expenses resulting from transactions
between subsidiaries and with the Company are eliminated in preparing the consolidated
financial statements. |
8
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(b) |
|
Foreign currency: |
|
|
|
|
Transactions in foreign currencies are translated to the respective functional currencies
of the subsidiaries of the Company at exchange rates at the dates of the transactions.
Monetary assets and liabilities denominated in foreign currencies at the reporting date are
retranslated to the functional currency at the exchange rate at that date. The foreign
currency gain or loss on monetary items is the difference between amortized cost in the
functional currency at the beginning of the period, adjusted for effective interest and
payments during the period, and the amortized cost in foreign currency translated at the
exchange rate at the end of the reporting period. |
|
|
|
|
Foreign currency differences arising on translation are recognized in net profit (loss),
except for differences arising on the translation of available-for-sale equity instruments,
which are recognized in other comprehensive income. Non-monetary assets and liabilities
denominated in foreign currencies that are measured at fair value are translated to the
functional currency at the exchange rate at the date that the fair value was determined.
Non-monetary items that are measured at historical cost in a foreign currency are
translated using the exchange rate at the date of the transaction. |
|
|
(c) |
|
Revenue recognition: |
|
|
|
|
Collaboration agreements that include multiple deliverables are considered to be
multi-element arrangements. Under this type of arrangement, the identification of separate
units of accounting is required and revenue is allocated among the separate units based on
their relative fair values. |
|
|
|
|
Payments received under the collaboration agreement may include upfront payments, milestone
payments, research services, royalties and license fees. Revenues for each unit of
accounting are recorded as described below: |
|
(i) |
|
Sale of goods: |
|
|
|
|
Revenues from the sale of goods are recognized when the Company has transferred to the
buyer the significant risks and rewards of ownership of the goods, there is no
continuing management involvement with the goods, and the amount of revenue can be
measured reliably. |
|
|
(ii) |
|
Royalties and license fees: |
|
|
|
|
Royalties and license fees are recognized when conditions and events under the license
agreement have occurred and collectibility is reasonably assured. |
9
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(c) |
|
Revenue recognition (continued): |
|
(iii) |
|
Research services: |
|
|
|
|
Revenues from research contracts are recognized when services to be provided are
rendered and all conditions under the terms of the underlying agreement are met. |
|
(a) |
|
Upfront payments and initial technology access fees: |
|
|
|
|
Upfront payments and initial technology access fees are deferred and recognized as
revenue on a systematic basis over the period during which the related products or
services are delivered and all obligations are performed. |
|
|
(b) |
|
Milestone payments: |
|
|
|
|
Revenues subject to the achievement of milestones are recognized only when the
specified events have occurred and collectibility is reasonably assured. |
|
(d) |
|
Cost of sales: |
|
|
|
|
Cost of sales represents the cost of goods sold and includes the cost of raw materials,
supplies, direct overhead charges, unallocated indirect costs related to production as well
as write-down of inventories. Other direct costs such as manufacturing start-up costs
between validation and the achievement of normal production are expensed as incurred. |
|
|
(e) |
|
Employee benefits: |
|
|
|
|
Salaries and short-term employee benefits: |
|
|
|
|
Salaries and short-term employee benefit obligations are measured on an undiscounted basis
and are expensed as the related service is provided. A liability is recognized for the
amount expected to be paid under short-term profit-sharing or cash bonus plans if the
Company has a legal or constructive obligation to pay an amount as a result of past
services rendered by an employee and the obligation can be estimated reliably. |
|
|
|
|
Post-employment benefits: |
|
|
|
|
Post-employment benefits include a defined contribution plan under which an entity pays
fixed contributions into a separate entity and will have no legal or constructive
obligation to pay further amounts. Obligations for contributions to defined contribution
plans are recognized as an employee benefit expense when due. Prepaid contributions are
recognized as an asset to the extent that a cash refund or a reduction in future payments
is available. The Companys defined contribution plan comprises the registered retirement
savings plan, the Quebec Pension Plan and unemployment insurance. |
10
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(e) |
|
Employee benefits (continued): |
|
|
|
|
Termination benefits: |
|
|
|
|
Termination benefits are recognized as an expense when the Company is committed
demonstrably, without realistic possibility of withdrawal, to a formal detailed plan to
either terminate employment before the normal retirement date, or to provide termination
benefits as a result of an offer made to encourage voluntary redundancy. |
|
|
(f) |
|
Finance income and finance costs: |
|
|
|
|
Finance income comprises interest income on available-for-sale financial assets and gains
(losses) on the disposal of available-for-sale financial assets. Interest income is
recognized as it accrues in profit (loss), using the effective interest method. |
|
|
|
|
Finance costs are comprised of bank charges, impairment losses on financial assets
recognized in profit (loss) and foreign currency gains and losses which are reported on a
net basis. |
|
|
(g) |
|
Inventories: |
|
|
|
|
Inventories are presented at the lower of cost, determined using the first-in first-out
method, or net realizable value. Inventory costs include the purchase price and other costs
directly related to the acquisition of materials, and other costs incurred in bringing the
inventories to their present location and condition. Inventory costs also include the
costs directly related to the conversion of materials to finished goods, such as direct
labour, and a systematic allocation of fixed and variable production overhead, including
manufacturing depreciation expense. The allocation of fixed production overheads to the
cost of inventories is based on the normal capacity of the production facilities. Normal
capacity is the average production expected to be achieved over a number of periods under
normal circumstances. |
|
|
|
|
Net realizable value is the estimated selling price in the Companys ordinary course of
business, less the estimated costs of completion and selling expenses. |
|
|
(h) |
|
Property and equipment: |
|
|
|
|
Recognition and measurement: |
|
|
|
|
Items of property and equipment are recognized at cost less accumulated depreciation and
accumulated impairment losses. Cost includes expenditure that is directly attributable to
the acquisition of the asset and the costs of dismantling and removing the item and
restoring the site on which it is located, if any. |
11
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(h) |
|
Property and equipment (continued): |
|
|
|
|
Recognition and measurement (continued): |
|
|
|
|
When parts of an item of property and equipment have different useful lives, they are
accounted for as separate items (major components) of property and equipment. |
|
|
|
|
Gains and losses on disposal of an item of property and equipment are determined by
comparing the proceeds from disposal with the carrying amount of property and equipment,
and are recognized in net profit (loss). |
|
|
|
|
Subsequent costs: |
|
|
|
|
The cost of replacing a part of an item of property and equipment is recognized in the
carrying amount of the item if it is probable that the future economic benefits embodied
within the part will flow to the Company, and its cost can be measured reliably. The
carrying amount of the replaced part is derecognized. The costs of the day-to-day servicing
of property and equipment are recognized in profit (loss) as incurred. |
|
|
|
|
Depreciation: |
|
|
|
|
The estimated useful lives and the methods of depreciation for the current and comparative
periods are as follows: |
|
|
|
|
|
|
|
|
|
Asset |
|
Method |
|
|
Rate/Period |
|
|
|
|
|
|
|
|
|
|
|
Computer equipment |
|
Declining balance |
|
|
50 |
% |
Laboratory equipment |
|
Declining balance |
|
|
20 |
% |
|
|
and straight-line |
|
5 years |
Office furniture and equipment |
|
Declining balance |
|
|
20 |
% |
Leasehold improvements |
|
Straight-line |
|
Lower of term of lease |
|
|
|
|
|
|
or economic life |
|
This most closely reflects the expected pattern of consumption of the future economic
benefits embodied in the asset.
Estimates for depreciation methods, useful lives and residual values are reviewed at each
reporting period-end and adjusted, if appropriate.
12
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(i) |
|
Intangible assets: |
|
|
|
|
Research and development: |
|
|
|
|
Expenditure on research activities, undertaken with the prospect of gaining new scientific
or technical knowledge and understanding, is expensed as incurred. |
|
|
|
|
Development activities involve a plan or design for the production of new or substantially
improved products and processes. Development expenditure is capitalized only if development
costs can be measured reliably, the product or process is technically and commercially
feasible, future economic benefits are probable, and the Company intends to and has
sufficient resources to complete development and to use or sell the asset. These criteria
are usually met when a regulatory filing has been made in a major market and approval is
considered highly probable. The expenditure capitalized includes the cost of materials,
direct labour, and overhead costs that are directly attributable to preparing the asset for
its intended use. Other development expenditures are expensed as incurred. Capitalized
development expenditures are measured at cost less accumulated amortization and accumulated
impairment losses. |
|
|
|
|
During the periods ended May 31, 2010 and 2009, November 30, 2009 and as at December 1,
2008, no development expenditures were capitalized. |
|
|
(j) |
|
Financial instruments: |
|
|
|
|
The Companys financial instruments are classified into one of three categories: loans and
receivables, available-for-sale financial assets and other financial liabilities. Loans and
receivables and other financial liabilities are measured at amortized cost. |
|
|
|
|
The Company has classified its bonds as available-for-sale financial assets. The Company
has classified cash, and trade and other receivables as loans and receivables, and accounts
payable and accrued liabilities as other financial liabilities. |
|
|
|
|
Available-for-sale financial assets are non-derivative financial assets that are designated
as available-for-sale and that are not classified in any of the other categories.
Subsequent to initial recognition, they are measured at fair value and changes therein,
other than impairment losses and foreign currency differences on available-for-sale debt
instruments, are recognized in other comprehensive income and presented within equity. When
an investment is derecognized, the cumulative gain or loss in other comprehensive income is
transferred to profit (loss). |
13
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(k) |
|
Other assets: |
|
|
|
|
Other assets consist of prepaid expenses for research supplies that are not expected to be
used within one year from the date of the consolidated statement of financial position. |
|
|
|
|
Research supplies are purchased in advance, in accordance with specific regulatory
requirements, to be used in connection with the Companys clinical trials. |
|
|
(l) |
|
Leases: |
|
|
|
|
Operating lease payments are recognized in net profit (loss) on a straight-line basis over
the term of the lease. |
|
|
|
|
Lease inducements arising from leasehold improvements allowances and rent-free periods form
an integral part of the total lease cost and are deferred and recognized in net profit
(loss) over the term of the lease on a straight-line basis. |
|
|
(m) |
|
Impairment: |
|
|
|
|
Financial assets: |
|
|
|
|
A financial asset not carried at fair value through profit or loss is assessed at each
consolidated financial statement reporting date to determine whether there is objective
evidence that it is impaired. The Company considers that a financial asset is impaired if
objective evidence indicates that one or more loss events had a negative effect on the
estimated future cash flows of that asset that can be estimated reliably. |
|
|
|
|
An impairment test is performed, on an individual basis, for each material financial asset.
Other individually non-material financial assets are tested as groups of financial assets
with similar risk characteristics. Impairment losses are recognized in net profit (loss). |
|
|
|
|
An impairment loss in respect of a financial asset measured at amortized cost is calculated
as the difference between its carrying amount and the present value of the estimated future
cash flows discounted at the assets original effective interest rate. Losses are
recognized in net profit (loss) and reflected in an allowance account against the
respective financial asset. Interest on the impaired asset continues to be recognized
through the unwinding of the discount. When a subsequent event causes the amount of
impairment loss to decrease, the decrease in impairment loss is reversed through net profit
(loss). |
14
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(m) |
|
Impairment (continued): |
|
|
|
|
Financial assets (continued): |
|
|
|
|
Impairment losses on available-for-sale investment securities are recognized by
transferring the cumulative loss that has been recognized in other comprehensive income,
and presented in unrealized gains/losses on available-for-sale financial assets in equity,
to net profit (loss). The cumulative loss that is removed from other comprehensive income
and recognized in net profit (loss) is the difference between the acquisition cost, net of
any principal repayment and amortization, and the current fair value, less any impairment
loss previously recognized in net profit (loss). Changes in impairment provisions
attributable to time value are reflected as a separate component of interest income. |
|
|
|
|
If, in a subsequent period, the fair value of an impaired available-for-sale debt security
increases and the increase can be related objectively to an event occurring after the
impairment loss was recognized in net profit (loss), then the impairment loss is reversed,
with the amount of the reversal recognized in net profit (loss). However, any subsequent
recovery in the fair value of an impaired available-for-sale equity security is recognized
in other comprehensive income. |
|
|
|
|
Non-financial assets: |
|
|
|
|
The carrying amounts of the Companys non-financial assets, other than inventories and
deferred tax assets, are reviewed at each reporting date to determine whether there is any
indication of impairment. If such an indication exists, the recoverable amount is
estimated. |
|
|
|
|
The recoverable amount of an asset or a cash-generating unit is the greater of its value in
use and its fair value less costs to sell. In assessing value in use, the estimated future
cash flows are discounted to their present value using a pre-tax discount rate that
reflects current market assessments of the time value of money and the risks specific to
the asset. For the purpose of impairment testing, assets are grouped together into the
smallest group of assets that generates cash inflows from continuing use that are largely
independent of cash inflows from other assets or groups of assets (''cash-generating
unit). Impairment losses recognized in prior periods are determined at each reporting
date for any indications that the loss has decreased or no longer exists. An impairment
loss is reversed if there has been a change in the estimates used to determine the
recoverable amount. An assets carrying amount, increased through reversal of an impairment
loss, must not exceed the carrying amount that would have been determined, net of
depreciation or amortization, if no impairment loss had been recognized. |
15
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(n) |
|
Provisions: |
|
|
|
|
A provision is recognized if, as a result of a past event, the Company has a present legal
or constructive obligation that can be estimated reliably, and it is probable that an
outflow of economic benefits will be required to settle the obligation. Provisions are
assessed by discounting the expected future cash flows at a pre-tax rate that reflects
current market assessments of the time value of money and the risks specific to the
liability. The unwinding of the discount on provisions is recognized in finance costs. |
|
|
|
|
Onerous contracts: |
|
|
|
|
A provision for onerous contracts is recognized when the expected benefits to be derived by
the Company from a contract are lower than the unavoidable cost of meeting its obligations
under the contract. The provision is measured at the present value of the lower of the
expected cost of terminating the contract and the expected net cost of continuing with the
contract. Before a provision is established, the Company recognizes any impairment loss on
the assets associated with that contract. There were no onerous contracts as at May 31,
2010 and 2009, November 30, 2009 and December 1, 2008. |
|
|
|
|
Site restoration: |
|
|
|
|
Where there is a legal or constructive obligation to restore leased premises to good
condition, except for normal aging on expiry or early termination of the lease, the
resulting costs are provisioned up to the discounted value of estimated future costs and
increase the carrying amount of the corresponding item of property and equipment. The
Company amortizes the cost of restoring leased premises and recognizes an unwinding of
discount expense on the liability related to the term of the lease. |
|
|
|
|
Contingent liability: |
|
|
|
|
A contingent liability is a possible obligation that arises from past events and of which
the existence will be confirmed only by the occurrence or non-occurrence of one or more
uncertain future events not wholly within the control of the Company; or a present
obligation that arises from past events (and therefore exists), but is not recognized
because it is not probable that a transfer or use of assets, provision of services or any
other transfer of economic benefits will be required to settle the obligation, or the
amount of the obligation cannot be estimated reliably. |
16
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(o) |
|
Income taxes: |
|
|
|
|
Income tax expense comprises current and deferred tax. Current tax and deferred tax are
recognized in net profit (loss), except to the extent that they relate to items recognized
directly in other comprehensive income or in equity. |
|
|
|
|
Current tax: |
|
|
|
|
Current tax is the expected tax payable or receivable on the taxable income or loss for the
year, using tax rates enacted or substantively enacted at the reporting date, and any
adjustment to tax payable in respect of previous years. The Company establishes provisions
where appropriate on the basis of amounts expected to be paid to the tax authorities. |
|
|
|
|
Deferred tax: |
|
|
|
|
Deferred tax is recognized in respect of temporary differences between the carrying amounts
of assets and liabilities for financial reporting purposes and the amounts used for
taxation purposes. Deferred tax is measured at the tax rates that are expected to be
applied to temporary differences when they reverse, based on the laws that have been
enacted or substantively enacted by the reporting date. |
|
|
|
|
A deferred tax liability is generally recognized for all taxable temporary differences. |
|
|
|
|
A deferred tax asset is recognized for unused tax losses and deductible temporary
differences, to the extent that it is probable that future taxable profits will be
available against which they can be utilized. Deferred tax assets are reviewed at each
reporting date and are reduced to the extent that it is no longer probable that the related
tax benefit will be realized. |
|
|
(p) |
|
Share-based compensation: |
|
|
|
|
The Company records share-based compensation related to employee stock options granted
using the fair value-based method estimated using the Black-Scholes model. Under this
method, compensation cost is measured at fair value at the date of grant and expensed, as
employee benefits, over the period in which employees unconditionally become entitled to
the award. The amount recognized as an expense is adjusted to reflect the number of awards
for which the related service conditions are expected to be met, such that the amount
ultimately recognized as an expense is based on the number of awards that do meet the
related service and non-market performance conditions at the vesting date. |
|
|
|
|
Share-based payment arrangements in which the Company receives goods or services as
consideration for its own equity instruments are accounted for as equity-settled
share-based payment transactions, regardless of how the equity instruments are obtained by
the Company. |
17
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(p) |
|
Share-based compensation (continued): |
|
|
|
|
As permitted by IFRS 1, the Company elected not to restate options that were granted before
November 7, 2002 and those granted after November 7, 2002 that were fully vested prior to
the date of transition to IFRS. |
|
|
(q) |
|
Government grants: |
|
|
|
|
Government grants, consisting of grants and research investment tax credits, are recorded
as a reduction of the related expense or cost of the asset acquired. Government grants are
recognized when there is reasonable assurance that the Company has met the requirements of
the approved grant program and there is reasonable assurance that the grant will be
received. |
|
|
(r) |
|
Share capital: |
|
|
|
|
Common shares: |
|
|
|
|
Common shares are classified as equity. Incremental costs directly attributable to the
issue of common shares and share options are recognized as a deduction from equity, net of
any tax effects. |
|
|
(s) |
|
Earnings per share: |
|
|
|
|
The Company presents basic and diluted earnings per share (''EPS) data for its common
shares. Basic EPS is calculated by dividing the net profit or loss attributable to common
shareholders of the Company by the weighted average number of common shares outstanding
during the period, adjusted for own shares held, if applicable. Diluted EPS is determined
by adjusting the profit or loss attributable to common shareholders and the weighted
average number of common shares outstanding, adjusted for own shares held, if applicable,
for the effects of all dilutive potential common shares, which consist of the stock options
granted to employees. |
|
|
(t) |
|
New standards and interpretations not yet applied: |
|
|
|
|
Certain pronouncements were issued by the IASB or International Financial Reporting
Interpretations Committee that are mandatory for accounting periods beginning on or after
January 1, 2010 or later periods. Many of these updates are not applicable or are
inconsequential to the Company and have been excluded from the discussion below. The
remaining pronouncements are being assessed to determine their impact on the Companys
results and financial position: |
18
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(t) |
|
New standards and interpretations not yet applied (continued): |
|
|
|
|
Annual improvements to IFRS: |
|
|
|
|
The IASBs improvements to IFRS published in April 2009 contain fifteen amendments to
twelve standards that result in accounting changes for presentation, recognition or
measurement purposes largely for annual periods beginning on or after January 1, 2010, with
early adoption permitted. These amendments were considered by the Company and deemed to be
not applicable to the Company other than for the amendment to IAS 17 Leases relating to
leases which include both land and buildings elements. In this case, the Company early
adopted this amendment. |
|
|
|
|
The IASBs improvements to IFRS contain seven amendments that result in accounting changes
for presentation, recognition or measurement purposes. The most significant features of the
IASBs annual improvements project published in May 2010 are included under the specific
revisions to standards discussed below. |
|
(i) |
|
IFRS 3: |
|
|
|
|
Revision to IFRS 3, Business Combinations: |
|
|
|
|
Effective for annual periods beginning on or after July 1, 2010, with earlier adoption
permitted. |
|
|
|
|
Clarification on the following areas: |
|
|
|
the choice of measuring non-controlling interests at fair value or at
the proportionate share of the acquirees net assets applies only to instruments
that represent present ownership interests and entitle their holders to a
proportionate share of the net assets in the event of liquidation. All other
components of non-controlling interest are measured at fair value unless another
measurement basis is required by IFRS. |
|
|
|
|
application guidance relating to the accounting for share-based
payments in IFRS 3 applies to all share-based payment transactions that are part
of a business combination, including unreplaced awards (i.e., unexpired awards
over the acquiree shares that remain outstanding rather than being replaced by the
acquirer) and voluntarily replaced share-based payment awards. |
19
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(t) |
|
New standards and interpretations not yet applied (continued): |
|
|
|
|
Annual improvements to IFRS (continued): |
|
(ii) |
|
IFRS 7: |
|
|
|
|
Amendment to IFRS 7, Financial Instruments: Disclosures: |
|
|
|
|
Effective for annual periods beginning on or after January 1, 2011, with earlier
adoption permitted. |
|
|
|
|
Multiple clarifications related to the disclosure of financial instruments and in
particular in regards to transfers of financial assets. |
|
|
(iii) |
|
IAS 1: |
|
|
|
|
Amendment to IAS 1, Presentation of Financial Statements: |
|
|
|
|
Effective for annual periods beginning on or after January 1, 2011, with earlier
adoption permitted. |
|
|
|
|
Entities may present the analysis of the components of other comprehensive income
either in the statement of changes in equity or within the notes to the financial
statements. |
|
|
(iv) |
|
IAS 27: |
|
|
|
|
Amendment to IAS 27, Consolidated and Separate Financial Statements: |
|
|
|
|
Effective for annual periods beginning on or after January 1, 2011, with earlier
adoption permitted. |
|
|
|
|
The 2008 revisions to this standard resulted in consequential amendments to IAS 21, The
Effects of Changes in Foreign Exchange Rates, IAS 28, Investments in Associates, and
IAS 31, Interests in Joint Ventures. IAS 27 now provides that these amendments are to
be applied prospectively. |
20
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(t) |
|
New standards and interpretations not yet applied (continued): |
|
|
|
|
Annual improvements to IFRS (continued): |
|
(v) |
|
IAS 34: |
|
|
|
|
Amendment to IAS 34, Interim Financial Reporting: |
|
|
|
|
Effective for annual periods beginning on or after January 1, 2011, with earlier
adoption permitted. |
|
|
|
|
The amendments place greater emphasis on the disclosure principles for interim
financial reporting involving significant events and transactions, including changes to
fair value measurements and the need to update relevant information from the most
recent annual report. |
New or revised standards and interpretations:
In addition, the following new or revised standards and interpretations have been issued
but are not yet applicable to the Company:
|
(i) |
|
IFRS 8: |
|
|
|
|
IFRS 8, Operating Segments (revised): |
|
|
|
|
Effective for annual periods beginning on or after January 1, 2010. |
|
|
|
|
Requires purchase information about segment assets. |
|
|
(ii) |
|
IFRS 9: |
|
|
|
|
New standard IFRS 9, Financial Instruments: |
|
|
|
|
Effective for annual periods beginning on or after January 1, 2013, with earlier
adoption permitted. |
|
|
|
|
As part of the project to replace IAS 39, Financial Instruments: Recognition and
Measurement, this standard retains but simplifies the mixed measurement model and
establishes two primary measurement categories for financial assets. More specifically,
the standard: |
|
|
|
deals with classification and measurement of financial assets establishes two primary measurement categories for financial assets: amortized cost and fair value |
21
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(t) |
|
New standards and interpretations not yet applied (continued): |
|
|
|
|
New or revised standards and interpretations (continued): |
|
(ii) |
|
IFRS 9 (continued): |
|
|
|
|
New standard IFRS 9, Financial Instruments (continued): |
|
|
|
classification depends on entitys business model and the contractual
cash flow characteristics of the financial asset |
|
|
|
|
eliminates the existing categories: held to maturity, available for
sale, and loans and receivables. |
|
|
|
Certain changes were also made regarding the fair value option for financial
liabilities and accounting for certain derivatives linked to unquoted equity
instruments. |
4. |
|
Revenue and deferred revenue: |
On October 28, 2008, the Company entered into a collaboration and licensing agreement with EMD
Serono, Inc. (EMD Serono), an affiliate of Merck KGaA, of Darmstadt, Germany, regarding the
exclusive commercialization rights of tesamorelin in the United States for the treatment of
excess abdominal fat in HIV-infected patients with lipodystrophy (the Initial Product). The
Company retains all tesamorelin commercialization rights outside of the United States.
Under the terms of the agreement, the Company is responsible for the development of the Initial
Product up to obtaining marketing approval in the United States. The Company is also
responsible for product production and for the development of a new formulation of the initial
product. EMD Serono is responsible for conducting product commercialization activities.
At the closing of the agreement, on December 15, 2008, the Company received US$30,000
(CAD$36,951), which includes an initial payment of US$22,000 (CAD$27,097) and US$8,000
(CAD$9,854) as a subscription for common shares in the Company by Merck KGaA at a price of
US$3.67 (CAD$4.52) per share. The Company may receive up to US$215,000, which amount includes
the initial payment of US$22,000, the equity investment of US$8,000, as well as payments based
on the achievement of certain development, regulatory and sales milestones. The Company will
also be entitled to receive increasing royalties on annual net sales of tesamorelin in the
United States, if applicable.
22
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
4. |
|
Revenue and deferred revenue (continued): |
|
|
|
The initial payment of $27,097 has been deferred and is being amortized over its estimated
service period for developing a new formulation of the Initial Product. This period may be
modified in the future based on additional information that may be received by the Company. For
the six-month period ended May 31, 2010, an amount of $3,423 related to this transaction was
recognized as revenue. As at May 31, 2010, the deferred revenues related to this transaction
amounted to $17,114 (November 30, 2009 $20,537). |
|
|
|
On August 12, 2009, the US Food and Drug Administration accepted the New Drug Application
(NDA) made by the Company for tesamorelin. Under the terms of the Companys Collaboration and
Licensing Agreement with EMD Serono, the acceptance of the tesamorelin NDA resulted in a
milestone payment of US$10,000 (CAD$10,884). This milestone payment has been recorded in the
third quarter of 2009. |
|
|
|
The Company may conduct research and development for additional indications. Under the
collaboration and licensing agreement, EMD Serono will have the option to commercialize
additional indications for tesamorelin in the United States. If it exercises this option, EMD
Serono will pay half of the development costs related to such additional indications. In such
cases, the Company will also have the right, subject to an agreement with EMD Serono, to
participate in the promotion of the additional indications. |
During the second quarter of 2010, the Company received subscriptions in the amount of $15 ($7
for the same period in 2009) for the issue of 2,880 common shares (2,550 for the same period in
2009) in connection with its share purchase plan.
|
(a) |
|
Shareholder rights plan: |
|
|
|
|
On February 10, 2010, the Board of Directors of the Company adopted a shareholder rights
plan (the ''Plan), effective as of that date. The Plan is designed to provide adequate
time for the Board of Directors and the shareholders, to assess an unsolicited takeover bid
for the Company. In addition, the Plan provides the Board of Directors with sufficient time
to explore and develop alternatives for maximizing shareholder value if a takeover bid is
made, as well as provide shareholders with an equal opportunity to participate if a
takeover bid is made, as well as provide shareholders with an equal opportunity to
participate in a takeover bid to receive full and fair value for their common shares. The
Plan will expire at the close of the Companys annual meeting of shareholders in 2013. |
23
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Share capital (continued): |
|
(a) |
|
Shareholder rights plan (continued): |
|
|
|
|
The rights issued under the Plan will initially attach to and trade with the common shares
and no separate certificates will be issued unless a triggering event occurs. The rights
will become exercisable only when a person, including any party related to it, acquires or
attempts to acquire 20% or more of the outstanding shares without complying with the
Permitted Bid provisions of the Plan or without approval of the Board of Directors.
Should such an acquisition occur or be announced, each right would, upon exercise, entitle
a rights holder, other than the acquiring person and related persons, to purchase common
shares at a 50% discount to the market price at the time. |
|
|
|
|
Under the Plan, a Permitted Bid is a bid made to all holders of the common shares and which
is open for acceptance for no less than 60 days. If, at the end of 60 days, at least 50% of
the outstanding common shares, other than those owned by the offeror and certain related
parties, have been tendered, the offeror may take up and pay for the common shares, but
must extend the bid for a further 10 days to allow other shareholders to tender. |
|
|
(b) |
|
Share purchase plan: |
|
|
|
|
The Share Purchase Plan entitles full-time and part-time employees of the Company who, on
the participation date, are residents of Canada, are not under a probationary period and do
not hold, directly or indirectly, five percent (5%) or more of the Companys outstanding
common shares, to directly subscribe for common shares of the Company. Under the Share
Purchase Plan, a maximum of 550,000 common shares may be issued to employees. |
|
|
|
|
On May 1 and November 1 of each year (the ''Participation Dates), an employee may
subscribe for a number of common shares under the Share Purchase Plan for an amount that
does not exceed 10% of that employees gross annual salary for that year. Under the Share
Purchase Plan, the Board of Directors has the authority to suspend or defer a subscription
of common shares, or to decide that no subscription of common shares will be allowed on a
Participation Date if it is in the Companys best interest. |
|
|
|
|
The Share Purchase Plan provides that the number of common shares that may be issued to
insiders, at any time, under all share-based compensation arrangements of the Company,
cannot exceed 10% of the Companys outstanding common shares, and the number of common
shares issued to insiders, within any one-year period, under all security-based
compensation arrangements, cannot exceed 10% of the outstanding common shares. |
24
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Share capital (continued): |
|
(b) |
|
Share purchase plan (continued): |
|
|
|
|
The subscription price for each new common share subscribed for under the Share Purchase
Plan is equal to the weighted average closing price of the common shares on the Toronto
Stock Exchange during a period of five days prior to the Participation Date. Employees may
not assign the rights granted under the Share Purchase Plan. |
|
|
|
|
An employee may elect to pay the subscription price for common shares in cash or through an
interest-free loan from the Company. Loans granted by the Company under the Share Purchase
Plan are repayable through salary withholdings over a period not exceeding two years. All
loans may be repaid prior to the scheduled repayment at any time. The loans granted to any
employee may at no time exceed 10% of that employees current annual gross salary. All
common shares purchased through an interest-free loan are hypothecated to secure full and
final repayment of the loan and are held by a trustee until repayment in full. Loans are
immediately due and payable on the occurrence of any of the following events: (i)
termination of employment; (ii) sale or seizure of the hypothecated common shares; (iii)
bankruptcy or insolvency of the employee; or (iv) suspension of the payment of an
employees salary or revocation of the employees right to salary withholdings. |
|
|
|
|
At May 31, 2010, $98 (November 30, 2009 $149; December 1, 2008 $150) was receivable
under these loans. |
|
|
(c) |
|
Stock option plan: |
|
|
|
|
The Company has established a stock option plan under which it can grant to its directors,
officers, employees, researchers and consultants non-transferable options for the purchase
of common shares. The exercise date of an option may not be later than 10 years after the
grant date. A maximum number of 5,000,000 options can be granted under the plan. Generally,
the options vest at the date of the grant or over a period up to 5 years. As at May 31,
2010, 1,017,501 options could still be granted by the Company (May 31 1,218,667). |
|
|
|
|
All options are to be settled by physical delivery of shares. |
25
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Share capital (continued): |
|
(c) |
|
Stock option plan (continued): |
|
|
|
|
Changes in outstanding options granted under the Companys stock option plan for the year
ended November 30, 2009 and the six-month period ended May 31, 2010 were as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
|
|
|
|
exercise price |
|
|
|
Number |
|
|
per share |
|
|
|
|
|
|
|
|
$ |
|
Options as at December 1, 2008 |
|
|
2,161,800 |
|
|
|
6.52 |
|
|
Granted |
|
|
680,500 |
|
|
|
1.83 |
|
Expired |
|
|
(58,500 |
) |
|
|
5.16 |
|
Forfeited |
|
|
(118,000 |
) |
|
|
9.92 |
|
|
|
|
|
|
|
|
|
|
|
Options as at November 30, 2009 |
|
|
2,665,800 |
|
|
|
5.20 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
265,000 |
|
|
|
3.84 |
|
Expired |
|
|
(10,000 |
) |
|
|
8.65 |
|
Forfeited |
|
|
(27,667 |
) |
|
|
3.15 |
|
Exercised |
|
|
(55,161 |
) |
|
|
1.66 |
|
|
|
|
|
|
|
|
|
|
|
Options as at May 31, 2010 |
|
|
2,837,972 |
|
|
|
5.15 |
|
|
The fair value of the options granted was estimated at the grant date using the
Black-Scholes model and the following weighted average assumptions:
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
Risk-free interest rate |
|
|
2.46 |
% |
|
|
1.79 |
% |
Volatility |
|
|
81 |
% |
|
|
79 |
% |
Average option life in years |
|
|
7.5 |
|
|
|
7.5 |
|
Dividend yield |
|
Nil |
|
|
Nil |
|
Grant-date share price |
|
$ |
3.84 |
|
|
$ |
1.83 |
|
Option exercise price |
|
$ |
3.84 |
|
|
$ |
1.83 |
|
|
26
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Share capital (continued): |
|
(c) |
|
Stock option plan (continued): |
|
|
|
|
The risk-free interest rate is based on the implied yield on a Canadian Treasury
zero-coupon issue with a remaining term equal to the expected term of the option. The
volatility is based solely on historical volatility equal to the expected term of the
option. The average life of the options is estimated considering the vesting period, the
term of the option and the length of time that similar grants have remained outstanding in
the past. Dividend yield was excluded from the calculation, since it is the present policy
of the Company not to retain in cash in order to keep funds available to finance the
Companys growth. |
|
|
|
|
The following table summarizes the measurement date weighted average fair value of stock
options granted during the periods ended May 31, 2010 and 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
Number of |
|
|
grant-date |
|
Periods ended May 31 (6 months) |
|
options |
|
|
fair value |
|
|
|
|
|
|
|
|
$ |
|
2010 |
|
|
265,000 |
|
|
|
2.90 |
|
2009 |
|
|
660,500 |
|
|
|
1.34 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
Number of |
|
|
grant-date |
|
Periods ended May 31 (3 months) |
|
options |
|
|
fair value |
|
|
|
|
|
|
|
|
$ |
|
|
2010 |
|
|
|
|
|
|
|
|
2009 |
|
|
70,000 |
|
|
|
1.38 |
|
|
The Black-Scholes model used by the Company to calculate option values was developed
to estimate the fair value of freely tradable, fully transferable options without vesting
restrictions, which significantly differs from the Companys stock option awards. This
model also requires four highly subjective assumptions, including future stock price
volatility and average option life, which greatly affect the calculated values.
27
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Share capital (continued): |
|
(d) |
|
Earnings per share: |
|
|
|
|
The calculation of basic earnings per share at May 31, 2010 was based on the net loss
attributable to common shareholders of the Company of ($9,012) (2009 ($16,281)), and a
weighted average number of common shares outstanding of 60,452,993 (2009 60,227,527),
calculated as follows: |
|
|
|
|
|
|
|
|
|
|
|
May 31, |
|
|
May 31, |
|
|
|
2010 |
|
|
2009 |
|
|
Issued common shares at December 1 |
|
|
60,429,343 |
|
|
|
58,215,090 |
|
Effect of share options exercised |
|
|
23,268 |
|
|
|
|
|
Effect of shares issued during the year |
|
|
332 |
|
|
|
2,012,437 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares at May 31 |
|
|
60,452,943 |
|
|
|
60,227,527 |
|
|
At May 31, 2010, 1,147,166 options (2009 1,393,959) were excluded from the diluted
weighted average number of common shares calculation as their effect would have been
anti-dilutive.
6. |
|
Supplemental information: |
The following transactions were conducted by the Company and did not impact cash flows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 31, |
|
|
May 31, |
|
|
November 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2009 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
Additions to property and equipment included in accounts payable and
accrued liabilities |
|
|
61 |
|
|
|
9 |
|
|
|
183 |
|
|
Except for changes related to the Companys adoption of IFRS, these amended unaudited interim
consolidated financial statements do not reflect events occurring after July 7, 2010, the date
of the filing of the consolidated financial statements prepared in accordance with Canadian
GAAP. The annual audited consolidated financial statements of the Company prepared in
accordance with IFRS have been filed concurrently with these amended unaudited interim
consolidated financial statements. These amended unaudited interim consolidated financial
statements should be read in connection with the annual consolidated financial statements for
additional disclosures with respect to subsequent events.
28
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
As stated in note 2 (a), the Company has applied IFRS 1 and the accounting policies set out in
note 3 in preparing the financial statements for the period ended May 31, 2010, the comparative
period ended May 31, 2009, for the year ended November 30, 2009, and for the opening IFRS
statement of financial position as at December 1, 2008 (the Companys date of transition).
In preparing these consolidated financial statements in accordance with IFRS 1, the Company has
applied the mandatory exceptions and certain of the optional exemptions from full retrospective
application of IFRS.
The Company elected to apply the following optional exemptions from full retrospective
application:
|
(i) |
|
Share-based payment transaction exemption: |
|
|
|
|
The Company has elected to apply the share-based payment exemption. It applied IFRS 2 from
December 1, 2008 to those stock options that were issued after November 7, 2002 but that
had not vested by December 1, 2008. The application of the exemption is detailed below. |
|
|
(ii) |
|
Designation of financial assets and financial liabilities exemption: |
|
|
|
|
The Company elected to re-designate cash from the held for trading category to loans and
receivables. |
As required by IFRS 1, estimates made under IFRS at the date of transition must be consistent
with estimates made for the same date under previous GAAP, unless there is evidence that those
estimates were in error.
In preparing its opening IFRS consolidated statement of financial position, the Company has
adjusted amounts reported previously in financial statements prepared in accordance with
Canadian GAAP.
An explanation of how the transition from previous Canadian GAAP to IFRS has affected the
Companys financial position, financial performance and cash flows is set out in the following
tables and accompanying notes.
29
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
|
Reconciliation of equity as at December 1, 2008 and November 30, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 1, 2008 |
|
|
November 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Note |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
|
|
|
|
|
133 |
|
|
|
|
|
|
|
|
|
|
|
133 |
|
|
|
1,519 |
|
|
|
|
|
|
|
|
|
|
|
1,519 |
|
Bonds |
|
|
|
|
|
|
10,955 |
|
|
|
|
|
|
|
|
|
|
|
10,955 |
|
|
|
10,036 |
|
|
|
|
|
|
|
|
|
|
|
10,036 |
|
Trade and other
receivables |
|
|
|
|
|
|
610 |
|
|
|
|
|
|
|
|
|
|
|
610 |
|
|
|
375 |
|
|
|
|
|
|
|
|
|
|
|
375 |
|
Tax credits and
grants receivable |
|
|
(a |
) |
|
|
1,784 |
|
|
|
|
|
|
|
(333 |
) |
|
|
1,451 |
|
|
|
1,666 |
|
|
|
|
|
|
|
(333 |
) |
|
|
1,333 |
|
Inventories |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,225 |
|
|
|
|
|
|
|
|
|
|
|
2,225 |
|
Research supplies |
|
|
(a |
) |
|
|
301 |
|
|
|
|
|
|
|
(301 |
) |
|
|
|
|
|
|
287 |
|
|
|
|
|
|
|
(287 |
) |
|
|
|
|
Prepaid expenses |
|
|
(a |
) |
|
|
397 |
|
|
|
|
|
|
|
342 |
|
|
|
739 |
|
|
|
302 |
|
|
|
|
|
|
|
328 |
|
|
|
630 |
|
|
Total current assets |
|
|
|
|
|
|
14,180 |
|
|
|
|
|
|
|
(292 |
) |
|
|
13,888 |
|
|
|
16,410 |
|
|
|
|
|
|
|
(292 |
) |
|
|
16,118 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bonds |
|
|
|
|
|
|
35,249 |
|
|
|
|
|
|
|
|
|
|
|
35,249 |
|
|
|
51,807 |
|
|
|
|
|
|
|
|
|
|
|
51,807 |
|
Property and equipment |
|
|
|
|
|
|
1,299 |
|
|
|
|
|
|
|
|
|
|
|
1,299 |
|
|
|
1,229 |
|
|
|
|
|
|
|
|
|
|
|
1,229 |
|
Other assets |
|
|
(a |
) |
|
|
2,817 |
|
|
|
|
|
|
|
(41 |
) |
|
|
2,776 |
|
|
|
41 |
|
|
|
|
|
|
|
(41 |
) |
|
|
|
|
|
Total non-current assets |
|
|
|
|
|
|
39,365 |
|
|
|
|
|
|
|
(41 |
) |
|
|
39,324 |
|
|
|
53,077 |
|
|
|
|
|
|
|
(41 |
) |
|
|
53,036 |
|
|
Total assets |
|
|
|
|
|
|
53,545 |
|
|
|
|
|
|
|
(333 |
) |
|
|
53,212 |
|
|
|
69,487 |
|
|
|
|
|
|
|
(333 |
) |
|
|
69,154 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
and accrued liabilities |
|
|
(a |
) |
|
|
7,198 |
|
|
|
|
|
|
|
(333 |
) |
|
|
6,865 |
|
|
|
5,901 |
|
|
|
|
|
|
|
(333 |
) |
|
|
5,568 |
|
Current portion of
deferred revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,847 |
|
|
|
|
|
|
|
|
|
|
|
6,847 |
|
|
Total current liabilities |
|
|
|
|
|
|
7,198 |
|
|
|
|
|
|
|
(333 |
) |
|
|
6,865 |
|
|
|
12,748 |
|
|
|
|
|
|
|
(333 |
) |
|
|
12,415 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,691 |
|
|
|
|
|
|
|
|
|
|
|
13,691 |
|
|
Total non-current liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,691 |
|
|
|
|
|
|
|
|
|
|
|
13,691 |
|
|
Total liabilities |
|
|
|
|
|
|
7,198 |
|
|
|
|
|
|
|
(333 |
) |
|
|
6,865 |
|
|
|
26,439 |
|
|
|
|
|
|
|
(333 |
) |
|
|
26,106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
|
|
|
|
269,219 |
|
|
|
|
|
|
|
|
|
|
|
269,219 |
|
|
|
279,169 |
|
|
|
|
|
|
|
|
|
|
|
279,169 |
|
Contributed surplus |
|
|
(b |
) |
|
|
5,585 |
|
|
|
175 |
|
|
|
|
|
|
|
5,760 |
|
|
|
6,484 |
|
|
|
273 |
|
|
|
|
|
|
|
6,757 |
|
Deficit |
|
|
(b |
) |
|
|
(228,829 |
) |
|
|
(175 |
) |
|
|
|
|
|
|
(229,004 |
) |
|
|
(243,887 |
) |
|
|
(273 |
) |
|
|
|
|
|
|
(244,160 |
) |
Accumulated other
comprehensive income |
|
|
|
|
|
|
372 |
|
|
|
|
|
|
|
|
|
|
|
372 |
|
|
|
1,282 |
|
|
|
|
|
|
|
|
|
|
|
1,282 |
|
|
Total equity |
|
|
|
|
|
|
46,347 |
|
|
|
|
|
|
|
|
|
|
|
46,347 |
|
|
|
43,048 |
|
|
|
|
|
|
|
|
|
|
|
43,048 |
|
|
Total liabilities and equity |
|
|
|
|
|
|
53,545 |
|
|
|
|
|
|
|
(333 |
) |
|
|
53,212 |
|
|
|
69,487 |
|
|
|
|
|
|
|
(333 |
) |
|
|
69,154 |
|
|
30
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
|
Reconciliation of equity as at May 31, 2010 and 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 31, 2010 |
|
|
May 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Note |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
|
|
|
|
|
3,497 |
|
|
|
|
|
|
|
|
|
|
|
3,497 |
|
|
|
3,834 |
|
|
|
|
|
|
|
|
|
|
|
3,834 |
|
Bonds |
|
|
|
|
|
|
5,292 |
|
|
|
|
|
|
|
|
|
|
|
5,292 |
|
|
|
12,776 |
|
|
|
|
|
|
|
|
|
|
|
12,776 |
|
Trade and other
receivables |
|
|
|
|
|
|
176 |
|
|
|
|
|
|
|
|
|
|
|
176 |
|
|
|
276 |
|
|
|
|
|
|
|
|
|
|
|
276 |
|
Tax credits and
grants receivable |
|
|
(a |
) |
|
|
2,002 |
|
|
|
|
|
|
|
(333 |
) |
|
|
1,669 |
|
|
|
2,874 |
|
|
|
|
|
|
|
(333 |
) |
|
|
2,541 |
|
Inventories |
|
|
|
|
|
|
4,496 |
|
|
|
|
|
|
|
|
|
|
|
4,496 |
|
|
|
1,594 |
|
|
|
|
|
|
|
|
|
|
|
1,594 |
|
Research supplies |
|
|
(a |
) |
|
|
271 |
|
|
|
|
|
|
|
(271 |
) |
|
|
|
|
|
|
697 |
|
|
|
|
|
|
|
(697 |
) |
|
|
|
|
Prepaid expenses |
|
|
(a |
) |
|
|
663 |
|
|
|
|
|
|
|
312 |
|
|
|
975 |
|
|
|
523 |
|
|
|
|
|
|
|
958 |
|
|
|
1,481 |
|
|
Total current assets |
|
|
|
|
|
|
16,397 |
|
|
|
|
|
|
|
(292 |
) |
|
|
16,105 |
|
|
|
22,574 |
|
|
|
|
|
|
|
(72 |
) |
|
|
22,502 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bonds |
|
|
|
|
|
|
40,259 |
|
|
|
|
|
|
|
|
|
|
|
40,259 |
|
|
|
44,714 |
|
|
|
|
|
|
|
|
|
|
|
44,714 |
|
Property and equipment |
|
|
|
|
|
|
1,161 |
|
|
|
|
|
|
|
|
|
|
|
1,161 |
|
|
|
1,211 |
|
|
|
|
|
|
|
|
|
|
|
1,211 |
|
Other assets |
|
|
(a |
) |
|
|
41 |
|
|
|
|
|
|
|
(41 |
) |
|
|
|
|
|
|
2,390 |
|
|
|
|
|
|
|
(261 |
) |
|
|
2,129 |
|
|
Total non-current assets |
|
|
|
|
|
|
41,461 |
|
|
|
|
|
|
|
(41 |
) |
|
|
41,420 |
|
|
|
48,315 |
|
|
|
|
|
|
|
(261 |
) |
|
|
48,054 |
|
|
Total assets |
|
|
|
|
|
|
57,858 |
|
|
|
|
|
|
|
(333 |
) |
|
|
57,525 |
|
|
|
70,889 |
|
|
|
|
|
|
|
(333 |
) |
|
|
70,556 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
and accrued liabilities |
|
|
(a |
) |
|
|
7,045 |
|
|
|
|
|
|
|
(333 |
) |
|
|
6,712 |
|
|
|
5,483 |
|
|
|
|
|
|
|
(333 |
) |
|
|
5,150 |
|
Current portion of
deferred revenue |
|
|
|
|
|
|
6,852 |
|
|
|
|
|
|
|
|
|
|
|
6,852 |
|
|
|
6,853 |
|
|
|
|
|
|
|
|
|
|
|
6,853 |
|
|
Total current liabilities |
|
|
|
|
|
|
13,897 |
|
|
|
|
|
|
|
(333 |
) |
|
|
13,564 |
|
|
|
12,336 |
|
|
|
|
|
|
|
(333 |
) |
|
|
12,003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other liabilities |
|
|
|
|
|
|
42 |
|
|
|
|
|
|
|
|
|
|
|
42 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
|
|
|
|
10,268 |
|
|
|
|
|
|
|
|
|
|
|
10,268 |
|
|
|
17,114 |
|
|
|
|
|
|
|
|
|
|
|
17,114 |
|
|
Total non-current liabilities |
|
|
|
|
|
|
10,310 |
|
|
|
|
|
|
|
|
|
|
|
10,310 |
|
|
|
17,114 |
|
|
|
|
|
|
|
|
|
|
|
17,114 |
|
|
Total liabilities |
|
|
|
|
|
|
24,207 |
|
|
|
|
|
|
|
(333 |
) |
|
|
23,874 |
|
|
|
29,450 |
|
|
|
|
|
|
|
(333 |
) |
|
|
29,117 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
|
|
|
|
279,329 |
|
|
|
|
|
|
|
|
|
|
|
279,329 |
|
|
|
279,080 |
|
|
|
|
|
|
|
|
|
|
|
279,080 |
|
Contributed surplus |
|
|
(b |
) |
|
|
6,948 |
|
|
|
195 |
|
|
|
|
|
|
|
7,143 |
|
|
|
6,085 |
|
|
|
272 |
|
|
|
|
|
|
|
6,357 |
|
Deficit |
|
|
(b |
) |
|
|
(252,977 |
) |
|
|
(195 |
) |
|
|
|
|
|
|
(253,172 |
) |
|
|
(245,013 |
) |
|
|
(272 |
) |
|
|
|
|
|
|
(245,285 |
) |
Accumulated other
comprehensive income |
|
|
|
|
|
|
351 |
|
|
|
|
|
|
|
|
|
|
|
351 |
|
|
|
1,287 |
|
|
|
|
|
|
|
|
|
|
|
1,287 |
|
|
Total equity |
|
|
|
|
|
|
33,651 |
|
|
|
|
|
|
|
|
|
|
|
33,651 |
|
|
|
41,439 |
|
|
|
|
|
|
|
|
|
|
|
41,439 |
|
|
Total liabilities and equity |
|
|
|
|
|
|
57,858 |
|
|
|
|
|
|
|
(333 |
) |
|
|
57,525 |
|
|
|
70,889 |
|
|
|
|
|
|
|
(333 |
) |
|
|
70,556 |
|
|
31
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
|
Reconciliation of comprehensive income for the year ended November 30, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Note |
|
|
GAAP |
|
|
ments |
|
|
fication |
|
|
IFRS |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
10,884 |
|
|
|
10,884 |
|
Upfront payments and initial technology access fees |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
6,560 |
|
|
|
6,560 |
|
Royalties and license fees |
|
|
(c |
) |
|
|
17,468 |
|
|
|
|
|
|
|
(17,444 |
) |
|
|
24 |
|
Interest |
|
|
(c |
) |
|
|
2,252 |
|
|
|
|
|
|
|
(2,252 |
) |
|
|
|
|
|
Total revenue |
|
|
|
|
|
|
19,720 |
|
|
|
|
|
|
|
(2,252 |
) |
|
|
17,468 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses, net of tax credits |
|
|
(b), (c |
) |
|
|
20,431 |
|
|
|
33 |
|
|
|
346 |
|
|
|
20,810 |
|
Selling and market development expenses |
|
|
(b), (c |
) |
|
|
2,583 |
|
|
|
10 |
|
|
|
4,269 |
|
|
|
6,862 |
|
General and administrative expenses |
|
|
(b), (c |
) |
|
|
7,149 |
|
|
|
55 |
|
|
|
(661 |
) |
|
|
6,543 |
|
Patents |
|
|
(c |
) |
|
|
346 |
|
|
|
|
|
|
|
(346 |
) |
|
|
|
|
Fees associated with the collaboration and licensing
agreement |
|
|
(c |
) |
|
|
4,269 |
|
|
|
|
|
|
|
(4,269 |
) |
|
|
|
|
|
Total operating expenses |
|
|
|
|
|
|
34,778 |
|
|
|
98 |
|
|
|
(661 |
) |
|
|
34,215 |
|
|
Results from operating activities |
|
|
|
|
|
|
(15,058 |
) |
|
|
(98 |
) |
|
|
(1,591 |
) |
|
|
(16,747 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
2,252 |
|
|
|
2,252 |
|
Finance costs |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
(661 |
) |
|
|
(661 |
) |
|
Total net finance income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,591 |
|
|
|
1,591 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
(15,058 |
) |
|
|
(98 |
) |
|
|
|
|
|
|
(15,156 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income, net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value of available-for-sale financial assets,
net of tax |
|
|
|
|
|
|
1,039 |
|
|
|
|
|
|
|
|
|
|
|
1,039 |
|
Net change in fair value of available-for-sale financial assets
transferred to net loss, net of tax |
|
|
|
|
|
|
(129 |
) |
|
|
|
|
|
|
|
|
|
|
(129 |
) |
|
Other comprehensive income for the year |
|
|
|
|
|
|
910 |
|
|
|
|
|
|
|
|
|
|
|
910 |
|
|
Total comprehensive income for the year |
|
|
|
|
|
|
(14,148 |
) |
|
|
(98 |
) |
|
|
|
|
|
|
(14,246 |
) |
|
32
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
|
Reconciliation of comprehensive income for the three-month periods ended May 31, 2010 and 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 31, 2010 |
|
|
May 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Note |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Upfront payments
and initial
technology
access fees |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
1,712 |
|
|
|
1,712 |
|
|
|
|
|
|
|
|
|
|
|
1,711 |
|
|
|
1,711 |
|
Royalties and license
fees |
|
|
(c |
) |
|
|
1,717 |
|
|
|
|
|
|
|
(1,712 |
) |
|
|
5 |
|
|
|
1,717 |
|
|
|
|
|
|
|
(1,711 |
) |
|
|
6 |
|
Interest |
|
|
(c |
) |
|
|
509 |
|
|
|
|
|
|
|
(509 |
) |
|
|
|
|
|
|
600 |
|
|
|
|
|
|
|
(600 |
) |
|
|
|
|
|
Total revenue |
|
|
|
|
|
|
2,226 |
|
|
|
|
|
|
|
(509 |
) |
|
|
1,717 |
|
|
|
2,317 |
|
|
|
|
|
|
|
(600 |
) |
|
|
1,717 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
expenses, net of
tax credits |
|
|
(b), (c |
) |
|
|
4,092 |
|
|
|
(50 |
) |
|
|
136 |
|
|
|
4,178 |
|
|
|
5,274 |
|
|
|
5 |
|
|
|
76 |
|
|
|
5,355 |
|
Selling and market
development
expenses |
|
|
(b), (c |
) |
|
|
764 |
|
|
|
1 |
|
|
|
|
|
|
|
765 |
|
|
|
540 |
|
|
|
5 |
|
|
|
|
|
|
|
545 |
|
General and
administrative
expenses |
|
|
(b), (c |
) |
|
|
2,057 |
|
|
|
(3 |
) |
|
|
(95 |
) |
|
|
1,959 |
|
|
|
1,857 |
|
|
|
14 |
|
|
|
(316 |
) |
|
|
1,555 |
|
Patents |
|
|
(c |
) |
|
|
136 |
|
|
|
|
|
|
|
(136 |
) |
|
|
|
|
|
|
76 |
|
|
|
|
|
|
|
(76 |
) |
|
|
|
|
|
Total operating expenses |
|
|
|
|
|
|
7,049 |
|
|
|
(52 |
) |
|
|
(95 |
) |
|
|
6,902 |
|
|
|
7,747 |
|
|
|
24 |
|
|
|
(316 |
) |
|
|
7,455 |
|
|
Results from operating
activities |
|
|
|
|
|
|
(4,823 |
) |
|
|
52 |
|
|
|
(414 |
) |
|
|
(5,185 |
) |
|
|
(5,430 |
) |
|
|
(24 |
) |
|
|
(284 |
) |
|
|
(5,738 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
509 |
|
|
|
509 |
|
|
|
|
|
|
|
|
|
|
|
600 |
|
|
|
600 |
|
Finance costs |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
(95 |
) |
|
|
(95 |
) |
|
|
|
|
|
|
|
|
|
|
(316 |
) |
|
|
(316 |
) |
|
Total net finance income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
414 |
|
|
|
414 |
|
|
|
|
|
|
|
|
|
|
|
284 |
|
|
|
284 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
(4,823 |
) |
|
|
52 |
|
|
|
|
|
|
|
(4,771 |
) |
|
|
(5,430 |
) |
|
|
(24 |
) |
|
|
|
|
|
|
(5,454 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income, net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value
of available-for-sale
financial assets, net of tax |
|
|
|
|
|
|
(740 |
) |
|
|
|
|
|
|
|
|
|
|
(740 |
) |
|
|
668 |
|
|
|
|
|
|
|
|
|
|
|
668 |
|
Net change in fair value
of available-for-sale
financial assets
transferred to net loss,
net of tax |
|
|
|
|
|
|
(94 |
) |
|
|
|
|
|
|
|
|
|
|
(94 |
) |
|
|
(47 |
) |
|
|
|
|
|
|
|
|
|
|
(47 |
) |
|
Other comprehensive income
for the period |
|
|
|
|
|
|
(834 |
) |
|
|
|
|
|
|
|
|
|
|
(834 |
) |
|
|
621 |
|
|
|
|
|
|
|
|
|
|
|
621 |
|
|
Total comprehensive income
for the period |
|
|
|
|
|
|
(5,657 |
) |
|
|
52 |
|
|
|
|
|
|
|
(5,605 |
) |
|
|
(4,809 |
) |
|
|
(24 |
) |
|
|
|
|
|
|
(4,833 |
) |
|
33
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
|
Reconciliation of comprehensive income for the six-month periods ended May 31, 2010 and 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 31, 2010 |
|
|
May 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Note |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Upfront payments
and initial
technology
access fees |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
3,423 |
|
|
|
3,423 |
|
|
|
|
|
|
|
|
|
|
|
3,137 |
|
|
|
3,137 |
|
Royalties and license
fees |
|
|
(c |
) |
|
|
3,434 |
|
|
|
|
|
|
|
(3,423 |
) |
|
|
11 |
|
|
|
3,149 |
|
|
|
|
|
|
|
(3,137 |
) |
|
|
12 |
|
Interest |
|
|
(c |
) |
|
|
1,087 |
|
|
|
|
|
|
|
(1,087 |
) |
|
|
|
|
|
|
1,177 |
|
|
|
|
|
|
|
(1,177 |
) |
|
|
|
|
|
Total revenue |
|
|
|
|
|
|
4,521 |
|
|
|
|
|
|
|
(1,087 |
) |
|
|
3,434 |
|
|
|
4,326 |
|
|
|
|
|
|
|
(1,177 |
) |
|
|
3,149 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
expenses, net of
tax credits |
|
|
(b), (c |
) |
|
|
8,033 |
|
|
|
(72 |
) |
|
|
340 |
|
|
|
8,301 |
|
|
|
10,921 |
|
|
|
33 |
|
|
|
121 |
|
|
|
11,075 |
|
Selling and market
development
expenses |
|
|
(b), (c |
) |
|
|
1,380 |
|
|
|
5 |
|
|
|
|
|
|
|
1,385 |
|
|
|
1,021 |
|
|
|
5 |
|
|
|
4,269 |
|
|
|
5,295 |
|
General and
administrative
expenses |
|
|
(b), (c |
) |
|
|
3,858 |
|
|
|
(11 |
) |
|
|
(143 |
) |
|
|
3,704 |
|
|
|
4,178 |
|
|
|
59 |
|
|
|
(745 |
) |
|
|
3,492 |
|
Patents |
|
|
(c |
) |
|
|
340 |
|
|
|
|
|
|
|
(340 |
) |
|
|
|
|
|
|
121 |
|
|
|
|
|
|
|
(121 |
) |
|
|
|
|
Other expenses |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
|
|
|
(4,269 |
) |
|
|
|
|
|
Total operating expenses |
|
|
|
|
|
|
13,611 |
|
|
|
(78 |
) |
|
|
(143 |
) |
|
|
13,390 |
|
|
|
20,510 |
|
|
|
97 |
|
|
|
(745 |
) |
|
|
19,862 |
|
|
Results from operating
activities |
|
|
|
|
|
|
(9,090 |
) |
|
|
78 |
|
|
|
(944 |
) |
|
|
(9,956 |
) |
|
|
(16,184 |
) |
|
|
(97 |
) |
|
|
(432 |
) |
|
|
(16,713 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
1,087 |
|
|
|
1,087 |
|
|
|
|
|
|
|
|
|
|
|
1,177 |
|
|
|
1,177 |
|
Finance costs |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
(143 |
) |
|
|
(143 |
) |
|
|
|
|
|
|
|
|
|
|
(745 |
) |
|
|
(745 |
) |
|
Total net finance income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
944 |
|
|
|
944 |
|
|
|
|
|
|
|
|
|
|
|
432 |
|
|
|
432 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
(9,090 |
) |
|
|
78 |
|
|
|
|
|
|
|
(9,012 |
) |
|
|
(16,184 |
) |
|
|
(97 |
) |
|
|
|
|
|
|
(16,281 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income, net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value
of available-for-sale
financial assets, net of tax |
|
|
|
|
|
|
(737 |
) |
|
|
|
|
|
|
|
|
|
|
(737 |
) |
|
|
985 |
|
|
|
|
|
|
|
|
|
|
|
985 |
|
Net change in fair value
of available-for-sale
financial assets
transferred to net loss,
net of tax |
|
|
|
|
|
|
(194 |
) |
|
|
|
|
|
|
|
|
|
|
(194 |
) |
|
|
(70 |
) |
|
|
|
|
|
|
|
|
|
|
(70 |
) |
|
Other comprehensive income
for the period |
|
|
|
|
|
|
(931 |
) |
|
|
|
|
|
|
|
|
|
|
(931 |
) |
|
|
915 |
|
|
|
|
|
|
|
|
|
|
|
915 |
|
|
Total comprehensive income
for the period |
|
|
|
|
|
|
(10,021 |
) |
|
|
78 |
|
|
|
|
|
|
|
(9,943 |
) |
|
|
(15,269 |
) |
|
|
(97 |
) |
|
|
|
|
|
|
(15,366 |
) |
|
34
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
|
Material adjustments to the consolidated statement of cash flows for 2010 and 2009: |
|
|
|
There are no material differences between the consolidated statement of cash flows presented
under IFRS and the consolidated statement of cash flows presented under previous Canadian GAAP. |
|
|
|
Notes to the reconciliations: |
|
(a) |
|
Reclassification in the consolidated statement of financial position: |
|
|
|
|
Certain corresponding figures as at December 1, 2008, November 30, 2009, May 31, 2009 and
2010 have been reclassified to conform to the new presentation under IFRS. |
|
|
(b) |
|
Share-based compensation: |
|
|
|
|
In certain situations, stock options granted vest in installments over a specified vesting
period. When the only vesting condition is service from the grant date to the vesting date
of each tranche awarded, then each installment should be accounted for as a separate
share-based payment arrangement under IFRS, otherwise known as graded vesting. Canadian
GAAP permits an entity the accounting policy choice with respect to graded vesting awards.
Each installment can be considered as a separate award, each with a different vesting
period, consistent with IFRS, or the arrangement can be treated as a single award with a
vesting period based on the average vesting period of the installments depending on the
policy elected. |
|
|
|
|
The Companys policy under Canadian GAAP was to treat graded vesting awards under the
latter method and, as a result, an adjustment of $175 was required on the application of
IFRS 2 at the transition date and an adjustment of $98 was required for the restated
November 30, 2009, $97 for May 31, 2009 and ($78) for May 31, 2010 as shown below: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 1, |
|
|
November 30, |
|
|
May 31, |
|
|
May 31, |
|
|
|
2008 |
|
|
2009 |
|
|
2009 |
|
|
2010 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Consolidated statement of comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase in research and development expenses |
|
|
|
|
|
|
33 |
|
|
|
33 |
|
|
|
(72 |
) |
Increase in selling and market development expenses |
|
|
|
|
|
|
10 |
|
|
|
5 |
|
|
|
5 |
|
Increase in general and administrative expenses |
|
|
|
|
|
|
55 |
|
|
|
59 |
|
|
|
(11 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustment to net loss and total comprehensive loss |
|
|
|
|
|
|
98 |
|
|
|
97 |
|
|
|
(78 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
(175 |
) |
|
|
(273 |
) |
|
|
(272 |
) |
|
|
(195 |
) |
Increase in contributed surplus |
|
|
175 |
|
|
|
273 |
|
|
|
272 |
|
|
|
195 |
|
|
35
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Six-month periods ended May 31, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
(c) |
|
Reclassification in the consolidated statement of comprehensive income: |
|
|
|
|
Under IFRS, the Company elected to present expenses using a classification based on their
function and presents net finance income separately. The effect of these changes is
summarized below: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November 30, |
|
|
May 31, |
|
|
May 31, |
|
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
Decrease in interest |
|
|
(2,252 |
) |
|
|
(1,087 |
) |
|
|
(1,177 |
) |
Increase in finance income |
|
|
2,252 |
|
|
|
1,087 |
|
|
|
1,177 |
|
Increase in research and development expenses |
|
|
346 |
|
|
|
340 |
|
|
|
121 |
|
Decrease in patent fees |
|
|
(346 |
) |
|
|
(340 |
) |
|
|
(121 |
) |
Decrease in general and administrative expenses |
|
|
(661 |
) |
|
|
(143 |
) |
|
|
(745 |
) |
Increase in finance costs |
|
|
661 |
|
|
|
143 |
|
|
|
745 |
|
Increase in selling and market development activities |
|
|
4,269 |
|
|
|
|
|
|
|
4,269 |
|
Decrease in other expenses |
|
|
(4,269 |
) |
|
|
|
|
|
|
(4,269 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in presentation were also made to the revenue caption in order to conform with
the new presentation under IFRS as noted below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November 30, |
|
|
May 31, |
|
|
May 31, |
|
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
Decrease in royalties and license fees |
|
|
(17,444 |
) |
|
|
(3,423 |
) |
|
|
(3,137 |
) |
Increase in upfront payments and initial technology access fees |
|
|
6,560 |
|
|
|
3,423 |
|
|
|
3,137 |
|
Increase in milestone payments |
|
|
10,884 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36
ex-99.17
Exhibit 99.17
MANAGEMENTS DISCUSSION AND ANALYSIS
FOR THE THREE-MONTH AND SIX-MONTH PERIODS ENDED MAY 31, 2010
The following Managements Discussion and Analysis (MD&A) provides Managements point of view on
the financial position and the results of operations of Theratechnologies Inc. (Theratechnologies
or the Company), for the three-month and six-month periods ended May 31, 2010, as compared to the
three-month and six-month periods ended May 31, 2009. This view contains certain factors that the
Company believes may affect its prospective financial condition, cash flows and results of
operations. The unaudited interim consolidated financial statements have been prepared in
accordance with Canadian generally accepted accounting principles (GAAP). This MD&A should be
read in conjunction with the unaudited interim consolidated financial statements of the Company and
the notes thereto as at May 31, 2010, as well as the MD&A and audited consolidated financial
statements including the related notes thereto as at November 30, 2009. Unless specified otherwise,
all amounts are in Canadian dollars.
Financial Overview
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company
targets unmet medical needs in financially attractive specialty markets where it can retain all or
some of the commercial rights to its products. Its most advanced compound, tesamorelin, is an
analogue of the human growth hormone releasing factor.
The Companys growth strategy is centered upon the development of tesamorelin. In late 2008,
Theratechnologies entered into a collaboration and licensing agreement with EMD Serono, Inc. (EMD
Serono) (an affiliate of Merck KGaA, Darmstadt, Germany), for the exclusive commercialization
rights to tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in the United States. The principal strategic objective of Theratechnologies is to
obtain regulatory approval for tesamorelin in this indication and good progress was made in the
second quarter by participating in the U.S. Food and Drug Administration (FDA or the Agency)
Endocrinologic and Metabolic Drugs Advisory Committee. On May 27, 2010, the Committee recommended
by a 16 to 0 unanimous vote that tesamorelin be granted marketing approval by the FDA for this
treatment. Although advisory committees provide their recommendations to the FDA, the final
decisions on marketing approvals are made by the Agency. The FDA has indicated that the action goal
date, which is the target date for the FDA to complete its review of the tesamorelin New Drug
Application (NDA), will be July 27, 2010. If tesamorelin is approved, the Company expects to
receive regulatory milestone payments, royalties and additional milestone payments from sales of
tesamorelin by EMD Serono in the U.S.
In addition, Theratechnologies has begun building inventory in preparation for the launch of
tesamorelin in the U.S., in the event of FDA approval. In the coming months, the Company will
continue building inventory.
In the event of approval of tesamorelin, the anticipated 2010 adjusted burn rate of $24,000,000
could be increased by 5 to 10%. Principal components of the potential increase in spending include
the qualification of back-up suppliers for tesamorelin and the drugs fill and finish operation, as
well as preparations for the filing of a New Drug Submission in Canada. Most of these costs would
be associated to projects that are non-repetitive in nature and would be related to the
acceleration of activities in the current business plan.
Revenues
Consolidated revenues for the three-month period ended May 31, 2010, amounted to $2,226,000,
compared to $2,317,000 for 2009. The decreased revenues for the second quarter of 2010 are related
to lower interest revenues due to a lower cash position and a lower interest rate on investments
compared to the same period in 2009. For the six-month period ended May 31, 2010, consolidated
revenues were $4,521,000, compared to $4,326,000 for the same period in 2009. The
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
increased revenues for the six-month period in 2010 are related to a longer amortization period (6
months in 2010 versus 5.5 months in 2009) for the initial payment received within the collaboration
and licensing agreement with EMD Serono.
The initial payment received upon the closing of the agreement with EMD Serono of $27,097,000 has
been deferred and is being amortized over its estimated service period on a straight-line basis.
This period may be modified in the future based on additional information that the Company may
receive. For the three-month period ended May 31, 2010, an amount of $1,711,000 ($1,711,000 for the
same period in 2009) was recognized as revenue related to this transaction, while an amount of
$3,423,000 was recognized as revenue for the six-month period related to this transaction
($3,137,000 for the same period in 2009). At May 31, 2010, the deferred revenues related to this
transaction recorded on the balance sheet amounted to $17,114,000.
R&D Activities
Research and development (R&D) expenses, before tax credits, totalled $4,259,000 for the second
quarter of 2010, compared to $5,696,000 in 2009. For the six-month period ended May 31, 2010, R&D
expenses were $8,368,000, compared to $12,011,000 for the same period in 2009, representing a
decrease of 30.3%. The R&D expenses incurred in the second quarter of 2010 are mainly related to
regulatory activities connected with the preparation for the FDA Advisory Committee meeting,
whereas the expenses incurred in the second quarter of 2009 were principally related to the end of
the Phase 3 clinical trials evaluating tesamorelin in HIV-associated lipodystrophy and the
preparation of the NDA which was submitted to the FDA in May 2009. This explains the significant
reduction in R&D expenses in accordance with the Companys plans.
Other Expenses
For the second quarter of 2010, general and administrative expenses amounted to $2,057,000,
compared to $1,857,000 for the same period in 2009. For the six-month period ended May 31, 2010,
general and administrative expenses amounted to $3,858,000, compared to $4,178,000 for the same
period in 2009. The increase in the second quarter of 2010 is due to costs associated with
heightened communication activities related to the FDA Advisory Committee meeting as well as
increases in other administrative expenses, partially offset by a reduction in the foreign exchange
loss. The higher expenses in the six-month period of the prior year were primarily due to costs
associated with revising the Companys business plan and an increase in foreign exchange loss for
the year.
Selling and market development expenses amounted to $764,000 for the second quarter of 2010,
compared to $540,000 for the same period in 2009. For the six-month period ended May 31, 2010,
selling and market development expenses amounted to $1,380,000, compared to $1,021,000 for the same
period in 2009. The increase in the selling and market development expenses are principally due to
business development and market research expenses for territories outside the United States. These
expenses also include activities associated with the management of the agreement with EMD Serono.
Net Results
Taking into account the revenues and expenses described above, the Company recorded a second
quarter net loss of $4,823,000 ($0.08 per share), compared to a net loss of $5,430,000 ($0.09 per
share) for the same period in 2009. For the six-month period ended May 31, 2010, the net loss was
$9,090,000 ($0.15 per share), compared to a net loss of $16,184,000 ($0.27 per share) for the same
period in 2009.
The net loss in the second quarter of 2010 includes a revenue of $1,711,000 related to the
agreement with EMD Serono. Excluding this item, the adjusted net loss amounted to $6,534,000 in
2010, a decrease of 8.5% compared to the same period in 2009. For the six-month period, the net
loss included revenue and fees related to the agreement with EMD Serono. Excluding those items, the
adjusted net loss amounted to $12,513,000, compared to $15,052,000 for the same period in 2009,
representing a decrease of 16.9%.
2
Financial Position
At May 31, 2010, liquidities, which include cash and bonds, amounted to $49,048,000, and tax
credits receivable amounted to $2,002,000, for a total of $51,050,000.
Taking into account the revenues and expenses described above, for the three-month period ended May
31, 2010, the burn rate from operating activities, excluding changes in operating assets and
liabilities, was $4,387,000, compared to $4,988,000 in 2009. Excluding the revenue and fees related
to the agreement with EMD Serono, the adjusted burn rate from operating activities, excluding
changes in operating assets and liabilities, was $6,098,000 for the quarter ended May 31, 2010,
compared to $6,699,000 for the second quarter of 2009, a decrease of 9%.
Taking into account the revenues and expenses described above, for the six-month period ending May
31, 2010, the burn rate from operating activities, excluding changes in operating assets and
liabilities, was $8,248,000, compared to $15,400,000 for the same period in 2009. Excluding the
revenue and fees associated with the agreement with EMD Serono, the adjusted burn rate from
operating activities, excluding changes in operating assets and liabilities, was $11,671,000,
compared to $14,268,000 for the corresponding period in 2009, representing a decrease of 18.2%.
Quarterly Financial Information
The selected financial information provided below is derived from the Companys unaudited quarterly
financial statements for each of the last eight quarters. This information has been restated
following the adoption of the Canadian Institute of Chartered Accountants (CICA) Handbook Section
3064, Goodwill and Intangible Assets.
(in thousands of Canadian dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
Q2 |
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Revenues |
|
$ |
2,226 |
|
|
$ |
2,295 |
|
|
$ |
2,246 |
|
|
$ |
13,148 |
|
|
$ |
2,317 |
|
|
$ |
2,009 |
|
|
$ |
616 |
|
|
$ |
710 |
|
Net (loss) earnings |
|
$ |
(4,823 |
) |
|
$ |
(4,267 |
) |
|
$ |
(4,698 |
) |
|
$ |
5,824 |
|
|
$ |
(5,430 |
) |
|
$ |
(10,754 |
) |
|
$ |
(15,145 |
) |
|
$ |
(11,220 |
) |
Basic and diluted (loss) earnings per share |
|
$ |
(0.08 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.08 |
) |
|
$ |
0.10 |
|
|
$ |
(0.09 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.19 |
) |
|
As described above, the increased revenues in 2010 and 2009 are related to the amortization of
the initial payment received at the closing of the agreement with EMD Serono, as well as the
milestone payment of $10,884,000 recorded in August 2009. The increase in the fourth quarter net
loss in 2008 is due to impairment charges for intellectual property.
Non-GAAP Measures
The Company uses measures that do not conform to GAAP to assess its operating performance.
Securities regulators require that companies caution readers that earnings and other measures
adjusted to a basis other than GAAP do not have standardized meanings and are unlikely to be
comparable to similar measures used by other companies. Accordingly, these measures should not be
considered in isolation. The Company uses non-GAAP measures such as adjusted net loss and the
adjusted burn rate from operating activities before changes in operating assets and liabilities, to
measure its performance from one period to the next without including changes caused by certain
items that could potentially distort the analysis of trends in its operating performance, and
because such measures provide meaningful information on the Companys financial condition and
operating results.
3
Definition and Reconciliation of Non-GAAP Measures
In order to measure performance from one period to another, without accounting for changes related
to the impact of revenues and fees associated with the collaboration and license agreement with EMD
Serono, management uses adjusted net loss and adjusted burn rate from operating activities before
changes in operating assets and liabilities. These items are excluded because they affect the
comparability of the financial results and could potentially distort the analysis of trends in the
Companys operating performance. The exclusion of these items does not necessarily indicate that
they are non-recurring.
(Thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 31st |
|
|
May 31st |
|
|
|
(3 months) |
|
|
(6 months) |
|
Adjusted net loss |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Net loss, per the financial statements |
|
$ |
(4,823 |
) |
|
$ |
(5,430 |
) |
|
$ |
(9,090 |
) |
|
$ |
(16,184 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue associated with a collaboration and license
agreement (note 6 to the consolidated financial
statements) |
|
|
(1,711 |
) |
|
|
(1,711 |
) |
|
|
(3,423 |
) |
|
|
(3,137 |
) |
Fees associated with collaboration and license agreement |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
Adjusted net loss |
|
$ |
(6,534 |
) |
|
$ |
(7,141 |
) |
|
$ |
(12,513 |
) |
|
$ |
(15,052 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 31st |
|
|
May 31st |
|
|
|
(3 months) |
|
|
(6 months) |
|
Adjusted burn rate before changes in operating assets and liabilities |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Burn rate before changes in operating assets and liabilities, per
the financial statements |
|
$ |
(4,387 |
) |
|
$ |
(4,988 |
) |
|
$ |
(8,248 |
) |
|
$ |
(15,400 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue associated with a collaboration and license agreement (note
6 to the consolidated financial statements) |
|
|
(1,711 |
) |
|
|
(1,711 |
) |
|
|
(3,423 |
) |
|
|
(3,137 |
) |
Fees associated with collaboration and license agreement |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
Adjusted burn rate before changes in operating assets and liabilities |
|
$ |
(6,098 |
) |
|
$ |
(6,699 |
) |
|
$ |
(11,671 |
) |
|
$ |
(14,268 |
) |
|
|
|
New Accounting Policies
In February 2008, the Accounting Standards Board of Canada (AcSB) announced that accounting
standards in Canada, as used by public companies, will converge with International Financial
Reporting Standards (IFRS). The Companys changeover from current Canadian GAAP to IFRS applies
to the fiscal year beginning December 1, 2011 (the Changeover date), when the Company will report
financial information for the first quarter ending February 29, 2012, and that of the comparative
period in accordance with IFRS.
IFRS uses a conceptual framework similar to Canadian GAAP, but presents significant differences in
recognition, measurement and the disclosure of information. In the period leading up to the
conversion, the AcSB will continue to issue accounting standards that are better aligned with IFRS,
thus mitigating the impact of conversion to IFRS. Further, the International Accounting Standards
Board (IASB) will continue to issue new, or amend existing accounting standards during the
conversion period. It will therefore be impossible to determine the final and complete impact on
the Companys consolidated financial statements of applying IFRS prior to knowing all applicable
IFRS standards at the Changeover date.
4
Conversion Plan
The Companys IFRS convergence project includes four steps: diagnostic and planning, detailed
analysis, design, and implementation.
Phase One: Diagnostic Phase This phase involves establishing a transition plan to IFRS and the
initial identification of differences between Canadian GAAP and IFRS.
Phase Two: Detailed Analysis This phase involves a comprehensive assessment of the differences
between the Companys current accounting policies and the requirements of IFRS in order to evaluate
the impact on the Company. In addition, the detailed analysis will identify training requirements,
and determine eventual changes to business processes and information systems.
Phase Three: Design This phase consists of an analysis of the available accounting options under
IFRS, notably the exceptions, exemptions and actual choices available for the transition and the
preparation of draft IFRS financial statements and the accompanying notes. In addition, it is
during this phase that changes to the business processes and the information systems are designed.
Phase Four: Implementation This phase involves implementing changes to systems, business
processes and internal controls, determining the opening IFRS transition balance sheet and the
impact on taxation, parallel accounting under Canadian GAAP and IFRS and preparing detailed
reconciliations between Canadian GAAP and IFRS financial statements.
Conversion
Progress
The Company has completed the Diagnostic Phase in which the preliminary plan for the transition
from current GAAP to IFRS was completed and a team to implement the project was formed. The team,
overseen by the senior financial officers, provides governance, management and support for the
entire project and meets with the members of the Audit Committee quarterly in order to provide an
update on the progress achieved and to discuss important issues. A similar exercise is also
performed with the external auditors.
The Company has now begun the Detailed Analysis Phase which entails a comprehensive analysis of the
IFRS changes identified in the Diagnostic Phase and the exemptions concerning the transition to
IFRS as foreseen in IFRS 1.
Potential Impact on the Company
According to the comparative analysis of the current IFRS with Canadian GAAP, upon which the
Companys accounting practices are now based, the principal changes could affect the following
accounting practices:
|
|
Presentation of financial statements |
|
|
Foreign exchange conversion |
This list is not comprehensive and only lists the principal differences in accounting practices
that, according to the Companys current analysis, will flow from the conversion to IFRS.
However, analysis of the changes is still in progress and certain decisions remain to be made with
respect to available choices of accounting practices. Furthermore, the organizations overseeing
Canadian GAAP and IFRS have significant ongoing projects that could affect the ultimate differences
between Canadian GAAP and IFRS and their impact on the Companys consolidated financial statements
in future years. The areas of differences should be based on existing Canadian GAAP and the IFRS
that will be in effect on November 30, 2012. At this point in time, the Company
5
is not able to
reliably quantify the full impact of these differences on its consolidated financial statements.
The Company continues to evaluate the impact of transitioning to IFRS on the communication of its
financial results. At present, the impact of this transition on the Companys financial position
and future operating results can neither be determined nor estimated in a reasonable fashion.
Outstanding Share Data
On July 6, 2010, the number of shares issued and outstanding was 60,497,934, while outstanding
options granted under the stock option plan were 2,897,472.
Contractual Obligations
There were no material changes in contractual obligations during the first six months of the year,
other than in the ordinary course of business.
Economic and Industry Factors
Economic and industry factors were substantially unchanged from those reported in the Companys
2009 Annual Report.
Forward-Looking Information
This MD&A for the second quarter of 2010 contains certain statements that are considered
forward-looking information within the meaning of applicable securities legislation. This
forward-looking information includes, but is not limited to, information regarding the approval of
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
by the FDA, the receipt of milestone payments and/or royalties under the agreement entered into
with EMD Serono, the filing of a New Drug Submission in Canada, the potential increase in the
adjusted burn rate, and the completion of a conversion plan to IFRS. Furthermore, the words will,
may, could, should, outlook, believe, plan, envisage, anticipate, expect and
estimate, or variations of them denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties include, but are not limited to, the risk that the FDA
does not approve tesamorelin for the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy, the risk that the payment of milestones is delayed or not received or that the
royalties from the sale of tesamorelin are not received, the risk that the preparation of a New
Drug Submission in Canada is delayed or is not completed, the risk that the Company is unable to
enter into commercial agreements with third parties to qualify back-up suppliers of tesamorelin,
and the risk that the timeline for preparing a conversion plan to IFRS is not met.
Although the forward-looking information contained herein is based upon what the Company believes
are reasonable assumptions, investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking information. Certain assumptions
made in preparing the forward-looking information and the Companys objectives include the
assumption, among others, that the FDA will approve tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy, sales of tesamorelin in the United
States will be successful, no issue will occur in the preparation of a New Drug Submission in
Canada, the Company is able to enter into commercial agreements with third parties to qualify
back-up suppliers of tesamorelin, and the Company will not experience any difficulties in preparing
a conversion plan to IFRS.
Consequently, all of the forward-looking information is qualified by the foregoing cautionary
statements, and there can be no guarantee that the results or developments anticipated by the
Company will be realized or, even if substantially realized, that they will have the expected
6
consequences or effects on the Company, its business, its financial condition or its results of
operation. Furthermore, the forward-looking information reflects current expectations regarding
future events only as of the date of release of this MD&A.
Investors are referred to the Companys public filings available at www.sedar.com. In particular,
further details on the risks and descriptions of the risks are disclosed in the Risk and
Uncertainties section of the Companys Annual Information Form, dated February 23, 2010, for the
year ended November 30, 2009. This MD&A is dated July 7, 2010, and has been approved by the Audit
Committee.
###
7
ex-99.18
Exhibit 99.18
Consolidated Financial Statements of
(Unaudited)
THERATECHNOLOGIES INC.
Six-month periods ended May 31, 2010 and 2009
THERATECHNOLOGIES INC.
Consolidated Financial Statements
(Unaudited)
Periods ended May 31, 2010 and 2009
|
|
|
|
|
Financial Statements |
|
|
|
|
|
|
|
|
|
Consolidated Balance Sheets |
|
|
1 |
|
Consolidated Statements of Operations |
|
|
2 |
|
Consolidated Statements of Comprehensive Loss |
|
|
3 |
|
Consolidated Statements of Shareholders Equity |
|
|
45 |
|
Consolidated Statements of Cash Flows |
|
|
6 |
|
Notes to Consolidated Financial Statements |
|
|
7 |
|
THERATECHNOLOGIES INC.
Consolidated
Balance Sheets
(Unaudited)
May 31, 2010 and November 30, 2009
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
May 31, |
|
|
November 30, |
|
|
|
2010 |
|
|
2009 |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
3,497 |
|
|
$ |
1,519 |
|
Bonds |
|
|
5,292 |
|
|
|
10,036 |
|
Accounts receivable |
|
|
176 |
|
|
|
375 |
|
Tax credits receivable |
|
|
2,002 |
|
|
|
1,666 |
|
Inventories |
|
|
4,496 |
|
|
|
2,225 |
|
Research supplies |
|
|
271 |
|
|
|
287 |
|
Prepaid expenses |
|
|
663 |
|
|
|
302 |
|
|
|
|
|
16,397 |
|
|
|
16,410 |
|
|
|
|
|
|
|
|
|
|
Bonds |
|
|
40,259 |
|
|
|
51,807 |
|
Property and equipment |
|
|
1,161 |
|
|
|
1,229 |
|
Other assets |
|
|
41 |
|
|
|
41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
57,858 |
|
|
$ |
69,487 |
|
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
7,045 |
|
|
$ |
5,901 |
|
Current portion of deferred revenues (note 6) |
|
|
6,852 |
|
|
|
6,847 |
|
|
|
|
|
13,897 |
|
|
|
12,748 |
|
|
|
|
|
|
|
|
|
|
Deferred revenues (note 6) |
|
|
10,268 |
|
|
|
13,691 |
|
Deferred lease inducements |
|
|
42 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Capital stock (note 3) |
|
|
279,329 |
|
|
|
279,169 |
|
Contributed surplus |
|
|
6,948 |
|
|
|
6,484 |
|
|
|
|
|
|
|
|
|
|
Accumulated other comprehensive income |
|
|
351 |
|
|
|
1,282 |
|
Deficit |
|
|
(252,977 |
) |
|
|
(243,887 |
) |
|
|
|
|
(252,626 |
) |
|
|
(242,605 |
) |
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
33,651 |
|
|
|
43,048 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
57,858 |
|
|
$ |
69,487 |
|
|
See accompanying notes to unaudited consolidated financial statements.
1
THERATECHNOLOGIES INC.
Consolidated
Statement of Operations
(Unaudited)
Periods ended May 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 31, |
|
May 31, |
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
|
(3 months) |
|
|
(6 months) |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalties, technologies
and other (note 6) |
|
$ |
1,717 |
|
|
$ |
1,717 |
|
|
$ |
3,434 |
|
|
$ |
3,149 |
|
Interest |
|
|
509 |
|
|
|
600 |
|
|
|
1,087 |
|
|
|
1,177 |
|
|
|
|
|
2,226 |
|
|
|
2,317 |
|
|
|
4,521 |
|
|
|
4,326 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
4,259 |
|
|
|
5,696 |
|
|
|
8,368 |
|
|
|
12,011 |
|
Tax credits |
|
|
(167 |
) |
|
|
(422 |
) |
|
|
(335 |
) |
|
|
(1,090 |
) |
|
|
|
|
4,092 |
|
|
|
5,274 |
|
|
|
8,033 |
|
|
|
10,921 |
|
General and administrative |
|
|
2,057 |
|
|
|
1,857 |
|
|
|
3,858 |
|
|
|
4,178 |
|
Selling and market
development |
|
|
764 |
|
|
|
540 |
|
|
|
1,380 |
|
|
|
1,021 |
|
Patents |
|
|
136 |
|
|
|
76 |
|
|
|
340 |
|
|
|
121 |
|
Fees associated with
collaboration and
licensing agreement
(note 6) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
|
7,049 |
|
|
|
7,747 |
|
|
|
13,611 |
|
|
|
20,510 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,823 |
) |
|
$ |
(5,430 |
) |
|
$ |
(9,090 |
) |
|
$ |
(16,184 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share (note 3 (c)) |
|
$ |
(0.08 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.27 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares outstanding |
|
|
60,467,564 |
|
|
|
60,395,481 |
|
|
|
60,452,993 |
|
|
|
60,227,527 |
|
|
See accompanying notes to unaudited consolidated financial statements.
2
THERATECHNOLOGIES INC.
Consolidated Statements of Comprehensive Loss
(Unaudited)
Periods ended May 31, 2010 and 2009
(In thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 31, |
|
May 31, |
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
|
(3 months) |
|
|
(6 months) |
|
Net loss |
|
$ |
(4,823 |
) |
|
$ |
(5,430 |
) |
|
$ |
(9,090 |
) |
|
$ |
(16,184 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (losses) gains on
available-for-sale financial
assets |
|
|
(740 |
) |
|
|
668 |
|
|
|
(737 |
) |
|
|
985 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification adjustment
for gains and losses on
available-for-sale financial
assets |
|
|
(94 |
) |
|
|
(47 |
) |
|
|
(194 |
) |
|
|
(70 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(5,657 |
) |
|
$ |
(4,809 |
) |
|
$ |
(10,021 |
) |
|
$ |
(15,269 |
) |
|
See accompanying notes to unaudited consolidated financial statements.
3
THERATECHNOLOGIES
INC.
Consolidated
Statements of Shareholders Equity
(Unaudited)
Six-month period ended May 31, 2010
(In thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
compre- |
|
|
|
|
|
|
|
|
|
Capital stock |
|
|
Contributed |
|
|
hensive |
|
|
|
|
|
|
|
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
income |
|
|
Deficit |
|
|
Total |
|
|
Balance, November 30, 2009 |
|
|
60,429,393 |
|
|
$ |
279,169 |
|
|
$ |
6,484 |
|
|
$ |
1,282 |
|
|
$ |
(243,887 |
) |
|
$ |
43,048 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of share capital (note 3) |
|
|
2,880 |
|
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash proceeds |
|
|
55,161 |
|
|
|
91 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
91 |
|
Ascribed value |
|
|
|
|
|
|
54 |
|
|
|
(54 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
518 |
|
|
|
|
|
|
|
|
|
|
|
518 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,090 |
) |
|
|
(9,090 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains on available-for-
sale financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(931 |
) |
|
|
|
|
|
|
(931 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, May 31, 2010 |
|
|
60,487,434 |
|
|
$ |
279,329 |
|
|
$ |
6,948 |
|
|
$ |
351 |
|
|
$ |
(252,977 |
) |
|
$ |
33,651 |
|
|
See accompanying notes to unaudited consolidated financial statements.
4
THERATECHNOLOGIES INC.
Consolidated Statements of Shareholders Equity, Continued
(Unaudited)
Six-month period ended May 31, 2009
(In thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
compre- |
|
|
|
|
|
|
|
|
|
Capital stock |
|
|
Contributed |
|
|
hensive |
|
|
|
|
|
|
|
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
income |
|
|
Deficit |
|
|
Total |
|
|
Balance, November 30, 2008 |
|
|
58,215,090 |
|
|
$ |
269,219 |
|
|
$ |
5,585 |
|
|
$ |
372 |
|
|
$ |
(228,230 |
) |
|
$ |
46,946 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in accounting policies
(note 2 (a)) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(599 |
) |
|
|
(599 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of share capital
(notes 3 and 6) |
|
|
2,182,387 |
|
|
|
9,861 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,861 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
500 |
|
|
|
|
|
|
|
|
|
|
|
500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,184 |
) |
|
|
(16,184 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains on available-for-
sale financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
915 |
|
|
|
|
|
|
|
915 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, May 31, 2009 |
|
|
60,397,477 |
|
|
$ |
279,080 |
|
|
$ |
6,085 |
|
|
$ |
1,287 |
|
|
$ |
(245,013 |
) |
|
$ |
41,439 |
|
|
See accompanying notes to unaudited consolidated financial statements.
5
THERATECHNOLOGIES INC.
Consolidated Statements of Cash Flows
(Unaudited)
Periods ended May 31, 2010 and 2009
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 31, |
|
May 31, |
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
|
(3 months) |
|
|
(6 months) |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,823 |
) |
|
$ |
(5,430 |
) |
|
$ |
(9,090 |
) |
|
$ |
(16,184 |
) |
Adjustments for: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization
of property and equipment |
|
|
135 |
|
|
|
147 |
|
|
|
282 |
|
|
|
284 |
|
Lease inducements
and amortization |
|
|
42 |
|
|
|
|
|
|
|
42 |
|
|
|
|
|
Stock-based compensation |
|
|
259 |
|
|
|
295 |
|
|
|
518 |
|
|
|
500 |
|
|
|
|
|
(4,387 |
) |
|
|
(4,988 |
) |
|
|
(8,248 |
) |
|
|
(15,400 |
) |
Changes in operating assets
and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest receivable on bonds |
|
|
216 |
|
|
|
167 |
|
|
|
379 |
|
|
|
(802 |
) |
Accounts receivable |
|
|
105 |
|
|
|
283 |
|
|
|
199 |
|
|
|
359 |
|
Tax credits receivable |
|
|
(168 |
) |
|
|
(422 |
) |
|
|
(336 |
) |
|
|
(1,090 |
) |
Inventories |
|
|
(2,245 |
) |
|
|
|
|
|
|
(2,271 |
) |
|
|
(1,594 |
) |
Research supplies |
|
|
(1 |
) |
|
|
93 |
|
|
|
16 |
|
|
|
226 |
|
Prepaid expenses |
|
|
51 |
|
|
|
(67 |
) |
|
|
(361 |
) |
|
|
(126 |
) |
Accounts payable and
accrued liabilities |
|
|
3,046 |
|
|
|
(1,540 |
) |
|
|
1,266 |
|
|
|
(1,668 |
) |
Deferred revenues |
|
|
(1,715 |
) |
|
|
(1,714 |
) |
|
|
(3,418 |
) |
|
|
23,967 |
|
|
|
|
|
(711 |
) |
|
|
(3,200 |
) |
|
|
(4,526 |
) |
|
|
19,272 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,098 |
) |
|
|
(8,188 |
) |
|
|
(12,774 |
) |
|
|
3,872 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share issuance |
|
|
68 |
|
|
|
7 |
|
|
|
106 |
|
|
|
9,861 |
|
Share issue costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8 |
) |
|
|
|
|
68 |
|
|
|
7 |
|
|
|
106 |
|
|
|
9,853 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions to property and equipment |
|
|
(161 |
) |
|
|
(133 |
) |
|
|
(336 |
) |
|
|
(235 |
) |
Acquisition of bonds |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(19,631 |
) |
Disposal of bonds |
|
|
5,356 |
|
|
|
5,257 |
|
|
|
14,982 |
|
|
|
9,842 |
|
|
|
|
|
5,195 |
|
|
|
5,124 |
|
|
|
14,646 |
|
|
|
(10,024 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash |
|
|
165 |
|
|
|
(3,057 |
) |
|
|
1,978 |
|
|
|
3,701 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, beginning of period |
|
|
3,332 |
|
|
|
6,891 |
|
|
|
1,519 |
|
|
|
133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, end of period |
|
$ |
3,497 |
|
|
$ |
3,834 |
|
|
$ |
3,497 |
|
|
$ |
3,834 |
|
|
See note 4 (a) for supplemental cash flow information.
See accompanying notes to unaudited consolidated financial statements.
6
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements
(Unaudited)
Periods ended May 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
1. |
|
Basis of presentation: |
|
|
The financial statements included in this report are unaudited and reflect normal and recurring
adjustments which are, in the opinion of the Company, considered necessary for a fair
presentation of its results. These financial statements have been prepared in conformity with
Canadian generally accepted accounting principles (GAAP). The same accounting policies as
described in the Companys latest annual report have been used. However, these financial
statements do not include all disclosures required under GAAP and, accordingly, should be read
in connection with the financial statements and the notes thereto included in the Companys
latest annual report. These interim financial statements have not been reviewed by the
auditors. |
2. |
|
New accounting policies: |
|
(a) |
|
Adoption of new accounting standards: |
|
|
|
Goodwill and intangible assets |
|
|
|
|
Effective with the commencement of its 2009 fiscal year, the Company adopted the Canadian
Institute of Chartered Accountants (CICA) Handbook Section 3064, Goodwill and
Intangible Assets, which will replace Section 3062, Goodwill and Other Intangible Assets,
and Section 3450, Research and Development Costs. The standard provides guidance on the
recognition of intangible assets in accordance with the definition of an asset and the
criteria for asset recognition, whether these assets are separately acquired or internally
developed. The impact of adopting this standard has been to increase the opening deficit
and to reduce other assets as at December 1, 2008 by $599, respectively, which is the
amount of patent costs related to periods prior to these dates. |
|
|
|
|
Lease inducements |
|
|
|
|
Lease inducements arising from leasehold improvements allowance and rent-free inducements
received are deferred and amortized over the term of the lease on a straight-line basis. |
7
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended May 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
2. |
|
New accounting policies (continued): |
|
(b) |
|
Future accounting changes: |
|
|
|
International Financial Reporting Standards |
|
|
|
|
In February 2008, Canadas Accounting Standards Board (AcSB) confirmed that Canadian
GAAP, as used by publicly accountable enterprises, would be fully converged into
International Financial Reporting Standards (IFRS), as issued by the International
Accounting Standards Board (IASB). The changeover date is for interim and annual
financial statements relating to fiscal years beginning on or after January 1, 2011. As a
result, the Company will be required to report under IFRS for its 2012 interim and annual
financial statements. The Company will convert to these new standards according to the
timetable set within these new rules. The Company is in a process to determine the impact
of adopting the standards on its consolidated financial statements. |
|
|
During the second quarter of 2010, the Company received subscriptions in the amount of $15 ($7
for the same period in 2009) for the issue of 2,880 common shares (2,550 for the same period in
2009) in connection with its share purchase plan. |
|
(a) |
|
Shareholder rights plan: |
|
|
|
On February 10, 2010, the Board of Directors of the Company adopted a shareholder rights
plan (the Plan), effective as of such date. The Plan is designed to provide adequate
time for the Board of Directors, and the shareholders, to assess an unsolicited takeover
bid for the Company. In addition, the Plan provides the Board of Directors with sufficient
time to explore and develop alternatives for maximizing shareholder value if a takeover bid
is made, as well as provide shareholders with an equal opportunity to participate in a
takeover bid and receive full and fair value for their common shares (the Common Shares).
The Plan, if approved by the shareholders, will expire at the close of the Companys annual
meeting of shareholders in 2013. |
|
|
|
|
The rights issued under the Plan will initially attach to and trade with the Common Shares
and no separate certificates will be issued unless an event triggering these rights occurs.
The rights will become exercisable only when a person, including any party related to it,
acquires or attempts to acquire 20% or more of the outstanding Common Shares without
complying with the ''Permitted Bid provisions of the Plan or without approval of the
Board of Directors. Should such an acquisition occur or be announced, each right would,
upon exercise, entitle a rights holder, other than the acquiring person and related
persons, to purchase Common Shares at a 50% discount to the market price at the time. |
8
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended May 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
3. |
|
Capital stock (continued): |
|
(a) |
|
Shareholder rights plan (continued): |
|
|
|
Under the Plan, a Permitted Bid is a bid made to all holders of the Common Shares and which
is open for acceptance for no less than 60 days. If, at the end of the 60-day period, at
least 50% of the outstanding Common Shares, other than those owned by the offeror and
certain related parties, have been tendered, the offeror may take up and pay for the Common
Shares but must extend the bid for a further 10 days to allow other shareholders to tender. |
|
(b) |
|
Stock option plan: |
|
|
|
|
Changes in outstanding options granted under the Companys stock option plan for the year
ended November 30, 2009 and the six-month period ended May 31, 2010 were as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
|
|
|
|
exercise price |
|
|
|
Number |
|
|
per share |
|
|
Options as at November 30, 2008 |
|
|
2,161,800 |
|
|
$ |
6.52 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
680,500 |
|
|
|
1.83 |
|
Cancelled and expired |
|
|
(176,500 |
) |
|
|
8.34 |
|
|
|
|
|
|
|
|
|
|
|
Options as at November 30, 2009 |
|
|
2,665,800 |
|
|
|
5.20 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
265,000 |
|
|
|
3.84 |
|
Cancelled and expired |
|
|
(37,667 |
) |
|
|
4.61 |
|
Exercised |
|
|
(55,161 |
) |
|
|
1.66 |
|
|
|
|
|
|
|
|
|
|
|
Options as at May 31, 2010 |
|
|
2,837,972 |
|
|
$ |
5.15 |
|
|
9
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended May 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
3. |
|
Capital stock (continued): |
|
(c) |
|
Stock-based compensation and other stock-based payments: |
|
|
|
|
The estimated fair value of the options granted was estimated at the date of grant using
the Black-Scholes option pricing model with the following weighted average assumptions: |
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
Risk-free interest rate |
|
|
2.46 |
% |
|
|
1.80 |
% |
Volatility |
|
|
81 |
% |
|
|
79 |
% |
Average option life in years |
|
|
6 |
|
|
|
6 |
|
Dividend yield |
|
Nil |
|
|
Nil |
|
|
|
|
|
The risk-free interest rate is based on the implied yield on a Canadian Treasury
zero-coupon issue with a remaining term equal to the expected term of the option. The
volatility is based solely on historical volatility equal to the expected term of the
option. The average life of the options is estimated considering the vesting period, the
term of the option and the length of time that similar grants have remained outstanding in
the past. Dividend yield was excluded from the calculation, since it is the present policy
of the Company not to retain in cash in order to keep funds available to finance the
Companys growth. |
|
|
|
|
The following table summarizes the weighted average fair value of stock options granted
during the periods ended May 31, 2010 and 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average |
|
|
|
Number of |
|
|
grant-date |
|
Periods ended May 31 (6 months) |
|
options |
|
|
fair value |
|
|
2010 |
|
|
265,000 |
|
|
$ |
2.96 |
|
2009 |
|
|
660,500 |
|
|
|
1.24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average |
|
|
|
Number of |
|
|
grant-date |
|
Periods ended May 31 (3 months) |
|
options |
|
|
fair value |
|
|
2010 |
|
|
|
|
|
$ |
|
|
2009 |
|
|
70,000 |
|
|
|
1.27 |
|
|
10
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended May 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
3. |
|
Capital stock (continued): |
|
(d) |
|
Diluted loss per share: |
|
|
|
|
Diluted loss per share was not presented as the effect of options would have been
anti-dilutive. All options outstanding at the end of the year could potentially dilute the
basic earnings per share in the future. |
4. |
|
Supplemental information: |
|
(a) |
|
The following transactions were conducted by the Company and did not impact cash
flows: |
|
|
|
|
|
|
|
|
|
|
|
May 31, |
|
|
November 30, |
|
|
|
2010 |
|
|
2009 |
|
Additions to property and equipment included in
accounts payable and accrued liabilities |
|
$ |
61 |
|
|
$ |
183 |
|
|
|
(b) |
|
For the six-month period ended May 31, 2010, the Company has reclassified in net loss
$194 of realized gains on available-for-sale financial assets previously recorded in
accumulated other comprehensive income ($70 in 2009). |
|
|
|
|
On May 31, 2010, the accumulated other comprehensive loss was composed of unrealized gains
on available-for-sale financial assets of $351 (gains of $1,282 on November 30, 2009). |
|
|
(c) |
|
For the periods ended May 31, 2010 and 2009, the following items were included in the
determination of the Companys net loss: |
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
Amortization of property and equipment |
|
$ |
282 |
|
|
$ |
284 |
|
Stock-based compensation |
|
|
518 |
|
|
|
500 |
|
|
5. |
|
Financial instruments: |
|
(a) |
|
Carrying value and fair value: |
|
|
|
|
The Company has determined that the carrying values of its short-term financial assets and
liabilities, including cash, accounts receivable, as well as accounts payable and accrued
liabilities, approximate their fair value because of the relatively short period to
maturity of these instruments. |
11
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended May 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
5. Financial instruments (continued):
|
(a) |
|
Carrying value and fair value (continued): |
|
|
|
|
Bonds and investments in public companies are stated at estimated fair value, determined by
inputs that are directly observable (Level 2 inputs). |
|
|
(b) |
|
Interest income and expenses: |
|
|
|
|
Interest income consists of interest earned on cash and bonds. |
|
|
(c) |
|
Loss on exchange: |
|
|
|
|
General and administrative expenses include a loss on foreign exchange of $135 ($727 in
2009) for the six-month period ended May 31, 2010. |
6. |
|
Collaboration and licensing agreement: |
|
On October 28, 2008, the Company entered into a collaboration and licensing agreement with EMD
Serono, Inc. (EMD Serono), an affiliate of Merck KGaA, of Darmstadt, Germany, regarding the
exclusive commercialization rights of tesamorelin in the United States for the treatment of
excess abdominal fat in HIV-infected patients with lipodystrophy (the Initial Product). The
Company retains all tesamorelin commercialization rights outside of the United States. |
|
|
Under the terms of the agreement, the Company is responsible for the development of the Initial
Product up to obtaining marketing approval in the United States. The Company is also
responsible for product production and for the development of a new formulation of the initial
product. EMD Serono is responsible for conducting product commercialization activities. |
|
|
At the closing of the agreement, on December 15, 2008, the Company received US$30,000
(CAD$36,951), which includes an initial payment of US$22,000 (CAD$27,097) and US$8,000
(CAD$9,854) as a subscription for common shares in the Company by Merck KGaA at a price of
US$3.67 (CAD$4.52) per share. The Company may receive up to US$215,000, which amount includes
the initial payment of US$22,000, the equity investment of US$8,000, as well as payments based
on the achievement of certain development, regulatory and sales milestones. The Company will
also be entitled to receive increasing royalties on annual net sales of tesamorelin in the
United States, if applicable. |
|
|
The initial payment of $27,097 has been deferred and is being amortized over its estimated
service period on a straight-line basis. This period may be modified in the future based on
additional information that may be received by the Company. For the six-month period ended May
31, 2010, an amount of $3,423 related to this transaction was recognized as revenue. At May 31,
2010, the deferred revenues related to this transaction amounted to $17,114. |
12
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended May 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
6. |
|
Collaboration and licensing agreement (continued): |
|
On August 12, 2009, the US Food and Drug Administration accepted the New Drug Application
(NDA) made by the Company for tesamorelin. Under the terms of the Companys Collaboration and
Licensing Agreement with EMD Serono, the acceptance of the tesamorelin NDA resulted in a
milestone payment of US$10,000 (CAD$10,884). This milestone payment has been recorded in the
third quarter of 2009. |
|
|
The Company may conduct research and development for additional indications. Under the
Collaboration and Licensing Agreement, EMD Serono will have the option to commercialize
additional indications for tesamorelin in the United States. If it exercises this option, EMD
Serono will pay half of the development costs related to such additional indications. In such
cases, the Company will also have the right, subject to EMD Seronos agreement, to participate
in the promotion of the additional indications. |
13
ex-99.19
Exhibit 99.19
EXPLANATORY NOTE
This amended Managements Discussion and Analysis (MD&A), for the three months ended February
28, 2010 and February 28, 2009 reflects the Companys adoption of International Financial Reporting
Standards (IFRS), as issued by the International Accounting Standards Board (IASB). The
Company originally filed a MD&A for the three months ended February 28, 2010 and February 28, 2009
on March 23, 2010. That MD&A was based on financial statements prepared in accordance with
generally accepted accounting principles in Canada (Canadian GAAP). In the fourth quarter of
2010, the Company filed a request to adopt IFRS two years in advance of the date required by the
Accounting Standards Board. The request was approved by the regulatory authorities. The Company is
filing amended interim consolidated financial statements and this amended MD&A to comply with this
approval.
This amended MD&A continues to describe conditions, trends results and outlook as of March 23,
2010, which was the date of the original MD&A. Except for the changes related to the Companys
adoption of IFRS, this amended MD&A does not reflect events occurring after March 23, 2010 and the
Company has not modified or updated the discussion and analysis from its original filing.
This amended MD&A and the amended interim consolidated financial statements for the periods
ended February 28, 2010 and 2009 supersede the Companys original filings and should be read in
conjunction with the consolidated financial statements as at November 30, 2010 and 2009 prepared in
accordance with IFRS.
AMENDED MANAGEMENTS DISCUSSION AND ANALYSIS
For the three-month period ended February 28, 2010
The following amended MD&A provides Managements point of view on the financial position and the
results of operations of Theratechnologies Inc. (Theratechnologies or the Company), for the
three-month period ended February 28, 2010, as compared to the three-month period ended February
28, 2009. This view contains information that the Company believes may affect its prospective
financial condition, cash flows and results of operations. The amended unaudited interim
consolidated financial statements have been prepared in accordance with International Financial
Reporting Standards (IFRS). This amended MD&A should be read in conjunction with the amended
unaudited interim consolidated financial statements of the Company and the notes thereto as at
February 28, 2010, as well as the MD&A and audited consolidated financial statements including the
related notes thereto as at November 30, 2010. Unless specified otherwise, all amounts are in
Canadian dollars.
Financial Overview
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company
targets unmet medical needs in financially attractive specialty markets where it can retain all or
part of the commercial rights to its products. Its most advanced compound, tesamorelin, is an
analogue of the human growth hormone releasing factor. In 2009, Theratechnologies submitted a New
Drug Application to the U.S. Food and Drug Administration, seeking approval of tesamorelin for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The Companys growth
strategy is centered on the commercialization of tesamorelin in the United States and in other
markets for HIV-associated lipodystrophy, as well as the development of clinical programs for
tesamorelin in other medical conditions.
The U.S. Food and Drug Administration (FDA) has set a date of May 27, 2010 for the Endocrinologic
and Metabolic Drugs Advisory Committee meeting. The purpose of the meeting is to review
Theratechnologies New Drug Application (NDA) for tesamorelin, which was submitted on May 29,
2009. The Advisory Committee meeting was originally scheduled for February 24, 2010 but was
postponed due to administrative delays at the FDA. As a result of this postponement, the FDA
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
has indicated that the action goal date, which is the target date for the FDA to complete its
review of the tesamorelin NDA, will be July 27, 2010.
The role of the Advisory Committee is to provide the FDA with advice from independent experts and
other interested parties on the use of tesamorelin. Even though advisory committees address
questions posed to them through public meetings, the final decision on the approval of a product
remains solely with the FDA.
An article entitled, Effects of Tesamorelin, a Growth Hormone-Releasing Factor, in HIV-Infected
Patients With Abdominal Fat Accumulation: A Randomized Placebo-Controlled Trial With a Safety
Extension, has been published in the March 1st issue of The Journal of Acquired Immune Deficiency
Syndromes (JAIDS). The article outlines, in detail, the 52-week data of the second Phase 3 trial,
in evaluating tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy. Top-line results of the study were first disclosed in December 2008.
On February 25, 2010, the Australian Patent Office granted Theratechnologies patent number
2003229222 entitled GRF Analogue Compositions and their Use covering the pharmaceutical
formulation and the method of treating HIV-associated lipodystrophy with tesamorelin. Obtaining
this patent provides protection for tesamorelin in Australia until May 2013. On December 29, 2009,
the Brazil Patent and Trademark Office issued a patent to Theratechnologies for tesamorelin
granting protection in that territory until December 2019.
Revenue
Consolidated revenue for the three-month period ended February 28, 2010, amounted to $1,717,000
compared to $1,432,000 for 2009. The increased revenues in 2010 are related to a longer
amortization period (3 months in 2010 versus 2.5 months in 2009) for the initial payment of the
collaboration and licensing agreement with EMD Serono, Inc. (EMD Serono).
The initial payment of $27,097,000 has been deferred and is being amortized over its estimated
service period on a straight-line basis. This period may be modified in the future based on
additional information that the Company may receive. For the three-month period ended February 28,
2010, an amount of $1,711,000 ($1,426,000 for the same period in 2009) related to this transaction
was recognized as revenue. At February 28, 2010, the deferred revenues related to this transaction
recorded on the balance sheet amounted to $18,826,000.
R&D Activities
Research and development (R&D) expenditures net of tax credits totalled $4,123,000 for the first
quarter of 2010, compared to $5,720,000 in 2009. The R&D expenses incurred in the first quarter of
2010 are mainly related to the primary objective of the Company, which encompasses the regulatory
activities connected with the preparation for the FDA Advisory Committee meeting. This explains the
planned reduction in R&D expenses. The research and development expenses incurred in the first
quarter of 2009 are essentially related to closing activities for the confirmatory Phase 3 study.
Selling and Market Development Expenses
Selling and market development costs amounted to $620,000 for the first quarter of 2010, compared
to $4,750,000 in 2009. The selling and market development expenses in 2010 are principally composed
of business development and market research expenses outside the United States and the costs of
managing the agreement with EMD Serono. In 2009, the Company incurred expenses totalling $4,269,000
in connection with professional fees related to the transaction with EMD Serono.
General and Administrative Expenses
For the first quarter of 2010, general and administrative expenses amounted to $1,745,000, compared
to $1,937,000 in 2009. The 2010 expenses were comparable to those of 2009, with the exception of
costs associated with revising the Companys business plan in 2009.
2
Net Financial Income
Finance income in the first quarter of 2010 amounted to $578,000 compared to $577,000 in 2009.
Finance costs in the first quarter of 2010 were $48,000 compared to $429,000 in 2009. Finance costs
in 2009 include an exchange loss of $416,000 incurred upon the conversion of the initial payment
from EMD Serono to Canadian dollars.
Net Results
Reflecting the changes in revenues and expenses described above, the Company recorded a first
quarter 2010 net loss of $4,241,000 ($0.07 per share), compared to a net loss of $10,827,000 ($0.18
per share) in 2009.
Quarterly Financial Information
The selected financial information provided below is derived from the Companys unaudited quarterly
financial statements for each of the last eight quarters.
(in thousands of Canadian dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
2009 |
|
2008 (1) |
|
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
amended |
|
|
amended |
|
|
amended |
|
|
amended |
|
|
amended |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Revenues |
|
$ |
1,717 |
|
|
$ |
1,718 |
|
|
$ |
12,601 |
|
|
$ |
1,717 |
|
|
$ |
1,432 |
|
|
$ |
616 |
|
|
$ |
710 |
|
|
$ |
716 |
|
Net (loss) earnings |
|
$ |
(4,241 |
) |
|
$ |
(4,654 |
) |
|
$ |
5,779 |
|
|
$ |
(5,454 |
) |
|
$ |
(10,827 |
) |
|
$ |
(15,145 |
) |
|
$ |
(11,220 |
) |
|
$ |
(11,382 |
) |
Basic and diluted
(loss)
earnings per share |
|
$ |
(0.07 |
) |
|
$ |
(0.08 |
) |
|
$ |
0.10 |
|
|
$ |
(0.09 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.20 |
) |
|
|
|
|
(1) |
|
Theratechnologies adopted IFRS in fiscal 2010 with a transition date of
December 1, 2008. Consequently, the selected financial information for the year ended
November 30, 2008, as presented in our 2009 Audited Consolidated Financial Statements, which were
presented in conformity with Canadian GAAP, was not restated in accordance with IFRS and
accordingly, is not comparable with the information for fiscal 2010 and 2009. |
As described above, the increased revenues in 2010 and 2009 are related to the amortization of the
initial payment received at the closing of the agreement with EMD Serono, as well as the milestone
payment of $10,884,000 recorded in August 2009. The increase in the fourth quarter net loss in
2008 is due to impairment charges for intellectual property.
Financial Position
At February 28, 2010, cash and bonds amounted to $55,289,000, and tax credits and grants receivable
amounted to $1,501,000 for a total of $56,790,000.
For the three-month period ended February 28, 2010, the cash used for operating activities,
excluding changes in operating assets and liabilities, was $3,861,000, compared to $10,412,000 in
2009.
3
Subsequent events
Except for changes related to the Companys adoption of IFRS, this amended MD&A does not reflect
events occurring after March 23, 2010, the date of the filing of the MD&A prepared in accordance
with Canadian GAAP. The annual MD&A of the Company prepared in accordance with IFRS has been filed
concurrently with this amended MD&A. This amended MD&A should be read in connection with the
November 30, 2010 annual financial statements and the related MD&A for additional disclosures with
respect to subsequent events.
Transition to IFRS
The Company has applied IFRS 1 and the accounting policies set out in note 3 in preparing the
financial statements for the period ended February 28, 2010, the comparative information for the
period ended February 28, 2009, for the year ended November 30, 2009, and for the opening IFRS
statement of financial position as at December 1, 2008 (the Companys date of transition).
In preparing these interim consolidated financial statements in accordance with IFRS 1, the Company
has applied the mandatory exceptions and certain of the optional exemptions from full retrospective
application of IFRS.
The Company elected to apply the following optional exemptions from full retrospective application:
(i) |
|
Share-based payment transaction exemption: |
|
|
|
The Company has elected to apply the share-based payment exemption. It applied IFRS 2 from
December 1, 2008 to those stock options that were issued after November 7, 2002 but that
had not vested by December 1, 2008. The application of the exemption is detailed below. |
|
(ii) |
|
Designation of financial assets and financial liabilities exemption: |
|
|
|
The Company elected to re-designate cash from the held for trading category to loans and
receivables. |
As required by IFRS 1, estimates made under IFRS at the date of transition must be consistent with
estimates made for the same date under previous GAAP, unless there is evidence that those estimates
were in error.
In preparing its opening IFRS consolidated statement of financial position, the Company has
adjusted amounts reported previously in financial statements prepared in accordance with Canadian
GAAP.
An explanation of how the transition from previous Canadian GAAP to IFRS has affected the Companys
financial position, financial performance and cash flows is set out in note 8 of the amended
unaudited interim consolidated financial statements for the periods ended February 28, 2010 and
2009.
Outstanding Share Data
On March 22, 2010, the number of shares issued and outstanding was 60,450,890, while outstanding
options granted under the stock option plan were 2,883,636.
Contractual Obligations
There were no material changes in contractual obligations during the quarter, other than in the
ordinary course of business.
4
Economic and Industry Factors
Economic and industry factors were substantially unchanged from those reported in the Companys
2009 Annual Report.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Companys website at
www.theratech.com. Additional information, including the Annual Information Form and the
Annual Report, is also available on SEDAR at www.sedar.com.
Forward-looking Information
This press release and the Managements Discussion and Analysis for the first quarter incorporated
therein contain certain statements that are considered forward-looking information within the
meaning of applicable securities legislation. This forward-looking information includes, but is not
limited to, information regarding the pursuit of the Companys business plan with the funds that it
has available, the search for partners in new markets and the completion of a transition plan for
IFRS. Furthermore, the words will, may, could, should, outlook, believe, plan,
envisage, anticipate, expect and estimate, or variations of them denote forward-looking
information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties include, but are not limited to, the risk that the
Companys funding needs may change, and that the Company is unable to conclude agreements with
partners in new markets for tesamorelin.
Although the forward-looking information contained herein is based upon what the Company believes
are reasonable assumptions, investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking information. Certain assumptions
made in preparing the forward-looking information and the Companys objectives include the
assumption, among others, that the operating activities of the Company will conform to its business
plan, and the Company will reach agreements with partners in new markets for tesamorelin.
Consequently, all of the forward-looking information is qualified by the foregoing cautionary
statements, and there can be no guarantee that the results or developments anticipated by the
Company will be realized or, even if substantially realized, that they will have the expected
consequences or effects on the Company, its business, its financial condition or its results of
operation. Furthermore, the forward-looking information reflects current expectations regarding
future events only as of the date of release of this press release.
Investors are referred to the Companys public filings available at www.sedar.com. In
particular, further details on these risks and descriptions of these risks are disclosed in the
Risk and Uncertainties section of the Companys Annual Information Form, dated February 23, 2010,
for the year ended November 30, 2009.
5
ex-99.20
Exhibit 99.20
Amended Consolidated Financial Statements of
(Unaudited)
THERATECHNOLOGIES INC.
Three-month periods ended February 28, 2010 and 2009
THERATECHNOLOGIES INC.
Amended Consolidated Financial Statements
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
|
|
|
|
|
Amended Financial Statements |
|
|
|
|
Consolidated Statement of Financial Position |
|
|
1 |
|
|
Consolidated Statement of Comprehensive Income |
|
|
2 |
|
|
Consolidated Statement of Changes in Equity |
|
|
3 |
|
|
Consolidated Statement of Cash Flows |
|
|
5 |
|
|
Notes to the Consolidated Financial Statements |
|
|
6 |
|
EXPLANATORY NOTE
These amended unaudited consolidated financial statements of Theratechnologies Inc. (the
Company) for the three-month periods ended February 28, 2010 and 2009 reflect the Companys
adoption of International Financial Reporting Standards (''IFRS), as issued by the International
Accounting Standards Board (''IASB). In the fourth quarter of 2010, The Company filed a request
to adopt IFRS two years in advance of the date required by the Accounting Standards Board. The
request was approved by the regulatory authorities. The Company is filing these amended
consolidated financial statements to comply with this approval.
The Companys Audit Committee originally approved the unaudited consolidated financial statements
for the three-month periods ended February 28, 2010 and 2009 on March 23, 2010 and those financial
statements were filed on March 23, 2010. Those financial statements were prepared in accordance
with generally accepted accounting principles in Canada (Canadian GAAP). Except for the changes
related to the Companys adoption of IFRS, these amended unaudited consolidated financial
statements do not reflect events occurring after March 23, 2010. These amended unaudited
consolidated financial statements supersede the Companys original filing and should be read in
connection with the consolidated financial statements as at November 30, 2010 and 2009 prepared in
accordance with IFRS.
THERATECHNOLOGIES INC.
Consolidated
Statement of Financial Position
(Unaudited)
As at February 28, 2010, November 30, 2009 and December 1, 2008
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
February 28, |
|
|
November 30, |
|
|
December 1, |
|
|
|
Note |
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
|
|
|
|
|
3,332 |
|
|
|
1,519 |
|
|
|
133 |
|
Bonds |
|
|
|
|
|
|
6,264 |
|
|
|
10,036 |
|
|
|
10,955 |
|
Trade and other receivables |
|
|
|
|
|
|
281 |
|
|
|
375 |
|
|
|
610 |
|
Tax credits and grants receivable |
|
|
|
|
|
|
1,501 |
|
|
|
1,333 |
|
|
|
1,451 |
|
Inventories |
|
|
|
|
|
|
2,251 |
|
|
|
2,225 |
|
|
|
|
|
Prepaid expenses |
|
|
|
|
|
|
1,025 |
|
|
|
630 |
|
|
|
739 |
|
|
Total current assets |
|
|
|
|
|
|
14,654 |
|
|
|
16,118 |
|
|
|
13,888 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bonds |
|
|
|
|
|
|
45,693 |
|
|
|
51,807 |
|
|
|
35,249 |
|
Property and equipment |
|
|
|
|
|
|
1,209 |
|
|
|
1,229 |
|
|
|
1,299 |
|
Other assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,776 |
|
|
Total non-current assets |
|
|
|
|
|
|
46,902 |
|
|
|
53,036 |
|
|
|
39,324 |
|
|
Total assets |
|
|
|
|
|
|
61,556 |
|
|
|
69,154 |
|
|
|
53,212 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
|
|
|
|
3,740 |
|
|
|
5,568 |
|
|
|
6,865 |
|
Current portion of deferred revenue |
|
|
4 |
|
|
|
6,855 |
|
|
|
6,847 |
|
|
|
|
|
|
Total current liabilities |
|
|
|
|
|
|
10,595 |
|
|
|
12,415 |
|
|
|
6,865 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
4 |
|
|
|
11,980 |
|
|
|
13,691 |
|
|
|
|
|
|
Total non-current liabilities |
|
|
|
|
|
|
11,980 |
|
|
|
13,691 |
|
|
|
|
|
|
Total liabilities |
|
|
|
|
|
|
22,575 |
|
|
|
26,106 |
|
|
|
6,865 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
5 |
|
|
|
279,230 |
|
|
|
279,169 |
|
|
|
269,219 |
|
Contributed surplus |
|
|
|
|
|
|
6,967 |
|
|
|
6,757 |
|
|
|
5,760 |
|
Deficit |
|
|
|
|
|
|
(248,401 |
) |
|
|
(244,160 |
) |
|
|
(229,004 |
) |
Accumulated other comprehensive income |
|
|
|
|
|
|
1,185 |
|
|
|
1,282 |
|
|
|
372 |
|
|
Total equity |
|
|
|
|
|
|
38,981 |
|
|
|
43,048 |
|
|
|
46,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent events |
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity |
|
|
|
|
|
|
61,556 |
|
|
|
69,154 |
|
|
|
53,212 |
|
|
See accompanying notes to unaudited consolidated financial statements.
1
THERATECHNOLOGIES INC.
Consolidated Statement of Comprehensive Income
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note |
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Research services: |
|
|
|
|
|
|
|
|
|
|
|
|
Upfront payments and initial technology access fees |
|
|
4 |
|
|
|
1,711 |
|
|
|
1,426 |
|
Royalties and license fees |
|
|
|
|
|
|
6 |
|
|
|
6 |
|
|
Total revenue |
|
|
|
|
|
|
1,717 |
|
|
|
1,432 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses, net of tax credits of $168 (2009 - $668) |
|
|
|
|
|
|
4,123 |
|
|
|
5,720 |
|
Selling and market development expenses |
|
|
|
|
|
|
620 |
|
|
|
4,750 |
|
General and administrative expenses |
|
|
|
|
|
|
1,745 |
|
|
|
1,937 |
|
|
Total operating expenses |
|
|
|
|
|
|
6,488 |
|
|
|
12,407 |
|
|
Results from operating activities |
|
|
|
|
|
|
(4,771 |
) |
|
|
(10,975 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income |
|
|
|
|
|
|
578 |
|
|
|
577 |
|
Finance costs |
|
|
|
|
|
|
(48 |
) |
|
|
(429 |
) |
|
Total net financial income |
|
|
|
|
|
|
530 |
|
|
|
148 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
(4,241 |
) |
|
|
(10,827 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss, net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value available-for-sale financial assets, net of tax |
|
|
|
|
|
|
3 |
|
|
|
317 |
|
Net change in fair value available-for-sale financial assets transferred to net loss, net of tax |
|
|
|
|
|
|
(100 |
) |
|
|
(23 |
) |
|
|
|
|
|
|
|
|
(97 |
) |
|
|
294 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the period |
|
|
|
|
|
|
(4,338 |
) |
|
|
(10,533 |
) |
|
|
Basic and diluted loss per share |
|
|
5 |
|
|
|
(0.07 |
) |
|
|
(0.18 |
) |
|
See accompanying notes to unaudited consolidated financial statements.
2
THERATECHNOLOGIES INC.
Consolidated Statement of Changes in Equity
(Unaudited)
Three-month period ended February 28, 2010
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
or losses on |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
available-for-sale |
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
Contributed |
|
|
financial |
|
|
|
|
|
|
|
|
|
Note |
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
assets (i) |
|
|
Deficit |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Balance as at November 30, 2009 |
|
|
|
|
|
|
60,429,393 |
|
|
|
279,169 |
|
|
|
6,757 |
|
|
|
1,282 |
|
|
|
(244,160 |
) |
|
|
43,048 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the period: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,241 |
) |
|
|
(4,241 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value of available-for-sale financial assets, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
3 |
|
Net change in fair value of available-for-sale financial assets transferred to net loss,
net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(100 |
) |
|
|
|
|
|
|
(100 |
) |
|
Total comprehensive loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(97 |
) |
|
|
(4,241 |
) |
|
|
(4,338 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transactions with owners, recorded directly in equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation for stock option plan |
|
|
5 |
(c) |
|
|
|
|
|
|
|
|
|
|
233 |
|
|
|
|
|
|
|
|
|
|
|
233 |
|
Exercise of stock option: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Monetary consideration |
|
|
5 |
(c) |
|
|
21,164 |
|
|
|
38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38 |
|
Attributed value |
|
|
5 |
(c) |
|
|
|
|
|
|
23 |
|
|
|
(23 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contributions by owners |
|
|
|
|
|
|
21,164 |
|
|
|
61 |
|
|
|
210 |
|
|
|
|
|
|
|
|
|
|
|
271 |
|
|
Balance as at February 28, 2010 |
|
|
|
|
|
|
60,450,557 |
|
|
|
279,230 |
|
|
|
6,967 |
|
|
|
1,185 |
|
|
|
(248,401 |
) |
|
|
38,981 |
|
|
|
|
|
(i) |
|
Accumulated other comprehensive income. |
3
THERATECHNOLOGIES INC.
Consolidated Statement of Changes in Equity, Continued
(Unaudited)
Three-month period ended February 28, 2009
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
or losses on |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
available-for-sale |
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
Contributed |
|
|
financial |
|
|
|
|
|
|
|
|
|
Note |
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
assets (i) |
|
|
Deficit |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Balance as at November 30, 2008 |
|
|
|
|
|
|
58,215,090 |
|
|
|
269,219 |
|
|
|
5,760 |
|
|
|
372 |
|
|
|
(229,004 |
) |
|
|
46,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the period: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,827 |
) |
|
|
(10,827 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value of available-for-sale financial assets, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
317 |
|
|
|
|
|
|
|
317 |
|
Net change in fair value of available-for-sale financial assets transferred to net loss,
net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(23 |
) |
|
|
|
|
|
|
(23 |
) |
|
Total comprehensive income (loss) for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
294 |
|
|
|
(10,827 |
) |
|
|
(10,533 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transactions with owners, recorded directly in equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue of common shares |
|
|
4 |
|
|
|
2,179,837 |
|
|
|
9,854 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,854 |
|
Share-based compensation plan: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation for stock option plan |
|
|
5 |
(c) |
|
|
|
|
|
|
|
|
|
|
278 |
|
|
|
|
|
|
|
|
|
|
|
278 |
|
|
Total contributions by owners |
|
|
|
|
|
|
2,179,837 |
|
|
|
9,854 |
|
|
|
278 |
|
|
|
|
|
|
|
|
|
|
|
10,132 |
|
|
Balance as at February 28, 2009 |
|
|
|
|
|
|
60,394,927 |
|
|
|
279,073 |
|
|
|
6,038 |
|
|
|
666 |
|
|
|
239,831 |
|
|
|
45,946 |
|
|
|
|
|
(i) |
|
Accumulated other comprehensive income. |
See accompanying notes to unaudited consolidated financial statements.
4
THERATECHNOLOGIES INC.
Consolidated Statement of Cash Flows
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars)
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
|
|
$ |
|
|
$ |
|
Operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
|
(4,241 |
) |
|
|
(10,827 |
) |
Adjustments for: |
|
|
|
|
|
|
|
|
Depreciation of property and equipment |
|
|
147 |
|
|
|
137 |
|
Share-based compensation |
|
|
233 |
|
|
|
278 |
|
|
Operating activities before changes in operating assets and liabilities |
|
|
(3,861 |
) |
|
|
(10,412 |
) |
|
|
|
|
|
|
|
|
|
Change in accrued interest income on bonds |
|
|
163 |
|
|
|
(969 |
) |
Change in trade and other receivables |
|
|
94 |
|
|
|
51 |
|
Change in tax credits and grants receivable |
|
|
165 |
|
|
|
(335 |
) |
Change in inventories |
|
|
(26 |
) |
|
|
(1,594 |
) |
Change in prepaid expenses |
|
|
(395 |
) |
|
|
(470 |
) |
Change in other assets |
|
|
|
|
|
|
568 |
|
Change in accounts payable and accrued liabilities |
|
|
(2,113 |
) |
|
|
(460 |
) |
Change in deferred revenue |
|
|
(1,703 |
) |
|
|
25,681 |
|
|
|
|
|
(3,815 |
) |
|
|
22,472 |
|
|
Cash flows from operating activities |
|
|
(7,676 |
) |
|
|
12,060 |
|
|
|
|
|
|
|
|
|
|
Financing activities: |
|
|
|
|
|
|
|
|
Proceeds from issue of share capital |
|
|
|
|
|
|
9,854 |
|
Proceeds from exercise of stock options |
|
|
38 |
|
|
|
|
|
Share issue costs |
|
|
|
|
|
|
(8 |
) |
|
Cash flows from financing activities |
|
|
38 |
|
|
|
9,846 |
|
|
|
|
|
|
|
|
|
|
Investing activities: |
|
|
|
|
|
|
|
|
Acquisition of property and equipment |
|
|
(175 |
) |
|
|
(102 |
) |
Proceeds from sale of bonds |
|
|
9,626 |
|
|
|
4,585 |
|
Acquisition of bonds |
|
|
|
|
|
|
(19,631 |
) |
|
Cash flows from (used in) investing activities |
|
|
9,451 |
|
|
|
(15,148 |
) |
|
|
|
|
|
|
|
|
|
|
Net change in cash |
|
|
1,813 |
|
|
|
6,758 |
|
|
|
|
|
|
|
|
|
|
Cash as at December 1 |
|
|
1,519 |
|
|
|
133 |
|
|
|
|
|
|
|
|
|
|
|
Cash as at February 28 |
|
|
3,332 |
|
|
|
6,891 |
|
|
See note 6 for supplemental cash flow information.
See accompanying notes to unaudited consolidated financial statements.
5
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
|
|
Theratechnologies Inc. is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The
Company targets unmet medical needs in specialty markets where it can retain all or some of the
commercial rights to its products. Its most advanced component, tesamorelin, is an analogue of
the human growth hormone releasing factor peptides. |
|
|
|
The consolidated financial statements include the accounts of Theratechnologies Inc. and its
wholly-owned subsidiaries (together referred to as the ''Company and individually as ''the
subsidiaries of the Company). |
|
|
|
Theratechnologies Inc. is incorporated under Part 1A of the Québec Companies Act and is
domiciled in Quebec, Canada. The Company is located at 2310 boul. Alfred-Nobel, Montreal,
Quebec, H4S 2B4. |
|
(a) |
|
Statement of compliance: |
|
|
|
|
These amended interim consolidated financial statements of the Company have been prepared
in accordance with International Financial Reporting Standards (''IFRSs) as issued by the
International Accounting Standards Board (''IASB). The Companys first IFRS financial
statements were for the annual period ended November 30, 2010 and were prepared using
December 1, 2008 as the date of transition. In preparing the accompanying amended interim
financial statements, the Company applied IFRS 1, First-time Adoption of International
Financial Reporting Standards as disclosed in note 8. |
|
|
|
|
These amended interim consolidated financial statements have been prepared in accordance
with IAS 34, Interim Financial Reporting. However, they should not be read in conjunction
with the notes to the Companys audited consolidated financial statements for the year
ended November 30, 2009 as those were prepared in accordance with Canadian GAAP. The
Companys interim consolidated financial statements as previously filed were also prepared
in accordance with Canadian GAAP. Canadian GAAP differs in some areas from IFRS. In
preparing these amended interim consolidated financial statements, management amended the
accounting and valuation methods previously applied in the Canadian GAAP financial
statements to comply with IFRS. The Companys annual consolidated financial statements as
at November 30, 2010 and 2009 and for the years then ended have been concurrently filed
with these amended unaudited interim consolidated financial statements. The same accounting
policies as described in note 3 of these amended interim consolidated financial statements
were used. The comparative figures for 2009 were also restated to reflect these
adjustments. |
6
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
2. |
|
Basis of preparation (continued): |
|
(a) |
|
Statement of compliance (continued): |
|
|
|
|
Certain information and footnote disclosures which are considered material to the
understanding of the Companys amended interim consolidated financial statements and which
are normally included in annual financial statements prepared in accordance with IFRS are
presented in note 3 along with reconciliations and descriptions of the effect of the
transition from Canadian GAAP to IFRS on equity, earnings and comprehensive income
presented in note 8. These amended interim consolidated financial statements do not include
all disclosures required under IFRS and accordingly should be read in connection with the
aforementioned annual financial statements and the notes thereto. These amended interim
consolidated financial statements have not been reviewed by the Companys auditors. |
|
|
|
|
These amended unaudited interim consolidated financial statements were authorized for issue
by the Audit Committee on February 8, 2011. |
|
|
(b) |
|
Basis of measurement: |
|
|
|
|
The Companys consolidated financial statements have been prepared on a going concern and
historical cost basis, except for available-for-sale financial assets which are measured at
fair value. |
|
|
|
|
The methods used to measure fair value are discussed in note 22 included in the Companys
annual financial statements dated February 8, 2011. |
|
|
(c) |
|
Functional and presentation currency: |
|
|
|
|
These amended interim consolidated financial statements are presented in Canadian dollars,
which is the Companys functional currency. All financial information presented in Canadian
dollars has been rounded to the nearest thousand. |
|
|
(d) |
|
Use of estimates and judgements: |
|
|
|
|
The preparation of the Companys amended interim consolidated financial statements in
conformity with IFRSs requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and the reported amounts of revenues
and expenses during the reporting period. |
|
|
|
|
Information about critical judgements in applying accounting policies and assumption and
estimation uncertainties that have the most significant effect on the amounts recognized in
the amended interim consolidated financial statements relate to the timing of revenue
recognition, the valuation of share-based compensation and the realizability of deferred
income tax assets. |
7
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
2. |
|
Basis of preparation (continued): |
|
(d) |
|
Use of estimates and judgements (continued): |
|
|
|
|
Other areas of judgement and uncertainty relate to the estimation of accruals for clinical
trial expenses, the recoverability of inventories, the measurement of the amount and
assessment of the recoverability of tax credits and grants receivable and the
capitalization of development expenditures. |
|
|
|
|
Reported amounts and note disclosure reflect the overall economic conditions that are most
likely to occur and anticipated measures management intends to take. Actual results could
differ from those estimates. |
|
|
|
|
The above estimates and assumptions are reviewed regularly. Revisions to accounting
estimates are recognized in the period in which the estimates are revised and in any future
periods affected. |
3. |
|
Significant accounting policies: |
|
|
The accounting policies set out below have been applied consistently to all periods presented
in these amended interim consolidated financial statements and in preparing the opening IFRS
statement of financial position at December 1, 2008, the date of transition to IFRSs. |
|
|
|
The accounting policies have been applied consistently by the subsidiaries of the Company. |
|
(a) |
|
Basis of consolidation: |
|
|
|
|
The financial statements of subsidiaries are included in the consolidated financial
statements from the date on which control commences until the date on which control ceases.
Subsidiaries are entities controlled by the Company. Control is present where the Company
has the power to govern the financial and operating policies of the entity so as to obtain
benefits from its activities. In assessing control, potential voting rights that are
exercisable currently are taken into consideration. The accounting policies of subsidiaries
are changed when necessary to align them with the policies adopted by the Company. |
|
|
|
|
Reciprocal balances and transactions, revenues and expenses resulting from transactions
between subsidiaries and with the Company are eliminated in preparing the consolidated
financial statements. |
8
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(b) |
|
Foreign currency: |
|
|
|
|
Transactions in foreign currencies are translated to the respective functional currencies
of the subsidiaries of the Company at exchange rates at the dates of the transactions.
Monetary assets and liabilities denominated in foreign currencies at the reporting date are
retranslated to the functional currency at the exchange rate at that date. The foreign
currency gain or loss on monetary items is the difference between amortized cost in the
functional currency at the beginning of the period, adjusted for effective interest and
payments during the period, and the amortized cost in foreign currency translated at the
exchange rate at the end of the reporting period. |
|
|
|
|
Foreign currency differences arising on translation are recognized in net profit (loss),
except for differences arising on the translation of available-for-sale equity instruments,
which are recognized in other comprehensive income. Non-monetary assets and liabilities
denominated in foreign currencies that are measured at fair value are translated to the
functional currency at the exchange rate at the date that the fair value was determined.
Non-monetary items that are measured at historical cost in a foreign currency are
translated using the exchange rate at the date of the transaction. |
|
|
(c) |
|
Revenue recognition: |
|
|
|
|
Collaboration agreements that include multiple deliverables are considered to be
multi-element arrangements. Under this type of arrangement, the identification of separate
units of accounting is required and revenue is allocated among the separate units based on
their relative fair values. |
|
|
|
|
Payments received under the collaboration agreement may include upfront payments, milestone
payments, research services, royalties and license fees. Revenues for each unit of
accounting are recorded as described below: |
|
(i) |
|
Sale of goods: |
|
|
|
|
Revenues from the sale of goods are recognized when the Company has transferred to the
buyer the significant risks and rewards of ownership of the goods, there is no
continuing management involvement with the goods, and the amount of revenue can be
measured reliably. |
|
|
(ii) |
|
Royalties and license fees: |
|
|
|
|
Royalties and license fees are recognized when conditions and events under the license
agreement have occurred and collectibility is reasonably assured. |
9
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(c) |
|
Revenue recognition (continued): |
|
(iii) |
|
Research services: |
|
|
|
|
Revenues from research contracts are recognized when services to be provided are
rendered and all conditions under the terms of the underlying agreement are met. |
|
(a) |
|
Upfront payments and initial technology access fees: |
|
|
|
|
Upfront payments and initial technology access fees are deferred and recognized as
revenue on a systematic basis over the period during which the related products or
services are delivered and all obligations are performed. |
|
|
(b) |
|
Milestone payments: |
|
|
|
|
Revenues subject to the achievement of milestones are recognized only when the
specified events have occurred and collectibility is reasonably assured. |
|
(d) |
|
Cost of sales: |
|
|
|
|
Cost of sales represents the cost of goods sold and includes the cost of raw materials,
supplies, direct overhead charges, unallocated indirect costs related to production as well
as write-down of inventories. Other direct costs such as manufacturing start-up costs
between validation and the achievement of normal production are expensed as incurred. |
|
|
(e) |
|
Employee benefits: |
|
|
|
|
Salaries and short-term employee benefits: |
|
|
|
|
Salaries and short-term employee benefit obligations are measured on an undiscounted basis
and are expensed as the related service is provided. A liability is recognized for the
amount expected to be paid under short-term profit-sharing or cash bonus plans if the
Company has a legal or constructive obligation to pay an amount as a result of past
services rendered by an employee and the obligation can be estimated reliably. |
|
|
|
|
Post-employment benefits: |
|
|
|
|
Post-employment benefits include a defined contribution plan under which an entity pays
fixed contributions into a separate entity and will have no legal or constructive
obligation to pay further amounts. Obligations for contributions to defined contribution
plans are recognized as an employee benefit expense when due. Prepaid contributions are
recognized as an asset to the extent that a cash refund or a reduction in future payments
is available. The Companys defined contribution plan comprises the registered retirement
savings plan, the Quebec Pension Plan and unemployment insurance. |
10
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(e) |
|
Employee benefits (continued): |
|
|
|
|
Termination benefits: |
|
|
|
|
Termination benefits are recognized as an expense when the Company is committed
demonstrably, without realistic possibility of withdrawal, to a formal detailed plan to
either terminate employment before the normal retirement date, or to provide termination
benefits as a result of an offer made to encourage voluntary redundancy. |
|
|
(f) |
|
Finance income and finance costs: |
|
|
|
|
Finance income comprises interest income on available-for-sale financial assets and gains
(losses) on the disposal of available-for-sale financial assets. Interest income is
recognized as it accrues in profit (loss), using the effective interest method. |
|
|
|
|
Finance costs are comprised of bank charges, impairment losses on financial assets
recognized in profit (loss) and foreign currency gains and losses which are reported on a
net basis. |
|
|
(g) |
|
Inventories: |
|
|
|
|
Inventories are presented at the lower of cost, determined using the first-in first-out
method, or net realizable value. Inventory costs include the purchase price and other costs
directly related to the acquisition of materials, and other costs incurred in bringing the
inventories to their present location and condition. Inventory costs also include the
costs directly related to the conversion of materials to finished goods, such as direct
labour, and a systematic allocation of fixed and variable production overhead, including
manufacturing depreciation expense. The allocation of fixed production overheads to the
cost of inventories is based on the normal capacity of the production facilities. Normal
capacity is the average production expected to be achieved over a number of periods under
normal circumstances. |
|
|
|
|
Net realizable value is the estimated selling price in the Companys ordinary course of
business, less the estimated costs of completion and selling expenses. |
|
|
(h) |
|
Property and equipment: |
|
|
|
|
Recognition and measurement: |
|
|
|
|
Items of property and equipment are recognized at cost less accumulated depreciation and
accumulated impairment losses. Cost includes expenditure that is directly attributable to
the acquisition of the asset and the costs of dismantling and removing the item and
restoring the site on which it is located, if any. |
11
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(h) |
|
Property and equipment (continued): |
|
|
|
|
Recognition and measurement (continued): |
|
|
|
|
When parts of an item of property and equipment have different useful lives, they are
accounted for as separate items (major components) of property and equipment. |
|
|
|
|
Gains and losses on disposal of an item of property and equipment are determined by
comparing the proceeds from disposal with the carrying amount of property and equipment,
and are recognized in net profit (loss). |
|
|
|
|
Subsequent costs: |
|
|
|
|
The cost of replacing a part of an item of property and equipment is recognized in the
carrying amount of the item if it is probable that the future economic benefits embodied
within the part will flow to the Company, and its cost can be measured reliably. The
carrying amount of the replaced part is derecognized. The costs of the day-to-day servicing
of property and equipment are recognized in profit (loss) as incurred. |
|
|
|
|
Depreciation: |
|
|
|
|
The estimated useful lives and the methods of depreciation for the current and comparative
periods are as follows: |
|
|
|
|
|
|
|
Asset |
|
Method |
|
Rate/Period |
|
Computer equipment
|
|
Declining balance
|
|
|
50% |
Laboratory equipment
|
|
Declining balance
|
|
|
20% |
|
|
and straight-line
|
|
5 years
|
Office furniture and equipment
|
|
Declining balance
|
|
|
20% |
Leasehold improvements
|
|
Straight-line
|
|
Lower of term of lease
|
|
|
|
|
or economic life
|
|
|
|
|
This most closely reflects the expected pattern of consumption of the future economic
benefits embodied in the asset. |
|
|
|
|
Estimates for depreciation methods, useful lives and residual values are reviewed at each
reporting period-end and adjusted, if appropriate. |
12
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(i) |
|
Intangible assets: |
|
|
|
|
Research and development: |
|
|
|
|
Expenditure on research activities, undertaken with the prospect of gaining new scientific
or technical knowledge and understanding, is expensed as incurred. |
|
|
|
|
Development activities involve a plan or design for the production of new or substantially
improved products and processes. Development expenditure is capitalized only if development
costs can be measured reliably, the product or process is technically and commercially
feasible, future economic benefits are probable, and the Company intends to and has
sufficient resources to complete development and to use or sell the asset. These criteria
are usually met when a regulatory filing has been made in a major market and approval is
considered highly probable. The expenditure capitalized includes the cost of materials,
direct labour, and overhead costs that are directly attributable to preparing the asset for
its intended use. Other development expenditures are expensed as incurred. Capitalized
development expenditures are measured at cost less accumulated amortization and accumulated
impairment losses. |
|
|
|
|
During the periods ended February 28, 2010 and 2009, November 30, 2009 and as at December
1, 2008, no development expenditures were capitalized. |
|
|
(j) |
|
Financial instruments: |
|
|
|
|
The Companys financial instruments are classified into one of three categories: loans and
receivables, available-for-sale financial assets and other financial liabilities. Loans and
receivables and other financial liabilities are measured at amortized cost. |
|
|
|
|
The Company has classified its bonds as available-for-sale financial assets. The Company
has classified cash, and trade and other receivables as loans and receivables, and accounts
payable and accrued liabilities as other financial liabilities. |
|
|
|
|
Available-for-sale financial assets are non-derivative financial assets that are designated
as available-for-sale and that are not classified in any of the other categories.
Subsequent to initial recognition, they are measured at fair value and changes therein,
other than impairment losses and foreign currency differences on available-for-sale debt
instruments, are recognized in other comprehensive income and presented within equity. When
an investment is derecognized, the cumulative gain or loss in other comprehensive income is
transferred to profit (loss). |
13
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(k) |
|
Other assets: |
|
|
|
|
Other assets consist of prepaid expenses for research supplies that are not expected to be
used within one year from the date of the consolidated statement of financial position. |
|
|
|
|
Research supplies are purchased in advance, in accordance with specific regulatory
requirements, to be used in connection with the Companys clinical trials. |
|
|
(l) |
|
Leases: |
|
|
|
|
Operating lease payments are recognized in net profit (loss) on a straight-line basis over
the term of the lease. |
|
|
|
|
Lease inducements arising from leasehold improvement allowances and rent-free periods form
an integral part of the total lease cost and are deferred and recognized in net profit
(loss) over the term of the lease on a straight-line basis. |
|
|
(m) |
|
Impairment: |
|
|
|
|
Financial assets: |
|
|
|
|
A financial asset not carried at fair value through profit or loss is assessed at each
consolidated financial statement reporting date to determine whether there is objective
evidence that it is impaired. The Company considers that a financial asset is impaired if
objective evidence indicates that one or more loss events had a negative effect on the
estimated future cash flows of that asset that can be estimated reliably. |
|
|
|
|
An impairment test is performed, on an individual basis, for each material financial asset.
Other individually non-material financial assets are tested as groups of financial assets
with similar risk characteristics. Impairment losses are recognized in net profit (loss). |
|
|
|
|
An impairment loss in respect of a financial asset measured at amortized cost is calculated
as the difference between its carrying amount and the present value of the estimated future
cash flows discounted at the assets original effective interest rate. Losses are
recognized in net profit (loss) and reflected in an allowance account against the
respective financial asset. Interest on the impaired asset continues to be recognized
through the unwinding of the discount. When a subsequent event causes the amount of
impairment loss to decrease, the decrease in impairment loss is reversed through net profit
(loss). |
14
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(m) |
|
Impairment (continued): |
|
|
|
|
Financial assets (continued): |
|
|
|
|
Impairment losses on available-for-sale investment securities are recognized by
transferring the cumulative loss that has been recognized in other comprehensive income,
and presented in unrealized gains/losses on available-for-sale financial assets in equity,
to net profit (loss). The cumulative loss that is removed from other comprehensive income
and recognized in net profit (loss) is the difference between the acquisition cost, net of
any principal repayment and amortization, and the current fair value, less any impairment
loss previously recognized in net profit (loss). Changes in impairment provisions
attributable to time value are reflected as a separate component of interest income. |
|
|
|
|
If, in a subsequent period, the fair value of an impaired available-for-sale debt security
increases and the increase can be related objectively to an event occurring after the
impairment loss was recognized in net profit (loss), then the impairment loss is reversed,
with the amount of the reversal recognized in net profit (loss). However, any subsequent
recovery in the fair value of an impaired available-for-sale equity security is recognized
in other comprehensive income. |
|
|
|
|
Non-financial assets: |
|
|
|
|
The carrying amounts of the Companys non-financial assets, other than inventories and
deferred tax assets, are reviewed at each reporting date to determine whether there is any
indication of impairment. If such an indication exists, the recoverable amount is
estimated. |
|
|
|
|
The recoverable amount of an asset or a cash-generating unit is the greater of its value in
use and its fair value less costs to sell. In assessing value in use, the estimated future
cash flows are discounted to their present value using a pre-tax discount rate that
reflects current market assessments of the time value of money and the risks specific to
the asset. For the purpose of impairment testing, assets are grouped together into the
smallest group of assets that generates cash inflows from continuing use that are largely
independent of cash inflows from other assets or groups of assets (''cash-generating
unit). Impairment losses recognized in prior periods are determined at each reporting
date for any indications that the loss has decreased or no longer exists. An impairment
loss is reversed if there has been a change in the estimates used to determine the
recoverable amount. An assets carrying amount, increased through reversal of an impairment
loss, must not exceed the carrying amount that would have been determined, net of
depreciation or amortization, if no impairment loss had been recognized. |
15
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(n) |
|
Provisions: |
|
|
|
|
A provision is recognized if, as a result of a past event, the Company has a present legal
or constructive obligation that can be estimated reliably, and it is probable that an
outflow of economic benefits will be required to settle the obligation. Provisions are
assessed by discounting the expected future cash flows at a pre-tax rate that reflects
current market assessments of the time value of money and the risks specific to the
liability. The unwinding of the discount on provisions is recognized in finance costs. |
|
|
|
|
Onerous contracts: |
|
|
|
|
A provision for onerous contracts is recognized when the expected benefits to be derived by
the Company from a contract are lower than the unavoidable cost of meeting its obligations
under the contract. The provision is measured at the present value of the lower of the
expected cost of terminating the contract and the expected net cost of continuing with the
contract. Before a provision is established, the Company recognizes any impairment loss on
the assets associated with that contract. There were no onerous contracts as at February
28, 2010 and 2009, November 30, 2009 and December 1, 2008. |
|
|
|
|
Site restoration: |
|
|
|
|
Where there is a legal or constructive obligation to restore leased premises to good
condition, except for normal aging on expiry or early termination of the lease, the
resulting costs are provisioned up to the discounted value of estimated future costs and
increase the carrying amount of the corresponding item of property and equipment. The
Company amortizes the cost of restoring leased premises and recognizes an unwinding of
discount expense on the liability related to the term of the lease. |
|
|
|
|
Contingent liability: |
|
|
|
|
A contingent liability is a possible obligation that arises from past events and of which
the existence will be confirmed only by the occurrence or non-occurrence of one or more
uncertain future events not wholly within the control of the Company; or a present
obligation that arises from past events (and therefore exists), but is not recognized
because it is not probable that a transfer or use of assets, provision of services or any
other transfer of economic benefits will be required to settle the obligation, or the
amount of the obligation cannot be estimated reliably. |
16
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(o) |
|
Income taxes: |
|
|
|
|
Income tax expense comprises current and deferred tax. Current tax and deferred tax are
recognized in net profit (loss), except to the extent that they relate to items recognized
directly in other comprehensive income or in equity. |
|
|
|
|
Current tax: |
|
|
|
|
Current tax is the expected tax payable or receivable on the taxable income or loss for the
year, using tax rates enacted or substantively enacted at the reporting date, and any
adjustment to tax payable in respect of previous years. The Company establishes provisions
where appropriate on the basis of amounts expected to be paid to the tax authorities. |
|
|
|
|
Deferred tax: |
|
|
|
|
Deferred tax is recognized in respect of temporary differences between the carrying amounts
of assets and liabilities for financial reporting purposes and the amounts used for
taxation purposes. Deferred tax is measured at the tax rates that are expected to be
applied to temporary differences when they reverse, based on the laws that have been
enacted or substantively enacted by the reporting date. |
|
|
|
|
A deferred tax liability is generally recognized for all taxable temporary differences. |
|
|
|
|
A deferred tax asset is recognized for unused tax losses and deductible temporary
differences, to the extent that it is probable that future taxable profits will be
available against which they can be utilized. Deferred tax assets are reviewed at each
reporting date and are reduced to the extent that it is no longer probable that the related
tax benefit will be realized. |
|
|
(p) |
|
Share-based compensation: |
|
|
|
|
The Company records share-based compensation related to employee stock options granted
using the fair value-based method estimated using the Black-Scholes model. Under this
method, compensation cost is measured at fair value at the date of grant and expensed, as
employee benefits, over the period in which employees unconditionally become entitled to
the award. The amount recognized as an expense is adjusted to reflect the number of awards
for which the related service conditions are expected to be met, such that the amount
ultimately recognized as an expense is based on the number of awards that do meet the
related service and non-market performance conditions at the vesting date. |
|
|
|
|
Share-based payment arrangements in which the Company receives goods or services as
consideration for its own equity instruments are accounted for as equity-settled
share-based payment transactions, regardless of how the equity instruments are obtained by
the Company. |
17
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(p) |
|
Share-based compensation (continued): |
|
|
|
|
As permitted by IFRS 1, the Company elected not to restate options that were granted before
November 7, 2002 and those granted after November 7, 2002 that were fully vested prior to
the date of transition to IFRS. |
|
|
(q) |
|
Government grants: |
|
|
|
|
Government grants, consisting of grants and research investment tax credits, are recorded
as a reduction of the related expense or cost of the asset acquired. Government grants are
recognized when there is reasonable assurance that the Company has met the requirements of
the approved grant program and there is reasonable assurance that the grant will be
received. |
|
|
(r) |
|
Share capital: |
|
|
|
|
Common shares: |
|
|
|
|
Common shares are classified as equity. Incremental costs directly attributable to the
issue of common shares and share options are recognized as a deduction from equity, net of
any tax effects. |
|
|
(s) |
|
Earnings per share: |
|
|
|
|
The Company presents basic and diluted earnings per share (''EPS) data for its common
shares. Basic EPS is calculated by dividing the net profit or loss attributable to common
shareholders of the Company by the weighted average number of common shares outstanding
during the period, adjusted for own shares held, if applicable. Diluted EPS is determined
by adjusting the profit or loss attributable to common shareholders and the weighted
average number of common shares outstanding, adjusted for own shares held, if applicable,
for the effects of all dilutive potential common shares, which consist of the stock options
granted to employees. |
|
|
(t) |
|
New standards and interpretations not yet applied: |
|
|
|
|
Certain pronouncements were issued by the IASB or International Financial Reporting
Interpretations Committee that are mandatory for accounting periods beginning on or after
January 1, 2010 or later periods. Many of these updates are not applicable or are
inconsequential to the Company and have been excluded from the discussion below. The
remaining pronouncements are being assessed to determine their impact on the Companys
results and financial position: |
18
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(t) |
|
New standards and interpretations not yet applied (continued): |
|
|
|
|
Annual improvements to IFRS: |
|
|
|
|
The IASBs improvements to IFRS published in April 2009 contain fifteen amendments to
twelve standards that result in accounting changes for presentation, recognition or
measurement purposes largely for annual periods beginning on or after January 1, 2010, with
early adoption permitted. These amendments were considered by the Company and deemed to be
not applicable to the Company other than for the amendment to IAS 17 Leases relating to
leases which include both land and buildings elements. In this case, the Company early
adopted this amendment. |
|
|
|
|
In addition, the following new or revised standards and interpretations have been issued
but are not yet applicable to the Company: |
|
(i) |
|
IFRS 8: |
|
|
|
|
IFRS 8, Operating Segments (revised): |
|
|
|
|
Effective for annual periods beginning on or after January 1, 2010. |
|
|
|
|
Requires purchase information about segment assets. |
|
|
(ii) |
|
IFRS 9: |
|
|
|
|
New standard IFRS 9, Financial Instruments: |
|
|
|
|
Effective for annual periods beginning on or after January 1, 2013, with earlier
adoption permitted. |
|
|
|
|
As part of the project to replace IAS 39, Financial Instruments: Recognition and
Measurement, this standard retains but simplifies the mixed measurement model and
establishes two primary measurement categories for financial assets. More specifically,
the standard: |
|
|
|
deals with classification and measurement of financial assets |
|
|
|
|
establishes two primary measurement categories for financial assets:
amortized cost and fair value |
|
|
|
|
classification depends on entitys business model and the contractual
cash flow characteristics of the financial asset |
|
|
|
|
eliminates the existing categories: held to maturity, available for
sale, and loans and receivables. |
19
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
3. |
|
Significant accounting policies (continued): |
|
(t) |
|
New standards and interpretations not yet applied (continued): |
|
|
|
|
Annual improvements to IFRS (continued): |
|
(ii) |
|
IFRS 9 (continued): |
|
|
|
|
New standard IFRS 9, Financial Instruments (continued): |
|
|
|
|
Certain changes were also made regarding the fair value option for financial
liabilities and accounting for certain derivatives linked to unquoted equity
instruments. |
4. |
|
Revenue and deferred revenue: |
|
|
On October 28, 2008, the Company entered into a collaboration and licensing agreement with EMD
Serono Inc. (''EMD Serono), an affiliate of the Group Merck KGaA, of Darmstadt, Germany,
regarding the exclusive commercialization rights of tesamorelin in the United States for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy (the ''Initial
Product). The Company retains all tesamorelin commercialization rights outside of the United
States. |
|
|
|
Under the terms of the agreement, the Company is responsible for the development of the Initial
Product up to obtaining marketing approval in the United States. The Company is also
responsible for product production and for the development of a new formulation of the Initial
Product. EMD Serono is responsible for conducting product commercialization activities. |
|
|
|
At the closing of the agreement on December 15, 2008, the Company received US$30,000
(CAD$36,951), which includes an initial payment of US$22,000 (CAD$27,097) and US$8,000
(CAD$9,854) as a subscription for common shares in the Company by Merck KGaA at a price of
US$3.67 (CAD$4.52) per share. The Company may receive up to US$215,000, which amount includes
the initial payment of US$22,000, the equity investment of US$8,000, as well as payments based
on the achievement of certain development, regulatory and sales milestones. The Company will
also be entitled to receive increasing royalties on annual net sales of tesamorelin in the
United States, if applicable. |
|
|
|
The initial payment of $27,097 has been deferred and is being amortized over the estimated
period for developing a new formulation of the Initial Product. This period may be modified in
the future based on additional information that may be received by the Company. For the
three-month period ended February 28, 2010, an amount of $1,711 (2009 $1,426) related to
this transaction was recognized as revenue. As at February 28, 2010, the deferred revenue
related to this transaction amounted to $18,826 (November 30, 2009 $20,537). |
20
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
4. |
|
Revenue and deferred revenue (continued): |
|
|
On August 12, 2009, the US Food and Drug Administration accepted the New Drug Application
(''NDA) made by the Company for tesamorelin. Under the terms of the Companys collaboration
and licensing agreement with EMD Serono, the acceptance of the tesamorelin NDA resulted in a
milestone payment of US$10,000 (CAD$10,884). This milestone payment has been recorded in the
third quarter of 2009. |
|
|
|
The Company may conduct research and development activities for additional indications. Under
the collaboration and licensing agreement, EMD Serono will also have the option to
commercialize additional indications for tesamorelin in the United States. If it exercises this
option, EMD Serono will pay half of the development costs related to such additional
indications. In such cases, the Company will also have the right, subject to an agreement with
EMD Serono, to participate in promoting these additional indications. |
|
(a) |
|
Shareholder rights plan: |
|
|
|
|
On February 10, 2010, the Board of Directors of the Company adopted a shareholder rights
plan (the ''Plan), effective as of that date. The Plan is designed to provide adequate
time for the Board of Directors and the shareholders, to assess an unsolicited takeover bid
for the Company. In addition, the Plan provides the Board of Directors with sufficient time
to explore and develop alternatives for maximizing shareholder value if a takeover bid is
made, as well as provide shareholders with an equal opportunity to participate if a
takeover bid is made, as well as provide shareholders with an equal opportunity to
participate in a takeover bid to receive full and fair value for their common shares. The
Plan, if approved by the shareholders, will expire at the close of the Companys annual
meeting of shareholders in 2013. |
|
|
|
|
The rights issued under the Plan will initially attach to and trade with the common shares
and no separate certificates will be issued unless a triggering event occurs. The rights
will become exercisable only when a person, including any party related to it, acquires or
attempts to acquire 20% or more of the outstanding shares without complying with the
''Permitted Bid provisions of the Plan or without approval of the Board of Directors.
Should such an acquisition occur or be announced, each right would, upon exercise, entitle
a rights holder, other than the acquiring person and related persons, to purchase common
shares at a 50% discount to the market price at the time. |
21
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Share capital (continued): |
|
(a) |
|
Shareholder rights plan (continued): |
|
|
|
|
Under the Plan, a Permitted Bid is a bid made to all holders of the common shares and which
is open for acceptance for not less than 60 days. If, at the end of 60 days, at least 50%
of the outstanding common shares, other than those owned by the offeror and certain related
parties, have been tendered, the offeror may take up and pay for the common shares, but
must extend the bid for a further 10 days to allow other shareholders to tender. |
|
|
(b) |
|
Share purchase plan: |
|
|
|
|
The Share Purchase Plan entitles full-time and part-time employees of the Company who, on
the participation date, are residents of Canada, are not under a probationary period and do
not hold, directly or indirectly, five percent (5%) or more of the Companys outstanding
common shares, to directly subscribe for common shares of the Company. Under the Share
Purchase Plan, a maximum of 550,000 common shares may be issued to employees. |
|
|
|
|
On May 1 and November 1 of each year (the ''Participation Dates), an employee may
subscribe for a number of common shares under the Share Purchase Plan for an amount that
does not exceed 10% of that employees gross annual salary for that year. Under the Share
Purchase Plan, the Board of Directors has the authority to suspend or defer a subscription
of common shares, or to decide that no subscription of common shares will be allowed on a
Participation Date if it is in the Companys best interest. |
|
|
|
|
The Share Purchase Plan provides that the number of common shares that may be issued to
insiders, at any time, under all share-based compensation arrangements of the Company,
cannot exceed 10% of the Companys outstanding common shares, and the number of common
shares issued to insiders, within any one-year period, under all security-based
compensation arrangements, cannot exceed 10% of the outstanding common shares. |
|
|
|
|
The subscription price for each new common share subscribed for under the Share Purchase
Plan is equal to the weighted average closing price of the common shares on the Toronto
Stock Exchange during a period of five days prior to the Participation Date. Employees may
not assign the rights granted under the Share Purchase Plan. |
22
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Share capital (continued): |
|
(b) |
|
Share purchase plan (continued): |
|
|
|
|
An employee may elect to pay the subscription price for common shares in cash or through an
interest-free loan from the Company. Loans granted by the Company under the Share Purchase
Plan are repayable through salary withholdings over a period not exceeding two years. All
loans may be repaid prior to the scheduled repayment at any time. The loans granted to any
employee may at no time exceed 10% of that employees current annual gross salary. All
common shares purchased through an interest-free loan are hypothecated to secure full and
final repayment of the loan and are held by a trustee until repayment in full. Loans are
immediately due and payable on the occurrence of any of the following events: (i)
termination of employment; (ii) sale or seizure of the hypothecated common shares; (iii)
bankruptcy or insolvency of the employee; or (iv) suspension of the payment of an
employees salary or revocation of the employees right to salary withholdings. |
|
|
|
|
At February 28, 2010, $114 (November 30, 2009 $149; December 1, 2008 $150) was
receivable under these loans. |
|
|
(c) |
|
Stock option plan: |
|
|
|
|
The Company has established a stock option plan under which it can grant to its directors,
officers, employees, researchers and consultants non-transferable options for the purchase
of common shares. The exercise date of an option may not be later than 10 years after the
grant date. A maximum number of 5,000,000 options can be granted under the plan. Generally,
the options vest at the date of the grant or over a period up to 5 years. As at February
28, 2010, 1,005,501 options could still be granted by the Company (February 28 -
1,238,667). |
|
|
|
|
All options are to be settled by physical delivery of shares. |
23
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Share capital (continued): |
|
(c) |
|
Stock option plan (continued): |
|
|
|
|
Changes in outstanding options granted under the Companys stock option plan for the year
ended November 30, 2009 and the three-month period ended February 28, 2010 were as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
|
|
|
|
exercise price |
|
|
|
Options |
|
|
per option |
|
|
|
|
|
|
|
|
$ |
|
Options at December 1, 2008 |
|
|
2,161,800 |
|
|
|
6.52 |
|
Granted |
|
|
680,500 |
|
|
|
1.83 |
|
Expired |
|
|
(58,500 |
) |
|
|
5.16 |
|
Forfeited |
|
|
(118,000 |
) |
|
|
9.92 |
|
|
|
|
|
|
|
|
|
|
|
Options at November 30, 2009 |
|
|
2,665,800 |
|
|
|
5.20 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
265,000 |
|
|
|
3.84 |
|
Expired |
|
|
|
|
|
|
|
|
Forfeited |
|
|
(25,667 |
) |
|
|
3.26 |
|
Exercised |
|
|
(21,164 |
) |
|
|
1.80 |
|
|
|
|
|
|
|
|
|
|
|
Options at February 28, 2010 |
|
|
2,883,969 |
|
|
|
5.12 |
|
|
|
|
The fair value of the options granted was estimated at the grant date using the
Black-Scholes model and the following weighted average assumptions: |
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
Risk-free interest rate |
|
|
2.46 |
% |
|
|
1.79 |
% |
Volatility |
|
|
81 |
% |
|
|
79 |
% |
Average option life in years |
|
|
7.5 |
|
|
|
7.5 |
|
Dividend yield |
|
Nil |
|
|
Nil |
|
Grant-date share price |
|
$ |
3.84 |
|
|
$ |
1.83 |
|
Option exercise price |
|
$ |
3.84 |
|
|
$ |
1.83 |
|
|
24
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Share capital (continued): |
|
(c) |
|
Stock option plan (continued): |
|
|
|
|
The risk-free interest rate is based on the implied yield on a Canadian Government
zero-coupon issue with a remaining term equal to the expected term of the option. The
volatility is based solely on historical volatility equal to the expected life of the
option. The life of the options is estimated considering the vesting period at the grant
date, the life of the option and the average length of time of similar grants have remained
outstanding in the past. The dividend yield was excluded from the calculation, since it is
the present policy of the Company to retain in all earnings to finance operations and
future growth. |
|
|
|
|
The following table summarizes the measurement date weighted average fair value of stock
options granted during the periods ended February 28, 2010 and 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
Number of |
|
|
grant-date |
|
|
|
options |
|
|
fair value |
|
|
|
|
|
|
|
$ |
|
2010 |
|
|
265,000 |
|
|
|
2.90 |
|
2009 |
|
|
590,500 |
|
|
|
1.33 |
|
|
|
|
The Black-Scholes model used by the Company to calculate option values was developed
to estimate the fair value of freely tradable, fully transferable options without vesting
restrictions, which significantly differs from the Companys stock option awards. This
model also requires four highly subjective assumptions, including future stock price
volatility and average option life, which greatly affect the calculated values. |
25
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
5. |
|
Share capital (continued): |
|
(d) |
|
Earnings per share: |
|
|
|
|
The calculation of basic earnings per share at February 28, 2010 was based on the net loss
attributable to common shareholders of the Company of ($4,241) (2009 ($10,827)), and a
weighted average number of common shares outstanding of 60,438,098 (2009 60,055,841),
calculated as follows: |
|
|
|
|
|
|
|
|
|
|
|
February 28, |
|
|
February 28, |
|
|
|
2010 |
|
|
2009 |
|
|
Issued common shares at December 1 |
|
|
60,429,393 |
|
|
|
58,215,090 |
|
Effect of share options exercised |
|
|
8,705 |
|
|
|
|
|
Effect of shares issued during the year |
|
|
|
|
|
|
1,840,751 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares at February 28 |
|
|
60,438,098 |
|
|
|
60,055,841 |
|
|
|
|
|
At February 28, 2010, 1,157,166 options (2009 2,391,130) were excluded from the
diluted weighted average number of common shares calculation as their effect would have
been anti-dilutive. |
6. |
|
Statement of cash flows: |
|
|
The Company entered into the following transactions which had no impact on the cash flows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
February 28, |
|
|
February 28, |
|
|
November 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2009 |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
Additions to property and equipment included in accounts payable
and accrued liabilities |
|
|
135 |
|
|
|
31 |
|
|
|
183 |
|
|
|
|
Except for changes related to the Companys adoption of IFRS, these amended unaudited interim
consolidated financial statements do not reflect events occurring after March 23, 2010, the
date of the filing of the consolidated financial statements prepared in accordance with
Canadian GAAP. The annual audited consolidated financial statements of the Company prepared in
accordance with IFRS have been filed concurrently with these amended unaudited interim
consolidated financial statements. These amended unaudited interim consolidated financial
statements should be read in connection with the annual consolidated financial statements for
additional disclosures with respect to subsequent events. |
26
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
|
|
As stated in note 2 (a), the Company has applied IFRS 1 and the accounting policies set out in
note 3 in preparing the financial statements for the period ended February 28, 2010, the
comparative period ended February 28, 2009, for the year ended November 30, 2009, and for the
opening IFRS statement of financial position as at December 1, 2008 (the Companys date of
transition). |
|
|
|
In preparing these consolidated financial statements in accordance with IFRS 1, the Company has
applied the mandatory exceptions and certain of the optional exemptions from full retrospective
application of IFRS. |
|
|
|
The Company elected to apply the following optional exemptions from full retrospective
application: |
|
(i) |
|
Share-based payment transaction exemption: |
|
|
|
|
The Company has elected to apply the share-based payment exemption. It applied IFRS 2 from
December 1, 2008 to those stock options that were issued after November 7, 2002 but that
had not vested by December 1, 2008. The application of the exemption is detailed below. |
|
|
(ii) |
|
Designation of financial assets and financial liabilities exemption: |
|
|
|
|
The Company elected to re-designate cash from the held for trading category to loans and
receivables. |
|
|
As required by IFRS 1, estimates made under IFRS at the date of transition must be consistent
with estimates made for the same date under previous GAAP, unless there is evidence that those
estimates were in error. |
|
|
|
In preparing its opening IFRS consolidated statement of financial position, the Company has
adjusted amounts reported previously in financial statements prepared in accordance with
Canadian GAAP. |
|
|
|
An explanation of how the transition from previous Canadian GAAP to IFRS has affected the
Companys financial position, financial performance and cash flows is set out in the following
tables and accompanying notes. |
27
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
Reconciliation of equity as at December 1, 2008 and November 30, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 1, 2008 |
|
|
November 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Note |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
|
|
|
|
|
133 |
|
|
|
|
|
|
|
|
|
|
|
133 |
|
|
|
1,519 |
|
|
|
|
|
|
|
|
|
|
|
1,519 |
|
Bonds |
|
|
|
|
|
|
10,955 |
|
|
|
|
|
|
|
|
|
|
|
10,955 |
|
|
|
10,036 |
|
|
|
|
|
|
|
|
|
|
|
10,036 |
|
Trade and other
receivables |
|
|
|
|
|
|
610 |
|
|
|
|
|
|
|
|
|
|
|
610 |
|
|
|
375 |
|
|
|
|
|
|
|
|
|
|
|
375 |
|
Tax credits and
grants receivable |
|
|
(a |
) |
|
|
1,784 |
|
|
|
|
|
|
|
(333 |
) |
|
|
1,451 |
|
|
|
1,666 |
|
|
|
|
|
|
|
(333 |
) |
|
|
1,333 |
|
Inventories |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,225 |
|
|
|
|
|
|
|
|
|
|
|
2,225 |
|
Research supplies |
|
|
(a |
) |
|
|
301 |
|
|
|
|
|
|
|
(301 |
) |
|
|
|
|
|
|
287 |
|
|
|
|
|
|
|
(287 |
) |
|
|
|
|
Prepaid expenses |
|
|
(a |
) |
|
|
397 |
|
|
|
|
|
|
|
342 |
|
|
|
739 |
|
|
|
302 |
|
|
|
|
|
|
|
328 |
|
|
|
630 |
|
|
Total current assets |
|
|
|
|
|
|
14,180 |
|
|
|
|
|
|
|
(292 |
) |
|
|
13,888 |
|
|
|
16,410 |
|
|
|
|
|
|
|
(292 |
) |
|
|
16,118 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bonds |
|
|
|
|
|
|
35,249 |
|
|
|
|
|
|
|
|
|
|
|
35,249 |
|
|
|
51,807 |
|
|
|
|
|
|
|
|
|
|
|
51,807 |
|
Property and equipment |
|
|
|
|
|
|
1,299 |
|
|
|
|
|
|
|
|
|
|
|
1,299 |
|
|
|
1,229 |
|
|
|
|
|
|
|
|
|
|
|
1,229 |
|
Other assets |
|
|
(a |
) |
|
|
2,817 |
|
|
|
|
|
|
|
(41 |
) |
|
|
2,776 |
|
|
|
41 |
|
|
|
|
|
|
|
(41 |
) |
|
|
|
|
|
Total non-current assets |
|
|
|
|
|
|
39,365 |
|
|
|
|
|
|
|
(41 |
) |
|
|
39,324 |
|
|
|
53,077 |
|
|
|
|
|
|
|
(41 |
) |
|
|
53,036 |
|
|
Total assets |
|
|
|
|
|
|
53,545 |
|
|
|
|
|
|
|
(333 |
) |
|
|
53,212 |
|
|
|
69,487 |
|
|
|
|
|
|
|
(333 |
) |
|
|
69,154 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
and accrued liabilities |
|
|
(a |
) |
|
|
7,198 |
|
|
|
|
|
|
|
(333 |
) |
|
|
6,865 |
|
|
|
5,901 |
|
|
|
|
|
|
|
(333 |
) |
|
|
5,568 |
|
Current portion of
deferred revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,847 |
|
|
|
|
|
|
|
|
|
|
|
6,847 |
|
|
Total current liabilities |
|
|
|
|
|
|
7,198 |
|
|
|
|
|
|
|
(333 |
) |
|
|
6,865 |
|
|
|
12,748 |
|
|
|
|
|
|
|
(333 |
) |
|
|
12,415 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,691 |
|
|
|
|
|
|
|
|
|
|
|
13,691 |
|
|
Total non-current liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,691 |
|
|
|
|
|
|
|
|
|
|
|
13,691 |
|
|
Total liabilities |
|
|
|
|
|
|
7,198 |
|
|
|
|
|
|
|
(333 |
) |
|
|
6,865 |
|
|
|
26,439 |
|
|
|
|
|
|
|
(333 |
) |
|
|
26,106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
|
|
|
|
269,219 |
|
|
|
|
|
|
|
|
|
|
|
269,219 |
|
|
|
279,169 |
|
|
|
|
|
|
|
|
|
|
|
279,169 |
|
Contributed surplus |
|
|
(b |
) |
|
|
5,585 |
|
|
|
175 |
|
|
|
|
|
|
|
5,760 |
|
|
|
6,484 |
|
|
|
273 |
|
|
|
|
|
|
|
6,757 |
|
Deficit |
|
|
(b |
) |
|
|
(228,829 |
) |
|
|
(175 |
) |
|
|
|
|
|
|
(229,004 |
) |
|
|
(243,887 |
) |
|
|
(273 |
) |
|
|
|
|
|
|
(244,160 |
) |
Accumulated other
comprehensive income |
|
|
|
|
|
|
372 |
|
|
|
|
|
|
|
|
|
|
|
372 |
|
|
|
1,282 |
|
|
|
|
|
|
|
|
|
|
|
1,282 |
|
|
Total equity |
|
|
|
|
|
|
46,347 |
|
|
|
|
|
|
|
|
|
|
|
46,347 |
|
|
|
43,048 |
|
|
|
|
|
|
|
|
|
|
|
43,048 |
|
|
Total liabilities and equity |
|
|
|
|
|
|
53,545 |
|
|
|
|
|
|
|
(333 |
) |
|
|
53,212 |
|
|
|
69,487 |
|
|
|
|
|
|
|
(333 |
) |
|
|
69,154 |
|
|
28
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
Reconciliation of equity as at February 28, 2010 and 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
February 28, 2010 |
|
|
February 28, 2009 |
|
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Note |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$$ |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
|
|
|
|
|
3,332 |
|
|
|
|
|
|
|
|
|
|
|
3,332 |
|
|
|
6,891 |
|
|
|
|
|
|
|
|
|
|
|
6,891 |
|
Bonds |
|
|
|
|
|
|
6,264 |
|
|
|
|
|
|
|
|
|
|
|
6,264 |
|
|
|
9,786 |
|
|
|
|
|
|
|
|
|
|
|
9,786 |
|
Trade and other
receivables |
|
|
|
|
|
|
281 |
|
|
|
|
|
|
|
|
|
|
|
281 |
|
|
|
559 |
|
|
|
|
|
|
|
|
|
|
|
559 |
|
Tax credits and
grants receivable |
|
|
(a |
) |
|
|
1,834 |
|
|
|
|
|
|
|
(333 |
) |
|
|
1,501 |
|
|
|
2,452 |
|
|
|
|
|
|
|
(333 |
) |
|
|
2,119 |
|
Inventories |
|
|
|
|
|
|
2,251 |
|
|
|
|
|
|
|
|
|
|
|
2,251 |
|
|
|
1,594 |
|
|
|
|
|
|
|
|
|
|
|
1,594 |
|
Research supplies |
|
|
(a |
) |
|
|
270 |
|
|
|
|
|
|
|
(270 |
) |
|
|
|
|
|
|
711 |
|
|
|
|
|
|
|
(711 |
) |
|
|
|
|
Prepaid expenses |
|
|
(a |
) |
|
|
714 |
|
|
|
|
|
|
|
311 |
|
|
|
1,025 |
|
|
|
456 |
|
|
|
|
|
|
|
767 |
|
|
|
1,223 |
|
|
Total current assets |
|
|
|
|
|
|
14,946 |
|
|
|
|
|
|
|
(292 |
) |
|
|
14,654 |
|
|
|
22,449 |
|
|
|
|
|
|
|
(277 |
) |
|
|
22,172 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bonds |
|
|
|
|
|
|
45,693 |
|
|
|
|
|
|
|
|
|
|
|
45,693 |
|
|
|
52,712 |
|
|
|
|
|
|
|
|
|
|
|
52,712 |
|
Property and equipment |
|
|
|
|
|
|
1,209 |
|
|
|
|
|
|
|
|
|
|
|
1,209 |
|
|
|
1,247 |
|
|
|
|
|
|
|
|
|
|
|
1,247 |
|
Other assets |
|
|
(a |
) |
|
|
41 |
|
|
|
|
|
|
|
(41 |
) |
|
|
|
|
|
|
2,264 |
|
|
|
|
|
|
|
(56 |
) |
|
|
2,208 |
|
|
Total non-current assets |
|
|
|
|
|
|
46,943 |
|
|
|
|
|
|
|
(41 |
) |
|
|
46,902 |
|
|
|
56,223 |
|
|
|
|
|
|
|
(56 |
) |
|
|
56,167 |
|
|
Total assets |
|
|
|
|
|
|
61,889 |
|
|
|
|
|
|
|
(333 |
) |
|
|
61,556 |
|
|
|
78,672 |
|
|
|
|
|
|
|
(333 |
) |
|
|
78,339 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
and accrued liabilities |
|
|
|
|
|
|
4,073 |
|
|
|
|
|
|
|
(333 |
) |
|
|
3,740 |
|
|
|
7,045 |
|
|
|
|
|
|
|
(333 |
) |
|
|
6,712 |
|
Current portion of
deferred revenue |
|
|
|
|
|
|
6,855 |
|
|
|
|
|
|
|
|
|
|
|
6,855 |
|
|
|
6,856 |
|
|
|
|
|
|
|
|
|
|
|
6,856 |
|
|
Total current liabilities |
|
|
|
|
|
|
10,928 |
|
|
|
|
|
|
|
(333 |
) |
|
|
10,595 |
|
|
|
13,901 |
|
|
|
|
|
|
|
(333 |
) |
|
|
13,568 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
|
|
|
|
11,980 |
|
|
|
|
|
|
|
|
|
|
|
11,980 |
|
|
|
18,825 |
|
|
|
|
|
|
|
|
|
|
|
18,825 |
|
|
Total non-current liabilities |
|
|
|
|
|
|
11,980 |
|
|
|
|
|
|
|
|
|
|
|
11,980 |
|
|
|
18,825 |
|
|
|
|
|
|
|
|
|
|
|
18,825 |
|
|
Total liabilities |
|
|
|
|
|
|
22,908 |
|
|
|
|
|
|
|
(333 |
) |
|
|
22,575 |
|
|
|
32,726 |
|
|
|
|
|
|
|
(333 |
) |
|
|
32,393 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
|
|
|
|
279,230 |
|
|
|
|
|
|
|
|
|
|
|
279,230 |
|
|
|
279,073 |
|
|
|
|
|
|
|
|
|
|
|
279,073 |
|
Contributed surplus |
|
|
(b |
) |
|
|
6,720 |
|
|
|
247 |
|
|
|
|
|
|
|
6,967 |
|
|
|
5,790 |
|
|
|
248 |
|
|
|
|
|
|
|
6,038 |
|
Deficit |
|
|
(b |
) |
|
|
(248,154 |
) |
|
|
(247 |
) |
|
|
|
|
|
|
(248,401 |
) |
|
|
(239,583 |
) |
|
|
(248 |
) |
|
|
|
|
|
|
(239,831 |
) |
Accumulated other
comprehensive income |
|
|
|
|
|
|
1,185 |
|
|
|
|
|
|
|
|
|
|
|
1,185 |
|
|
|
666 |
|
|
|
|
|
|
|
|
|
|
|
666 |
|
|
Total equity |
|
|
|
|
|
|
38,981 |
|
|
|
|
|
|
|
|
|
|
|
38,981 |
|
|
|
45,946 |
|
|
|
|
|
|
|
|
|
|
|
45,946 |
|
|
Total liabilities and equity |
|
|
|
|
|
|
61,889 |
|
|
|
|
|
|
|
(333 |
) |
|
|
61,556 |
|
|
|
78,672 |
|
|
|
|
|
|
|
(333 |
) |
|
|
78,339 |
|
|
29
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
Reconciliation of comprehensive income for the year ended November 30, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Note |
|
|
GAAP |
|
|
ments |
|
|
fication |
|
|
IFRS |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
10,884 |
|
|
|
10,884 |
|
Upfront payments and initial technology access fees |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
6,560 |
|
|
|
6,560 |
|
Royalties and license fees |
|
|
(c |
) |
|
|
17,468 |
|
|
|
|
|
|
|
(17,444 |
) |
|
|
24 |
|
Interest |
|
|
(c |
) |
|
|
2,252 |
|
|
|
|
|
|
|
(2,252 |
) |
|
|
|
|
|
Total revenue |
|
|
|
|
|
|
19,720 |
|
|
|
|
|
|
|
(2,252 |
) |
|
|
17,468 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses, net of tax credits |
|
|
(b),(c |
) |
|
|
20,431 |
|
|
|
33 |
|
|
|
346 |
|
|
|
20,810 |
|
Selling and market development expenses |
|
|
(b),(c |
) |
|
|
2,583 |
|
|
|
10 |
|
|
|
4,269 |
|
|
|
6,862 |
|
General and administrative expenses |
|
|
(b),(c |
) |
|
|
7,149 |
|
|
|
55 |
|
|
|
(661 |
) |
|
|
6,543 |
|
Patents |
|
|
(c |
) |
|
|
346 |
|
|
|
|
|
|
|
(346 |
) |
|
|
|
|
Fees associated with the collaboration and licensing
agreement |
|
|
(c |
) |
|
|
4,269 |
|
|
|
|
|
|
|
(4,269 |
) |
|
|
|
|
|
Total operating expenses |
|
|
|
|
|
|
34,778 |
|
|
|
98 |
|
|
|
(661 |
) |
|
|
34,215 |
|
|
Results from operating activities |
|
|
|
|
|
|
(15,058 |
) |
|
|
(98 |
) |
|
|
(1,591 |
) |
|
|
(16,747 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
2,252 |
|
|
|
2,252 |
|
Finance costs |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
(661 |
) |
|
|
(661 |
) |
|
Total net finance income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,591 |
|
|
|
1,591 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
(15,058 |
) |
|
|
(98 |
) |
|
|
|
|
|
|
(15,156 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income, net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value of available-for-sale financial assets,
net of tax |
|
|
|
|
|
|
1,039 |
|
|
|
|
|
|
|
|
|
|
|
1,039 |
|
Net change in fair value of available-for-sale financial assets
transferred to net loss, net of tax |
|
|
|
|
|
|
(129 |
) |
|
|
|
|
|
|
|
|
|
|
(129 |
) |
|
Other comprehensive income for the year |
|
|
|
|
|
|
910 |
|
|
|
|
|
|
|
|
|
|
|
910 |
|
|
Total comprehensive income for the year |
|
|
|
|
|
|
(14,148 |
) |
|
|
(98 |
) |
|
|
|
|
|
|
(14,246 |
) |
|
30
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
Reconciliation of comprehensive income for the three-month periods ended February 28, 2010 and
2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
February 28, 2010 |
|
|
February 28, 2009 |
|
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
IFRS |
|
|
IFRS |
|
|
|
|
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Canadian |
|
|
adjust- |
|
|
reclassi- |
|
|
|
|
|
|
Note |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
GAAP |
|
|
ments |
|
|
fications |
|
|
IFRS |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Upfront payments
and initial
technology
access fees |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
1,711 |
|
|
|
1,711 |
|
|
|
|
|
|
|
|
|
|
|
1,426 |
|
|
|
1,426 |
|
Royalties and license
fees |
|
|
(c |
) |
|
|
1,717 |
|
|
|
|
|
|
|
(1,711 |
) |
|
|
6 |
|
|
|
1,432 |
|
|
|
|
|
|
|
(1,426 |
) |
|
|
6 |
|
Interest |
|
|
(c |
) |
|
|
578 |
|
|
|
|
|
|
|
(578 |
) |
|
|
|
|
|
|
577 |
|
|
|
|
|
|
|
(577 |
) |
|
|
|
|
|
Total revenue |
|
|
|
|
|
|
2,295 |
|
|
|
|
|
|
|
(578 |
) |
|
|
1,717 |
|
|
|
2,009 |
|
|
|
|
|
|
|
(577 |
) |
|
|
1,432 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
expenses, net of
tax credits |
|
|
(b),(c |
) |
|
|
3,941 |
|
|
|
(22 |
) |
|
|
204 |
|
|
|
4,123 |
|
|
|
5,647 |
|
|
|
28 |
|
|
|
45 |
|
|
|
5,720 |
|
Selling and market
development
expenses |
|
|
(b),(c |
) |
|
|
616 |
|
|
|
4 |
|
|
|
|
|
|
|
620 |
|
|
|
481 |
|
|
|
|
|
|
|
4,269 |
|
|
|
4,750 |
|
General and
administrative
expenses |
|
|
(b),(c |
) |
|
|
1,801 |
|
|
|
(8 |
) |
|
|
(48 |
) |
|
|
1,745 |
|
|
|
2,321 |
|
|
|
45 |
|
|
|
(429 |
) |
|
|
1,937 |
|
Patents |
|
|
(c |
) |
|
|
204 |
|
|
|
|
|
|
|
(204 |
) |
|
|
|
|
|
|
45 |
|
|
|
|
|
|
|
(45 |
) |
|
|
|
|
Other expenses |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
|
|
|
(4,269 |
) |
|
|
|
|
|
Total operating expenses |
|
|
|
|
|
|
6,562 |
|
|
|
(26 |
) |
|
|
(48 |
) |
|
|
6,488 |
|
|
|
12,763 |
|
|
|
73 |
|
|
|
(429 |
) |
|
|
12,407 |
|
|
Results from operating
activities |
|
|
|
|
|
|
(4,267 |
) |
|
|
26 |
|
|
|
(530 |
) |
|
|
(4,771 |
) |
|
|
(10,754 |
) |
|
|
(73 |
) |
|
|
(148 |
) |
|
|
(10,975 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
578 |
|
|
|
578 |
|
|
|
|
|
|
|
|
|
|
|
577 |
|
|
|
577 |
|
Finance costs |
|
|
(c |
) |
|
|
|
|
|
|
|
|
|
|
(48 |
) |
|
|
(48 |
) |
|
|
|
|
|
|
|
|
|
|
(429 |
) |
|
|
(429 |
) |
|
Total net finance income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
530 |
|
|
|
530 |
|
|
|
|
|
|
|
|
|
|
|
148 |
|
|
|
148 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
(4,267 |
) |
|
|
26 |
|
|
|
|
|
|
|
(4,241 |
) |
|
|
(10,754 |
) |
|
|
(73 |
) |
|
|
|
|
|
|
(10,827 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income, net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in fair value
of available-for-sale
financial assets, net of tax |
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
3 |
|
|
|
317 |
|
|
|
|
|
|
|
|
|
|
|
317 |
|
Net change in fair value
of available-for-sale
financial assets
transferred to net loss,
net of tax |
|
|
|
|
|
|
(100 |
) |
|
|
|
|
|
|
|
|
|
|
(100 |
) |
|
|
(23 |
) |
|
|
|
|
|
|
|
|
|
|
(23 |
) |
|
Other comprehensive income
for the period |
|
|
|
|
|
|
(97 |
) |
|
|
|
|
|
|
|
|
|
|
(97 |
) |
|
|
294 |
|
|
|
|
|
|
|
|
|
|
|
294 |
|
|
Total comprehensive income
for the period |
|
|
|
|
|
|
(4,364 |
) |
|
|
|
|
|
|
|
|
|
|
(4,338 |
) |
|
|
(10,460 |
) |
|
|
(73 |
) |
|
|
|
|
|
|
(10,533 |
) |
|
31
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
|
Material adjustments to the consolidated statement of cash flows for 2010 and 2009: |
|
|
|
There are no material differences between the consolidated statement of cash flows presented
under IFRS and the consolidated statement of cash flows presented under previous Canadian GAAP. |
|
|
|
Notes to the reconciliations: |
|
(a) |
|
Reclassification in the consolidated statement of financial position: |
|
|
|
|
Certain corresponding figures as at December 1, 2008, November 30, 2009, February 28, 2009
and 2010 have been reclassified to conform to the new presentation under IFRS. |
|
|
(b) |
|
Share-based compensation: |
|
|
|
|
In certain situations, stock options granted vest in installments over a specified vesting
period. When the only vesting condition is service from the grant date to the vesting date
of each tranche awarded, then each installment should be accounted for as a separate
share-based payment arrangement under IFRS, otherwise known as graded vesting. Canadian
GAAP permits an entity the accounting policy choice with respect to graded vesting awards.
Each installment can be considered as a separate award, each with a different vesting
period, consistent with IFRS, or the arrangement can be treated as a single award with a
vesting period based on the average vesting period of the installments depending on the
policy elected. |
|
|
|
|
The Companys policy under Canadian GAAP was to treat graded vesting awards under the
latter method and, as a result, an adjustment of $175 was required on the application of
IFRS 2 at the transition date and an adjustment of $98 was required for the restated
November 30, 2009, $73 for February 28, 2009 and ($26) for February 28, 2010 as shown
below: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 1, |
|
|
November 30, |
|
|
February 28, |
|
|
February 28, |
|
|
|
2008 |
|
|
2009 |
|
|
2009 |
|
|
2010 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Consolidated statement of comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase in research and development expenses |
|
|
|
|
|
|
33 |
|
|
|
28 |
|
|
|
(22 |
) |
Increase in selling and market development expenses |
|
|
|
|
|
|
10 |
|
|
|
|
|
|
|
4 |
|
Increase in general and administrative expenses |
|
|
|
|
|
|
55 |
|
|
|
45 |
|
|
|
(8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustment to net loss and total comprehensive loss |
|
|
|
|
|
|
98 |
|
|
|
73 |
|
|
|
(26 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
(175 |
) |
|
|
(273 |
) |
|
|
(248 |
) |
|
|
(247 |
) |
Increase in contributed surplus |
|
|
175 |
|
|
|
273 |
|
|
|
248 |
|
|
|
247 |
|
|
32
THERATECHNOLOGIES INC.
Notes to the Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of Canadian dollars, except per share amounts)
8. |
|
Transition to IFRS (continued): |
|
(c) |
|
Reclassification in the consolidated statement of comprehensive income: |
|
|
|
|
Under IFRS, the Company elected to present expenses using a classification based on their
function and presents net finance income separately. The effect of these changes is
summarized below: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November 30, |
|
|
February 28, |
|
|
February 28, |
|
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
Decrease in interest |
|
|
(2,252 |
) |
|
|
(578 |
) |
|
|
(577 |
) |
Increase in finance income |
|
|
2,252 |
|
|
|
578 |
|
|
|
577 |
|
Increase in research and development expenses |
|
|
346 |
|
|
|
204 |
|
|
|
45 |
|
Decrease in patent fees |
|
|
(346 |
) |
|
|
(204 |
) |
|
|
(45 |
) |
Decrease in general and administrative expenses |
|
|
(661 |
) |
|
|
(48 |
) |
|
|
(429 |
) |
Increase in finance costs |
|
|
661 |
|
|
|
48 |
|
|
|
429 |
|
Increase in selling and market development activities |
|
|
4,269 |
|
|
|
|
|
|
|
4,269 |
|
Decrease in other expenses |
|
|
(4,269 |
) |
|
|
|
|
|
|
(4,269 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in presentation were also made to the revenue caption in order to conform with
the new presentation under IFRS as noted below: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November 30, |
|
|
February 28, |
|
|
February 28, |
|
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
Decrease in royalties and license fees |
|
|
(17,444 |
) |
|
|
(1,711 |
) |
|
|
(1,426 |
) |
Increase in upfront payments and initial technology access fees |
|
|
6,560 |
|
|
|
1,711 |
|
|
|
1,426 |
|
Increase in milestone payments |
|
|
10,884 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33
ex-99.21
Exhibit 99.21
July 27,
2010
In order to correct a typographical error contained in the consolidated financial statements of
the Company for the three (3) month period ended February 28, 2010 and 2009 (the Financial
Statements) and to comply with certain rules related to continuous disclosure obligation, the
Company refiles, as of today, a corrected version of its Financial Statements.
The only correction to the Financial Statements relates to the deletion of the word Draft on
each page of the Financial Statements. Except for this correction, the Financial Statements, as
initially filed, remain unchanged.
The Company files simultaneously with this letter the corrected version of the Financial
Statements.
(signed) Jocelyn Lafond
Jocelyn Lafond
Vice President, Legal Affairs
Corrected as at July 27, 2010
Consolidated Financial Statements of
(Unaudited)
THERATECHNOLOGIES INC.
Three-month periods ended February 28, 2010 and 2009
Corrected as at July 27, 2010
THERATECHNOLOGIES INC.
Consolidated Financial Statements
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
|
|
|
|
|
Financial Statements |
|
|
|
|
|
|
|
|
|
Consolidated Balance Sheets |
|
|
1 |
|
Consolidated Statements of Operations |
|
|
2 |
|
Consolidated Statements of Comprehensive Loss |
|
|
2 |
|
Consolidated Statements of Shareholders Equity |
|
|
3 - 4 |
|
Consolidated Statements of Cash Flows |
|
|
5 |
|
Notes to Consolidated Financial Statements |
|
|
6 |
|
Corrected as at July 27, 2010
THERATECHNOLOGIES INC.
Consolidated Balance Sheets
(Unaudited)
February 28, 2010 and November 30, 2009
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
February 28, |
|
|
November 30, |
|
|
|
2010 |
|
|
2009 |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
3,332 |
|
|
$ |
1,519 |
|
|
|
|
|
|
|
|
|
|
Bonds |
|
|
6,264 |
|
|
|
10,036 |
|
Accounts receivable |
|
|
281 |
|
|
|
375 |
|
Tax credits receivable |
|
|
1,834 |
|
|
|
1,666 |
|
Inventories |
|
|
2,251 |
|
|
|
2,225 |
|
Research supplies |
|
|
270 |
|
|
|
287 |
|
Prepaid expenses |
|
|
714 |
|
|
|
302 |
|
|
|
|
|
14,946 |
|
|
|
16,410 |
|
|
|
Bonds |
|
|
45,693 |
|
|
|
51,807 |
|
Property and equipment |
|
|
1,209 |
|
|
|
1,229 |
|
Other assets |
|
|
41 |
|
|
|
41 |
|
|
|
|
|
$ |
61,889 |
|
|
$ |
69,487 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
4,073 |
|
|
$ |
5,901 |
|
Current portion of deferred revenues (note 6) |
|
|
6,855 |
|
|
|
6,847 |
|
|
|
|
|
10,928 |
|
|
|
12,748 |
|
|
|
|
|
|
|
|
|
|
Deferred revenues (note 6) |
|
|
11,980 |
|
|
|
13,691 |
|
|
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Capital stock (note 3) |
|
|
279,230 |
|
|
|
279,169 |
|
Contributed surplus |
|
|
6,720 |
|
|
|
6,484 |
|
|
|
|
|
|
|
|
|
|
Accumulated other comprehensive income |
|
|
1,185 |
|
|
|
1,282 |
|
Deficit |
|
|
(248,154 |
) |
|
|
(243,887 |
) |
|
|
|
|
(246,969 |
) |
|
|
(242,605 |
) |
|
|
Total shareholders equity |
|
|
38,981 |
|
|
|
43,048 |
|
|
|
|
|
$ |
61,889 |
|
|
$ |
69,487 |
|
|
See accompanying notes to unaudited consolidated financial statements.
1
Corrected as at July 27, 2010
THERATECHNOLOGIES INC.
Consolidated Statement of Operations
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
Revenues: |
|
|
|
|
|
|
|
|
Royalties, technologies and other (note 6) |
|
$ |
1,717 |
|
|
$ |
1,432 |
|
Interest |
|
|
578 |
|
|
|
577 |
|
|
|
|
|
2,295 |
|
|
|
2,009 |
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
4,109 |
|
|
|
6,315 |
|
Tax credits |
|
|
(168 |
) |
|
|
(668 |
) |
|
|
|
|
3,941 |
|
|
|
5,647 |
|
General and administrative |
|
|
1,801 |
|
|
|
2,321 |
|
Selling and market development |
|
|
616 |
|
|
|
481 |
|
Patents |
|
|
204 |
|
|
|
45 |
|
Fees associated with collaboration and licensing agreement (note 6) |
|
|
|
|
|
|
4,269 |
|
|
|
|
|
6,562 |
|
|
|
12,763 |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,267 |
) |
|
$ |
(10,754 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share (note 3 (d)) |
|
$ |
(0.07 |
) |
|
$ |
(0.18 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding |
|
|
60,438,098 |
|
|
|
60,055,841 |
|
|
Consolidated Statements of Comprehensive Loss
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
Net loss |
|
$ |
(4,267 |
) |
|
$ |
(10,754 |
) |
Unrealized gains on available-for-sale financial assets |
|
|
3 |
|
|
|
317 |
|
Reclassification adjustment for gains and losses on
available-for-sale financial assets |
|
|
(100 |
) |
|
|
(23 |
) |
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(4,364 |
) |
|
$ |
(10,460 |
) |
|
See accompanying notes to unaudited consolidated financial statements.
2
Corrected as at July 27, 2010
THERATECHNOLOGIES INC.
Consolidated Statements of Shareholders Equity
(Unaudited)
Three-month period ended February 28, 2010
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
compre- |
|
|
|
|
|
|
|
|
|
Capital stock |
|
|
Contributed |
|
|
hensive |
|
|
|
|
|
|
|
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
income |
|
|
Deficit |
|
|
Total |
|
|
Balance, November 30, 2009 |
|
|
60,429,393 |
|
|
$ |
279,169 |
|
|
$ |
6,484 |
|
|
$ |
1,282 |
|
|
$ |
(243,887 |
) |
|
$ |
43,048 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash proceeds |
|
|
21,164 |
|
|
|
38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38 |
|
Ascribed value |
|
|
|
|
|
|
23 |
|
|
|
(23 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
259 |
|
|
|
|
|
|
|
|
|
|
|
259 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,267 |
) |
|
|
(4,267 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized gains and
losses on available-for-sale
financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(97 |
) |
|
|
|
|
|
|
(97 |
) |
|
Balance, February 28, 2010 |
|
|
60,450,557 |
|
|
$ |
279,230 |
|
|
$ |
6,720 |
|
|
$ |
1,185 |
|
|
$ |
(248,154 |
) |
|
$ |
38,981 |
|
|
See accompanying notes to unaudited consolidated financial statements.
3
Corrected as at July 27, 2010
THERATECHNOLOGIES INC.
Consolidated Statements of Shareholders Equity, Continued
(Unaudited)
Three-month periods ended February 28, 2009
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
compre- |
|
|
|
|
|
|
|
|
|
Capital stock |
|
|
Contributed |
|
|
hensive |
|
|
|
|
|
|
|
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
income |
|
|
Deficit |
|
|
Total |
|
|
Balance, November 30, 2008 |
|
|
58,215,090 |
|
|
$ |
269,219 |
|
|
$ |
5,585 |
|
|
$ |
372 |
|
|
$ |
(228,230 |
) |
|
$ |
46,946 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in accounting
policies (note 2 (a)) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(599 |
) |
|
|
(599 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of share capital (note 6) |
|
|
2,179,837 |
|
|
|
9,854 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,854 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
205 |
|
|
|
|
|
|
|
|
|
|
|
205 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,754 |
) |
|
|
(10,754 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized gains and
losses on available-for-sale
financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
294 |
|
|
|
|
|
|
|
294 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, February 28, 2009 |
|
|
60,394,927 |
|
|
$ |
279,073 |
|
|
$ |
5,790 |
|
|
$ |
666 |
|
|
$ |
(239,583 |
) |
|
$ |
45,946 |
|
|
See accompanying notes to unaudited consolidated financial statements.
4
Corrected as at July 27, 2010
THERATECHNOLOGIES INC.
Consolidated Statements of Cash Flows
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,267 |
) |
|
$ |
(10,754 |
) |
Adjustments for: |
|
|
|
|
|
|
|
|
Amortization of property and equipment |
|
|
147 |
|
|
|
137 |
|
Stock-based compensation |
|
|
259 |
|
|
|
205 |
|
|
|
|
|
(3,861 |
) |
|
|
(10,412 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Interest receivable on bonds |
|
|
163 |
|
|
|
(969 |
) |
Accounts receivable |
|
|
94 |
|
|
|
76 |
|
Tax credits receivable |
|
|
(168 |
) |
|
|
(668 |
) |
Inventories |
|
|
(26 |
) |
|
|
(1,594 |
) |
Research supplies |
|
|
17 |
|
|
|
133 |
|
Prepaid expenses |
|
|
(412 |
) |
|
|
(59 |
) |
Accounts payable and accrued liabilities |
|
|
(1,780 |
) |
|
|
(128 |
) |
Deferred revenues |
|
|
(1,703 |
) |
|
|
25,681 |
|
|
|
|
|
(3,815 |
) |
|
|
22,472 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,676 |
) |
|
|
12,060 |
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Share issuance |
|
|
38 |
|
|
|
9,854 |
|
Share issue costs |
|
|
|
|
|
|
(8 |
) |
|
|
|
|
38 |
|
|
|
9,846 |
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Additions to property and equipment |
|
|
(175 |
) |
|
|
(102 |
) |
Acquisition of bonds |
|
|
|
|
|
|
(19,631 |
) |
Disposal of bonds |
|
|
9,626 |
|
|
|
4,585 |
|
|
|
|
|
9,451 |
|
|
|
(15,148 |
) |
|
|
Net change in cash |
|
|
1,813 |
|
|
|
6,758 |
|
|
|
|
|
|
|
|
|
|
Cash, beginning of period |
|
|
1,519 |
|
|
|
133 |
|
|
|
|
|
|
|
|
|
|
|
Cash, end of period |
|
$ |
3,332 |
|
|
$ |
6,891 |
|
|
See note 4 (a) for supplemental cash flow information.
See accompanying notes to unaudited consolidated financial statements.
5
Corrected as at July 27, 2010
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars, except per share amounts)
1. |
|
Basis of presentation: |
|
|
|
The financial statements included in this report are unaudited and reflect normal and recurring
adjustments which are, in the opinion of the Company, considered necessary for a fair
presentation of its results. These financial statements have been prepared in conformity with
Canadian generally accepted accounting principles (GAAP). The same accounting policies as
described in the Companys latest annual report have been used. However, these financial
statements do not include all disclosures required under GAAP and, accordingly, should be read
in connection with the financial statements and the notes thereto included in the Companys
latest annual report. These interim financial statements have not been reviewed by the
auditors. |
|
2. |
|
New accounting policies: |
|
(a) |
|
Adoption of new accounting standards: |
|
|
|
|
Goodwill and intangible assets |
|
|
|
|
Effective with the commencement of its 2009 fiscal year, the Company adopted the Canadian
Institute of Chartered Accountants (CICA) Handbook Section 3064, Goodwill and
Intangible Assets, which will replace Section 3062, Goodwill and Other Intangible Assets,
and Section 3450, Research and Development Costs. The standard provides guidance on the
recognition of intangible assets in accordance with the definition of an asset and the
criteria for asset recognition, whether these assets are separately acquired or internally
developed. The impact of adopting this standard has been to increase the opening deficit
and to reduce other assets at December 1, 2008 by $599, respectively, which is the amount
of patent costs related to periods prior to these dates. |
|
|
(b) |
|
Future accounting changes: |
|
|
|
|
International Financial Reporting Standards |
|
|
|
|
In February 2008, Canadas Accounting Standards Board (AcSB) confirmed that Canadian
GAAP, as used by publicly accountable enterprises, would be fully converged into
International Financial Reporting Standards (IFRS), as issued by the International
Accounting Standards Board (IASB). The changeover date is for interim and annual
financial statements relating to fiscal years beginning on or after January 1, 2011. As a
result, the Company will be required to report under IFRS for its 2012 interim and annual
financial statements. The Company will convert to these new standards according to the
timetable set within these new rules. The Company will determine at a future date the
impact of adopting the standards on its consolidated financial statements. |
6
Corrected as at July 27, 2010
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars, except per share amounts)
|
(a) |
|
Shareholder rights plan: |
|
|
|
|
On February 10, 2010, the Board of Directors of the Company adopted a shareholder rights
plan (the Plan), effective as of such date. The Plan is designed to provide adequate
time for the Board of Directors, and the shareholders, to assess an unsolicited takeover
bid for the Company. In addition, the Plan provides the Board of Directors with sufficient
time to explore and develop alternatives for maximizing shareholder value if a takeover bid
is made, as well as provide shareholders with an equal opportunity to participate in a
takeover bid and receive full and fair value for their common shares (the Common Shares).
The Plan, if approved by the shareholders, will expire at the close of the Companys annual
meeting of shareholders in 2013. |
|
|
|
|
The rights issued under the Plan will initially attach to and trade with the Common Shares
and no separate certificates will be issued unless an event triggering these rights occurs.
The rights will become exercisable only when a person, including any party related to it,
acquires or attempts to acquire 20% or more of the outstanding Common Shares without
complying with the Permitted Bid provisions of the Plan or without approval of the
Board of Directors. Should such an acquisition occur or be announced, each right would,
upon exercise, entitle a rights holder, other than the acquiring person and related
persons, to purchase Common Shares at a 50% discount to the market price at the time. |
|
|
|
|
Under the Plan, a Permitted Bid is a bid made to all holders of the Common Shares and which
is open for acceptance for not less than 60 days. If, at the end of 60 days at least 50% of
the outstanding Common Shares, other than those owned by the offeror and certain related
parties, have been tendered, the offeror may take up and pay for the Common Shares but must
extend the bid for a further 10 days to allow other shareholders to tender. |
7
Corrected as at July 27, 2010
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars, except per share amounts)
3. |
|
Capital stock (continued): |
|
(b) |
|
Stock option plan: |
|
|
|
|
Changes in outstanding options granted under the Companys stock option plan for the year
ended November 30, 2009 and the three-month period ended February 28, 2010 were as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
|
|
|
|
exercise price |
|
|
|
Number |
|
|
per share |
|
|
Options as at November 30, 2008 (audited) |
|
|
2,161,800 |
|
|
$ |
6.52 |
|
|
Granted |
|
|
680,500 |
|
|
|
1.83 |
|
Cancelled and expired |
|
|
(176,500 |
) |
|
|
8.34 |
|
|
|
Options as at November 30, 2009 (audited) |
|
|
2,665,800 |
|
|
|
5.20 |
|
|
Granted |
|
|
265,000 |
|
|
|
3.84 |
|
Cancelled and expired |
|
|
(25,667 |
) |
|
|
3.26 |
|
Exercised |
|
|
(21,164 |
) |
|
|
1.80 |
|
|
|
Options as at February 28, 2010 |
|
|
2,883,969 |
|
|
$ |
5.12 |
|
|
|
(c) |
|
Stock-based compensation and other stock-based payments: |
|
|
|
|
The estimated fair value of the options granted was estimated at the date of grant using
the Black-Scholes option pricing model with the following weighted average assumptions: |
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
Risk-free interest rate |
|
|
2.46 |
% |
|
|
1.79 |
% |
Volatility |
|
|
81 |
% |
|
|
79 |
% |
Average option life in years |
|
|
6 |
|
|
|
6 |
|
Dividend yield |
|
Nil |
|
|
Nil |
|
|
8
Corrected as at July 27, 2010
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars, except per share amounts)
3. |
|
Capital stock (continued): |
|
(c) |
|
Stock-based compensation and other stock-based payments (continued): |
|
|
|
|
The risk-free interest rate is based on the implied yield on a Canadian Treasury
zero-coupon issue with a remaining term equal to the expected term of the option. The
volatility is based solely on historical volatility equal to the expected term of the
option. The average life of the options is estimated considering the vesting period, the
term of the option and the length of time of similar grants have remained outstanding in
the past. Dividend yield was excluded from the calculation, since it is the present policy
of the Company not to retain in cash in order to keep funds available to finance the
Companys growth. |
|
|
The following table summarizes the weighted average fair value of stock options granted
during the periods ended February 28, 2010 and 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average |
|
|
|
Number of |
|
|
grant-date |
|
|
|
options |
|
|
fair value |
|
|
2010 |
|
|
265,000 |
|
|
$ |
2.96 |
|
2009 |
|
|
590,500 |
|
|
|
1.24 |
|
|
|
(d) |
|
Diluted loss per share: |
|
|
|
|
Diluted loss per share was not presented as the effect of options would have been
anti-dilutive. All options outstanding at the end of the year could potentially dilute the
basic earnings per share in the future. |
4. |
|
Supplemental information: |
|
(a) |
|
The following transactions were conducted by the Company and did not impact cash
flows: |
|
|
|
|
|
|
|
|
|
|
|
February 28, |
|
|
November 30, |
|
|
|
2010 |
|
|
2009 |
|
|
Additions to property and equipment included in
accounts payable and accrued liabilities |
|
$ |
135 |
|
|
$ |
183 |
|
|
9
Corrected as at July 27, 2010
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars, except per share amounts)
4. |
|
Supplemental information (continued): |
|
(b) |
|
For the three-month period ended February 28, 2010, the Company has reclassified in
net loss $100 of realized gains on available-for-sale financial assets previously recorded
in accumulated other comprehensive income ($23 in 2009). |
|
|
|
|
On February 28, 2010, the accumulated other comprehensive loss was composed of unrealized
gains on available-for-sale financial assets of $1,185 (gain of $1,282 on November 30,
2009). |
|
|
(c) |
|
For the three-month periods ended February 28, 2010 and 2009, the following items
were included in the determination of the Companys net loss: |
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
Amortization of property and equipment |
|
$ |
147 |
|
|
$ |
137 |
|
Stock-based compensation |
|
|
259 |
|
|
|
205 |
|
|
5. |
|
Financial instruments: |
|
(a) |
|
Carrying value and fair value: |
|
|
|
|
The Company has determined that the carrying values of its short-term financial assets and
liabilities, including cash, accounts receivable, as well as accounts payable and accrued
liabilities, approximate their fair value because of the relatively short period to
maturity of these instruments. |
|
|
|
|
Bonds and investments in public companies are stated at estimated fair value, determined by
inputs that are directly observable (Level 2 inputs). |
|
|
(b) |
|
Interest income and expenses: |
|
|
|
|
Interest income consists of interest earned on cash and bonds. |
10
Corrected as at July 27, 2010
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars, except per share amounts)
5. |
|
Financial instruments (continued): |
|
(c) |
|
Loss on exchange: |
|
|
|
|
General and administrative expenses include a loss on foreign exchange of $44 ($416 in
2009) for the three-month period ended February 28, 2010. |
6. |
|
Collaboration and licensing agreement: |
|
|
|
On October 28, 2008, the Company entered into a collaboration and licensing agreement with EMD
Serono, Inc. (EMD Serono), and affiliate of Merck KGaA, of Darmstadt, Germany, regarding the
exclusive commercialization rights of tesamorelin in the United States for the treatment of
excess abdominal fat in HIV-infected patients with lipodystrophy (the Initial Product). The
Company retains all tesamorelin commercialization rights outside of the United States. |
|
|
|
Under the terms of the agreement, the Company is responsible for the development of the Initial
Product up to obtaining marketing approval in the United States. The Company is also
responsible for product production and for the development of a new formulation of the initial
product. EMD Serono is responsible for conducting product commercialization activities. |
|
|
|
At the closing of the agreement, on December 15, 2008, the Company received US$30,000
(CAD$36,951), which includes an initial payment of US$22,000 (CAD$27,097) and US$8,000
(CAD$9,854) as a subscription for common shares in the Company by Merck KGaA at a price of
US$3.67 (CAD$4.52) per share. The Company may receive up to US$215,000, which amount includes
the initial payment of US$22,000, the equity investment of US$8,000, as well as payments based
on the achievement of certain development, regulatory and sales milestones. The Company will
also be entitled to receive increasing royalties on annual net sales of tesamorelin in the
United States, if applicable. |
|
|
|
The initial payment of $27,097 has been deferred and is being amortized over its estimated
service period on a straight-line basis. This period may be modified in the future based on
additional information that may be received by the Company. For the three-month period ended
February 28, 2010, an amount of $1,711 related to this transaction was recognized as revenue.
At February 28, 2010, the deferred revenues related to this transaction amounted to $18,826. |
|
|
|
On August 12, 2009, the US Food and Drug Administration accepted the New Drug Application
(NDA) made by the Company for tesamorelin. Under the terms of the Companys Collaboration and
Licensing Agreement with EMD Serono, the acceptance of the tesamorelin NDA resulted in a
milestone payment of US$10,000 (CAD$10,884). This milestone payment has been recorded in the
third quarter of 2009. |
11
Corrected as at July 27, 2010
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars, except per share amounts)
6. |
|
Collaboration and licensing agreement (continued): |
|
|
|
The Company may conduct research and development for additional indications. Under the
Collaboration and Licensing Agreement, EMD Serono will have the option to commercialize
additional indications for tesamorelin in the United States. If it exercises this option, EMD
Serono will pay half of the development costs related to such additional indications. In such
cases, the Company will also have the right, subject to EMD Seronos agreement, to participate
in the promotion of the additional indications. |
12
ex-99.22
Exhibit 99.22
MANAGEMENTS DISCUSSION AND ANALYSIS FOR THE FIRST QUARTER
Revenues
Consolidated revenues for the three-month period ended February 28, 2010, amounted to $2,295,000
compared to $2,009,000 for 2009. The increased revenues in 2010 are related to a longer
amortization period (3 months in 2010 versus 2.5 months in 2009) for the initial payment of the
collaboration and licensing agreement with EMD Serono, Inc. (EMD Serono).
The initial payment of $27,097,000 has been deferred and is being amortized over its estimated
service period on a straight-line basis. This period may be modified in the future based on
additional information that the Company may receive. For the three-month period ended February 28,
2010, an amount of $1,711,000 ($1,426,000 for the same period in 2009) related to this transaction
was recognized as revenue. At February 28, 2010, the deferred revenues related to this transaction
recorded on the balance sheet amounted to $18,826,000.
R&D Activities
Research and development (R&D) expenditures, before tax credits, totalled $4,109,000 for the
first quarter of 2010, compared to $6,315,000 in 2009. The R&D expenses incurred in the first
quarter of 2010 are mainly related to the primary objective of the Company, which encompasses the
regulatory activities connected with the preparation for the FDA Advisory Committee meeting. This
explains the planned reduction in R&D expenses. The research and development expenses incurred in
the first quarter of 2009 are essentially related to closing activities for the confirmatory Phase
3 study.
Other Expenses
For the first quarter of 2010, general and administrative expenses amounted to $1,801,000, compared
to $2,321,000 for the same period in 2009. These expenses are comparable to those of 2009, with the
exception of exchange loss and the costs associated with revising the Companys business plan in
2009.
Selling and market development costs amounted to $616,000 for the first quarter of 2010, compared
to $481,000 for the same period in 2009. The sales and market development expenses are principally
composed of business development and market research expenses outside the United States and the
costs of managing the agreement with EMD Serono.
In the first quarter of 2010, patents amounted to $204,000 and were principally related to costs
associated with patents for the preclinical programs.
In 2009, the Company incurred expenses of $4,269,000 associated with the closing of the
agreement with EMD Serono.
Net Results
Taking into account the revenues and expenses described above, the Company recorded a first
quarter 2010 net loss of $4,267,000 ($0.07 per share), compared to a net loss of $10,754,000
($0.18 per share) for the same period in 2009.
The net loss in 2010 includes revenues of $1,711,000 related to the agreement with EMD Serono.
Excluding this item, the adjusted net loss (see Annex A) amounted to $5,978,000 in 2010, a decrease
of 24.4% compared to the same period in 2009.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
Quarterly Financial Information
The selected financial information provided below is derived from the Companys unaudited quarterly
financial statements for each of the last eight quarters. This information has been restated
following the adoption of the Canadian Institute of Chartered Accountants (CICA) Handbook Section
3064, Goodwill and Intangible Assets.
(in thousands of Canadian dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Revenues |
|
$ |
2,295 |
|
|
$ |
2,246 |
|
|
$ |
13,148 |
|
|
$ |
2,317 |
|
|
$ |
2,009 |
|
|
$ |
616 |
|
|
$ |
710 |
|
|
$ |
716 |
|
Net (loss) earnings |
|
$ |
(4,267 |
) |
|
$ |
(4,698 |
) |
|
$ |
5,824 |
|
|
$ |
(5,430 |
) |
|
$ |
(10,754 |
) |
|
$ |
(15,145 |
) |
|
$ |
(11,220 |
) |
|
$ |
(11,382 |
) |
Basic and
diluted
(loss)
earnings
per share |
|
$ |
(0.07 |
) |
|
$ |
(0.08 |
) |
|
$ |
0.10 |
|
|
$ |
(0.09 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.20 |
) |
|
As described above, the increased revenues in 2010 and 2009 are related to the amortization of
the initial payment received at the closing of the agreement with EMD Serono, as well as the
milestone payment of $10,884,000 recorded in August 2009. The increase in the fourth quarter net
loss in 2008 is due to impairment charges for intellectual property.
Financial Position
At February 28, 2010, liquidities, which include cash and bonds, amounted to $55,289,000, and tax
credits receivable amounted to $1,834,000 for a total of $57,123,000.
For the three-month period ended February 28, 2010, the burn rate from operating activities,
excluding changes in operating assets and liabilities, was $3,861,000, compared to $10,412,000 in
2009. Excluding the revenue of $1,711,000 related to the agreement with EMD Serono, the adjusted
burn rate from operating activities, excluding changes in operating assets and liabilities (see
Annex A), was $5,572,000 for the quarter ended February 28, 2010, compared to $7 569 000 for the
first quarter of 2009, a decrease of 26.4%.
New Accounting Policies
In February 2008, the Accounting Standards Board of Canada (AcSB) announced that accounting
standards in Canada, as used by public companies, will converge with International Financial
Reporting Standards (IFRS). The Companys changeover date from current Canadian generally
accepted accounting principles (GAAP) to IFRS applies to the interim and annual financial
statements of the fiscal year beginning December 1, 2011, when the Company will report financial
information for both the first quarter and comparative period using IFRS.
IFRS uses a conceptual framework similar to Canadian GAAP, but there are significant differences in
recognition, measurement and disclosures.
The Companys IFRS convergence project includes four steps: diagnostic and planning, detailed
analysis, design, and implementation.
Phase One: Diagnostic Phase - This phase involves establishing a project plan for IFRS convergence
and the initial identification of differences between Canadian GAAP and IFRS. The Company is
currently assessing the conversion of its consolidated financial statements to IFRS and expects to
complete this phase in the next quarter. It is not presently possible to determine the impact of
converting to IFRS on the consolidated financial statements or on the Companys business because
the diagnostic phase has not been completed. Once it is completed, the Company will be in a
position to confirm the schedule for the following phases.
2
Phase Two: Detailed Analysis This phase involves a comprehensive assessment of the differences
between IFRS and the Companys current accounting policies in order to evaluate the impact on the
Company. In addition, the detailed analysis will identify training requirements, and determine
eventual changes to business processes and information systems.
Phase Three: Design This phase consists of an analysis of the available accounting options under
IFRS, notably the exceptions, exemptions and actual choices available for the transition and the
preparation of draft IFRS financial statements and the accompanying notes. In addition, it is
during this phase that changes to the business processes and the information systems are designed.
Phase Four: Implementation This phase involves implementing changes to systems, business
processes and internal controls, determining the opening IFRS transition balance sheet and the
impact on taxation, parallel accounting under Canadian GAAP and IFRS and preparing detailed
reconciliations between Canadian GAAP and IFRS financial statements.
Outstanding Share Data
On March 22, 2010, the number of shares issued and outstanding was 60,450,890, while
outstanding options granted under the stock option plan were 2,883,636.
Contractual Obligations
There were no material changes in contractual obligations during the quarter, other than in the
ordinary course of business.
Economic and Industry Factors
Economic and industry factors were substantially unchanged from those reported in the Companys
2009 Annual Report.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company
targets unmet medical needs in financially attractive specialty markets where it can retain all or
part of the commercial rights to its products. Its most advanced compound, tesamorelin, is an
analogue of the human growth hormone releasing factor. In 2009, Theratechnologies submitted a New
Drug Application to the U.S. Food and Drug Administration, seeking approval of tesamorelin for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The Companys growth
strategy is centered on the commercialization of tesamorelin in the United States and in other
markets for HIV-associated lipodystrophy, as well as the development of clinical programs for
tesamorelin in other medical conditions.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Companys website at
www.theratech.com. Additional information, including the Annual Information Form and the
Annual Report, is also available on SEDAR at www.sedar.com.
Forward-Looking Information
This press release and the Managements Discussion and Analysis for the first quarter incorporated
therein contain certain statements that are considered forward-looking information within the
meaning of applicable securities legislation. This forward-looking information includes, but is not
limited to, information regarding the pursuit of the Companys business plan with the funds that it
has available, the search for partners in new markets and the completion of a transition plan for
IFRS. Furthermore, the words will, may, could, should, outlook, believe, plan,
envisage, anticipate, expect and estimate, or variations of them denote forward-looking
information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
3
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties include, but are not limited to, the risk that the
Companys funding needs may change, that the Company is unable to conclude agreements with partners
in new markets for tesamorelin and that the timeline for preparing a transition plan for IFRS is
not met.
Although the forward-looking information contained herein is based upon what the Company believes
are reasonable assumptions, investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking information. Certain assumptions
made in preparing the forward-looking information and the Companys objectives include the
assumption, among others, that the operating activities of the Company will conform to its business
plan, the Company will reach agreements with partners in new markets for tesamorelin and the
Company will not experience any difficulties in preparing a transition plan for IFRS.
Consequently, all of the forward-looking information is qualified by the foregoing cautionary
statements, and there can be no guarantee that the results or developments anticipated by the
Company will be realized or, even if substantially realized, that they will have the expected
consequences or effects on the Company, its business, its financial condition or its results of
operation. Furthermore, the forward-looking information reflects current expectations regarding
future events only as of the date of release of this press release.
Investors are referred to the Companys public filings available at www.sedar.com. In
particular, further details on these risks and descriptions of these risks are disclosed in the
Risk and Uncertainties section of the Companys Annual Information Form, dated February 23, 2010,
for the year ended November 30, 2009.
Information:
Andrea Gilpin
Vice President, IR & Communications
Phone: 514-336-7800, ext. 205
communications@theratech.com
Luc Tanguay
Senior Executive Vice President and
Chief Financial Officer
Phone: 514-336-7800, ext. 204
ltanguay@theratech.com
4
ANNEX A
Non-GAAP measures
The Company uses measures that do not conform to generally accepted accounting principles (GAAP)
to assess its operating performance. Securities regulators require that companies caution readers
that earnings and other measures adjusted to a basis other than GAAP do not have standardized
meanings and are unlikely to be comparable to similar measures used by other companies.
Accordingly, these measures should not be considered in isolation. The Company uses non-GAAP
measures such as adjusted net loss and the adjusted burn rate from operating activities before
changes in operating assets and liabilities, to measure its performance from one period to the next
without including changes caused by certain items that could potentially distort the analysis of
trends in its operating performance, and because such measures provide meaningful information on
the Companys financial condition and operating results.
Definition and reconciliation of non-GAAP measures
In order to measure performance from one period to another, without accounting for changes related
to revenues and fees associated with the collaboration and license agreement with EMD Serono,
management uses adjusted net loss and adjusted burn rate from operating activities before changes
in operating assets and liabilities. These items are excluded because they affect the comparability
of the financial results and could potentially distort the analysis of trends in the Companys
operating performance. The exclusion of these items does not necessarily indicate that they are
non-recurring.
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
(Thousands of dollars) |
|
2010 |
|
|
2009 |
|
Adjusted net loss |
|
|
|
|
|
|
|
|
Net loss, per the financial statements |
|
$ |
(4,267 |
) |
|
$ |
(10,754 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
Revenues associated with a collaboration and license agreement
(note 6 to the consolidated financial statements) |
|
$ |
(1,711 |
) |
|
$ |
(1,426 |
) |
Fees associated with collaboration and license agreement |
|
|
|
|
|
$ |
4,269 |
|
|
|
|
Adjusted net loss |
|
$ |
(5,978 |
) |
|
$ |
(7,911 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
|
|
2010 |
|
|
2009 |
|
Adjusted burn rate before changes in operating assets and
liabilities |
|
|
|
|
|
|
|
|
Burn rate before changes in operating assets and liabilities, per the
financial statements |
|
$ |
(3,861 |
) |
|
$ |
(10,412 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
Revenues associated with a collaboration and license agreement
(note 6 to the consolidated financial statements) |
|
$ |
(1,711 |
) |
|
$ |
(1,426 |
) |
Fees associated with collaboration and license agreement |
|
|
|
|
|
$ |
4,269 |
|
|
|
|
Adjusted burn rate before changes in operating assets and liabilities |
|
$ |
(5,572 |
) |
|
$ |
(7,569 |
) |
|
|
|
5
ex-99.23
DRAFT
Exhibit 99.23
Consolidated Financial Statements of
(Unaudited)
THERATECHNOLOGIES INC.
Three-month periods ended February 28, 2010 and 2009
DRAFT
THERATECHNOLOGIES INC.
Consolidated Financial Statements
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
Financial Statements
DRAFT
THERATECHNOLOGIES INC.
Consolidated Balance Sheets
(Unaudited)
February 28, 2010 and November 30, 2009
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
February 28, |
|
|
November 30, |
|
|
|
2010 |
|
|
2009 |
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
3,332 |
|
|
$ |
1,519 |
|
Bonds |
|
|
6,264 |
|
|
|
10,036 |
|
Accounts receivable |
|
|
281 |
|
|
|
375 |
|
Tax credits receivable |
|
|
1,834 |
|
|
|
1,666 |
|
Inventories |
|
|
2,251 |
|
|
|
2,225 |
|
Research supplies |
|
|
270 |
|
|
|
287 |
|
Prepaid expenses |
|
|
714 |
|
|
|
302 |
|
|
|
|
|
14,946 |
|
|
|
16,410 |
|
|
|
|
|
|
|
|
|
|
Bonds |
|
|
45,693 |
|
|
|
51,807 |
|
Property and equipment |
|
|
1,209 |
|
|
|
1,229 |
|
Other assets |
|
|
41 |
|
|
|
41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
61,889 |
|
|
$ |
69,487 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
4,073 |
|
|
$ |
5,901 |
|
Current portion of deferred revenues (note 6) |
|
|
6,855 |
|
|
|
6,847 |
|
|
|
|
|
10,928 |
|
|
|
12,748 |
|
|
|
|
|
|
|
|
|
|
Deferred revenues (note 6) |
|
|
11,980 |
|
|
|
13,691 |
|
|
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Capital stock (note 3) |
|
|
279,230 |
|
|
|
279,169 |
|
Contributed surplus |
|
|
6,720 |
|
|
|
6,484 |
|
|
|
|
|
|
|
|
|
|
Accumulated other comprehensive income |
|
|
1,185 |
|
|
|
1,282 |
|
Deficit |
|
|
(248,154 |
) |
|
|
(243,887 |
) |
|
|
|
|
(246,969 |
) |
|
|
(242,605 |
) |
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
38,981 |
|
|
|
43,048 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
61,889 |
|
|
$ |
69,487 |
|
|
See accompanying notes to unaudited consolidated financial statements.
18/03/2010 1:37 PM
1
DRAFT
THERATECHNOLOGIES INC.
Consolidated Statement of Operations
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
Revenues: |
|
|
|
|
|
|
|
|
Royalties, technologies and other (note 6) |
|
$ |
1,717 |
|
|
$ |
1,432 |
|
Interest |
|
|
578 |
|
|
|
577 |
|
|
|
|
|
2,295 |
|
|
|
2,009 |
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
4,109 |
|
|
|
6,315 |
|
Tax credits |
|
|
(168 |
) |
|
|
(668 |
) |
|
|
|
|
3,941 |
|
|
|
5,647 |
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
1,801 |
|
|
|
2,321 |
|
Selling and market development |
|
|
616 |
|
|
|
481 |
|
Patents |
|
|
204 |
|
|
|
45 |
|
Fees associated with collaboration and licensing agreement (note 6) |
|
|
|
|
|
|
4,269 |
|
|
|
|
|
6,562 |
|
|
|
12,763 |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,267 |
) |
|
$ |
(10,754 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share (note 3 (d)) |
|
$ |
(0.07 |
) |
|
$ |
(0.18 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding |
|
|
60,438,098 |
|
|
|
60,055,841 |
|
|
Consolidated Statements of Comprehensive Loss
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
Net loss |
|
$ |
(4,267 |
) |
|
$ |
(10,754 |
) |
Unrealized gains on available-for-sale financial assets |
|
|
3 |
|
|
|
317 |
|
Reclassification adjustment for gains and losses on
available-for-sale financial assets |
|
|
(100 |
) |
|
|
(23 |
) |
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(4,364 |
) |
|
$ |
(10,460 |
) |
|
See accompanying notes to unaudited consolidated financial statements.
18/03/2010 1:37 PM
2
DRAFT
THERATECHNOLOGIES INC.
Consolidated Statements of Shareholders Equity
(Unaudited)
Three-month period ended February 28, 2010
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
compre- |
|
|
|
|
|
|
|
|
|
Capital stock |
|
|
Contributed |
|
|
hensive |
|
|
|
|
|
|
|
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
income |
|
|
Deficit |
|
|
Total |
|
|
Balance, November 30, 2009 |
|
|
60,429,393 |
|
|
$ |
279,169 |
|
|
$ |
6,484 |
|
|
$ |
1,282 |
|
|
$ |
(243,887 |
) |
|
$ |
43,048 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash proceeds |
|
|
21,164 |
|
|
|
38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38 |
|
Ascribed value |
|
|
|
|
|
|
23 |
|
|
|
(23 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
259 |
|
|
|
|
|
|
|
|
|
|
|
259 |
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,267 |
) |
|
|
(4,267 |
) |
|
Change in unrealized gains and
losses on available-for-sale
financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(97 |
) |
|
|
|
|
|
|
(97 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, February 28, 2010 |
|
|
60,450,557 |
|
|
$ |
279,230 |
|
|
$ |
6,720 |
|
|
$ |
1,185 |
|
|
$ |
(248,154 |
) |
|
$ |
38,981 |
|
|
See accompanying notes to unaudited consolidated financial statements.
18/03/2010 1:37 PM
3
DRAFT
THERATECHNOLOGIES INC.
Consolidated Statements of Shareholders Equity, Continued
(Unaudited)
Three-month periods ended February 28, 2009
(in
thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
compre- |
|
|
|
|
|
|
|
|
|
Capital stock |
|
|
Contributed |
|
|
hensive |
|
|
|
|
|
|
|
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
income |
|
|
Deficit |
|
|
Total |
|
|
Balance, November 30, 2008 |
|
|
58,215,090 |
|
|
$ |
269,219 |
|
|
$ |
5,585 |
|
|
$ |
372 |
|
|
$ |
(228,230 |
) |
|
$ |
46,946 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in accounting
policies (note 2 (a)) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(599 |
) |
|
|
(599 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of share capital (note 6) |
|
|
2,179,837 |
|
|
|
9,854 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,854 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
205 |
|
|
|
|
|
|
|
|
|
|
|
205 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,754 |
) |
|
|
(10,754 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized gains and
losses on available-for-sale
financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
294 |
|
|
|
|
|
|
|
294 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, February 28, 2009 |
|
|
60,394,927 |
|
|
$ |
279,073 |
|
|
$ |
5,790 |
|
|
$ |
666 |
|
|
$ |
(239,583 |
) |
|
$ |
45,946 |
|
|
See accompanying notes to unaudited consolidated financial statements.
18/03/2010 1:37 PM
4
DRAFT
THERATECHNOLOGIES INC.
Consolidated Statements of Cash Flows
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,267 |
) |
|
$ |
(10,754 |
) |
Adjustments for: |
|
|
|
|
|
|
|
|
Amortization of property and equipment |
|
|
147 |
|
|
|
137 |
|
Stock-based compensation |
|
|
259 |
|
|
|
205 |
|
|
|
|
|
(3,861 |
) |
|
|
(10,412 |
) |
|
|
|
|
|
|
|
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Interest receivable on bonds |
|
|
163 |
|
|
|
(969 |
) |
Accounts receivable |
|
|
94 |
|
|
|
76 |
|
Tax credits receivable |
|
|
(168 |
) |
|
|
(668 |
) |
Inventories |
|
|
(26 |
) |
|
|
(1,594 |
) |
Research supplies |
|
|
17 |
|
|
|
133 |
|
Prepaid expenses |
|
|
(412 |
) |
|
|
(59 |
) |
Accounts payable and accrued liabilities |
|
|
(1,780 |
) |
|
|
(128 |
) |
Deferred revenues |
|
|
(1,703 |
) |
|
|
25,681 |
|
|
|
|
|
(3,815 |
) |
|
|
22,472 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,676 |
) |
|
|
12,060 |
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Share issuance |
|
|
38 |
|
|
|
9,854 |
|
Share issue costs |
|
|
|
|
|
|
(8 |
) |
|
|
|
|
38 |
|
|
|
9,846 |
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Additions to property and equipment |
|
|
(175 |
) |
|
|
(102 |
) |
Acquisition of bonds |
|
|
|
|
|
|
(19,631 |
) |
Disposal of bonds |
|
|
9,626 |
|
|
|
4,585 |
|
|
|
|
|
9,451 |
|
|
|
(15,148 |
) |
|
|
|
|
|
|
|
|
|
|
Net change in cash |
|
|
1,813 |
|
|
|
6,758 |
|
|
|
|
|
|
|
|
|
|
Cash, beginning of period |
|
|
1,519 |
|
|
|
133 |
|
|
|
|
|
|
|
|
|
|
|
Cash, end of period |
|
$ |
3,332 |
|
|
$ |
6,891 |
|
|
See note 4 (a) for supplemental cash flow information.
See accompanying notes to unaudited consolidated financial statements.
18/03/2010 1:37 PM
5
DRAFT
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars, except per share amounts)
1. |
|
Basis of presentation: |
|
|
The financial statements included in this report are unaudited and reflect normal and
recurring adjustments which are, in the opinion of the Company, considered necessary for a fair
presentation of its results. These financial statements have been prepared in conformity with
Canadian generally accepted accounting principles (GAAP). The same accounting policies as
described in the Companys latest annual report have been used. However, these financial
statements do not include all disclosures required under GAAP and, accordingly, should be read
in connection with the financial statements and the notes thereto included in the Companys
latest annual report. These interim financial statements have not been reviewed by the
auditors. |
2. |
|
New accounting policies: |
|
(a) |
|
Adoption of new accounting standards: |
|
|
|
Goodwill and intangible assets |
|
|
|
Effective with the commencement of its 2009 fiscal year, the Company adopted the
Canadian Institute of Chartered Accountants (CICA) Handbook Section 3064, Goodwill and
Intangible Assets, which will replace Section 3062, Goodwill and Other Intangible Assets,
and Section 3450, Research and Development Costs. The standard provides guidance on the
recognition of intangible assets in accordance with the definition of an asset and the
criteria for asset recognition, whether these assets are separately acquired or internally
developed. The impact of adopting this standard has been to increase the opening deficit
and to reduce other assets at December 1, 2008 by $599, respectively, which is the amount
of patent costs related to periods prior to these dates. |
|
(b) |
|
Future accounting changes: |
|
|
|
International Financial Reporting Standards |
|
|
|
In February 2008, Canadas Accounting Standards Board (AcSB) confirmed that Canadian
GAAP, as used by publicly accountable enterprises, would be fully converged into
International Financial Reporting Standards (IFRS), as issued by the International
Accounting Standards Board (IASB). The changeover date is for interim and annual
financial statements relating to fiscal years beginning on or after January 1, 2011. As a
result, the Company will be required to report under IFRS for its 2012 interim and annual
financial statements. The Company will convert to these new standards according to the
timetable set within these new rules. The Company will determine at a future date the
impact of adopting the standards on its consolidated financial statements. |
18/03/2010 1:37 PM
6
DRAFT
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars, except per share amounts)
|
(a) |
|
Shareholder rights plan: |
|
|
|
On February 10, 2010, the Board of Directors of the Company adopted a shareholder
rights plan (the ''Plan), effective as of such date. The Plan is designed to provide
adequate time for the Board of Directors, and the shareholders, to assess an unsolicited
takeover bid for the Company. In addition, the Plan provides the Board of Directors with
sufficient time to explore and develop alternatives for maximizing shareholder value if a
takeover bid is made, as well as provide shareholders with an equal opportunity to
participate in a takeover bid and receive full and fair value for their common shares (the
Common Shares). The Plan, if approved by the shareholders, will expire at the close of
the Companys annual meeting of shareholders in 2013. |
|
|
|
|
The rights issued under the Plan will initially attach to and trade with the Common
Shares and no separate certificates will be issued unless an event triggering these rights
occurs. The rights will become exercisable only when a person, including any party related
to it, acquires or attempts to acquire 20% or more of the outstanding Common Shares without
complying with the ''Permitted Bid provisions of the Plan or without approval of the
Board of Directors. Should such an acquisition occur or be announced, each right would,
upon exercise, entitle a rights holder, other than the acquiring person and related
persons, to purchase Common Shares at a 50% discount to the market price at the time. |
|
|
|
|
Under the Plan, a Permitted Bid is a bid made to all holders of the Common Shares and
which is open for acceptance for not less than 60 days. If, at the end of 60 days at least
50% of the outstanding Common Shares, other than those owned by the offeror and certain
related parties, have been tendered, the offeror may take up and pay for the Common Shares
but must extend the bid for a further 10 days to allow other shareholders to tender. |
18/03/2010 1:37 PM
7
DRAFT
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars, except per share amounts)
3. |
|
Capital stock (continued): |
|
|
|
Changes in outstanding options granted under the Companys stock option plan for the
year ended November 30, 2009 and the three-month period ended February 28, 2010 were as
follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
|
|
|
|
exercise price |
|
|
|
Number |
|
|
per share |
|
|
Options as at November 30, 2008 (audited) |
|
|
2,161,800 |
|
|
$ |
6.52 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
680,500 |
|
|
|
1.83 |
|
Cancelled and expired |
|
|
(176,500 |
) |
|
|
8.34 |
|
|
|
|
|
|
|
|
|
|
|
Options as at November 30, 2009 (audited) |
|
|
2,665,800 |
|
|
|
5.20 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
265,000 |
|
|
|
3.84 |
|
Cancelled and expired |
|
|
(25,667 |
) |
|
|
3.26 |
|
Exercised |
|
|
(21,164 |
) |
|
|
1.80 |
|
|
|
|
|
|
|
|
|
|
|
Options as at February 28, 2010 |
|
|
2,883,969 |
|
|
$ |
5.12 |
|
|
|
(c) |
|
Stock-based compensation and other stock-based payments: |
|
|
|
The estimated fair value of the options granted was estimated at the date of grant using
the Black-Scholes option pricing model with the following weighted average assumptions: |
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
Risk-free interest rate |
|
|
2.46 |
% |
|
|
1.79 |
% |
Volatility |
|
|
81 |
% |
|
|
79 |
% |
Average option life in years |
|
|
6 |
|
|
|
6 |
|
Dividend yield |
|
Nil |
|
|
Nil |
|
18/03/2010 1:37 PM
8
DRAFT
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars, except per share amounts)
3. |
|
Capital stock (continued): |
|
(c) |
|
Stock-based compensation and other stock-based payments (continued): |
|
|
|
The risk-free interest rate is based on the implied yield on a Canadian Treasury
zero-coupon issue with a remaining term equal to the expected term of the option. The
volatility is based solely on historical volatility equal to the expected term of the
option. The average life of the options is estimated considering the vesting period, the
term of the option and the length of time of similar grants have remained outstanding in
the past. Dividend yield was excluded from the calculation, since it is the present policy
of the Company not to retain in cash in order to keep funds available to finance the
Companys growth. |
|
|
|
The following table summarizes the weighted average fair value of stock options
granted during the periods ended February 28, 2010 and 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average |
|
|
|
Number of |
|
|
grant-date |
|
|
|
options |
|
|
fair value |
|
|
2010 |
|
|
265,000 |
|
|
$ |
2.96 |
|
2009 |
|
|
590,500 |
|
|
|
1.24 |
|
|
(d) |
|
Diluted loss per share: |
|
|
|
Diluted loss per share was not presented as the effect of options would have been
anti-dilutive. All options outstanding at the end of the year could potentially dilute the
basic earnings per share in the future. |
4. |
|
Supplemental information: |
|
(a) |
|
The following transactions were conducted by the Company and did not impact cash
flows: |
|
|
|
|
|
|
|
|
|
|
|
February 28, |
|
|
November 30, |
|
|
|
2010 |
|
|
2009 |
|
|
Additions to property and equipment included in
accounts payable and accrued liabilities |
|
$ |
135 |
|
|
$ |
183 |
|
18/03/2010 1:37 PM
9
DRAFT
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars, except per share amounts)
4. |
|
Supplemental information (continued): |
|
(b) |
|
For the three-month period ended February 28, 2010, the Company has reclassified in net
loss $100 of realized gains on available-for-sale financial assets previously recorded in
accumulated other comprehensive income ($23 in 2009). |
On February 28, 2010, the accumulated
other comprehensive loss was composed of unrealized gains on available-for-sale financial
assets of $1,185 (gain of $1,282 on November 30, 2009).
|
(c) |
|
For the three-month periods ended February 28, 2010 and 2009, the following items were
included in the determination of the Companys net loss: |
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
2009 |
|
Amortization of property and equipment |
|
$ |
147 |
|
|
$ |
137 |
|
Stock-based compensation |
|
|
259 |
|
|
|
205 |
|
5. |
|
Financial instruments: |
|
(a) |
|
Carrying value and fair value: |
|
|
|
|
The Company has determined that the carrying values of its short-term financial assets and
liabilities, including cash, accounts receivable, as well as accounts payable and accrued
liabilities, approximate their fair value because of the relatively short period to
maturity of these instruments. |
|
|
|
|
Bonds and investments in public companies are stated at estimated fair value, determined by
inputs that are directly observable (Level 2 inputs). |
|
|
(b) |
|
Interest income and expenses: |
|
|
|
|
Interest income consists of interest earned on cash and bonds. |
18/03/2010 1:37 PM
10
DRAFT
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars, except per share amounts)
5. |
|
Financial instruments (continued): |
|
(c) |
|
Loss on exchange: |
|
|
|
|
General and administrative expenses include a loss on foreign exchange of $44 ($416 in
2009) for the three-month period ended February 28, 2010. |
6. |
|
Collaboration and licensing agreement: |
|
|
|
On October 28, 2008, the Company entered into a collaboration and licensing agreement with EMD
Serono, Inc. (EMD Serono), and affiliate of Merck KGaA, of Darmstadt, Germany, regarding the
exclusive commercialization rights of tesamorelin in the United States for the treatment of
excess abdominal fat in HIV-infected patients with lipodystrophy (the Initial Product). The
Company retains all tesamorelin commercialization rights outside of the United States. |
|
|
|
Under the terms of the agreement, the Company is responsible for the development of the Initial
Product up to obtaining marketing approval in the United States. The Company is also
responsible for product production and for the development of a new formulation of the initial
product. EMD Serono is responsible for conducting product commercialization activities. |
|
|
|
At the closing of the agreement, on December 15, 2008, the Company received US$30,000
(CAD$36,951), which includes an initial payment of US$22,000 (CAD$27,097) and US$8,000
(CAD$9,854) as a subscription for common shares in the Company by Merck KGaA at a price of
US$3.67 (CAD$4.52) per share. The Company may receive up to US$215,000, which amount includes
the initial payment of US$22,000, the equity investment of US$8,000, as well as payments based
on the achievement of certain development, regulatory and sales milestones. The Company will
also be entitled to receive increasing royalties on annual net sales of tesamorelin in the
United States, if applicable. |
|
|
|
The initial payment of $27,097 has been deferred and is being amortized over its estimated
service period on a straight-line basis. This period may be modified in the future based on
additional information that may be received by the Company. For the three-month period ended
February 28, 2010, an amount of $1,711 related to this transaction was recognized as revenue.
At February 28, 2010, the deferred revenues related to this transaction amounted to $18,826. |
On August 12, 2009, the US Food and Drug Administration accepted the New Drug Application (NDA)
made by the Company for tesamorelin. Under the terms of the Companys Collaboration and
Licensing Agreement with EMD Serono, the acceptance of the tesamorelin NDA resulted in a
milestone payment of US$10,000 (CAD$10,884). This milestone payment has been recorded in the
third quarter of 2009.
18/03/2010 1:37 PM
11
DRAFT
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended February 28, 2010 and 2009
(in thousands of dollars, except per share amounts)
6. |
|
Collaboration and licensing agreement (continued): |
|
|
|
The Company may conduct research and development for additional indications. Under the
Collaboration and Licensing Agreement, EMD Serono will have the option to commercialize
additional indications for tesamorelin in the United States. If it exercises this option, EMD
Serono will pay half of the development costs related to such additional indications. In such
cases, the Company will also have the right, subject to EMD Seronos agreement, to participate
in the promotion of the additional indications. |
18/03/2010 1:37 PM
12
ex-99.24
Exhibit 99.24
MANAGEMENTS DISCUSSION AND ANALYSIS FOR THE FOURTH QUARTER
Revenues
Consolidated revenues for the three-month period ended November 30, 2009, amounted to $2,246,000
compared to $616,000 for the same period in 2008. For the year ended November 30, 2009,
consolidated revenues were $19,720,000 compared to $2,641,000 for the same period in 2008.
Royalties, technologies and other
The increased revenues in 2009 are related to the initial payment received on December 15, 2008,
upon the closing of the collaboration and licensing agreement with EMD Serono, Inc. (EMD Serono)
as well as the receipt of a milestone payment of $10,884,000 during the third quarter of 2009.
The payment of US $30,000,000 (CAD $36,951,000) included an initial payment of US $22,000,000 (CAD
$27,097,000) and a subscription for common shares by Merck KGaA at a price of US $3.67 (CAD $4.52)
per share, resulting in gross proceeds of US $8,000,000 (CAD $9,854,000). The initial payment of
$27,097,000 has been deferred and is being amortized over its estimated service period on a
straight-line basis. This period may be modified in the future based on additional information that
the Company may receive related to the estimated service period. For the year ended November 30,
2009, an amount of $6,560,000 related to this transaction was recognized as revenue. At November
30, 2009, the deferred revenues related to this transaction recorded on the balance sheet amounted
to $20,537,000.
The milestone payment of $10,884,000, received during the third quarter under the terms of the
collaboration and licensing agreement with EMD Serono, is associated with the acceptance by the
U.S. Food and Drug Administration (FDA) to review the New Drug Application (NDA) for
tesamorelin that was submitted by Theratechnologies on May 29, 2009. Under the terms of the
collaboration and licensing agreement with EMD Serono, a milestone payment of US $10,000,000 was
associated with the FDAs acceptance to review the NDA for tesamorelin. All milestone payments,
including the aforementioned payment, are recorded as they are earned, upon the achievement of
predetermined milestones specified in the agreement.
Interest
Interest revenues for the three-month period ended November 30, 2009, amounted to $528,000 compared
to $518,000 for the same period in 2008. For the year ended November 30, 2009, interest revenues
were $2,252,000 compared to $2,427,000 for the same period in 2008. The decrease in interest
revenues during the three-month period is associated with lower interest rates during the year,
which translated to a lower return on investment. In the fourth quarter of 2009, this decrease in
interest rates was compensated by an increase in the average level of investments.
R&D Activities
Research and Development (R&D) expenditures, before tax credits, totalled $4,534,000 for the
fourth quarter of 2009, compared to $6,313,000 for the same period in 2008, representing a decrease
of 28.2%. For the year ended November 30, 2009, R&D expenditures were $22,226,000, compared to
$35,326,000 for the same period in 2008, representing a decrease of 37.1%. These lower levels of
R&D expenses are due to the conclusion of the Phase 3 clinical program in the first half of 2009.
The R&D expenses in 2009 include a non-recurring charge of $1,377,000 associated with research
material produced to obtain stability data and to validate the commercial production process as
requested by the FDA. The R&D expenses incurred in the fourth quarter of 2009 are mainly related to
follow up on the regulatory filing notably managing responses to the FDAs questions, a normal part
of the review process, and the preparation for the FDA Advisory Committee meeting as well as the
preparation for larger-scale production of tesamorelin.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
Other Expenses
For the fourth quarter of 2009, general and administrative expenses amounted to $1,634,000,
compared to $1,874,000 for the same period in 2008. For the year ended November 30, 2009, general
and administrative expenses amounted to $7,149,000 compared to $6,185,000 for the same period in
2008. The increased expenses in 2009 are principally due to a higher exchange loss as well as costs
associated with revising the Companys business plan in the first quarter.
The exchange losses are due to the conversion of monetary assets and liabilities denominated in
foreign currencies into Canadian dollar equivalents using rates of exchange in effect on the
balance sheet date.
Selling and market development costs amounted to $1,067,000 for the fourth quarter of 2009,
compared to $1,124,000 for the same period in 2008. For the year ended November 30, 2009, selling
and market development expenses amounted to $2,583,000, compared to $3,811,000 for the same period
in 2008. The decrease in selling and market development costs is due to the signing of an agreement
with EMD Serono for the U.S. commercialization of tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy. Since the signing of this agreement, the sales and
market development expenses are principally composed of business development expenses outside the
United States and the costs of managing the agreement with EMD Serono.
In the fourth quarter of 2008, Theratechnologies conducted an impairment test on the intellectual
property of the ExoPep platform following a review of the development strategy by Management for
new products. As a consequence, the Company wrote off the carrying amount of this intellectual
property in 2008. The write-off of $4,571,000 is included in Patents, amortization and impairment
of other assets in the consolidated statement of earnings.
In 2008, the Company incurred an impairment of $578,000 related to stock options held in a
publicly-traded company.
Net Results
Taking into account the changes in revenues and expenses described above, the Company recorded a
fourth quarter net loss of $4,698,000 ($0.08 loss per share), compared to a net loss of $15,145,000
($0.26 loss per share) for the same period in 2008. For the year ended November 30, 2009, the net
loss was $15,058,000 ($0.25 loss per share), compared to a net loss of $48,611,000 ($0.85 loss per
share) for the same period in 2008. The net loss in 2008 included the previously described decline
in impairment charges, totalling $5,149,000.
The fourth quarter 2009 net loss includes revenues of $1,711,000 related to the agreement with EMD
Serono. Excluding this item, the adjusted net loss (see Annex A) amounted to $6,409,000, a decrease
of 57.7% compared to the same period in 2008. For the year ended November 30, 2009, the net loss
included revenue of $17,444,000 and a non-recurring charge of $4,269,000 related to the agreement
with EMD Serono. Excluding these two items, the adjusted net loss (see Annex A) amounted to
$28,233,000, a decrease of 41.9% compared to the same period in 2008.
Quarterly Financial Information
The selected financial information provided below is derived from the Companys unaudited quarterly
financial statements for each of the last eight quarters. This information has been restated
following the adoption of the Canadian Institute of Chartered Accountants (CICA) Handbook Section
3064, Goodwill and Intangible Assets.
(in thousands of Canadian dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Revenues |
|
$ |
2,246 |
|
|
$ |
13,148 |
|
|
$ |
2,317 |
|
|
$ |
2,009 |
|
|
$ |
616 |
|
|
$ |
710 |
|
|
$ |
716 |
|
|
$ |
599 |
|
Net earnings (net loss) |
|
$ |
(4,698 |
) |
|
$ |
5,824 |
|
|
$ |
(5,430 |
) |
|
$ |
(10,754 |
) |
|
$ |
(15,145 |
) |
|
$ |
(11,220 |
) |
|
$ |
(11,382 |
) |
|
$ |
(10,864 |
) |
Basic and diluted
benefit (loss) per share |
|
$ |
(0.08 |
) |
|
$ |
0.10 |
|
|
$ |
(0.09 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.20 |
) |
|
As described above, the increased revenues in 2009 are related to the amortization of the
initial payment received at the closing of the agreement with EMD Serono, as well as the milestone
payment of $10,884,000 recorded in August 2009. The increase in the fourth quarter net loss in
2008 is due to impairment charges for intellectual property.
Financial Position
At November 30, 2009, liquidities, which include cash and bonds, amounted to $63,362,000, and tax
credits receivable amounted to $1,666,000 for a total of $65,028,000.
For the three-month period ended November 30, 2009, the burn rate from operating activities,
excluding changes in operating assets and liabilities, was $4,333,000, compared to $9,559,000 for
the same period in 2008. Excluding the revenue of $1,711,000 related to the agreement with EMD
Serono, the adjusted burn rate from operating activities, excluding changes in operating assets and
liabilities (see Annex A), was $6,044,000, a decrease of 36.8%, compared to the corresponding
period in 2008.
For the year ended November 30, 2009, the burn rate from operating activities, excluding changes in
operating assets and liabilities, was $13,547,000, compared to $41,592,000 for the same period in
2008. The decrease in the 2009 burn rate is principally related to the payments received under the
agreement with EMD Serono as well as the decline in R&D expenditures and in selling and market
development costs. Excluding the revenue of $17,444,000 and the non-recurring charge of $4,269,000
related to the agreement with EMD Serono, the adjusted burn rate from operating activities,
excluding changes in operating assets and liabilities (see Annex A), was $26,722,000, a decrease of
35.8%, compared to the corresponding period in 2008.
Subsequent Events
Shareholder rights plan
On February 10, 2010, the Board of Directors of the Company adopted a shareholder rights plan (the
Plan), effective as of such date. The Plan is designed to provide adequate time for the Board of
Directors, and the shareholders, to assess an unsolicited takeover bid for Theratechnologies. In
addition, the Plan provides the Board of Directors with sufficient time to explore and develop
alternatives for maximizing shareholder value if a takeover bid is made, as well as provide
shareholders with an equal opportunity to participate in a takeover bid to receive full and fair
value for their common shares (the Common Shares). The Plan, if approved by the shareholders at
the Companys next Annual and Special Meeting to be held in March 2010, will expire at the close of
the Companys annual meeting of shareholders in 2013.
The rights issued under the Plan will initially attach to and trade with the Common Shares and no
separate certificates will be issued unless an event triggering these rights occurs. The rights
will become exercisable only when a person, including any party related to it, acquires or attempts
to acquire 20 percent or more of the outstanding Common Shares without complying with the
Permitted Bid provisions of the Plan or without approval of the Board of Directors. Should such
an acquisition occur or be announced, each right would, upon exercise, entitle a rights holder,
other than the acquiring person and related persons, to purchase Common Shares at a 50 percent
discount to the market price at the time.
Under the Plan, a Permitted Bid is a bid made to all holders of the Common Shares and which is open
for acceptance for not less than 60 days. If at the end of 60 days at least 50 percent of the
outstanding Common Shares, other than those owned by the offeror and certain related parties have
been tendered, the offeror may take up and pay for the Common Shares but must extend the bid for a
further 10 days to allow other shareholders to tender.
Granting of stock options
On December 8, 2009, the Company granted 265,000 options at an exercise price of $3.84 per share
and cancelled 19,167 options at a weighted exercise price of $2.38 per share in connection with its
stock option plan.
New Accounting Policies
Refer to Note 2 of the Companys unaudited Consolidated Financial Statements for the fourth quarter
of 2009.
The impact of adopting Section 3064, Goodwill and Intangible Assets, of the CICA Handbook was to
increase the opening deficit and to reduce other assets on December 1, 2007 and 2008 by $941,000
and $599,000 respectively. These amounts correspond to adjustments made to patent costs related to
periods prior to these dates. Furthermore, following the adoption of this standard, patents and
amortization of other assets presented in the consolidated statements of earnings were reduced by
$342,000 for the year ended November 30, 2008.
Outstanding Share Data
On February 9, 2010, the number of shares issued and outstanding was 60,449,225, while outstanding
options granted under the stock option plan were 2,891,801.
Contractual Obligations
The Company rents its premises under an operating lease expiring in April 2010. In 2009, the lease
was renewed by the Company and the lessor for a period of 11 years ending April 30, 2021. Refer to
Note 7 of the Companys unaudited Consolidated Financial Statements for the fourth quarter of 2009.
In addition, during and after the year ended November 30, 2009, the Company entered into long-term
supply agreements with third parties in anticipation of the commercialization of tesamorelin.
Certain of these agreements stipulate an obligation to purchase minimum quantities of products in
certain circumstances.
Economic and Industry Factors
Economic and industry factors were substantially unchanged from those reported in the Companys
2008 Annual Report.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products for commercialization. The Company targets unmet medical needs in
financially attractive specialty markets where it can retain all or part of the commercial rights
to its products. Its most advanced compound, tesamorelin, is an analogue of the human growth
hormone releasing factor. In 2009, Theratechnologies submitted a New Drug Application (NDA) to the
United States Food and Drug Administration (FDA), seeking approval of tesamorelin for the treatment
of excess abdominal fat in HIV-infected patients with lipodystrophy. The Companys growth strategy
is centered on the commercialization of tesamorelin in the United States and in other markets for
HIV-associated lipodystrophy as well as the development of clinical programs for tesamorelin in
other medical conditions.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Companys website at
www.theratech.com. Additional information, including the Annual Information Form and the
Annual Report, is also available on SEDAR at www.sedar.com.
Forward-Looking Information
This press release and the Managements Discussion and Analysis for the fourth quarter incorporated
therein contain certain statements that are considered forward-looking information within the
meaning of applicable securities legislation. This forward-looking information includes, but is not
limited to, information regarding the commercialization of tesamorelin in HIV-associated
lipodystrophy, the receipt of royalties related to the commercialisation of tesamorelin, the
development of new markets for tesamorelin, the conclusion of partnership agreements and the
liquidity needs to finance the Companys operations. Furthermore, the words will, may, could,
should, outlook, believe, plan, envisage, anticipate, expect and estimate, or the
negatives of these terms or variations of them and the use of the conditional tense as well as
similar expressions denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties include, but are not limited to, the risk that the
Company may not obtain all required approvals from regulatory agencies to market its products, the
risk that the Companys products may not be accepted by the market, and the delays that may occur
if the Company encounters problems with a third-party supplier of services.
Although the forward-looking information contained herein is based upon what the Company believes
are reasonable assumptions, investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking information. Certain assumptions
made in preparing the forward-looking information and the Companys objectives include the
assumption, among others, that the FDA will approve tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy, that the Companys business plan will
not be substantially modified and that current relationships with the Companys third-party
suppliers of services and products will remain good.
Consequently, all of the forward-looking information is qualified by the foregoing cautionary
statements, and there can be no guarantee that the results or developments anticipated by the
Company will be realized or, even if substantially realized, that they will have the expected
consequences or effects on the Company, its business, its financial condition or its results of
operation. Furthermore, the forward-looking information reflects current expectations regarding
future events only as of the date of release of this press release.
Investors are referred to the Companys public filings available at www.sedar.com. In
particular, further details and descriptions of these risks and other factors are disclosed in the
Risk and Uncertainties section of the Companys Annual Information Form, dated February 24, 2009,
for the year ended November 30, 2008. The Company does not undertake to update or amend such
forward-looking information whether as a result of new information, future events or otherwise,
except as may be required by applicable law.
Information:
Andrea Gilpin
Vice President, IR & Communications
Phone: 514-336-7800, ext. 205
communications@theratech.com
Luc Tanguay
Senior Executive Vice President and
Chief Financial Officer
Phone: 514-336-7800, ext. 204
ltanguay@theratech.com
ANNEX A
Non-GAAP measures
The Company uses measures that do not conform to generally accepted accounting principles (GAAP)
to assess its operating performance. Securities regulators require that companies caution readers
that earnings and other measures adjusted to a basis other than GAAP do not have standardized
meanings and are unlikely to be comparable to similar measures used by other companies.
Accordingly, these measures should not be considered in isolation. The Company uses non-GAAP
measures such as adjusted net loss and the adjusted burn rate from operating activities before
changes in operating assets and liabilities, to measure its performance from one period to the next
without including changes caused by certain items that could potentially distort the analysis of
trends in its operating performance, and because such measures provide meaningful information on
the Companys financial condition and operating results.
Definition and reconciliation of non-GAAP measures
In order to measure performance from one period to another, without accounting for changes related
to revenues and fees associated with the collaboration and license agreement with EMD Serono,
management uses adjusted net loss and adjusted burn rate before changes in operating assets and
liabilities. These items are excluded because they affect the comparability of the financial
results and could potentially distort the analysis of trends in the Companys operating
performance. The exclusion of these items does not necessarily indicate that they are
non-recurring.
(Thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November 30th |
|
|
November 30th |
|
|
|
(3 months) |
|
|
(12 months) |
|
Adjusted net loss |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Net loss, per the financial statements |
|
$ |
(4,698 |
) |
|
$ |
(15,145 |
) |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues associated with a
collaboration and license agreement
(note 7 to the consolidated financial
statements) |
|
|
(1,711 |
) |
|
|
|
|
|
|
(17,444 |
) |
|
|
|
|
Fees associated with collaboration
and license agreement |
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted net loss |
|
$ |
(6,409 |
) |
|
$ |
(15,145 |
) |
|
$ |
(28,233 |
) |
|
$ |
(48,611 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November 30th |
|
|
November 30th |
|
|
|
(3 months) |
|
|
(12 months) |
|
Adjusted burn rate before changes in operating assets and liabilities |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Burn rate before
changes in
operating assets
and liabilities,
per the financial
statements |
|
$ |
(4,333 |
) |
|
$ |
(9,559 |
) |
|
$ |
(13,547 |
) |
|
$ |
(41,592 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues associated
with a
collaboration and
license agreement
(note 7 to the
consolidated
financial
statements) |
|
|
(1,711 |
) |
|
|
|
|
|
|
(17,444 |
) |
|
|
|
|
Fees associated
with collaboration
and license
agreement |
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted burn rate
before changes in
operating assets
and liabilities |
|
$ |
(6,044 |
) |
|
$ |
(9,559 |
) |
|
$ |
(26,722 |
) |
|
$ |
(41,592 |
) |
|
|
|
|
|
|
|
ex-99.25
Exhibit 99.25
Consolidated Financial Statements of
(Unaudited)
THERATECHNOLOGIES INC.
Periods ended November 30, 2009 and 2008
THERATECHNOLOGIES INC.
Consolidated Financial Statements
(Unaudited)
Periods ended November 30, 2009 and 2008
Financial Statements
|
|
|
|
|
Consolidated Balance Sheets |
|
|
1 |
|
Consolidated Statements of Earnings |
|
|
2 |
|
Consolidated Statements of Comprehensive Loss |
|
|
3 |
|
Consolidated Statement of Shareholders Equity |
|
|
4 |
|
Consolidated Statements of Cash Flows |
|
|
6 |
|
Notes to Consolidated Financial Statements |
|
|
7 |
|
THERATECHNOLOGIES INC.
Consolidated Balance Sheets
(Unaudited)
November 30, 2009 and 2008
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
(Restated - |
|
|
|
|
|
|
|
note 2 (a)) |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
1,519 |
|
|
$ |
133 |
|
Bonds |
|
|
10,036 |
|
|
|
10,955 |
|
Accounts receivable |
|
|
375 |
|
|
|
610 |
|
Tax credits receivable |
|
|
1,666 |
|
|
|
1,784 |
|
Inventories |
|
|
2,225 |
|
|
|
|
|
Research supplies |
|
|
287 |
|
|
|
301 |
|
Prepaid expenses |
|
|
302 |
|
|
|
397 |
|
|
|
|
|
16,410 |
|
|
|
14,180 |
|
|
|
|
|
|
|
|
|
|
Bonds |
|
|
51,807 |
|
|
|
35,249 |
|
Property and equipment |
|
|
1,229 |
|
|
|
1,299 |
|
Other assets |
|
|
41 |
|
|
|
2,817 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
69,487 |
|
|
$ |
53,545 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
5,901 |
|
|
$ |
7,198 |
|
Current portion of deferred revenues (note 6) |
|
|
6,847 |
|
|
|
|
|
|
|
|
|
12,748 |
|
|
|
7,198 |
|
|
|
|
|
|
|
|
|
|
Deferred revenues (note 6) |
|
|
13,691 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Capital stock (note 3) |
|
|
279,169 |
|
|
|
269,219 |
|
Contributed surplus |
|
|
6,484 |
|
|
|
5,585 |
|
|
|
|
|
|
|
|
|
|
Accumulated other comprehensive income |
|
|
1,282 |
|
|
|
372 |
|
Deficit |
|
|
(243,887 |
) |
|
|
(228,829 |
) |
|
|
|
|
(242,605 |
) |
|
|
(228,457 |
) |
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
43,048 |
|
|
|
46,347 |
|
|
|
|
|
|
|
|
|
|
Commitments (note 7) |
|
|
|
|
|
|
|
|
Subsequent events (note 8) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
69,487 |
|
|
$ |
53,545 |
|
|
See accompanying notes to unaudited consolidated financial statements.
1
THERATECHNOLOGIES INC.
Consolidated Statements of Earnings
(Unaudited)
Periods ended November 30, 2009 and 2008
(in thousands of dollars, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fourth quarter |
|
|
Year |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
(Restated - |
|
|
|
|
|
|
(Restated - |
|
|
|
|
|
|
|
note 2 (a)) |
|
|
|
|
|
|
note 2 (a)) |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalties, technologies
and other (note 6) |
|
$ |
1,718 |
|
|
$ |
98 |
|
|
$ |
17,468 |
|
|
$ |
214 |
|
Interest |
|
|
528 |
|
|
|
518 |
|
|
|
2,252 |
|
|
|
2,427 |
|
|
|
|
|
2,246 |
|
|
|
616 |
|
|
|
19,720 |
|
|
|
2,641 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
4,534 |
|
|
|
6,313 |
|
|
|
22,226 |
|
|
|
35,326 |
|
Tax credits |
|
|
(411 |
) |
|
|
(334 |
) |
|
|
(1,795 |
) |
|
|
(2,111 |
) |
|
|
|
|
4,123 |
|
|
|
5,979 |
|
|
|
20,431 |
|
|
|
33,215 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
1,634 |
|
|
|
1,874 |
|
|
|
7,149 |
|
|
|
6,185 |
|
Selling and market
development |
|
|
1,067 |
|
|
|
1,124 |
|
|
|
2,583 |
|
|
|
3,811 |
|
Patents, amortization and
impairment of other assets |
|
|
120 |
|
|
|
4,727 |
|
|
|
346 |
|
|
|
5,239 |
|
Fees associated with the
strategic review process |
|
|
|
|
|
|
1,479 |
|
|
|
|
|
|
|
2,224 |
|
Fees associated with
collaboration and
licensing agreement
(note 6) |
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
|
|
|
|
|
6,944 |
|
|
|
15,183 |
|
|
|
34,778 |
|
|
|
50,674 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss before
undernoted item |
|
|
(4,698 |
) |
|
|
(14,567 |
) |
|
|
(15,058 |
) |
|
|
(48,033 |
) |
Realized loss on
impairment of
available-for-sale
financial assets (note 4 (b)) |
|
|
|
|
|
|
(578 |
) |
|
|
|
|
|
|
(578 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,698 |
) |
|
$ |
(15,145 |
) |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share (note 3 (c)) |
|
$ |
(0.08 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.85 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares outstanding |
|
|
60,403,790 |
|
|
|
58,165,795 |
|
|
|
60,314,309 |
|
|
|
57,415,468 |
|
|
See accompanying notes to unaudited consolidated financial statements.
2
THERATECHNOLOGIES INC.
Consolidated Statements of Comprehensive Loss
(Unaudited)
Periods ended November 30, 2009 and 2008
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fourth quarter |
|
|
Year |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
(Restated - |
|
|
|
|
|
|
(Restated - |
|
|
|
|
|
|
|
note 2 (a)) |
|
|
|
|
|
|
note 2 (a)) |
|
|
Net loss |
|
$ |
(4,698 |
) |
|
$ |
(15,145 |
) |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Losses) unrealized gains on
available-for-sale financial
assets |
|
|
(288 |
) |
|
|
71 |
|
|
|
1,039 |
|
|
|
133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification adjustment for
gains and losses on available-for-sale financial assets
(note 4 (b)) |
|
|
(11 |
) |
|
|
572 |
|
|
|
(129 |
) |
|
|
572 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(4,997 |
) |
|
$ |
(14,502 |
) |
|
$ |
(14,148 |
) |
|
$ |
(47,906 |
) |
|
See accompanying notes to unaudited consolidated financial statements.
3
THERATECHNOLOGIES INC.
Consolidated Statement of Shareholders Equity
(Unaudited)
Period ended November 30, 2009
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
compre- |
|
|
|
|
|
|
|
|
|
Capital stock |
|
|
Contributed |
|
|
hensive |
|
|
|
|
|
|
|
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
income |
|
|
Deficit |
|
|
Total |
|
|
Balance, November 30, 2008 |
|
|
58,215,090 |
|
|
$ |
269,219 |
|
|
$ |
5,585 |
|
|
$ |
372 |
|
|
$ |
(228,829 |
) |
|
$ |
46,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of share capital
(notes 3 and 6) |
|
|
2,214,303 |
|
|
|
9,950 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,950 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
899 |
|
|
|
|
|
|
|
|
|
|
|
899 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(15,058 |
) |
|
|
(15,058 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized gains and
losses on available-for-sale
financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
910 |
|
|
|
|
|
|
|
910 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, November 30, 2009 |
|
|
60,429,393 |
|
|
$ |
279,169 |
|
|
$ |
6,484 |
|
|
$ |
1,282 |
|
|
$ |
(243,887 |
) |
|
$ |
43,048 |
|
|
See accompanying notes to unaudited consolidated financial statements.
4
THERATECHNOLOGIES INC.
Consolidated Statement of Shareholders Equity, Continued
(Unaudited)
Period ended November 30, 2008
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
compre- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
hensive |
|
|
|
|
|
|
|
|
|
Capital stock |
|
|
Contributed |
|
|
income |
|
|
|
|
|
|
|
|
|
Number |
|
|
Dollars |
|
|
surplus |
|
|
(loss) |
|
|
Deficit |
|
|
Total |
|
|
Balance, November 30, 2007 |
|
|
54,531,133 |
|
|
$ |
238,842 |
|
|
$ |
4,807 |
|
|
$ |
(333 |
) |
|
$ |
(177,339 |
) |
|
$ |
65,977 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in accounting policies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(941 |
) |
|
|
(941 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of share capital |
|
|
3,564,291 |
|
|
|
29,899 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,899 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share issue costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,938 |
) |
|
|
(1,938 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash proceeds |
|
|
119,666 |
|
|
|
397 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
397 |
|
Ascribed value |
|
|
|
|
|
|
81 |
|
|
|
(81 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
859 |
|
|
|
|
|
|
|
|
|
|
|
859 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(48,611 |
) |
|
|
(48,611 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized gains and
losses on available-for-sale
financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
705 |
|
|
|
|
|
|
|
705 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, November 30, 2008 |
|
|
58,215,090 |
|
|
$ |
269,219 |
|
|
$ |
5,585 |
|
|
$ |
372 |
|
|
$ |
(228,829 |
) |
|
$ |
46,347 |
|
|
See accompanying notes to unaudited consolidated financial statements.
5
THERATECHNOLOGIES INC.
Consolidated Statements of Cash Flows
(Unaudited)
Periods ended November 30, 2009 and 2008
(in thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fourth quarter |
|
|
Year |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
(Restated - |
|
|
|
|
|
|
(Restated - |
|
|
|
|
|
|
|
note 2 (a)) |
|
|
|
|
|
|
note 2 (a)) |
|
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,698 |
) |
|
$ |
(15,145 |
) |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
Adjustments for: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of property
and equipment |
|
|
171 |
|
|
|
160 |
|
|
|
612 |
|
|
|
625 |
|
Amortization and impairment
of other assets |
|
|
|
|
|
|
4,667 |
|
|
|
|
|
|
|
4,957 |
|
Stock-based compensation |
|
|
194 |
|
|
|
181 |
|
|
|
899 |
|
|
|
859 |
|
Realized loss on impairment of
available-for-sale financial assets |
|
|
|
|
|
|
578 |
|
|
|
|
|
|
|
578 |
|
|
|
|
|
(4,333 |
) |
|
|
(9,559 |
) |
|
|
(13,547 |
) |
|
|
(41,592 |
) |
Changes in operating assets
and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest receivable on bonds |
|
|
(195 |
) |
|
|
219 |
|
|
|
(923 |
) |
|
|
405 |
|
Accounts receivable |
|
|
(155 |
) |
|
|
(20 |
) |
|
|
260 |
|
|
|
(134 |
) |
Tax credits receivable |
|
|
1,501 |
|
|
|
(335 |
) |
|
|
118 |
|
|
|
(366 |
) |
Inventories |
|
|
(631 |
) |
|
|
|
|
|
|
(2,225 |
) |
|
|
|
|
Research supplies |
|
|
742 |
|
|
|
(498 |
) |
|
|
2,765 |
|
|
|
582 |
|
Prepaid expenses |
|
|
421 |
|
|
|
109 |
|
|
|
95 |
|
|
|
17 |
|
Accounts payable and
accrued liabilities |
|
|
1,166 |
|
|
|
(3,765 |
) |
|
|
(1,424 |
) |
|
|
(1,324 |
) |
Deferred revenues |
|
|
(1,714 |
) |
|
|
|
|
|
|
20,538 |
|
|
|
|
|
|
|
|
|
1,135 |
|
|
|
(4,290 |
) |
|
|
19,204 |
|
|
|
(820 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,198 |
) |
|
|
(13,849 |
) |
|
|
5,657 |
|
|
|
(42,412 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share issuance |
|
|
89 |
|
|
|
121 |
|
|
|
9,950 |
|
|
|
30,296 |
|
Share issue costs |
|
|
|
|
|
|
(23 |
) |
|
|
(8 |
) |
|
|
(1,930 |
) |
|
|
|
|
89 |
|
|
|
98 |
|
|
|
9,942 |
|
|
|
28,366 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Addition to property
and equipment |
|
|
(117 |
) |
|
|
(31 |
) |
|
|
(407 |
) |
|
|
(301 |
) |
Acquisition of bonds |
|
|
(9,480 |
) |
|
|
(4,815 |
) |
|
|
(29,111 |
) |
|
|
(17,987 |
) |
Disposal of bonds |
|
|
1,500 |
|
|
|
9,115 |
|
|
|
15,305 |
|
|
|
29,889 |
|
|
|
|
|
(8,097 |
) |
|
|
4,269 |
|
|
|
(14,213 |
) |
|
|
11,601 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in cash |
|
|
(11,206 |
) |
|
|
(9,482 |
) |
|
|
1,386 |
|
|
|
(2,445 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, beginning of period |
|
|
12,725 |
|
|
|
9,615 |
|
|
|
133 |
|
|
|
2,578 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, end of period |
|
$ |
1,519 |
|
|
$ |
133 |
|
|
$ |
1,519 |
|
|
$ |
133 |
|
|
See note 4 (a) for supplemental cash flow information.
See accompanying notes to unaudited consolidated financial statements.
6
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements
(Unaudited)
Periods ended November 30, 2009 and 2008
(in thousands of dollars, except per share amounts)
1. |
|
Basis of presentation: |
|
|
|
The financial statements included in this report are unaudited and reflect normal and recurring
adjustments which are, in the opinion of the Company, considered necessary for a fair
presentation of its results. These financial statements have been prepared in conformity with
Canadian generally accepted accounting principles. The same accounting policies as described
in the Companys latest Annual Report have been used, except as described in note 2 below.
However, these financial statements do not include all disclosures required under generally
accepted accounting principles and, accordingly, should be read in connection with the
financial statements and the notes thereto included in the Companys latest Annual Report.
These interim financial statements have not been reviewed by the auditors. |
|
2. |
|
New accounting policies: |
|
(a) |
|
Adoption of new accounting standards: |
|
|
|
|
Goodwill and intangible assets |
|
|
|
|
Effective with the commencement of its 2009 fiscal year, the Company adopted the Canadian
Institute of Chartered Accountants (CICA) Handbook Section 3064, Goodwill and Intangible
Assets, which will replace Section 3062, Goodwill and Other Intangible Assets, and Section
3450, Research and Development Costs. The standard provides guidance on the recognition of
intangible assets in accordance with the definition of an asset and the criteria for asset
recognition, whether these assets are separately acquired or internally developed. The
impact of adopting this standard has been to increase the opening deficit and to reduce
other assets at December 1, 2007 and 2008 by $941 and $599, respectively, which is the
amount of patent costs related to periods prior to these dates. Furthermore, following the
adoption of this standard, patents and amortization of other assets presented on the
consolidated statements of earnings were reduced by $342 for the year ended November 30,
2008. |
|
|
|
|
Inventories |
|
|
|
|
Effective with the commencement of its 2009 fiscal year, the Company adopted CICA Section
3031, Inventories, which replaces Section 3030 and harmonizes the Canadian standards
related to inventories with International Financial Reporting Standards (''IFRS). This
Section provides changes to the measurement and more extensive guidance on the
determination of cost, including allocation of overhead; narrows the permitted cost
formulas; requires impairment testing; and expands the disclosure requirements to increase
transparency. As the Company had no inventories on November 30, 2008, the adoption of this
section had no impact on the Companys consolidated financial statements. |
7
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended November 30, 2009 and 2008
(in thousands of dollars, except per share amounts)
2. |
|
New accounting policies (continued): |
|
(a) |
|
Adoption of new accounting standards (continued): |
|
|
|
|
Credit risk and fair value of financial assets and financial liabilities |
|
|
|
|
On January 20, 2009, the Emerging Issues Committee (EIC) of the Accounting Standards
Board (AcSB) issued EIC Abstract 173, Credit Risk and Fair Value of Financial Assets
and Financial Liabilities, which establishes that an entitys own credit risk and the
credit risk of the counterparty should be taken into account in determining the fair value
of financial assets and financial liabilities, including derivative instruments. EIC 173 is
applied retrospectively, without restatement of prior years, to all financial assets and
liabilities measured at fair value in the interim and annual financial statements for
periods ending on or after January 20, 2009. The adoption of EIC 173 did not have an
impact on the consolidated financial statements of the Company. |
|
|
|
|
Financial instruments Disclosures |
|
|
|
|
In June 2009, the AcSB issued amendments to CICA Handbook Section 3862, Financial
Instruments Disclosures, in order to align with International Financial Reporting
Standard IFRS 7, Financial Instruments: Disclosures. This Section has been amended to
include additional disclosure requirements about fair value measurements of financial
instruments and to enhance liquidity risk disclosure. The amendments establish a three-tier
fair value hierarchy, which prioritizes the inputs used in measuring fair value. These
tiers include: Level 1, defined as observable inputs such as quoted prices in active
markets; Level 2, defined as inputs other than quoted prices in active markets that are
either directly or indirectly observable; and Level 3, defined as unobservable inputs in
which little or no market data exists, therefore requiring an entity to develop its own
assumptions. The amendments apply to annual financial statements relating to fiscal years
ended after September 30, 2009 and are applicable to the Company as at November 30, 2009.
The amended section relates to disclosure only and did not impact the financial results of
the Company. |
|
|
(b) |
|
Future accounting changes: |
|
|
|
|
Business Combinations, consolidated financial statements and non-controlling
interests |
|
|
|
|
The CICA issued three new accounting standards in January 2009: Section 1582, Business
Combinations, Section 1601, Consolidated Financial Statements, and Section 1602,
Non-controlling Interests. The Company is in the process of evaluating the requirements of
the new standards. |
8
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended November 30, 2009 and 2008
(in thousands of dollars, except per share amounts)
2. |
|
New accounting policies (continued): |
|
(b) |
|
Future accounting changes (continued): |
|
|
|
|
Business Combinations, consolidated financial statements and non-controlling interests
(continued) |
|
|
|
|
Section 1582 establishes standards for the accounting for a business combination. It
provides the Canadian equivalent to International Financial Reporting Standard IFRS 3 -
Business Combinations. The section applies prospectively to business combinations for which
the acquisition date is on or after the beginning of the first annual reporting period
beginning on or after January 1, 2011 and early application is permitted. |
|
|
|
|
Section 1601 establishes standards for the preparation of consolidated financial
statements. Section 1602 establishes standards for accounting for a non-controlling
interest in a subsidiary in consolidated financial statements. It is equivalent to the
corresponding provisions of International Financial Reporting Standard IAS 27 Consolidated and Separate Financial Statements, Sections 1601 and 1602, and applies to
interim and annual consolidated financial statements relating to fiscal years beginning on
or after January 1, 2011 and early application is permitted. |
|
|
|
|
International Financial Reporting Standards |
|
|
|
|
In February 2008, Canadas AcSB confirmed that Canadian generally accepted accounting
principles, as used by publicly accountable enterprises, will be fully converged into IFRS,
as issued by the International Accounting Standards Board (IASB). The changeover date is
for interim and annual financial statements relating to fiscal years beginning on or after
January 1, 2011. As a result, the Company will be required to report under IFRS for its
2012 interim and annual financial statements. The Company will convert to these new
standards according to the timetable set within these new rules. The Company will
determine at a future date the impact of adopting the standards on its consolidated
financial statements. |
9
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended November 30, 2009 and 2008
(in thousands of dollars, except per share amounts)
3. |
|
Capital stock: |
|
|
|
Under the terms of the agreement with EMD Serono Inc. (EMD Serono), the Company issued
2,179,837 common shares for a cash consideration of $9,854 (see note 6). |
|
|
|
In 2009, the Company received subscriptions in the amount of $96 for the issue of 34,466 common
shares in connection with its share purchase plan. |
|
(a) |
|
Stock option plan: |
|
|
|
|
Changes in outstanding options granted under the Companys stock option plan for the years
ended November 30, 2009 and 2008 were as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
Number |
|
|
exercise price |
|
|
Options as at November 30, 2007 |
|
|
2,207,633 |
|
|
$ |
6.32 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
111,000 |
|
|
|
7.98 |
|
Exercised |
|
|
(119,666 |
) |
|
|
3.32 |
|
Cancelled |
|
|
(37,167 |
) |
|
|
9.57 |
|
|
|
|
|
|
|
|
|
|
|
Options as at November 30, 2008 |
|
|
2,161,800 |
|
|
|
6.52 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
680,500 |
|
|
|
1.83 |
|
Cancelled and expired |
|
|
(176,500 |
) |
|
|
8.34 |
|
|
|
|
|
|
|
|
|
|
|
Options as at November 30, 2009 |
|
|
2,665,800 |
|
|
$ |
5.20 |
|
|
|
(b) |
|
Stock-based compensation and other stock-based payments: |
|
|
|
|
The estimated fair value of the options granted was estimated at the date of grant using
the Black-Scholes option pricing model with the following weighted average assumptions: |
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
Risk-free interest rate |
|
|
1.83 |
% |
|
|
3.36 |
% |
Volatility |
|
|
79.5 |
% |
|
|
70.4 |
% |
Average option life in years |
|
|
6 |
|
|
|
6 |
|
Dividend yield |
|
Nil |
|
|
Nil |
|
|
10
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended November 30, 2009 and 2008
(in thousands of dollars, except per share amounts)
3. |
|
Capital stock (continued): |
|
(b) |
|
Stock-based compensation and other stock-based payments (continued): |
|
|
|
|
The risk-free interest rate is based on the implied yield on a Canadian Treasury
zero-coupon issue with a remaining term equal to the expected term of the option. The
volatility is based solely on historical volatility equal to the expected average life of
the option. The average life of the options is estimated considering the vesting period,
the term of the option and the average length of time similar grants have remained
outstanding in the past. Dividend yield was excluded from the calculation, since it is the
present policy of the Company to retain all earnings to finance operations and future
growth. |
|
|
|
|
The following table summarizes the weighted average fair value of stock options granted
during the periods ended November 30, 2009 and 2008: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average |
|
|
|
Number |
|
|
grant date |
|
|
|
of options |
|
|
fair value |
|
|
2009 |
|
|
680,500 |
|
|
$ |
1.26 |
|
2008 |
|
|
111,000 |
|
|
$ |
5.16 |
|
|
|
(c) |
|
Diluted loss per share: |
|
|
|
|
Diluted loss per share was not presented as the effect of options ongoing would have been
anti-dilutive. All options outstanding at the end of the year could potentially dilute the
basic earnings per share in the future. |
11
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended November 30, 2009 and 2008
(in thousands of dollars, except per share amounts)
4. |
|
Supplemental information: |
|
(a) |
|
Statement of cash flows: |
|
|
|
|
The following transactions were conducted by the Company and did not impact cash flows: |
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
(Restated - |
|
|
|
|
|
|
|
note 2 (a)) |
|
|
Additions to property and equipment included in
accounts payable and accrued liabilities |
|
$ |
183 |
|
|
$ |
48 |
|
Share issue costs included in accounts
payable and accrued liabilities |
|
|
|
|
|
|
8 |
|
|
|
(b) |
|
In 2009, the Company has reclassified in net earnings $129 of realized gains on
available-for-sale financial assets previously recorded in accumulated other comprehensive
income. |
|
|
|
|
In 2008, the Company has reclassified in net earnings $572 of realized losses on
available-for-sale financial assets previously recorded in accumulated other comprehensive
income. The realized loss includes an impairment loss of $578 related to a decline in
value that is other than temporary for stock options held in a public company. |
|
|
|
|
On November 30, 2008, the accumulated other comprehensive loss was composed of unrealized
gains on available-for-sale financial assets of $1,282 (gain of $372 on November 30, 2008). |
|
|
(c) |
|
The Company received tax credits of $1,912 in 2009 ($1,746 in 2008). |
|
|
(d) |
|
The following items were included in the determination of the Companys net loss: |
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
(Restated - |
|
|
|
|
|
|
|
note 2 (a)) |
|
|
Amortization of property and equipment |
|
$ |
612 |
|
|
$ |
625 |
|
Amortization and write-off of other assets |
|
|
|
|
|
|
4,957 |
|
Stock-based compensation |
|
|
899 |
|
|
|
859 |
|
|
12
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended November 30, 2009 and 2008
(in thousands of dollars, except per share amounts)
5. |
|
Financial instruments: |
|
(a) |
|
Carrying value and fair value: |
|
|
|
|
The Company has determined that the carrying values of its short-term financial assets and
liabilities, including cash, accounts receivable, as well as accounts payable and accrued
liabilities, approximate their fair value because of the relatively short period to
maturity of the instruments. |
|
|
|
|
Bonds and investments in public companies are stated at estimated fair value, determined by
inputs that are directly observable (Level 2 inputs). |
|
|
(b) |
|
Interest income and expenses: |
|
|
|
|
Interest income consists of interest earned on cash and bonds. |
|
|
(c) |
|
Loss on exchange: |
|
|
|
|
General and administrative expenses include a loss on foreign exchange of $635 (loss of
$247 in 2008) for the year ended November 30, 2009. |
6. |
|
Collaboration and licensing agreement: |
|
|
|
On October 28, 2008, the Company entered into a collaboration and licensing agreement with EMD
Serono, an affiliate of Merck KGaA, regarding the exclusive commercialization rights of
tesamorelin in the United States for the treatment of excess abdominal fat in HIV infected
patients with lipodystrophy (the Initial Product). Theratechnologies retains all tesamorelin
commercialization rights outside of the US. |
|
|
|
Under the terms of the agreement, the Company is responsible for the development of the Initial
Product up to obtaining marketing approval in the United States. The Company is also
responsible for product production and for the development of a new formulation of the Initial
Product. EMD Serono is responsible for conducting product commercialization activities. |
|
|
|
At the closing of the agreement, on December 15, 2008, the Company received US$30,000
(CAD$36,951), which includes an initial payment of US$22,000 (CAD$27,097) and US$8,000
(CAD$9,854) as a subscription for common shares in the Company by Merck KGaA at a price of
US$3.67 (CAD$4.52) per share. The Company may receive up to US$215,000, which amount includes
the initial payment of US$22,000, the equity investment of US$8,000, as well as payments based
on the achievement of certain development, regulatory and sales milestones. The Company will
also be entitled to receive escalating royalties on annual net sales of tesamorelin in the US. |
13
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended November 30, 2009 and 2008
(in thousands of dollars, except per share amounts)
6. |
|
Collaboration and licensing agreement (continued): |
|
|
|
The initial payment of $27,097 has been deferred and is being amortized over its estimated
service period on a straight-line basis. This period may be modified in the future based on
additional information that may be received by the Company. For the year ended November 30,
2009, an amount of $6,560 related to this transaction was recognized as revenue. At November
30, 2009, the deferred revenues related to this transaction amounted to $20,537. |
|
|
|
On August 12, 2009, the US Food and Drug Administration accepted the New Drug Application
(NDA) made by the Company for tesamorelin. Under the terms of the Companys collaboration and
licensing agreement with EMD Serono, the acceptance of the tesamorelin NDA resulted in a
milestone payment of US$10,000 (CAD$10,884). This milestone payment has been recorded in the
third quarter of 2009. |
|
|
|
The Company may conduct research and development for additional indications. EMD Serono will
have the option to commercialize additional indications for tesamorelin in the US. If it
exercises this option, EMD Serono will pay half of the development costs related to such
additional indications. In such cases, the Company will also have the right, subject to EMD
Seronos agreement, to participate in the promotion of the additional indications. |
|
7. |
|
Commitments: |
|
(a) |
|
Rental of premises: |
|
|
|
|
The Company rents premises under an operating lease (the Lease) expiring in April 2010.
The Lease was renewed by the Company and the lessor during the 2009 financial year for a
period of 11 years ending April 30, 2021. Under the terms of the Lease, the Company has
also been granted two renewal options for periods of five years each. The minimum payments
required under the terms of the Lease are as follows: |
|
|
|
|
|
2010 |
|
$ |
340 |
|
2011 |
|
|
55 |
|
2012 |
|
|
655 |
|
2013 |
|
|
655 |
|
2014 |
|
|
655 |
|
2015 |
|
|
273 |
|
Thereafter |
|
|
3,943 |
|
|
|
|
|
$ |
6,576 |
|
|
14
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended November 30, 2009 and 2008
(in thousands of dollars, except per share amounts)
7. |
|
Commitments (continued): |
|
(a) |
|
Rental of premises (continued): |
|
|
|
|
The Company has committed to pay the lessor for its share of some operating expenses of the
leased premises. This amount has been set at $240 for the year beginning May 1, 2010 and
will be increased by 2.5% annually for the duration of the Lease. |
|
|
|
|
The lessor will provide the Company an amount of $728 to allow it to undertake leasehold
improvements. |
|
|
|
|
The Company has issued an irrevocable letter of credit in favour of the lessor in the
amount of $323 which will be cancelled April 30, 2010 under the terms of the Lease renewal,
along with a first rank movable mortgage in the amount of $1,150 covering all the Companys
tangible assets located in the rented premises. This mortgage, however, can be subordinated
to those of lending institutions. |
|
|
(b) |
|
Long-term supply agreements: |
|
|
|
|
During and after the year ended November 30, 2009, the Company entered into long-term
supply agreements with third parties in anticipation of the commercialization of
tesamorelin. Certain of these agreements stipulate an obligation to purchase minimum
quantities of products in certain circumstances. |
|
|
(c) |
|
Credit facility: |
|
|
|
|
The Company has a credit facility available in the amount of $1,800, bearing interest at
prime plus 0.5% and secured by bonds. Under the credit facility, the market value of
investments held must always be equivalent to 150% of amounts drawn under the facility. If
the market value falls below $7,000, the Company will provide the bank with a first rank
movable hypothec of $1,850 on securities judged satisfactory by the bank. |
|
|
|
|
As at November 30, 2009 and 2008, with the exception of the letter of credit mentioned in
(a) above, the credit facility available to the Company was not utilized. |
15
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended November 30, 2009 and 2008
(in thousands of dollars, except per share amounts)
|
(a) |
|
On February 10, 2010, the Companys Board of Directors has adopted a shareholder
rights plan (the Plan), effective as of such date. The Plan is designed to provide
adequate time for the Board of Directors and the shareholders to assess an unsolicited
takeover bid for the Company, to provide the Board of Directors with sufficient time to
explore and develop alternatives for maximizing shareholder value, if a takeover bid is
made, and to provide shareholders with an equal opportunity to participate in a takeover
bid and receive full and fair value for their common shares (the Common Shares). |
|
|
|
|
The Plan, if approved by the shareholders, will expire at the close of the Companys annual
meeting of shareholders in 2013. |
|
|
|
|
The rights issued under the Plan will initially attach to and trade with the Common Shares
and no separate certificates will be issued unless an event triggering these rights occurs.
The rights will become exercisable only when a person, including any party related to it,
acquires or attempts to acquire 20 percent or more of the outstanding Common Shares without
complying with the ''Permitted Bid provisions of the Plan or without approval of the
Board of Directors. Should such an acquisition occur or be announced, each right would,
upon exercise, entitle a rights holder, other than the acquiring person and related
persons, to purchase Common shares at a 50 percent discount to the market price at the
time. |
|
|
|
|
Under the Plan, a Permitted Bid is a bid made to all holders of the Common Shares and which
is open for acceptance for not less than 60 days. If, at the end of 60 days at least 50
percent of the outstanding Common Shares, other than those owned by the offeror and certain
related parties, have been tendered, the offeror may take up and pay for the Common Shares
but must extend the bid for a further 10 days to allow other shareholders to tender. |
|
|
(b) |
|
On December 8, 2009, the Company granted 265,000 options at an exercise price of
$3.84 per share and cancelled 19,167 options at a weighted exercise price of $2.38 per
share in connection with its stock option plan. |
9. |
|
Comparative figures: |
|
|
|
Certain of the 2008 comparative figures have been reclassified to conform with the financial
statement presentation adopted in 2009. |
16
ex-99.26
Exhibit 99.26
NOTICE OF ANNUAL AND SPECIAL MEETING OF SHAREHOLDERS
To the shareholders of Theratechnologies Inc. (the Corporation):
NOTICE IS HEREBY GIVEN that an annual and special meeting of shareholders (the Meeting) of the
Corporation will be held at the Sheraton Montreal Center, 1201 René-Lévesque Blvd. West, Montreal,
Québec, on Wednesday, May 18, 2011 at 10:00 a.m., local time, for the following purposes:
|
(1) |
|
to receive the consolidated financial statements for the fiscal year ended November 30, 2010,
as well as the auditors report thereon; |
|
|
(2) |
|
to elect directors for the ensuing year; |
|
|
(3) |
|
to appoint auditors for the ensuing year and authorize the directors to set their
compensation; |
|
|
(4) |
|
to consider, and if deemed advisable, to pass a special resolution (the text of which is
attached as Appendix A to the accompanying Management Proxy Circular), with or without
amendments, amendmending the articles of the Corporation to add a provision entitling the
directors to appoint one or more additional directors, the whole as described in the
accompanying Management Proxy Circular; and |
|
|
(5) |
|
to transact such other business as may properly come before the Meeting. |
DATED at Montreal, Québec, Canada, April 14, 2011.
|
|
|
|
|
BY ORDER OF THE BOARD OF DIRECTORS |
|
|
|
|
|
|
|
|
|
|
|
Jocelyn Lafond |
|
|
Corporate Secretary |
ex-99.27
Exhibit 99.27
|
|
|
THERATECHNOLOGIES INC.
|
|
9th Floor, 100 University Avenue
Toronto, Ontario M5J 2Y1
www.computershare.com
|
Security Class
Holder Account Number
Form of Proxy Annual and Special Meeting of Shareholders to be held on May 18, 2011
This Form of Proxy is solicited by and on behalf of Management.
Notes to proxy
1. |
|
Every holder has the right to appoint some other person or company
of their choice, who need not be a holder, to attend and act on
their behalf at the meeting, or at any adjournment thereof. If you
wish to appoint a person or company other than the persons whose
names are printed herein, please insert the name of your chosen
proxyholder in the space provided (see reverse). |
|
2. |
|
If the securities are registered in the name of more than one owner (for
example, joint ownership, trustees, executors, etc.), then all those
registered should sign this proxy. If you are voting on behalf of a
corporation or another individual you may be required to provide documentation
evidencing your power to sign this proxy with signing capacity stated. |
|
3. |
|
This proxy should be signed in the exact manner as the name appears on the proxy. |
|
4. |
|
If this proxy is not dated, it will be deemed to bear the date on which it is mailed by
Management to the holder. |
|
5. |
|
The securities represented by this proxy will be voted as directed by
the holder; however, if such a direction is not made in respect of any
matter, this proxy will be voted as recommended by Management. |
|
6. |
|
The securities represented by this proxy will be voted or withheld from
voting, in accordance with the instructions of the holder, on any ballot
that may be called for and, if the holder has specified a choice with
respect to any matter to be acted on, the securities will be voted
accordingly. |
|
|
|
|
|
7.
|
|
This proxy confers discretionary authority in respect of amendments to matters identified in
the Notice of Meeting or other matters that may properly come before the meeting.
|
|
Fold |
8. |
|
This proxy should be read in conjunction with the accompanying documentation provided by
Management. |
Proxies submitted must be received prior to 5:00 p.m., Eastern Time, on May 16, 2011.
VOTE USING THE TELEPHONE OR INTERNET 24 HOURS A DAY 7 DAYS A WEEK!
|
|
|
|
|
|
Call the number listed BELOW from a touch
|
|
Go to the following web site: |
tone telephone.
|
|
www.investorvote.com |
|
1-866-732-VOTE (8683) Toll Free |
|
|
If you vote by telephone or the Internet, DO NOT mail back this proxy.
Voting by mail may be the only method for securities held in the name of a corporation or
securities being voted on behalf of another individual.
Voting by mail or by Internet are the only methods by which a holder may appoint a
person as proxyholder other than the Management nominees named on the reverse of this
proxy. Instead of mailing this proxy, you may choose one of the two voting methods
outlined above to vote this proxy.
To vote by telephone or the Internet, you will need to provide your CONTROL NUMBER listed below.
CONTROL NUMBER
|
|
|
|
|
|
|
Appointment of Proxyholder |
|
|
|
|
|
|
|
The undersigned shareholder of
Theratechnologies Inc. (the
Corporation) hereby appoints:
Paul Pommier, Chairman of the
Board, or failing him, John-Michel
Huss, President and Chief
Executive Officer
|
|
OR
|
|
Print the name of the person
you are appointing if this
person is someone other than
the Management Nominees
listed herein.
|
|
|
as my proxyholder to attend and act for and on my behalf at the Annual
and Special Meeting of Shareholders of the Corporation to be held at the
Sheraton Montreal, 1201 Boulevard René-Levesque West, Montreal, Québec, on
Wednesday, May 18, 2011 at 10:00 a.m., (the Meeting), and at any
adjournment thereof, with full power of substitution and with all the powers
which the undersigned could exercice with respect to his/her common shares if
personnally present at the Meeting. The shares are to be voted, on any
ballot, in accordance with the instructions given below:
VOTING RECOMMENDATIONS BY MANAGEMENT ARE INDICATED BY HIGHLIGHTED TEXT OVER THE BOXES.
|
|
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|
For
|
|
Withhold |
|
|
|
|
|
|
|
|
|
|
|
1. Election of Directors |
|
|
|
c |
|
c |
|
|
|
|
|
|
|
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|
|
Vote FOR or WITHHOLD from voting with respect to the election of directors. |
|
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|
|
|
|
|
Fold |
|
|
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|
For
|
|
Withhold |
|
|
|
|
|
|
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|
|
|
|
2. Appointment of Auditors |
|
|
|
c |
|
c |
|
|
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|
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|
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|
Vote FOR or WITHHOLD from voting with respect to the appointment of auditors.
|
|
|
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|
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For
|
|
Against
|
|
Withhold |
|
|
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|
|
3. Resolution 2011-1 Approving the Amendments to the Articles of the Corporation |
|
c |
|
c |
|
c |
|
|
|
|
|
|
|
|
|
|
|
Vote FOR, AGAINST or WITHHOLD from voting with respect to resolution 2011-1. |
|
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|
Fold |
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Authorized Signature(s) - This section must be completed for your instructions to be executed.
|
|
Signature(s)
|
|
Date |
|
I authorize you to act in accordance with my instructions set out above. I hereby revoke any
proxy previously given with respect to the Meeting. If no voting instructions are indicated above,
this Proxy will be voted as recommended by Management.
|
|
|
|
DD/MM/YY |
|
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|
|
|
|
|
Interim Financial Statements - Mark
this box if you would like to
receive Interim Financial Statements
and accompanying Managements
Discussion and Analysis by mail.
|
|
o
|
|
Annual Report - Mark this box if you
would like to receive the Annual
Report and accompanying Managements
Discussion and Analysis by mail.
|
|
o |
If you are not mailing back your proxy, you may register online to receive the above financial
report(s) by mail at www.computershare.com/mailinglist.
ex-99.28
Exhibit 99.28
NOTICE OF ANNUAL AND SPECIAL MEETING
OF SHAREHOLDERS TO BE HELD ON
WEDNESDAY, MAY 18, 2011
AND
MANAGEMENT PROXY CIRCULAR
APRIL 14, 2011
NOTICE OF ANNUAL AND SPECIAL MEETING OF SHAREHOLDERS
To the shareholders of Theratechnologies Inc. (the Corporation):
NOTICE IS HEREBY GIVEN that an annual and special meeting of shareholders (the Meeting) of the
Corporation will be held at the Sheraton Montreal Center, 1201 René-Lévesque Blvd. West, Montreal,
Québec, on Wednesday, May 18, 2011 at 10:00 a.m., local time, for the following purposes:
|
(1) |
|
to receive the consolidated financial statements for the fiscal year ended November 30, 2010,
as well as the auditors report thereon; |
|
|
(2) |
|
to elect directors for the ensuing year; |
|
|
(3) |
|
to appoint auditors for the ensuing year and authorize the directors to set their compensation; |
|
|
(4) |
|
to consider, and if deemed advisable, to pass a special resolution (the text of which is
attached as Appendix A to the accompanying Management Proxy Circular), with or without amendments,
amendmending the articles of the Corporation to add a provision entitling the directors to appoint
one or more additional directors, the whole as described in the accompanying Management Proxy
Circular; and |
|
|
(5) |
|
to transact such other business as may properly come before the Meeting. |
DATED at Montreal, Québec, Canada, April 14, 2011.
BY ORDER OF THE BOARD OF DIRECTORS
Jocelyn Lafond
Corporate Secretary
MANAGEMENT PROXY CIRCULAR
The information contained in this management proxy circular (the Circular) is given as at April
14, 2011, except as otherwise noted. All dollar amounts set forth herein are expressed in Canadian
dollars and the symbol $ refers to the Canadian dollar, unless otherwise indicated.
TABLE OF CONTENTS
|
|
|
|
|
ITEM I. INFORMATION RELATING TO THE ANNUAL AND SPECIAL MEETING |
|
|
1 |
|
1. Voting |
|
|
1 |
|
A. By Proxy |
|
|
1 |
|
B. In Person |
|
|
2 |
|
C. Voting Securities and Principal Holders |
|
|
2 |
|
2. Subjects To Be Treated at the Meeting |
|
|
3 |
|
A. Receipt of Financial Statements |
|
|
3 |
|
B. Election of Directors |
|
|
3 |
|
C. Appointment of Auditors |
|
|
6 |
|
D. Amendment to the Articles of the Corporation |
|
|
7 |
|
E. Other Matters to be Acted Upon |
|
|
7 |
|
ITEM II. COMPENSATION |
|
|
9 |
|
1. Executive Compensation |
|
|
9 |
|
A. Compensation Discussion & Analysis |
|
|
9 |
|
B. Summary Compensation Table |
|
|
15 |
|
C. Incentive Plan Awards |
|
|
18 |
|
D. Termination and Change of Control Provisions |
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|
21 |
|
E. Performance Graph |
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|
25 |
|
F. Other Information |
|
|
26 |
|
2. Director Compensation |
|
|
27 |
|
A. Determination of Director Compensation |
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27 |
|
B. Director Compensation Table |
|
|
28 |
|
C. Incentive Plan Awards |
|
|
29 |
|
D. Other Information |
|
|
31 |
|
ITEM III. CORPORATE GOVERNANCE DISCLOSURE |
|
|
32 |
|
1. Board of Directors |
|
|
32 |
|
A. Independence |
|
|
32 |
|
B. Meetings of the Board |
|
|
32 |
|
C. Other Board Memberships |
|
|
33 |
|
2. Mandate of the Board of Directors |
|
|
33 |
|
3. Position Descriptions |
|
|
33 |
|
4. Orientation and Continuing Education |
|
|
33 |
|
5. Ethical Business Code of Conduct |
|
|
33 |
|
6. Corporate Governance and Nomination of Directors |
|
|
34 |
|
7. Compensation |
|
|
34 |
|
A. Independence |
|
|
34 |
|
B. Meetings of the Compensation Committee |
|
|
34 |
|
8. Audit Committee |
|
|
35 |
|
A. Independence |
|
|
35 |
|
B. Meetings of the Audit Committee |
|
|
35 |
|
9. Strategic Committee |
|
|
35 |
|
10. Financing Committee |
|
|
36 |
|
ITEM IV. OTHER INFORMATION |
|
|
37 |
|
1. Additional Documentation |
|
|
37 |
|
2. Approval by the Board Of Directors |
|
|
37 |
|
APPENDIX A Resolution 2011-1 Amendment to the articles of the corporation |
|
|
|
|
APPENDIX B Compensation Committee Charter |
|
|
|
|
APPENDIX C Mandate of the Board of Directors |
|
|
|
|
APPENDIX D Director Orientation and Continuing Education Policy |
|
|
|
|
APPENDIX E Nominating and Corporate Governance Committee Charter |
|
|
|
|
ITEM I. INFORMATION RELATING TO THE ANNUAL AND SPECIAL MEETING
1. Voting
You may vote your shares either through a proxy or in person at the annual and special meeting of
shareholders of the Corporation (the Meeting).
A. By Proxy
Solicitation of Proxies
This Circular is provided in connection with the solicitation by the management of
Theratechnologies Inc. (the Corporation or Theratechnologies) of proxies to be used at the
Meeting of the Corporation to be held on Wednesday, May 18, 2011, at the time, place and for the
purposes set forth in the attached Notice of Annual and Special Meeting of Shareholders (the
Notice of Meeting) and at any continuation of the Meeting after adjournment thereof.
The solicitation of proxies is being primarily made by mail but proxies may also be solicited by
telephone, telecopier or other personal contact by officers or other employees of the Corporation.
The entire cost of the solicitation will be borne by the Corporation.
Terms of Proxy Grant
By completing the enclosed form of proxy, or the one provided by your intermediary, you appoint the
persons proposed in that form to represent your interests and vote your shares on your behalf at
the Meeting. The persons named in the enclosed form of proxy are directors or officers of the
Corporation.
However, you have the right to appoint a person or Corporation other than the ones designated in
the form of proxy to represent you at the Meeting. To do this, you must insert such persons name
in the blank space provided in the form of proxy enclosed hereto or complete
another form of proxy. It is not necessary to be a shareholder of the Corporation in order to act
as a proxy.
If you hold your shares through an intermediary (a stockbroker, a bank, a trust, a trustee, etc.),
you are not a registered shareholder in the registry of shareholders of the Corporation held by
Computershare Trust Company of Canada (Computershare). Therefore, you cannot vote your shares
directly at the Meeting. If this is your situation, you will receive from your intermediary
explanation as to how to appoint proxies and have them vote your shares. To ensure that your
instructions are respected, you must deliver them to your intermediary within the prescribed
deadline. For any questions, please contact your intermediary directly.
Proxy Voting
The persons named or appointed in the form of proxy will, on a show of hands or any ballot that may
be called, vote (or withhold from voting) your shares in respect of which they are appointed as
proxies in accordance with the instructions given in the form of proxy. In the absence of
instructions, the voting rights attached to the shares referred to in your form of proxy will be
exercised FOR the matters mentioned in the attached Notice of Meeting.
Furthermore, the enclosed form of proxy confers upon the proxy holder a discretionary power with
respect to amendments or variations to matters identified in the Notice of Meeting and with respect
to all other matters which may properly come before the Meeting, or any continuation after
adjournment thereof.
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However, to our knowledge, all matters to be brought before the Meeting are mentioned in
appropriate fashion in the Notice of Meeting.
Delivery of Form of Proxy and Deadlines
If you hold your shares personally and are a registered shareholder in the registry of shareholders
of the Corporation, please send the completed form of proxy to the Secretary of the Corporation,
c/o Computershare Trust Company of Canada, 1100 University Street, 12th Floor, Montreal,
Québec H3B 2G7, prior to 5:00 p.m. (Eastern time) on May 16, 2011 (unless you attend the Meeting in
person). All shares represented by proper proxies accompanied by duly completed declarations
received by Computershare at the latest on such date and prior to such time will be voted in
accordance with your instructions as specified in the proxy form on any ballot that may be called
at the Meeting.
If you hold your shares through an intermediary, please proceed as indicated in the documentation
sent by your intermediary and within the deadlines specified therein. For any questions, please
contact your intermediary directly.
Revocation of a Proxy
You may, at any time, including any continuation of the Meeting after adjournment thereof, revoke a
proxy for any business with respect to which said proxy confers a vote that has not already been
cast.
If you hold your shares personally and are a registered shareholder in the registry of shareholders of the Corporation, please send a written notice to revoke a proxy bearing your signature or that
of your proxy (or a representative of your proxy if your proxy is a Corporation) to the Secretary
of the Corporation, c/o Computershare Trust Company of Canada, 1100 University Street,
12th Floor, Montreal, Québec H3B 2G7, prior to 5:00 p.m. (Eastern time) on May 16, 2011.
You may also revoke a proxy in person at the Meeting by making a request to that effect to the
Secretary of the Corporation.
If you hold your shares through an intermediary, please proceed as indicated in the documentation
sent by your intermediary and within the deadlines specified therein. For any questions, please
contact your intermediary directly.
B. In Person
If you hold your shares personally and are a registered shareholder in the registry of shareholders of the Corporation, you may present yourself on the date, at the time and place set forth in the
Notice of Meeting and register with the representatives of Computershare who will be at the
Meeting. You should then follow voting instructions given by the Chairman of the Meeting.
If you hold your shares through an intermediary and you wish to vote your shares in person at the
Meeting, please proceed as indicated in the documentation sent by your intermediary. For any
questions, please contact your intermediary directly.
C. Voting Securities and Principal Holders
As at April 13, 2011, there were 60,799,932 common shares (the Common Shares)
of the Corporation issued and outstanding. The Common Shares are the only securities with respect
to which a voting right may be exercised at the Meeting. Each Common Share entitles its holder to
one vote with respect to the matters voted on at the Meeting.
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Holders of Common Shares whose names are registered on the lists of shareholders of the
Corporation as at 5:00 p.m. (Eastern time) on April 13, 2011, being the date fixed by the
Corporation for determination of the registered holders of Common Shares who are entitled to
receive notice of the Meeting (the Record Date), will be entitled to exercise their voting rights
attached to the Common Shares in respect of which they are so registered at the Meeting, or any
continuation after adjournment thereof, if present or represented by proxy thereat. However, even
if you have acquired Common Shares after the Record Date, you will be entitled to vote at the
Meeting if, at least twenty-four (24) hours prior to the Meeting, you produce certificates for such
Common Shares properly endorsed by the seller, or if you otherwise establish that you own such
Common Shares and have requested that your name be included on the list of shareholders entitled to
receive the Notice of Meeting.
To our knowledge, no person beneficially owns, or controls or directs control, directly or
indirectly, over more than ten percent (10%) of the outstanding Common Shares of the Corporation,
other than Stewardship Partners Investment Counsel Inc. who, based exclusively on a report filed on
the Canadian System for Electronic Document Analysis and Retrieval (SEDAR) on July 7, 2010, holds
approximately 10.1%.
2. Subjects To Be Treated at the Meeting
Please find below a description of the items listed in the Notice of Meeting.
A. Receipt of Financial Statements
The consolidated financial statements for the fiscal year ended November 30, 2010 together with the
auditors report thereon will be presented at the Meeting. The financial statements are included in
the Corporations 2010 annual report, which has been mailed to you if you requested it, along with
this Circular. The financial statements are also available on SEDAR at www.sedar.com. No vote is
required on this matter.
B. Election of Directors
The shareholders at the Meeting will elect the directors of the Corporation for the coming year.
Composition of the Board of Directors
The articles of the Corporation provide that the board of directors of the Corporation (the Board
of Directors) must consist of a minimum of three (3) and a maximum of twenty (20) directors. The
Board of Directors is currently composed of nine (9) directors and shareholders are asked to elect
nine (9) directors for the coming years.
On November 30, 2010, the former President and Chief Executive Officer of the Corporation resigned
as a director and was replaced by John-Michel Huss, the current President and Chief Executive
Officer, who became a director on December 2, 2010.
Nominees
All of the nominees for the director positions of the Corporation are elected for a one year term
ending at the next annual meeting of shareholders or when his successor is elected, unless he
resigns or the position becomes vacant as a result of death, dismissal or otherwise, prior to the
said meeting. We do not contemplate that any of the nominees will be unable to fulfill his mandate
as director. Unless instructions are given to abstain from voting with regard to the election of
directors, the persons whose names
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appear on the enclosed form of proxy will vote FOR the election of the nominees whose names
are set out in the table below.
Although shareholders are asked to vote on a slate of directors at the Meeting, the Nominating and
Corporate Governance Committee has undertaken a review of its governance policies, which include
the election mode of its directors at shareholders meetings. See Corporate Governance and
Nomination of Directors below.
The following table states the names of all persons proposed for election as directors, their
province or state and country of residence, their principal occupation, the position held in the
Corporation (if any), the year in which they first became directors of the Corporation and the
number of Common Shares they own, directly or indirectly, or over which they exercise control or
direction. To obtain additional information regarding the biographical notes of the nominees,
shareholders can consult Item 4.1 of the Corporations 2010 annual information form dated February
22, 2011 available on SEDAR at www.sedar.com.
The information relating to the number of Common Shares held by the nominees in the table below is
at the date of this Circular and is based exclusively on reports filed on the Canadian System for
Electronic Disclosure by Insiders as at that date. The information appearing under Cease Trade
Orders, Bankruptcies, Penalties or Sanctions is based on the statements made by the nominees.
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Indirectly, |
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of |
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or Over Which |
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Deferred |
Name, Province or State |
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Director |
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Control or |
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Share |
and Country of Residence |
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Principal Occupation |
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Since |
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Direction is Exercised |
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Units |
Paul Pommier(1) (2) (3) (4) (5)
Québec, Canada |
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Chairman of the Board of the Corporation |
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1997 |
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190,100 |
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20,998 |
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Gilles Cloutier(3) (5) |
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Corporate Director |
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2003 |
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71,000 |
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3,000 |
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North Carolina,
United States |
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A. Jean de Grandpré(2) (3) (4) (5) |
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Corporate Director |
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1993 |
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200,000 |
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5,250 |
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Québec, Canada |
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Robert G. Goyer(3) |
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Emeritus Professor Faculty of |
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2005 |
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10,000 |
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5,250 |
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Québec, Canada |
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Pharmacy Université de Montreal |
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John-Michel Huss(4)
Québec, Canada |
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President and Chief Executive
Officer of the Corporation |
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2010 |
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44,248 |
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Gérald A. Lacoste(1) (3) (5) |
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Corporate Director |
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2006 |
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11,000 |
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5,250 |
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Québec, Canada |
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Bernard Reculeau(2) |
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Corporate Director |
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2005 |
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18,100 |
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3,000 |
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Paris, France |
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Jean-Denis Talon(1) (2)(4) Québec, Canada |
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Chairman of the Board AXA Canada (Insurance Corporation) |
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2001 |
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65,000 |
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3,000 |
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Luc Tanguay(4)
Québec, Canada |
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Senior Executive Vice President
and Chief Financial Officer of the Corporation |
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1993 |
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83,000 |
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27,572 |
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(1) |
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Member of the Audit Committee |
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(2) |
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Member of the Compensation Committee |
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(3) |
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Member of the Nominating and Corporate Governance
Committee |
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(4) |
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Member of the Financing Committee |
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(5) |
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Member
of the Strategic Committee |
Biographical Note of John-Michel Huss
John-Michel Huss, MBA. President & Chief Executive Officer. John-Michel Huss brings more than 20
years of global experience in the pharmaceutical industry to Theratechnologies. He began his career
at Merck & Co., occupying various sales and marketing positions in the United States and in Europe.
In 1996, he accepted an International Product Manager position at the headquarters of F. Hoffman-La
Roche, in Basel, Switzerland. Mr. Huss joined Sanofi-Synthelabo GmbH in 1999, where he held
positions in Germany and in Canada. He was appointed General Manager of the Swiss subsidiary at
Sanofi in 2007 (Sanofi-Synthelabo merged with Aventis in 2004) and, in 2009, was promoted to the
position of Chief of Staff, Office of the CEO, in Paris.
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Cease Trade Orders, Bankruptcies, Penalties or Sanctions
Except as described below, to the knowledge of management of the Corporation, no nominee (a) is, as
at the date of the Circular, or has been within the ten (10) years before the date of the Circular,
a director or executive officer of any company (including the Corporation) that, while that person
was acting in that capacity, (i) was the subject of a cease trade or similar order or an order that
denied the relevant company access to any exemption under securities legislation, for a period of
more than thirty consecutive days; (ii) was subject to an event that resulted, after the director
or executive officer ceased to be a director or executive officer, in the company being the subject
of a cease trade or similar order or an order that denied the relevant company access to any
exemption under securities legislation, for a period of more than thirty consecutive days; or (iii)
within a year of that person ceasing to act in that capacity, became bankrupt, made a proposal
under any legislation relating to bankruptcy or insolvency or was subject to or instituted any
proceedings, arrangement or compromise with creditors or had a receiver, receiver manager or
trustee appointed to hold its assets; or (b) has, within the ten (10) years before the date of the
Circular, become bankrupt, made a proposal under any legislation relating to bankruptcy or
insolvency, or become subject to or instituted any proceedings, arrangement or compromise with
creditors, or had a receiver, receiver manager or trustee appointed to hold his assets.
Jean-Denis Talon was a member of the board of directors of Toptent Inc. (Toptent) from August 1,
2007 to November 26, 2009. On December 3, 2009, Toptent filed a notice of intention to make a
proposal under the Bankruptcy and Insolvency Act (Canada) (the Bankruptcy Act). Subsequently, on
May 7, 2010, Toptent filed a proposal under the Bankruptcy Act. The proposal was accepted by
Toptents creditors on May 20, 2010.
Luc Tanguay was a member of the board of directors of Ambrilia Biopharma Inc. (Ambrilia) from
August 22, 2006 to March 30, 2010. On July 31, 2009, Ambrilia obtained court protection from its
creditors under the Companies Creditors Arrangement Act (Canada) (the CCAA). The purpose of the
order issued by the court granting Ambrilia protection from its creditors was to provide Ambrilia
and its subsidiaries the opportunity to restructure its affairs. On July 31, 2009, the Toronto
Stock Exchange
(TSX) halted the trading of Ambrilias shares pending its review of Ambrilias meeting the
requirements for continuous listing. On January 31, 2011, the TSX decided to delist the common
shares of Ambrilia at the close of market on March 4, 2011 for failure to meet the continued
listing requirements of the TSX. The common shares remain suspended from trading. On April 8, 2011,
Ambrilia announced that it would seek permission to terminate the protection granted by the
Superior Court pursuant to the CCAA and, upon permission of the Court, it would file for bankruptcy
pursuant to the Bankruptcy Act.
C. Appointment of Auditors
The Corporations auditors for the current fiscal year must be elected at the Meeting. We propose
the appointment of KPMG LLP, chartered accountants from Montreal, who have been the Corporations
auditors since October 19, 1993. They will hold office until the next annual meeting of
shareholders or until their successors are appointed.
The table below sets forth the fees paid to the auditors of the Corporation for the financial years
ended November 30, 2010 and November 30, 2009.
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Financial Year Ended |
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Financial Year Ended |
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November 30, 2010 |
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November 30, 2009 |
Audit Fees(1) |
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$ |
122,000 |
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$ |
80,000 |
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Audit-Related Fees (1) |
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$ |
158,025 |
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$ |
17,500 |
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Tax Fees (2) |
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$ |
56,600 |
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$ |
39,626 |
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All Other Fees |
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(1) |
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Audit-related fees relate principally to services rendered in connection with the
Corporations financial statements and for the financial year ended November 30, 2010, audit fees
paid to KPMG also included fees related to services rendered in connection with the audit of IFRS
adjustments and the translation of the financial statements to IFRS standards. |
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(2) |
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Tax fees relate to services rendered in connection with the preparation of corporate tax
returns and general tax advice. |
Unless instructions are given to abstain from voting with regard to the appointment of the
auditors, the persons whose names appear on the enclosed form of proxy will vote FOR the
appointment of KPMG LLP, chartered accountants, as auditors of the Corporation, and to authorize
that compensation for their services be determined by the Board of Directors.
D. Amendment to the Articles of the Corporation
On February 14, 2011, the Business Corporation Act (Québec) (the Business Act) came into force
and replaced the Companies Act (Québec). The Corporation is now governed by the Business Act. The
Business Act provides that if the articles of a corporation so provide, the board of directors of a
corporation may appoint one or more additional directors until the next annual shareholders
meeting. The Business Act provides that the number of directors may not exceed one third of the
number of directors elected at the previous annual shareholders meeting.
The current articles of the Corporation do not contain a provision allowing the Board of Directors
to appoint new directors.
Recommendation of the Board of Directors
At the Meeting, shareholders will be asked to consider and, if deemed advisable, to approve the
amendment to the articles of the Corporation by passing Resolution 2011-1, substantially in the
form of the resolution attached as Appendix A to this Circular. Resolution 2011-1 must be passed by
two-thirds of the votes cast by shareholders entitled to vote who are represented in person or by
proxy at the Meeting and who vote in respect of that resolution.
In the context of the approval by the Food and Drug Administration of the United States of the
Corporations first product, EGRIFTA®, and the current review by the Nominating and
Corporate Governance Committee of its governance practices and the succession plan for the Board of
Directors, the Board of Directors considers the approval of the proposed amendments to the articles
of the Corporation to be appropriate and in the best interests of the Corporation. The Board of
Directors recommends that shareholders vote for Resolution 2011-1.
Unless instructions are given to vote against, or abstain from voting on, Resolution 2011-1, the
persons whose names appear in the enclosed form of proxy will vote FOR the passing of Resolution
2011-1.
E. Other Matters to be Acted Upon
The Corporation will consider and transact such other business as may properly come before the
Meeting or any adjournment thereof. Management of the Corporation knows of no other matters to come
before the
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Meeting other than those referred to in the Notice of Meeting. Should any other matters
properly come before the Meeting, the Common Shares represented by the proxy solicited hereby will
be voted on such matter in accordance with the best judgment of the persons voting the proxy.
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ITEM II. COMPENSATION
The compensation of the executive officers and directors of the Corporation is determined by the
compensation committee of the Corporation (the Compensation Committee). The Compensation
Committee is composed of four (4) independent directors, namely A. Jean de Grandpré, who was the
chair of the Compensation Committee until December 31, 2010, Paul Pommier, Bernard Reculeau and
Jean-Denis Talon (who has been acting as chair since January 2011). The mandate, obligations and
duties of the Compensation Committee are described in Appendix B to this Circular. The Compensation
Committee reviews the compensation of directors and executive officers. At a meeting held after the
end of the Corporations financial year, the Compensation Committee reviews the compensation of
executive officers for the last completed financial year and determines the compensation for the
ensuing year.
1. Executive Compensation
A. Compensation Discussion & Analysis
Objectives of the Compensation Program
To achieve its business plan, the Corporation requires a strong and capable executive team. This
justifies the need for an executive program that will attract, retain, motivate and reward its
executive officers. The Corporation is committed to a compensation policy that is competitive and
drives business performance.
What the Compensation Program is Designed to Reward
The compensation program of the Corporation (the Compensation Program) is designed to reward the
executive officers for (i) implementing strategies, both in the short and the long term, to realize
the business plan of the Corporation and (ii) meeting the annual corporate objectives. It is also
designed to enhance its share value and, thereby, create economic value.
The Compensation Program provides reasonable and competitive total executive compensation.
Remuneration and incentive components are established to compete with remuneration practices of
similar companies that are involved in the biopharmaceutical and pharmaceutical industries.
To establish base salary and bonus compensation levels, the Corporation generally studies, among
other things, the competitive market environment and reviews information published in the Rx & D
Compensation Survey and the proxy circulars of other publicly listed biotechnology companies whose
stage of development and market capitalization are similar or more advanced than those of the
Corporation. The Compensation Committee also takes into consideration the financial needs of the
Corporation, its business plan and the Corporations annual corporate objectives before determining
the Corporations own Compensation Program.
At the beginning of the financial year 2010, the Compensation Committee met to determine the base
salary of each executive officer. In order to set the base salary of its executive officers for
that financial year, the Compensation Committee considered publicly available economic data
regarding the variation of the Consumer Price Index and publicly available data regarding
forecasted salary percentage increase for that year. The Compensation Committee also considered the
importance of the objectives to be attained by the executive officers and the Corporation
during that year. No independent third-party report was prepared in the financial year 2010.
However, the Compensation
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Committee used the report prepared for the Corporation by Towers Watson (formerly Towers
Perrin), an independent third-party consulting firm, at the end of the financial year 2009 (the
2009 Report) to set the annual base salary of the executive officers for the financial year 2010.
The 2009 Report contained an annual comparative analysis of the total compensation paid to the
Corporations executive officers against the total compensation paid to executive officers in
various companies. Towers Watsons analysis was based on a reference market of the following 19
companies (the Benchmarked Companies):
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AEterna Zentaris Inc. |
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§ |
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Angiotech Pharmaceuticals Inc. |
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§ |
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AstraZeneca Canada Inc. |
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§ |
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Bayer Inc. |
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§ |
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Beckman Coulter Canada Inc. |
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§ |
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Biogen Idec Canada Inc. |
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§ |
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BioMS Medical Corp. |
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§ |
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Cardiome Pharma Corp. |
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§ |
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Eli Lilly Canada Inc. |
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§ |
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Hoffman La Roche Limited |
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§ |
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Labopharm Inc. |
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§ |
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Life Technologies Corporation |
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§ |
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MDS Inc. |
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§ |
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Methylgene Inc. |
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§ |
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Bellus Health Inc. |
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§ |
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Patheon Inc. |
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§ |
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QLT Inc. |
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§ |
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Sanofi Pasteur Limited |
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Transition Therapeutics Inc. |
Overall, Towers Watsons 2009 Report concluded that the aggregate compensation paid to the Named
Executive Officers (as defined below) of the Corporation was below the median and, in certain
circumstances, at the median of the aggregate compensation paid by the Benchmarked Companies to
individuals holding the same position as those of the Named Executive Officers.
Decision-Making Process
For the financial year ended November 30, 2010, the proposed annual compensation for each of the
executive officers, other than for the President and Chief Executive Officer, was prepared by the
former President and Chief Executive Officer but was presented by the Chairman of the Board to the
Compensation Committee and reviewed by the Compensation Committee. The compensation for the
President and Chief Executive Officer is determined by the Compensation Committee. However, with
the departure of Mr. Yves Rosconi at the end of the financial year ended November 30, 2010, the
compensation of the new President and Chief Executive Officer, Mr. John-Michel Huss, was determined
by the Board of Directors. The Compensation Committee reports and makes a recommendation to the
Board of Directors on the proposed compensation of executive officers. The Board of Directors
approves grants of share options and deferred share units if, upon the recommendation of the
Compensation Committee, it deems it advisable.
Elements of Compensation Program
The major elements of the Corporations executive Compensation Program are base salary, short-term
performance reward program that takes the form of cash bonuses, and long-term
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incentives through the granting of stock options and/or deferred share units. All proposed
changes to any compensation component of an executive officer are first reviewed internally by the
President and Chief Executive Officer and the Senior Executive Vice President and Chief Financial
Officer. The proposed changes are then presented to the Compensation Committee.
Base Salary
Base salaries for each of the executive officers are based on the experience, expertise and
competencies of each executive officer. In reference to the Benchmarked Companies used for
comparison, the salaries of the Named Executive Officers and other executive officers are generally
at the median (50th percentile). However, the Compensation Committee has no firm policy
on setting the base salary at the median and, accordingly, base salaries may be set below or above
the median.
Performance Reward Program
The short-term performance reward program is designed to recognize the contribution of each
executive officer in helping the Corporation to attain its corporate objectives and to increase its
value. Bonuses are granted if the annual corporate objectives are met by the Corporation and in
accordance with an executive officer performance and the results achieved or surpassed by such
executive officer in connection with such corporate objectives. When and if the Corporation
generates significant revenues from the sale of his products, financial criteria may be factored
into the determination of this program.
The target bonus payment for the former President and Chief Executive Officer was set at 50% of his
base salary and the target bonus payment for the Senior Executive Vice President and Chief
Financial Officer is set at 50% of his base salary. For the other three Named Executive Officers,
the target bonus payment is set at 33 1/3% of their respective base salary. Based on the 2009
Report, these target bonus payments were at the 75th percentile when compared against
the Benchmarked Companies, except for the target bonus payment of the former President and Chief
Executive Officer which was at the median.
For the year ended November 30, 2010, the Corporations principal objective was to obtain approval
from the Food and Drug Administration of the United States for the commercialization of tesamorelin
in HIV-infected patients with lipodystrophy. The second corporate objective of the Corporation
consisted in working with our commercial partner in the United States for the preparation of the
commercialization of tesamorelin in such country further to the execution of our collaboration and
licensing agreement with EMD Serono, Inc. The third corporate objective of the Corporation
consisted in expanding the territories where tesamorelin for the treatment of HIV-infected patients
with lipodystophy could be commercialized. Finally, the last objective was to meet each of these
objectives in a cost-efficient manner to conserve the Corporations cash position and to manage its
burn rate.
The objectives of the Named Executive Officers were aligned with those of the Corporation. The
Compensation Committee did not mathematically weigh the objectives of the Corporation against each
other and the objectives of the Named Executive Officers against those of the Corporation in
determining the compensation of the Named Executive Officers for the last financial year. The
Compensation Committee rather considered all objectives with the attainment of the first corporate
objective as being the most important in order to set the compensation of the Named Executive
Officers for the last financial year.
|
|
|
Statement of Compensation
|
|
Page 11 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
Long-Term Incentive Program
During the financial year ended November 30, 2010, the Compensation committee retained the service
of Towers Watson, an independent third-party consulting firm, to assess the long-term incentive
program of the Corporation for its executive officers and directors. Based on their review of
various long-term incentive programs existing in various publicly listed companies, Towers Watsons
report recommended that the long-term incentive program of the Corporation be comprised of a stock
option plan and a deferred share unit plan.
The Corporations long-term incentive program is now composed of a share option plan (the Share
Option Plan) and a deferred share unit plan (the DSU Plan). The Share Option Plan was originally
adopted on December 6, 1993, and subsequently amended from time to time, in order to attract,
retain, motivate employees in key positions and align their interests with those of the
Corporations shareholders by allowing optionees to participate in the increased value of the
Common Shares. See Description of the Share Option Plan below.
The DSU Plan was adopted on December 10, 2010 in order to attract and retain directors and
executive officers and better align the interests of the directors and executive officers with
those of the shareholders in the creation of long-term value. See Description of the Deferred
Share Unit Plan below.
The Corporation has a share purchase plan but the share purchase plan is available to all employees
of the Corporation and the decision to subscribe for Common Shares under this plan rests with each
employee. For a description of the share purchase plan, see Other Information Description of
the Share Purchase Plan below.
The number of options and deferred share units (the DSU) granted is determined on the basis of
the position of each executive officer, the attainment of corporate objectives and the value of the
options and the Common Shares at the time of grant as part of the total compensation of an
executive officer. When assessing whether options should be granted to an executive officer, the
Compensation Committee also factors in the number of options held by an executive officer, their
vesting periods, expiry dates and exercise prices.
For the services performed by the executive officers in the financial year ended November 30, 2010,
on the recommendation of the Compensation Committee, the Board of Directors decided to grant DSU to
executive officers who were entitled to receive an annual cash bonus payment exceeding 100% of
their targeted annual bonus in payment of the tranche of their annual cash bonus which exceeded
100% of their annual targeted cash bonus. See Description of the Deferred Share Unit Plan below.
Description of the Share Option Plan
A maximum of 5,000,000 Common Shares have been reserved for stock option grants under the Share
Option Plan, of which, as at the date of the Circular, 788,172 options remain available for
issuance.
The Board of Directors administers the Share Option Plan. The Board of Directors designates the
optionees and determines the number of Common Shares underlying these options, the vesting period,
the exercise price and the expiry date of each option, as well as all other related matters, the
whole in compliance with the terms of the Share Option Plan and applicable legislative
provisions established by the securities regulatory authorities. Options granted to executive
officers generally
|
|
|
Statement of Compensation
|
|
Page 12 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
vest as to 33 1/3% on each year starting twelve (12) months after the date of grant. The Board
of Directors can modify or terminate the Share Option Plan subject to compliance with the rules set
forth by regulatory authorities. However, certain amendments require the approval of a majority of
the voting shareholders of the Corporation.
Unless otherwise determined by the Board of Directors, the options granted pursuant to the Share
Option Plan may be exercised within a maximum period of ten (10) years following their date of
grant, unless the optionees employment is terminated, other than for death, in which case the
optionees unexercised vested options, if any, may be exercised within a period of one hundred
eighty (180) days following the date of the employees termination. In the event of the death of an
optionee prior to the expiry date of his options, the optionees legal personal representative may
exercise the optionees unexercised vested options within twelve (12) months after the date of the
optionees death. The options granted in accordance with the Share Option Plan cannot be
transferred or assigned.
The exercise price at which the options may be granted pursuant to the Share Option Plan cannot be
less than the closing price of the Common Shares on the TSX on the day preceding the date of grant
of the options.
In addition, the Share Option Plan states that the number of Common Shares that may be issued to
insiders, at any time, under all security based compensation arrangements of the Corporation,
cannot exceed 10% of the outstanding Common Shares of the Corporation, and the number of Common
Shares issued to insiders, within any one year period, under all security based compensation
arrangements, cannot exceed 10% of the outstanding Common Shares. The number of Common Shares that
may be issued to non-employee directors, within any one year period, under all security based
compensation arrangements, cannot exceed 0.5% of the outstanding Common Shares of the Corporation.
During the financial year ended November 30, 2010, the Corporation granted options under the Share
Option Plan providing for the purchase of 335,000 Common Shares. These options were
granted in December 2009 as part of the compensation of the executive officers for the financial
year ended on November 30, 2009, except with respect to 70,000 options granted in June 2010 as part
of the compensation of the directors of the Corporation. No option under the Share Option Plan has
been granted by the Corporation since December 1, 2010.
The following table sets forth the information regarding the equity compensation plan of the
Corporation as at November 30, 2010.
|
|
|
Statement of Compensation
|
|
Page 13 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Securities |
|
|
|
|
|
|
|
|
|
|
to be Issued upon |
|
|
|
|
|
|
Number of Securities |
|
|
|
Exercise of Outstanding |
|
|
|
|
|
|
Remaining Available |
|
|
|
Options |
|
|
Weighted-average |
|
|
for Future Issuance |
|
|
|
(% of Issued and |
|
|
Exercise Price of |
|
|
under Equity |
|
Plan Category |
|
Outstanding Share Capital) |
|
|
Outstanding Option |
|
|
Compensation Plan |
|
Equity Compensation |
|
|
2,849,138 |
|
|
$ |
5.12 |
|
|
|
981,005 |
|
Plan Approved by Shareholders |
|
|
(4.70 |
%) |
|
|
|
|
|
|
|
|
Equity Compensation
Plans Not Approved
by Shareholders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
2,849,138 |
|
|
$ |
5.12 |
|
|
|
981,005 |
|
|
Description of the Deferred Share Unit Plan
On December 10, 2010, the Board of Directors adopted the DSU Plan for the benefit of its directors
and executive officers (the Beneficiaries). The goal of the DSU Plan is to increase the
Corporations ability to attract and retain high-quality individual to act as directors or
executive officers and better align the interests of the directors and executive officers with
those of the shareholders of the Corporation in the creation of long-term value. The DSU Plan was
also adopted to promote equity-based ownership in the Corporation. Under the terms of the DSU Plan,
Beneficiaries who are directors are entitled to elect to receive all or part of their annual
retainer to act as directors in DSU. In addition to his annual retainer, the Chairman of the Board
is also entitled to elect to receive all or part of his annual retainer as chair of the Board of
Directors in DSU. Beneficiaries who act as executive officers are entitled to elect to receive all
or part of their annual bonus, if any, in DSU. The value of a DSU (the DSU Value) is equal to the
average closing price of the Common Shares on The Toronto Stock Exchange on the date on which a
Beneficiary determines that he desires to receive or redeem DSU and during the four (4) previous
trading days. Beneficiaries who act as directors must elect to receive DSU before December 23 of a
calendar year for the ensuing calendar year whereas Beneficiaries who act as executive officers
must make that election within 48 hours after having been notified of their annual bonus. For the
purposes of granting DSU, the DSU Value for directors is determined as at December 31 of a calendar
year and the DSU Value for executive officers is determined on the second business day after they
have been notified of their annual bonus. DSU may only be redeemed when a Beneficiary ceases to act
as a director or an executive officer of the Corporation. On the date a Beneficiary ceases to act
as a director or executive officer (the Redemption Date), the Beneficiary must send a notice to
the Corporation (the Redemption Notice) specifying the date on which the DSU will be redeemed
(the Payment Date). The Payment Date must be no earlier than five (5) business days after the
date on which the Corporation receives the Redemption Notice and no later than November 30 of the
year following the Redemption Date. On the Payment Date, the Corporation must provide a Beneficiary
with an amount in cash equal to the
DSU Value on the Redemption Date. Beneficiaries may not sell, transfer or otherwise assign their
DSU or any rights associated therewith other than by will or in accordance with legislation
regarding the vesting and partition of successions. The Board of Directors administers the DSU Plan
and the DSU Plan provides that the Board of Directors may delegate all or part of its obligations
to the Compensation Committee or any other committee of the Board.
|
|
|
Statement of Compensation
|
|
Page 14 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
In connection with the approval of the DSU Plan, the Board of Directors adopted guidelines
regarding the ownership of DSU for both directors and executive officers and the granting of DSU.
With respect to the ownership of DSU, beginning in the financial year ending November 30, 2011, the
Board of Directors passed a resolution (i) requiring all of its directors to hold a number of
Common Shares and/or DSU having a value equal to at least 400% of their annual retainer, including,
in the case of the Chairman of the Board, his annual salary to act in such capacity; (ii)
recommending that the executive officers hold a number of Common Shares and/or DSU having a value
equal to at least 150% of their annual base salary; and (iii) recommending that the President and
Chief Executive Officer holds a number of Common Shares and/or DSU having a value equal to at least
300% of his annual base salary.
With respect to the granting of DSU, the Board of Directors decided to grant to each executive
officer who was entitled to be paid a cash bonus exceeding 100% of his targeted bonus for the
financial year ended November 30, 2010 DSU (in lieu of the cash portion) having a DSU Value equal
to the amount of his cash bonus exceeding 100% of his targeted bonus. In addition, as an incentive
to accumulate DSU of the Corporation, the Board of Directors decided to grant to each executive
officer who elected to convert up to 50% of his annual bonus into DSU in lieu of receiving a cash
payment an additional number of DSU equal to 33 1/3% of the number of DSU purchased through the
conversion of his annual cash bonus. The Board of Directors also decided to increase by 33 1/3% the
number of DSU to be granted to directors as complete or partial payment of their annual retainer
fees for the current financial year on the first tranche of 50% of his annual retainer.
B. Summary Compensation Table
The summary compensation table below details compensation for the financial years ended November
30, 2010 and 2009 for each of the President and Chief Executive Officer, the Senior Executive Vice
President and Chief Financial Officer, and the three other most highly compensated executive
officers of the Corporation (collectively the Named Executive Officers) for services rendered in
all capacities.
|
|
|
Statement of Compensation
|
|
Page 15 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-equity incentive plan |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
compensation ($) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share- |
|
Option- |
|
|
|
|
|
|
|
|
|
|
|
|
|
All other |
|
|
Name and |
|
|
|
|
|
|
|
|
|
based |
|
based |
|
Annual |
|
Long-term |
|
Pension |
|
compen- |
|
Total |
principal |
|
|
|
|
|
Salary |
|
awards(2) |
|
awards(6) |
|
incentive |
|
incentive |
|
value (17) |
|
sation(18) |
|
compensation |
position |
|
Year |
|
($) |
|
($) |
|
($) |
|
plans |
|
plans |
|
($) |
|
($) |
|
($) |
Yves Rosconi |
|
|
2010 |
|
|
|
466,789 |
(1) |
|
|
|
|
|
|
|
|
|
|
232,500 |
(12) |
|
|
|
|
|
|
22,000 |
|
|
|
|
|
|
|
721,289 |
|
President and |
|
|
2009 |
|
|
|
426,635 |
|
|
|
|
|
|
|
87,000 |
(7) |
|
|
225,000 |
|
|
|
|
|
|
|
21,000 |
|
|
|
|
|
|
|
759,635 |
|
Chief Executive
Officer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Luc Tanguay |
|
|
2010 |
|
|
|
366,404 |
|
|
|
57,914 |
(3) |
|
|
|
|
|
|
182,500 |
(13) |
|
|
|
|
|
|
22,000 |
|
|
|
|
|
|
|
628,818 |
|
Senior Executive |
|
|
2009 |
|
|
|
353,354 |
|
|
|
|
|
|
|
72,500 |
(8) |
|
|
176,000 |
|
|
|
|
|
|
|
21,000 |
|
|
|
|
|
|
|
622,854 |
|
Vice President and
Chief Financial
Officer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Christian Marsolais |
|
|
2010 |
|
|
|
245,942 |
|
|
|
34,150 |
(4) |
|
|
|
|
|
|
80,850 |
(14) |
|
|
|
|
|
|
7,531 |
|
|
|
|
|
|
|
368,473 |
|
Vice President, |
|
|
2009 |
|
|
|
220,846 |
|
|
|
|
|
|
|
168,000 |
(9) |
|
|
100,000 |
|
|
|
|
|
|
|
6,512 |
|
|
|
|
|
|
|
495,358 |
|
Clinical Research
and Medical
Affairs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Martine Ortega |
|
|
2010 |
|
|
|
225,865 |
|
|
|
40,750 |
(5) |
|
|
|
|
|
|
74,250 |
(15) |
|
|
|
|
|
|
6,413 |
|
|
|
|
|
|
|
347,278 |
|
Vice President, |
|
|
2009 |
|
|
|
215,827 |
|
|
|
|
|
|
|
134,750 |
(10) |
|
|
110,000 |
|
|
|
|
|
|
|
2,643 |
|
|
|
|
|
|
|
463,220 |
|
Compliance and
Regulatory Affairs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chantal Desrochers |
|
|
2010 |
|
|
|
246,946 |
|
|
|
|
|
|
|
|
|
|
|
65,000 |
(16) |
|
|
|
|
|
|
7,576 |
|
|
|
|
|
|
|
319,522 |
|
Vice President, |
|
|
2009 |
|
|
|
243,433 |
|
|
|
|
|
|
|
58,000 |
(11) |
|
|
72,000 |
|
|
|
|
|
|
|
7,174 |
|
|
|
|
|
|
|
380,607 |
|
Business
Development and
Commercialization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Mr. Rosconi received an additional amount of $41,135 (one month salary) in December
2010 to help with the transition of the new President and Chief Executive Officer. |
|
(2) |
|
DSU granted under the DSU Plan in December 2010. The DSU Value as at the date of grant was $
5.41. |
|
(3) |
|
10,705 DSU were granted to Mr. Tanguay. Of these 10,705 DSU, 5,083 ($27,500) were granted to
pay the difference between 100% of Mr. Tanguays annual targeted bonus ($182,500) and the
aggregate bonus he was awarded (115% or $210,000) and 5,622 were granted further to the
decision of the Board of Directors to increase by 33 1/3% the number of DSU that an executive
officer was entitled to receive upon electing to convert up to 50% of his annual cash bonus in DSU.
Mr. Tanguay elected to convert 50% ($91,250) of his annual cash bonus ($182,500) into DSU. See
note 13. |
|
(4) |
|
6,312 DSU were granted to Mr. Marsolais as payment of the difference between 100% of Mr.
Marsolais annual targeted bonus
($80,850) and the aggregate bonus he was awarded (142% or $115,000). See note 14. |
|
(5) |
|
7,532 DSU were granted to Mrs. Ortega as payment of the difference between 100% of Mrs.
Ortegas annual targeted bonus ($74,250) and the aggregated bonus she was awarded (155% or $
115,000). See note 15. |
|
(6) |
|
The value of the option-based awards for the financial year ended November 30, 2009 was
comprised of two grants for Mr. Marsolais and Mrs. Ortega: a grant made in December 2008 (the
December 2008 Grant) and a grant made in December 2009 (the December 2009 Grant). The value of
the option-based awards for Mr. Rosconi, Mr. Tanguay and Mrs. Desrochers is based on the December
2009 Grant. The value of the option-based awards was recalculated by taking into consideration the
International Financial Reporting Standards (the IFRS) further to the decision of the Corporation
to begin reporting its financial results using IFRS. The table below shows the differences between
the use of Canadian GAAP and IFRS in computing the value of the option-based awards using the
Black-Sholes-Merton model and the following assumptions: |
|
|
|
Statement of Compensation
|
|
Page 16 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 2008 Grant |
|
December 2009 Grant |
|
|
|
|
|
|
Canadian |
|
|
|
|
|
Canadian |
|
|
IFRS |
|
GAAP |
|
IFRS |
|
GAAP |
(i) Risk-free interest rate |
|
|
1.79 |
% |
|
|
1.79 |
% |
|
|
2.46 |
% |
|
|
2.46 |
% |
(ii) Expected volatibility in the
market price of the
Common Share |
|
|
79.33 |
% |
|
|
79.33 |
% |
|
|
80.96 |
% |
|
|
80.96 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(iii) Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(iv) Expected life |
|
7.5 years |
|
|
6.0 years |
|
|
7.5 years |
|
|
6.0 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value per option |
|
$ |
1.33 |
|
|
$ |
1.23 |
|
|
$ |
2.90 |
|
|
$ |
2.69 |
|
|
|
|
(7) |
|
Mr. Rosconi was granted 30,000 options as part of the December 2009 Grant. The use of the IFRS
method to calculate the option-based award value results in an increase of $6,180 over the
Canadian GAAP method. |
|
(8) |
|
Mr. Tanguay was granted 25,000 options as part of the December 2009 Grant. The use of the IFRS
method to calculate the option-based award value results in an increase of $5,150 over the
Canadian GAAP method. |
|
(9) |
|
Mr. Marsolais was granted 35,000 options as part of the December 2009 Grant. Mr. Marsolais was
also granted 50,000 options as part of the December 2008 Grand, of which 25,000 were granted
pursuant to the terms of his employment agreement and 25,000 were granted further to his
appointment as Vice President in August 2007. Subject to Mr. Marsolais being employed by the
Corporation, the 50,000 options were scheduled to be granted in the financial year 2008. However,
as a result of the strategic review process that was ongoing during this financial year, the Board
of Directors decided to defer the grant of those options until completion of the strategic review
process. The use of the IFRS method to calculate the option-based award value results in an
increase of $11,960 over the Canadian GAAP method. |
|
(10) |
|
Mrs. Ortega was granted 35,000 options as part of the December 2009 Grant. Mrs. Ortega was
also granted 25,000 options as part of the December 2008 Grant further to her appointment as Vice
President in August 2007. Subject to Mrs. Ortega being employed by the Corporation, these 25,000
options were scheduled to be granted in the financial year 2008. However, as a result of the
strategic review process that was ongoing during the financial year, the Board of Directors decided
to defer the grant of those options until completion of the strategic process. The use of the IFRS
method to calculate the option-based award value results in an increase of $9,585 over the
Canadian GAAP method. |
|
(11) |
|
Mrs. Desrochers was granted 20,000 options as part of the December 2009 Grant. The use of the
IFRS method to calculate the option-based award value results in an increase of $4,200 over the
Canadian GAAP method. |
|
(12) |
|
The amount received by Mr. Rosconi represents 100% of his targeted bonus ($232,500). As
President and Chief Executive Officer of the Corporation, Mr. Rosconis objectives were aligned
with the Corporations objectives. The Compensation Committee determined that he had met all of his
objectives by leading the various business units of the Corporation in getting tesamorelin for the
treatment of HIV-associated lipodystrophy approved by the Food and Drug Administration of the
United States. |
|
(13) |
|
The amount of $182,500 was paid to Mr. Tanguay as follows: $91,250 in cash; and $
91,250 through the issuance of 16,867 DSU. The 16,867 DSU were issued further to the decision of
Mr. Tanguay to convert 50% of his annual cash bonus into DSU. As Senior Executive Vice President
and Chief Financial Officer of the Corporation, Mr. Tanguays objectives were aligned with those of
the Corporation and included (i) managing the Corporations liquidities to ensure the corporate
objectives would be attained in a cost-efficient manner and according to the annual budget; (ii)
supervising the transition from Canadian GAAP to the IFRS; (iii) leading and conducting the risk
management analysis program of the Corporation; (iv) overseeing the internal controls and process
of the Corporation for compliance with securities regulation and (v) overseeing the investors
relations programme. |
|
(14) |
|
As Vice President, Clinical Research and Medical Affairs, of the
Corporation, Mr. Marsolais objectives were aligned with those of the Corporation and consisted in
(i) the preparation and supervision of the Advisory Committee meeting with the Food and Drug
Administration of the United States; and (ii) assisting the regulatory team getting tesamorelin for
the treatment of HIV-associated lipodystrophy approved by the Food and Drug Administration of the
United States. |
|
(15) |
|
As Vice President, Compliance and Regulatory Affairs, of the Corporation, Mrs. Ortegas
objectives were aligned with those of the Corporation and consisted in getting tesamorelin for the
treatment of HIV-associated lipodystrophy approved by the Food and Drug Administration of the
United States. |
|
(16) |
|
The amount received by Mrs. Desrochers represents 80% of her targeted bonus ($81,250). As Vice
President, Business Development and Commercialization of the Corporation, Mrs. Desrochers
objectives were aligned with those of the Corporation. The objectives of Mrs. Desrochers consisted
in (i) assisting the regulatory team getting tesamorelin for the treatment of HIV-associated
lipodystrophy approved by the Food and Drug Administration of the United States; (ii) overseeing
the alliance with the Corporations commercial partner in the United States in preparation for the
launch of tesamorelin for the treatment of HIV-associated lipodystrophy in the United |
|
|
|
Statement of Compensation
|
|
Page 17 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
States; and (iii) entering into alliance agreements with third parties for the
commercialization of tesamorelin for the treatment of HIV-associated lipodystrophy in
territories other than the United States. |
|
(17) |
|
Pension Value consists of the amount of the contribution made by the Corporation to a Named
Executive Officers registered retirement savings plan. The Corporation has a group-RRSP for all of
its employees under which the Corporation matches every dollar invested by an employee in such
group-RRSP. The contribution of the Corporation into such group-RRSP is limited to three percent
(3%) of the annual base salary of each employee. Under the terms of the employment agreements of
both Mr. Rosconi and Mr. Tanguay, the Corporation agreed to contribute on an annual basis to each
of Mr. Rosconis and Mr. Tanguays RRSP to the fullest amount permissible under Canadian laws. |
|
(18) |
|
Perquisites for each Named Executive Officer have not been included as they do not reach the
prescribed threshold of the lesser of $50,000 and 10% of each of the respective Named Executive
Officers salary for the last completed financial year. |
C. Incentive Plan Awards
Outstanding Option-Based Awards and Share-Based Awards
|
|
The table below details the outstanding option-based awards and share-based awards as at
November 30, 2010 for each of the Named Executive Officers. |
|
|
|
Statement of Compensation
|
|
Page 18 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option-Based Awards |
|
Share-Based Awards |
|
|
Number of |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
securities |
|
|
|
|
|
|
|
|
|
Value of |
|
Number of shares |
|
Market or payout |
|
|
underlying |
|
Option |
|
|
|
|
|
unexercised |
|
or units of shares |
|
value of share- |
|
|
unexercised |
|
exercice |
|
Option |
|
in-the-money |
|
that have not |
|
based awards that |
|
|
options |
|
price |
|
expiration |
|
options (1) |
|
vested |
|
have not vested |
Name |
|
(#) |
|
($) |
|
date |
|
($) |
|
(#) |
|
($) |
Yves Rosconi |
|
|
133,334 |
|
|
|
2.61 |
|
|
|
2014.10.01 |
|
|
|
405,335 |
|
|
|
|
|
|
|
|
|
President and |
|
|
133,334 |
|
|
|
1.24 |
|
|
|
2015.10.01 |
|
|
|
588,003 |
|
|
|
|
|
|
|
|
|
Chief Executive Officer |
|
|
25,000 |
|
|
|
8.23 |
|
|
|
2017.01.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
96,250 |
|
|
|
|
|
|
|
|
|
|
|
|
30,000 |
|
|
|
3.84 |
|
|
|
2019.12.08 |
|
|
|
54,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Luc Tanguay |
|
|
200,000 |
|
|
|
10.40 |
|
|
|
2011.10.30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Senior Executive |
|
|
200,000 |
|
|
|
8.00 |
|
|
|
2012.10.30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Vice President and |
|
|
125,000 |
|
|
|
1.94 |
|
|
|
2016.02.08 |
|
|
|
463,750 |
|
|
|
|
|
|
|
|
|
Chief Financial Officer |
|
|
25,000 |
|
|
|
8.23 |
|
|
|
2017.01.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
77,000 |
|
|
|
|
|
|
|
|
|
|
|
|
25,000 |
|
|
|
3.84 |
|
|
|
2019.12.08 |
|
|
|
45,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Christian Marsolais |
|
|
25,000 |
|
|
|
11.48 |
|
|
|
2017.07.11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Vice President, |
|
|
25,000 |
|
|
|
10.60 |
|
|
|
2017.08.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical Research |
|
|
1,000 |
|
|
|
8.50 |
|
|
|
2018.01.30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
and Medical Affairs |
|
|
65,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
250,250 |
|
|
|
|
|
|
|
|
|
|
|
|
35,000 |
|
|
|
3.84 |
|
|
|
2019.12.08 |
|
|
|
63,350 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Martine Ortega |
|
|
25,000 |
|
|
|
1.42 |
|
|
|
2016.07.06 |
|
|
|
105,750 |
|
|
|
|
|
|
|
|
|
Vice President, |
|
|
10,000 |
|
|
|
8.23 |
|
|
|
2017.01.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Compliance and |
|
|
25,000 |
|
|
|
11.48 |
|
|
|
2017.07.11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Regulatory Affairs |
|
|
25,000 |
|
|
|
10.60 |
|
|
|
2017.08.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,000 |
|
|
|
8.50 |
|
|
|
2018.01.30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
154,000 |
|
|
|
|
|
|
|
|
|
|
|
|
35,000 |
|
|
|
3.84 |
|
|
|
2019.12.08 |
|
|
|
63,350 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chantal Desrochers |
|
|
16,670 |
|
|
|
1.85 |
|
|
|
2015.03.16 |
|
|
|
63,346 |
|
|
|
|
|
|
|
|
|
Vice President, |
|
|
50,000 |
|
|
|
1.86 |
|
|
|
2016.03.30 |
|
|
|
189,500 |
|
|
|
|
|
|
|
|
|
Business Development, |
|
|
15,000 |
|
|
|
8.23 |
|
|
|
2017.01.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
and Commercialization |
|
|
15,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
57,750 |
|
|
|
|
|
|
|
|
|
|
|
|
20,000 |
|
|
|
3.84 |
|
|
|
2019.12.08 |
|
|
|
36,200 |
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The value of unexercised in-the-money options at financial year end is the difference between
the closing price of the Common Shares on November 30, 2010 ($5.65) on the TSX and the respective
exercise prices of the options. The value shown in this table does not represent the actual value
that a Named Executive Officer would have received if the options had been exercised as at November
30, 2010 since some of these options were not fully vested as of that date and, therefore, were not
exercisable. |
|
|
|
Statement of Compensation
|
|
Page 19 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
Incentive Plan Awards Value vested or earned during the year
The table below shows the value vested or earned during the year under each incentive plan as at
November 30, 2010 for each of the Named Executive Officers.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-equity incentive |
|
|
Option-based awards |
|
Share-based awards |
|
plan compensation |
|
|
Value vested during |
|
Value vested |
|
Value earned |
|
|
the year (1) |
|
during the year |
|
during the year |
Name |
|
($) |
|
($) |
|
($) |
Yves Rosconi |
|
|
19,749 |
(2) |
|
|
|
|
|
|
232,500 |
|
President and
Chief Executive Officer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Luc Tanguay |
|
|
15,798 |
(3) |
|
|
|
|
|
|
182,500 |
|
Senior Executive
Vice President and
Chief Financial Officer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Christian Marsolais |
|
|
51,348 |
(4) |
|
|
|
|
|
|
80,850 |
|
Vice President,
Clinical Research
and Medical Affairs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Martine Ortega |
|
|
31,599 |
(5) |
|
|
|
|
|
|
74,250 |
|
Vice President,
Compliance and
Regulatory Affairs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chantal Desrochers |
|
|
11,850 |
(6) |
|
|
|
|
|
|
65,000 |
|
Vice President,
Business Development,
and Commercialization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The value is determined by assuming that the options vested during the financial year would
have been exercised on the vesting date. The value corresponds to the difference between the
closing price of the Common Shares on the TSX on the vesting date and the exercise price of the
options on that date. |
|
(2) |
|
8,333 options having an exercise price of $1.80 vested on December 18, 2009. On that date, the
closing price of the Common Shares on the TSX was $4.17. (3) 6,666 options having an exercise price
of $1.80 vested on December 18, 2009. On that date, the closing price of the Common Shares on the
TSX was $4.17. |
|
(4) |
|
38,667 options vested in the last financial year, 21,666 of which had an exercise price lower
than the closing price of the Common Shares on the TSX on the vesting date. The 21,666 options have
an exercise price of $1.80 and vested on December 18, 2009. On that date, the closing price of the
Common Shares on the TSX was $4.17. |
|
(5) |
|
30,334 options vested in the last financial year, 13,333 of which had an exercise price lower
than the closing price of the Common Shares on the TSX on the vesting date. The 13,333 options have
an exercise price of $1.80 and vested on December 18, 2009. On that date, the closing price of the
Common Shares on the TSX was $4.17. |
|
(6) |
|
5,000 options having an exercise price of $1.80 vested on December 18, 2009. On that date, the
closing price of the Common Shares on the TSX was $4.17. |
|
(7) |
|
None of the DSU granted to the Named Executive Officers vested in the financial year ended
November 30, 2010 since they were granted in December 2010. To see the number and value of DSU
earned and granted to each Named Executive Officer in the last completed financial year, see
Summary Compensation Table above. |
|
|
|
Statement of Compensation
|
|
Page 20 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
D. Termination and Change of Control Provisions
Below is a summary of the employment agreements of each of the Named Executive Officers together
with a table detailing the value of the severance payment that would be payable by the Corporation
to each Named Executive Officer pursuant to his employment agreement if one of the events described
in the table had occurred on November 30, 2010.
Yves Rosconi
President and Chief Executive Officer
On October 21, 2004, the Corporation entered into an employment agreement for an indeterminate term
with Mr. Yves Rosconi. In addition to his base salary, Mr. Rosconi is entitled to the Corporations
benefits program and is eligible to receive an annual bonus based on attainment of objectives set
annually by the Corporations Board of Directors. Mr. Rosconi was also entitled to stock options,
which have all been granted. These options vested over a three-year period from the date of grant.
Under the terms of the agreement, Mr. Rosconi agreed to non-competition, non-solicitation,
non-disclosure and assignment of intellectual property provisions in favour of the Corporation. If
the Corporation terminates Mr. Rosconis employment without just and sufficient cause, he will
receive an amount equal to twelve (12) months of compensation (including bonus based on the last
granted and the value of the Corporations benefits to which he was then entitled). The payment
of this amount will be the sole monetary obligation of the Corporation. Furthermore, in the event
of a Change of Control (as defined below), his employment agreement provides for an indemnity
equal to twenty-four (24) months of compensation (including bonus based on the last granted
and the value of the Corporations benefits to which he was then entitled) if Mr. Rosconis
employment is terminated by the Corporation, and twelve (12) months if Mr. Rosconi resigns on his
own free will. In Mr. Rosconis agreement, a Change of Control is defined as a successful
take-over bid, as such term is defined in the Securities Act (Québec).
|
|
|
|
|
|
|
|
|
|
|
Severance |
|
Value of Stock Options (1) |
Events |
|
($) |
|
($) |
Retirement (2) |
|
|
|
|
|
|
1,025,420 |
|
|
|
|
|
|
|
|
|
|
Termination of Employment
without Just Cause (2) |
|
|
719,399 |
(4) |
|
|
1,025,420 |
|
|
|
|
|
|
|
|
|
|
Termination of Employment
in the event of
a Change of Control (3) |
|
|
1,438,798 |
(4) |
|
|
1,143,888 |
|
|
|
|
|
|
|
|
|
|
Voluntary Resignation
in the event of
a Change of Control (3) |
|
|
719,399 |
(4) |
|
|
1,143,888 |
|
|
|
|
|
|
|
|
|
|
Voluntary Resignation (2) |
|
|
|
|
|
|
1,025,420 |
|
|
|
|
(1) |
|
The value assumes that upon the occurrence of an event, all in-the-money vested options would
be exercised. The value is the difference between the closing price of the Common Shares on
November 30, 2010 on the TSX ($5.65) and the respective exercise price of each vested option as at
November 30, 2010. |
|
(2) |
|
Under the Share Option Plan, the termination of a persons employment with the Corporation
entitles him to exercise his vested options over a six-month period after the termination date. |
|
(3) |
|
Given the different definitions of Change of Control used in the employment agreements of the
Named Executive Officers, in computing the value of the stock options in the event of a Change of
Control, the Corporation assumed that all unvested options would vest as per the terms of Section
5.5 of its Share Option Plan and that all vested options having an exercise price lower than the
closing price of the Common Shares on November 30, 2010 on the TSX ($5.65) would be exercised. |
|
|
|
Statement of Compensation
|
|
Page 21 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
(4) |
|
As at November 30, 2010, the last bonus paid to Mr. Rosconi was the bonus he received for
the financial year 2009 which amounted to $225,000. |
Luc Tanguay
Senior Executive Vice President and Chief Financial Officer
The Corporation entered into an employment agreement for an indeterminate term with Mr. Luc Tanguay
on October 30, 2001. His agreement was subsequently amended on May 9, 2002, June 7, 2004 and
February 8, 2006. In addition to his base salary, Mr. Tanguay is entitled to the Corporations
benefits program and is eligible to receive an annual bonus based on the attainment of annual
objectives. Mr. Tanguay was also entitled to stock options, which have all been granted. Under the
terms of the agreement, Mr. Tanguay agreed to non-competition, non-solicitation, non-disclosure and
assignment of intellectual property provisions in favour of the Corporation. If the Corporation
terminates the employment of Mr. Tanguay without just and sufficient cause, he will receive an
amount equal to twenty-four (24) months of compensation (including bonus based on the last
granted and the value of the Corporations benefits to which he was then entitled). The payment
of this amount will be the sole monetary obligation of the Corporation. In addition, in the event
the employment of Mr. Tanguay is terminated for any reason, including death, he will be entitled to
exercise his stock options over a 24-month period, subject to the prior expiry of his stock options
in accordance with their terms. Furthermore, in the event of a Change of Control (as defined
below), his employment agreement provides for an indemnity equal to twenty-four (24) months of
compensation (including bonus based on the last granted and the value of the Corporations
benefits to which he was then entitled) if Mr. Tanguays employment is terminated by the
Corporation, and twelve (12) months if Mr. Tanguay resigns on his own free will. In Mr. Tanguays
agreement, a Change of Control is defined as a successful take-over bid, as such term is defined
in the Securities Act (Québec).
|
|
|
|
|
|
|
|
|
|
|
Severance |
|
Value of Stock Options (1) |
Events |
|
($) |
|
($) |
Retirement (2) |
|
|
|
|
|
|
489,414 |
|
Termination of Employment
without Just Cause (2) |
|
|
1,139,232 |
(4) |
|
|
489,414 |
|
Termination of Employment
in the event of
a Change of Control (2) (3) |
|
|
1,139,232 |
(4) |
|
|
586,000 |
|
Voluntary Resignation
in the event of
a Change of Control (2)(3) |
|
|
569,616 |
(4) |
|
|
586,000 |
|
Voluntary Resignation (2) |
|
|
|
|
|
|
489,414 |
|
|
|
|
(1) |
|
The value assumes that upon the occurrence of an event, all in-the-money vested options
would be exercised. The value is the difference between the closing price of the Common Shares on
November 30, 2010 on the TSX ($5.65) and the respective exercise price of each vested option as at
November 30, 2010. |
|
(2) |
|
Under the terms of Mr. Tanguays employment agreement, the termination of his employment with
the Corporation entitles him to exercise his vested options on the earlier of: twenty-four (24)
months from his termination date; and the expiry date of the vested options. |
|
(3) |
|
Given the different definitions of Change of Control used in the employment agreements of the
Named Executive Officers, in computing the value of the stock options in the event of a Change of
Control, the Corporation assumed that all unvested options would vest as per the terms of Section
5.5 of its Share Option Plan and that all vested options having an exercise price lower than the
closing price of the Common Shares on November 30, 2010 on the TSX ($5.65) would be exercised. |
|
|
|
|
|
|
Statement of Compensation
|
|
Page 22 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
(4) |
|
As at November 30, 2010, the last bonus paid to Mr. Tanguay was the bonus he received for the
financial year 2009 which amounted to $176,000. |
Christian Marsolais
Vice President, Clinical Research and Medical Affairs
The Corporation entered into an employment agreement for an indeterminate term with Mr. Christian
Marsolais on April 13, 2007. In addition to his base salary, Mr. Marsolais is entitled to the
Corporations benefits program and is eligible to receive an annual bonus based on attainment of
objectives set annually by the President and Chief Executive Officer. Mr. Marsolais was also
entitled to stock options, which have all been granted. These stock options vest over a three-year
period from the date of grant. Under the terms of the agreement, Mr. Marsolais agreed to
non-competition, non-solicitation, non-disclosure and assignment of intellectual property
provisions in favour of the Corporation. If the Corporation terminates Mr. Marsolais employment
without just and sufficient cause, he will receive an amount equal to nine (9) months of his annual
base salary. The payment of this amount will be the sole monetary obligation of the Corporation.
|
|
|
|
|
|
|
|
|
|
|
Severance |
|
Value of Stock Options (1) |
Events |
|
($) |
|
($) |
Retirement (2) |
|
|
|
|
|
|
83,414 |
|
Termination of Employment
without Just Cause (2) |
|
|
184,456 |
|
|
|
83,414 |
|
Termination of Employment
in the event of
a Change of Control (3) |
|
|
184,456 |
|
|
|
313,600 |
|
Voluntary Resignation
in the event of
a Change of Control (3) |
|
|
|
|
|
|
313,600 |
|
Voluntary Resignation (2) |
|
|
|
|
|
|
83,414 |
|
|
|
|
(1) |
|
The value assumes that upon the occurrence of an event, all in-the-money vested options
would be exercised. The value is the difference between the closing price of the Common Shares on
November 30, 2010 on the TSX ($5.65) and the respective exercise price of each vested option as at
November 30, 2010. |
|
(2) |
|
Under the Share Option Plan, the termination of a persons employment with the Corporation
entitles him to exercise his vested options over a six-month period after the termination date. |
|
(3) |
|
Given the different definitions of Change of Control used in the employment agreements of the
Named Executive Officers, in computing the value of the stock options in the event of a Change of
Control, the Corporation assumed that all unvested options would vest as per the terms of Section
5.5 of its Share Option Plan and that all vested options having an exercise price lower than the
closing price of the Common Shares on November 30, 2010 on the TSX ($5.65) would be exercised. |
Martine Ortega
Vice President, Compliance and Regulatory Affairs
The Corporation entered into an employment agreement for an indeterminate term with Mrs. Martine
Ortega on May 11, 2006. In addition to her base salary, Mrs. Ortega is entitled to the
Corporations benefits program and is eligible to receive an annual bonus based on attainment of
objectives set annually by the President and Chief Executive Officer. Mrs. Ortega was also entitled
to stock options, which have all been granted. These stock options vest over a three-year period
from the date of grant. Under the terms of the agreement, Mrs. Ortega agreed to non-solicitation,
non-disclosure and assignment of intellectual property provisions in favour of the Corporation. If
the Corporation terminates Mrs. Ortegas employment without just and sufficient cause, she will
receive an amount equal to nine (9) months of her annual base salary, if her termination occurs:
(i) in the
|
|
|
|
|
|
Statement of Compensation
|
|
Page 23 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
context of an internal reorganization of the Corporation or (ii) within two (2) years from the
date there occurs a Change of Control (as defined below) of the Corporation. The payment of this
amount will be the sole monetary obligation of the Corporation. In Mrs. Ortegas agreement, a
Change of Control is defined as a transaction resulting in the liquidation or winding-up of the
Corporation, delisting of the Corporations Common Shares on a stock exchange, the acquisition by a
third party of the control of the Corporation, the sale of all or substantially all of the assets
of the Corporation or the privatization or a merger of the Corporation.
|
|
|
|
|
|
|
|
|
|
|
Severance |
|
Value of Stock Options (1) |
Events |
|
($) |
|
($) |
Retirement (2) |
|
|
|
|
|
|
157,082 |
|
Termination of Employment
without Just Cause (2) |
|
|
169,399 |
|
|
|
157,082 |
|
Termination of Employment
in the event of
a Change of Control (3) |
|
|
169,399 |
|
|
|
323,100 |
|
Voluntary Resignation
in the event of
a Change of Control (3) |
|
|
|
|
|
|
323,100 |
|
Voluntary Resignation (2) |
|
|
|
|
|
|
157,082 |
|
|
|
|
(1) |
|
The value assumes that upon the occurrence of an event, all in-the-money vested options
would be exercised. The value is the difference between the closing price of the Common Shares on
November 30, 2010 on the TSX ($5.65) and the respective exercise price of each vested option as at
November 30, 2010. |
|
(2) |
|
Under the Share Option Plan, the termination of a persons employment with the Corporation
entitles him to exercise his vested options over a six-month period after the termination date. |
|
(3) |
|
Given the different definitions of Change of Control used in the employment agreements of the
Named Executive Officers, in computing the value of the stock options in the event of a Change of
Control, the Corporation assumed that all unvested options would vest as per the terms of Section
5.5 of its Share Option Plan and that all vested options having an exercise price lower than the
closing price of the Common Shares on November 30, 2010 on the TSX ($5.65) would be exercised. |
Chantal Desrochers
Vice President, Business Development and Commercialization
The Corporation entered into an employment agreement for an indeterminate term with Mrs. Chantal
Desrochers on March 14, 2005. In addition to her base salary, Mrs. Desrochers is entitled to the
Corporations benefits program and is eligible to receive an annual bonus based on attainment of
objectives set annually by the President and Chief Executive Officer. Mrs. Desrochers was also
entitled to stock options, which have all been granted. Under the terms of the agreement, Mrs.
Desrochers agreed to non-disclosure and assignment of intellectual property provisions in favour of
the Corporation. If the Corporation terminates Mrs. Desrochers employment without just and
sufficient cause, she will receive an amount equal to 12 months of her annual base salary. The
payment of this amount will be the sole monetary obligation of the Corporation.
|
|
|
|
|
|
Statement of Compensation
|
|
Page 24 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
|
|
|
|
|
|
|
|
Severance |
|
Value of Stock Options (1) |
Events |
|
($) |
|
($) |
Retirement (2) |
|
|
|
|
|
|
272,096 |
|
Termination of Employment
without Just Cause (2) |
|
|
246,946 |
|
|
|
272,096 |
|
Termination of Employment
in the event of
a Change of Control (3) |
|
|
246,946 |
|
|
|
346,796 |
|
Voluntary Resignation
in the event of
a Change of Control (3) |
|
|
|
|
|
|
346,796 |
|
Voluntary Resignation (2) |
|
|
|
|
|
|
272,096 |
|
|
|
|
(1) |
|
The value assumes that upon the occurrence of an event, all in-the-money vested options
would be exercised. The value is the difference between the closing price of the Common Shares on
November 30, 2010 on the TSX ($5.65) and the respective exercise price of each vested option as at
November 30, 2010. |
|
(2) |
|
Under the Share Option Plan, the termination of a persons employment with the Corporation
entitles him to exercise his vested options over a six-month period after the termination date. |
|
(3) |
|
Given the different definitions of Change of Control used in the employment agreements of the
Named Executive Officers, in computing the value of the stock options in the event of a Change of
Control, the Company assumed that all unvested options would vest as per the terms of Section 5.5
of its Share Option Plan and that all vested options having an exercise price lower than the
closing price of the Common Shares on November 30, 2010 on the TSX
($5.65) would be exercised. |
E. Performance Graph
The following graph compares a cumulative annual total shareholder return on a $100 investment in
the Common Shares of the Corporation (TH) with a cumulative total shareholder return on the
composite index S&P/TSX (previously known as the Toronto Stock Exchange 300 (TSE 300 Index))
assuming that all dividends are reinvested (S&P) and the AMEX biotech index (AMEX Biotech).
Return on a $100 Investment
from November 30, 2005 to November 30, 2010
|
|
|
|
|
|
Statement of Compensation
|
|
Page 25 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2006 |
|
2007 |
|
2008 |
|
2009 |
|
2010 |
|
Theratechnologies |
|
|
100.00 |
|
|
|
249.50 |
|
|
|
1004.95 |
|
|
|
159.41 |
|
|
|
325.74 |
|
|
|
559.41 |
|
S&P / TSX Composite Index |
|
|
100.00 |
|
|
|
117.81 |
|
|
|
126.47 |
|
|
|
85.65 |
|
|
|
105.76 |
|
|
|
119.67 |
|
AMEX Biotechnology Index |
|
|
100.00 |
|
|
|
114.31 |
|
|
|
123.06 |
|
|
|
88.50 |
|
|
|
131.89 |
|
|
|
169.61 |
|
The trend shown in the above performance graph indicates that, as at November 30 of each of
the 2006, 2007, 2008, 2009 and 2010 years, the annual total shareholder return on a $100 investment
in the Common Shares of the Corporation was above the S&P and approximately the same as the AMEX
Biotech. The base salaries of the Named Executives Officers were not linked to the trend regarding
the annual total shareholder return over the last five years. However, for this period, shareholder
return was one of the parameters taken into consideration in establishing the value of the
short-term performance reward for the Named Executive Officers.
F. Other Information
Description of the Share Purchase Plan
On February 16, 1999, the Board of Directors adopted a common share purchase plan (the Share
Purchase Plan). The Share Purchase Plan was thereafter amended from time to time and, more
recently, by the Board of Directors on February 24, 2009. The last amendments to the Share Purchase
Plan were approved by the shareholders on March 26, 2009 at the Corporations last annual and
special meeting of shareholders.
The Share Purchase Plan entitles full-time and part-time employees of the Corporation who, on a
Participation Date (as defined below), are residents of Canada, are not under a probationary period
and do not hold, directly or indirectly, five percent (5%) or more of the Corporations outstanding
Common Shares, to directly subscribe for Common Shares of the Corporation. The Share Purchase Plan
provides that a maximum of 550,000 Common Shares (0.91% of the issued and outstanding Common Shares
as at November 30, 2010) may be offered to employees. During the fiscal year ended November 30,
2010, the Corporation issued 2,880 Common Shares under the Share Purchase Plan (0.005% of the
issued and outstanding Common Shares as at November 30, 2010). As at the date of the Circular,
207,306 Common Shares remain available for issuance.
On May 1st and November 1st of each year (the Participation
Dates), an
employee may subscribe for a number of Common Shares under the Share Purchase Plan for an amount
that does not exceed during such year 10% of his annual gross salary during said year. Under the
Share Purchase Plan, the Board of Directors has the authority to suspend, differ or determine that
no subscription of Common Shares will be allowed on a Participation Date if it is in the best
interest of the Corporation.
The Share Purchase Plan provides that the number of Common Shares that may be issued to insiders,
at any time, under all security based compensation arrangements of the Corporation, cannot exceed
10% of the outstanding Common Shares, and the number of Common Shares issued to insiders, within
any one-year period, under all security based compensation arrangements, cannot exceed 10% of the
outstanding Common Shares.
The subscription price for each new Common Share subscribed pursuant to the Share Purchase Plan is
equal to the weighted average closing price of the Common Shares on the Toronto Stock Exchange
during a period of five (5) days prior to a Participation Date. Employees cannot assign or
otherwise alienate their rights in the Share Purchase Plan.
|
|
|
|
|
|
Statement of Compensation
|
|
Page 26 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
At the election of an employee, the subscription price for Common Shares may be paid in cash
or through an interest-free loan provided by the Corporation. The loans provided by the Corporation
under the Share Purchase Plan may be repayable by equal withholdings from a participants salary
for a period not exceeding two (2) years. All loans may be prepaid at all times. The loans granted
to any employee at any time must not exceed 10% of his current annual gross salary. All Common
Shares subscribed for through an interest-free loan are hypothecated to secure the full and final
repayment of the loan and are held by the trustee, Computershare, until such full repayment. Loans
are immediately due and repayable upon the occurrence of one of the following events: (i) the
termination of the employment of an employee; (ii) the sale or seizure of the Common Shares being
subject to a hypothec; (iii) the bankruptcy or insolvency of an employee; or (iv) the suspension of
the payment of an employees salary or the revocation of his right to salary withholdings.
Shareholder approval is not required for all amendments to the Share Purchase Plan. For example,
the Board of Directors may, without shareholder approval, make certain amendments of the following
nature to the Share Purchase Plan such as: (i) formal minor or technical amendments to any
provision of the Share Purchase Plan; (ii) corrections to any provision of the Share Purchase Plan
containing an ambiguity, defect, error or omission; or (iii) changes that do not require
shareholder approval as hereafter described. However, the following amendments require the approval
by a majority of the shareholders present at a duly called shareholders meeting:
|
(a) |
|
any extension of the term of the Share Purchase Plan; |
|
|
(b) |
|
any increase in the number of Common Shares reserved for issuance under the Share Purchase Plan; |
|
|
(c) |
|
any increase in the number of Common Shares that may be purchased annually by an employee; |
|
|
(d) |
|
any change in the formula to determine the subscription price of Common Shares; and |
|
|
(e) |
|
any increase in the amount an employee is authorized to borrow from the Corporation to purchase Common Shares under the Share Purchase Plan. |
Indebtedness of Executive Officers
As at the date of the Circular, none of the executive officers was indebted to the Corporation.
2. Director Compensation
A. Determination of Director Compensation
The Corporation has adopted a compensation policy for its directors who are not employed on a
full-time basis by the Corporation under which they are paid an annual retainer fee as well as
attendance fees. In addition, the Corporation reimburses the reasonable expenses incurred by each
director to attend meetings of the board or meetings of committees. In January 2008, the
Compensation Committee met and reassessed the compensation paid to all board members, committee
members and to the chairs of each committee. The last assessment of the compensation paid to
individuals acting as board members, committee members and chairs of such committees had occurred
in 2004. The assessment was based on a review of public documents filed by Canadian companies
listed on the TSX or NASDAQ market. Criteria such as fields of operation, market capitalization,
number of employees, stage of development, where applicable, and level of revenue were taken into
consideration by the Compensation Committee in reviewing in 2008 the compensation paid to
board members, committee members and to chairs of each committee. Based on the recommendation of
the Compensation Committee, effective January 1, 2008, the Board of
|
|
|
|
|
|
Statement of Compensation
|
|
Page 27 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
Directors approved the compensation described in the table below for individuals who are not
employees of the Corporation who act as board members, committee members and chairs of those
committees.
|
|
|
|
|
|
|
|
|
Position at |
|
|
|
|
Board Level or |
|
|
|
|
Committee Level |
|
Compensation |
|
Number |
Annual Retainer to Chair of the Board |
|
$ |
100,000 |
|
|
|
|
|
Annual Retainer to Board Members |
|
$ |
20,000 |
|
|
|
|
|
Annual Grant of Options |
|
|
|
|
|
|
10,000 |
|
Attendance Fees Paid for Each Meeting of the Board of Directors |
|
|
|
|
|
|
|
|
- in person |
|
$ |
2,000 |
|
|
|
|
|
- by conference call |
|
$ |
1,200 |
|
|
|
|
|
Annual Retainer to Chair of the Audit Committee |
|
$ |
10,000 |
|
|
|
|
|
Annual Retainer to Chair of each Committee (other than the Audit Committee) |
|
$ |
6,000 |
|
|
|
|
|
Annual Retainer to Committee Members |
|
$ |
4,000 |
|
|
|
|
|
Attendance Fees Paid for Each Meeting of a Committee(1) |
|
|
|
|
|
|
|
|
- in person |
|
$ |
1,500 |
|
|
|
|
|
- by conference call |
|
$ |
1,200 |
|
|
|
|
|
|
|
|
(1) |
|
No attendance fee is paid for meetings of the Finance Committee. |
B. Director Compensation Table
The following table details all components of the compensation provided to the directors of the
Corporation as at November 30, 2010 and the value thereof.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share- |
|
|
|
|
|
Non-equity |
|
|
|
|
|
|
|
|
|
|
|
|
based |
|
Option-based |
|
incentive plan |
|
Pension |
|
All other |
|
|
|
|
Fees earned |
|
awards |
|
awards (2) |
|
compensation |
|
value |
|
compensation |
|
Total |
Name |
|
($) |
|
($) |
|
($) |
|
($) |
|
($) |
|
($) |
|
($) |
Gilles Cloutier |
|
|
63,800 |
|
|
|
|
|
|
|
36,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
A. Jean de Grandpré |
|
|
83,600 |
|
|
|
|
|
|
|
36,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
119,800 |
|
Robert Goyer (1) |
|
|
40,300 |
|
|
|
|
|
|
|
36,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
76,500 |
|
Gérald A. Lacoste |
|
|
78,133 |
|
|
|
|
|
|
|
36,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
114,333 |
|
Paul Pommier |
|
|
197,967 |
|
|
|
|
|
|
|
36,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
234,167 |
|
Bernard Reculeau |
|
|
42,500 |
|
|
|
|
|
|
|
36,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
78,700 |
|
Jean-Denis Talon |
|
|
53,000 |
|
|
|
|
|
|
|
36,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
89,200 |
|
|
|
|
(1) |
|
The services of Mr. Goyer are provided to the Corporation by Clinipharm (1987) Inc.
(Clinipharm), a corporation controlled by Mr. Goyer, and all cash compensation for the services
of Mr. Goyer is paid to this entity. Based on information received from Clinipharm as at April 13,
2011, Mr. Goyer received no compensation from Clinipharm from December 1, 2009 to November 30,
2010. All options are granted to Mr. Goyer, personally. |
|
|
|
|
|
|
Statement of Compensation
|
|
Page 28 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
(2) |
|
The value of the awards is comprised of one grant that occurred on June 8, 2010 (the June 2010
Grant). As part of the June 2010 Grant, each director who is not an employee of the Corporation
was granted 10,000 options at an exercise price of $4.75. Each option has a ten-year term and vests
on the date of grant. The terms and conditions of those options are governed by the Share Option
Plan. |
|
|
|
The value of the option-based awards was calculated using the Black-Scholes-Merton model and
the IFRS using the following assumptions: |
|
|
|
(i) Risk-free interest rate: 2.61%; |
|
|
|
(ii) Expected volatility in the market price of the Common Shares: 81.77%;
|
|
|
|
(iii) Expected dividend yield: 0%; and
|
|
|
|
(iv) Expected life: 7.5 years |
|
|
|
Fair value per option: $3.62 |
C. Incentive Plan Awards
Outstanding Option-Based Awards and Share-Based Awards
The table below details the outstanding option-based awards and the share-based awards as at
November 30, 2010 for each of the directors who is not an employee of the Corporation.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option-Based Awards |
|
Share-Based Awards |
|
|
Number of |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
securities |
|
|
|
|
|
|
|
|
|
Value of |
|
Number of shares |
|
|
|
|
underlying |
|
|
|
|
|
|
|
|
|
unexercised |
|
or units of shares |
|
Market or payout value |
|
|
unexercised |
|
Option exercice |
|
|
|
|
|
in-the-money |
|
that have not |
|
of share-based awards |
|
|
options |
|
price |
|
Option expiration |
|
options (1) |
|
vested |
|
that have not vested |
Name |
|
(#) |
|
($) |
|
date |
|
($) |
|
(#) |
|
($) |
|
Gilles Cloutier |
|
|
5,000 |
|
|
|
5.40 |
|
|
|
2013.05.07 |
|
|
|
1,250 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
3.68 |
|
|
|
2014.05.03 |
|
|
|
9,850 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.75 |
|
|
|
2015.05.06 |
|
|
|
19,500 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.86 |
|
|
|
2016.03.30 |
|
|
|
18,950 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
8.29 |
|
|
|
2017.03.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
19,250 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
1.84 |
|
|
|
2019.03.28 |
|
|
|
38,100 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
4.75 |
|
|
|
2020.06.08 |
|
|
|
9,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A. Jean de Grandpré |
|
|
5,000 |
|
|
|
11.80 |
|
|
|
2011.05.10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
10.55 |
|
|
|
2012.05.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
5.40 |
|
|
|
2013.05.07 |
|
|
|
1,250 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
3.68 |
|
|
|
2014.05.03 |
|
|
|
9,850 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.75 |
|
|
|
2015.05.06 |
|
|
|
19,500 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.86 |
|
|
|
2016.03.30 |
|
|
|
18,950 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
8.29 |
|
|
|
2017.03.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
19,250 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
1.84 |
|
|
|
2019.03.28 |
|
|
|
38,100 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
4.75 |
|
|
|
2020.06.08 |
|
|
|
9,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert Goyer |
|
|
5,000 |
|
|
|
8.29 |
|
|
|
2017.03.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
4.75 |
|
|
|
2020.06.08 |
|
|
|
9,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gérald A. Lacoste |
|
|
5,000 |
|
|
|
1.86 |
|
|
|
2016.03.30 |
|
|
|
18,950 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
8.29 |
|
|
|
2017.03.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
19,250 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
1.84 |
|
|
|
2019.03.28 |
|
|
|
38,100 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
4.75 |
|
|
|
2020.06.08 |
|
|
|
9,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statement of Compensation
|
|
Page 29 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option-Based Awards |
|
Share-Based Awards |
|
|
Number of |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
securities |
|
|
|
|
|
|
|
|
|
Value of |
|
Number of shares |
|
|
|
|
underlying |
|
|
|
|
|
|
|
|
|
unexercised |
|
or units of shares |
|
Market or payout value |
|
|
unexercised |
|
Option exercice |
|
|
|
|
|
in-the-money |
|
that have not |
|
of share-based awards |
|
|
options |
|
price |
|
Option expiration |
|
options (1) |
|
vested |
|
that have not vested |
Name |
|
(#) |
|
($) |
|
date |
|
($) |
|
(#) |
|
($) |
|
Paul Pommier |
|
|
5,000 |
|
|
|
11.80 |
|
|
|
2011.05.10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
10.55 |
|
|
|
2012.05.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
5.40 |
|
|
|
2013.05.07 |
|
|
|
1,250 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
3.68 |
|
|
|
2014.05.03 |
|
|
|
9,850 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.75 |
|
|
|
2015.05.06 |
|
|
|
19,500 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.86 |
|
|
|
2016.03.30 |
|
|
|
18,950 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
8.29 |
|
|
|
2017.03.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
19,250 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
1.84 |
|
|
|
2019.03.28 |
|
|
|
38,100 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
4.75 |
|
|
|
2020.06.08 |
|
|
|
9,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bernard Reculeau |
|
|
5,000 |
|
|
|
1.86 |
|
|
|
2016.03.30 |
|
|
|
18,950 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
8.29 |
|
|
|
2017.03.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
19,250 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
1.84 |
|
|
|
2019.03.28 |
|
|
|
38,100 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
4.75 |
|
|
|
2020.06.08 |
|
|
|
9,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jean-Denis Talon |
|
|
5,000 |
|
|
|
11.80 |
|
|
|
2011.05.10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
10.55 |
|
|
|
2012.05.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
5.40 |
|
|
|
2013.05.07 |
|
|
|
1,250 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
3.68 |
|
|
|
2014.05.03 |
|
|
|
9,850 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.75 |
|
|
|
2015.05.06 |
|
|
|
19,500 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.86 |
|
|
|
2016.03.30 |
|
|
|
18,950 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
8.29 |
|
|
|
2017.03.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
19,250 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
1.84 |
|
|
|
2019.03.28 |
|
|
|
38,100 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
4.75 |
|
|
|
2020.06.08 |
|
|
|
9,000 |
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The value of unexercised in-the-money options at financial year end is the difference
between the closing price of the Common Shares on November 30, 2010 ($5.65) on the TSX and the
respective exercise price of the options. |
|
|
|
|
|
|
Statement of Compensation
|
|
Page 30 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
Incentive Plan Awards Value vested or earned during the year
The table below shows the value vested or earned during the year under each incentive plan as at
November 30, 2010 for each of the directors.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-equity incentive |
|
|
Option-based awards |
|
Share-based awards |
|
plan compensation |
|
|
Value vested during |
|
Value vested |
|
Value earned |
|
|
the year (1) |
|
during the year |
|
during the year |
Name |
|
($) |
|
($) |
|
($) |
Gilles Cloutier |
|
|
200 |
|
|
|
|
|
|
|
|
|
A. Jean de Grandpré |
|
|
200 |
|
|
|
|
|
|
|
|
|
Robert Goyer |
|
|
200 |
|
|
|
|
|
|
|
|
|
Gérald A. Lacoste |
|
|
200 |
|
|
|
|
|
|
|
|
|
Paul Pommier |
|
|
200 |
|
|
|
|
|
|
|
|
|
Bernard Reculeau |
|
|
200 |
|
|
|
|
|
|
|
|
|
Jean-Denis Talon |
|
|
200 |
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The value is determined by assuming that the options vested during the financial year would
have been exercised on the vesting date. The value corresponds to the difference between the
closing price of the Common Shares on the TSX on the vesting date ($4.77) and the exercise price of
the options on that date ($4.75). Options granted to directors as part of the June 2010 Grant
vested on their date of grant. In compliance with the Share Option Plan, the exercise price of the
options was equal to the closing price of the Common Shares on the day preceding the date of grant
of the options ($4.75). |
D. Other Information
Indebtedness of Directors
As at the date of the Circular, none of the directors of the Corporation and proposed nominee
for election as a director of the Corporation is indebted to the Corporation. During the
financial year ended on November 30, 2010, none of the directors of the Corporation was
indebted to the Corporation.
Liability Insurance of Directors and Officers
The Corporation purchases liability insurance for its directors and officers in the performance
of their duties. These insurance policies also cover the directors and officers of the
Corporations subsidiaries. During the fiscal year ended November 30, 2010, the policies
provided maximum coverage of $20,000,000 per claim, subject to a $200,000 deductible per
occurrence. Premiums paid by the Corporation for the policies amounted to $109,000. The
policies and the premiums do not distinguish between the insurance for the directors liability
and officers liability, the coverage being the same for both groups.
|
|
|
|
|
|
Statement of Compensation
|
|
Page 31 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
ITEM III. CORPORATE GOVERNANCE DISCLOSURE
The Board of Directors of the Corporation considers good corporate governance to be important to
the effective operations of the Corporation and to ensure that the Corporation is managed so as to
optimize shareholder value. The Nominating and Corporate Governance Committee is responsible for
examining the Corporations needs in this regard and addressing all issues that may arise from its
practices. This Committee ensures that the Corporations corporate governance practices comply with
Regulation 58-101 respecting Disclosure of Corporate Governance Practices (Québec) and oversees
their disclosure according to guidelines described in Policy Statement 58-201 to Corporate
Governance Guidelines
(Québec) (hereinafter collectively referred to as the Regulation).
1. Board of Directors
A. Independence
A majority of the Corporations directors are independent. Seven of the nine Board members meet the
criteria for independence defined by the Regulation, as none of them have a direct or indirect
material relationship with the Corporation.
|
|
|
|
|
Name |
|
Independence |
|
Material Relationship |
Gilles Cloutier
|
|
Yes
|
|
None |
A. Jean de Grandpré
|
|
Yes
|
|
None |
Robert Goyer
|
|
Yes
|
|
None |
Gérald A. Lacoste
|
|
Yes
|
|
None |
Paul Pommier
|
|
Yes
|
|
None |
Bernard Reculeau
|
|
Yes
|
|
None |
Jean-Denis Talon
|
|
Yes
|
|
None |
Luc Tanguay
|
|
No
|
|
Corporation Management |
Yves Rosconi (1)
|
|
No
|
|
Corporation Management |
|
|
|
(1) |
|
Yves Rosconi was replaced as a director of the Corporation on December 2, 2010 by Mr.
John-Michel Huss, the current President and Chief Executive Officer of the Corporation. |
The Chairman of the Board of the Corporation is Paul Pommier, an independent director within
the meaning of the Regulation.
B. Meetings of the Board
The table below details the directors attendances to the Board of Directors meetings held in the
financial year ended on November 30, 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
Name |
|
Number of Meetings |
|
Attendance |
|
Absence |
Gilles Cloutier |
|
|
9 |
|
|
|
8 |
|
|
|
1 |
|
A. Jean de Grandpré |
|
|
9 |
|
|
|
9 |
|
|
|
0 |
|
Robert Goyer |
|
|
9 |
|
|
|
9 |
|
|
|
0 |
|
Gérald A. Lacoste |
|
|
9 |
|
|
|
9 |
|
|
|
0 |
|
Paul Pommier |
|
|
9 |
|
|
|
9 |
|
|
|
0 |
|
Bernard Reculeau |
|
|
9 |
|
|
|
9 |
|
|
|
0 |
|
Jean-Denis Talon |
|
|
9 |
|
|
|
9 |
|
|
|
0 |
|
Luc Tanguay |
|
|
9 |
|
|
|
9 |
|
|
|
0 |
|
Yves Rosconi |
|
|
9 |
|
|
|
8 |
|
|
|
1 |
|
|
|
|
|
|
|
Corporate Governance Disclosure
|
|
Page 32 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
A meeting of independent directors, at which non-independent directors and members of
management are not in attendance, is planned as the last item of each Board meeting. Accordingly,
at the conclusion of each Board meeting, the Chairman determines, along with the other independent
directors, the relevance of meeting without non-independent directors and members of management.
During the financial year ended November 30, 2010, independent directors held three (3) meetings
without members of management.
C. Other Board Memberships
No director of the Corporation is a board member of another reporting issuer.
2. Mandate of the Board of Directors
The Board of Directors adopted the written mandate attached hereto as Appendix C which defines its
role and duties.
Consistent with its mandate of identifying key business risks facing the Corporation and
implementing systems to manage those risks, during the financial year ended November 30, 2009, the
Board of Directors undertook to review the various risks faced by the Corporation. To that end, the
Board of Directors delegated to the Audit Committee the responsibility of supervising the
management team involved in this process. The process was two-pronged: first, it consisted in
identifying the most important risks to the Corporation and, second, it consisted in reviewing and
testing the measures in place to manage the identified risks and, alternatively, create measures if
none was in place. During the financial year ended November 30, 2010, many existing measures were
tested and, where applicable, improved. In addition, where needed, certain measures were created to
address certain risks.
3. Position Descriptions
The Board of Directors has developed written position descriptions for the Chairman of the Board
and the Chairs of the Boards Committees. A position description was also developed for the
President and Chief Executive Officer.
4. Orientation and Continuing Education
The Orientation and Continuing Education Policy for newly appointed directors is attached hereto as
Appendix D.
In the last financial year, the Corporation provided its directors with reading material covering
topics in various fields, including biotechnology, corporate governance and executive compensation.
Members of the Audit Committee also continued to educate themselves with the IFRS accounting rules
adopted by the Corporation.
5. Ethical Business Code of Conduct
The Board of Directors has adopted a written ethical business code of conduct dated February 18,
2011 (the Code of Ethics) for the Corporations directors, executive officers and employees. The
Code of Ethics contains rules regarding human rights laws, the confidentiality of the Corporations
information, insider trading, conflicts of interest and the use of the Corporations information
technology systems. The Code of Ethics encourages and promotes ethical business conduct that
upholds integrity and fault prevention. The Code of Ethics is available on the Corporations
website (www.theratech.com).
|
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Corporate Governance Disclosure
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Management Proxy Circular
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Theratechnologies Inc. |
6. Corporate Governance and Nomination of Directors
The Nominating and Corporate Governance Committee is responsible for proposing new candidates for
Board nominations and for reviewing the Corporations governance practices. This Committee is
comprised exclusively of independent directors, namely Gerald Lacoste, who is the Chair, Gilles
Cloutier, A. Jean de Grandpré, Robert Goyer and Paul Pommier. A copy of the Committees Charter is
attached hereto as Appendix E.
The Nominating and Corporate Governance Committee met at the beginning of the current financial
year to discuss various governance matters, including the election mode of directors, the
assessment of the Board of Directors and each of its committees, the assessment of each director
and each committee member and succession planning.
The table below details members attendance to the Nominating and Corporate Governance Committees
meeting held in the financial year ended November 30, 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
Name |
|
Number of Meeting |
|
Attendance |
|
Absence |
Gérald A. Lacoste |
|
|
1 |
|
|
|
1 |
|
|
|
0 |
|
Gilles Cloutier |
|
|
1 |
|
|
|
1 |
|
|
|
0 |
|
Jean A. de Grandpré |
|
|
1 |
|
|
|
1 |
|
|
|
0 |
|
Robert Goyer |
|
|
1 |
|
|
|
1 |
|
|
|
0 |
|
Paul Pommier |
|
|
1 |
|
|
|
1 |
|
|
|
0 |
|
7. Compensation
A. Independence
The Compensation Committee is responsible for examining matters relating to the compensation of
directors and executive officers on behalf of the Board of Directors. The Compensation Committee is
comprised exclusively of independent directors, namely A. Jean de Grandpré, who acted as Chair
until December 31, 2010, Bernard Reculeau, Paul Pommier and Jean-Denis Talon, the current Chair. A
detailed description of the procedure used by the Compensation Committee to establish compensation
is provided under Item II of the Circular.
In the last financial year, the Compensation Committee retained the services of Tower Watson, an
independent third-party consulting firm, to assess the long-term incentive plan for both the
directors and executive officers. The work performed by Towers Watson resulted in the Board of
Directors adopting the DSU Plan. For a description of the DSU Plan, see Item II Long-term
Incentive Program Description of the Deferred Share Unit Plan.
B. Meetings of the Compensation Committee
The table below details members attendance to the Compensation Committees meetings held in the
financial year ended November 30, 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
Name |
|
Number of Meetings |
|
Attendance |
|
Absence |
A. Jean de Grandpré |
|
|
3 |
|
|
|
3 |
|
|
|
0 |
|
Paul Pommier |
|
|
3 |
|
|
|
3 |
|
|
|
0 |
|
Bernard Reculeau |
|
|
3 |
|
|
|
3 |
|
|
|
0 |
|
Jean-Denis Talon |
|
|
3 |
|
|
|
3 |
|
|
|
0 |
|
|
|
|
|
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Corporate Governance Disclosure
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Page 34 |
Management Proxy Circular
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|
Theratechnologies Inc. |
8. Audit Committee
A. Independence
The Corporation has an audit committee comprised of three independent directors, namely Paul
Pommier, who is the Chair, Gérald A. Lacoste and Jean-Denis Talon. Reference is made to Item 4.2 of
the Corporations annual information form dated February 22, 2011 for a description of the Audit
Committee.
Each member of the Audit Committee has acquired in-depth financial expertise giving each the
ability to read and understand a set of financial statements which presents the breadth and level
of complexity of accounting issues that are generally comparable to those that can reasonably be
expected to be raised in the Corporations financial statements.
B. Meetings of the Audit Committee
The table below details members attendance to the Audit Committees meetings held in the financial
year ended on November 30, 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
Name |
|
Number of Meetings |
|
Attendance |
|
Absence |
Gérald A. Lacoste |
|
|
4 |
|
|
|
4 |
|
|
|
0 |
|
Paul Pommier |
|
|
4 |
|
|
|
4 |
|
|
|
0 |
|
Jean-Denis Talon |
|
|
4 |
|
|
|
4 |
|
|
|
0 |
|
A meeting of the members, at which members of management are not in attendance, is planned as
the last item of each Audit Committee meeting when members of management are asked to attend Audit
Committee meetings. Accordingly, at the conclusion of each Audit Committee meeting, the Chairman
determines, along with the members, the relevance of meeting without members of management. During
the last financial year ended November 30, 2010, members held 4 meetings without members
of management.
9. Strategic Committee
The Strategic Committee was created in august 2007 to review potential strategic alternatives to
enhance shareholder value such as the entering into of a co-promotion or a partnership agreement
with regards to tesamorelin, the finding of a possible partner, acquiror or target business with a
view to complete a merger, a sale or an acquisition. As a result of the announcement in October
2008 of the collaboration and licensing agreement entered into between the Corporation and EMD
Serono, Inc., the mandate of the Strategic Committee was changed by the Board of Directors
The Strategic Committee currently has the following role and responsibilities:
- |
|
to evaluate and review the various business alternatives of the Corporation for enhancing shareholder
value (the Strategic Alternatives); |
|
- |
|
to make recommendations to the Board of Directors with respect to the Strategic Alternatives and to
undertake a process it considers appropriate in order to provide such recommendations; |
|
- |
|
if one of the Strategic Alternatives is approved by the Board of Directors, to maintain, on behalf of
the Board of Directors, a review of its implementation; and |
|
- |
|
to perform any action deemed necessary or advisable to comply with its duties and obligations under
applicable laws. |
|
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Corporate Governance Disclosure
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Page 35 |
Management Proxy Circular
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Theratechnologies Inc. |
Further to the announcement in June 2010 of the retirement of Mr. Yves Rosconi as President
and Chief Executive Officer of the Corporation, the Strategic Committee became responsible to
recruit a new President and Chief Executive Officer. In undertaking this mandate, the Strategic
Committee retained the services of Egon Zehnder International, and independent third-party
consulting firm specialized in the recruitment of senior executives. The Strategic Committee is
composed of four (4) independent directors, namely Paul Pommier, who is the Chair, Gilles Cloutier,
A. Jean de Grandpré and Gérald A. Lacoste.
The table below details the members attendance to the Strategic Committees meetings held in the
financial year ended on November 30, 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
Name |
|
Number of Meetings |
|
Attendance |
|
Absence |
Gilles Cloutier |
|
|
16 |
|
|
|
15 |
|
|
|
1 |
|
A. Jean de Grandpré |
|
|
16 |
|
|
|
16 |
|
|
|
0 |
|
Gérald A. Lacoste |
|
|
16 |
|
|
|
16 |
|
|
|
0 |
|
Paul Pommier |
|
|
16 |
|
|
|
16 |
|
|
|
0 |
|
A meeting of the members, at which members of management are not in attendance, is planned as
the last item of each Strategic Committee meeting when members of management are asked to attend
Strategic Committee meetings. Accordingly, at the conclusion of each Strategic Committee meeting,
the Chairman determines, along with the members, the relevance of meeting without members of
management. During the last financial year ended November 30, 2010, members held ten (10)
meetings without members of management.
10. Financing Committee
For the current financial year, the Financing Committee is composed of three (3) independent
directors, namely A. Jean de Grandpré, who is the Chair, Paul Pommier and Jean-Denis Talon, and the
President and Chief Executive Officer and the Senior Executive Vice President and Chief Financial
Officer. The Financing Committees mandate is to study and analyze financing matters. No meeting of
the Financing Committee was held in the financial year ended November 30, 2010.
|
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Corporate Governance Disclosure
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Page 36 |
Management Proxy Circular
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Theratechnologies Inc. |
ITEM IV. OTHER INFORMATION
1. Additional Documentation
The Corporation is a reporting issuer in all Canadian provinces and is required to file its
financial statements and Circular with each Canadian Securities Commission. Each year, the
Corporation also files an Annual Information Form with such commissions. The financial information
of the Corporation is provided in the Corporations comparative financial statements and
Managements Discussion & Analysis for its fiscal year ended November 30, 2010. Copies of the
Corporations financial statements, management proxy circular and Annual Information Form may be
obtained on request to the Secretary of the Corporation at the following address: 2310 Alfred-Nobel
Blvd, Montreal, Québec, H4S 2B4 or by consulting the SEDAR Website at www.sedar.com. The
Corporation may require the payment of a reasonable fee if the request is made by someone other
than a security holder of the Corporation, unless the Corporation is in the course of a
distribution of its securities pursuant to a short-form prospectus, in which case these documents
will be provided free of charge.
2. Approval by the Board Of Directors
The content and the sending of this Circular have been approved by the Board of Directors of the
Corporation on April 14, 2011.
Montreal, Québec, April 14, 2011.
Jocelyn Lafond
Corporate Secretary
|
|
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|
Other Information
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Page 37 |
Management Proxy Circular
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|
Theratechnologies Inc. |
APPENDIX A
SPECIAL RESOLUTION OF THE SHAREHOLDERS OF
THERATECHNOLOGIES INC. (THE CORPORATION)
RESOLUTION 2011-1
AMENDMENT TO THE ARTICLES OF THE CORPORATION
BE IT RESOLVED:
1. |
|
That the amendment to the articles of the Corporation to provide the directors with the right
to appoint one or more additional directors to hold office for a term expiring not later than
the close of the next annual shareholders meeting, subject to the total number of directors so
appointed not exceeding one third of the number of directors elected at the previous annual
shareholders meeting, be and is hereby approved; |
|
2. |
|
That the Corporation be, and it is hereby authorized, to file articles of amendment (the
Articles of Amendment) with the Enterprise Registrar and any other competent regulatory
authority; |
|
3. |
|
That any director or officer of the Corporation be, and is hereby authorized, to execute and
deliver the Articles of Amendment and any other document and instrument and to take such other
actions, for and on behalf of the Corporation, as such director or officer may deem necessary
or advisable to give effect to this resolution in his entire discretion, his determination
being conclusively evidenced by the execution and delivery of such documents or instruments
and the taking of such actions. |
|
|
|
|
|
|
Appendix A Resolution 2011-1 |
|
|
Management Proxy Circular
|
|
Theratechnologies Inc. |
APPENDIX B
COMPENSATION COMMITTEE CHARTER
I. Mandate
The Compensation Committee (the Committee) is responsible for assisting the Corporations Board
of Directors (the Board) in overseeing the following:
|
A. |
|
compensation of Senior Management; |
|
|
B. |
|
assessment of Senior Management; |
|
|
C. |
|
compensation of Directors; |
|
|
D. |
|
stock option grants; |
|
|
E. |
|
overall increase in total compensation. |
II. Obligations and Duties
The Committee carries out the duties usually entrusted to a compensation committee and any other
duty assigned from time to time by the Board. Specifically, the Committee is charged with the
following obligations and duties:
|
A. |
|
Compensation of Senior Management |
|
1. |
|
Develop a compensation policy for the Corporations Senior Management, notably
the Senior Management compensation structure, annual salary adjustments as well as the
creation and administration of short and long term incentive plans, stock options,
indirect advantages and benefits proposed by the President and Chief Executive Officer. |
|
|
2. |
|
Review and establish all forms of compensation to Senior Management. |
|
|
3. |
|
Oversee, as required, employment contracts and terminations of Senior
Management, notably severance pay. |
|
|
4. |
|
Oversee the Corporations annual report on Senior Management compensation part
of the Corporations continuous disclosure requirements under applicable laws and
regulations. |
|
B. |
|
Assessment of Senior Management |
|
1. |
|
Develop a written position description for the President and Chief Executive
Officer. |
|
|
2. |
|
Establish general objectives annually for the President and Chief Executive
Officer of the Corporation and for other members of senior management. |
|
|
|
|
|
|
Appendix B Compensation Committee Charter |
|
|
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
3. |
|
Examine and review annually the President and Chief Executive Officers
performance against specific performance criteria pre-established by the
Committee. |
|
|
4. |
|
Examine, in collaboration with the President and Chief Executive Officer,
the annual performance assessment of other senior managers. |
|
C. |
|
Compensation of Directors |
|
1. |
|
Recommend to the Board approval of the Directors Compensation Policy. |
|
|
2. |
|
Examine the compensation of Directors in relation to the risks and duties
of their position. |
|
1. |
|
Oversee, review as needed and recommend Board approval of the Corporation
Share Option Plan. |
|
|
2. |
|
The Committee may delegate, at its discretion, the plans administration
to members of the Corporations Management and employees. |
|
|
3. |
|
Examine, oversee and recommend Board approval of stock option grants,
specifically: |
|
a. |
|
the people to whom options are granted; |
|
|
b. |
|
the number of options granted; |
|
|
c. |
|
the exercise price of the options; |
|
|
d. |
|
the exercise period of the options; and |
|
|
e. |
|
all other conditions relating to options granted. |
|
4. |
|
Overall Increase in Total Compensation |
|
|
|
|
Approve annually the Corporations increase in overall compensation. |
III. External Advisors
In discharging its duties and responsibilities, the Committee is empowered to retain external legal
counsel or other external advisors, as appropriate. The Corporation shall provide the necessary
funds to secure the services of such advisors.
IV. Composition of the Committee
The Committee is composed of any number of Directors, but no less than three, as may be determined
by the Board from time to time by resolution. Each member of the Committee shall be independent
from the Corporation, as determined by the Board, in accordance with applicable laws, rules and
regulations.
|
|
|
|
|
|
Appendix B Compensation Committee Charter |
|
|
Management Proxy Circular
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|
Theratechnologies Inc. |
V. Term of the Mandate
Committee members are appointed by Board resolution to carry out their mandate extending from the
date of the appointment to the next annual general meeting of shareholders, or until successors are
so appointed.
VI. Vacancy
The Board may fill vacancies at any time by resolution. Subject to the constitution of the quorum,
the Committees members can continue to act even if there is one or many vacancies on the
Committee.
VII. Chairman
The Board appoints the Committee Chairman who will call and chair the meetings.
VIII. Secretary
Unless decided otherwise by resolution of the Board, the Secretary of the Corporation shall act as
Committee Secretary. The Secretary must attend Committee meetings and prepare the minutes. He/she
must provide notification of meetings as directed by the Committee Chairman. The Secretary is the
guardian of the Committees records, books and archives.
IX. Meeting Proceedings
The Committee establishes its own procedures as to how meetings are called and conducted. Unless it
is otherwise decided, the Committee shall meet privately and independently from Management at each
regularly scheduled meeting. In the absence of the regularly appointed Chairman, the meeting shall
be chaired by another Committee member selected among attending participants and appointed
accordingly. In the absence of the regularly appointed Secretary, Committee members shall designate
someone to carry out this duty.
X. Quorum and Vote
Unless the Board otherwise specifies by resolution, two Committee members shall constitute an
appropriate quorum for deliberation of items on the agenda. During meetings, decisions are reached
by a majority of votes from Committee members, unless the quorum is of two members, in which case
decisions are made by consensus of opinion.
XI. Records
The Committee keeps records that are deemed necessary for its deliberations and reports to the
Board on its activities and recommendations on a regular basis.
XII. Effective Date
This charter was adopted by the Directors at its May 3, 2004 Board meeting. It was amended by the
Directors during the February 8, 2006 Board meeting.
|
|
|
|
|
|
Appendix B Compensation Committee Charter |
|
|
Management Proxy Circular
|
|
Theratechnologies Inc. |
APPENDIX C
MANDATE OF THE BOARD OF DIRECTORS
I. Role
The Corporations Board of Directors (the Board) is ultimately responsible for the stewardship of
the Corporation and executes its mandate directly or after considering recommendations from its
related committees and Management.
Management is responsible for the Corporations day-to-day activities and is charged with realizing
strategic activities approved by the Board within the scope of its authorized business activities,
capitalization plan and Corporation directives. Management must report regularly to the Board on
matters relating to short-term results and long-term development activities.
II. Obligations and Responsibilities
The Board carries out the functions, performs duties and assumes the responsibilities entrusted by
the laws and regulations. The Board may delegate some of its responsibilities to Board committees
and Management within the scope of the Corporations General By-laws, the laws and the regulations.
Therefore, day-to-day management of the Corporations activities is entrusted to Senior Management,
which reports directly to the Board. One of the key functions of the Board is to appoint the
senior management team.
The functions and duties of Board members include, without limitation, the following functions and
duties:
|
A. |
|
Appointment, assessment, succession planning of Senior Management |
|
1. |
|
Select and appoint the President and Chief Executive Officer of the
Corporation. |
|
|
2. |
|
Oversee the appointment of other members of Senior Management. |
|
|
3. |
|
Ensure that the Corporation has a succession plan for the President and
Chief Executive Officer. |
|
|
4. |
|
Monitor the performance of the President and Chief Executive Officer and
others Executive Officers, with respect to pre-established objectives. |
|
B. |
|
Compensation of Directors |
|
1. |
|
Establish the compensation of Directors. |
|
C. |
|
Strategic Direction and Planning |
|
1. |
|
Adopt the Corporations strategic planning process. |
|
|
2. |
|
Approve the Corporations strategic plan and review Senior Managements
performance in implementing the plan. |
|
|
|
|
|
|
Appendix C Mandate of the Board of Directors |
|
|
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
3. |
|
Review the strategic plan annually, taking into account opportunities and
risks, and monitoring the Corporations performance against the plan. |
|
|
4. |
|
Review and approve the Corporations annual plans towards financing the
strategic plan. |
|
|
5. |
|
Review and approve the Corporations annual operating budget. |
|
|
6. |
|
Identify key business risks facing the Corporation and the implementation
of appropriate systems to manage these risks. |
|
|
7. |
|
Discuss with Management how the strategic environment is changing and the
key strategic issues. |
|
D. |
|
Corporate Behaviour and Governance |
|
1. |
|
Develop an approach to corporate governance, including the determination
of principles and guidelines for the Corporation. |
|
|
2. |
|
Obtain reasonable assurance of the integrity of the President and Chief
Executive Officer and other senior members of Management, and that they uphold
principles of integrity within the ranks of the Corporation. |
|
|
3. |
|
Oversee the implementation of a Corporation disclosure policies and
procedures. |
|
|
4. |
|
Monitor the integrity of the Corporations internal controls and
disclosure systems. |
|
|
5. |
|
Be available to receive feedback from stakeholders, which must be
provided in writing, at the Corporations head office, bearing the mention
Confidendial. |
|
1. |
|
Keep up-to-date with the regular programs and employees of the
Corporation. |
|
|
2. |
|
Upon request, join a committee and actively participate at its meetings. |
|
|
3. |
|
Be accessible, at least by telephone, to personnel and other Corporation
Directors, as required. |
|
|
4. |
|
Keep confidential information discussed during meetings. |
|
|
5. |
|
Attend regular and special Board meetings. |
|
|
6. |
|
Get to know other members of the Board and promote collegial
decision-making. |
III. External Advisors
In discharging its duties and responsibilities, the Board is empowered to retain external legal
counsel or other external advisors, as appropriate. The Corporation shall provide the necessary
funds to secure the services of such advisors.
|
|
|
|
|
|
Appendix C Mandate of the Board of Directors |
|
|
Management Proxy Circular
|
|
Theratechnologies Inc. |
IV. Composition of the Board
The Board consists of such number of Directors as the Board may determine from time to time by
resolution. The Board must assure itself that it is composed of Directors that are sufficiently
familiar with the business of the Corporation, and the risks it faces, to ensure active and
effective participation in the deliberations of the Board. Directors should have diverse
backgrounds and personal characteristics and traits as well as competencies and expertise that add
value to the Corporation. Finally, a majority of the Directors must be independent for the purposes
of National Policy 58-201 Corporate Governance Guidelines.
V. Board Meeting Procedures
The Board follows the procedure established in the Corporations General By-Laws.
VI. Records
The Corporations Secretary keeps the records required by law and any other relevant document.
VII. Effective Date
This written mandate was adopted by the Directors at its February 8, 2006 Board meeting.
|
|
|
|
|
|
Appendix C Mandate of the Board of Directors |
|
|
Management Proxy Circular
|
|
Theratechnologies Inc. |
APPENDIX D
DIRECTOR ORIENTATION AND CONTINUING EDUCATION POLICY
The Board must first ensure that every new nominee as Director possesses the necessary skill,
expertise, availability and knowledge to properly fulfil its mandate. Once a Director is
effectively elected, the Chairman of the Board, the President and Chief Executive Officer and
Secretary provide him with the specific information required for a well-informed contribution.
I. Purpose
The purpose of this Director Orientation and Continuing Education Policy (the Policy) is to set
forth the Corporations process of orientation for newly appointed Corporation Directors to
familiarize them with the role of the Corporations Board of Directors, its committees, its
directors, and the nature and operation of the Corporations business activities. The Policy also
indicates the elements of continuing education of the Board of Directors to ensure the Corporation
Directors maintain the skill and knowledge necessary to fulfill their obligations as directors.
II. Orientation of New Directors
Newly appointed Directors first meet with the Chairman of the Board to discuss the functioning of
the Board of Directors. Then, they meet with the President and Chief Executive Officer to discuss
the nature and operation of the Corporations business activities. As required, meetings may be set
up with other Senior Managers to further clarify some of the Corporations business activities.
Finally, the Secretary provides new directors with the following documents:
|
A. |
|
Copies of Board meeting minutes and written resolutions since the beginning of
the fiscal year (which may include those of the preceding fiscal year, depending of the date
of appointment), including a copy of the minutes of the last annual meeting; |
|
|
B. |
|
A schedule of Board Meetings for the year; |
|
|
C. |
|
The disclosure policies et procedures and the Undertaking form (for
signature); |
|
|
D. |
|
The policy on insider trading in force at Theratechnologies (with mention to
register as an insider with the Canadian securities agency through SEDI.ca and to prepare an
initial insider report within ten (10) days following appointment); |
|
|
E. |
|
Theratechnologies Share Option Plan; |
|
|
F. |
|
The latest annual report and accompanying information on Theratechnologies (fact
sheet, latest press releases, latest annual information form and corporate presentation); |
|
|
G. |
|
The Director Disclosure Form (to complete and return within afforded time); |
|
|
H. |
|
The General By-Laws, the Boards written mandate, the Audit Committee Charter,
Compensation Committee Charter, Nominating and Corporate Governance Charter; and |
|
|
I. |
|
The Directors and Senior Management coverage and compensation. |
|
|
|
|
|
|
Appendix D Director Orientation and Continuing Education Policy |
|
|
Management Proxy Circular
|
|
Theratechnologies Inc. |
III. Continuing Education
The following actions are taken to ensure the continuing education of Directors:
|
A. |
|
Management provides Directors, from time to time, with pertinent articles and
books relating to the Corporations business, its competitors, corporate governance and
regulatory issues; |
|
|
B. |
|
Key Corporation executives make regular presentations to the Board on business
activities; |
|
|
C. |
|
Certain consultants present to the Board on matters relevant to their role and
duties.
Consultants such as insurance brokers presenting on risks faced by the Corporation or
consultants presenting a long-term strategy for the Corporation; |
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The Secretary offers Directors continuing education in the form of presentations
on new legal and regulatory requirements that impact the Board. |
IV. Review
This Policy is reviewed and modified when the Board of Directors considers it necessary and
desirable.
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Appendix D Director Orientation and Continuing Education Policy |
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Management Proxy Circular
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Theratechnologies Inc. |
APPENDIX E
NOMINATING AND CORPORATE GOVERNANCE COMMITTEE CHARTER
I. Mandate
The Nominating and Corporate Governance Committee (the Committee) is responsible for assisting
the Corporations Board of Directors (the Board) in overseeing the following:
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Recruit candidates for the Board; |
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Review the size of the Board; |
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Composition of the Board; |
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Function of the Board; |
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Orientation and education of Board members; and |
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Governance. |
II. Obligations and Duties
The Committee carries out the duties usually entrusted to a Nominating and Corporate Governance
Committee and any other duty assigned from time to time by the Board. Specifically, the Committee
is charged with the following obligations and duties:
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Recruit Candidates for the Board |
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Identify potential candidates as members of the Corporations Board of
Directors. In so doing, the Committee will consider: |
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independence of candidates under the terms of National Policy
58-201 on corporate governance; |
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b. |
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the competencies, skills and personal characteristics sought in
candidates.
The Committee will determine what it considers necessary by assessing
competencies, skills and personal characteristics of the candidates in
relation to: (1) those generally required by the Board; (2) those already
present in other Board members; and (3) those which are a welcome
addition; and |
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c. |
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the availability of candidates. |
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All Board members may submit to the Committee potential candidates for
membership, and the Committee shall review such candidates in light of above
described competencies and skills desirable for the Board. |
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The Committee shall proceed as follows for the recruitment of candidates: |
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Appendix E Nominating and Corporate Governance Committee Charter |
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Management Proxy Circular
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Theratechnologies Inc. |
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as it is determined by the Committee and the Board of Directors that
Board vacancies must be filled or new members are desirable, the Chairman of
the Board of Directors shall make contact with candidates that have been
identified by the Committee per the above described criteria; |
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b. |
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upon a positive evaluation by the Chairman of the Board of Directors and
positive reaction from the candidate, at least two (2) members of the Board shall meet
with the candidate; and |
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c. |
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upon a positive evaluation by the two (2) Board members and the
continuing interest of the candidate, the Committee shall make a recommendation to the
Board of Directors, providing all pertinent background information for analysis and
discussion by the Directors. |
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Board Size |
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The Board must be composed of 3 to 20 directors, as per the Corporations articles of
incorporation and by law. As provided under the terms of the Corporation General By-Laws, the
Board shall exercise its power to establish by resolution the exact number of directors. In
this regard, the duties of the Committee are as follows: |
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Examine the size of the Board annually in view of assessing its effectiveness. |
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Consider modifications to the number of constituting members and issue its
recommendations to the Board. |
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Composition of the Board |
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Ensure that the Board is composed of Directors that are sufficiently familiar
with the business of the Corporation, and the risks it faces, to ensure active and
effective participation in the deliberations of the Board. |
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2. |
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Ensure that Directors have diverse backgrounds and personal characteristics and
traits as well as competencies and expertise that add value to the Corporation. |
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3. |
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Ensure that a majority of the directors are independent directors for the
purposes of National Policy 58-201 Corporate Governance Guidelines. |
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Examine the Boards functions and issue recommendations as to its obligations
and role. Among others, the Committee must regularly review the Boards written
mandate. |
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2. |
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Determine and review, as needed, the roles and mandates of Board committees and
issue recommendations. |
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Orientation and Continuing Education of Board Members |
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Develop an orientation and continuing education policy for Directors. |
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Appendix E Nominating and Corporate Governance Committee Charter |
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Management Proxy Circular
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Theratechnologies Inc. |
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1. |
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Follow corporate governance developments and, as required, advise the
Board of appropriate actions. |
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2. |
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Examine appropriate actions to promote ethical business conduct, issue
relevant recommendations to the Board and oversee their implementation. |
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3. |
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Examine conflict of interest issues that may be brought to the attention
of the Board and offer solutions. |
III. External Advisors
In discharging its duties and responsibilities, the Committee is empowered to retain external legal
counsel or other external advisors, as appropriate. The Corporation shall provide the necessary
funds to secure the services of such advisors.
IV. Composition of the Committee
The Committee is composed of any number of Directors, but no less than three, as may be determined
by the Board from time to time by resolution. Each member of the Committee shall be independent
from the Corporation, as determined by the Board in accordance with applicable laws, rules and
regulations.
V. Term of the Mandate
Committee members are appointed by Board resolution to carry out their mandate extending from the
date of the appointment to the next Annual General Meeting of Shareholders, or until successors are
so appointed.
VI. Vacancy
The Board may fill vacancies at any time by resolution. Subject to the constitution of the quorum,
the Committees members can continue to act even if there is one or many vacancies on the
Committee.
VII. Chairman
The Board appoints the Committee Chairman who will call and chair the meetings.
VIII. Secretary
Unless decided otherwise by resolution of the Board, the Secretary of the Corporation shall act as
Committee Secretary. The Secretary must attend Committee meetings and prepare the minutes. He must
provide notification of meetings as directed by the Committee Chairman. The Secretary is the
guardian of the Committees records, books and archives.
IX. Meeting Proceedings
The Committee establishes its own procedures as to how meetings are called and conducted. Unless it
is otherwise decided, the Committee shall meet privately and independently from Management at each
regularly scheduled meeting. In the absence of the regularly appointed Chairman, the meeting shall
be chaired by another Committee member selected among attending participants and appointed
accordingly.
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Appendix E Nominating and Corporate Governance Committee Charter |
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Management Proxy Circular
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Theratechnologies Inc. |
In the absence of the regularly appointed Secretary, Committee members shall designate someone
to carry out this duty.
X. Quorum and Vote
Unless the Board otherwise specifies by resolution, two Committee members shall constitute an
appropriate quorum for deliberation of items on the agenda. During meetings, decisions are reached
by a majority of votes from Committee members, unless the quorum is of two members, in which case
decisions are made by consensus of opinion.
XI. Records
The Committee keeps records that are deemed necessary for its deliberations and reports to the
Board on its activities and recommendations on a regular basis.
XII. Effective Date
This charter was adopted by the Directors during the February 8, 2006 Board meeting.
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Appendix E Nominating and Corporate Governance Committee Charter |
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Management Proxy Circular
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Theratechnologies Inc. |
ex-99.29
Exhibit 99.29
NOTICE OF ANNUAL AND SPECIAL MEETING OF SHAREHOLDERS
To the shareholders of Theratechnologies Inc. (the Company):
NOTICE IS HEREBY GIVEN that an annual and special meeting of shareholders (the Meeting) of the
Company will be held at the Centre Mont-Royal, 2200 Mansfield, Salon International, Montreal,
Québec, on Thursday, March 25, 2010 at 10:00 a.m., local time, for the following purposes:
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(1) |
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to receive the consolidated financial statements for the fiscal year ended November 30, 2009, as well
as the auditors report thereon; |
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(2) |
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to elect directors for the ensuing year; |
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(3) |
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to appoint auditors for the ensuing year and authorize the directors to set their compensation; |
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(4) |
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to consider, and if deemed advisable, to pass Resolution 2010-1 (the text of which is attached as
Appendix A to the accompanying Management Proxy Circular), with or without amendments,
approving the shareholder rights plan, the whole as described in the accompanying Management
Proxy Circular; and |
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(5) |
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to transact such other business as may properly come before the Meeting. |
DATED at Montreal, Québec, Canada, February 23, 2010.
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BY ORDER OF THE BOARD OF DIRECTORS
(signed) Jocelyn Lafond
Jocelyn Lafond
Corporate Secretary
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ex-99.30
Exhibit 99.30
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THERATECHNOLOGIES INC.
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9th Floor, 100 University Avenue
Toronto, Ontario M5J 2Y1
www.computershare.com |
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Security Class |
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Holder Account Number |
Form of Proxy Annual and Special Meeting of Shareholders to be held on March 25, 2010
This Form of Proxy is solicited by and on behalf of Management.
Notes to proxy
1. |
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Every holder has the right to appoint some other person or company of their choice, who need not be a holder, to attend and act on their
behalf at the meeting, or at any adjournment thereof. If you wish to appoint a person or company other than the persons whose names are
printed herein, please insert the name of your chosen proxyholder in the space provided (see reverse). |
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2. |
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If the securities are registered in the name of more than one owner (for example, joint ownership, trustees, executors, etc.), then all those registered
should sign this proxy. If you are voting on behalf of a corporation or another individual you may be required to provide documentation evidencing your
power to sign this proxy with signing capacity stated. |
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3. |
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This proxy should be signed in the exact manner as the name appears on the proxy. |
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4. |
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If this proxy is not dated, it will be deemed to bear the date on which it is mailed by Management to the holder. |
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5. |
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The securities represented by this proxy will be voted as directed by the holder; however, if such a direction is not made in respect of any
matter, this proxy will be voted as recommended by Management. |
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6. |
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The securities represented by this proxy will be voted or withheld from voting, in accordance with the instructions of the holder, on any ballot that
may be called for and, if the holder has specified a choice with respect to any matter to be acted on, the securities will be voted accordingly. |
7. |
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This proxy confers discretionary authority in respect of amendments to matters identified in the Notice of Meeting or other matters that may properly
come before the meeting. |
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8. |
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This proxy should be read in conjunction with the accompanying documentation provided by Management. |
Proxies submitted must be received prior to 5:00 p.m., Eastern Time, on March 23, 2010.
Appointment of Proxyholder
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The undersigned shareholder of Theratechnologies Inc. (the Company)
hereby appoints: PAUL POMMIER, Chairman of the Board, or failing him, YVES
ROSCONI, President and Chief Executive Officer
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OR
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Print the name of the person you are
appointing if this person is someone
other than the Management
Nominees listed herein.
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as my proxyholder to attend and act for and on my behalf at the Annual and Special Meeting of Shareholders of the Company to be held at the Centre Mont-Royal, 2200 Mansfield, Salon
International, Montreal, Québec, on Thursday, March 25, 2010 at 10:00 a.m., (the Meeting), and at any adjournment thereof, with full power of substitution and with all the powers which the
undersigned could exercice with respect to his/her common shares if personnally present at the Meeting. The shares are to be voted, on any ballot, in accordance with the instructions given
below:
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VOTING RECOMMENDATIONS BY MANAGEMENT ARE INDICATED BY HIGHLIGHTED TEXT OVER THE BOXES. |
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For
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Withhold |
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1. Election of Directors
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Vote FOR or WITHHOLD from voting with respect to the election of directors |
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Fold |
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For
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Withhold |
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2. Appointment of Auditors
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Vote FOR or WITHHOLD from voting with respect to the appointment of auditors. |
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For
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Against
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Withhold |
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3. Resolution 2010-1 Approving the Shareholder Rights Plan
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Vote FOR, AGAINST or WITHHOLD from voting with respect to resolution 2010-1. |
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Fold |
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Authorized Signature(s) This section must be completed for your
instructions to be executed.
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Signature(s)
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Date |
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I authorize you to act in accordance with my instructions set out above. I hereby revoke any proxy
previously given with respect to the Meeting. If no voting instructions are indicated above,
this Proxy will be voted as recommended by Management. |
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DD/MM/YY |
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Interim Financial Statements Mark this box if you would like to receive interim financial
statements and accompanying Managements Discussion and Analysis by mail.
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o
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Annual Report Mark this box if you would like to receive the
Annual Report and accompanying Managements Discussion and
Analysis by mail.
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o |
If you are not mailing back your proxy, you may register online to receive the above financial report(s) by mail at www.computershare.com/mailinglist.
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g
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0 8 3 4 8 2
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A R 1
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T H T Q
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+ |
ex-99.31
Exhibit 99.31
NOTICE OF ANNUAL AND SPECIAL MEETING
OF SHAREHOLDERS TO BE HELD ON
THURSDAY, MARCH 25, 2010
AND
MANAGEMENT PROXY CIRCULAR
FEBRUARY 23, 2010
NOTICE OF ANNUAL AND SPECIAL MEETING OF SHAREHOLDERS
To the shareholders of Theratechnologies Inc. (the Company):
NOTICE IS HEREBY GIVEN that an annual and special meeting of shareholders (the Meeting) of the
Company will be held at the Centre Mont-Royal, 2200 Mansfield, Salon International, Montreal,
Québec, on Thursday, March 25, 2010 at 10:00 a.m., local time, for the following purposes:
|
(1) |
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to receive the consolidated financial statements for the fiscal year ended November 30,
2009, as well as the auditors report thereon; |
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(2) |
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to elect directors for the ensuing year; |
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(3) |
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to appoint auditors for the ensuing year and authorize the directors to set their
compensation; |
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(4) |
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to consider, and if deemed advisable, to pass Resolution 2010-1 (the text of which is attached
as Appendix A to the accompanying Management Proxy Circular), with or without amendments, approving
the shareholder rights plan, the whole as described in the accompanying Management Proxy Circular;
and |
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(5) |
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to transact such other business as may properly come before the Meeting.
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DATED at Montreal, Québec, Canada, February 23, 2010.
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BY ORDER OF THE BOARD OF DIRECTORS |
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(signed) Jocelyn Lafond |
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Jocelyn Lafond
Corporate Secretary |
MANAGEMENT PROXY CIRCULAR
The information contained in this management proxy circular (the Circular) is given as at
February 23, 2010, except as otherwise noted. All dollar amounts set forth herein are expressed in
Canadian dollars and the symbol $ refers to the Canadian dollar, unless otherwise indicated.
TABLE OF CONTENTS
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ITEM I. INFORMATION RELATING TO THE ANNUAL AND SPECIAL MEETING |
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1 |
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1. Voting |
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1 |
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A. By Proxy |
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1 |
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B. In Person |
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2 |
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C. Voting Securities and Principal Holders |
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2 |
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2. Subjects To Be Treated at the Meeting |
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3 |
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A. Receipt of Financial Statements |
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3 |
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B. Election of Directors |
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3 |
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C. Appointment of Auditors |
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5 |
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D. Approval of Shareholder Rights Plan |
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6 |
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E. Other Matters to be Acted Upon |
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10 |
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ITEM II. COMPENSATION |
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11 |
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1. Executive Compensation |
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11 |
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A. Compensation Discussion & Analysis |
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11 |
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B. Summary Compensation Table |
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15 |
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C. Incentive Plan Awards |
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17 |
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D. Termination and Change of Control Provisions |
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19 |
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E. Performance Graph |
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24 |
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F. Other Information |
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25 |
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2. Director Compensation |
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26 |
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A. Determination of Director Compensation |
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26 |
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B. Director Compensation Table |
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27 |
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C. Incentive Plan Awards |
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28 |
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D. Other Information |
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31 |
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ITEM III. CORPORATE GOVERNANCE DISCLOSURE |
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32 |
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1. Board of Directors |
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32 |
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A. Independence |
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32 |
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B. Meetings of the Board |
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32 |
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C. Other Board Memberships |
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33 |
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2. Mandate of the Board of Directors |
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33 |
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3. Position Descriptions |
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33 |
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4. Orientation and Continuing Education |
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33 |
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5. Ethical Business Conduct |
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34 |
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6. Nomination of Directors |
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34 |
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7. Compensation |
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34 |
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A. Independence |
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34 |
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B. Meetings of the Compensation Committee |
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34 |
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8. Audit Committee |
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34 |
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A. Independence |
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34 |
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B. Meetings of the Audit Committee |
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35 |
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9. Other Committees |
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35 |
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A. Financing Committee |
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35 |
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B. Strategic Committee |
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35 |
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10. Assessment |
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36 |
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ITEM IV. OTHER INFORMATION |
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37 |
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1. Additional Documentation |
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37 |
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2. Approval By The Board Of Directors |
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37 |
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APPENDIX A Resolution 2010-1 Shareholder Rights Plan |
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APPENDIX B Compensation Committee Charter |
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APPENDIX C Mandate of the Board of Directors |
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APPENDIX D Director Orientation and Continuing Education Policy |
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APPENDIX E Nominating and Corporate Governance Committee Charter |
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ITEM I. INFORMATION RELATING TO THE ANNUAL AND SPECIAL MEETING
1. Voting
You may vote your shares either through a proxy or in person at the annual and special meeting of
shareholders of the Company (the Meeting).
A. By Proxy
Solicitation of Proxies
This Circular is furnished in connection with the solicitation by the management of
Theratechnologies Inc. (the Company or Theratechnologies) of proxies to be used at the Meeting
of the Company to be held on Thursday, March 25, 2010, at the time, place and for the purposes set
forth in the attached Notice of Annual and Special Meeting of Shareholders (the Notice of
Meeting) and at any continuation of the Meeting after adjournment thereof.
The solicitation of proxies is being primarily made by mail but proxies may also be solicited by
telephone, telecopier or other personal contact by officers or other employees of the Company. The
entire cost of the solicitation will be borne by the Company.
Terms of Proxy Grant
By completing the enclosed form of proxy, or the one provided by your intermediary, you appoint the
persons proposed in that form to represent your interests and vote your shares on your behalf at
the Meeting. The persons named in the enclosed form of proxy are directors or officers of the
Company.
However, you have the right to appoint a person or company other than the ones designated in the
form of proxy to represent you at the Meeting. To do this, you must insert such persons name in
the blank space provided in the form of proxy enclosed hereto or complete another form of proxy. It
is not necessary to be a shareholder of the Company in order to act as a proxy.
If you hold your shares through an intermediary (a stockbroker, a bank, a trust, a trustee, etc.),
you are not a registered shareholder in the registry of shareholders of the Company held by
Computershare Trust Company of Canada (Computershare). Therefore, you cannot vote your shares
directly at the Meeting. If this is your situation, you will receive from your intermediary
explanation as to how to appoint proxies and have them vote your shares. To ensure that your
instructions are respected, you must deliver them to your intermediary within the prescribed
deadline. For any questions, please contact your intermediary directly.
Proxy Voting
The persons named or appointed in the form of proxy will, on a show of hands or any ballot that may
be called, vote (or withhold from voting) your shares in respect of which they are appointed as
proxies in accordance with the instructions given in the form of proxy. In the absence of
instructions, the voting rights attached to the shares referred to in your form of proxy will be
exercised FOR the matters mentioned in the attached Notice of Meeting.
Furthermore, the enclosed form of proxy confers upon the proxy holder a discretionary power with
respect to amendments or variations to matters identified in the Notice of Meeting and with respect
to all other matters which may properly come before the Meeting, or any continuation after
adjournment thereof.
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Information
Relating to the Meeting
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Page 1 |
Management Proxy Circular
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Theratechnologies Inc. |
However, to our knowledge, all matters to be brought before the Meeting are mentioned in
appropriate fashion in the Notice of Meeting.
Delivery of Form of Proxy and Deadlines
If you hold your shares personally and are a registered shareholder in the registry of shareholders
of the Company, please send the completed form of proxy to the Secretary of the Company, c/o
Computershare Trust Company of Canada, 1100 University Street, 12th Floor, Montreal,
Québec H3B 2G7, prior to 5:00 p.m. (Eastern time) on March 23, 2010 (unless you attend the Meeting
in person). All shares represented by proper proxies accompanied by duly completed declarations
received by Computershare at the latest on such date and prior to such time will be voted in
accordance with your instructions as specified in the proxy form on any ballot that may be called
at the Meeting.
If you hold your shares through an intermediary, please proceed as indicated in the documentation
sent by your intermediary and within the deadlines specified therein. For any questions, please
contact your intermediary directly.
Revocation of a Proxy
You may, at any time, including any continuation of the Meeting after adjournment thereof, revoke a
proxy for any business with respect to which said proxy confers a vote that has not already been
cast.
If you hold your shares personally and are a registered shareholder in the registry of shareholders
of the Company, please send a written notice to revoke a proxy bearing your signature or that of
your proxy (or a representative of your proxy if your proxy is a company) to the Secretary of the
Company, c/o Computershare Trust Company of Canada, 1100 University Street, 12th Floor,
Montreal, Québec H3B 2G7, prior to 5:00 p.m. (Eastern time) on March 23, 2010. You may also revoke
a proxy in person at the Meeting by making a request to that effect to the Secretary of the
Company.
If you hold your shares through an intermediary, please proceed as indicated in the documentation
sent by your intermediary and within the deadlines specified therein. For any questions, please
contact your intermediary directly.
B. In Person
If you hold your shares personally and are a registered shareholder in the registry of shareholders
of the Company, you may present yourself on the date, at the time and place set forth in the Notice
of Meeting and register with the representatives of Computershare who will be at the Meeting. You
should then follow voting instructions given by the Chairman of the Meeting.
If you hold your shares through an intermediary and you wish to vote your shares in person at the
Meeting, please proceed as indicated in the documentation sent by your intermediary. For any
questions, please contact your intermediary directly.
C. Voting Securities and Principal Holders
As at February 22, 2010, there were 60,449,891 common shares (the Common Shares) of the Company
issued and outstanding. The Common Shares are the only securities with respect to which a voting
right may be exercised at the Meeting. Each Common Share entitles its holder to one vote with
respect to the matters voted on at the Meeting.
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Holders of Common Shares whose names are registered on the lists of shareholders of the Company as
at 5:00 p.m. (Eastern time) on February 22, 2010, being the date fixed by the Company for
determination of the registered holders of Common Shares who are entitled to receive notice of the
Meeting (the Record Date), will be entitled to exercise their voting rights attached to the
Common Shares in respect of which they are so registered at the Meeting, or any continuation after
adjournment thereof, if present or represented by proxy thereat. However, even if you have acquired
Common Shares after the Record Date, you will be entitled to vote at the Meeting if, at least
twenty-four (24) hours prior to the Meeting, you produce certificates for such Common Shares
properly endorsed by the seller, or if you otherwise establish that you own such Common Shares and
have requested that your name be included on the list of shareholders entitled to receive the
Notice of Meeting.
To our knowledge, no person beneficially owns, or controls or directs control, directly or
indirectly, over more than ten percent (10%) of the outstanding Common Shares of the Company.
2. Subjects To Be Treated at the Meeting
Please find below a description of the items listed in the Notice of Meeting.
A. Receipt of Financial Statements
The consolidated financial statements for the fiscal year ended November 30, 2009 together with the
auditors report thereon will be presented at the Meeting. The financial statements are included in
the Companys 2009 annual report, which has been mailed to you if you requested it, along with this
Circular. The financial statements are also available on SEDAR at
www.sedar.com. No vote is
required on this matter.
B. Election of Directors
The shareholders at the Meeting will appoint the directors of the Company for the coming year.
Composition of the Board of Directors
The articles of the Company provide that the board of directors of the Company (the Board of
Directors) must consist of a minimum of three (3) and a maximum of twenty (20) directors. The
Board of Directors has established that a number of nine (9) directors was well adapted to its size
and activities.
Nominees
All of the nominees for the director positions of the Company are elected for a one year term
ending at the next annual meeting of shareholders or when his successor is elected, unless he
resigns or the position becomes vacant as a result of death, dismissal or otherwise, prior to the
said meeting. We do not contemplate that any of the nominees will be unable to fulfill his mandate
as director. Unless instructions are given to abstain from voting with regard to the election of
directors, the persons whose names appear on the enclosed form of proxy will vote FOR the election
of the nominees whose names are set out in the table below.
At the Meeting, shareholders are asked to vote on a slate of directors. However, at a meeting of
the Nominating and Corporate Governance Committee held in December 2009, the members of
this committee agreed to review the election mode of directors for the next annual meeting of the
Company. The members of the committee will examine the opportunity to move from a bundled slate of
directors to an election of directors on an individual basis.
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The following table states the names of all persons proposed for election as directors, their
province or state and country of residence, their principal occupation, the position held in the
Company (if any), the year in which they first became directors of the Company and the number of
Common Shares they own, directly or indirectly, or over which they exercise control or direction.
To obtain additional information regarding the biographical notes of the nominees, shareholders can
consult item 4.1 of the Companys 2009 annual information form dated February 23, 2010 available on
SEDAR at www.sedar.com.
The information relating to the number of Common Shares held by the nominees in the table below and
under Cease Trade Orders, Bankruptcies, Penalties or Sanctions is based on the statements made by
the nominees.
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Number of Common |
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Shares of the Company |
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Owned, Directly or |
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Indirectly, |
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or Over Which |
Name, Province or State |
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Director |
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Control or |
and Country of Residence |
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Principal Occupation |
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Since |
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Direction is Exercised |
Paul Pommier(1) (2) (3) (4) (5) |
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Chairman of the Board of the |
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1997 |
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190,100 |
Québec, Canada |
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Company |
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Gilles Cloutier(3) (5) |
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Corporate Director |
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North Carolina, |
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2003 |
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51,000 |
United States |
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A. Jean de Grandpré(2) (3) (4) (5) |
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Corporate Director |
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1993 |
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200,000 |
Québec, Canada |
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Robert G. Goyer(3) |
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Emeritus Professor |
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Québec, Canada |
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Faculty of Pharmacy |
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2005 |
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10,000 |
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Université de Montreal |
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Gérald A. Lacoste(1) (3) (5) |
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Corporate Director |
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2006 |
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11,000 |
Québec, Canada |
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Bernard Reculeau(2) |
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Corporate Director |
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2005 |
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18,100 |
Paris, France |
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Yves Rosconi(4) |
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President and Chief Executive Officer |
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2004 |
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67,093 |
Québec, Canada |
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of the Company |
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Jean-Denis Talon(1) (2) |
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Chairman of the Board |
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Québec, Canada |
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AXA Canada |
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2001 |
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60,000 |
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(Insurance Company) |
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Luc Tanguay(4) |
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Senior Executive Vice President |
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Québec, Canada |
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and Chief Financial Officer of the |
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1993 |
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83,000 |
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Company |
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(1) |
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Member of the Audit Committee |
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(2) |
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Member of the Compensation
Committee |
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(3) |
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Member of the Nominating and Corporate Governance
Committee |
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(4) |
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Member of the Financing Committee |
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(5) |
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Member of the
Strategic
Review Committee |
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Cease Trade Orders, Bankruptcies, Penalties or Sanctions
Except as described below, to the knowledge of management of the Company, no nominee (a) is, as at
the date of the Circular, or has been within the ten (10) years before the date of the Circular, a
director or executive officer of any company (including the Company) that, while that person was
acting in that capacity, (i) was the subject of a cease trade or similar order or an order that
denied the relevant company access to any exemption under securities legislation, for a period of
more than thirty consecutive days; (ii) was subject to an event that resulted, after the director
or executive officer ceased to be a director or executive officer, in the company being the subject
of a cease trade or similar order or an order that denied the relevant company access to any
exemption under securities legislation, for a period of more than thirty consecutive days; or (iii)
within a year of that person ceasing to act in that capacity, became bankrupt, made a proposal
under any legislation relating to bankruptcy or insolvency or was subject to or instituted any
proceedings, arrangement or compromise with creditors or had a receiver, receiver manager or
trustee appointed to hold its assets; or (b) has, within the ten (10) years before the date of the
Circular, become bankrupt, made a proposal under any legislation relating to bankruptcy or
insolvency, or become subject to or instituted any proceedings, arrangement or compromise with
creditors, or had a receiver, receiver manager or trustee appointed to hold his assets.
Paul Pommier was a member of the board of directors of Royal Aviation Inc. from September 1996
until it was acquired by Canada 3000 Inc. in March 2001. Subsequently, at the end of 2001, Canada
3000 Inc. and its subsidiaries, including Royal Aviation Inc., made assignments in bankruptcy under
Section 49 of the
Bankruptcy and Insolvency Act (R.S. 1985, c. B-3) (the Bankruptcy Act).
Yves Rosconi was a member of the board of directors of Mistral Pharma Inc. from September 2007
until May 2008. On June 13, 2008, Mistral Pharma Inc. filed a notice of intention to make a
proposal to its creditors under the Bankruptcy Act and, on August 19, 2008, Mistral Pharma Inc.
filed a proposal under the Bankruptcy Act.
Luc Tanguay is currently a member of the board of directors of Ambrilia Biopharma Inc. (hereafter
Ambrilia) and has been a member since August 22, 2006. On July 31, 2009, Ambrilia obtained court
protection from its creditors under the Companies Creditors Arrangement Act (Canada). The purpose
of the order issued by the court granting Ambrilia protection from its creditors is to provide
Ambrilia and its subsidiaries the opportunity to restructure its affairs. Ambrilia is still under
court protection. In addition, on July 31, 2009, the Toronto Stock Exchange halted the trading of
Ambrilias shares pending its review of Ambrilias meeting the requirements for continuous listing.
On August 5, 2009, Ambrilia announced that its shares would resume trading.
C. Appointment of Auditors
The Companys auditors for the current fiscal year must be appointed at the Meeting. We propose the
appointment of KPMG LLP, chartered accountants from Montréal, who have been the Companys auditors
since October 19, 1993. They will hold office until the next annual meeting of shareholders or
until their successors are appointed.
The table below sets forth the fees paid to the auditors of the Company for the financial years
ended November 30, 2009 and November 30, 2008.
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Financial Year Ended |
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Financial Year Ended |
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November 30, 2009 |
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November 30, 2008 |
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Audit Fees |
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$ |
80,000 |
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$ |
77,000 |
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Audit-Related Fees (1) |
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$ |
17,500 |
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$ |
71,300 |
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Tax Fees (2) |
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$ |
39,626 |
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$ |
40,064 |
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All Other Fees |
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(1) |
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Audit-related fees relate principally to services rendered in connection with the
Companys quarterly financial statements. For the financial year ended November 30, 2008,
audit-related fees paid to KPMG also included fees related to services rendered in connection with
the Companys public offering. |
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(2) |
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Tax fees relate to services rendered in connection with the preparation of corporate tax
returns and general tax advice. |
Unless instructions are given to abstain from voting with regard to the appointment of
auditors, the persons whose names appear on the enclosed form of proxy will vote FOR the
appointment of KPMG LLP, chartered accountants, as auditors of the Company, and authorize that
compensation for their services be determined by the Board of Directors.
D. Approval of Shareholder Rights Plan
On February 10, 2010, the Board of Directors implemented a shareholder rights plan (the Rights
Plan), the terms and conditions of which are set out in a shareholder rights plan agreement (the
Rights Agreement) dated February 10, 2010 with Computershare Trust Services of Canada, as rights
agent. The Rights Plan is currently effective but is subject to approval by a majority of the votes
cast by shareholders, in person or by proxy, at the Meeting. If shareholders of the Company do not
approve the Rights Plan, it will cease to be effective and will terminate.
Purpose of the Rights Plan
The purpose of the Rights Plan is to ensure equal treatment of shareholders and to give adequate
time for shareholders to properly assess the merits of a bid without undue pressure, and to allow
competing bids to emerge. The Rights Plan is designed to give the Board of Directors time to
consider alternatives, allowing shareholders to receive full and fair value for their shares. The
Rights Plan was not adopted by the Board of Directors in response to any acquisition proposal and
is not designed to secure the continuance in office of the current management or the directors of
the Company. The adoption of the Rights Plan does not in any way lessen the duties of the directors
to fully and fairly examine all bids which may be made to acquire the Common Shares of the Company
and to exercise such duties with a view to the best interest of the shareholders and the Company.
Before deciding to adopt the Rights Plan, the Board of Directors considered the current
shareholdings of the Company and the legislative framework in Canada governing takeover bids. To
our knowledge, there is currently no person who beneficially owns, or controls or directs control,
directly or indirectly, over more than ten percent (10%) of the outstanding Common Shares of the
Company. Therefore, a person could acquire a de facto control of the Company through the purchase
of a number of Common Shares that would represent a percentage of Common Shares below 50% by
entering into private acquisition agreements without having to make an offer to all of the
shareholders.
Under provincial securities legislation, a takeover bid generally means an offer to acquire voting
or equity voting shares of a corporation that, together with shares already owned by the bidder and
certain parties related thereto, amount to 20% or more of the outstanding shares of that class.
The existing legislative framework for takeover bids in Canada presents the following concerns for
shareholders:
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1. |
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Time |
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Current legislation permits a takeover bid to expire 35 days after it is initiated. The Board
of Directors is of the view that this is not sufficient time to permit shareholders to
adequately consider a takeover bid and make a reasoned and unhurried decision. |
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2. |
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Pressure to Tender |
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A shareholder may feel compelled to tender his Common Shares pursuant to a takeover bid which
he considers to be inadequate, out of a concern that in failing to do so, the shareholder may
be left with illiquid or minority discounted Common Shares. The Rights Plan provides
shareholders with a mechanism which is intended to ensure that they can separate the decision
to tender, based on the merits of a bid, from the approval or disapproval of a particular
takeover bid. |
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3. |
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Unequal Treatment |
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Shareholders may not be treated equally if, as current securities legislation provides, an
important number of Common Shares is acquired pursuant to a private agreement in which a
small group of shareholders or a shareholder disposes of its Common Shares at a premium to
market price, which premium is not shared with the other shareholders of the Company. In
addition, a person may gradually accumulate Common Shares through stock exchange acquisitions
which results in an acquisition of control of the Company, without payment of fair value for
control or a fair sharing of a control premium amongst all shareholders. The Rights Plan
addresses these concerns by applying to all acquisitions of 20% or more of the Common Shares
of the Company, ensuring that shareholders receive equal treatment. |
The issue of rights (the Rights) will not in any way adversely alter the financial condition of
the Company and will not change the way in which shareholders trade their Common Shares. However,
by permitting holders of Rights other than an Acquiring Person (as defined below) to acquire
additional Common Shares of the Company at a discount to market value, the Rights may cause
substantial dilution to a person or group that acquires 20% or more of the outstanding Common
Shares other than by way of a Permitted Bid (as defined below). A potential bidder can avoid the
dilutive features of the Rights Plan by making a bid that conforms to the requirements of a
Permitted Bid.
The Company has reviewed the Rights Plan for conformity with current practices of Canadian
companies with respect to shareholder protection rights plans. We believe that the Rights Plan
preserves the fair treatment of shareholders, is consistent with best Canadian corporate practices
and addresses institutional investor guidelines.
Terms of the Rights Plan
The following is a summary of the principal terms of the Rights Agreement and is provided subject
to the terms and conditions thereof. A complete copy of the Rights Agreement has been filed and is
available on the System for Electronic Document Analysis and Retrieval (SEDAR) at
www.sedar.com.
Issue of Rights
In order to implement the Rights Plan, the Board of Directors authorized the Company to issue one
right in respect of each Common Share outstanding as of 6:00 p.m. (Montreal time) on February 9,
2010 (the Effective Date). One Right will also be issued and attached to each subsequently issued
Common Share.
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Rights-Exercise Privilege
The Rights will be separate from the Common Shares to which they are attached and will become
exercisable at the time (the Separation Time) that is ten (10) business days after the earlier
of: (i) the first date of public announcement that an Acquiring Person (as defined below) has
become such; (ii) the date of commencement of, or first public announcement in respect of, a
takeover bid which will permit an offeror to hold 20% or more of the Common Shares, other than by
an acquisition pursuant to a takeover bid permitted by the Rights Plan (a Permitted Bid as
defined below); (iii) the date upon which a Permitted Bid ceases to be a Permitted Bid; or (iv)
such other date as may be determined in good faith by the Board of Directors.
The acquisition permitting a person (an Acquiring Person), including others acting jointly or in
concert with such person, to hold 20% or more of the outstanding Common Shares, other than by way
of a Permitted Bid, is referred to as a Flip-in Event. Any Rights held by an Acquiring Person on
or after the earlier of the Separation Time or the first date of a public announcement (the Common
Share Acquisition Date) by the Company or an Acquiring Person that an Acquiring Person has become
such will become null and void upon the occurrence of a Flip-in Event. Ten (10) trading days after
the occurrence of the Common Share Acquisition Date, each Right (other than those held by the
Acquiring Person) will permit the holder to purchase for the exercise price that number of Common
Shares determined as follows: a value of twice the exercise price divided by the average weighted
market price for the last 20 trading days preceding the Common Share Acquisition Date. The exercise
price is currently $25 per Right, subject to adjustment provisions described in the Rights Plan.
Upon the occurrence of a Flip-in Event and the separation of the Rights from the Common Shares,
reported earnings per share on a fully diluted or non-diluted basis may be affected. Holders of
Rights who do not exercise their Rights upon the occurrence of a Flip-in Event may suffer
substantial dilution.
Lock-Up Agreements
A bidder may enter into lock-up agreements with the shareholders of the Company whereby such
shareholders agree to tender their Common Shares to the takeover bid (the Lock-up Bid) without a
Flip-in Event occurring. Any such agreement must permit or must have the effect to permit the
shareholder to withdraw the Common Shares to tender to another takeover bid or to support another
transaction that exceeds the value of the Lock-up Bid.
Certificates and Transferability
Prior to the Separation Time, the Rights will be evidenced by a legend imprinted on certificates
for Common Shares issued after the Effective Date. Rights are also attached to Common Shares
outstanding on the Effective Date, although share certificates will not bear such a legend. Prior
to the Separation Time, Rights will not be transferable separately from the Common Shares. From and
after the Separation Time, the Rights will be evidenced by Rights certificates, which will be
transferable and traded separately from the Common Shares.
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Permitted Bid Requirements
A Permitted Bid is a takeover bid that does not trigger the exercise of Rights. A Permitted Bid
is a bid that aims to acquire shares which, together with the other securities beneficially owned
by the bidder, represent not less than 20% of the outstanding Common Shares, which bid is made by
means of a takeover bid circular and satisfies the following requirements:
(i) |
|
the bid must be made to all holders of Common Shares; |
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(ii) |
|
the bid must include a condition without reservation providing that no share
tendered pursuant to the bid will be taken up prior to the expiry of a period of not less than
60 days and only if at such date more than 50% in aggregate of the outstanding shares held by
the shareholders other than the bidder, its associates and affiliates, and persons acting
jointly or in concert with such persons (the Independent Shareholders), have been tendered
pursuant to the bid and not withdrawn; |
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(iii) |
|
if more than 50% in aggregate of the shares held by Independent Shareholders
are tendered to the bid within the 60-day period, the bidder must make a public announcement
of that fact and the bid must remain open for deposits of shares for an additional ten (10)
business days from the date of such public announcement. |
Waiver and Redemptions
The Board of Directors acting in good faith may, prior to a Flip-in Event, waive the dilutive
effects of the Rights Plan in respect of a particular Flip-in Event that would result from a
takeover bid made by way of takeover bid circular to all holders of Common Shares, in which event
such waiver would be deemed also to be a waiver in respect of any other Flip-in Event. The Board of
Directors may also waive the Rights Plan in respect of a particular Flip-in Event that has occurred
through inadvertence, provided that the Acquiring Person that inadvertently triggered such Flip-in
Event reduces its beneficial holdings to less than 20% of the outstanding Common Shares within 14
days or any other period that may be specified by the Board of Directors. At any time prior to the
occurrence of a Flip-in Event, the Board of Directors may, subject to the prior approval of the
holders of Common Shares, elect to redeem all, but not less than all, of the outstanding Rights at
a price of $0.0001 per right.
Exemption for Investment Managers
Investment managers (for client accounts), trust companies and pension funds (acting in their
capacity as trustees and administrators) acquiring shares permitting them to hold 20% or more of
the Common Shares are exempt from triggering a Flip-in Event, provided that they are not making, or
are not part of a group making, a takeover bid.
Supplements and Amendments
The Company is authorized to make amendments to the Rights Plan to correct any clerical or
typographical error or to maintain the validity of the Rights Plan as a result of changes in laws
or regulations. Prior to the Meeting, the Company is authorized to amend or supplement the Rights
Plan as the Board of Directors may in good faith deem necessary or advisable. The Company will
issue a press release relating to any material amendment made to the Rights Plan prior to the
Meeting and will advise the shareholders of any such amendment at the Meeting. Material amendments
or supplements to the Rights Plan will require, subject to the regulatory authorities, the prior
approval of the shareholders or, after the Separation Time, holders of Rights.
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Theratechnologies Inc. |
Canadian Income Tax Consequences of the Rights Plan
Under the Income Tax Act (Canada) (the Tax Act), while the matter may be debated, the issue of
the Rights under the Rights Plan may be a taxable benefit, the fair market of value of which must
be included in the income of a recipient. The Company considers that the Rights, when issued, will
have no or negligible monetary value, there being only a remote possibility that the Rights will
ever be exercised. The Rights will be considered to have been acquired at no cost. The holder of
Rights may realize income or be subject to withholding tax under the Tax Act if the Rights become
exercisable, are exercised and are otherwise disposed of.
The information provided above is of a general nature and is not intended to constitute, nor should
it be construed as, legal or tax advice to any particular holder of Common Shares. Such holders are
advised to consult their own tax advisors regarding the consequences of acquiring, holding,
exercising or otherwise disposing of their Rights, taking into account their own particular
circumstances and applicable federal, provincial, territorial or foreign legislation.
Recommendation of the Board of Directors
At the Meeting, shareholders will be asked to consider and, if deemed advisable, to approve the
Rights Plan by passing Resolution 2010-1, substantially in the form of the resolution attached as
Appendix A to this Circular. Resolution 2010-1 must be passed by a majority of the votes cast by
shareholders entitled to vote who are represented in person or by proxy at the Meeting and who vote
in respect of that resolution.
The Board of Directors considers the approval of the Rights Plan to be appropriate and in the best
interests of the Company and recommends that shareholders vote in favour of Resolution 2010-1 to
approve the Rights Plan.
Unless instructions are given to vote against, or abstain from voting on, Resolution 2010-1, the
persons whose names appear in the enclosed form of proxy will vote FOR the passing of Resolution
2010-1.
E. |
|
Other Matters to be Acted Upon |
The Company will consider and transact such other business as may properly come before the Meeting
or any adjournment thereof. Management of the Company knows of no other matters to come before the
Meeting other than those referred to in the Notice of Meeting. Should any other matters properly
come before the Meeting, the Common Shares represented by the proxy solicited hereby will be voted
on such matter in accordance with the best judgment of the persons voting the proxy.
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Management Proxy Circular
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Theratechnologies Inc. |
ITEM
II. COMPENSATION
The compensation of the executive officers and directors of the Company is determined by the
compensation committee of the Company (the Compensation Committee). The Compensation Committee
is composed of four (4) independent directors, namely A. Jean de Grandpré, who is the chair of
the Compensation Committee, Paul Pommier, Bernard Reculeau and Jean-Denis Talon. The mandate,
obligations and duties of the Compensation Committee are described in Appendix B to this
Circular. The Compensation Committee reviews the compensation of executive officers at a meeting
held after the end of the Companys financial year. At this meeting, the Compensation Committee
reviews the compensation of executive officers for the past financial year and determines the
compensation for the ensuing year.
1. |
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Executive Compensation |
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A. |
|
Compensation Discussion & Analysis |
Objectives of the Compensation Program
To achieve its business plan, the Company requires a strong and capable executive team. This
justifies the need for an executive program that will attract, retain, motivate and reward its
executive officers. The Company is committed to a compensation policy that is competitive and
drives business performance.
What the Compensation Program is Designed to Reward
The compensation program of the Company (the Compensation Program) is designed to reward the
executive officers for implementing strategies, both in the short and the long term, to realize
the business plan of the Company to advance its drug development and commercialization programs.
It is also designed to enhance its share value and, thereby, create economic value.
The Compensation Program provides reasonable and competitive total executive compensation.
Remuneration and incentive components are established to compete with remuneration practices of
similar companies that are involved in the biopharmaceutical and pharmaceutical industries.
To establish base salary and bonus compensation levels, the Company generally studies, among
other things, the competitive market environment and reviews information published in the Rx & D
Compensation Survey and the proxy circulars of other publicly listed biotechnology companies
whose stage of development and market capitalization are similar or more advanced than those of
the Company. The Compensation Committee also takes into consideration the financial needs of the
Company, its business plan and the Companys annual corporate objectives before determining the
Companys own Compensation Program.
At the beginning of the financial year 2009, the Compensation Committee met to determine the
base salary of each executive officer. In order to set the base salary of its executive officers
for that financial year, the Compensation Committee considered publicly available economic data
regarding the variation of the Consumer Price Index and publicly available data regarding
forecasted salary percentage increase for that year. The Compensation Committee also considered
the importance of the objectives to be attained by the executive officers and the Company during
that year. No independent third-party report was prepared. However, at the end of the financial
year 2009, the Compensation Committee retained the services of Towers Perrin, an independent
third-party
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Statement of Executive Compensation
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Page 11 |
Management Proxy Circular
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|
Theratechnologies Inc. |
consulting firm, to conduct an annual comparative analysis of the compensation paid to
its executive officers against the compensation paid to executive officers in various companies.
Towers Perrins analysis was based on a reference market of the following 19 companies (the
Benchmarked Companies):
|
|
|
AEterna Zentaris Inc. |
|
|
|
|
Angiotech Pharmaceuticals Inc. |
|
|
|
|
AstraZeneca Canada Inc. |
|
|
|
|
Bayer Inc. |
|
|
|
|
Beckman Coulter Canada Inc. |
|
|
|
|
Biogen Idec Canada Inc. |
|
|
|
|
BioMS Medical Corp. |
|
|
|
|
Cardiome Pharma Corp. |
|
|
|
|
Eli Lilly Canada Inc. |
|
|
|
|
Hoffman La Roche Limited |
|
|
|
|
Labopharm Inc. |
|
|
|
|
Life Technologies Corporation |
|
|
|
|
MDS Inc. |
|
|
|
|
Methylgene Inc. |
|
|
|
|
Bellus Health Inc. |
|
|
|
|
Patheon Inc. |
|
|
|
|
QLT Inc. |
|
|
|
|
Sanofi Pasteur Limited |
|
|
|
|
Transition Therapeutics Inc. |
The Benchmarked Companies were reviewed and agreed to by the Compensation Committee.
Overall, Towers Perrins report concluded that the aggregate compensation paid to the Named
Executive Officers (as defined below) of the Company was below the median and, in certain
circumstances, at the median of the aggregate compensation paid by the Benchmarked Companies to
individuals holding the same position as those of the Named Executive Officers.
Decision-Making Process
The proposed annual compensation for each of the executive officers, other than for the
President and Chief Executive Officer, is presented by the President and Chief Executive Officer
to the Compensation Committee and reviewed by the Compensation Committee. The compensation for
the President and Chief Executive Officer is determined by the Compensation Committee. The
Compensation Committee reports and makes a recommendation to the Board of Directors on the
proposed compensation of executive officers. The Board of Directors approves grants of options
if, upon the recommendation of the Compensation Committee, it deems it advisable.
Elements of Compensation Program
The major elements of the Companys executive Compensation Program are base salary, short-term
performance reward program that takes the form of cash bonuses, and long-term incentives through
the granting of stock options. All proposed changes to any compensation component of an
executive officer are first reviewed internally by the President and Chief Executive Officer and
the Senior Executive Vice President and Chief Financial Officer. The proposed changes are then
presented to the Compensation Committee.
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Statement of Executive Compensation
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Page 12 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
Base Salary
Base salaries for each of the executive officers are based on the experience, expertise and
competencies of each executive officer. In reference to the Benchmarked Companies used for
comparison, the salaries of the Named Executive Officers and other executive officers are
generally at the median (50th percentile). However, the Compensation Committee has no
firm policy on setting the base salary at the median and, accordingly, base salaries may be set
below or above the median.
Performance Reward Program
The short-term performance reward program is designed to recognize the contribution of each
executive officer in helping the Company to attain its corporate objectives and to increase its
value. Bonuses are granted if the annual corporate objectives are met by the Company and in
accordance with the individual performance and the results achieved or surpassed by such
individual in connection with such corporate objectives. When and if the Company generates
significant revenues from the sale of his products, financial criteria will also be factored
into the determination of this program.
The target bonus payment for each of the President and Chief Executive Officer and the Senior
Executive Vice President and Chief Financial Officer is set at 50% of their respective base
salary. For the other three Named Executive Officers, the target bonus payment is set at 33 1/3
% of their respective base salary. These target bonus payments are at the 75th
percentile when compared against the Benchmarked Companies, except for the target bonus payment
of the President and Chief Executive Officer which is at the median.
For the year ended November 30, 2009, the Companys principal objective was to file a complete
New Drug Application to the Food and Drug Administration in the United States and to file it by
the end of the second quarter. The second corporate objective of the Company consisted in
organizing working committees with our commercial partner in the United States for the
preparation of the commercialization of tesamorelin in such country further to the execution of
our collaboration and licensing agreement with EMD Serono, Inc. at the beginning of our fiscal
year 2009. The third corporate objective of the Company was related to the negotiations of
supply
agreements with third-party service providers to ensure that the Company would have the
manufacturing capacity to supply tesamorelin to its commercial partner in the United States for
commercial sale in this country. The fourth corporate objective of the Company consisted in
exploring the potential of tesamorelin to be approved in countries other than the United States
for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy while
seeking partners to commercialize tesamorelin in those countries. The fifth corporate objective
of the Company consisted in pursuing the evaluation of other clinical programs in which
tesamorelin could be developed. Finally, the last objective was to meet each of these objectives
in a cost-efficient manner to conserve the Companys cash position and to manage its burn rate.
The objectives of the Named Executive Officers were aligned with those of the Company. The
Compensation Committee did not mathematically weight the objectives of the Company against each
other and the objectives of the Named Executive Officers against those of the Company in
determining the compensation of the Named Executive Officers for the last financial year. The
Compensation Committee rather considered all objectives with the attainment of the first
corporate objective as being the most relevant one in order to set the compensation of the Named
Executive Officers for the last financial year.
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Statement of Executive Compensation
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Page 13 |
Management Proxy Circular
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|
Theratechnologies Inc. |
Long-Term Incentive Program
The Companys long-term incentive program is composed of its share option plan (the Share
Option Plan) which was originally adopted on December 6, 1993, and subsequently amended from
time to time, in order to attract, retain, motivate employees in key positions and align their
interests with those of the Companys shareholders by allowing optionees to participate in the
increased value of the Common Shares. The Company has no share-based award. The Company has a
share purchase plan but the share purchase plan is available to all employees of the Company and
the decision to subscribe for Common Shares under this plan rests with each employee. For a
description of the share purchase plan, see Other Information Description of the Share
Purchase Plan below.
The number of options granted is determined on the basis of the position of each executive
officer, the attainment of corporate objectives and the value of the options at the time of
grant as part of the total compensation of an executive officer. When assessing whether options
should be granted to an executive officer, the Compensation Committee also factors in the number
of options held by an executive officer, their vesting periods, expiry dates and exercise
prices. When compared against the value of options granted by the Benchmarked Companies to
individuals holding the same positions as those of the Named Executive Officers, the estimated
annualized value of the options granted by the Company during the last five (5) years to its
Named Executive Officers is below and, in certain circumstances, at the median.
Description of the Share Option Plan
A maximum of 5,000,000 Common Shares have been reserved for stock option grants under the Share
Option Plan, of which, as at the date of the Circular, 999,001 options remain available for
issuance.
The Board of Directors administers the Share Option Plan. The Board of Directors designates the
optionees and determines the number of Common Shares underlying these options, the vesting
period, the exercise price and the expiry date of each option, as well as all other related
matters, the whole in compliance with the terms of the Share Option Plan and applicable
legislative provisions established by the securities regulatory authorities. Options granted to
executive officers generally vest as to 33 1/3% on each year starting twelve (12) months after
the date of grant. The Board of Directors can modify or terminate the Share Option Plan subject
to compliance with the rules set forth by regulatory authorities. However, certain amendments
require the approval of a majority of the voting shareholders of the Company.
Unless otherwise determined by the Board of Directors, the options granted pursuant to the Share
Option Plan may be exercised within a maximum period of ten (10) years following their date of
grant, unless the optionees employment is terminated, other than for death, in which case the
optionees unexercised vested options, if any, may be exercised within a period of one hundred
eighty (180) days following the date of the employees termination. In the event of the death of
an optionee prior to the expiry date of his options, the optionees legal personal
representative may exercise the optionees unexercised vested options within twelve (12) months
after the date of the optionees death. The options granted in accordance with the Share Option
Plan cannot be transferred or assigned.
The exercise price at which the options may be granted pursuant to the Share Option Plan cannot
be less than the closing price of the Common Shares on the TSX on the day preceding the date of
grant of the options.
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Statement of Executive Compensation
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Page 14 |
Management Proxy Circular
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Theratechnologies Inc. |
In addition, the Share Option Plan states that the number of Common Shares that may be
issued to insiders, at any time, under all security based compensation arrangements of the
Company, cannot exceed 10% of the outstanding Common Shares of the Company, and the number of
Common Shares issued to insiders, within any one year period, under all security based
compensation arrangements, cannot exceed 10% of the outstanding Common Shares. The number of
Common Shares that may be issued to non-employee directors, within any one year period, under
all security based compensation arrangements, cannot exceed 0.5% of the outstanding Common
Shares of the Company.
During the financial year ended November 30, 2009, the Company granted options under the Share
Option Plan providing for the purchase of 680,500 Common Shares. From December 1, 2009 to
February 22, 2010, the Company granted 265,000 options under the Share Option Plan, 155,000 of
which were granted to the Named Executive Officers as part of their compensation for the last
financial year ended November 30, 2009.
The following table sets forth the information regarding the equity compensation plan of the
Company as at November 30, 2009.
|
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|
|
|
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|
|
|
|
|
|
Number of Securities |
|
|
|
|
|
|
|
|
|
|
to be Issued upon |
|
|
|
|
|
|
Number of Securities |
|
|
|
Exercise of Outstanding |
|
|
|
|
|
|
Remaining Available |
|
|
|
Options |
|
|
Weighted-average |
|
|
for Future Issuance |
|
|
|
(% of Issued and |
|
|
Exercise Price of |
|
|
under Equity |
|
Plan Category |
|
Outstanding Share Capital) |
|
|
Outstanding Option |
|
|
Compensation Plan |
|
Equity Compensation |
|
|
|
|
|
$ |
5.20 |
|
|
|
1,244,834 |
|
Plan Approved by |
|
|
2,665,800 |
|
|
|
|
|
|
|
|
|
Shareholders |
|
|
(4.41 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity Compensation |
|
|
|
|
|
|
|
|
|
|
|
|
Plans Not Approved |
|
|
|
|
|
|
|
|
|
|
|
|
by Shareholders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
2,665,800 |
|
|
$ |
5.20 |
|
|
|
1,244,834 |
|
|
B. |
|
Summary Compensation Table |
The summary compensation table below details compensation for the financial year ended November
30, 2009 for each of the President and Chief Executive Officer, the Senior Executive Vice
President and Chief Financial Officer, and the three other most highly compensated executive
officers of the Company (collectively the Named Executive Officers) for services rendered in
all capacities.
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Statement of Executive Compensation
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Page 15 |
Management Proxy Circular
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Theratechnologies Inc. |
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Non-equity incentive plan |
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compensation ($) |
|
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Share- |
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Option- |
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All other |
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Name and |
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|
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|
|
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based |
|
|
based |
|
|
Annual |
|
|
Long-term |
|
|
Pension |
|
|
compen- |
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Total |
|
principal |
|
|
|
|
|
Salary |
|
|
awards |
|
|
awards(1) (2) |
|
|
incentive |
|
|
incentive |
|
|
value |
|
|
sation(13) |
|
|
compensation |
|
position |
|
Year |
|
|
($) |
|
|
($) |
|
|
($) |
|
|
plans |
|
|
plans |
|
|
($) |
|
|
($) |
|
|
($) |
|
|
Yves Rosconi
President and
Chief Executive
Officer |
|
|
2009 |
|
|
|
426,635 |
|
|
|
|
|
|
|
80,820 |
(3) |
|
|
225,000 |
(8) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
732,455 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Luc Tanguay
Senior Executive
Vice President and
Chief Financial
Officer |
|
|
2009 |
|
|
|
353,354 |
|
|
|
|
|
|
|
67,350 |
(4) |
|
|
176,000 |
(9) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
596,704 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Christian Marsolais
Vice President,
Clinical Research
and Medical
Affairs |
|
|
2009 |
|
|
|
220,846 |
|
|
|
|
|
|
|
156,040 |
(5) |
|
|
100,000 |
(10) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
476,886 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Martine Ortega
Vice President,
Compliance and
Regulatory Affairs |
|
|
2009 |
|
|
|
215,827 |
|
|
|
|
|
|
|
125,165 |
(6) |
|
|
110,000 |
(11) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
450,992 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
Jocelyn Lafond
Vice President,
Legal Affairs,
and Corporate
Secretary |
|
|
2009 |
|
|
|
200,769 |
|
|
|
|
|
|
|
142,570 |
(7) |
|
|
66,000 |
(12) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
409,339 |
|
|
|
|
(1) |
|
The value of the awards is comprised of two grants that occurred during the last financial
year. The first grant was made on December 18, 2008 (the December 2008 Grant) and the second
occurred on December 8, 2009 (the December 2009 Grant). Only the value of the options
received by Ms. Ortega, Mr. Marsolais and Mr. Lafond as part of the December 2008 Grant and
resulting as compensation for the financial year ended November 30, 2009 has been included in
this table. The value of the option-based awards was calculated using the Black-Scholes-Merton
model using the following assumptions: |
|
(i) |
|
Risk-free interest rate: 1.79%; |
|
|
(ii) |
|
Expected volatility in the market price of the Common Shares: 79.33%; |
|
|
(iii) |
|
Expected dividend yield: 0%; and |
|
|
(iv) |
|
Expected life: 6 years. |
|
|
|
Fair value per option: $1.235. |
|
(i) |
|
Risk-free interest rate: 2.46%; |
|
|
(ii) |
|
Expected volatility in the market price of the Common Shares: 80.96%; |
|
|
(iii) |
|
Expected dividend yield: 0%; and |
|
|
(iv) |
|
Expected life: 6 years. |
|
|
Fair value per option: $2.694 |
|
|
|
(2) |
|
The options granted as part of the December 2008 Grant vest over a three (3) year period as
to 33 1/3% beginning December 18, 2009. The options granted as part of the December 2009 Grant
vest over a three (3) year period as to 33 1/3% beginning on December 8, 2010. |
|
(3) |
|
Mr. Rosconi was granted 30,000 options as part of the
December 2009 Grant. |
|
(4) |
|
Mr. Tanguay was granted 25,000 options as part of the
December 2009 Grant. |
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Statement of Executive Compensation
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Page 16 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
(5) |
|
Mr. Marsolais was granted 35,000 options as part of the December 2009 Grant. Mr. Marsolais was
also granted 50,000 options as part of the December 2008 Grant, of which 25,000 were granted
pursuant to the terms of his employment agreement and 25,000 were granted further to his
appointment as Vice President in August 2007. Subject to Mr. Marsolais being employed by the
Company, these 50,000 options were scheduled to be granted in the financial year 2008. However, as
a result of the strategic review process that was ongoing during this financial year, the Board of
Directors decided to defer the grant of those options until completion of the strategic review
process. |
|
(6) |
|
Ms. Ortega was granted 35,000 options as part of the December 2009 Grant. Ms. Ortega was also
granted 25,000 options as part of the December 2008 Grant further to her appointment as Vice
President in August 2007. Subject to Ms. Ortega being employed by the Company, these 25,000 options
were scheduled to be granted in the financial year 2008. However, as a result of the strategic
review process that was ongoing during this financial year, the Board of Directors decided to defer
the grant of those options until completion of the strategic review process. |
|
(7) |
|
Mr. Lafond was granted 30,000 options as part of the December 2009 Grant. Mr. Lafond was also
granted 50,000 options as part of the December 2008 Grant, of which 25,000 were granted pursuant to
the terms of his employment agreement and 25,000 were granted further to his appointment as Vice
President in August 2007. Subject to Mr. Lafond being employed by the Company, these 50,000 options
were scheduled to be granted in the financial year 2008. However, as a result of the strategic
review process that was ongoing during this financial year, the Board of Directors decided to defer
the grant of those options until completion of the strategic review process. |
|
(8) |
|
The amount received by Mr. Rosconi represents 106% of his targeted bonus ($212,873). As
President and Chief Executive Officer of the Company, Mr. Rosconis objectives were aligned with
the Companys objectives. The Compensation Committee determined that he had exceeded his objectives
by leading the scientific and regulatory teams in filing a New Drug Application to the Food and
Drug Administration in the United States before the end of the second quarter. |
|
(9) |
|
The amount received by Mr. Tanguay represents 100% of his targeted bonus ($176,000). As Senior
Executive Vice President and Chief Financial Officer of the Company, Mr. Tanguays objectives were
aligned with those of the Company and included (i) managing the Companys liquidities to ensure the
corporate objectives would be attained in a cost-efficient manner and according to the annual
budget; (ii) supervising the negotiation of supply agreements with third parties for the
manufacture of tesamorelin on a commercial scale; (iii) overseeing the internal controls and
process of the Company for compliance with securities regulation; (iv) supervising the process
regarding the preparation of the Company to the new IFRS accounting rules; and (v) overseeing the
investors relations programme. |
|
(10) |
|
The amount received by Mr. Marsolais represents 135% of his targeted bonus ($73,615). As Vice
President, Clinical Research and Medical Affairs, of the Company, Mr. Marsolaiss objective were
aligned with those of the Company and consisted in the preparation and completion of the New Drug
Application to be filed with the Food and Drug Administration of the United States. |
|
(11) |
|
The amount received by Ms. Ortega represents 153% of her targeted bonus ($71,942). As Vice
President, Compliance and Regulatory Affairs, of the Company, Ms. Ortegas objectives were aligned
with those of the Company and included (i) leading the preparation of the New Drug Application to
ensure compliance with the Federal Food, Drug, and Cosmetic Act (United States); and (ii) managing
the filing process of the New Drug Application with the Food and Drug Administration in the United
States. |
|
(12) |
|
The amount received by Mr. Lafond represents 99% of his targeted bonus ($66,922). As Vice
President, Legal Affairs, and Corporate Secretary, of the Company, Mr. Lafonds objectives were
aligned with those of the Company. The main objective of Mr. Lafond consists in overseeing the
legal needs of the Company. In addition, the Compensation Committee determined that he had achieved
the following objectives (i) overseeing the anti-trust issues regarding the execution of the
collaboration and licensing agreement with EMD Serono, Inc.; (ii) assisting with the negotiations
of the supply agreements to manufacture tesamorelin on a commercial scale; and (iii) supporting the
legal needs of both the clinical research and regulatory teams. |
|
(13) |
|
Perquisites for each Named Executive Officer have not been included as they do not reach the
prescribed threshold of the lesser of $50,000 and 10% of each of the respective Named Executive
Officers salary for the last financial year. |
|
C. |
|
Incentive Plan Awards |
|
|
|
|
Outstanding Option-Based Awards and Share-Based Awards |
|
|
|
|
The table below details the outstanding option-based awards and share-based awards as at
November 30, 2009 for each of the Named Executive Officers. |
|
|
|
|
|
|
Statement of Executive Compensation
|
|
Page 17 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
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|
|
|
Option-Based Awards |
Share-Based Awards |
|
|
|
Number of |
|
|
|
|
|
|
|
|
|
|
Value of |
|
|
|
|
|
|
securities |
|
|
|
|
|
|
|
|
|
|
unexercised |
|
|
Number of shares |
|
|
Market or payout |
|
|
|
underlying |
|
|
Option |
|
|
|
|
|
|
in-the-money |
|
|
or units of shares |
|
|
value of share- |
|
|
|
unexercised |
|
|
exercice |
|
|
Option |
|
|
options |
|
|
that have not |
|
|
based awards that |
|
|
|
options |
|
|
price |
|
|
expiration |
|
|
(1) |
|
|
vested |
|
|
have not vested |
|
Name |
|
(#) |
|
|
($) |
|
|
Date |
|
|
($) |
|
|
(#) |
|
|
($) |
|
|
Yves Rosconi |
|
|
133,334 |
|
|
|
2.61 |
|
|
|
2014.10.01 |
|
|
|
90,667 |
|
|
|
|
|
|
|
|
|
President and |
|
|
133,334 |
|
|
|
1.24 |
|
|
|
2015.10.01 |
|
|
|
273,335 |
|
|
|
|
|
|
|
|
|
Chief Executive Officer |
|
|
25,000 |
|
|
|
8.23 |
|
|
|
2017.01.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
37,250 |
|
|
|
|
|
|
|
|
|
Luc Tanguay |
|
|
200,000 |
|
|
|
10.40 |
|
|
|
2011.10.30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Senior Executive |
|
|
200,000 |
|
|
|
8.00 |
|
|
|
2012.10.30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Vice President and |
|
|
125,000 |
|
|
|
1.94 |
|
|
|
2016.02.08 |
|
|
|
168,750 |
|
|
|
|
|
|
|
|
|
Chief Financial Officer |
|
|
25,000 |
|
|
|
8.23 |
|
|
|
2017.01.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
29,800 |
|
|
|
|
|
|
|
|
|
Christian Marsolais |
|
|
25,000 |
|
|
|
11.48 |
|
|
|
2017.07.11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Vice President, |
|
|
25,000 |
|
|
|
10.60 |
|
|
|
2017.08.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical Research |
|
|
1,000 |
|
|
|
8.50 |
|
|
|
2018.01.30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
and Medical Affairs |
|
|
65,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
96,850 |
|
|
|
|
|
|
|
|
|
Martine Ortega |
|
|
25,000 |
|
|
|
1.42 |
|
|
|
2016.07.06 |
|
|
|
46,750 |
|
|
|
|
|
|
|
|
|
Vice President, |
|
|
10,000 |
|
|
|
8.23 |
|
|
|
2017.01.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Compliance and |
|
|
25,000 |
|
|
|
11.48 |
|
|
|
2017.07.11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Regulatory Affairs |
|
|
25,000 |
|
|
|
10.60 |
|
|
|
2017.08.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,000 |
|
|
|
8.50 |
|
|
|
2018.01.30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
59,600 |
|
|
|
|
|
|
|
|
|
Jocelyn Lafond |
|
|
25,000 |
|
|
|
8.29 |
|
|
|
2017.03.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Vice President, |
|
|
25,000 |
|
|
|
10.60 |
|
|
|
2017.08.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Legal Affairs, |
|
|
65,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
96,850 |
|
|
|
|
|
|
|
|
|
and Corporate
Secretary |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The value of unexercised in-the-money options at financial year end is the difference between
the closing price of the Common Shares on November 30, 2009 ($3.29) on the TSX and the respective
exercise prices of the options. The value shown in this table does not represent the actual value
that a Named Executive Officer would have received if the options had been exercised as at November
30, 2009 since some of these options were not fully vested as of that date and, therefore, were not
exercisable. |
Incentive Plan Awards Value vested or earned during the year
The table below shows the value vested or earned during the year under each incentive plan as
at November 30, 2009 for each of the Named Executive Officers.
|
|
|
|
|
|
Statement of Executive Compensation
|
|
Page 18 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-equity incentive |
|
|
|
Option-based awards |
|
|
Share-based awards |
|
|
plan compensation |
|
|
|
Value vested during |
|
|
Value vested |
|
|
Value earned |
|
|
|
the year(1) |
|
|
during the year |
|
|
during the year |
|
Name |
|
($) |
|
|
($) |
|
|
($) |
|
Yves Rosconi |
|
|
|
|
|
|
|
|
|
|
225,000 |
|
President and
Chief Executive Officer |
|
|
|
|
|
|
|
|
|
|
|
|
Luc Tanguay |
|
|
|
|
|
|
|
|
|
|
176,000 |
|
Senior Executive
Vice President and
Chief Financial Officer |
|
|
|
|
|
|
|
|
|
|
|
|
Christian Marsolais |
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Vice President,
Clinical Research
and Medical Affairs |
|
|
|
|
|
|
|
|
|
|
|
|
Martine Ortega |
|
|
7,167 |
(2) |
|
|
|
|
|
|
110,000 |
|
Vice President,
Compliance and
Regulatory Affairs |
|
|
|
|
|
|
|
|
|
|
|
|
Jocelyn Lafond |
|
|
|
|
|
|
|
|
|
|
66,000 |
|
Vice President,
Legal Affairs,
and Corporate Secretary |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The value is determined by assuming that the options vested during the financial year would
have been exercised on the vesting date. The value corresponds to the difference between the
closing price of the Common Shares on the TSX on the vesting date and the exercise price of the
options on that date. |
|
(2) |
|
8,334 options having an exercise price of $1.42 vested on July 6, 2009. On that date, the
closing price of the Common Shares on the TSX was $2.28. |
D. Termination and Change of Control Provisions
Below is a summary of the employment agreements of each of the Named Executive Officers
together with a table detailing the value of the severance payment that would be payable by
the Company to each Named Executive Officer pursuant to his employment agreement if one of the
events described in the table had occurred on November 30, 2009.
Yves Rosconi
President and Chief Executive Officer
On October 21, 2004, the Company entered into an employment agreement for an indeterminate
term with Mr. Yves Rosconi. In addition to his base salary, Mr. Rosconi is entitled to the
Companys benefits program and is eligible to receive an annual bonus based on attainment of
objectives set annually by the Companys Board of Directors. Mr. Rosconi was also entitled to
stock options, which have all been granted. These options vested over a three-year period from
the date of grant. Under the terms of the agreement, Mr. Rosconi agreed to non-competition,
non-solicitation, non-disclosure and assignment of intellectual property provisions in favour
of the Company. If the Company terminates Mr. Rosconis employment without just and sufficient
cause, he will receive an
|
|
|
|
|
|
Statement of Executive Compensation
|
|
Page 19 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
amount equal to twelve (12) months of compensation (including bonus based on the last
granted and the value of the Companys benefits to which he was then entitled). The payment of
this amount will be the sole monetary obligation of the Company. Furthermore, in the event of a
Change of Control (as defined below), his employment agreement provides for an indemnity equal to
twenty-four (24) months of compensation (including bonus based on the last granted and the
value of the Companys benefits to which he was then entitled) if Mr. Rosconis employment is
terminated by the Company, and twelve (12) months if Mr. Rosconi resigns on his own free will. In
Mr. Rosconis agreement, a Change of Control is defined as a successful take-over bid, as such
term is defined in the Securities Act (Québec).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of Stock |
|
|
|
Severance |
|
|
Options (1) |
|
Events |
|
($) |
|
|
($) |
|
Retirement (2) |
|
|
|
|
|
|
364,002 |
|
Termination of Employment |
|
|
|
|
|
|
|
|
without Just Cause (2) |
|
|
678,535 |
(4) |
|
|
364,002 |
|
Termination of Employment
in the event of
a Change of Control (3) |
|
|
1,357,070 |
(4) |
|
|
401,252 |
|
Voluntary Resignation
in the event of
a Change of Control (3) |
|
|
678,535 |
(4) |
|
|
401,252 |
|
Voluntary Resignation (2) |
|
|
|
|
|
|
364,002 |
|
|
|
|
(1) |
|
The value assumes that upon the occurrence of an event, all vested options would be exercised.
The value is the difference between the closing price of the Common Shares on November 30, 2009 on
the TSX ($3.29) and the respective exercise price of each vested option as at November 30, 2009. |
|
(2) |
|
Under the Share Option plan, the termination of a persons employment with the Company entitles
him to exercise his vested options over a six-month period after the termination date. |
|
(3) |
|
Given the different definitions of Change of Control used in the employment agreements of the
Named Executive Officers, in computing the value of the stock options in the event of a Change of
Control, the Company assumed that all unvested options would vest as per the terms of Section 5.5
of its Share Option Plan and that all vested options having an exercise price lower than the
closing price of the Common Shares on November 30, 2009 on the TSX
($3.29) would be exercised. |
|
(4) |
|
As at November 30, 2009, the last bonus paid to Mr. Rosconi was the bonus he received for the
financial year 2008 which amounted to $230,000. |
Luc Tanguay
Senior Executive Vice President and Chief Financial Officer
The Company entered into an employment agreement for an indeterminate term with Mr. Luc Tanguay on
October 30, 2001. His agreement was subsequently amended on May 9, 2002, June 7, 2004 and February
8, 2006. In addition to his base salary, Mr. Tanguay is entitled to the Companys benefits program
and is eligible to receive an annual bonus based on the attainment of annual objectives. Mr.
Tanguay was also entitled to stock options, which have all been granted. Under the terms of the
agreement, Mr. Tanguay agreed to non-competition, non-solicitation, non-disclosure and assignment
of intellectual property provisions in favour of the Company. If the Company terminates the
employment of Mr. Tanguay without just and sufficient cause, he will receive an amount equal to
twenty-four (24) months of compensation (including bonus based on the last granted and the
value of the Companys benefits to which he was then entitled). The payment of this amount will be
the sole monetary obligation of the Company. In addition, in the event the employment of Mr.
Tanguay is terminated for any reason, including death, he will be entitled to exercise his stock
options over a 24-month period, subject to the prior expiry of his stock
|
|
|
|
|
|
Statement of Executive Compensation
|
|
Page 20 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
options in accordance with their terms. Furthermore, in the event of a Change of Control (as
defined below), his employment agreement provides for an indemnity equal to twenty-four (24) months
of compensation (including bonus based on the last granted and the value of the Companys
benefits to which he was then entitled) if Mr. Tanguays employment is terminated by the Company,
and twelve (12) months if Mr. Tanguay resigns on his own free will. In Mr. Tanguays agreement, a
Change of Control is defined as a successful take-over bid, as such term is defined in the
Securities Act (Québec).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of Stock |
|
|
|
Severance |
|
|
Options (1) |
|
Events |
|
($) |
|
|
($) |
|
Retirement (2) |
|
|
|
|
|
|
168,750 |
|
Termination of Employment
without Just Cause (2) |
|
|
1,140,508 |
(4) |
|
|
168,750 |
|
Termination of Employment
in the event of
a Change of Control (3) |
|
|
1,140,508 |
(4) |
|
|
198,550 |
|
Voluntary Resignation
in the event of
a Change of Control (3) |
|
|
570,254 |
(4) |
|
|
198,550 |
|
Voluntary Resignation (2) |
|
|
|
|
|
|
168,750 |
|
|
|
|
(1) |
|
The value assumes that upon the occurrence of an event, all vested options would be exercised.
The value is the difference between the closing price of the Common Shares on November 30, 2009 on
the TSX ($3.29) and the respective exercise price of each vested option as at November 30, 2009. |
|
(2) |
|
Under the Share Option plan, the termination of a persons employment with the Company entitles
him to exercise his vested options over a six-month period after the termination date. |
|
(3) |
|
Given the different definitions of Change of Control used in the employment agreements of the
Named Executive Officers, in computing the value of the stock options in the event of a Change of
Control, the Company assumed that all unvested options would vest as per the terms of Section 5.5
of its Share Option Plan and that all vested options having an exercise price lower than the
closing price of the Common Shares on November 30, 2009 on the TSX
($3.29) would be exercised. |
|
(4) |
|
As at November 30, 2009, the last bonus paid to Mr. Tanguay was the bonus he received for the
financial year 2008 which amounted to $195,000. |
Christian Marsolais
Vice President, Clinical Research and Medical Affairs
The Company entered into an employment agreement for an indeterminate term with Mr. Christian
Marsolais on April 13, 2007. In addition to his base salary, Mr. Marsolais is entitled to the
Companys benefits program and is eligible to receive an annual bonus based on attainment of
objectives set annually by the President and Chief Executive Officer. Mr. Marsolais was also
entitled to stock options, which have all been granted. These stock options vest over a three-year
period from the date of grant. Under the terms of the agreement, Mr. Marsolais agreed to
non-competition, non-solicitation, non-disclosure and assignment of intellectual property
provisions in favour of the Company. If the Company terminates Mr. Marsolais employment without
just and sufficient cause, he will receive an amount equal to nine (9) months of his annual base
salary. The payment of this amount will be the sole monetary obligation of the Company.
|
|
|
|
|
|
Statement of Executive Compensation
|
|
Page 21 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
|
|
|
|
|
|
|
|
Severance |
|
|
Value of Stock
Options (1) |
|
Events |
|
($) |
|
|
($) |
|
Retirement (2) |
|
|
|
|
|
|
|
|
Termination of Employment
without Just Cause (2) |
|
|
165,634 |
|
|
|
|
|
Termination of Employment
in the event of
a Change of Control (3) |
|
|
165,634 |
|
|
|
96,850 |
|
Voluntary Resignation
in the event of
a Change of Control (3) |
|
|
|
|
|
|
96,850 |
|
Voluntary Resignation (2) |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The value assumes that upon the occurrence of an event, all vested options would be exercised.
The value is the difference between the closing price of the Common Shares on November 30, 2009 on
the TSX ($3.29) and the respective exercise price of each vested option as at November 30, 2009. |
|
(2) |
|
Under the Share Option plan, the termination of a persons employment with the Company entitles
him to exercise his vested options over a six-month period after the termination date. |
|
(3) |
|
Given the different definitions of Change of Control used in the employment agreements of the
Named Executive Officers, in computing the value of the stock options in the event of a Change of
Control, the Company assumed that all unvested options would vest as per the terms of Section 5.5
of its Share Option Plan and that all vested options having an exercise price lower than the
closing price of the Common Shares on November 30, 2009 on the TSX
($3.29) would be exercised. |
Martine Ortega
Vice President, Compliance and Regulatory Affairs
The Company entered into an employment agreement for an indeterminate term with Ms. Martine Ortega
on May 11, 2006. In addition to her base salary, Ms. Ortega is entitled to the Companys benefits
program and is eligible to receive an annual bonus based on attainment of objectives set annually
by the President and Chief Executive Officer. Ms. Ortega was also entitled to stock options, which
have all been granted. These stock options vest over a three-year period from the date of grant.
Under the terms of the agreement, Ms. Ortega agreed to non-solicitation, non-disclosure and
assignment of intellectual property provisions in favour of the Company. If the Company terminates
Ms. Ortegas employment without just and sufficient cause, she will receive an amount equal to nine
(9) months of her annual base salary, if her termination occurs: (i) in the context of an internal
reorganization of the Company or (ii) within two (2) years from the date there occurs a Change of
Control (as defined below) of the Company. The payment of this amount will be the sole monetary
obligation of the Company. In Ms. Ortegas agreement, a Change of Control is defined as a
transaction resulting in the liquidation or winding-up of the Company, delisting of the Companys
Common Shares on a stock exchange, the acquisition by a third party of the control of the Company,
the sale of all or substantially all of the assets of the Company or the privatization or a merger
of the Company.
|
|
|
|
|
|
Statement of Executive Compensation
|
|
Page 22 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value of Stock |
|
|
|
Severance |
|
|
Options (1) |
|
Events |
|
($) |
|
|
($) |
|
Retirement (2) |
|
|
|
|
|
|
46,750 |
|
Termination of Employment
without Just Cause (2) |
|
|
161,870 |
|
|
|
46,750 |
|
Termination of Employment
in the event of
a Change of Control (3) |
|
|
161,870 |
|
|
|
106,350 |
|
Voluntary Resignation
in the event of
a Change of Control (3) |
|
|
|
|
|
|
106,350 |
|
Voluntary Resignation (2) |
|
|
|
|
|
|
46,750 |
|
|
|
|
(1) |
|
The value assumes that upon the occurrence of an event, all vested options would be exercised.
The value is the difference between the closing price of the Common Shares on November 30, 2009 on
the TSX ($3.29) and the respective exercise price of each vested option as at November 30, 2009. |
|
(2) |
|
Under the Share Option plan, the termination of a persons employment with the Company entitles
him to exercise his vested options over a six-month period after the termination date. |
|
(3) |
|
Given the different definitions of Change of Control used in the employment agreements of the
Named Executive Officers, in computing the value of the stock options in the event of a Change of
Control, the Company assumed that all unvested options would vest as per the terms of Section 5.5
of its Share Option Plan and that all vested options having an exercise price lower than the
closing price of the Common Shares on November 30, 2009 on the TSX
($3.29) would be exercised. |
Jocelyn Lafond
Vice President, Legal Affairs, and Corporate Secretary
The Company entered into an employment agreement for an indeterminate term with Mr. Jocelyn Lafond
on March 27, 2007. In addition to his base salary, Mr. Lafond is entitled to the Companys benefits
program and is eligible to receive an annual bonus based on attainment of objectives set annually
by the Senior Executive Vice President and Chief Financial Officer. Mr. Lafond was also entitled to
stock options, which have all been granted. These stock options vest over a three-year period from
the date of grant. Under the terms of the agreement, Mr. Lafond agreed to non-disclosure and
assignment of intellectual property provisions in favour of the Company. If the Company terminates
Mr. Lafonds employment without just and sufficient cause, he will receive an amount equal to 12
months of his annual base salary. The payment of this amount will be the sole monetary obligation
of the Company. Furthermore, in the event of a Change of Control, his employment agreement
provides for an indemnity equal to 12 months of his annual base salary if his employment is
terminated or if he resigns of his own free will within 24 months from such Change of Control. In
Mr. Lafonds agreement, a Change of Control is defined as a take-over bid, as such term is
defined in the Securities Act (Québec), and as any transaction pursuant to which a person acquires
the control of the Company.
|
|
|
|
|
|
Statement of Executive Compensation
|
|
Page 23 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
|
|
|
|
|
|
|
|
Severance |
|
|
Value of Stock Options(1) |
|
Events |
|
($) |
|
|
($) |
|
Retirement (2) |
|
|
|
|
|
|
|
|
Termination of Employment
without Just Cause (2) |
|
|
200,769 |
|
|
|
|
|
Termination of Employment
in the event of
a Change of Control (3) |
|
|
200,769 |
|
|
|
96,850 |
|
Voluntary Resignation
in the event of
a Change of Control (3) |
|
|
200,769 |
|
|
|
96,850 |
|
Voluntary Resignation (2) |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The value assumes that upon the occurrence of an event, all vested options would be exercised.
The value is the difference between the closing price of the Common Shares on November 30, 2009 on
the TSX ($3.29) and the respective exercise price of each vested option as at November 30, 2009. |
|
(2) |
|
Under the Share Option plan, the termination of a persons employment with the Company entitles
him to exercise his vested options over a six-month period after the termination date. |
|
(3) |
|
Given the different definitions of Change of Control used in the employment agreements of the
Named Executive Officers, in computing the value of the stock options in the event of a Change of
Control, the Company assumed that all unvested options would vest as per the terms of Section 5.5
of its Share Option Plan and that all vested options having an exercise price lower than the
closing price of the Common Shares on November 30, 2009 on the TSX
($3.29) would be exercised. |
E. Performance Graph
The following graph compares a cumulative annual total shareholder return on a $100 investment in
the Common Shares of the Company (TH) with a cumulative total shareholder return on the composite
index S&P/TSX (previously known as the Toronto Stock Exchange 300 (TSE 300 Index)) assuming that
all dividends are reinvested (S&P) and the AMEX biotech index (AMEX Biotech).
Return on a $100 Investment
from November 30,
2004 to November 30, 2009
|
|
|
|
|
|
Statement of Executive Compensation
|
|
Page 24 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 |
|
|
2005 |
|
|
2006 |
|
|
2007 |
|
|
2008 |
|
|
2009 |
|
|
Theratechnologies |
|
|
100,00 |
|
|
|
53,44 |
|
|
|
133,33 |
|
|
|
537,04 |
|
|
|
85,19 |
|
|
|
174,07 |
|
S&P / TSX Composite Index |
|
|
100,00 |
|
|
|
119,87 |
|
|
|
141,22 |
|
|
|
151,60 |
|
|
|
102,66 |
|
|
|
126,77 |
|
AMEX Biotechnology Index |
|
|
100,00 |
|
|
|
129,84 |
|
|
|
148,42 |
|
|
|
159,78 |
|
|
|
114,91 |
|
|
|
171,25 |
|
The trend shown in the above performance graph indicates that, as at November 30 of each of
the 2005, 2006, 2007, 2008 and 2009 year, the annual total shareholder return on a $100 investment
in the Common Shares of the Company was above the S&P and approximately the same as the AMEX
Biotech. The base salaries of the Named Executives Officers were not linked to the trend regarding
the annual total shareholder return over the last five years. For the same period, shareholder
return was one of the parameters taken into consideration in establishing the value of the
short-term performance reward for the Named Executive Officers.
F. Other Information
Description of the Share Purchase Plan
On February 16, 1999, the Board of Directors adopted a common share purchase plan (the Share
Purchase Plan). The Share Purchase Plan was thereafter amended from time to time and, more
recently, by the Board of Directors on February 24, 2009. The last amendments to the Share Purchase
Plan were approved by the shareholders on March 26, 2009 at the Companys last annual and special
meeting of shareholders.
The Share Purchase Plan entitles full-time and part-time employees of the Company who, on a
Participation Date (as defined below), are residents of Canada, are not under a probationary period
and do not hold, directly or indirectly, five percent (5%) or more of the Companys outstanding
Common Shares, to directly subscribe for Common Shares of the Company. The Share Purchase Plan
provides that a maximum of 550,000 Common Shares (0.91% of the issued and outstanding Common Shares
as at January 31, 2010) may be offered to employees. During the fiscal year ended November 30,
2009, the Company issued 34,466 Common Shares under the Share Purchase Plan (0.06% of the issued
and outstanding Common Shares as at January 31, 2010). As at the date of the Circular, 210,186
Common Shares remain available for issuance.
On May 1st and November 1st of each year (the Participation Dates), an
employee may subscribe for a number of Common Shares under the Share Purchase Plan for an amount
that does not exceed during such year 10% of his annual gross salary during said year. Under the
Share Purchase Plan, the Board of Directors has the authority to suspend, differ or determine that
no subscription of Common Shares will be allowed on a Participation Date if it is in the best
interest of the Company.
The Share Purchase Plan provides that the number of Common Shares that may be issued to insiders,
at any time, under all security based compensation arrangements of the Company, cannot exceed 10%
of the outstanding Common Shares, and the number of Common Shares issued to insiders, within any
one-year period, under all security based compensation arrangements, cannot exceed 10% of the
outstanding Common Shares.
The subscription price for each new Common Share subscribed pursuant to the Share Purchase Plan is
equal to the weighted average closing price of the Common Shares on the Toronto Stock Exchange
during a period of five (5) days prior to a Participation Date. Employees cannot assign or
otherwise alienate their rights in the Share Purchase Plan.
|
|
|
|
|
|
Statement of Executive Compensation
|
|
Page 25 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
At the election of an employee, the subscription price for Common Shares may be paid in cash
or through an interest-free loan provided by the Company. The loans provided by the Company under
the Share Purchase Plan may be repayable by equal withholdings from a participants salary for a
period not exceeding two (2) years. All loans may be prepaid at all times. The loans granted to any
employee at any time must not exceed 10% of his current annual gross salary. All Common Shares
subscribed for through an interest-free loan are hypothecated to secure the full and final
repayment of the loan and are held by the trustee, Computershare, until such full repayment. Loans
are immediately due and repayable upon the occurrence of one of the following events: (i) the
termination of the employment of an employee; (ii) the sale or seizure of the Common Shares being
subject to a hypothec; (iii) the bankruptcy or insolvency of an employee; or (iv) the suspension of
the payment of an employees salary or the revocation of his right to salary withholdings.
Shareholder approval is not required for all amendments to the Share Purchase Plan. For example,
the Board of Directors may, without shareholder approval, make certain amendments of the following
nature to the Share Purchase Plan such as: (i) formal minor or technical amendments to any
provision of the Share Purchase Plan; (ii) corrections to any provision of the Share Purchase Plan
containing an ambiguity, defect, error or omission; or (iii) changes that do not require
shareholder approval as hereafter described. However, the following amendments require the approval
by a majority of the shareholders present at a duly called shareholders meeting:
|
(a) |
|
any extension of the term of the Share Purchase Plan; |
|
|
(b) |
|
any increase in the number of Common Shares reserved for issuance under the Share Purchase Plan; |
|
|
(c) |
|
any increase in the number of Common Shares that may be purchased annually by an employee; |
|
|
(d) |
|
any change in the formula to determine the subscription price of Common Shares; and |
|
|
(e) |
|
any increase in the amount an employee is authorized to borrow from the Company to purchase Common Shares under the Share Purchase Plan. |
Indebtedness of Executive Officers
As at the date of the Circular, none of the executive officers was indebted to the Company, other
than for Routine Indebtedness (as defined in Regulation 51-102 respecting Continuous Disclosure
Obligations (Québec)). During the financial year ended on November 30, 2009, none of the executive
officers of the Company was indebted to the Company, other than for Routine Indebtedness.
2. |
|
Director Compensation |
|
A. |
|
Determination of Director Compensation |
The Company has adopted a compensation policy for its directors who are not employed on a full-time
basis by the Company under which they are paid an annual retainer fee as well as attendance fees.
In addition, the Company reimburses the reasonable expenses incurred by each director to attend
meetings of the board or meetings of committees. In January 2008, the Compensation Committee met
and reassessed the compensation paid to all board members, committee members and to the chairs of
each committee. The last assessment of the compensation paid to individuals acting as board
members, committee members and chairs of such committees had occurred in 2004. The assessment was
based on a review of public documents filed by Canadian companies listed on the TSX or NASDAQ
market. Criteriae such as fields of operation, market
|
|
|
|
|
|
Statement of Executive Compensation
|
|
Page 26 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
capitalization, number of employees, stage of development, where applicable, and level of
revenue were taken into consideration by the Compensation Committee in reviewing in 2008 the
compensation paid to board members, committee members and to chairs of each committee. Based on the
recommendation of the Compensation Committee, effective January 1, 2008, the Board of Directors
approved the compensation described in the table below for individuals who are not employees of the
Company who act as board members, committee members and chairs of those committees.
|
|
|
|
|
Position at |
|
|
|
Board Level or |
|
|
|
Committee Level |
|
Compensation |
|
Annual Retainer to Chair of the Board |
|
$ |
100,000 |
|
Annual Retainer to Board Members |
|
$ |
20,000 |
|
Annual Grant of Options (1) |
|
|
10,000 |
(2) |
Attendance Fees Paid for Each Meeting of the Board of Directors |
|
|
|
|
- in person |
|
$ |
2,000 |
|
- by conference call |
|
$ |
1,200 |
|
Annual Retainer to Chair of the Audit Committee |
|
$ |
10,000 |
|
Annual Retainer to Chair of each Committee (other than the Audit
Committee) |
|
$ |
6,000 |
|
Annual Retainer to Committee Members |
|
$ |
4,000 |
|
Attendance Fees Paid for Each Meeting of a Committee(3) |
|
|
|
|
- in person |
|
$ |
1,500 |
|
- by conference call |
|
$ |
1,200 |
|
|
|
|
(1) |
|
Options are usually granted at the board meeting following the annual meeting of shareholders. |
|
(2) |
|
At the time of the 2008 review, the Compensation Committee had set the annual grant of options
to each director at 10,000. However, as a result of the strategic review process that was ongoing,
the Board of Directors decided that the number of options that each director was entitled to
receive annually was to remain at 5,000. Further to the completion of the strategic review process,
during the last financial year, the Board of Directors passed a resolution in order to change that
number from 5,000 to 10,000. |
|
(3) |
|
No attendance fee is paid for meetings of the Finance Committee. |
B. Director Compensation Table
The following table details all components of the compensation provided to the directors of the
Company in the last financial year and the value thereof.
|
|
|
|
|
|
Statement of Executive Compensation
|
|
Page 27 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share- |
|
|
|
|
|
|
Non-equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
based |
|
|
Option-based |
|
|
incentive plan |
|
|
Pension |
|
|
All other |
|
|
|
|
|
|
Fees earned |
|
|
awards |
|
|
awards(2) |
|
|
compensation |
|
|
value |
|
|
compensation |
|
|
Total |
|
Name |
|
($) |
|
|
($) |
|
|
($) |
|
|
($) |
|
|
($) |
|
|
($) |
|
|
($) |
|
|
Gilles Cloutier |
|
|
46,767 |
|
|
|
|
|
|
|
12,740 |
|
|
|
|
|
|
|
|
|
|
|
1,500 |
(3) |
|
|
61,007 |
|
A. Jean de Grandpré |
|
|
62,300 |
|
|
|
|
|
|
|
12,740 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
75,040 |
|
Robert Goyer (1) |
|
|
38,267 |
|
|
|
|
|
|
|
12,740 |
|
|
|
|
|
|
|
|
|
|
|
1,500 |
(3) |
|
|
52,507 |
|
Gérald A. Lacoste |
|
|
58,200 |
|
|
|
|
|
|
|
12,740 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
70,940 |
|
Paul Pommier |
|
|
179,200 |
|
|
|
|
|
|
|
12,740 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
191,940 |
|
Bernard Reculeau |
|
|
39,400 |
|
|
|
|
|
|
|
12,740 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52,140 |
|
Jean-Denis Talon |
|
|
50,300 |
|
|
|
|
|
|
|
12,740 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
63,040 |
|
|
|
|
(1) |
|
The services of Mr. Goyer are provided to the Company by Clinipharm (1987) Inc.
(Clinipharm), a company controlled by Mr. Goyer, and all cash compensation for the services
of Mr. Goyer is paid to this entity. Based on information received from Clinipharm, Mr. Goyer
received from Clinipharm the amount of $10,000 from December 1, 2008 to June 30, 2009. The
fiscal year-end of Clinipharm is different from that of the Company and the amount to be
received, if any, by Mr. Goyer for the period running from July 1, 2009 to November 30, 2009
is unknown. All options are granted to Mr. Goyer, personally. |
|
(2) |
|
The value of the awards is comprised of one grant that occurred on March 28, 2009 (the March
2009 Grant). As part of the March 2009 Grant, each director was granted 10,000 options at an
exercise price of $1.84. Each option has a ten-year term and vests on the date of grant. The
terms and conditions of those options are governed by the Share Option Plan. |
|
|
The value of the option-based awards was calculated using the Black-Scholes-Merton model using
the following assumptions: |
|
(i) |
|
Risk-free interest rate: 1.9%; |
|
|
(ii) |
|
Expected volatility in the market price of the Common Shares: 80.27%; |
|
|
(iii) |
|
Expected dividend yield: 0%; and |
|
|
(iv) |
|
Expected life: 6 years. |
|
|
|
Fair value per option: $1.274 |
|
|
|
|
|
The value of the awards does not include the 5,000 options that were granted as part of the
December 2008 Grant since these options were granted as compensation for the financial year
2008. These 5,000 options were not granted in the financial year 2008 as a result of the
strategic review process that was ongoing during that financial year. These 5,000 options were
granted at an exercise price of $1.80, vested on the date of grant and have a ten-year term. The
terms and conditions of those options are governed by the Share Option Plan. |
|
(3) |
|
This amount was paid to each of Mr. Cloutier and Mr. Goyer, through Clinipharm in the latter
case, for their ad hoc advice on certain clinical matters. Both Mr. Cloutier and Mr. Goyer
were formerly on the scientific committee and used to receive an annual compensation of $2,000
each to act as such. However, for the financial year ended on November 30, 2009, the Board of
Directors determined that it was in the best interests of the Company to abandon this
committee and to compensate Mr. Cloutier and Mr. Goyer if, and when, their services are
required with attendance fees similar to those paid to members of committees. |
|
|
Outstanding Option-Based Awards and Share-Based Awards |
|
|
|
The table below details the outstanding option-based awards and the share-based awards as at
November 30, 2009 for each of the directors. |
|
|
|
|
|
|
Statement of Executive Compensation
|
|
Page 28 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option-Based Awards |
|
|
Share-Based Awards |
|
|
|
Number of |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
securities |
|
|
|
|
|
|
|
|
|
|
Value of |
|
|
Number of shares |
|
|
Market or payout |
|
|
|
underlying |
|
|
Option |
|
|
|
|
|
|
unexercised |
|
|
or units of shares |
|
|
value of share- |
|
|
|
unexercised |
|
|
exercice |
|
|
Option |
|
|
in-the-money |
|
|
that have not |
|
|
based awards that |
|
|
|
options |
|
|
price |
|
|
expiration |
|
|
options(1) |
|
|
vested |
|
|
have not vested |
|
Name |
|
(#) |
|
|
($) |
|
|
date |
|
|
($) |
|
|
(#) |
|
|
($) |
|
|
Gilles Cloutier |
|
|
5,000 |
|
|
|
5.40 |
|
|
|
2013.05.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
3.68 |
|
|
|
2014.05.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.75 |
|
|
|
2015.05.06 |
|
|
|
7,700 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.86 |
|
|
|
2016.03.30 |
|
|
|
7,150 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
8.29 |
|
|
|
2017.03.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
7,450 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
1.84 |
|
|
|
2019.03.28 |
|
|
|
14,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A. Jean de Grandpré |
|
|
5,000 |
|
|
|
8.65 |
|
|
|
2010.05.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
11.80 |
|
|
|
2011.05.10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
10.55 |
|
|
|
2012.05.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
5.40 |
|
|
|
2013.05.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
3.68 |
|
|
|
2014.05.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.75 |
|
|
|
2015.05.06 |
|
|
|
7,700 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.86 |
|
|
|
2016.03.30 |
|
|
|
7,150 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
8.29 |
|
|
|
2017.03.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
7,450 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
1.84 |
|
|
|
2019.03.28 |
|
|
|
14,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert Goyer |
|
|
5,000 |
|
|
|
1.75 |
|
|
|
2015.05.06 |
|
|
|
7,700 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.86 |
|
|
|
2016.03.30 |
|
|
|
7,150 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
8.29 |
|
|
|
2017.03.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
7,450 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
1.84 |
|
|
|
2019.03.28 |
|
|
|
14,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gérald A. Lacoste |
|
|
5,000 |
|
|
|
1.86 |
|
|
|
2016.03.30 |
|
|
|
7,150 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
8.29 |
|
|
|
2017.03.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
7,450 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
1.84 |
|
|
|
2019.03.28 |
|
|
|
14,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Paul Pommier |
|
|
5,000 |
|
|
|
8.65 |
|
|
|
2010.05.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
11.80 |
|
|
|
2011.05.10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
10.55 |
|
|
|
2012.05.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
5.40 |
|
|
|
2013.05.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
3.68 |
|
|
|
2014.05.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.75 |
|
|
|
2015.05.06 |
|
|
|
7,700 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.86 |
|
|
|
2016.03.30 |
|
|
|
7,150 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
8.29 |
|
|
|
2017.03.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
7,450 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
1.84 |
|
|
|
2019.03.28 |
|
|
|
14,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bernard Reculeau |
|
|
5,000 |
|
|
|
1.86 |
|
|
|
2016.03.30 |
|
|
|
7,150 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
8.29 |
|
|
|
2017.03.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
7,450 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
1.84 |
|
|
|
2019.03.28 |
|
|
|
14,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statement of Executive Compensation
|
|
Page
29 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option-Based Awards |
|
|
Share-Based Awards |
|
|
|
Number of |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
securities |
|
|
|
|
|
|
|
|
|
|
Value of |
|
|
Number of shares |
|
|
Market or payout |
|
|
|
underlying |
|
|
Option |
|
|
|
|
|
|
unexercised |
|
|
or units of shares |
|
|
value of share- |
|
|
|
unexercised |
|
|
exercice |
|
|
Option |
|
|
in-the-money |
|
|
that have not |
|
|
based awards that |
|
|
|
options |
|
|
price |
|
|
expiration |
|
|
options(1) |
|
|
vested |
|
|
have not vested |
|
Name |
|
(#) |
|
|
($) |
|
|
date |
|
|
($) |
|
|
(#) |
|
|
($) |
|
|
Jean-Denis Talon |
|
|
5,000 |
|
|
|
11.80 |
|
|
|
2011.05.10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
10.55 |
|
|
|
2012.05.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
5.40 |
|
|
|
2013.05.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
3.68 |
|
|
|
2014.05.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.75 |
|
|
|
2015.05.06 |
|
|
|
7,700 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.86 |
|
|
|
2016.03.30 |
|
|
|
7,150 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
8.29 |
|
|
|
2017.03.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
1.80 |
|
|
|
2018.12.18 |
|
|
|
7,450 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
1.84 |
|
|
|
2019.03.28 |
|
|
|
14,500 |
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The value of unexercised in-the-money options at financial year end is the difference
between the closing price of the Common Shares on November 30, 2009 ($3.29) on the TSX and the
respective exercise prices of the options. |
|
|
Incentive Plan Awards Value vested or earned during the year |
|
|
|
The table below shows the value vested or earned during the year under each incentive plan as
at November 30, 2009 for each of the directors. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-equity incentive |
|
|
Option-based awards |
|
Share-based awards |
|
plan compensation |
|
|
Value vested during |
|
Value vested |
|
Value earned |
|
|
the year(1) |
|
during the year |
|
during the year |
Name |
|
($) |
|
($) |
|
($) |
Gilles Cloutier |
|
|
|
|
|
|
|
|
|
|
|
|
A. Jean de Grandpré |
|
|
|
|
|
|
|
|
|
|
|
|
Robert Goyer |
|
|
|
|
|
|
|
|
|
|
|
|
Gérald A. Lacoste |
|
|
|
|
|
|
|
|
|
|
|
|
Paul Pommier |
|
|
|
|
|
|
|
|
|
|
|
|
Bernard Reculeau |
|
|
|
|
|
|
|
|
|
|
|
|
Jean-Denis Talon |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The value is determined by assuming that the options vested during the financial year
would have been exercised on the vesting date. The value corresponds to the difference between
the closing price of the Common Shares on the TSX on the vesting date and the exercise price
of the options on that date. Options granted to directors as part of the March 2009 Grant
vested on their date of grant which was a day where the TSX was closed for business. No value
was recorded for those options since their exercise price was equal to the closing price of
the Common Shares on the day preceding the date of grant of the options. |
|
|
|
|
|
|
Statement of Executive Compensation
|
|
Page
30 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
D. Other Information
Indebtedness of Directors
As at the date of the Circular, none of the directors of the Company and proposed nominee for
election as a director of the Company is indebted to the Company. During the financial year
ended on November 30, 2009, none of the directors of the Company was indebted to the Company.
Liability Insurance of Directors and Officers
The Company purchases liability insurance for its directors and officers in the performance of
their duties. These insurance policies also cover the directors and officers of the Companys
subsidiaries. During the fiscal year ended November 30, 2009, the policies provided maximum
coverage of $20,000,000 per claim, subject to a $200,000 deductible per occurrence. Premiums
paid by the Company for the policies amounted to $109,000. The policies and the premiums do not
distinguish between the insurance for the directors liability and officers liability, the
coverage being the same for both groups.
|
|
|
|
|
|
Statement of Executive Compensation
|
|
Page 31 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
ITEM III. CORPORATE GOVERNANCE DISCLOSURE
The Board of Directors of the Company considers good corporate governance to be important to the
effective operations of the Company and to ensure that the Company is managed so as to optimize
shareholder value. The Nominating and Corporate Governance Committee is responsible for examining
the Companys needs in this regard and addressing all issues that may arise from its practices.
This Committee ensures that the Companys corporate governance practices comply with Regulation
58-101 respecting Disclosure of Corporate Governance Practices (Québec) and oversees their
disclosure according to guidelines described in Policy Statement 58-201 to Corporate Governance
Guidelines (Québec) (hereinafter collectively referred to as the Regulation).
1. Board of Directors
A. Independence
A majority of the Companys directors are independent. Seven of the nine Board members meet the
criteria for independence defined by the Regulation, as none of them have a direct or indirect
material relationship with the Company.
|
|
|
|
|
Name |
|
Independence |
|
Material Relationship |
Gilles Cloutier
|
|
Yes
|
|
None |
A. Jean de Grandpré
|
|
Yes
|
|
None |
Robert Goyer
|
|
Yes
|
|
None |
Gérald A. Lacoste
|
|
Yes
|
|
None |
Paul Pommier
|
|
Yes
|
|
None |
Bernard Reculeau
|
|
Yes
|
|
None |
Jean-Denis Talon
|
|
Yes
|
|
None |
Luc Tanguay
|
|
No
|
|
Company Management |
Yves Rosconi
|
|
No
|
|
Company Management |
The Chairman of the Board of the Company is Paul Pommier, an independent director within the
meaning of the Regulation.
B. Meetings of the Board
The table below details the directors attendances to the Board of Directors meetings held in the
fiscal year ended on November 30, 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
Name |
|
Number of Meetings |
|
Attendance |
|
Absence |
Gilles Cloutier |
|
|
7 |
|
|
|
7 |
|
|
|
0 |
|
A. Jean de Grandpré |
|
|
7 |
|
|
|
7 |
|
|
|
0 |
|
Robert Goyer |
|
|
7 |
|
|
|
7 |
|
|
|
0 |
|
Gérald A. Lacoste |
|
|
7 |
|
|
|
7 |
|
|
|
0 |
|
Paul Pommier |
|
|
7 |
|
|
|
7 |
|
|
|
0 |
|
Bernard Reculeau |
|
|
7 |
|
|
|
7 |
|
|
|
0 |
|
Jean-Denis Talon |
|
|
7 |
|
|
|
7 |
|
|
|
0 |
|
Luc Tanguay |
|
|
7 |
|
|
|
7 |
|
|
|
0 |
|
Yves Rosconi |
|
|
7 |
|
|
|
7 |
|
|
|
0 |
|
|
|
|
|
|
|
Corporate
Governance Disclosure
|
|
Page 32 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
A meeting of independent directors, at which non-independent directors and members of
management are not in attendance, is planned as the last item of each Board meeting. Accordingly,
at the conclusion of each Board meeting, the Chairman determines, along with the other independent
directors, the relevance of meeting without non-independent directors and members of management.
During the fiscal year ended November 30, 2009, independent directors held no meeting without
non-independent directors and members of management.
C. Other Board Memberships
As detailed in the following table, only one of the Companys directors is a board member of an
other reporting issuer.
|
|
|
Name |
|
Reporting Issuer |
Luc Tanguay
|
|
Ambrilia Biopharma Inc. |
2. Mandate of the Board of Directors
The Board of Directors adopted the written mandate attached hereto as Appendix C which defines its
role and duties.
Consistent with its mandate of identifying key business risks facing the Company and implementing
systems to manage those risks, during the last financial year, the Board of Directors undertook to
review the various risks faced by the Company. To that end, the Board of Directors delegated to the
Audit Committee the responsibility of supervising the management team involved in this process. The
process is two-pronged: first, it consists in identifying the most important risks and, second, it
consists in reviewing and testing the measures in place to manage the identified risks or,
alternatively, create measures if none is in place. During the last financial year, the first part
of the review process was completed and, in the current financial year, the measures in place will
be tested and, if need be, improved or created.
3. Position Descriptions
The Board of Directors has developed written position descriptions for the Chairman of the Board
and the Chairs of the Boards Committees. A position description was also developed for the
President and Chief Executive Officer.
4. Orientation and Continuing Education
The Orientation and Continuing Education Policy for newly appointed directors is attached hereto as
Appendix D.
In the last financial year, the members of the Audit Committee attended a seminar organized by the
Companys auditors, KPMG LLP, on the upcoming IFRS accounting rules. In addition, throughout the
last financial year, the Company provided its directors with reading material covering topics in
various fields, including biotechnology, corporate governance and executive compensation.
In the current financial year, directors will be invited to attend a seminar on Bill 63, the
Business Corporations Act (Québec), the new act intended to replace the Companies Act (Québec).
|
|
|
|
|
|
Corporate
Governance Disclosure
|
|
Page 33 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
5. Ethical Business Conduct
The Board of Directors has not adopted a written ethical business code of conduct for the Companys
directors, executive officers and employees. However, it has a series of internal policies
substantially covering the same issues as those found in a business code of conduct
(confidentiality, harassment and whistleblowing). In addition, it encourages and promotes ethical
business conduct that upholds integrity and fault prevention.
In the event a director or an executive officer has a material interest in any transaction or
agreement, the matter may initially be reviewed by the Nominating and Corporate Governance
Committee to determine the scope of the interest and its impact on managements decision-making.
The Committee will report its findings to the Board of Directors, which will take appropriate
action to ensure independent exercise of judgement. In the event a director has a material interest
in any transaction or agreement, such director must disclose, without delay, this conflict of
interest and follow the rules provided by the General By-Laws of the Company.
6. Nomination of Directors
The Nominating and Corporate Governance Committee is responsible for proposing new candidates for
Board nominations. This Committee is exclusively composed of independent directors. A copy of the
Committees Charter is attached hereto as Appendix E.
7. Compensation
A. Independence
The Compensation Committee is responsible for examining matters relating to compensation of
directors and executive officers on behalf of the Board of Directors. The Compensation Committee is
comprised exclusively of independent directors. A detailed description of the procedure used by the
Compensation Committee to establish compensation is provided under Item II of the Circular.
B. Meetings of the Compensation Committee
The table below details members attendance to the Compensation Committees meetings held in the
financial year ended November 30, 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
Name |
|
Number of Meetings |
|
Attendance |
|
Absence |
A. Jean de Grandpré |
|
|
2 |
|
|
|
2 |
|
|
|
0 |
|
Paul Pommier |
|
|
2 |
|
|
|
2 |
|
|
|
0 |
|
Bernard Reculeau |
|
|
2 |
|
|
|
2 |
|
|
|
0 |
|
Jean-Denis Talon |
|
|
2 |
|
|
|
2 |
|
|
|
0 |
|
At each meeting of the Compensation Committee, its members meet without members of
management.
8. Audit Committee
A. Independence
The Company has an audit committee comprised of three independent directors, namely Paul Pommier,
who is the Chair, Gérald A. Lacoste and Jean-Denis Talon. Reference is made to section 4.2 of the
Companys annual information form dated February 23, 2010 for a description of the Audit Committee.
|
|
|
|
|
|
Corporate
Governance Disclosure
|
|
Page 34 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
Each member of the Audit Committee has acquired in-depth financial expertise giving each the
ability to read and understand a set of financial statements which presents the breadth and level
of complexity of accounting issues that are generally comparable to those that can reasonably be
expected to be raised in the Companys financial statements.
B. Meetings of the Audit Committee
The table below details members attendance to the Audit Committees meetings held in the financial
year ended on November 30, 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
Name |
|
Number of Meetings |
|
Attendance |
|
Absence |
Gérald A. Lacoste |
|
|
5 |
|
|
|
5 |
|
|
|
0 |
|
Paul Pommier |
|
|
5 |
|
|
|
5 |
|
|
|
0 |
|
Jean-Denis Talon |
|
|
5 |
|
|
|
5 |
|
|
|
0 |
|
A meeting of the members, at which members of management are not in attendance, is planned
as the last item of each Audit Committee meeting when members of management are asked to attend
Audit Committee meetings. Accordingly, at the conclusion of each Audit Committee meeting, the
Chairman determines, along with the members, the relevance of meeting without members of
management. During the last financial year ended November 30, 2009, members held one (1) meeting
without members of management.
9. Other Committees
A. Financing Committee
In addition to the Audit Committee, the Nominating and Corporate Governance Committee and the
Compensation Committee, the Board of Directors created a Financing Committee composed of two
independent directors and two directors who are executive officers of the Company. The Financing
Committees mandate is to study and analyze financing matters. No meeting of the Financing
Committee was held in the financial year ended November 30, 2009.
B. Strategic Committee
In August 2007, the Board of Directors created a Strategic Review Committee comprised of four (4)
independent directors, namely Paul Pommier, who is the Chair, Gilles Cloutier, A. Jean de Grandpré
and Gérald A. Lacoste. The mandate of the Strategic Review Committee consisted in reviewing
potential strategic alternatives to enhance shareholder value such as the entering into of a
co-promotion or a partnership agreement with regards to tesamorelin, the finding of a possible
partner, acquiror or target business with a view to complete a merger, a sale or an acquisition. As
a result of the announcement in October 2008 of the collaboration and licensing agreement entered
into between the Company and EMD Serono, Inc., the mandate of the Strategic Review Committee was
changed by the Board of Directors in December 2008 to assist executive officers and recommend to
the Board of Directors a business strategy to further the growth of the Company.
The Strategic Review Committee currently has the following role and responsibilities:
|
|
|
to evaluate and review the various business alternatives of the
Company for enhancing shareholder value (the Strategic
Alternatives); |
|
|
|
|
to make recommendations to the Board of Directors with respect to the
Strategic Alternatives and to undertake a process it considers
appropriate in order to provide such recommendations; |
|
|
|
|
|
|
Corporate
Governance Disclosure
|
|
Page 35 |
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
|
|
if one of the Strategic Alternatives is approved by the Board of
Directors, to maintain, on behalf of the Board of Directors, a
review of its implementation; and |
|
|
|
|
to perform any action deemed necessary or advisable to comply
with its duties and obligations under applicable laws. |
The table below details the members attendance to the Strategic Committees meetings held in the
financial year ended on November 30, 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
Name |
|
Number of Meetings |
|
Attendance |
|
Absence |
Gilles Cloutier |
|
|
5 |
|
|
|
4 |
|
|
|
1 |
|
A. Jean de Grandpré |
|
|
5 |
|
|
|
5 |
|
|
|
0 |
|
Gérald A. Lacoste |
|
|
5 |
|
|
|
5 |
|
|
|
0 |
|
Paul Pommier |
|
|
5 |
|
|
|
5 |
|
|
|
0 |
|
A meeting of the members, at which members of management are not in attendance, is planned
as the last item of each Strategic Committee meeting when members of management are asked to attend
Strategic Committee meetings. Accordingly, at the conclusion of each Strategic Committee meeting,
the Chairman determines, along with the members, the relevance of meeting without members of
management. During the last financial year ended November 30, 2009, members held two (2) meetings
without members of management.
10. Assessment
While there is no formal process for assessing directors on an ongoing basis, the directors are
free to discuss specific situations from time to time amongst themselves and/or with the Chairman
of the Board and, if deemed necessary, steps are taken to remedy a situation.
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Corporate
Governance Disclosure
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Page 36 |
Management Proxy Circular
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Theratechnologies Inc. |
ITEM IV. OTHER INFORMATION
1. Additional Documentation
The Company is a reporting issuer in all Canadian provinces and is required to file its financial
statements and Circular with each Canadian Securities Commission. Each year, the Company also files
an Annual Information Form with such commissions. The financial information of the Company is
provided in the Companys comparative financial statements and Managements Discussion & Analysis
for its fiscal year ended November 30, 2009. Copies of the Companys financial statements,
management proxy circular and Annual Information Form may be obtained on request to the Secretary
of the Company at the following address: 2310 Alfred-Nobel Blvd, Montreal, Québec, H4S 2B4 or by
consulting the SEDAR Website at www.sedar.com. The Company may require the payment of a reasonable
fee if the request is made by someone other than a security holder of the Company, unless the
Company is in the course of a distribution of its securities pursuant to a short-form prospectus,
in which case these documents will be provided free of charge.
2. Approval by the Board Of Directors
The content and the sending of this Circular have been approved by the Board of Directors of the
Company on February 22, 2010.
Montreal, Québec, February 23, 2010.
|
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(signed) Jocelyn Lafond |
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Jocelyn Lafond |
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Corporate Secretary |
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Other Information
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Page 37 |
Management Proxy Circular
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Theratechnologies Inc. |
APPENDIX A
RESOLUTION OF THE SHAREHOLDERS OF
THERATECHNOLOGIES INC. (THE COMPANY)
RESOLUTION 2010-1
SHAREHOLDER RIGHTS PLAN
BE IT RESOLVED:
1. |
|
That the shareholder rights plan adopted by the Board of Directors of the Company on February
10, 2010 be and is hereby approved; |
|
2. |
|
That any director or officer of the Company be and is hereby authorized to execute and
deliver such documents and instruments and to take such other actions as such director or
officer may deem necessary or advisable to give effect to this resolution in his entire
discretion, his determination being conclusively evidenced by the execution and delivery of
such documents or instruments and the taking of such actions. |
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APPENDIX A RESOLUTION 2010-1
|
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Management Proxy Circular
|
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Theratechnologies Inc. |
APPENDIX B
COMPENSATION COMMITTEE CHARTER
I. Mandate
The Compensation Committee (the Committee) is responsible for assisting the Companys Board of
Directors (the Board) in overseeing the following:
|
A. |
|
compensation of Senior Management; |
|
|
B. |
|
assessment of Senior Management; |
|
|
C. |
|
compensation of Directors; |
|
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D. |
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stock option grants; |
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|
E. |
|
overall increase in total compensation. |
II. Obligations and Duties
The Committee carries out the duties usually entrusted to a compensation committee and any other
duty assigned from time to time by the Board. Specifically, the Committee is charged with the
following obligations and duties:
|
A. |
|
Compensation of Senior Management |
|
1. |
|
Develop a compensation policy for the Companys Senior Management,
notably the Senior Management compensation structure, annual salary
adjustments as well as the creation and administration of short and long term
incentive plans, stock options, indirect advantages and benefits proposed by
the President and Chief Executive Officer. |
|
|
2. |
|
Review and establish all forms of compensation to Senior Management. |
|
|
3. |
|
Oversee, as required, employment contracts and terminations of Senior
Management, notably severance pay. |
|
|
4. |
|
Oversee the Companys annual report on Senior Management compensation
part of the Companys continuous disclosure requirements under applicable laws
and regulations. |
|
B. |
|
Assessment of Senior Management |
|
1. |
|
Develop a written position description for the President and Chief
Executive Officer. |
|
|
2. |
|
Establish general objectives annually for the President and Chief
Executive Officer of the Company and for other members of senior management. |
|
|
|
|
|
|
Appendix B Compensation Committee Charter
Management Proxy Circular
|
|
Theratechnologies
Inc. |
|
3. |
|
Examine and review annually the President and Chief Executive
Officers performance against specific performance criteria pre-established by
the Committee. |
|
|
4. |
|
Examine, in collaboration with the President and Chief Executive
Officer, the annual performance assessment of other senior managers. |
|
C. |
|
Compensation of Directors |
|
1. |
|
Recommend to the Board approval of the Directors Compensation Policy. |
|
|
2. |
|
Examine the compensation of Directors in relation to the risks and
duties of their position. |
|
1. |
|
Oversee, review as needed and recommend Board approval of the Company
Share Option Plan. |
|
|
2. |
|
The Committee may delegate, at its discretion, the plans
administration to members of the Companys Management and employees. |
|
|
3. |
|
Examine, oversee and recommend Board approval of stock option grants,
specifically: |
|
a. |
|
the people to whom options are granted; |
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|
b. |
|
the number of options granted; |
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|
c. |
|
the exercise price of the options; |
|
|
d. |
|
the exercise period of the options; and |
|
|
e. |
|
all other conditions relating to options
granted. |
|
4. |
|
Overall Increase in Total Compensation |
|
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|
|
Approve annually the Companys increase in overall compensation. |
III. External Advisors
In discharging its duties and responsibilities, the Committee is empowered to retain external legal
counsel or other external advisors, as appropriate. The Company shall provide the necessary funds
to secure the services of such advisors.
IV. Composition of the Committee
The Committee is composed of any number of Directors, but no less than three, as may be determined
by the Board from time to time by resolution. Each member of the Committee shall be independent
from the Company, as determined by the Board, in accordance with applicable laws, rules and
regulations.
|
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|
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Appendix B Compensation Committee Charter
Management Proxy Circular
|
|
Theratechnologies Inc. |
V. Term of the Mandate
Committee members are appointed by Board resolution to carry out their mandate extending from the
date of the appointment to the next annual general meeting of shareholders, or until successors are
so appointed.
VI. Vacancy
The Board may fill vacancies at any time by resolution. Subject to the constitution of the quorum,
the Committees members can continue to act even if there is one or many vacancies on the
Committee.
VII. Chairman
The Board appoints the Committee Chairman who will call and chair the meetings.
VIII. Secretary
Unless decided otherwise by resolution of the Board, the Secretary of the Company shall act as
Committee Secretary. The Secretary must attend Committee meetings and prepare the minutes. He/she
must provide notification of meetings as directed by the Committee Chairman. The Secretary is the
guardian of the Committees records, books and archives.
IX. Meeting Proceedings
The Committee establishes its own procedures as to how meetings are called and conducted. Unless it
is otherwise decided, the Committee shall meet privately and independently from Management at each
regularly scheduled meeting. In the absence of the regularly appointed Chairman, the meeting shall
be chaired by another Committee member selected among attending participants and appointed
accordingly. In the absence of the regularly appointed Secretary, Committee members shall designate
someone to carry out this duty.
X. Quorum and Vote
Unless the Board otherwise specifies by resolution, two Committee members shall constitute an
appropriate quorum for deliberation of items on the agenda. During meetings, decisions are reached
by a majority of votes from Committee members, unless the quorum is of two members, in which case
decisions are made by consensus of opinion.
XI. Records
The Committee keeps records that are deemed necessary for its deliberations and reports to the
Board on its activities and recommendations on a regular basis.
XII. Effective Date
This charter was adopted by the Directors at its May 3, 2004 Board meeting. It was amended by the
Directors during the February 8, 2006 Board meeting.
|
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Appendix B Compensation Committee Charter
Management Proxy Circular
|
|
Theratechnologies Inc. |
MANDATE OF THE BOARD OF DIRECTORS |
I. Role
The Companys Board of Directors (the Board) is ultimately responsible for the stewardship of the
Company and executes its mandate directly or after considering recommendations from its related
committees and Management.
Management is responsible for the Companys day-to-day activities and is charged with realizing
strategic activities approved by the Board within the scope of its authorized business activities,
capitalization plan and company directives. Management must report regularly to the Board on
matters relating to short-term results and long-term development activities.
II. Obligations and Responsibilities
The Board carries out the functions, performs duties and assumes the responsibilities entrusted by
the laws and regulations. The Board may delegate some of its responsibilities to Board committees
and Management within the scope of the Companys General By-laws, the laws and the regulations.
Therefore, day-to-day management of the Companys activities is entrusted to Senior Management,
which reports directly to the Board. One of the key functions of the Board is to appoint the senior
management team.
The functions and duties of Board members include, without limitation, the following functions and
duties:
|
A. |
|
Appointment, assessment, succession planning of Senior Management |
|
1. |
|
Select and appoint the President and Chief Executive Officer of the
Company. |
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|
2. |
|
Oversee the appointment of other members of Senior Management. |
|
|
3. |
|
Ensure that the Company has a succession plan for the President and
Chief Executive Officer. |
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|
4. |
|
Monitor the performance of the President and Chief Executive Officer
and others Executive Officers, with respect to pre-established objectives. |
|
B. |
|
Compensation of Directors |
|
1. |
|
Establish the compensation of Directors. |
|
C. |
|
Strategic Direction and Planning |
|
1. |
|
Adopt the Companys strategic planning process. |
|
|
2. |
|
Approve the Companys strategic plan and review Senior Managements
performance in implementing the plan. |
|
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|
|
|
|
Appendix C Mandate of the Board of Directors
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
3. |
|
Review the strategic plan annually, taking into account opportunities
and risks, and monitoring the Companys performance against the plan. |
|
|
4. |
|
Review and approve the Companys annual plans towards financing the
strategic plan. |
|
|
5. |
|
Review and approve the Companys annual operating budget. |
|
|
6. |
|
Identify key business risks facing the Company and the implementation
of appropriate systems to manage these risks. |
|
|
7. |
|
Discuss with Management how the strategic environment is changing and
the key strategic issues. |
|
D. |
|
Corporate Behaviour and Governance |
|
1. |
|
Develop an approach to corporate governance, including the
determination of principles and guidelines for the Company. |
|
|
2. |
|
Obtain reasonable assurance of the integrity of the President and
Chief Executive Officer and other senior members of Management, and that they
uphold principles of integrity within the ranks of the Company. |
|
|
3. |
|
Oversee the implementation of a Company disclosure policies and
procedures. |
|
|
4. |
|
Monitor the integrity of the Companys internal controls and
disclosure systems. |
|
|
5. |
|
Be available to receive feedback from stakeholders, which must be
provided in writing, at the Companys head office, bearing the mention
Confidendial. |
|
1. |
|
Keep up-to-date with the regular programs and employees of the
Company. |
|
|
2. |
|
Upon request, join a committee and actively participate at its
meetings. |
|
|
3. |
|
Be accessible, at least by telephone, to personnel and other Company
Directors, as required. |
|
|
4. |
|
Keep confidential information discussed during meetings. |
|
|
5. |
|
Attend regular and special Board meetings. |
|
|
6. |
|
Get to know other members of the Board and promote collegial
decision-making. |
III. External Advisors
In discharging its duties and responsibilities, the Board is empowered to retain external legal
counsel or other external advisors, as appropriate. The Company shall provide the necessary funds
to secure the services of such advisors.
|
|
|
|
|
|
Appendix C Mandate of the Board of Directors
Management Proxy Circular
|
|
Theratechnologies Inc. |
IV. Composition of the Board
The Board consists of such number of Directors as the Board may determine from time to time by
resolution. The Board must assure itself that it is composed of Directors that are sufficiently
familiar with the business of the Company, and the risks it faces, to ensure active and effective
participation in the deliberations of the Board. Directors should have diverse backgrounds and
personal characteristics and traits as well as competencies and expertise that add value to the
Company. Finally, a majority of the Directors must be independent for the purposes of National
Policy 58-201 Corporate Governance Guidelines.
V. Board Meeting Procedures
The Board follows the procedure established in the Companys General By-Laws.
VI. Records
The Companys Secretary keeps the records required by law and any other relevant document.
VII. Effective Date
This written mandate was adopted by the Directors at its February 8, 2006 Board meeting.
|
|
|
|
|
|
Appendix C Mandate of the Board of Directors
Management Proxy Circular
|
|
Theratechnologies Inc. |
APPENDIX D
DIRECTOR ORIENTATION AND CONTINUING EDUCATION POLICY
The Board must first ensure that every new nominee as Director possesses the necessary skill,
expertise, availability and knowledge to properly fulfil its mandate. Once a Director is
effectively elected, the Chairman of the Board, the President and Chief Executive Officer and
Secretary provide him with the specific information required for a well-informed contribution.
I. Purpose
The purpose of this Director Orientation and Continuing Education Policy (the Policy) is to set
forth the Companys process of orientation for newly appointed Company Directors to familiarize
them with the role of the Companys Board of Directors, its committees, its directors, and the
nature and operation of the Companys business activities. The Policy also indicates the elements
of continuing education of the Board of Directors to ensure the Company Directors maintain the
skill and knowledge necessary to fulfill their obligations as directors.
II. Orientation of New Directors
Newly appointed Directors first meet with the Chairman of the Board to discuss the functioning of
the Board of Directors. Then, they meet with the President and Chief Executive Officer to discuss
the nature and operation of the Companys business activities. As required, meetings may be set up
with other Senior Managers to further clarify some of the Companys business activities. Finally,
the Secretary provides new directors with the following documents:
|
A. |
|
Copies of Board meeting minutes and written resolutions since the beginning of
the fiscal year (which may include those of the preceding fiscal year, depending of the
date of appointment), including a copy of the minutes of the last annual meeting; |
|
|
B. |
|
A schedule of Board Meetings for the year; |
|
|
C. |
|
The disclosure policies et procedures and the Undertaking form (for
signature); |
|
|
D. |
|
The policy on insider trading in force at Theratechnologies (with mention to
register as an insider with the Canadian securities agency through SEDI.ca and to prepare
an initial insider report within ten (10) days following appointment); |
|
|
E. |
|
Theratechnologies Share Option Plan; |
|
|
F. |
|
The latest annual report and accompanying information on Theratechnologies
(fact sheet, latest press releases, latest annual information form and corporate
presentation); |
|
|
G. |
|
The Director Disclosure Form (to complete and return within afforded time); |
|
|
H. |
|
The General By-Laws, the Boards written mandate, the Audit Committee Charter,
Compensation Committee Charter, Nominating and Corporate Governance Charter; and |
|
|
I. |
|
The Directors and Senior Management coverage and compensation. |
|
|
|
|
|
|
Appendix D Director Orientation and Continuing Education Policy
Management Proxy Circular
|
|
Theratechnologies Inc. |
III. Continuing Education
The following actions are taken to ensure the continuing education of Directors:
|
A. |
|
Management provides Directors, from time to time, with pertinent articles and
books relating to the Companys business, its competitors, corporate governance and
regulatory issues; |
|
|
B. |
|
Key Company executives make regular presentations to the Board on business
activities; |
|
|
C. |
|
Certain consultants present to the Board on matters relevant to their role and duties.
Consultants such as insurance brokers presenting on risks faced by the Company or
consultants presenting a long-term strategy for the Company; |
|
|
D. |
|
The Secretary offers Directors continuing education in the form of
presentations on new legal and regulatory requirements that impact the Board. |
IV. Review
This Policy is reviewed and modified when the Board of Directors considers it necessary and
desirable.
|
|
|
|
|
|
Appendix D Director Orientation and Continuing Education Policy
Management Proxy Circular
|
|
Theratechnologies Inc. |
APPENDIX E
NOMINATING AND CORPORATE GOVERNANCE COMMITTEE CHARTER
I. Mandate
The Nominating and Corporate Governance Committee (the Committee) is responsible for assisting
the Companys Board of Directors (the Board) in overseeing the following:
|
A. |
|
Recruit candidates for the Board; |
|
|
B. |
|
Review the size of the Board; |
|
|
C. |
|
Composition of the Board; |
|
|
D. |
|
Function of the Board; |
|
|
E. |
|
Orientation and education of Board members; and |
|
|
F. |
|
Governance. |
II. Obligations and Duties
The Committee carries out the duties usually entrusted to a Nominating and Corporate Governance
Committee and any other duty assigned from time to time by the Board. Specifically, the Committee
is charged with the following obligations and duties:
|
A. |
|
Recruit Candidates for the Board |
|
1. |
|
Identify potential candidates as members of the Companys Board of
Directors. In so doing, the Committee will consider: |
|
a. |
|
independence of candidates under the terms of National Policy
58-201 on corporate governance; |
|
|
b. |
|
the competencies, skills and personal characteristics sought in candidates.
The Committee will determine what it considers necessary by
assessing competencies, skills and personal characteristics of the
candidates in relation to: (1) those generally required by the
Board; (2) those already present in other Board members; and (3) those which are a welcome addition; and |
|
|
c. |
|
the availability of candidates. |
|
2. |
|
All Board members may submit to the Committee potential candidates for
membership, and the Committee shall review such candidates in light of above
described competencies and skills desirable for the Board. |
|
|
3. |
|
The Committee shall proceed as follows for the recruitment of
candidates: |
|
|
|
|
|
|
Appendix E Nominating and Corporate Governance Committee Charter
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
a. |
|
as it is determined by the Committee and the Board of Directors that
Board vacancies must be filled or new members are desirable, the Chairman
of the Board of Directors shall make contact with candidates that have
been identified by the Committee per the above described criteria; |
|
|
b. |
|
upon a positive evaluation by the Chairman of the Board of Directors
and positive reaction from the candidate, at least two (2) members of the Board
shall meet with the candidate; and |
|
|
c. |
|
upon a positive evaluation by the two (2) Board members and the
continuing interest of the candidate, the Committee shall make a recommendation to
the Board of Directors, providing all pertinent background information for analysis
and discussion by the Directors. |
|
B. |
|
Board Size |
|
|
|
|
The Board must be composed of 3 to 20 directors, as per the Companys articles of
incorporation and by law. As provided under the terms of the Company General By-Laws, the
Board shall exercise its power to establish by resolution the exact number of directors. In
this regard, the duties of the Committee are as follows: |
|
1. |
|
Examine the size of the Board annually in view of assessing its effectiveness. |
|
|
2. |
|
Consider modifications to the number of constituting members and issue its
recommendations to the Board. |
|
C. |
|
Composition of the Board |
|
1. |
|
Ensure that the Board is composed of Directors that are sufficiently familiar
with the business of the Company, and the risks it faces, to ensure active and
effective participation in the deliberations of the Board. |
|
|
2. |
|
Ensure that Directors have diverse backgrounds and personal characteristics
and traits as well as competencies and expertise that add value to the Company. |
|
|
3. |
|
Ensure that a majority of the directors are independent directors for the
purposes of National Policy 58-201 Corporate Governance Guidelines. |
|
1. |
|
Examine the Boards functions and issue recommendations as to its obligations
and role. Among others, the Committee must regularly review the Boards written
mandate. |
|
|
2. |
|
Determine and review, as needed, the roles and mandates of Board committees
and issue recommendations. |
|
E. |
|
Orientation and Continuing Education of Board Members |
|
|
|
|
Develop an orientation and continuing education policy for Directors. |
|
|
|
|
|
|
Appendix E Nominating and Corporate Governance Committee Charter
Management Proxy Circular
|
|
Theratechnologies Inc. |
|
1. |
|
Follow corporate governance developments and, as required, advise the
Board of appropriate actions. |
|
|
2. |
|
Examine appropriate actions to promote ethical business conduct, issue
relevant recommendations to the Board and oversee their implementation. |
|
|
3. |
|
Examine conflict of interest issues that may be brought to the
attention of the Board and offer solutions. |
III. External Advisors
In discharging its duties and responsibilities, the Committee is empowered to retain external legal
counsel or other external advisors, as appropriate. The Company shall provide the necessary funds
to secure the services of such advisors.
IV. Composition of the Committee
The Committee is composed of any number of Directors, but no less than three, as may be determined
by the Board from time to time by resolution. Each member of the Committee shall be independent
from the Company, as determined by the Board in accordance with applicable laws, rules and
regulations.
V. Term of the Mandate
Committee members are appointed by Board resolution to carry out their mandate extending from the
date of the appointment to the next Annual General Meeting of Shareholders, or until successors are
so appointed.
VI. Vacancy
The Board may fill vacancies at any time by resolution. Subject to the constitution of the quorum,
the Committees members can continue to act even if there is one or many vacancies on the
Committee.
VII. Chairman
The Board appoints the Committee Chairman who will call and chair the meetings.
VIII. Secretary
Unless decided otherwise by resolution of the Board, the Secretary of the Company shall act as
Committee Secretary. The Secretary must attend Committee meetings and prepare the minutes. He
must provide notification of meetings as directed by the Committee Chairman. The Secretary is the
guardian of the Committees records, books and archives.
IX. Meeting Proceedings
The Committee establishes its own procedures as to how meetings are called and conducted. Unless it
is otherwise decided, the Committee shall meet privately and independently from Management at each
regularly scheduled meeting. In the absence of the regularly appointed Chairman, the meeting shall
be chaired by another Committee member selected among attending participants and appointed
accordingly.
|
|
|
|
|
|
Appendix E Nominating and Corporate Governance Committee Charter
Management Proxy Circular
|
|
Theratechnologies Inc. |
In the absence of the regularly appointed Secretary, Committee members shall designate someone to
carry out this duty.
X. Quorum and Vote
Unless the Board otherwise specifies by resolution, two Committee members shall constitute an
appropriate quorum for deliberation of items on the agenda. During meetings, decisions are reached
by a majority of votes from Committee members, unless the quorum is of two members, in which case
decisions are made by consensus of opinion.
XI. Records
The Committee keeps records that are deemed necessary for its deliberations and reports to the
Board on its activities and recommendations on a regular basis.
XII. Effective Date
This charter was adopted by the Directors during the February 8, 2006 Board meeting.
|
|
|
|
|
|
Appendix E Nominating and Corporate Governance Committee Charter
Management Proxy Circular
|
|
Theratechnologies Inc. |
ex-99.32
Exhibit 99.32
MATERIAL CHANGE REPORT
Regulation 51-102 Respecting Continuous Disclosure Obligations
Form 51-102F3
1. |
|
NAME AND ADDRESS OF COMPANY: |
|
|
|
THERATECHNOLOGIES INC.
2310 Alfred-Nobel Boulevard
Montreal, Québec
Canada H4S 2B4 |
|
2. |
|
DATE OF MATERIAL CHANGE: |
|
|
|
June 2, 2011 |
|
3. |
|
NEWS RELEASE: |
|
|
|
A news release describing this material change was issued on June 2, 2011 on Marketwire.
A copy of the news release is available on the SEDAR website at www.sedar.com. |
|
4. |
|
SUMMARY OF MATERIAL CHANGE: |
|
|
|
On June 2, 2011, Theratechnologies Inc. (the Corporation) announced that it had
re-evaluated its research and development business model (the R&D Model). The review of
the R&D Model resulted in the collective dismissal of 24 employees and the Corporation
estimates a reduction in payroll expenses of approximately $300,000 for the remainder of
fiscal 2011 and approximately $2.5 million for fiscal 2012. |
|
5. |
|
FULL DESCRIPTION OF MATERIAL CHANGE: |
|
|
|
On June 2, 2011, the Corporation announced that it had re-evaluated its R&D Model. The
Corporation intends to call upon partners in the public and private arena to help it bring
its research and development project forward. The review of the R&D Model resulted in the
collective dismissal of 24 employees and the Corporation estimates a reduction in payroll
expenses of approximately $300,000 for the remainder of fiscal 2011 and approximately $2.5
million for fiscal 2012. |
|
6. |
|
RELIANCE ON SUBSECTION 7.1(2) OR (3) OF NATIONAL INSTRUMENT 51-102: |
|
|
|
Not applicable. |
|
7. |
|
OMITTED INFORMATION: |
|
|
|
Not applicable. |
- 2 -
8. |
|
EXECUTIVE OFFICER: |
|
|
|
For further information, contact Jocelyn Lafond, Vice President, Legal Affairs, and
Corporate Secretary of the Company at (514) 336-4804, ext. 288. |
|
9. |
|
DATE OF REPORT: |
|
|
|
June 3, 2011 |
ex-99.33
Exhibit 99.33
MATERIAL CHANGE REPORT
Regulation 51-102 Respecting Continuous Disclosure Obligations
Form 51-102F3
1. |
|
NAME AND ADDRESS OF COMPANY: |
|
|
THERATECHNOLOGIES INC.
2310 Alfred-Nobel Boulevard
Montreal, Québec
Canada H4S 2B4 |
|
2. |
|
DATE OF MATERIAL CHANGE:
May 18, 2011 |
|
3. |
|
NEWS RELEASE: |
|
|
A news release describing this material change was issued on May 18, 2011 on Marketwire.
A copy of the news release is available on the SEDAR website at www.sedar.com. |
4. |
|
SUMMARY OF MATERIAL CHANGE: |
|
|
On May 18, 2011, Theratechnologies Inc. (the Corporation) announced that it is applying
to list its common shares on the NASDAQ market in the United States. |
5. |
|
FULL DESCRIPTION OF MATERIAL CHANGE: |
|
|
On May 18, 2011, the Corporation announced that it is applying to list its common shares
on the NASDAQ market in the United States. |
6. |
|
RELIANCE ON SUBSECTION 7.1(2) OR (3) OF NATIONAL INSTRUMENT 51-102: |
|
|
Not applicable. |
|
7. |
|
OMITTED INFORMATION: |
|
|
|
Not applicable. |
|
8. |
|
EXECUTIVE OFFICER: |
|
|
For further information, contact Jocelyn Lafond, Vice President, Legal Affairs, and
Corporate Secretary of the Company at (514) 336-4804, ext. 288. |
ex-99.34
Exhibit 99.34
MATERIAL CHANGE REPORT
Regulation 51-102 Respecting Continuous Disclosure Obligations
Form 51-102F3
1. |
|
NAME AND ADDRESS OF COMPANY: |
|
|
|
THERATECHNOLOGIES INC.
2310 Alfred-Nobel Boulevard
Montreal, Québec
Canada H4S 2B4 |
|
2. |
|
DATE OF MATERIAL CHANGE: |
|
|
|
February 22, 2011 |
|
3. |
|
NEWS RELEASE: |
|
|
|
A news release describing this material change was issued on February 22, 2011 on
Marketwire. A copy of the news release is available on the SEDAR website at
www.sedar.com. |
|
4. |
|
SUMMARY OF MATERIAL CHANGE: |
|
|
|
On February 22, 2011, Theratechnologies Inc. (the Company) announced a new clinical
program for muscle wasting in Chronic Obstructive Pulmonary Disease (COPD) using the
Companys lead compound, tesamorelin, a human growth hormone releasing factor (GRF)
analogue. |
|
5. |
|
FULL DESCRIPTION OF MATERIAL CHANGE: |
|
|
|
On February 22, 2011, the Company announced a new clinical program for muscle wasting in
COPD using the Companys lead compound, tesamorelin, a GRF analogue.
Based on tesamorelins anabolic properties, the Company has chosen to pursue the development of
its lead compound in muscle wasting in patients with COPD as its second indication. COPD
is characterized by progressive airflow obstruction due to chronic bronchitis or
emphysema leading in certain cases to muscle wasting, a decrease of muscle mass and
deterioration in functionality. Previously, the Company completed a Phase 2 trial in
stable ambulatory COPD patients which demonstrated a statistically significant increase
in lean body mass. The Company intends to commence a second Phase 2 clinical study in the
second half of 2011 to test different dosages of tesamorelin with a new formulation. |
|
|
|
The Phase 2 clinical study will evaluate the use of tesamorelin in a randomized, placebo
controlled study with approximately 200 COPD patients, in Global Initiative for Chronic
Obstructive Lung Disease (GOLD) stage II and III, with muscle wasting. |
|
|
Patients will be randomized to receive either one of two different dosages of tesamorelin
or placebo each day for six months. Theratechnologies intends to randomize its first
patient in the second half of 2011. The primary endpoint will be an increase in lean body
mass. Other efficacy endpoints will be measured, such as a six-minute walking distance
test, exercise endurance time, and quality of life (daily activities). Safety assessments
will include monitoring of adverse events and laboratory evaluations. If the Phase 2
study is successful, two Phase 3 studies (one pivotal and one confirmatory) are to be
conducted in parallel. This clinical trial program is estimated to take approximately
four years and will use a new and more concentrated formulation of tesamorelin. The new
formulation will require a smaller volume of injection and is expected to be stable at
room temperature. |
|
6. |
|
RELIANCE ON SUBSECTION 7.1(2) OR (3) OF NATIONAL INSTRUMENT 51-102: |
|
|
|
Not applicable. |
|
7. |
|
OMITTED INFORMATION: |
|
|
|
Not applicable. |
|
8. |
|
EXECUTIVE OFFICER: |
|
|
|
For further information, contact Jocelyn Lafond, Vice President, Legal Affairs, and
Corporate Secretary of the Company at (514) 336-4804, ext. 288. |
|
9. |
|
DATE OF REPORT: |
|
|
|
February 22, 2011 |
- 2 -
ex-99.35
Exhibit 99.35
MATERIAL CHANGE REPORT
Regulation 51-102 Respecting Continuous Disclosure Obligations
Form 51-102F3
1. |
|
NAME AND ADDRESS OF COMPANY: |
|
|
|
THERATECHNOLOGIES INC.
2310 Alfred-Nobel Boulevard
Montreal, Québec
Canada H4S 2B4 |
|
2. |
|
DATE OF MATERIAL CHANGE: |
|
|
|
February 3, 2011 |
|
3. |
|
NEWS RELEASE: |
|
|
|
A news release describing this material change was issued on February 3, 2011 on
Marketwire. A copy of the news release is available on the SEDAR website at
www.sedar.com. |
|
4. |
|
SUMMARY OF MATERIAL CHANGE: |
|
|
|
On February 3, 2011, Theratechnologies Inc. (the Company) announced the execution of a
distribution and licensing agreement (the Agreement) with Ferrer Internacional S.A.
(Ferrer) for the commercialization rights to tesamorelin in Europe, Russia, South
Korea, Taiwan and certain central Asian countries for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy. |
|
5. |
|
FULL DESCRIPTION OF MATERIAL CHANGE: |
|
|
|
On February 3, 2011, the Company announced the execution of the Agreement with Ferrer for
the commercialization rights to tesamorelin in Europe, Russia, South Korea, Taiwan and
certain central Asian countries for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. |
|
|
|
Under the terms of the Agreement, Ferrer will be responsible for conducting all
regulatory and commercialization activities in connection with tesamorelin for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in the
territories subject to the Agreement. Theratechnologies will be responsible for the
manufacture and supply of tesamorelin to Ferrer. Ferrer will purchase tesamorelin at a
transfer price equal to the higher of a significant percentage of the net selling price
and a predetermined floor price. Theratechnologies has the option to co-promote
tesamorelin for the reduction of excess abdominal fat in HIV-infected patients with
lipodystrophy in the territories. Theratechnologies has kept all development rights to
tesamorelin for other indications and will be responsible for conducting research and |
|
|
development for any additional programs. Ferrer has the option to enter into a
codevelopment and commercialization agreement using tesamorelin relating to any such new
indications. The terms and conditions of such a co-development and commercialization
agreement will be negotiated based on any additional program chosen for development. |
|
6. |
|
RELIANCE ON SUBSECTION 7.1(2) OR (3) OF NATIONAL INSTRUMENT 51-102: |
|
|
|
Not applicable. |
|
7. |
|
OMITTED INFORMATION: |
|
|
|
Not applicable. |
|
8. |
|
EXECUTIVE OFFICER: |
|
|
|
For further information, contact Jocelyn Lafond, Vice President, Legal Affairs, and
Corporate Secretary of the Company at (514) 336-4804, ext. 288. |
|
9. |
|
DATE OF REPORT: |
|
|
|
February 10, 2011 |
- 2 -
ex-99.36
Exhibit 99.36
MATERIAL CHANGE REPORT
Regulation 51-102 Respecting Continuous Disclosure Obligations
Form 51-102F3
1. |
|
NAME AND ADDRESS OF COMPANY: |
|
|
|
THERATECHNOLOGIES INC.
2310 Alfred-Nobel Boulevard
Montreal, Québec
Canada H4S 2B4 |
|
2. |
|
DATE OF MATERIAL CHANGE: |
|
|
|
December 6, 2010 |
|
3. |
|
NEWS RELEASE: |
|
|
|
A news release was issued concerning this material change on December 6, 2010 on
Marketwire. A copy of the news release is available at SEDAR website at www.sedar.com. |
|
4. |
|
SUMMARY OF MATERIAL CHANGE: |
|
|
|
On December 6, 2010, Theratechnologies Inc. (the Company) announced the execution of a
distribution and licensing agreement (the Agreement) with Sanofi-Aventis (Sanofi) for
the commercialization rights to EGRIFTA® (tesamorelin for injection) in Latin
America, Africa and the Middle East for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy. |
|
5. |
|
FULL DESCRIPTION OF MATERIAL CHANGE: |
|
|
|
On December 6, 2010, the Company announced the execution of the Agreement with Sanofi for
the commercialization rights to EGRIFTA® (tesamorelin for injection) in Latin
America, Africa and the Middle East for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy. |
|
|
|
Under the terms of the Agreement, the Company will be responsible to supply
EGRIFTA® to Sanofi. Sanofi will buy EGRIFTA® from the Company at
an undisclosed selling price. The Company has kept all future development rights to
EGRIFTA® and will be responsible for conducting additional research and
development for any additional programs. Sanofi will be responsible to conduct all
regulatory activities in the aforementioned territories in connection with EGRIFTA®
for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy, including seeking the approval of EGRIFTA® in the different
countries. The Company granted Sanofi an option to commercialize EGRIFTA® in
the aforementioned territories for other uses. |
|
6. |
|
RELIANCE ON SUBSECTION 7.1(2) OF
REGULATION 51-102: |
|
|
|
Not applicable. |
|
7. |
|
OMITTED INFORMATION: |
|
|
|
Not applicable. |
8. |
|
SENIOR OFFICER: |
|
|
|
For further information, contact Jocelyn Lafond, Vice President, Legal Affairs, and
Corporate Secretary of Theratechnologies Inc., at (514) 336-4804, ext. 288. |
|
9. |
|
DATE OF REPORT: |
|
|
|
December 16, 2010. |
- 2 -
ex-99.37
Exhibit 99.37
MATERIAL CHANGE REPORT
Regulation 51-102 Respecting Continuous Disclosure Obligations
Form 51-102F3
1. |
|
NAME AND ADDRESS OF COMPANY: |
|
|
|
THERATECHNOLOGIES INC.
2310 Alfred-Nobel Boulevard
Montreal, Québec
Canada H4S 2B4 |
|
2. |
|
DATE OF MATERIAL CHANGE: |
|
|
|
November 11, 2010 |
|
3. |
|
NEWS RELEASE: |
|
|
|
A news release was issued concerning this material change on November 11, 2010 on
Marketwire. A copy of the news release is available at SEDAR website at www.sedar.com. |
|
4. |
|
SUMMARY OF MATERIAL CHANGE: |
|
|
|
On November 11, 2010, Theratechnologies Inc. (the Company) announced that the U.S. Food
and Drug Administration (FDA) approved EGRIFTA® (tesamorelin for injection)
as the first and only treatment indicated to reduce excess abdominal fat in HIV-infected
patients with lipodystrophy (abdominal lipohypertrophy). |
|
|
|
EGRIFTA® (tesamorelin for injection) was developed by the Company and will be exclusively
commercialized in the U.S. by EMD Serono, Inc. (EMD Serono), an affiliate of Merck KGaA,
of Darmstadt, Germany, under the terms of a collaboration and licensing agreement. Under
the terms of this agreement, the FDA marketing approval is associated with milestone
payments totaling US$25 million (approximately CAN$25 million). |
|
|
|
The FDA has requested the following three post-marketing requirements: a long-term
observational safety study for tesamorelin acetate (EGRIFTA®), a single vial formulation -
the development of a new presentation of the same formulation, and a clinical trial to
assess whether EGRIFTA® (tesamorelin for injection) has an impact on diabetic retinopathy
in diabetic HIV-infected patients with lipodystrophy and excess abdominal fat. |
|
5. |
|
FULL DESCRIPTION OF MATERIAL CHANGE: |
|
|
|
Approval of EGRIFTA® |
|
|
|
On November 11, 2010, the Company announced that the FDA approved EGRIFTA®
(tesamorelin for injection) as the first and only treatment indicated to reduce excess
abdominal fat in HIV-infected patients with lipodystrophy (abdominal lipohypertrophy). |
|
|
|
Limitations of use |
|
|
|
There are limitations of use associated with EGRIFTA® (tesamorelin for injection). Since
the long-term cardiovascular safety and potential long-term cardiovascular benefit of
EGRIFTA® (tesamorelin for injection) treatment have not been studied and |
|
|
are not known, careful consideration should be given whether to continue EGRIFTA® (tesamorelin
for injection) treatment in patients who do not show a clear efficacy response as judged by
the degree of reduction in visceral adipose tissue (VAT) measured by waist circumference (WC)
or CT scan. EGRIFTA® (tesamorelin for injection) is not indicated for weight loss management
(weight neutral effect). There are no data to support improved compliance with antiretroviral
therapies in HIV-positive patients taking EGRIFTA® (tesamorelin for injection). |
|
|
|
Post-Marketing Requirements |
|
|
|
The FDA has requested the following three post-marketing requirements: a long-term
observational safety study for tesamorelin acetate (EGRIFTA®), a single vial
formulation the development of a new presentation of the same formulation, and a
clinical trial to assess whether EGRIFTA® (tesamorelin for injection) has an impact
on diabetic retinopathy in diabetic HIV-infected patients with lipodystrophy and
excess abdominal fat. |
|
|
|
Commercialization of EGRIFTA® |
|
|
|
EGRIFTA® (tesamorelin for injection) was developed by the Company and will be
exclusively commercialized in the U.S. by EMD Serono, an affiliate of Merck KGaA,
of Darmstadt, Germany, under the terms of a collaboration and licensing agreement
entered into in 2008 between the Company and EMD Serono. Under the terms of this
agreement, the FDA marketing approval is associated with milestone payments
totaling US$25 million (approximately CAN$25 million). |
|
|
|
EGRIFTA® Phase 3 Trials |
|
|
|
The FDA approval of EGRIFTA® (tesamorelin for injection) was based on two multi-center,
randomized, double-blind, placebo-controlled Phase 3 studies consisting of a 26-week
main phase and a 26-week extension phase of 816 HIV-infected patients with excess
abdominal fat associated with lipodystrophy. |
|
|
|
The primary endpoint of the 26-week main phase was the percent change in VAT from
baseline, as assessed by computed tomography (CT) scan at the L4-L5 vertebral level. |
|
|
|
In both Phase 3 studies, patients received either EGRIFTA® (tesamorelin for injection)
or placebo for 26 weeks. Patients initially randomized to EGRIFTA® (tesamorelin for
injection) were then re-randomized to receive either EGRIFTA® (tesamorelin for
injection) or placebo for an additional 26-week treatment period, whereas patients
receiving placebo were switched to EGRIFTA® (tesamorelin for injection). In the first
study, at baseline, mean VAT was 178 cm2 for the patients who received
EGRIFTA® (tesamorelin for injection) and was 171 cm2 for the patients who
received placebo. In the second study, at baseline, mean VAT was 186 cm2 for
the patients who received EGRIFTA® (tesamorelin for injection) and was 195
cm2 for the patients who received placebo. Patients treated with EGRIFTA® (tesamorelin for injection) experienced a
statistically significant least-squares mean
decrease from baseline in VAT of 27 cm2 compared to an increase of 4
cm2 for patients on placebo [(95% CI for the mean treatment difference of
-31 cm2 (-39 cm2, -24 cm2)] in the first study, and a
statistically significant decrease from baseline in VAT of 21 cm2 compared
to no change in VAT for patients on placebo [(95% CI for the mean treatment difference
of -21 cm2 (-29 cm2, -12 cm2)] in the second study
during the 26-week main phase. This represents a
statistically significant least-squares mean decrease from baseline in VAT of 18% for
patients treated with EGRIFTA® (tesamorelin for injection) compared to an increase of 2%
for patients on placebo [(95% CI for the mean treatment difference of -20% (-24%,
-15%)] in the first study, and a statistically significant decrease from baseline of
14% for patients treated with EGRIFTA® (tesamorelin for injection) |
|
|
compared to a decrease of 2% for patients on placebo [(95% CI for the mean treatment
difference of -12% (-16%, -7%)] in the second study during the 26-week main phase. |
|
|
|
In the first study, at baseline, mean waist circumference was 104 cm for the
patients who received EGRIFTA® (tesamorelin for injection) and was 105 cm for the
patients who received placebo. In the second study, at baseline, mean waist
circumference was 105 cm for the patients who received EGRIFTA® (tesamorelin for
injection) and for the patients who received placebo. Treatment with EGRIFTA®
(tesamorelin for injection) resulted in a statistically significant least-squares
mean decrease from baseline in waist circumference of -3 cm compared to a decrease
of -1 cm for patients on placebo [(95% CI for the mean treatment difference of -2
cm (-2.8 cm, -0.9 cm)] in the first study, and a statistically significant decrease
from baseline of -2 cm compared to a decrease of -1 cm for patients on placebo
[(95% CI for the mean treatment difference of -1 cm (-2.5 cm, -0.3 cm)] in the
second study during the 26-week main phase. The decreases in VAT and waist
circumference observed after 26 weeks of treatment were sustained in patients who
received EGRIFTA® (tesamorelin for injection) over 52 weeks. |
|
|
|
Important Risk Information |
|
|
|
EGRIFTA® (tesamorelin for injection) is contraindicated in women who are pregnant, in
patients with disruption of the hypothalamic-pituitary axis due to hypophysectomy,
hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma, in patients
with known hypersensitivity to tesamorelin and/or mannitol (excipient) and in patients
with active malignancies (either newly diagnosed or recurrent). Any preexisting
malignancy should be inactive and its treatment complete prior to instituting therapy
with EGRIFTA® (tesamorelin for injection). If pregnancy occurs, EGRIFTA® (tesamorelin
for injection) therapy should be discontinued. |
|
|
|
EGRIFTA® (tesamorelin for injection) induces the release of endogenous growth hormone
(GH), a known growth factor, thus, patients with active malignancy should not be
treated with EGRIFTA® (tesamorelin for injection). For patients with a history of
non-malignant neoplasms, EGRIFTA® (tesamorelin for injection) therapy should be
initiated after careful evaluation of the potential benefit of treatment. For patients
with a history of treated and stable malignancies, EGRIFTA® (tesamorelin for injection)
therapy should be initiated only after careful evaluation of the potential benefit of
treatment relative to the risk of reactivation of the underlying malignancy. In
addition, the decision to start treatment with EGRIFTA® (tesamorelin for injection)
should be considered carefully based on the increased background risk of malignancies
in HIV-positive patients. |
|
|
|
EGRIFTA® (tesamorelin for injection) stimulates GH production and increases serum IGF-I.
Given that IGF-I is a growth factor and the effect of prolonged elevations in IGF-I
levels on the development or progression of malignancies is unknown, IGF-I levels
should be monitored closely during EGRIFTA®(tesamorelin for injection) therapy. Careful
consideration should be given to discontinuing EGRIFTA® (tesamorelin for injection) in
patients with persistent elevations of IGF-I levels (e.g., >3 SDS), particularly if
the efficacy response is not robust (e.g., based on visceral adipose tissue changes
measured by waist circumference or CT scan). During the clinical trials, patients were
monitored every three months. Among patients who received EGRIFTA® (tesamorelin for
injection) for 26 weeks, 47.4% had IGF-I levels greater than 2 standard deviation
score (SDS), and 35.6% had SDS >3, with this effect seen as early as 13 weeks of
treatment. Among those patients who
remained on EGRIFTA® (tesamorelin for injection) for a total of 52 weeks, at the end of
treatment 33.7% had IGF-I SDS >2 and 22.6% had IGF-I SDS >3. |
|
|
Fluid retention may occur during EGRIFTA® (tesamorelin for injection) therapy and is thought
to be related to the induction of GH secretion. It manifests as increased tissue turgor and
musculoskeletal discomfort resulting in a variety of adverse reactions (e.g., edema,
arthralgia, carpal tunnel syndrome) which are either transient or resolve with
discontinuation of treatment. |
|
|
|
EGRIFTA® (tesamorelin for injection) treatment may result in glucose intolerance. During
the Phase 3 clinical trials, the percentages of patients with elevated HbA1c (≥ 6.5%)
from baseline to Week 26 were 4.5% and 1.3% in the EGRIFTA® (tesamorelin for injection)
and placebo groups, respectively. An increased risk of developing diabetes with EGRIFTA®
(tesamorelin for injection) (HbA1c level ≥ 6.5%) relative to placebo was observed
[intent-to-treat hazard ratio of 3.3 (CI 1.4, 9.6)]. Therefore, glucose status should
be carefully evaluated prior to initiating EGRIFTA® (tesamorelin for injection)
treatment. In addition, all patients treated with EGRIFTA® (tesamorelin for injection)
should be monitored periodically for changes in glucose metabolism to diagnose those
who develop impaired glucose tolerance or diabetes. Diabetes is a known cardiovascular
risk factor and patients who develop glucose intolerance have an elevated risk for
developing diabetes. Caution should be exercised in treating HIV-positive patients with
lipodystrophy with EGRIFTA® (tesamorelin for injection) if they develop glucose
intolerance or diabetes, and careful consideration should be given to discontinuing
EGRIFTA® (tesamorelin for injection) treatment in patients who do not show a clear
efficacy response as judged by the degree of reduction in visceral adipose tissue by
waist circumference or CT scan measurements. Since EGRIFTA® (tesamorelin for injection)
increases IGF-I, patients with diabetes who are receiving ongoing treatment with
EGRIFTA® (tesamorelin for injection) should be monitored at regular intervals for
potential development or worsening of retinopathy. |
|
|
|
Hypersensitivity reactions may occur in patients treated with EGRIFTA® (tesamorelin for
injection). Hypersensitivity reactions occurred in 3.6% of patients with HIV-associated
lipodystrophy treated with EGRIFTA® (tesamorelin for injection) in the Phase 3 clinical
trials. These reactions included pruritus, erythema, flushing, urticaria, and other
rash. In cases of suspected hypersensitivity reactions, patients should be advised to
seek prompt medical attention, and treatment with EGRIFTA® (tesamorelin for injection)
should be discontinued immediately. |
|
|
|
EGRIFTA® (tesamorelin for injection) treatment may cause injection site reactions,
including injection site erythema, pruritus, pain, irritation, and bruising. The
incidence of injection site reactions was 24.5% in EGRIFTA® (tesamorelin for
injection)-treated patients and 14.4% in placebo-treated patients during the first 26
weeks of treatment in the Phase 3 clinical trials. For patients who continued EGRIFTA®
(tesamorelin for injection) for an additional 26 weeks, the incidence of injection site
reactions was 6.1%. In order to reduce the incidence of injection site reactions, it is
recommended to rotate the site of injection to different areas of the abdomen. |
|
|
|
Increased mortality in patients with acute critical illness due to complications
following open heart surgery, abdominal surgery or multiple accidental trauma, or those
with acute respiratory failure has been reported after treatment with pharmacologic
amounts of growth hormone. EGRIFTA® (tesamorelin for injection) has not been studied in
patients with acute critical illness. Since EGRIFTA® (tesamorelin for injection)
stimulates growth hormone production, careful consideration should be given to
discontinuing EGRIFTA® (tesamorelin for injection) in critically ill patients. |
|
|
|
EGRIFTA® (tesamorelin for injection) is contraindicated in pregnant women. During
pregnancy, visceral adipose tissue increases due to normal metabolic and hormonal
changes. Modifying this physiologic change of pregnancy with EGRIFTA® (tesamorelin |
|
|
for injection) offers no known benefit and could result in fetal harm. Tesamorelin
acetate administration to rats during organogenesis and lactation resulted in
hydrocephalus in offspring at a dose approximately two and four times the clinical
dose, respectively, based on measured drug exposure (AUC). If pregnancy occurs,
discontinue EGRIFTA® (tesamorelin for injection) therapy. If this drug is used during
pregnancy, or if the patient becomes pregnant while taking this drug, the patient
should be apprised of the potential hazard to the fetus. |
|
|
|
Because of both the potential for HIV-1 infection transmission and serious adverse reactions
in nursing infants, mothers receiving EGRIFTA® (tesamorelin for injection) should be
instructed not to human milk-feed. It is not known whether EGRIFTA® (tesamorelin for
injection) is excreted in human milk. |
|
|
|
Safety and effectiveness in pediatric patients have not been established. EGRIFTA® (tesamorelin for injection) should not be used in children with open epiphyses, among
whom
excess GH and IGF-I may result in linear growth acceleration and excessive growth. |
|
|
|
There is no information on the use of EGRIFTA® (tesamorelin for injection) in patients greater
than 65 years of age with HIV and lipodystrophy. |
|
|
|
Safety, efficacy, and pharmacokinetics of EGRIFTA® (tesamorelin for injection) in patients
with renal or hepatic impairment have not been established. |
|
|
|
The most commonly reported adverse reactions (>5% and more frequent than placebo) are
arthralgia [13.3% of patients receiving EGRIFTA® (tesamorelin for injection) and 11.0% of
patients receiving placebo], pain in extremity [6.1% of patients receiving EGRIFTA® (tesamorelin for injection) and 4.6% of patients receiving placebo], myalgia
[5.5% of
patients receiving EGRIFTA® (tesamorelin for injection) and 1.9% of patients receiving
placebo], injection site erythema [8.5% of patients receiving EGRIFTA® (tesamorelin for
injection) and 2.7% of patients receiving placebo], injection site pruritus [7.6% of patients
receiving EGRIFTA® (tesamorelin for injection) and 0.8% of patients receiving placebo], and
peripheral edema [6.1% of patients receiving EGRIFTA® (tesamorelin for injection) and 2.3% of
patients receiving placebo]. |
|
|
|
During the first 26 weeks of treatment (main phase), discontinuations as a result of
adverse reactions occurred in 9.6% of patients receiving EGRIFTA® (tesamorelin for
injection) and 6.8% of patients receiving placebo. Apart from patients with
hypersensitivity reactions identified during the studies and who were discontinued per
protocol (2.2%), the most common reasons for discontinuation of EGRIFTA® (tesamorelin for
injection) treatment were adverse reactions due to the effect of GH (4.2%) and local
injection site reactions (4.6%). |
|
6. |
|
RELIANCE ON SUBSECTION 7.1(2) OF
REGULATION 51-102: |
|
|
|
Not applicable. |
|
7. |
|
OMITTED INFORMATION: |
|
|
|
Not applicable. |
|
8. |
|
SENIOR OFFICER: |
|
|
|
For further information, contact Jocelyn Lafond, Vice President, Legal Affairs, and
Corporate Secretary of Theratechnologies Inc., at (514) 336-4804, ext. 288. |
9. |
|
DATE OF REPORT: |
|
|
|
November 19, 2010. |
ex-99.38
Exhibit 99.38
MATERIAL CHANGE REPORT
Regulation 51-102 Respecting Continuous Disclosure Obligations
Form 51-102F3
1. |
|
NAME AND ADDRESS OF COMPANY: |
|
|
|
THERATECHNOLOGIES INC.
2310 Alfred-Nobel Boulevard
Montreal, Québec
Canada H4S 2B4 |
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DATE OF MATERIAL CHANGE: |
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September 1, 2010 |
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NEWS RELEASE: |
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A news release was issued concerning this material change on September 1, 2010 on
Marketwire. A copy of the news release is available at SEDAR website at www.sedar.com. |
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SUMMARY OF MATERIAL CHANGE: |
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On September 1, 2010, Theratechnologies Inc. (the Company) announced the appointment of
a new president and chief executive officer who will assume his responsibilities in the
coming months. |
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FULL DESCRIPTION OF MATERIAL CHANGE: |
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On September 1, 2010, the Company announced that Mr. John-Michel T. Huss was appointed
as the new president and chief executive officer of the Company. Mr. Huss will assume
his responsibilities in the coming months. |
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RELIANCE ON SUBSECTION 7.1(2) OF
REGULATION 51-102: |
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Not applicable. |
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OMITTED INFORMATION: |
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Not applicable. |
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8. |
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SENIOR OFFICER: |
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For further information, contact Jocelyn Lafond, Vice President, Legal Affairs, and
Corporate Secretary of Theratechnologies Inc., at (514) 336-4804, ext. 288. |
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9. |
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DATE OF REPORT: |
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September 1, 2010. |
ex-99.39
Exhibit 99.39
MATERIAL CHANGE REPORT
Regulation 51-102 Respecting Continuous Disclosure Obligations
Form 51-102F3
1. |
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NAME AND ADDRESS OF COMPANY: |
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THERATECHNOLOGIES INC.
2310 Alfred-Nobel Boulevard
Montreal, Québec
Canada H4S 2B4 |
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2. |
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DATE OF MATERIAL CHANGE: |
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June 2, 2010 |
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3. |
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NEWS RELEASE: |
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A news release was issued concerning this material change on June 2, 2010 on Marketwire.
A copy of the news release is available at SEDAR website at www.sedar.com. |
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4. |
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SUMMARY OF MATERIAL CHANGE: |
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On June 2, 2010, Theratechnologies Inc. (the Company) announced that Mr. Yves Rosconi,
its President and Chief Executive Officer, informed the Board of Directors of his
decision to retire on December 31, 2010. |
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5. |
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FULL DESCRIPTION OF MATERIAL CHANGE: |
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On June 2, 2010, the Company announced that Mr. Yves Rosconi, its President and Chief
Executive Officer, informed the Board of Directors of his decision to retire on December
31, 2010. |
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The strategic committee of the Board of Directors will begin the formal search for a
new President and Chief Executive Officer having the requisite experience to pursue
the Companys business plan and its growth. |
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6. |
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RELIANCE ON SUBSECTION 7.1(2) OF
REGULATION 51-102: |
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Not applicable. |
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7. |
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OMITTED INFORMATION: |
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Not applicable. |
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8. |
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SENIOR OFFICER: |
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For further information, contact Jocelyn Lafond, Vice President, Legal Affairs, and
Corporate Secretary of Theratechnologies Inc., at (514) 336-4804, ext. 288. |
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9. |
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DATE OF REPORT: |
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June 8, 2010. |
ex-99.40
Exhibit 99.40
MATERIAL CHANGE REPORT
Regulation 51-102 Respecting Continuous Disclosure Obligations
FORM 51-102F3
Item 1 |
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Name and Address of Company |
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THERATECHNOLOGIES INC. (Theratechnologies or the Company)
2310 Alfred-Nobel Boulevard
Montreal, Québec
Canada H4S 2B4 |
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Item 2 |
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Date of Material Change |
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February 10, 2010. |
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Item 3 |
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News Release |
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A news release describing the nature and substance of the material change was issued on
Marketwire on February 10, 2010. A copy of the news release is available at SEDAR
website at www.sedar.com. |
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Item 4 |
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Summary of Material Change |
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Theratechnologies announced on February 10, 2010 that its Board of Directors adopted a
shareholder rights plan agreement dated February 10, 2010 by and between the Company and
Computershare Trust Company of Canada (the Rights Plan), effective at the close of
trading on the same day. The Rights were issued on the same day to holders of record on
February 9, 2010 at the close of the stock markets. Shareholders will be asked to approve
the Plan at the Companys next annual and special meeting to be held on March 25, 2010
(the Shareholders Meeting). The Plan, if approved by the shareholders, will expire at
the close of the Companys annual meeting of shareholders in 2013. |
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Item 5 |
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Full Description of Material Change |
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On February 10, 2010, the Company announced that it had adopted the Rights Plan,
effective as of that date. |
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The Rights Plan is designed to provide adequate time for the Board of Directors and the
shareholders to assess an unsolicited takeover bid for Theratechnologies, to provide the
Board of Directors with sufficient time to explore and develop alternatives for
maximizing shareholder value if a takeover bid is made, and to provide shareholders with
an equal opportunity to
participate in a takeover bid and receive full and fair value for their common shares. |
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The following text provides a summary of the principal terms of the Rights Plan and is
provided subject to the terms and conditions thereof. A complete copy of the Shareholder
Rights Plan Agreement is available at www.sedar.com. |
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Term of the Rights Plan |
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The Rights Plan came into effect on February 10, 2010. The Rights were issued on the
same day to holders of record on February 9, 2010 at the close of the stock markets.
Shareholders will be asked to approve the Rights Plan at the Companys next annual and
special meeting to be held on March 25, 2010. The Rights Plan, if approved by the
shareholders, will expire at the close of the Companys annual meeting of shareholders
in 2013. |
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Issue of Rights |
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In order to implement the Rights Plan, the Board of Directors authorized the Company to
issue one right in respect of each common share (the Common Share) outstanding as of
6:00 p.m. (Montreal time) on February 9, 2010 (the Effective Date). One Right will
also be issued and attached to each subsequently issued Common Share. |
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Rights-Exercise Privilege |
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The Rights will be separate from the Common Shares to which they are attached and will
become exercisable at the time (the Separation Time) that is ten business days after
the earlier of: (i) the first date of public announcement that an Acquiring Person (as
defined below) has become such; (ii) the date of commencement of, or first public
announcement in respect of, a takeover bid which will permit an offeror to hold 20% or
more of the Common Shares, other than by an acquisition pursuant to a takeover bid
permitted by the Rights Plan (a Permitted Bid as defined below); (iii) the date upon
which a Permitted Bid ceases to be a Permitted Bid; or (iv) such other date as may be
determined in good faith by the Board of Directors. |
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The acquisition permitting a person (an Acquiring Person), including others acting jointly or in concert with such person, to hold 20% or more of the outstanding Common
Shares, other than by way of a Permitted Bid, is referred to as a Flip-in Event. Any
Rights held by an Acquiring Person on or after the earlier of the Separation Time or the
first date of public announcement (the Common Share Acquisition Date) by the Company
or an Acquiring Person that an Acquiring Person has become such, will become null and
void upon the occurrence of a Flip-in Event. Ten trading days after the occurrence of
the Common Share Acquisition Date, each Right (other than those held by the Acquiring
Person) will permit the holder to purchase for the exercise price, that number of shares
determined as follows: a value of twice the exercise price divided by the average
weighted market price for the last 20 trading days
preceding the Common Share Acquisition Date. The exercise price is currently $25 per
Right, subject to adjustment in accordance with the Rights Plan. |
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To the knowledge of the senior executives of the Company, as of February 9, 2010, no
natural or legal person owns or owned 20% or more of the Common Shares. |
- 2 -
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The Issue of Rights is not initially dilutive. Upon the occurrence of a Flip-in Event
and the separation of the Rights from the attached shares, reported earnings per share
on a fully diluted or non-diluted basis may be affected. Holders of Rights who do not
exercise their Rights upon the occurrence of a Flip-in Event may suffer substantial
dilution. |
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Lock-Up Agreements |
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A bidder may enter into lock-up agreements with the shareholders of the Company whereby
such shareholders agree to tender their shares to the takeover bid (the Lockup Bid)
without a Flip-in Event occurring. Any such agreement must permit or must have the
effect to permit the shareholder to withdraw the shares to tender to another takeover
bid or to support another transaction that exceeds the value of the Lock-up Bid. |
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Certificates and Transferability |
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Prior to the Separation Time, the Rights will be evidenced by a legend imprinted on
certificates for Common Shares issued after the Effective Date. Rights are also attached
to shares outstanding on the Effective Date, although share certificates will not bear
such a legend. Prior to the Separation Time, Rights will not be transferable separately
from the attached shares. From and after the Separation Time, the Rights will be
evidenced by Rights certificates, which will be transferable and traded separately from
the shares. |
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Permitted Bid Requirements |
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A Permitted Bid is a takeover bid that does not trigger the exercise of Rights. A
Permitted Bid is a bid that aims to acquire shares which, together with the other
securities beneficially owned by the bidder, represent not less than 20% of the
outstanding Common Shares, which bid is made by means of a takeover bid circular and
satisfies the following requirements: |
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(i) |
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the bid must be made to all holders of Common Shares; |
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(ii) |
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the bid must include a condition without reservation providing that
no share tendered pursuant to the bid will be taken up prior to the expiry of
a period of not less than 60 days and only if at such date more than 50% in
aggregate of the outstanding shares held by the shareholders other than the
bidder, its associates and affiliates, and persons acting jointly or in
concert with such persons (the Independent Shareholders) have been tendered
pursuant to the bid and not withdrawn; |
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(iii) |
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if more than 50% in aggregate of the shares held by
Independent Shareholders are tendered to the bid within the 60-day period,
the bidder must make a public announcement of that fact and the bid must
remain open for deposits of shares for an additional 10 business days from
the date of such public announcement. |
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Waiver and Redemptions |
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The Board of Directors acting in good faith may, prior to a Flip-in Event, waive the
dilutive effects of the Rights Plan in respect of a particular Flip-in Event that would
result from a takeover bid made by way of takeover bid circular to all holders of shares,
in which event such waiver would be deemed also to be a waiver in respect of any other
Flip-in Event. The Board of Directors may also waive the Rights Plan in respect of a
particular Flip-in Event that has occurred through inadvertence, provided that the
Acquiring Person that inadvertently triggered such Flip-in Event reduces its beneficial
holdings to less than 20% of the outstanding Common Shares within 14 days or any other
period that may be specified by the Board of Directors. At any time prior to the
occurrence of a Flip-in Event, the Board of Directors may, subject to the prior approval
of the holders of Common Shares, elect to redeem all, but not less than all, of the
outstanding Rights at a price of $0.0001 per right. |
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Exemption for Investment Managers |
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Investment managers (for client accounts), trust companies and pension funds (acting in
their capacity as trustees and administrators) acquiring shares permitting them to hold
20% or more of the Common Shares are exempt from triggering a Flip-in Event, provided
that they are not making, or are not part of a group making, a takeover bid. |
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Supplements and Amendments |
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The Company is authorized to make amendments to the Rights Plan to correct any clerical
or typographical error or to maintain the validity of the Rights Plan as a result of
changes in laws or regulations. Prior to the Shareholders Meeting, the Company is
authorized to amend or supplement the Rights Plan as the Board of Directors may in good
faith deem necessary or advisable. The Company will issue a press release relating to any
material amendment made to the Rights Plan prior to the Shareholders Meeting and will
advise the shareholders of any such amendment at the Shareholders Meeting. Material
amendments or supplements to the Rights Plan will require, subject to the regulatory
authorities, the prior approval of the shareholders or, after the Separation Time,
holders of Rights. |
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Item 6 |
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Reliance on subsection 7.1(2) or (3) of National Instrument 51-102 |
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Not applicable. |
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Item 7 |
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Omitted Information |
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Not applicable. |
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Item 8 |
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Executive Officer |
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For further information, contact Jocelyn Lafond, Vice President, Legal Affairs, and
Corporate Secretary of the Company at (514) 336-4804, ext. 288. |
- 4 -
Item 9 |
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Date of Report |
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February 11, 2010 |
- 5 -
ex-99.41
Exhibit 99.41
News Release
Theratechnologies Announces Filing of European Marketing Authorization
Application for Tesamorelin
Montréal, Canada June 6, 2011 Theratechnologies Inc. (Theratechnologies) (TSX: TH) today
announced that its partner, Ferrer Internacional S.A. (Ferrer), has filed a Marketing
Authorization Application (MAA) with the European Medicines Agency (EMA) for tesamorelin, an
analogue of the growth hormone-releasing factor (GRF), proposed for the treatment of excess
abdominal fat in adult HIV-infected patients with lipodystrophy.
Currently there are no approved treatments for lipodystrophy in HIV-infected patients available
in the European Union. Based on Theratechnologies estimates, approximately 212,000
HIV-infected patients in Europe are affected by lipodystrophy.
This European regulatory filing for tesamorelin constitutes an important step forward in
meeting our corporate objective of maximizing the commercial potential of our flagship product
in major markets, said Mr. John-Michel T. Huss, President and Chief Executive Officer of
Theratechnologies. This also represents an important step towards addressing a critical, yet
unmet medical need for HIV-infected patients with lipodystrophy throughout the European Union.
We were very pleased to obtain FDA approval for tesamorelin in the U.S. and we are confident
that our ability to help meet these patient needs, in partnership with Ferrer, will also be
recognized in Europe, concluded Mr. Huss.
Under a distribution and licensing agreement between the two companies, Ferrer holds the
commercialization rights to tesamorelin for the treatment of excess abdominal fat in adult
HIV-infected patients with lipodystrophy in Europe and is responsible for conducting all
related regulatory and commercialization activities. Ferrer is a privately-held international
pharmaceutical company based in Barcelona, Spain, and operates in over 60 countries.
The MAA, submitted under the name TESAMORELIN FERRER, is based on the positive results from
two Phase 3 clinical trials, which enrolled more than 800 patients, and follows a marketing
approval by the US Food and Drug Administration received in November 2010. In the U.S.,
tesamorelin is marketed under the trade name EGRIFTA®.
The EMAs review of the MAA for tesamorelin will follow their centralized marketing
authorization procedure, which includes validation, assessment and decision-making processes.
If approved, tesamorelin will receive marketing authorization for the 27 European Union member
countries as well as for Iceland, Liechtenstein and Norway.
About EGRIFTA®
EGRIFTA®, a once-daily injection, is a novel, stabilized analogue of GRF. GRF is a
hypothalamic peptide that acts on the pituitary cells in the brain to stimulate the synthesis
and pulsatile release of endogenous growth hormone (GH). GH has been
shown to play an important role in regulating lipid metabolism and body composition (e.g.,
increasing muscle mass and reducing fat) 1.
About HIV-Associated Lipodystrophy
Several factors, including a patients antiretroviral drug regimen and the HIV virus itself,
are thought to contribute to HIV-associated lipodystrophy, which is characterized by body
composition changes. The changes in body composition may include accumulation of excess
abdominal fat accumulation, which is known as abdominal lipohypertrophy.
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical company that discovers and develops
innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor
peptides. Its first product, EGRIFTA® (tesamorelin for injection), was approved by
the United States Food and Drug Administration in November 2010. To date, EGRIFTA®
is the only approved therapy for the reduction of excess abdominal fat in HIV-infected patients
with lipodystrophy. EGRIFTA® has not been approved in Canada.
EGRIFTA® is currently marketed in the United States by EMD Serono pursuant to a
collaboration and licensing agreement executed in October 2008. In addition, Theratechnologies
has signed distribution and licensing agreements with a subsidiary of Sanofi granting them the
exclusive commercialization rights for EGRIFTA® for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy in Latin America, Africa and the
Middle East and with Ferrer Internacional S.A. granting them the exclusive commercialization
rights for EGRIFTA® for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy in Europe, Russia, South Korea, Taiwan, Thailand and certain
central Asian countries.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Companys website at
www.theratech.com. Additional information, including the Annual Information Form and the Annual
Report, is also available on SEDAR at www.sedar.com.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking
information within the meaning of applicable securities legislation. This forward-looking
information includes, but is not limited to, information regarding the number of HIV-infected
patients in Europe affected by lipodystrophy and the potential approval of tesamorelin for the
treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond Theratechnologies control that could cause
actual results to differ materially from those that are disclosed in or implied by such
forward-looking information. These assumptions include, but are not limited to, that the EMA
will approve tesamorelin for the treatment of excess
2
abdominal fat in adult HIV-infected patients with lipodystrophy, that no additional clinical
trials will be required by the EMA in order to approve tesamorelin and that the data consulted
by Theratechnologies in calculating the number of HIV-patients affected by lipodystrophy in
Europe were accurate. These risks and uncertainties include, but are not limited to, the risk
that the EMA does not approve tesamorelin for the treatment of excess abdominal fat in adult
HIV-infected patients with lipodystrophy, that the EMA requires additional clinical studies
prior to make any decision regarding the approval or non-approval of tesamorelin and that the
data consulted by Theratechnologies in calculating the number of HIV-patients affected by
lipodystrophy in Europe were not accurate.
Theratechnologies refers potential investors to the Risks and Uncertainties section of its
Annual Information Form (the AIF) dated February 22, 2011. The AIF is available at
www.sedar.com under Theratechnologies public filings. The reader is cautioned to consider
these and other risks and uncertainties carefully and not to put undue reliance on
forward-looking statements. Forward-looking information reflects current expectations regarding
future events and speaks only as of the date of this press release and represents
Theratechnologies expectations as of that date.
1Grunfeld C et al. J Acquir Immune Defic Syndr; 45:286-297 (2007). Lo J et al. JAMA,
300: 509518 (2008).
Contact:
Serge Vallières
NATIONAL Public Relations
Phone: 514 843-7171
3
ex-99.42
Exhibit 99.42
THERATECHNOLOGIES ADOPTS NEW R&D BUSINESS MODEL TO STRENGTHEN
ITS GROWTH POTENTIAL
Montreal, Quebec June 2, 2011 Theratechnologies Inc. (Theratechnologies) (TSX: TH)
announced today that it has re-evaluated its R&D business model.
Theratechnologies is at a major turning point in its evolution as a company. Recently, its flagship
product, EGRIFTA® (tesamorelin for injection), earned FDA approval in the U.S. Also,
Theratechnologies partners are in the process of preparing regulatory applications for
EGRIFTA® in several other major markets, including the European Union and a number of
Latin American countries. In this context, Theratechnologies has now revisited its R&D business
model in order to strengthen its growth potential.
As stated at our last annual meeting of shareholders, the launch of EGRIFTA® in the
United States is a success by any standard. As Theratechnologies enters into the next phase of its
evolution, it is our ability to adapt that will determine our future success. I hope that our new
R&D business model based on innovation, openness and flexibility will become the industry
standard, declared Mr. John-Michel T. Huss, President and Chief Executive Officer of
Theratechnologies.
The future of R&D undoubtedly lies in the public and private sectors ability to work in close
collaboration. While relying on Theratechnologies established partnership experience, we will
systematically call upon partners in the public and private arena to help us bring our R&D
projects forward, added Mr. Huss.
Consequently, the restructuring of R&D activities will lead to a workforce reduction affecting
24 employees. John Michel T. Huss met with Theratechnologies employees this afternoon to
discuss the companys new business model and its impact on its research and development
activities.
Theratechnologies estimates that this restructuring will result in a reduction in payroll expenses
of approximately $300,000 for the remainder of fiscal 2011, and a reduction of approximately $2.5
million for fiscal 2012.
All affected employees will be met with individually and will be provided with all the
pertinent information concerning their situation, and offered the level of support they
require, following this announcement.
We are fully aware of the fact that this is a difficult situation for our employees at
Theratechnologies and we are doing everything we can to mitigate the impact of this
decision on affected employees. We will do our utmost to ensure that our impacted colleagues
are treated with both respect and dignity, concluded Mr. Huss.
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical company that discovers and develops
innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor
peptides. Its first product, EGRIFTA® (tesamorelin for injection), was approved by the
United
States Food and Drug Administration in November 2010. To date, EGRIFTA® is the only
approved therapy for the reduction of excess abdominal fat in HIV-infected patients with
lipodystrophy. EGRIFTA® is not approved in Canada.
EGRIFTA® is currently marketed in the United States by EMD Serono pursuant to a
collaboration and licensing agreement executed in October 2008. In addition, Theratechnologies has
signed distribution and licensing agreements with a subsidiary of Sanofi granting them the
exclusive commercialization rights for EGRIFTA® for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy in Latin America, Africa and the Middle East and
with Ferrer Internacional S.A. granting them the exclusive commercialization rights for
EGRIFTA® for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in Europe, Russia, South Korea, Taiwan, Thailand and certain central Asian
countries.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information
includes, but is not limited to, information regarding the growth of Theratechnologies.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond Theratechnologies control that could cause
actual results to differ materially from those that are disclosed in or implied by such
forward-looking information. These assumptions include, but are not limited to, that regulatory
agencies in countries outside of the United States will approve EGRIFTA®, that the
research and development business model adopted by Theratechnologies will help advance its
research and development activities, and that on the long term, Theratechnologies will benefit
from a reduction in its operating costs. These risks and uncertainties include, but are not
limited to, the risk that EGRIFTA® is not approved by regulatory agencies outside of
the United States, that Theratechnologies cannot find adequate partners or that contractual
provisions with these partners are not suitable, or that the expected cost savings do not
materialize.
The Company refers potential investors to the Risks and Uncertainties section of its Annual
Information Form (the AIF) dated February 22, 2011. The AIF is available at www.sedar.com under
Theratechnologies public filings. The reader is cautioned to consider these and other risks and
uncertainties carefully and not to put undue reliance on forward-looking statements.
Forward-looking information reflects current expectations regarding future events and speaks only
as of the date of this press release and represents Theratechnologies expectations as of that
date.
ex-99.43
Exhibit 99.43
News Release
For immediate release
THERATECHNOLOGIES HOLDS ANNUAL AND SPECIAL MEETING OF SHAREHOLDERS
AFTER A YEAR MARKED BY HISTORIC ACHIEVEMENT
FDA approval of EGRIFTA® paves the way to growth strategy
Montreal, Canada May 18, 2011 Theratechnologies Inc. (TSX: TH) (Theratechnologies or the
Company) today held its annual and special meeting of shareholders in Montreal. It was an
opportunity to celebrate a milestone year and to review the Companys prospects as it develops the
full potential of its flagship product, EGRIFTA®.
In his remarks to shareholders, Mr. Paul Pommier, Chairman of the Board of Theratechnologies,
expressed his satisfaction over the Food and Drug Administrations (FDA) approval of
EGRIFTA®.
Earning FDA approval is a significant achievement. Theratechnologies is one of the few Canadian
biotech companies to have successfully steered a molecule from discovery to marketing approval,
said Mr. Pommier.
Mr. Pommier explained that the FDAs approval set the stage for two important partnership
agreements, with Sanofi and with Ferrer Internacional S.A. These partnerships support
Theratechnologies objective of maximizing the commercial value of EGRIFTA® in markets
around the world. He also announced that Theratechnologies is applying to list its shares on the
NASDAQ market in the United States.
Mr. Pommier read the prepared address of President and CEO John-Michel Huss, who was not able to
attend the meeting. Mr. Huss absence was due to ophthalmic surgery that he underwent yesterday to
treat a detached retina in his right eye. His doctors expect a short recovery; however, the surgery
could not have been delayed without causing additional risk to Mr. Huss. (Quotations from Mr. Huss
in this news release were taken from his prepared remarks.)
The launch of EGRIFTA® in the United States
is a success by any standards. We are
tracking at 100 additional prescriptions per week, declared John-Michel Huss. Royalty revenues
are now starting to flow and several important regulatory filings are slated in the coming months
with EGRIFTA® now licensed in most major markets around the world, he added.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Saint Laurent, Québec, Canada H4S
2A4
Phone: (514) 336-7800 Fax: (514) 336-7242
www.theratech.com thera@theratech.com
Shareholders were also updated on the upcoming clinical program using tesamorelin to treat
muscle wasting in chronic obstructive pulmonary disease (COPD).
We know from our past clinical work that tesamorelin has potential to do more than reduce
abdominal fat. It has also been shown to increase muscle mass, which makes it a potential treatment
for muscle wasting, said Mr. Huss. If the increase in lean body mass translates into an
improvement of functionality, that will be a huge step forward for COPD-patients suffering from
muscle wasting, he added. The COPD clinical program is expected to begin in September 2011.
The COPD clinical program is part of a four-pronged strategy aimed at growing the Company and
building value for shareholders. This strategy is based on:
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Maximizing global commercial opportunities for EGRIFTA® |
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Developing tesamorelin to treat muscle wasting |
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Solidifying our position as a leader in the field of novel GRF products |
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Pursuing external growth opportunities |
In his prepared remarks, Mr. Huss announced that the Company is working on synthesizing a second
generation GRF analog that may have the potential for administration methods other than injection.
If we succeed, this will be a major improvement for patients, he stated.
Theratechnologies Senior Executive Vice-President and Chief Financial Officer, Mr. Luc Tanguay,
provided an overview of the Companys financial position, commenting on the results for the first
quarter of 2011, which were announced earlier in April. He reminded shareholders that
Theratechnologies had completed the first quarter with $56.3 million in liquidities. He also added
that consolidated revenues were up significantly for the quarter, reflecting early product sales to
the Companys U.S. partner. With $56.3 million in liquidities, the Company is well positioned to
pursue its organic growth, noted Mr. Tanguay. Company expenses for 2011 are expected to be in the
range of $26 million, excluding the cost of goods sold and depreciation.
At the meeting, Companys shareholders re-elected current members of the Board of Directors,
designated KPMG LLP as auditors of the Company for the ensuing year and passed a resolution to
amend the Articles of the Corporation to enable the Board of Directors to name up to one-third of
the number of directors elected at each annual meeting of shareholders.
- 2 -
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical Corporation that discovers and develops
innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor
peptides. Its first product, EGRIFTA® (tesamorelin for injection), was approved by the
United States Food and Drug Administration in November 2010. To date, EGRIFTA® is the
only approved therapy for the reduction of excess abdominal fat in HIV-infected patients with
lipodystrophy.
EGRIFTA® is currently marketed in the United States by EMD
Serono pursuant to a
collaboration and licensing agreement executed in October 2008. In addition, the Corporation has
signed distribution and licensing agreements with a subsidiary of Sanofi granting them the
exclusive commercialization rights for EGRIFTA® for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy in Latin America, Africa and the Middle East and
with Ferrer Internacional S.A. granting them the exclusive commercialization rights for
EGRIFTA® for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in Europe, Russia, South Korea, Taiwan, Thailand and certain central Asian countries.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Companys website at
www.theratech.com. Additional information, including the Annual Information Form and the Annual
Report, is also available on SEDAR at www.sedar.com.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information includes,
but is not limited to, information regarding the revenue to be generated as a result of sales of
EGRIFTA® to EMD Serono and the receipt of royalties from EMD Serono in connection with
the sale of EGRIFTA® in the United States, the successful use of tesamorelin to treat
muscle wasting in COPD, the potential of discovering a new GRF analog and the new routes of
administration of such analog and the Companys growth based on its strategy. Furthermore, the
words will, may, could, should, outlook, believe, plan, envisage, anticipate,
expect and estimate, or the negatives of these terms, or variations of them and the use of the
future and conditional tenses as well as similar expressions denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties include, but are not limited to, the risk that
EGRIFTA® is not approved in all or some of the territories referred to in this press
release (other than the United States of America), that the revenue and royalties we expect to
generate from sales of EGRIFTA® are lower than anticipated, that the supply of
EGRIFTA® to our commercial partners is delayed or suspended as a result of problems with
our suppliers, that EGRIFTA® is withdrawn from the market as a result of defects or
recalls, that our intellectual property is not
- 3 -
adequately protected, that the data generated in the Phase 2 clinical trial using tesamorelin for
the treatment of muscle wasting in COPD are not potent enough to pursue the conduct of a clinical
program for this disease and that our liquidity level decreases based on unexpected activities that
must be carried out in order to achieve our business plan.
Certain assumptions made in preparing the forward-looking information and the Companys objectives
include the assumption that EGRIFTA® for the reduction of excess abdominal fat in
HIV-infected patients with lipodystrophy will receive approvals in the territories referred to in
this press release (other than the United States of America), that no additional clinical studies
will be required to obtain these approvals, EGRIFTA® will be accepted by the marketplace
in the United States and will be on the list of reimbursed drugs by third-party payors, that
relations with third-party suppliers of EGRIFTA® will be conflict-free and that such
third-party suppliers will have enough capacity to manufacture and supply EGRIFTA® to
meet its demand and will manufacture on a timely-basis, that the Company will succeed in
implementing its four-pronged strategy, that tesamorelin will be successful in treating muscle
wasting in COPD and that the Companys business plan will not be substantially modified.
Consequently, the forward-looking information is qualified by the foregoing cautionary statements,
and there can be no guarantee that the results or developments anticipated by the Company will be
realized or, even if substantially realized, that they will have the expected consequences or
effects on the Company, its business, its financial condition or its results of operations.
Furthermore, the forward-looking information reflects current expectations regarding future events
only as of the date of this press release.
Investors are referred to the Companys public filings available at http://www.sedar.com/. In
particular, further details on the risks and descriptions of the risks are disclosed in the Risks
and Uncertainties section of the Companys Annual Information Form dated February 22, 2011 for the
year ended November 30, 2010.
-30-
Information:
Jean-Sébastien Lamoureux
514-843-2368
jslamoureux@national.ca
- 4 -
ex-99.44
Exhibit 99.44
Subject: Media advisory
THERATECHNOLOGIES HOLDS ANNUAL AND SPECIAL MEETING OF
SHAREHOLDERS
MONTREAL (Quebec), May 16, 2011Theratechnologies Inc. (TSX:TH) (Theratechnologies) will hold
its annual and special meeting of shareholders in Montreal this Wednesday, May 18, at 10 am.
|
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Datebook |
|
|
What:
|
|
Annual and special meeting of shareholders of Theratechnologies |
|
|
|
When:
|
|
Wednesday, May 18, at 10 am |
|
|
|
Where:
|
|
Sheraton Montreal, 1201 René-Lévesque West Blvd., Montréal |
|
|
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Who:
|
|
Mr. Paul Pommier, Chairman of the Board
Mr. Luc Tanguay, Senior Executive Vice-President and Chief Financial Officer |
Please note that Mr. John-Michel Huss will not be able to attend the annual and special meeting of
shareholders. His absence is due to ophthalmic surgery that he will undergo to treat a retinal
detachment in his right eye. His doctors expect a short recovery; however, the surgery cannot be
delayed without causing additional risk to Mr. Huss.
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical Corporation that discovers and develops
innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor
peptides. Its first product, EGRIFTA® (tesamorelin for injection), was approved by the United
States Food and Drug Administration in
November 2010. To date, EGRIFTA® is the only approved therapy for the reduction of excess abdominal
fat in HIV-infected patients with lipodystrophy.
EGRIFTA® is currently marketed in the United States by EMD Serono pursuant to a collaboration and
licensing agreement executed in October 2008. In addition, the Corporation has signed distribution
and licensing agreements with a subsidiary of Sanofi-aventis granting them the exclusive
commercialization rights for EGRIFTA® for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy in Latin America, Africa and the Middle East and with Ferrer
Internacional S.A. granting them the exclusive commercialization rights for EGRIFTA® for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in Europe, Russia,
South Korea, Taiwan, Thailand and certain central Asian countries.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Corporations website at
www.theratech.com. Additional information about the Corporation is also available on SEDAR at
www.sedar.com.
INFORMATION:
Roch
Landriault
514-843-2345
rlandriault@national.ca
-30-
ex-99.45
Exhibit 99.45
News Release
Theratechnologies announces results for the first quarter 2011
Commercial activities now underway in the United States
Montréal, Canada April 12, 2011 - Theratechnologies (TSX: TH) today announced its financial
results for the quarter ended February 28, 2011, the first reporting period to include revenues and
expenses directly related to the EGRIFTA® launch in the United States. For reference,
the Managements Discussion and Analysis for the first quarter 2011 with the associated Financial
Statements can be found at www.theratech.com or at www.sedar.com.
First quarter financial highlights included:
|
Ø |
|
Consolidated revenues were up significantly in the quarter reflecting early product
sales to the Companys U.S. partner |
|
|
Ø |
|
R&D expenses were down 27% in the quarter |
|
|
Ø |
|
Continued Balance Sheet strength with a cash position of $56,327,000 at quarter end |
With EGRIFTA® sales now accruing and royalty revenues beginning in the second quarter,
we are establishing a foundation to further develop the Company, stated Mr. John-Michel T. Huss,
President and CEO of Theratechnologies. It is still in the early days but from what we see thus
far, we are very encouraged about the prospects for EGRIFTA®, he said. The upcoming
few months will also be exciting as our partners begin regulatory submissions in Europe and
selected Latin American markets for HIV-associated lipodystrophy, Mr. Huss concluded.
With $56 million in cash, the Company is well positioned to pursue its clinical program in muscle
wasting in COPD, added Mr. Luc Tanguay, Senior Executive Vice President & CFO of
Theratechnologies.
Financial Highlights
For the three-month period ending February 28, 2011:
Consolidated revenues amounted to $3,518,000 for the quarter, compared to $1,717,000 for the
corresponding period in 2010, an increase of 104.9%. The higher revenues in 2011 include $1,798,000
generated from the sales of EGRIFTA® to EMD Serono.
Cost of Sales totaled $2,595,000, for the first quarter. Cost of sales exceeded
EGRIFTA® sales revenue principally due to raw materials purchased prior to negotiating
our current long-term procurement agreements, an inventory write-down of $375,000 related to an
unfavorable foreign currency difference and costs associated with validating a second
EGRIFTA® supplier. There were no costs related to the production of
EGRIFTA® in the first quarter of 2010, as we only began producing inventories through
our third-party suppliers during the second half of 2010, in anticipation of the launch of
EGRIFTA® in the United States.
Research and development (R&D) expenses totaled $2,993,000 for the first quarter of 2011,
compared to $4,123,000 for the same period in 2010, a decrease of 27.4% . The R&D expenses incurred
in the first quarter are related to the preparation for the Phase 2 clinical trial evaluating
tesamorelin in muscle wasting associated with COPD, to the work on a new formulation and a new
presentation of EGRIFTA®, as well as to the development of novel growth hormone
releasing factor peptides. R&D expenses also include all regulatory, manufacturing and clinical
activities to support our three commercial partners, as well as follow up on the post-approval
commitments. The R&D expenses incurred in the first quarter of 2010 were mainly related to the
regulatory activities connected with the preparation for the FDA Advisory Committee meeting which
took place on May 26, 2010.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
Selling and market development expenses amounted to $477,000 for the first quarter, compared
to $620,000 for the same period in 2010, a decrease of 23.1% . The decrease is principally due to
the signing of distribution and licensing agreements with Sanofi and Ferrer which transferred
responsibility for all marketing expenses to the licensees. Selling and market development expenses
continue to include activities associated with the management of the agreements with our three
partners.
General and administrative expenses amounted to $3,215,000 for the first quarter, compared to
$1,745,000 for the same period in 2010. The higher expenses were principally due to costs
associated with the change in leadership of the Company, many of which were entirely expensed in
the first quarter 2011. Additional expenses were also incurred in relation to deferred stock units
granted to the members of the Board of Directors during the first quarter. Although the deferred
stock units replace a part of their annual compensation, the deferred stock units were entirely
expensed in the three-month period.
Net Financial Charges
Interest revenues for the first quarter 2011 amounted to $372,000 compared to $578,000 for the
same period in 2010. Lower interest revenues for 2011 were due to a lower yield on the portfolio
during the period.
As at November 30, 2010, the foreign currency difference arising from the conversion of the
US$25,000,000 milestone payment from EMD Serono into the functional currency of the Company
resulted in a net foreign exchange gain of $635,000 as of November 30, 2010. However, in the first
quarter, when this amount was converted to Canadian dollars, a foreign exchange loss of $550,000
was incurred. The foreign exchange loss for the same period in 2010 was $44,000.
Net loss in the first quarter was $5,932,000, or $0.10 per share, compared to a net loss of
$4,241,000, or $0.07 per share for the same period in 2010.
Financial Position
At February 28, 2011, liquidities, which include cash and bonds, amounted to $55,842,000 and tax
credits receivable amounted to $485,000, for a total of $56,327,000.
Taking into account the revenues and expenses described above, for the three-month period ended
February 28, 2011, use of cash from operating activities, was $7,764,000, compared to $7,676,000
for the same period in 2010. Use of cash includes changes in trade and other receivables, related
to product sales to EMD Serono.
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical Corporation that discovers and develops
innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor
peptides. Its first product, EGRIFTA® (tesamorelin for injection), was approved by the
United States Food and Drug Administration in November 2010. To date, EGRIFTA® is the
only approved therapy for the reduction of excess abdominal fat in HIV-infected patients with
lipodystrophy.
EGRIFTA® is currently marketed in the United States by EMD Serono pursuant to a
collaboration and licensing agreement executed in October 2008. In addition, the Corporation has
signed distribution and licensing agreements with a subsidiary of Sanofi-aventis granting them the
exclusive commercialization rights for EGRIFTA® for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy in Latin America, Africa and the Middle East and
with Ferrer Internacional S.A. granting them the exclusive commercialization rights for
EGRIFTA® for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in Europe, Russia, South Korea, Taiwan, Thailand and certain central Asian countries.
2
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Companys website at
www.theratech.com. Additional information, including the Annual Information Form and the
Annual Report, is also available on SEDAR at www.sedar.com.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information includes,
but is not limited to, information regarding the preparation and filing of applications seeking
regulatory approval of EGRIFTA® in the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy in various territories outside of the United States, the revenue to be generated
as a result of sales of EGRIFTA® to EMD Serono and the receipt of royalties from
EMD Serono in connection with the sale of EGRIFTA® in the United States. Furthermore, the words
will, may, could, should, outlook, believe, plan, envisage, anticipate, expect
and estimate, or the negatives of these terms, or variations of them and the use of the future
and conditional tenses as well as similar expressions denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties include, but are not limited to, the risk that EGRIFTA®
is not approved in all or some of the territories referred to in this press release, the revenue
and royalties we expect to generate from sales of EGRIFTA® are lower than anticipated, the supply
of EGRIFTA® to our commercial partners is delayed or suspended as a result of problems with our
suppliers, EGRIFTA® is withdrawn from the market as a result of defects or recalls, our
intellectual property is not adequately protected and our liquidity level decreases based on
unexpected activities that must be carried out in order to achieve our business plan.
Although the forward-looking information contained in this press release is based upon what the
Company believes are reasonable assumptions, investors are cautioned against placing undue reliance
on this information since actual results may vary from the forward-looking information. Certain
assumptions made in preparing the forward-looking information and the Companys objectives include
the assumption that EGRIFTA® for the reduction of excess abdominal fat in HIV-infected patients
with lipodystrophy will receive approvals in the territories referred to in this press release, no
additional clinical studies will be required to obtain these approvals, EGRIFTA® will be accepted
by the marketplace in the United States and will be on the list of reimbursed drugs by third-party
payers, relations with third-party suppliers of EGRIFTA® will be conflict-free and that such
third-party suppliers will have enough capacity to manufacture and supply EGRIFTA® to meet its
demand and will manufacture on a timely-basis and that the Companys business plan will not be
substantially modified.
Consequently, the forward-looking information is qualified by the foregoing cautionary statements,
and there can be no guarantee that the results or developments anticipated by the Company will be
realized or, even if substantially realized, that they will have the expected consequences or
effects on the Company, its business, its financial condition or its results of operations.
Furthermore, the forward-looking information reflects current expectations regarding future events
only as of the date of this press release.
Investors are referred to the Companys public filings available at www.sedar.com. In
particular, further details on the risks and descriptions of the risks are disclosed in the Risks
and Uncertainties section of the Companys Annual Information Form, dated February 22, 2011, for
the year ended November 30, 2010. This press release is dated April 12, 2011, and has been approved
by the Audit Committee.
-30-
3
Information:
Andrea Gilpin
Vice President, IR & Communications
Phone: 514-336-7800, ext. 205
communications@theratech.com
Luc Tanguay
Senior Executive Vice President and
Chief Financial Officer
Phone:
514-336-7800, ext. 204
ltanguay@theratech.com
4
ex-99.46
Exhibit 99.46
News Release
Theratechnologies decides to withdraw its cross-border offering
Montréal, Canada March 8, 2011 Theratechnologies Inc. (TSX: TH) today announced that it
has decided not to pursue its public offering in Canada and the United States due to an expected
offering price which was not acceptable to the Corporation. The decision to withdraw the offering
was made by the Board of Directors and demonstrates the Corporations commitment to its
shareholders.
We are not proceeding with this offering as we believe that the Corporation has a much higher
intrinsic value than what the market is currently reflecting, commented Mr. John-Michel T. Huss,
President and CEO of Theratechnologies. We believe strongly in the commercial success of
EGRIFTA® and I can assure you that we remain fully committed to increasing value for
our shareholders, concluded Mr. Huss.
The decision does not affect the Corporations strategy and the Corporation intends to pursue its
business plan accordingly. With its existing financial resources, the Corporation expects to begin
its Phase 2 clinical trial relating to muscle wasting in chronic obstructive pulmonary disease
(COPD), to complete its new formulation of EGRIFTA®, and to continue research and
development of novel GRF peptides.
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical Corporation that discovers and develops
innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor
peptides. Its first product, EGRIFTA® (tesamorelin for injection), was approved by the United
States Food and Drug Administration in November 2010. To date, EGRIFTA® is the only approved
therapy for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
EGRIFTA® is currently marketed in the United States by EMD Serono pursuant to a collaboration and
licensing agreement executed in October 2008. In addition, the Corporation has signed distribution
and licensing agreements with a subsidiary of Sanofi-aventis granting them the exclusive
commercialization rights for EGRIFTA® for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy in Latin America, Africa and the Middle East and with Ferrer
Internacional S.A. granting them the exclusive commercialization rights for EGRIFTA® for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in Europe, Russia,
South Korea, Taiwan, Thailand and certain central Asian countries.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Corporations website at
www.theratech.com. Additional information about the Corporation is also available on SEDAR
at www.sedar.com.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information includes,
but is not limited to, information regarding the beginning of our Phase 2 clinical trial relating
to muscle wasting in COPD, the completion of our new formulation of EGRIFTA® and the
successful commercialization of EGRIFTA® in the United States and in other territories.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Corporations control, that could cause
actual results to differ materially from those that are disclosed in or implied by such
forward-looking information. These risks and uncertainties include, but are not limited to: the
risk that we do not obtain positive results from our Phase 2 clinical trial for muscle wasting in
COPD, that we are
unable to complete the new formulation of EGRIFTA® and that
EGRIFTA® is not successfully commercialized in the United States or in other
territories.
Certain assumptions made in preparing the forward-looking information include, among others, that
results from the Phase 2 clinical trials for muscle wasting in COPD will be positive, that the new
formulation for EGRIFTA® will be completed and that EGRIFTA® will be
successfully commercialized in the United States and in other territories.
All of the forward-looking information is qualified by the foregoing cautionary statements.
Forward-looking information reflects current expectations regarding future events only as of the
date of release of this press release. The Corporation refers potential investors to the Risks and
Uncertainties section of its Annual Information Form (the AIF) dated February 22, 2011. The AIF
is available at www.sedar.com under the Corporations public filings. The reader is cautioned to
consider these and other risks and uncertainties carefully and not to put undue reliance on
forward-looking statements.
-30-
Information:
Andrea Gilpin
Vice President, IR & Communications
Phone: 514-336-7800, ext. 205
communications@theratech.com
ex-99.47
Exhibit 99.47
News Release
Theratechnologies files preliminary prospectus for cross-border offering
Montréal, Canada February 22, 2011 Theratechnologies Inc. (TSX: TH) today announced that
it has filed a preliminary short form base PREP prospectus with the securities administrators in
each of the provinces of Canada and a registration statement on Form F-10 with the U.S. Securities
and Exchange Commission in connection with an offering of approximately 11 million common shares.
This offering will be Theratechnologies initial public offering in the United States.
The offering will be made predominantly to investors in the United States. Application has been
made to list the common shares on the Nasdaq Global Market under the symbol THER. The Companys
common shares will also continue to trade on the Toronto Stock Exchange under the symbol TH. The
Company will grant the underwriters an option to purchase up to an additional number of common
shares not to exceed 15% of the number of shares issued pursuant to the offering, within 30 days of
the date of the underwriting agreement to cover over-allotments, if any. All of the common shares
to be sold in the offering will be newly issued.
The Company plans to use the net proceeds from the offering to advance its clinical program
relating to muscle wasting in chronic obstructive pulmonary disease (COPD), to complete its new
formulation of EGRIFTA® and tesamorelin, to continue research and development of novel
GRF peptides, for potential acquisitions, and for working capital and other general corporate
purposes.
Jefferies & Company, Inc., Stifel, Nicolaus & Company, Inc., RBC Capital Markets, LLC and BMO
Capital Markets Corporation are acting as joint book-running managers for the proposed offering.
Desjardins Securities International Inc. and NBF Securities (USA) Corp. are acting as co-managers
for the proposed offering. The Companys common shares are being offered in Canada by Stifel
Nicolaus Canada Inc., RBC Dominion Securities Inc., BMO Nesbitt Burns Inc., Desjardins Securities
Inc. and National Bank Financial Inc.
The offering will be made by means of a prospectus when available. A copy of the preliminary
prospectus may be obtained by contacting Jefferies & Company, Inc. at 520 Madison Avenue, New York,
NY 10022 (telephone: 212-284-2300), Stifel, Nicolaus & Company, Inc. at One Montgomery, 36th Floor,
SF, CA 94104 (telephone: 415-364-2720), RBC Capital Markets, LLC at Three World Financial Center,
200 Vesey Street, 8th floor, New York, NY 10281 (telephone: 877-822-4089) or BMO Capital Markets at
3 Times Square, 27th Floor, New York, NY, 10036 (telephone: 800-414-3627).
This offering is subject to customary conditions and regulatory approvals, including the
effectiveness of the registration statement filed under the Securities Act of 1933 and the approval
of the Toronto Stock Exchange. A registration statement relating to these securities has been filed
with the U.S. Securities and Exchange Commission but has not yet become effective. These securities
may not be sold nor may offers to buy be accepted prior to the time the registration statement
becomes effective. This press release shall not constitute an offer to sell or a solicitation of an
offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which
such an offer, solicitation or sale would be unlawful prior to the registration or qualification
under the securities laws of any such state or jurisdiction.
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical company that discovers and develops
innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor
peptides. Its first product, EGRIFTA® (tesamorelin for injection), was approved by the United
States Food and Drug Administration in November 2010. To date, EGRIFTA® is the only approved
therapy for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
EGRIFTA® is currently marketed in the United States by EMD Serono pursuant to a collaboration and
licensing agreement executed in October 2008. In addition, the Company has signed
distribution and licensing agreements with a subsidiary of Sanofi-aventis granting them the
exclusive commercialization rights for EGRIFTA® for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy in Latin America, Africa and the Middle East and with
Ferrer Internacional S.A. granting them the exclusive commercialization rights for EGRIFTA® for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in Europe, Russia,
South Korea, Taiwan, Thailand and certain central Asian countries.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Companys website at
www.theratech.com. Additional information about the Company is also available on SEDAR at
www.sedar.com.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control, that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. Although the forward-looking information contained in this press release is based upon
what the Company believes are reasonable assumptions, investors are cautioned against placing undue
reliance on this information since actual results may vary materially from the forward-looking
information contained in this press release.
Consequently, all of the forward-looking information contained in this press release is qualified
by the foregoing cautionary statements, and there can be no guarantee that the results or
developments that the Company anticipates will be realized or, even if substantially realized, that
they will have the expected consequences or effects on its business, financial condition or results
of operation.
Investors are referred to the Companys public filings available at www.sedar.com. In particular,
further details on these risks and descriptions of these risks are disclosed in the Risks Factors
section of the Companys Annual Information Form for the year ended November 30, 2010.
-30-
Information:
Andrea Gilpin
Vice President, IR & Communications
Phone:
514-336-7800, ext. 205
communications@theratech.com
ex-99.48
Exhibit 99.48
News Release
Theratechnologies announces new clinical program in muscle wasting in Chronic Obstructive
Pulmonary Disease (COPD)
Montréal, Canada February 22, 2011 - Theratechnologies (TSX: TH) today announced a new
clinical program for muscle wasting in Chronic Obstructive Pulmonary Disease (COPD) using the
Companys lead compound, tesamorelin, a human growth hormone releasing factor (GRF) analogue.
Based on tesamorelins anabolic properties, the Company has chosen to pursue the development of its
lead compound in muscle wasting in patients with COPD as its second indication. COPD is
characterized by progressive airflow obstruction due to chronic bronchitis or emphysema leading in
certain cases to muscle wasting, a decrease of muscle mass and deterioration in functionality.
Previously, Theratechnologies completed a Phase 2 trial in stable ambulatory COPD patients which
demonstrated a statistically significant increase in lean body mass. The Company intends to
commence a second Phase 2 clinical study in the second half of 2011 to test different dosages of
tesamorelin with a new formulation.
Based on available market and industry data, the Company estimates that in 2009, the number of
diagnosed COPD patients in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage
II or III suffering from a muscle wasting condition, with a body mass index under 25, was
approximately 3.1 million in the United States, France, Germany, Italy, United Kingdom, Spain and
Japan.
There are a large number of patients who suffer from muscle wasting in COPD and it is our hope
that we can eventually improve the condition of those patients in need, stated Mr. John-Michel T.
Huss, President and CEO of Theratechnologies. Expanding into this new disease area will allow us
to maximize the global commercial potential of tesamorelin, he commented. This is further
evidence regarding our ability to deliver on our promise, as a management team, and a demonstration
of our commitment to grow our company as well as solidify the future of Theratechnologies, Mr.
Huss concluded.
The Phase 2 clinical study will evaluate the use of tesamorelin in a randomized, placebo controlled
study with approximately 200 COPD patients, in GOLD stage II and III, with muscle wasting. Patients
will be randomized to receive either one of two different dosages of tesamorelin or placebo each
day for six months. Theratechnologies intends to randomize its first patient in the second half of
2011. The primary endpoint will be an increase in lean body mass. Other efficacy endpoints will be
measured, such as a six-minute walking distance test, exercise endurance time, and quality of life
(daily activities). Safety assessments will include monitoring of adverse events and laboratory
evaluations. If the Phase 2 study is successful, two Phase 3 studies (one pivotal and one
confirmatory) are to be conducted in parallel. This clinical trial program is estimated to take
approximately four years and will use a new and more concentrated formulation of tesamorelin. The
new formulation will require a smaller volume of injection and is expected to be stable at room
temperature.
We have already led a successful clinical program based on the lipolytic properties of tesamorelin
and are now expanding into muscle wasting in COPD based on the anabolic properties of tesamorelin,
commented Dr. Christian Marsolais, Vice-President, Clinical Research and Medical Affairs. We are
hoping to demonstrate that the increase of muscle mass by tesamorelin will have a positive impact
on the functionality of the COPD patients with muscle wasting, he concluded.
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical company that discovers and develops
innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor
peptides. Its first product, EGRIFTA® (tesamorelin for injection), was approved by the United
States Food and Drug Administration in November 2010. To date, EGRIFTA® is the only approved
therapy for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
EGRIFTA® is currently marketed in the United States by EMD Serono pursuant to a collaboration and
licensing agreement executed in October 2008. In addition, the Company has signed distribution and
licensing agreements with a subsidiary of Sanofi-aventis granting them the exclusive
commercialization rights for EGRIFTA® for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy in Latin America, Africa and the Middle East and with Ferrer
Internacional S.A. granting them the exclusive commercialization rights for EGRIFTA® for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in Europe, Russia,
South Korea, Taiwan, Thailand and certain central Asian countries.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Companys website at
www.theratech.com. Additional information about the Company is also available on SEDAR at
www.sedar.com.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information includes,
but is not limited to, information regarding the ability to begin the clinical trials on time and
the estimated length of the clinical trials, that the clinical program outlined in treating
patients with muscle wasting in COPD will be successful in building lean body mass and that our
assumptions of the market size are accurate . The words will, may, could, should,
outlook, believe, plan, envisage, anticipate, expect and estimate, or the negatives
of these terms or variations of them and the use of future or conditional tenses as well as similar
expressions denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control, that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties include, but are not limited to, the risk that the
results of the administration of tesamorelin for muscle wasting in COPD patients differ from those
in HIV-patients suffering from excess abdominal fat associated with lipodystrophy, that the
clinical trials take longer than expected and are more costly, that unexpected serious adverse
events impact negatively our business, that physicians do not perceive a need to treat these
patients, that our third-party manufacturers will be unable to supply tesamorelin for these studies
without impacting our other programs and that the market size is smaller than anticipated.
Although the forward-looking information contained in this press release is based upon what the
Company believes are reasonable assumptions, investors are cautioned against placing undue reliance
on this information since actual results may vary materially from the forward-looking information
contained in this press release. Certain assumptions made in preparing the forward-looking
information include the assumption that tesamorelin will build lean body mass for patients with
muscle wasting in COPD, that clinical trials will be completed on schedule and on budget, that no
serious adverse events negatively impact our business, that physicians desire a treatment for those
patients with muscle wasting in COPD, that relations with third-party suppliers of tesamorelin will
be conflict-free and that such third-party suppliers will have enough capacity to manufacture and
supply tesmorelin to meet its demand and on a timely-basis and that our estimated market size is
accurate.
Consequently, all of the forward-looking information contained in this press release is qualified
by the foregoing cautionary statements, and there can be no guarantee that the results or
developments that the Company anticipates will be realized or, even if substantially realized, that
they will have the expected consequences or effects on its business, financial condition or results
of operation.
Investors are referred to the Companys public filings available at www.sedar.com. In particular,
further details on these risks and descriptions of these risks are disclosed in the Risks and
Uncertainties section of the Companys Managements Discussion and Analysis for the year ended
November 30, 2010.
-30-
Information:
Andrea Gilpin
Vice President, IR & Communications
Phone:
514-336-7800, ext. 205
communications@theratech.com
ex-99.49
Exhibit 99.49
News Release
Theratechnologies announces results for the 2010 fiscal year
Montréal, Canada February 9, 2011 - Theratechnologies (TSX: TH) today announced its
financial results for the fiscal year ended November 30, 2010. For reference, the Managements
Discussion and Analysis (MD&A) for the fiscal year 2010 with the associated Audited
Consolidated Financial Statements can be found at www.theratech.com or at www.sedar.com.
2010 Financial Highlights
Receipt of a $25,000,000 milestone payment in November and lower R&D expenditures throughout the
year strengthened the Companys cash position and contributed to record revenues and earnings in
fiscal 2010.
Highlights included:
|
Ø |
|
Consolidated revenue of $31,868,000 |
|
|
Ø |
|
R&D expenses decreased 32% to $14,064,000 |
|
|
Ø |
|
Net profit of $8,930,000 |
|
|
Ø |
|
Cash and bonds of $64,550,000 at fiscal year end. |
2010 was an exceptional year for Theratechnologies, stated Mr. John-Michel T. Huss, President and
CEO of Theratechnologies. Our success in the Food and Drug Administration (FDA) regulatory
process led to the approval of EGRIFTA®, he noted. We now have a solid business and financial
foundation on which to further build the Company, Mr. Huss concluded.
With the receipt of a substantial milestone payment from our partner EMD Serono, we are entering
the new year with a good cash position, said Mr. Luc Tanguay, Senior Executive Vice President &
CFO of Theratechnologies. This year, we expect to receive revenues from sales of the finished
product and royalties of EGRIFTA® in the United States. We also expect the amount of
our expenses for fiscal 2011 to be similar to those of 2010, noted Mr. Tanguay.
Financial Highlights
The financial highlights presented in this press release are taken from the Companys MD&A and
Audited Consolidated Financial Statements which have been prepared in accordance with International
Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board
(IASB). The Companys financial statements were previously prepared in accordance with Canadian
Generally Accepted Accounting Principles (GAAP). For more information regarding the conversion to
IFRS, please refer to the heading Conversion to IFRS of the Companys MD&A and to note 27 of the
Audited Consolidated Financial Statements, which were the Companys first consolidated financial
statements prepared in accordance with IFRS.
For the 12-month period ending November 30, 2010:
Consolidated revenue for the year ended November 30, 2010 was $31,868,000, compared to $17,468,000
in 2009. The increased revenue in 2010 was related to a milestone payment of US$25,000,000
(C$25,000,000) received from EMD Serono on November 30, 2010 associated with the satisfaction of
the condition of approval of EGRIFTA® by the FDA. In fiscal 2009, a payment of
US$10,000,000 (C$10,884,000) was received from EMD Serono following the acceptance by the FDA of
the Companys New Drug Application (NDA) for EGRIFTA® in conformity with the
collaboration and licensing agreement with EMD Serono.
Research and development (R&D) expenses, net of tax credits, amounted to $14,064,000 for the year
ended November 30, 2010 compared to $20,810,000 in 2009, a decrease of 32.4%. The
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
majority of R&D expenses incurred in fiscal 2010 are related to follow-up on work derived from
the regulatory filing with the FDA, notably responding to the FDAs questions, and preparation for
the FDA Advisory Committee meeting. In fiscal 2009, the expenses were principally associated with
completing the Phase 3 clinical trials evaluating tesamorelin in HIV-associated lipodystrophy and
the preparation of the NDA, which was submitted to the FDA in May 2009. The significant decline in
R&D expenses was in accordance with the Companys projected R&D expenses for fiscal 2010.
Cost of Sales
In fiscal 2010, the Company began producing, through its third-party suppliers, inventories in
anticipation of the launch of EGRIFTA® in the United States. Cost of sales in fiscal
2010 related to this activity amounted to $469,000 which includes a charge of $192,000, in order to
value the inventories at their net realizable value. This write-down was due to raw materials that
were not originally bought under the conditions of the Companys current long-term procurement
agreements. Cost of sales also included unallocated costs related to the production fees associated
with the start-up of the manufacturing process.
General and administrative expenses amounted to $8,002,000 for the year ended November 30, 2010,
compared to $6,543,000 for the same period in fiscal 2009. The higher expenses in 2010 are
primarily due to the cost and expenses associated with professional fees for the recruitment of the
new President and Chief Executive Officer, increased corporate communication associated with the
FDA Advisory Committee meeting and FDA approval, and conversion of the financial statements to
IFRS, as well as costs and expenses related to variation in share-based compensation expenses. The
expenses for the year ended November 30, 2009, include the costs associated with the revision of
the Companys three-year business plan which were not repeated in fiscal 2010.
Selling and market development expenses amounted to $2,670,000 for the year ended November 30, 2010
compared to $6,862,000 in fiscal 2009. The selling and market development expenses in fiscal 2010
are principally composed of business development and market research expenses outside the United
States and the costs of managing the agreement with EMD Serono. In fiscal 2009, expenses totaling
$4,269,000 were incurred in connection with professional fees related to the transaction with EMD
Serono.
Net Financial Income
For the year ended November 30, 2010, interest income was $1,562,000 compared to $2,123,000 in
fiscal 2009. The year-over-year decline is due to lower average cash positions and a decrease in
yield on the Companys bond portfolio. Receipt of the $25,000,000 milestone payment from EMD Serono
in November 2010 strengthened the Companys cash position to a level comparable to that of year-end
2009. Finance costs in fiscal 2010 were a gain of $493,000 compared to an expense of $661,000 in
fiscal 2009. Finance costs in fiscal 2010 benefited from a net foreign currency gain of $511,000
compared to a net foreign currency loss of $635,000 in 2009.
Net profit was $8,930,000 for the 2010 fiscal year compared to a net loss of $15,156,000 in 2009.
Financial Position
At November 30, 2010, cash and bonds amounted to $64,550,000, and tax credits and grants receivable
amounted to $332,000, for a total of $64,882,000. The cash flow from operating activities,
excluding changes in operating assets and liabilities, was $11,160,000 for fiscal 2010 compared to
a use of cash of $13,547,000 for the same period in 2009. The cash flow generated in fiscal 2010 is
principally related to payments received under the agreement with EMD Serono as well as decreases
in R&D expenses and in selling and market development expenses.
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical company that discovers and develops
innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor
peptides. Its first product, EGRIFTA® (tesamorelin for injection), was approved by the United
2
States Food and Drug Administration in November 2010. To date, EGRIFTA® is the only approved
therapy for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
EGRIFTA® is currently marketed in the United States by EMD Serono pursuant to a collaboration and
licensing agreement entered into by the Company and EMD Serono in October 2008. In addition, the
Company has signed distribution and licensing agreements with Sanofi-aventis granting them the
exclusive commercialization rights for EGRIFTA® for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy in Latin America, Africa and the Middle East and with
Ferrer granting them the exclusive commercialization rights for EGRIFTA® for the treatment of
excess abdominal fat in HIV-infected patients with lipodystrophy in Europe, Russia, South Korea,
Taiwan, Thailand and certain central Asian countries.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Companys website at
www.theratech.com. Additional information about the Company is also available on SEDAR
at www.sedar.com.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information includes,
but is not limited to, information regarding the preparation and filing of applications seeking
regulatory approval of EGRIFTA® in the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy in various territories outside of the United States, the revenue to be generated
as a result of sales of EGRIFTA® to EMD Serono and the receipt of royalties from EMD Serono in
connection with the sale of EGRIFTA® in the United States. Furthermore, the words will, may,
could, should, outlook, believe, plan, envisage, anticipate, expect and estimate,
or the negatives of these terms or variations of them and the use of future or conditional tenses
as well as similar expressions denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control, that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties are described under the section Risks and
Uncertainties of the MD&A for the year ended November 30, 2010 and include, but are not limited
to, the risk that EGRIFTA® is not approved in all or some of the territories referred to in the
MD&A, the revenue and royalties we expect to generate from sales of EGRIFTA® is lower than
anticipated, the supply of EGRIFTA® to our commercial partners is delayed or suspended as a result
of problems with our suppliers, EGRIFTA® is withdrawn from the market as a result of defects or
recalls, our intellectual property is not adequately protected and our liquidity level decreases
based on unexpected activities that must be carried out in order to achieve our business plan.
Although the forward-looking information contained in this press release is based upon what the
Company believes are reasonable assumptions, investors are cautioned against placing undue reliance
on this information since actual results may vary materially from the forward-looking information
contained in this press release. Certain assumptions made in preparing the forward-looking
information include the assumption that tesamorelin for the reduction of excess abdominal fat in
HIV-infected patients with lipodystrophy will receive approval in the territories referred to in
this press release, no additional clinical studies will be required to obtain said regulatory
approval of tesamorelin, EGRIFTA® will be accepted by the marketplace in the United States and will
be on the list of reimbursed drugs by third-party payers, relations with third-party suppliers of
EGRIFTA® will be conflict-free and that such third-party suppliers will have enough capacity to
manufacture and supply EGRIFTA® to meet its demand and on a timely-basis and that the Companys
business plan will not be substantially modified.
3
Consequently, all of the forward-looking information contained in this press release is qualified
by the foregoing cautionary statements, and there can be no guarantee that the results or
developments that the Company anticipates will be realized or, even if substantially realized, that
they will have the expected consequences or effects on its business, financial condition or results
of operation.
Investors are referred to the Companys public filings available at www.sedar.com. In particular,
further details on these risks and descriptions of these risks are disclosed in the Risks and
Uncertainties section of the Companys MD&A for the year ended November 30, 2010.
-30-
Information:
Andrea Gilpin
Vice President, IR & Communications
Phone: 514-336-7800, ext. 205
communications@theratech.com
Luc Tanguay
Senior Executive Vice President and
Chief Financial Officer
Phone: 514-336-7800, ext. 204
ltanguay@theratech.com
4
ex-99.50
Exhibit 99.50
News Release
Theratechnologies and Ferrer Announce a Distribution & Licensing Agreement for Tesamorelin
in Europe
Montréal, Canada and Barcelona, Spain February 3, 2011Theratechnologies (TSX: TH) and
Ferrer Internacional S.A. (Ferrer) announced today that they have entered into a distribution
and licensing agreement providing Ferrer with the commercialization rights to tesamorelin in
Europe, Russia, South Korea, Taiwan and certain central Asian countries for the treatment of
excess abdominal fat in HIV-infected patients with lipodystrophy. Ferrer is a privately-held
international pharmaceutical company based in Barcelona, Spain, which operates in over 60
countries.
Terms of the Agreement
Under the terms of the agreement, Ferrer will be responsible for conducting all regulatory and
commercialization activities in connection with tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy in the territories subject to the agreement.
Theratechnologies will be responsible for the manufacture and supply of tesamorelin to Ferrer.
Ferrer will purchase tesamorelin at a transfer price equal to the higher of a significant
percentage of the net selling price and a predetermined floor price. Theratechnologies has the
option to co-promote tesamorelin for the reduction of excess abdominal fat in HIV-infected
patients with lipodystrophy in the territories. Theratechnologies has kept all development rights
to tesamorelin for other indications and will be responsible for conducting research and
development for any additional programs. Ferrer has the option to enter into a co-development and
commercialization agreement using tesamorelin relating to any such new indications. The terms and
conditions of such a co-development and commercialization agreement will be negotiated based on
any additional program chosen for development.
With signed partnerships in the major markets, we have met our corporate objectives and have
positioned Theratechnologies extremely well for future growth, commented Mr. John-Michel T.
Huss, President and CEO of Theratechnologies. In 2010, Ferrer had over $1 billion in sales and
was amongst the fastest growing pharmaceutical companies in Europe with a 16% growth rate in
international sales, continued Mr. Huss. Furthermore, Ferrers regulatory expertise has
resulted in many European active registration dossiers which I believe will be an important
driver to the future success of tesamorelin in Europe. Undoubtedly, Ferrers dynamism and strong
collaborative spirit will be important in the commercial success of tesamorelin in these regions.
I am assured that with Ferrer at our side, patients in these territories will have access to
tesamorelin as rapidly as possible, concluded Mr. Huss.
Market trends are clear, said Jordi Ramentol, CEO of Ferrer, the future will be determined by
the ability of new treatments to address unmet clinical needs and tesamorelin is an excellent
example of such an approach. We are excited about this opportunity to sign this agreement with
Theratechnologies for the commercialization of tesamorelin in these territories, commented Mr.
Ramentol. It is also of great pride to
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
be able to offer tesamorelin, upon approval, to healthcare professionals and patients,
concluded Mr. Ramentol.
Conference Call and Webcast
The Company will hold a conference call and webcast February 3 at 8:30 a.m. to discuss this
strategic agreement. To participate, please dial: 1-416-981-9017 or 1-800-738-1032 (toll free).
Please dial-in five minutes prior to the teleconference in order to ensure your participation.
The webcast will be available on the Companys website at http://www.theratech.com or at
http://www.gowebcasting.com/2192. A replay of the conference call will be available from 10:30
a.m. today, February 3, 2011, until February 17, 2011 at 11:59 p.m. at the following number:
1-416-626-4100, pass code 21510203# or 1-800-558-5253, pass code 21510203#. The webcast will be
posted for 15 days at the link indicated above.
About tesamorelin
Tesamorelin is an analogue of the human growth hormone releasing factor (GRF) shown to reduce
excess abdominal fat in HIV-infected patients with lipodystrophy. GRF is a hypothalamic peptide
that acts on the pituitary cells in the brain to stimulate the synthesis and release of
endogenous growth hormone. Tesamorelin is approved for sale for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy in the United States alone and in no
other country, including Canada. Tesamorelin is being exclusively commercialized in the United
States by EMD Serono under the brand name EGRIFTA®.
About HIV-Associated Lipodystrophy
Several factors, including a patients antiretroviral drug regimen and the HIV virus itself, are
thought to contribute to HIV-associated lipodystrophy, which is characterized by body
composition changes. The changes in body composition may include accumulation of excess
abdominal fat accumulation, which is known as abdominal lipohypertrophy.
About Theratechnologies
Theratechnologies (TSX:TH) is a biopharmaceutical company that discovers and develops innovative
therapeutic products, with an emphasis on peptides. The Company targets unmet medical needs in
specialty markets where its commercialization strategy is to retain all or part of the
commercial rights to its products. Its most advanced compound, tesamorelin, an analogue of the
human growth hormone releasing factor, was recently approved by the U.S. Food and Drug
Administration as the only treatment for excess abdominal fat in HIV-infected patients with
lipodystrophy. Tesamorelin is being exclusively commercialized in the United States by EMD
Serono for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
under the brand name EGRIFTA®. Theratechnologies granted the exclusive distribution rights to
tesamorelin in Latin America, Africa and the Middle East to sanofi-aventis for the treatment of
excess abdominal fat in HIV-infected patient with lipodystrophy.
For more information on Theratechnologies, please visit www.theratech.com
About Grupo Ferrer
Grupo Ferrer is a privately-held European R&D-based pharmaco-chemical and medical device company
headquartered in Barcelona, Spain. Founded in 1959, the
2
group encompasses today 45 companies developing its activities in Europe, Latin America, Africa,
Middle East, Asia and the United States. In total, Ferrers human healthcare products are being
commercialized in 93 countries through 26 direct subsidiaries (including Joint Ventures) and 70
partners and distributors.
Ferrer carries out activities throughout the full value chain of the pharma business, from R&D
to international marketing, including fine chemicals development and both raw material and
pharmaceutical product manufacturing. For this purpose, Ferrer Grupo has research centres in
Spain and Germany, as well as manufacturing sites in Europe and Latin America.
Ferrers regulatory expertise has resulted in more than 400 active registration dossiers in
Europe, including high added-value products for orphan and life-threatening diseases.
The aim of Ferrers corporate strategy is to establish alliances and long-term relationships
with biotechnology and pharmaceutical companies within its strategic therapeutic areas. The
company holds a long track record of agreements signed with big multinationals as well as with
medium size pharmaceutical companies and small biotech or R&D base companies.
Ferrer also has in its portfolio a range of products that provide an excellent level of synergy
with tesamorelin. In the area of HIV, the company currently commercializes Targretin
(bexarotene) and Panretin (alitretinoin), in respiratory, Oslif (indacaterol) for COPD and
Aeriseal for emphysema, and various products in metabolism (diabetes, bone metabolism and
dyslipidemias). The company has experience with high value-added products, for very specific
indications (i.e., Remodulin for PPH) that may have specific requirements in terms of
administration (injectables, subcutaneous pumps, etc.) and that require a cold chain
distribution (i.e. Aeriseal).
For more information on Ferrer, please visit www.ferrergrupo.com.
Theratechnologies Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information
includes, but is not limited to, information regarding the growth of Theratechnologies, the
regulatory approval of tesamorelin for the reduction of excess abdominal fat in HIV-infected
patients with lipodystrophy in Europe and in the other territories mentioned herein, and the
commercialization of tesamorelin in Europe.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. The assumptions used in making such forward-looking information include, among
others, that regulatory agencies in countries outside of the United States will approve
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy, and that Ferrer will be successful in the commercialization of tesamorelin in
Europe for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
These risks and uncertainties include, but are not limited to: the risk that tesamorelin is not
approved by regulatory agencies outside of the United States, or even if approved, the risk that
3
tesamorelin is not accepted by the marketplace where it will be commercialized and as such,
results in weak sales of the product which may impact the Companys growth.
The Company refers potential investors to the Risks and Uncertainties section of its Annual
Information Form (the AIF) dated February 23, 2010. The AIF is available at www.sedar.com under
the Companys public filings. The reader is cautioned to consider these and other risks and
uncertainties carefully and not to put undue reliance on forward-looking statements.
Forward-looking information reflects current expectations regarding future events and speaks only
as of the date of this press release and represents the Companys expectations as of that date.
-30-
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Theratechnologies Contact:
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Ferrer Contact: |
Andrea Gilpin
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María Real Bela |
Vice President, IR & Communications
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Accounts Director |
Theratechnologies Inc.
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Phone: +34 91. 411.13.47 |
Phone: 514-336-7800 x 205
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mariareal@cariotipomh5.com |
communications@theratech.com |
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4
ex-99.51
Exhibit 99.51
News Release
FOR IMMEDIATE RELEASE
Attention Business/Financial Editors and Analysts
Notice of Conference Call:
Theratechnologies Announces a Partnership Agreement
Montréal, Canada February 2, 2011 Theratechnologies (TSX:TH) advises of an upcoming
conference call and webcast to discuss the signing of a partnership agreement for tesamorelin.
The call will be moderated by Dr. Andrea Gilpin, Vice President, IR & Communications, at
Theratechnologies. Mr. John-Michel T. Huss, President and CEO, will lead the call and Mr. Luc
Tanguay, Senior Executive Vice President and Chief Financial Officer, will also be
participating.
The conference call will take place tomorrow, Thursday, February 3, at 8:30 a.m. (Eastern
Standard Time). Prior to the call, a press release will be issued at approximately 8:00 a.m.
February 3, 2011 Conference Call and Webcast
For the conference call, interested participants are asked to dial the following numbers:
1-416-981-9017 or 1-800-738-1032 (toll free). Please call five minutes prior to the conference
in order to ensure your participation. You can access the webcast at the following links:
http://www.gowebcasting.com/2192 and www.theratech.com.
A replay of the conference call will be available from February 3, 2011 at 10:30 a.m. to
February 17, 2011 at 11:59 p.m. at the following number: 416-626-4100, pass code 21510203 or
1-800-558-5253, code 21510203 #. The webcast will be posted for 15 days at the following links:
http://www.gowebcasting.com/2192 and www.theratech.com.
About Theratechnologies
Theratechnologies (TSX:TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides. The Company targets unmet medical
needs in specialty markets where its commercialization strategy is to retain all or part of the
commercial rights to its products. Its most advanced compound, tesamorelin, an analogue of the
human growth hormone releasing factor, was recently approved by the U.S. Food and Drug
Administration as the only treatment for excess abdominal fat in HIV-infected patients with
lipodystrophy. Tesamorelin is being exclusively commercialized in the U.S. by EMD Serono under
the brand name EGRIFTA® for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy. Theratechnologies granted the exclusive distribution rights to tesamorelin in
Latin America, Africa and the Middle East to sanofi-aventis for the treatment of excess
abdominal fat in HIV-infected patient with lipodystrophy.
Contact:
Andrea Gilpin
VP, IR & Communications
Theratechnologies Inc.
514 336-7800, ext. 205
communications@theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2A4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
ex-99.52
Exhibit 99.52
News Release
THERATECHNOLOGIES ANNOUNCES A DISTRIBUTION AND LICENSING AGREEMENT FOR
EGRIFTA® IN LATIN AMERICA, AFRICA AND THE MIDDLE
EAST WITH SANOFI-AVENTIS
Montréal, Canada December 6, 2010 Theratechnologies (TSX: TH) announced today that a
distribution and licensing agreement was signed with sanofi-aventis (Sanofi), for the
commercialization rights to EGRIFTA® (tesamorelin for injection) in Latin America,
Africa and the Middle East for the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy.
Terms of the Agreement
Under the terms of the Agreement, Theratechnologies will be responsible to supply
EGRIFTA® to Sanofi. Sanofi will buy EGRIFTA® from Theratechnologies at an
undisclosed selling price. Theratechnologies has kept all future development rights to
EGRIFTA® and will be responsible for conducting research and development for any
additional programs. Sanofi will be responsible to conduct all regulatory activities in the
aforementioned territories in connection with EGRIFTA® for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy, including seeking the approval of
EGRIFTA® in the different countries. Theratechnologies granted Sanofi an option to
commercialize EGRIFTA® in the aforementioned countries for other uses.
Having worked in the sanofi-aventis group for the last 11 years, I am confident that this
collaboration will be a strong and fruitful one for both of us. Building long-lasting mutually
beneficial relationships will be a key to success for Theratechnologies. This is another critical
step towards bringing value to our shareholders and further demonstrates our ability to execute
our business plan, commented Mr. John-Michel T. Huss, President and CEO of Theratechnologies.
Sanofis strong foothold and knowledge in these countries are invaluable assets to lead the
submission process to the various regulatory agencies. Moreover, Sanofis extensive
commercialization experience, which I know of first-hand, will be an important aspect of
providing market access to EGRIFTA® as rapidly as possible, concluded Mr. Huss.
The structure of this agreement clearly emphasizes that we believe strongly in the potential of
EGRIFTA® in these territories, noted Mr. Luc Tanguay, Senior Executive Vice
President and CFO of Theratechnologies. This transaction is structured for Theratechnologies to
receive a fair percentage of the selling price which will have a direct effect on our recurring
revenues, and on the bottom-line, as we do not need to directly increase our expenses in order to
achieve these revenues, concluded Mr. Tanguay.
Conference Call and Webcast
The Company will hold a conference call and webcast today at 8:30 a.m. to discuss this strategic
agreement. To participate, please dial: 1-416-981-9000 or 1-800-785-6380 (toll free). Please
dial-in five minutes prior to the teleconference in order to ensure your participation. The
webcast will be available on the Companys website at http://www.theratech.com and at
http://www.gowebcasting.com/2144.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
A replay of the conference call will be available from 10:30 a.m. today, December 6, 2010,
until December 20, 2010, at 11:59 p.m. at the following number: 1-416-626-4100, pass code
21495399# or 1-800-558-5253, pass code 21495399#. The webcast will be posted for 15 days at the
link indicated above.
About EGRIFTA®
EGRIFTA®(tesamorelin for injection) is a synthetic analogue of the human growth hormone
releasing factor (GRF) shown to reduce visceral fat in HIV-infected patients with excess
abdominal fat associated with lipodystrophy. GRF is a hypothalamic peptide that acts on the
pituitary cells in the brain to stimulate the synthesis and release of endogenous growth
hormone. EGRIFTA® is approved for sale in the United States only.
About HIV-Associated Lipodystrophy
Several factors, including a patients antiretroviral drug regimen and the HIV virus itself, are
thought to contribute to HIV-associated lipodystrophy, which is characterized by body
composition changes. The changes in body composition may include excess abdominal fat
accumulation, which is known as abdominal lipohypertrophy.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides. The Company targets unmet medical
needs in specialty markets where it can retain all or part of the commercial rights to its
products. Its most advanced product, tesamorelin, an analogue of the human growth hormone
releasing factor, was recently approved by the U.S. Food and Drug Administration as the first
and only treatment for excess abdominal fat in HIV-infected patients with lipodystrophy.
Tesamorelin is being exclusively commercialized in the U.S. by EMD Serono under the brand name
EGRIFTA®.
For more information, please visit www.theratech.com
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes
therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris
(EURONEXT: SAN) and in New York (NYSE: SNY).
For more information on Sanofi-aventis, visit http://www.sanofi-aventis.com
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information
includes, but is not limited to: information regarding the growth of Theratechnologies.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. The assumptions made include, among others, that regulatory agencies in countries
outside of the United States will also approve EGRIFTA®, and that Sanofi will be successful in
commercializing
2
EGRIFTA® in the territories outlined in this press release. These risks and uncertainties
include, but are not limited to: the risk that EGRIFTA® is not approved by regulatory agencies
outside of the United States, or the risk that the commercialization efforts for EGRIFTA® do not
result in the expected growth of the Company.
The Company refers potential investors to the Risks and Uncertainties section of its Annual
Information Form (the AIF) dated February 23, 2010. The AIF is available at www.sedar.com
under the Companys public filings. The reader is cautioned to consider these and other risks
and uncertainties carefully and not to put undue reliance on forward-looking statements.
Forward-looking information reflects current expectations regarding future events and speaks
only as of the date of this press release and represents the Companys expectations as of that
date.
-30-
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514-336-7800 x 205
communications@theratech.com
3
ex-99.53
Exhibit 99.53
News Release
FOR IMMEDIATE RELEASE
Attention Business/Financial Editors and Analysts
NOTICE OF CONFERENCE CALL & MEDIA ADVISORY
THERATECHNOLOGIES ANNOUNCES A PARTNERSHIP AGREEMENT
Montréal, Canada December 5, 2010 Theratechnologies (TSX:TH) advises of an upcoming
conference call and webcast to discuss the signing of a partnership agreement for
EGRIFTA®. The call will be moderated by Dr. Andrea Gilpin, Vice President, IR &
Communications, at Theratechnologies. Mr. John-Michel T. Huss, President and CEO, will lead the
call and Mr. Luc Tanguay, Senior Executive Vice President and Chief Financial Officer, will also
be participating.
The conference call will take place tomorrow, Monday, December 6, at 8:30 a.m. (Eastern Standard
Time). Prior to the call, a press release will be issued at approximately 8:00 a.m.
December 6, 2010 Conference Call and Webcast
For the conference call, interested participants are asked to dial the following numbers:
1-416-981-9000 or 1-800-785-6380 (toll free). Please call five minutes prior to the conference
in order to ensure your participation. You can access the webcast at the following links:
http://www.gowebcasting.com/2144 and www.theratech.com.
A replay of the conference call will be available from December 6, 2010 at 10:30 a.m. to
December 20, 2010 at 11:59 p.m. at the following number: 416-626-4100, pass code 21495399 or
1-800-558-5253, code 21495399 #. The webcast will be posted for 15 days at the following links:
http://www.gowebcasting.com/2144 and www.theratech.com.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides. The Company targets unmet medical
needs in specialty markets where it can retain all or part of the commercial rights to its
products. Its most advanced product, tesamorelin, an analogue of the human growth hormone
releasing factor, was recently approved by the U.S. Food and Drug Administration as the first
and only treatment for excess abdominal fat in HIV-infected patients with lipodystrophy.
Tesamorelin is being exclusively commercialized in the U.S. by EMD Serono under the brand name
EGRIFTA®.
Contact:
Andrea Gilpin
VP, IR & Communications
Theratechnologies Inc.
514 336-7800, ext. 205
communications@theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2A4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
ex-99.54
Exhibit 99.54
Theratechnologies plans early adoption of International Financial Reporting Standards
Montréal, Canada December 2, 2010 Theratechnologies Inc. (the Company) (TSX: TH) announced
today that it has been granted exemptive relief from the Canadian securities regulatory authorities
to prepare its November 30, 2010 financial statements in accordance with International Financial
Reporting Standards (IFRS) with a transition date of December 1, 2008: two financial years ahead
of the mandatory conversion date for Canadian public companies. The comparative year ended November
30, 2009 will be restated from Canadian Generally Accepted Accounting Principles (GAAP) to IFRS.
IFRS Conversion Plan
The Company has established a formal project plan and a detailed timetable to manage the
transition. It has also allocated substantial internal resources and is working with its auditors
to ensure a timely and accurate conversion. The conversion project is being monitored by senior
members of the finance team which report regularly to the Audit Committee and the Board of
Directors the progress of the convergence project through communication and meetings. As a result
of the training program and the analysis of the differences between IFRS and Canadian GAAP
affecting the Company, the Company believes that its applicable personnel have obtained an
appropriate understanding of IFRS as it applies to the Companys financial reporting. While new
controls are being put into place to address certain unique IFRS accounting and disclosure
requirements, the Company does not anticipate comprehensive changes to its current accounting and
consolidation systems, its internal controls nor its disclosure control process as a result of the
conversion to IFRS.
Impact of Adoption of IFRS
IFRS are premised on a conceptual framework similar to Canadian GAAP, although significant
differences exist in certain matters of recognition, measurement and disclosure. The adoption of
IFRS will not have an impact on the Companys reported net cash flows, nor will it have a material
impact on its consolidated balance sheet and its statement of operations. The Company currently
expects that the only significant impact of all of the differences on its December 1, 2008 opening
balance sheet under IFRS compared to its November 30, 2008 balance sheet under Canadian GAAP will
be in a credit to contributed surplus of approximately $200,000 with the offset to retained
earnings.
First-time Adoption of IFRS
The adoption of IFRS requires the application of IFRS 1, First-time Adoption of International
Financial Reporting Standards (IFRS 1), which provides guidance for an entitys initial adoption
of IFRS. IFRS 1 generally requires retrospective application of IFRS as effective at the end of its
first annual IFRS reporting period. However, IFRS 1 also provides for certain optional exemptions
and mandatory exceptions to this retrospective treatment. The only optional exemption available
under IFRS 1 which the Company expects to apply in preparation of its first financial statements
under IFRS is with respect to IFRS 2, Share-based payments (IFRS 2). IFRS 2 encourages
application of IFRS 2, Share based payments provisions to equity instruments granted on or before
November 7, 2002, but permits the application only to equity instruments granted after November 7,
2002 that had not vested by the transition date. The Company will apply IFRS 2 only to equity
instruments granted after November 7, 2002 that had not vested by the date of transition.
Further optional exemptions are provided under IFRS 1. However, these exemptions will not impact
our adoption of IFRS. Hindsight is not permitted to create or revise estimates. Estimates
previously made by the Company under Canadian GAAP cannot be revised for the application of IFRS
except where necessary to reflect any difference in accounting policies.
Impact of IFRS on the Companys Financial Statements
The adoption of IFRS will result in some changes to the Companys accounting policies that are
applied in the recognition, measurement and disclosure of balances and transactions in its
financial statements. However, based on its evaluation to date, the Company does not expect any
changes to its accounting policies that would result in significant changes to line items within
its financial statements.
The following provides a summary of the Companys evaluation of potential changes to accounting
policies in key areas:
IFRS 2, Share-based Payments (IFRS 2)
Under IFRS, when stock option awards vest gradually, each tranche is to be considered as a separate
award, while under Canadian GAAP, companies can make a policy choice to consider gradually vested
tranches as a single award. Similarly, the IFRS standard requires that forfeiture estimates be
established at the time of the initial fair value assessment of share-based payments rather than to
account for the forfeitures as they occur. Therefore, the compensation expense will have to be
recognized over the expected term of each tranche and take into account the impact of the
differences in accounting for forfeitures. The Company has performed its preliminary calculation
and concluded that a reclassification adjustment between equity captions of approximately $200,000
will be recorded at the transition date.
IAS 36, Impairment (IAS 36)
Under Canadian GAAP impairment standards for non-financial assets, a write-down to estimated fair
value is recognized if the estimated undiscounted future cash flows from an asset or group of
assets are less than their carrying value. IAS 36 requires a write-down to be recognized if the
recoverable amount, determined as the higher of the estimated fair value less costs to sell or
value in use is less than carrying value. The Company has performed impairment testing as of
December 1, 2008 and has concluded that there is no impairment charge under IFRS. No impairment
indicators were identified for the period between the transition date and November 30, 2009. IAS 36
also permits the reversal of certain impairment charges where conditions have changed. The Company
reviewed past impairment charges and concluded that there was no justification for reversal of past
impairment charges.
IAS 1, Presentation of Financial Statement (IAS 1)
Financial statement presentation is addressed in conjunction with the related IFRS standards.
Certain additional disclosures will be required in the notes to the financial statements and the
statement of operations will be modified to reflect a presentation by function. The Company is
currently working on preliminary IFRS financial statements in accordance with IAS 1, Presentation
of Financial Statements which will be completed in the last quarter of 2010.
Other Standards
Based on the results of the comparative analysis of the current IFRS with Canadian GAAP, the
Company has also completed its assessment of the following standards and determined that, other
than enhanced disclosures, no material adjustments would result regarding:
Property plant and equipment
Leases
Revenue recognition
Provisions, contingent assets and contingent liabilities
Foreign exchange
Intangible assets
Inventories
Employee benefits
The Company is in the process of completing its analysis of the few remaining potential differences
identified, but does not expect material adjustments to be required.
The Company continues to assess the aggregate effect of adopting IFRS, and the relevant changes in
accounting policies. Key milestones for the remainder of the year which are in line with the
Companys plan include:
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Documenting and embedding changes to systems, business processes and internal
controls, as required; |
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Completion of the opening transition balance sheet; |
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Preparation of detailed reconciliations of Canadian GAAP to IFRS financial
statements; |
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Continued training programs for the Companys finance team and other affected
parties, as necessary; |
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Audit Committee approval of IFRS financial statements and Management Discussion and
Analysis; and |
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Restate under IFRS previous interim financial statements and associated Management
Discussion and Analysis filed in 2010. |
Subsequent Disclosures
Further disclosures of the IFRS transition process will be presented in:
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the Companys Managements Discussion and Analysis for the interim reporting period
for the third-quarter ended August 31, 2010 which will include the quantitative
information regarding the impact of adopting IFRS on key line items in the interim
financial statements, and in the Companys Managements Discussion and Analysis for the
annual reporting period for the year ending November 30, 2010 which will include the
quantitative information regarding the impact of adopting IFRS on key line items in the
annual financial statements; |
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the Companys first financial statements prepared in accordance with IFRS for the
year ending November 30, 2010, which will include notes disclosing transitional
information and disclosure of new accounting policies under IFRS. The annual financial
statements for year ending November 30, 2010 will also include the restated 2009
financial statements for the comparative period, adjusted to comply with IFRS. |
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides. The Company targets unmet medical
needs in specialty markets where it can retain all or part of the commercial rights to its
products. Its most advanced product, tesamorelin, an analogue of the human growth hormone releasing
factor, was recently approved by the U.S. Food and Drug Administration as the first and only
treatment indicated to reduce excess abdominal fat in HIV-infected patients with lipodystrophy.
Tesamorelin is being exclusively commercialized in the U.S. by EMD Serono under the brand name
EGRIFTA®.
For more information, please visit www.theratech.com.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Companys website at
www.theratech.com. Additional information, including the Annual Information Form and the Annual
Report, is also available on SEDAR at www.sedar.com.
Forward-Looking Information
Forward-looking statements in this press release include information being provided to allow
investors and others to obtain a better understanding of the Companys IFRS transition plan and the
resulting possible effects on its financial statements. This information includes statements about
the timeline for the Companys conversion to IFRS, the Companys readiness to transition from
current Canadian GAAP to IFRS, and the impact of the conversion to IFRS on the Companys accounting
policies, financial reporting, accounting systems and business processes. Certain information set
forth in this news release may contain forward-looking statements that involve substantial known
and unknown risks and uncertainties. These forward-looking statements are subject to numerous risks
and uncertainties, certain of which are beyond the control of the Company, including, but not
limited to, the impact of general economic conditions, industry conditions, risks associated with
the uncertainty of clinical trials and results, currency fluctuations, dependence upon regulatory
approvals, the uncertainty of obtaining additional financing , research and development risks, and
comprehensive changes to its current accounting and consolidation systems, its internal controls,
and its disclosure control process as a result of the conversion to IFRS. Readers are cautioned
that the assumptions used in the preparation of such information, although considered reasonable at
the time of preparation, may prove to be imprecise and, as such, undue reliance should not be
placed on forward-looking statements.
The Company refers potential investors to the Risks and Uncertainties section of its Annual
Information Form (the AIF) dated February 23, 2010. The AIF is available at www.sedar.com under
the Companys public filings. The reader is cautioned to consider these and other risks and
uncertainties carefully and not to put undue reliance on forward-looking statements.
Forward-looking information reflects current expectations regarding future events and speaks only
as of the date of this press release and represents the Companys expectations as of that date.
ex-99.55
Exhibit 99.55
News Release
THERATECHNOLOGIES WELCOMES THE ARRIVAL OF ITS
NEW PRESIDENT AND CEO
Montréal, Canada December 1, 2010 Theratechnologies (TSX: TH) announced today that Mr.
John-Michel T. Huss has assumed his responsibilities as the new President and Chief Executive
Officer of Theratechnologies.
This will be a stimulating change for me and I am very much looking forward to working with the
Theratechnologies team and using my experience to advance the Company towards becoming a
sustainable biotechnology company, commented Mr. Huss, President and Chief Executive Officer of
Theratechnologies. My goal in the coming weeks will be to get to know the team and review the
business plan, with the intention of meeting the investment community early next year, he
concluded.
We are excited about Johns arrival and the Board is committed to supporting him during this
transition period to ensure all goes smoothly, commented Mr. Paul Pommier, Chairman of the
Board of Directors of Theratechnologies. As a proven leader with considerable experience in
marketing, commercialization and business development, John has an impressive track record of
producing results, continued Mr. Pommier. Were confident that John, together with his
extensive business development experience and our strong management team, will be able to
maximize Theratechnologies revenues, and in so doing, take the Company to the next level which
should benefit all of our stakeholders, concluded Mr. Pommier.
Previously, Mr. Huss was Chief of Staff, Office of the CEO, of sanofi-aventis in Paris. Mr. Huss
has over 20 years experience in the pharmaceutical industry in various international positions
and was responsible for various disease areas including diabetes and metabolism. Mr. Huss began
his career in 1990, at Merck & Co., Inc., primarily in sales and marketing in the U.S., Germany
and Switzerland. In 1996, he was offered a position with F. Hoffman-La Roche as an International
Product Manager at their Basel headquarters in Switzerland. In 1999, he joined Sanofi-Synthelabo
GmbH, as Business Unit Director and held various positions of increasing responsibility in
marketing and sales. He became General Manager in Switzerland in 2007. During his tenure at
sanofi-aventis (Sanofi-Synthelabo merged with Aventis in 2004), he held positions in Germany,
Canada, Switzerland and France. Mr. Huss completed his first university degree in Applied
Linguistics in Germany and then received a MBA in the U.S., specializing in International
Business.
Conference Call and Webcast
The Company will hold a conference call and webcast on Wednesday, December 1 at 10:30 a.m. to
discuss Mr. Huss arrival at Theratechnologies. To participate, please dial: 1-416-981-9000 or
1-800-785-6380 (toll free). Please dial-in five minutes prior to the teleconference in order to
ensure your participation. The webcast will be available on the Companys website at
http://www.theratech.com or at http://www.gowebcasting.com/2139. A replay of the conference call
will be available from 12:30 p.m. today, December 1, 2010, until December 16, 2010 at 11:59 p.m.
at the following number: 1-416-626-4100, pass code 21493110# or 1-800-558-5253, pass code
21493110#. The webcast will be posted for 15 days at the links indicated above.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides. The Company targets unmet medical
needs in specialty markets where it can retain all or part of the commercial rights to its
products. Its most advanced product, tesamorelin, an analogue of the human growth hormone
releasing factor, was recently approved by the U.S. Food and Drug Administration as the first
and
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
only treatment indicated to reduce excess abdominal fat in HIV-infected patients with
lipodystrophy. Tesamorelin is being exclusively commercialized in the U.S. by EMD Serono under
the brand name EGRIFTA®.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information
includes, but is not limited to: information regarding the growth of Theratechnologies.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. The assumptions made include, among others, that regulatory agencies in countries
outside of the United States will also approve EGRIFTA®, and that the Company will
be successful in commercializing EGRIFTA®. These risks and uncertainties include,
but are not limited to: the risk that EGRIFTA® is not approved by regulatory
agencies outside of the United States, or the risk that the commercialization efforts for
EGRIFTA® do not result in the expected growth of the Company.
The Company refers potential investors to the Risks and Uncertainties section of its Annual
Information Form (the AIF) dated February 23, 2010. The AIF is available at www.sedar.com
under the Companys public filings. The reader is cautioned to consider these and other risks
and uncertainties carefully and not to put undue reliance on forward-looking statements.
Forward-looking information reflects current expectations regarding future events and speaks
only as of the date of this press release and represents the Companys expectations as of that
date.
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514-336-7800 x 205
communications@theratech.com
2
ex-99.56
Exhibit 99.56
News Release
FDA Approves EGRIFTA® (tesamorelin for injection): The First and Only
Treatment for the Reduction of Excess Abdominal Fat in HIV-Infected Patients with Lipodystrophy
Clinical Trials Demonstrate Reduction in VAT and Waist Circumference
Important Milestone Payments To Be Received
Montréal, Canada November 11, 2010 - Theratechnologies (TSX: TH) announced today that the U.S.
Food and Drug Administration (FDA) has approved EGRIFTA® (tesamorelin for injection)
as the first and only treatment indicated to reduce excess abdominal fat in HIV-infected patients
with lipodystrophy (abdominal lipohypertrophy). EGRIFTA®(tesamorelin for injection) was developed
by Theratechnologies and will be exclusively commercialized in the U.S. by EMD Serono, Inc. (EMD
Serono), an affiliate of Merck KGaA, of Darmstadt, Germany, under the terms of a collaboration and
licensing agreement.
There are limitations of use associated with EGRIFTA® (tesamorelin for injection). Since the
long-term cardiovascular safety and potential long-term cardiovascular benefit of EGRIFTA®
(tesamorelin for injection) treatment have not been studied and are not known, careful
consideration should be given whether to continue EGRIFTA® (tesamorelin for injection) treatment in
patients who do not show a clear efficacy response as judged by the degree of reduction in visceral
adipose tissue (VAT) measured by waist circumference (WC) or CT scan. EGRIFTA® (tesamorelin for
injection) is not indicated for weight loss management (weight neutral effect). There are no data
to support improved compliance with antiretroviral therapies in HIV-positive patients taking
EGRIFTA® (tesamorelin for injection).
Theratechnologies is very pleased to receive marketing approval for EGRIFTA® from the
FDA. We are one of the very few Canadian biotechnology companies to have successfully discovered,
developed and brought a drug to the market on our own. This milestone represents a significant
achievement which will benefit both patients and our shareholders, commented Yves Rosconi,
President and CEO of Theratechnologies.
We are confident that EMD Serono will successfully commercialize EGRIFTA® in the United States,
given their track record and expertise with other metabolic disorders, noted Paul Pommier,
Chairman of the Board of Directors of Theratechnologies. Theratechnologies will continue to focus
on signing partnerships outside of the United States in order to access additional markets for
EGRIFTA® in HIV-infected patients with excess abdominal fat associated with lipodystrophy, Mr.
Pommier concluded.
While antiretroviral therapy is extremely important in the management of patients with HIV
infection, some patients are experiencing excess abdominal fat associated with lipodystrophy, which
can be difficult to manage, said Fereydoun Firouz, President and CEO, EMD Serono. EMD Serono has
maintained a commitment to advancing science and medicine in this area of unmet medical need, and
it will continue to remain a focus for the organization. We are committed to making a difference in
peoples lives, and look forward to making EGRIFTA® available for patients as soon as possible.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: (514) 336-7800 Fax: (514) 336-7242 www.theratech.com
In 2008, Theratechnologies entered into a collaboration and licensing agreement with EMD
Serono, for the exclusive commercialization rights to EGRIFTA® (tesamorelin for injection) in
the United States for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy. Under the terms of this agreement, the FDA marketing approval is associated
with milestone payments totaling US$25 million (approximately CAN$25 million). EGRIFTA® is the
proposed brand name to be used globally.
The efficacy and safety of EGRIFTA® (tesamorelin for injection) was evaluated in two Phase 3
multi-center, randomized, double-blind, placebo-controlled clinical trials, which demonstrated
statistically significant decreases in VAT and WC versus placebo in HIV-infected patients who
suffer from excess abdominal fat associated with lipodystrophy.
The FDA has requested the following three post-marketing requirements: a long-term
observational safety study for tesamorelin acetate (EGRIFTA®), a single vial formulation the
development of a new presentation of the same formulation, and a clinical trial to assess
whether EGRIFTA® (tesamorelin for injection) has an impact on diabetic retinopathy in diabetic
HIV-infected patients with lipodystrophy and excess abdominal fat.
Having a FDA-approved treatment available for this condition is an important goal for the HIV
population, said Steven Grinspoon, M.D., Professor of Medicine at Harvard Medical School,
Director of the Massachusetts General Hospital Program in Nutritional Metabolism, and lead
investigator for EGRIFTA®(tesamorelin for injection) trials in the U.S. Although lifestyle
modification could be a valuable first step for HIV patients with abdominal fat accumulation,
results to date from lifestyle and exercise studies have been inconsistent with respect to the
reduction in abdominal lipohypertrophy. Until today, physicians did not have access to
approved drug options to treat this complication, added Dr. Grinspoon. Having been involved
in the clinical development of EGRIFTA® over the past 7 years, I am pleased that we have
published data demonstrating that EGRIFTA® reduces VAT, with no adverse effects on
subcutaneous adipose tissue. It is also important to monitor IGF-1 levels and impaired glucose
tolerance in patients receiving EGRIFTA®. I am encouraged that, for the first time, patients
in the United States with this serious condition will have a FDA-approved treatment option
available to them, concluded Dr. Grinspoon.
About EGRIFTA® (tesamorelin for injection) Phase 3 Trials
The FDA approval of EGRIFTA® (tesamorelin for injection) was based on two multi-center,
randomized, double-blind, placebo-controlled Phase 3 studies consisting of a 26-week main
phase and a 26-week extension phase of 816 HIV-infected patients with excess abdominal fat
associated with lipodystrophy.
The primary endpoint of the 26-week main phase was the percent change in VAT from baseline, as
assessed by computed tomography (CT) scan at the L4-L5 vertebral level.
In both Phase 3 studies, patients received either EGRIFTA® (tesamorelin for injection) or
placebo for 26 weeks. Patients initially randomized to EGRIFTA® (tesamorelin for injection)
were then re-randomized to receive either EGRIFTA® (tesamorelin for injection) or placebo for
an additional 26-week treatment period, whereas patients receiving placebo were switched to
EGRIFTA® (tesamorelin for injection). In the first study, at baseline, mean VAT was 178
cm2 for the patients who received EGRIFTA® (tesamorelin for injection) and was 171
cm2 for the patients who received placebo. In the second study, at baseline, mean
VAT was 186 cm2 for the patients who received EGRIFTA® (tesamorelin for injection)
and was 195 cm2 for the patients who received placebo. Patients treated with
2
EGRIFTA® (tesamorelin for injection) experienced a statistically significant least-squares mean
decrease from baseline in VAT of 27 cm2 compared to an increase of 4 cm2 for
patients on placebo [(95% CI for the mean treatment difference of -31 cm2 (-39
cm2, -24 cm2)] in the first study, and a statistically significant decrease
from baseline in VAT of 21 cm2 compared to no change in VAT for patients on placebo
[(95% CI for the mean treatment difference of -21 cm2 (-29 cm2, -12
cm2)] in the second study during the 26-week main phase. This represents a statistically
significant least-squares mean decrease from baseline in VAT of 18% for patients treated with
EGRIFTA® (tesamorelin for injection) compared to an increase of 2% for patients on placebo [(95% CI
for the mean treatment difference of -20% (-24%, -15%)] in the first study, and a statistically
significant decrease from baseline of 14% for patients treated with EGRIFTA®(tesamorelin for
injection) compared to a decrease of 2% for patients on placebo [(95% CI for the mean treatment
difference of -12% (-16%, -7%)] in the second study during the 26-week main phase.
In the first study, at baseline, mean waist circumference was 104 cm for the patients who received
EGRIFTA® (tesamorelin for injection) and was 105 cm for the patients who received placebo. In the
second study, at baseline, mean waist circumference was 105 cm for the patients who received
EGRIFTA® (tesamorelin for injection) and for the patients who received placebo. Treatment with
EGRIFTA® (tesamorelin for injection) resulted in a statistically significant least-squares mean
decrease from baseline in waist circumference of -3 cm compared to a decrease of -1 cm for patients
on placebo [(95% CI for the mean treatment difference of -2 cm (-2.8 cm, -0.9 cm)] in the first
study, and a statistically significant decrease from baseline of -2 cm compared to a decrease of -1
cm for patients on placebo [(95% CI for the mean treatment difference of -1 cm (-2.5 cm, -0.3 cm)]
in the second study during the 26-week main phase. The decreases in VAT and waist circumference
observed after 26 weeks of treatment were sustained in patients who received EGRIFTA® (tesamorelin
for injection) over 52 weeks.
Important Risk Information
EGRIFTA® (tesamorelin for injection) is contraindicated in women who are pregnant, in patients with
disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary
tumor/surgery, head irradiation or head trauma, in patients with known hypersensitivity to
tesamorelin and/or mannitol (excipient) and in patients with active malignancies (either newly
diagnosed or recurrent). Any preexisting malignancy should be inactive and its treatment complete
prior to instituting therapy with EGRIFTA® (tesamorelin for injection). If pregnancy occurs,
EGRIFTA® (tesamorelin for injection) therapy should be discontinued.
EGRIFTA® (tesamorelin for injection) induces the release of endogenous growth hormone (GH), a
known growth factor, thus, patients with active malignancy should not be treated with EGRIFTA®
(tesamorelin for injection). For patients with a history of non-malignant neoplasms, EGRIFTA®
(tesamorelin for injection) therapy should be initiated after careful evaluation of the potential
benefit of treatment. For patients with a history of treated and stable malignancies, EGRIFTA®
(tesamorelin for injection) therapy should be initiated only after careful evaluation of the
potential benefit of treatment relative to the risk of reactivation of the underlying malignancy.
In addition, the decision to start treatment with EGRIFTA® (tesamorelin for injection) should be
considered carefully based on the increased background risk of malignancies in HIV-positive
patients.
EGRIFTA® (tesamorelin for injection) stimulates GH production and increases serum IGF-I. Given that
IGF-I is a growth factor and the effect of prolonged elevations in IGF-I levels
3
on the development or progression of malignancies is unknown, IGF-I levels should be monitored
closely during EGRIFTA® (tesamorelin for injection) therapy. Careful consideration should be given
to discontinuing EGRIFTA® (tesamorelin for injection) in patients with persistent elevations of
IGF-I levels (e.g., >3 SDS), particularly if the efficacy response is not robust (e.g., based on
visceral adipose tissue changes measured by waist circumference or CT scan). During the clinical
trials, patients were monitored every three months. Among patients who received EGRIFTA®
(tesamorelin for injection) for 26 weeks, 47.4% had IGF-I levels greater than 2 standard deviation
score (SDS), and 35.6% had SDS >3, with this effect seen as early as 13 weeks of treatment.
Among those patients who remained on EGRIFTA®(tesamorelin for injection) for a total of 52 weeks,
at the end of treatment 33.7% had IGF-I SDS >2 and 22.6% had IGF-I SDS >3.
Fluid retention may occur during EGRIFTA® (tesamorelin for injection) therapy and is thought to be
related to the induction of GH secretion. It manifests as increased tissue turgor and
musculoskeletal discomfort resulting in a variety of adverse reactions (e.g., edema, arthralgia,
carpal tunnel syndrome) which are either transient or resolve with discontinuation of treatment.
EGRIFTA® (tesamorelin for injection) treatment may result in glucose intolerance. During the Phase
3 clinical trials, the percentages of patients with elevated HbA1c ( 6.5%) from baseline to Week
26 were 4.5% and 1.3% in the EGRIFTA® (tesamorelin for injection) and placebo groups, respectively.
An increased risk of developing diabetes with EGRIFTA® (tesamorelin for injection) (HbA1c level
6.5%) relative to placebo was observed [intent-to-treat hazard ratio of 3.3 (CI 1.4, 9.6)].
Therefore, glucose status should be carefully evaluated prior to initiating EGRIFTA® (tesamorelin
for injection) treatment. In addition, all patients treated with EGRIFTA® (tesamorelin for
injection) should be monitored periodically for changes in glucose metabolism to diagnose those who
develop impaired glucose tolerance or diabetes. Diabetes is a known cardiovascular risk factor and
patients who develop glucose intolerance have an elevated risk for developing diabetes. Caution
should be exercised in treating HIV-positive patients with lipodystrophy with EGRIFTA® (tesamorelin
for injection) if they develop glucose intolerance or diabetes, and careful consideration should be
given to discontinuing EGRIFTA® (tesamorelin for injection) treatment in patients who do not show a
clear efficacy response as judged by the degree of reduction in visceral adipose tissue by waist
circumference or CT scan measurements. Since EGRIFTA® (tesamorelin for injection) increases IGF-I,
patients with diabetes who are receiving ongoing treatment with EGRIFTA® (tesamorelin for
injection) should be monitored at regular intervals for potential development or worsening of
retinopathy.
Hypersensitivity reactions may occur in patients treated with EGRIFTA® (tesamorelin for injection).
Hypersensitivity reactions occurred in 3.6% of patients with HIV-associated lipodystrophy treated
with EGRIFTA® (tesamorelin for injection) in the Phase 3 clinical trials. These reactions included
pruritus, erythema, flushing, urticaria, and other rash. In cases of suspected hypersensitivity
reactions, patients should be advised to seek prompt medical attention, and treatment with EGRIFTA®
(tesamorelin for injection) should be discontinued immediately.
EGRIFTA® (tesamorelin for injection) treatment may cause injection site reactions, including
injection site erythema, pruritus, pain, irritation, and bruising. The incidence of injection site
reactions was 24.5% in EGRIFTA® (tesamorelin for injection)-treated patients and 14.4% in
placebo-treated patients during the first 26 weeks of treatment in the Phase 3 clinical trials. For
patients who continued EGRIFTA® (tesamorelin for injection)
4
for an additional 26 weeks, the incidence of injection site reactions was 6.1%. In order to reduce
the incidence of injection site reactions, it is recommended to rotate the site of injection to
different areas of the abdomen.
Increased mortality in patients with acute critical illness due to complications following open
heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory
failure has been reported after treatment with pharmacologic amounts of growth hormone. EGRIFTA®
(tesamorelin for injection) has not been studied in patients with acute critical illness. Since
EGRIFTA® (tesamorelin for injection) stimulates growth hormone production, careful consideration
should be given to discontinuing EGRIFTA® (tesamorelin for injection) in critically ill patients.
EGRIFTA® (tesamorelin for injection) is contraindicated in pregnant women. During pregnancy,
visceral adipose tissue increases due to normal metabolic and hormonal changes. Modifying this
physiologic change of pregnancy with EGRIFTA® (tesamorelin for injection) offers no known benefit
and could result in fetal harm. Tesamorelin acetate administration to rats during organogenesis and
lactation resulted in hydrocephalus in offspring at a dose approximately two and four times the
clinical dose, respectively, based on measured drug exposure (AUC). If pregnancy occurs,
discontinue EGRIFTA® (tesamorelin for injection) therapy. If this drug is used during pregnancy, or
if the patient becomes pregnant while taking this drug, the patient should be apprised of the
potential hazard to the fetus.
Because of both the potential for HIV-1 infection transmission and serious adverse reactions in
nursing infants, mothers receiving EGRIFTA® (tesamorelin for injection) should be instructed not to
human milk-feed. It is not known whether EGRIFTA® (tesamorelin for injection) is excreted in human
milk.
Safety and effectiveness in pediatric patients have not been established. EGRIFTA® (tesamorelin
for injection) should not be used in children with open epiphyses, among whom excess GH and IGF-I
may result in linear growth acceleration and excessive growth.
There is no information on the use of EGRIFTA® (tesamorelin for injection) in patients greater than
65 years of age with HIV and lipodystrophy.
Safety, efficacy, and pharmacokinetics of EGRIFTA® (tesamorelin for injection) in patients with
renal or hepatic impairment have not been established.
The most commonly reported adverse reactions (>5% and more frequent than placebo) are arthralgia
[13.1% of patients receiving EGRIFTA® (tesamorelin for injection) and 11.0% of patients receiving
placebo], pain in extremity [6.1% of patients receiving EGRIFTA® (tesamorelin for injection) and
4.6% of patients receiving placebo], myalgia [5.5% of patients receiving EGRIFTA® (tesamorelin for
injection) and 1.9% of patients receiving placebo], injection site erythema [8.5% of patients
receiving EGRIFTA® (tesamorelin for injection) and 2.7% of patients receiving placebo], injection
site pruritus [7.6% of patients receiving EGRIFTA® (tesamorelin for injection) and 0.8% of patients
receiving placebo], and peripheral edema [6.1% of patients receiving EGRIFTA® (tesamorelin for
injection) and 2.3% of patients receiving placebo].
During the first 26 weeks of treatment (main phase), discontinuations as a result of adverse
reactions occurred in 9.6% of patients receiving EGRIFTA®(tesamorelin for injection) and
5
6.8% of patients receiving placebo. Apart from patients with hypersensitivity reactions identified
during the studies and who were discontinued per protocol (2.2%), the most common reasons for
discontinuation of EGRIFTA®(tesamorelin for injection) treatment were adverse reactions due to the
effect of GH (4.2%) and local injection site reactions (4.6%).
About EGRIFTA® (tesamorelin for injection)
EGRIFTA®(tesamorelin for injection) is a synthetic analogue of the human growth hormone releasing
factor (GRF) shown to reduce visceral fat in HIV-infected patients with excess abdominal fat
associated with lipodystrophy. GRF is a hypothalamic peptide that acts on the pituitary cells in
the brain to stimulate the synthesis and release of endogenous growth hormone.
EGRIFTA® (tesamorelin for injection) is approved for sale in the United States only.
About HIV-Associated Lipodystrophy
Several factors, including a patients antiretroviral drug regimen and the HIV virus itself are
thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition
changes. The changes in body composition may include excess abdominal fat accumulation, which is
known as abdominal lipohypertrophy.
Please see full prescribing information for EGRIFTA® (tesamorelin for injection) at
www.emdserono.com.
Conference Call and Webcast
Theratechnologies will hold a conference call and webcast today at 8:30 a.m. (Eastern Standard
Time) to discuss the approval of EGRIFTA® (tesamorelin for injection) by the FDA.
To participate, please dial: 1-416-981-9005 or 1-800-931-6427 (toll free). Please dial in five
minutes prior to the conference in order to ensure your participation. The webcast will be
accessible at the following links: www.gowebcasting.com/2099 and www.theratech.com/ .
A replay of the conference call will be available from 10:30 a.m. today, November 11, 2010, until
November 26, 2010 at 11:59 p.m. at the following number: 1-416-626-4100, pass code 21488561# or
1-800-558-5253, pass code 21488561#. The webcast will be posted for 30 days at the links indicated
above.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company
targets unmet medical needs in specialty markets where it can retain all or part of the commercial
rights to its products. Its most advanced compound, tesamorelin, is an analogue of the human growth
hormone releasing factor. Tesamorelin will be exclusively commercialized in the U.S. by EMD Serono
under the brand name EGRIFTA®. The Companys growth strategy is centered on the commercialization
of EGRIFTA® (tesamorelin for injection) in the United States through an agreement with EMD Serono,
Inc. for the reduction of excess abdominal fat associated with lipodystrophy in HIV-infected
patients. Moreover, Theratechnologies growth strategy will also derive from the commercialization
of EGRIFTA® (tesamorelin for injection) in
6
other markets for HIV-associated lipodystrophy, as well as the development of clinical programs for
EGRIFTA® (tesamorelin for injection) in other medical conditions.
For more information, please visit www.theratech.com
About EMD Serono, Inc.
EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US
biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems
to improve peoples lives. The company has strong market positions in neurodegenerative diseases,
with Rebif® (interferon beta-1a), as well as in endocrinology, with Saizen® (somatropin (rDNA
origin) for injection) and Serostim® (somatropin (rDNA origin) for injection). EMD Serono is a
leader in reproductive health, with Gonal-f® (follitropin alfa for injection), Luveris® (lutropin
alfa for injection) and Ovidrel® Prefilled Syringe (choriogonadotropin alfa injection). In
addition, EMD Serono is growing its expertise and presence in the area of oncology, with more than
10 projects currently in development. With a clear focus on the patient and a leadership presence
in the biopharmaceutical industry, EMD Seronos US footprint continues to grow, with more than 1100
employees around the country and fully integrated commercial, clinical and research operations in
the companys home state of Massachusetts.
For more information, please visit www.emdserono.com
Forward Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information includes,
but is not limited to, information regarding the receipt of milestone payments by EMD Serono as a
result of the obtaining of marketing approval for EGRIFTA®(tesamorelin for injection), the efficacy
of EGRIFTA®(tesamorelin for injection) in selectively reducing VAT, the capacity of the Company to
obtain regulatory approval and commercialize EGRIFTA®(tesamorelin for injection) in additional
markets, the growth of Theratechnologies through the development of EGRIFTA®(tesamorelin for
injection) in additional clinical programs in other medical conditions and the capacity of the
Company to enter into commercial agreements with partners for the commercialization of
EGRIFTA®(tesamorelin for injection) in additional markets. The Company disclaims any liability
resulting from the statements made by EMD Serono in this press release and under the section About
EMD Serono, Inc.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control, and, accordingly, could
cause actual results to differ materially from those that are disclosed in or implied by such
forward-looking information. These risks and uncertainties include, but are not limited to: the
risk that the Company may not receive the regulatory milestones under the collaboration and
licensing agreement entered into with EMD Serono, that the administration of EGRIFTA®(tesamorelin
for injection) does not have the same effect in reducing VAT on all patients, that
EGRIFTA®(tesamorelin for injection) is not approved for commercial sale by regulatory agencies in
geographies other than the United States, that the design of additional clinical programs may not
be begun or, if begun, must be suspended, or that the Company will not find additional partners or
that, if and when found, it will not be able to enter into commercialization agreements with such
partners on reasonable and commercially-acceptable terms.
7
Certain assumptions made in preparing the forward-looking information include, among others, that
EMD Serono will meet its obligations under the collaboration and licensing agreement and that the
Company will receive these milestones, that patients administered with EGRIFTA®(tesamorelin for
injection) will benefit from a reduction in VAT, that regulatory agencies in other geographies
will also approve EGRIFTA®(tesamorelin for injection), that results from additional clinical
programs will be positive, and that the Company, by itself or through third parties, will be able
to commercialize EGRIFTA®(tesamorelin for injection) in additional markets.
All of the forward-looking information is qualified by the foregoing cautionary statements.
Forward-looking information reflects current expectations regarding future events only as of the
date of release of this press release. The Company refers potential investors to the Risks and
Uncertainties section of its Annual Information Form (the AIF) dated February 23, 2010. The AIF
is available at www.sedar.com under the Companys public filings. The reader is cautioned to
consider these and other risks and uncertainties carefully and not to put undue reliance on
forward-looking statements. Forward-looking information reflects current expectations regarding
future events and speaks only as of the date of this press release and represents the Companys
expectations as of that date.
-30-
Contact:
Investor relations contact
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514-336-4804, ext. 205
communications@theratech.com
Media contact
Roch Landriault
National Public Relations
Phone: 514-843-2345
rlandriault@national.ca
8
ex-99.57
Exhibit 99.57
News Release
FOR IMMEDIATE RELEASE
Attention Business/Financial Editors and Analysts
NOTICE OF CONFERENCE CALL & MEDIA ADVISORY:
THERATECHNOLOGIES ANNOUNCES FDAS FINAL DECISION ON ITS NEW DRUG
APPLICATION FOR TESAMORELIN
Montréal, Canada November 10, 2010 Theratechnologies (TSX:TH) advises of an upcoming
conference call and webcast to discuss the final decision of the U.S. Food and Drug
Administration regarding Theratechnologies New Drug Application (NDA). The call will be
moderated by Dr. Andrea Gilpin, Vice President, IR & Communications, at Theratechnologies. Mr.
Yves Rosconi, President and CEO, Mr. Luc Tanguay, Senior Executive Vice President and Chief
Financial Officer, Dr. Christian Marsolais, Vice President, Clinical Research and Medical
Affairs, Dr. Martine Ortega, Vice President, Compliance and Regulatory Affairs and Mr. Pierre
Perazzelli, Vice President, Pharmaceutical Development will also be participating.
The conference call will take place tomorrow, November 11, at 8:30 a.m. (Eastern Standard Time).
Prior to the call, a press release will be issued at approximately 7:30 a.m.
November 11, 2010 conference call and webcast
For the conference call, interested participants are asked to dial the following numbers:
416-981-9005 or 1-800-931-6427 (toll free). Please call five minutes prior to the conference in
order to ensure your participation. You can access the webcast at the following links:
www.gowebcasting.com/2099 and www.theratech.com.
A replay of the conference call will be available from November 11, 2010 at 10:30 a.m. to
November 26, 2010 at 11:59 p.m. at the following number: 416-626-4100, pass code 21488561# or
1-800-558-5253, code 21488561#. The webcast will be posted for 30 days at the following links:
www.gowebcasting.com/2099 and www.theratech.com.
About Theratechnologies
Theratechnologies (TSX:TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The
Company targets unmet medical needs in specialty markets where it can retain all or part of the
commercial rights to its products. Its most advanced compound, tesamorelin, is an analogue of
the human growth hormone releasing factor. In 2009, Theratechnologies submitted a New Drug
Application to the U.S. Food and Drug Administration (FDA), seeking approval of tesamorelin
for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The
Companys growth strategy is centered on the commercialization of tesamorelin in the United
States through an agreement with EMD Serono, Inc. for HIV-associated lipodystrophy. Moreover,
Theratechnologies growth strategy will also derive from the commercialization of tesamorelin in
other markets for HIV-associated lipodystrophy, as well as the development of clinical programs
for tesamorelin in other medical conditions.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information
includes, but is not limited to: information regarding the growth of Theratechnologies through
the development of tesamorelin and additional clinical programs.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2A4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
- 2 -
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control, that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. The assumptions made include the assumption, among others, that the FDA will
approve tesamorelin for commercial sale in the United States, that regulatory agencies in other
countries will also approve tesamorelin, and that results from additional clinical programs will
be positive. These risks and uncertainties include, but are not limited to: the risk that
tesamorelin is not approved by the FDA for commercial sale in the United States and/or by
regulatory agencies in geographies other than the Unites States, or the risk that the design of
additional clinical programs may not be begun or, if begun, must be suspended.
The Company refers potential investors to the Risks and Uncertainties section of its Annual
Information Form (the AIF) dated February 23, 2010. The AIF is available at www.sedar.com
under the Companys public filings. The reader is cautioned to consider these and other risks
and uncertainties carefully and not to put undue reliance on forward-looking statements.
Forward-looking information reflects current expectations regarding future events and speaks
only as of the date of this press release and represents the Companys expectations as of that
date.
Contact:
Andrea Gilpin
VP, IR & Communications
Theratechnologies Inc.
514 336-7800, ext. 205
communications@theratech.com
ex-99.58
Exhibit 99.58
News Release
THERATECHNOLOGIES ANNOUNCES THE RETIREMENT DATE FOR
THE PRESIDENT AND CEO: MR. YVES ROSCONI
Montréal, Canada October 14, 2010 Theratechnologies (TSX: TH) announced today that
following a recent meeting of its Board of Directors, it was agreed that Mr. Yves Rosconi will
retire from the Company on November 30, 2010 with Mr. John-Michel T. Huss assuming his
responsibilities as the new President and Chief Executive Officer on December 1, 2010. Mr.
Rosconi will remain available as an advisor to the new President and Chief Executive Officer
until the end of the year. Mr. Rosconi has been at the helm of Theratechnologies for the last
six years and was responsible for leading the late-stage clinical program for tesamorelin in
HIV-associated lipodystrophy as well as the regulatory process towards product approval in the
United States. Mr. Rosconi also played an important role in signing a partnership for the
exclusive commercialization rights to tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy in the United States.
While there is never a perfect time for a transition, John and I, along with the Board of
Directors, have mutually agreed on this timing and feel that Theratechnologies is well
positioned for the future, noted Mr. Rosconi. The opportunities and responsibilities of this
job have been a tremendous experience for which I will always be grateful. I am proud to have
served Theratechnologies and have especially enjoyed working with the Board of Directors, the
investment community, Theratechnologies external collaborators as well as the internal team,
concluded Mr. Rosconi.
Yves has been an excellent CEO for Theratechnologies. He was the right leader at the right time
and was able to bring focus and discipline to the Company during a time when it was greatly
needed. Under his direction, Theratechnologies produced results that culminated into a Company
that is well positioned for growth in the future, commented Mr. Paul Pommier, Chairman of the
Board of Directors of Theratechnologies. On behalf of the Board of Directors, I would like to
thank Yves for his dedication and hard work over the past six years and wish him all the best
during his retirement, said Mr. Pommier.
About Theratechnologies
Theratechnologies (TSX:TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The
Company targets unmet medical needs in specialty markets where it can retain all or part of the
commercial rights to its products. Its most advanced compound, tesamorelin, is an analogue of
the human growth hormone releasing factor. In 2009, Theratechnologies submitted a New Drug
Application to the U.S. Food and Drug Administration (FDA), seeking approval of tesamorelin
for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The
Companys growth strategy is centered on the commercialization of tesamorelin in the United
States through an agreement with EMD Serono, Inc. for HIV-associated lipodystrophy. Moreover,
Theratechnologies growth strategy will also derive from the commercialization of tesamorelin in
other markets for HIV-associated lipodystrophy, as well as the development of clinical programs
for tesamorelin in other medical conditions.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information
includes, but is not limited to: information regarding the growth of Theratechnologies through
the development of tesamorelin and additional clinical programs.
Forward-looking information is based upon a number of assumptions and is subject to a number of
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
risks and uncertainties, many of which are beyond the Companys control, that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. The assumptions made include the assumption, among others, that the FDA will
approve tesamorelin for commercial sale in the United States, that regulatory agencies in other
countries will also approve tesamorelin, and that results from additional clinical programs will
be positive. These risks and uncertainties include, but are not limited to: the risk that
tesamorelin is not approved by the FDA for commercial sale in the United States and/or by
regulatory agencies in geographies other than the Unites States, or the risk that the design of
additional clinical programs may not be begun or, if begun, must be suspended.
The Company refers potential investors to the Risks and Uncertainties section of its Annual
Information Form (the AIF) dated February 23, 2010. The AIF is available at www.sedar.com
under the Companys public filings. The reader is cautioned to consider these and other risks
and uncertainties carefully and not to put undue reliance on forward-looking statements.
Forward-looking information reflects current expectations regarding future events and speaks
only as of the date of this press release and represents the Companys expectations as of that
date.
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514-336-7800 x 205
communications@theratech.com
2
ex-99.59
Exhibit 99.59
Theratechnologies announces results for the third quarter 2010
Lower burn rate and solid financial position
Montréal, Canada October 12, 2010 - Theratechnologies (TSX: TH) today announced its
financial results for the third quarter ended August 31, 2010. For reference, the Managements
Discussion and Analysis for the third quarter 2010 with the associated Financial Statements can be
found at www.theratech.com/en/investor-relations/financial-reports-theratechnologies.php or
at www.sedar.com.
Third quarter financial highlights included:
|
Ø |
|
Consolidated revenues of $2,152,000 |
|
|
Ø |
|
Burn rate of $2,629,000 and an adjusted burn rate of $4,340,000 |
|
|
Ø |
|
Liquidity of $43,933,000 as at August 31, 2010 |
Operating and financial results are in line with the objectives of the Company, noted Mr. Luc
Tanguay, Senior Executive Vice President & CFO of Theratechnologies. With close to $44 million in
liquidities and an adjusted burn rate 32% lower than the third quarter of 2009, we are in a good
position to pursue our business plan, Mr. Tanguay added.
Financial Highlights
For the three- and nine-month periods ending August 31, 2010:
Ø |
|
Consolidated revenues amounted to $2,152,000 for the quarter and $6,673,000 for the
nine-month period, compared to $13,148,000 and $17,474,000 for the corresponding periods in
2009. The higher revenues in 2009 are due to the receipt of a milestone payment of
$10,884,000 in the third quarter of 2009 associated with the U.S. Food and Drug
Administration (FDA) agreement to review the New Drug Application (NDA) for tesamorelin,
pursuant to the collaboration and licensing agreement with EMD Serono, Inc. (EMD Serono). |
|
Ø |
|
Research and development (R&D) expenses are significantly lower than those of the
previous year, reflecting the completion of the tesamorelin Phase 3 clinical program in 2009.
Before tax credits, R&D expenses totalled $2,930,000 for the quarter and $11,298,000 for the
nine-month period, compared to $5,681,000 and $17,692,000 for the corresponding periods in
2009, representing decreases of 48% and 36% respectively. The R&D expenses incurred in the
third quarter of 2010 are mainly related to the primary objective of the Company, which is to
obtain the regulatory approval of tesamorelin for the treatment excess abdominal fat in
HIV-infected patients with lipodystrophy in the United States. |
|
Ø |
|
General and administrative expenses amounted to $2,225,000 for the quarter and $6,083,000
for the nine-month period, compared to $1,337,000 and $5,515,000 for the corresponding
periods in 2009. The increase in general and administrative expenses is principally due to
professional fees associated with the recruitment of the new President and Chief Executive
Officer, a variation in stock-based compensation expense and foreign exchange rate
fluctuations. The higher expenses in the nine-month period are principally due to heightened
communication activities related to the FDA Advisory Committee meeting as well as an increase
in other administrative expenses partially offset by a reduction in the loss on foreign
exchange. The increase for the nine-month period is less, in relative terms, than that of the
third quarter because of costs associated with revising the Companys business plan incurred
in early 2009. |
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
Ø |
|
Selling and market development expenses amounted to $521,000 for the quarter and $1,901,000 for
the nine-month period compared to $495,000 and $1,516,000 for the corresponding periods in 2009.
The increase in the selling and market development expenses is principally due to business
development and market research studies for territories outside the United States. These
expenses also include activities associated with the management of the collaboration and
licensing agreement with EMD Serono. |
|
Ø |
|
Net loss recorded by the Company was $3,277,000, representing $0.05 per share for the quarter
and $12,367,000 representing $0.20 per share for the nine-month period compared to net earnings
of $5,824,000 representing $0.10 per share and a net loss of $10,360,000 representing $0.17 per
share for the corresponding periods in 2009. The profit recorded in the third quarter of 2009
was due to the receipt of a milestone payment of $10,884,000 associated with the FDAs agreement
to review the NDA for tesamorelin, pursuant to the collaboration and licensing agreement with
EMD Serono. |
|
Ø |
|
Financial Position |
|
|
|
At August 31, 2010, liquidities, which include cash and bonds, amounted
to $43,419,000, and tax credits receivable amounted to $514,000, for a total of $43,933,000. |
|
|
|
|
The burn rate from operating activities, excluding changes in operating
assets and liabilities, was $2,629,000 in the quarter and $10,877,000 for the nine-month
period compared to a cash flow of $6,186,000 and a burn rate of $9,214,000 for the
corresponding periods in 2009. Excluding the revenues and fees associated with the agreement
with EMD Serono, the adjusted burn rate from operating activities, excluding changes in
operating assets and liabilities, was $4,340,000 in the quarter and $16,011,000 for the
nine-month period compared to $6,410,000 and $20,678,000 for the corresponding periods in
2009. |
|
|
|
|
In light of a lower expense level and cost control measures, the Company
anticipates that the adjusted burn rate for 2010 will be between $22,000,000 and $23,000,000,
and thus will be less than the initially forecasted adjusted burn rate of $24,000,000. |
Non-GAAP Measures
The Company uses measures that do not conform to Canadian Generally Accepted Accounting Principles
(GAAP) to assess its operating performance. Securities regulators require that companies caution
readers that earnings and other measures adjusted to a basis other than GAAP do not have
standardized meanings and are unlikely to be comparable to similar measures used by other
companies. Accordingly, these measures should not be considered in isolation. The Company uses
non-GAAP measures such as adjusted net loss and the adjusted burn rate from operating activities
before changes in operating assets and liabilities, to measure its performance from one period to
the next without including changes caused by certain items that could potentially distort the
analysis of trends in its operating performance, and because such measures provide meaningful
information on the Companys financial condition and operating results. Please refer to the
Managements Discussion and Analysis for the three- and nine-month periods ended August 31, 2010
for more details on how these non-GAAP measures are calculated.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company
targets unmet medical needs in specialty markets where it can retain all or part of the commercial
rights to its products. Its most advanced compound, tesamorelin, is an analogue of the human growth
hormone releasing factor. In 2009, Theratechnologies submitted a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA), seeking approval of tesamorelin for the treatment of
excess abdominal fat in HIV-infected patients with lipodystrophy. The Companys growth strategy is
centered on the commercialization of tesamorelin in the United States through an agreement with EMD
Serono, Inc. for HIV-associated lipodystrophy. Moreover, Theratechnologies growth strategy will
also derive from the commercialization of tesamorelin in
2
other markets for HIV-associated lipodystrophy, as well as from the development of clinical
programs for tesamorelin in other medical conditions.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Companys website at
www.theratech.com. Additional information, including the Annual Information Form and the
Annual Report, is also available on SEDAR at www.sedar.com.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information includes,
but is not limited to, information regarding the potential decrease in the adjusted burn rate for
2010, the growth strategy of the Company by way of the commercialization of tesamorelin in the U.S.
market as well as in other markets, and the development of tesamorelin for the treatment of other
medical conditions. Furthermore, the words will, may, could, should, outlook, believe,
plan, envisage, anticipate, expect and estimate, or variations of them denote
forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties include, but are not limited to, the risk that
unexpected expenses increase the adjusted burn rate, that the FDA does not approve tesamorelin for
the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy, that the Company
is unable to commercialize tesamorelin in other markets because, among other reasons, the
non-approval of tesamorelin in those markets or the non-acceptance of the product in those markets,
and that the results of clinical studies for the development of tesamorelin for the treatment of
other medical conditions are inconclusive, resulting in the termination of these studies.
Although the forward-looking information contained herein is based upon what the Company believes
are reasonable assumptions, investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking information. Certain assumptions
made in preparing the forward-looking information and the Companys objectives include the
assumption, among others, that the FDA and regulatory agencies in other countries will approve
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy,
sales of tesamorelin in the United States and in other markets will be successful, and that the
results of clinical studies for the development of tesamorelin for the treatment of other medical
conditions will be conclusive.
Consequently, all of the forward-looking information is qualified by the foregoing cautionary
statements and there can be no guarantee that the results or developments anticipated by the
Company will be realized or, even if substantially realized, that they will have the expected
consequences or effects on the Company, its business, its financial condition or its results of
operations. Furthermore, the forward-looking information reflects current expectations regarding
future events only as of the date of release of this press release.
Investors
are referred to the Companys public filings available at
www.sedar.com. In particular,
further details on these risks and descriptions of these risks are disclosed in the Risks and
Uncertainties section of the Companys Annual Information Form, dated February 23, 2010, for the
year ended November 30, 2009.
- 30 -
3
Information:
Andrea Gilpin
Vice President, IR & Communications
Phone: 514-336-7800, ext. 205
communications@theratech.com
Luc Tanguay
Senior Executive Vice President and
Chief Financial Officer
Phone: 514-336-7800, ext. 204
ltanguay@theratech.com
4
ex-99.60
Exhibit 99.60
News Release
Theratechnologies to present at BioContact Québec
Montréal, Canada, October 5, 2010 Theratechnologies (TSX:TH) announced today that Yves
Rosconi, President and Chief Executive Officer, will present a corporate overview of the Company
on Wednesday, October 6, 2010,at 2:30 p.m., at BioContact Québec. The event is being held at the
Château Frontenac Hotel in Quebec City. BioContact Québec is a biopharmaceutical partnership
symposium attended by over 800 participants.
About Theratechnologies
Theratechnologies (TSX:TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The
Company targets unmet medical needs in specialty markets where it can retain all or part of the
commercial rights to its products. Its most advanced compound, tesamorelin, is an analogue of
the human growth hormone releasing factor. In 2009, Theratechnologies submitted a New Drug
Application to the U.S. Food and Drug Administration (FDA), seeking approval of tesamorelin
for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The
Companys growth strategy is centered on the commercialization of tesamorelin in the United
States through an agreement with EMD Serono, Inc. for HIV-associated lipodystrophy. Moreover,
Theratechnologies growth will also derive from the commercialization of tesamorelin in other
markets for HIV-associated lipodystrophy, as well as the development of clinical programs for
tesamorelin in other medical conditions.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information
includes, but is not limited to: information regarding the growth of Theratechnologies through
the development of tesamorelin and additional clinical programs.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control, that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. The assumptions made include the assumption, among others, that the FDA will
approve tesamorelin for commercial sale in the United States, that regulatory agencies in other
countries will also approve tesamorelin, and that results from additional clinical programs will
be positive. These risks and uncertainties include, but are not limited to: the risk that
tesamorelin is not approved by the FDA for commercial sale in the United States and/or by
regulatory agencies in geographies other than the Unites States, or the risk that the design of
additional clinical programs may not be begun or, if begun, must be suspended.
The Company refers potential investors to the Risks and Uncertainties section of its Annual
Information Form (the AIF) dated February 23, 2010. The AIF is available at www.sedar.com
under the Companys public filings. The reader is cautioned to consider these and other risks
and uncertainties carefully and not to put undue reliance on forward-looking statements.
Forward-looking information reflects current expectations regarding future events and speaks
only as of the date of this press release and represents the Companys expectations as of that
date.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
-30-
Contact:
Andrea Gilpin
Vice president, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
ex-99.61
Exhibit 99.61
News Release
Theratechnologies to present at UBS Global Life Sciences Conference
Montréal, Canada, September 20, 2010 Theratechnologies (TSX:TH) announced today that
Yves Rosconi, President and Chief Executive Officer, will present a corporate overview of the
Company, on Wednesday, September 22, at 10:00 a.m., at the 2010 UBS Global Life Sciences
Conference. The event is being held at the Grand Hyatt Hotel in New York City.
About Theratechnologies
Theratechnologies (TSX:TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The
Company targets unmet medical needs in specialty markets where it can retain all or part of the
commercial rights to its products. Its most advanced compound, tesamorelin, is an analogue of
the human growth hormone releasing factor. In 2009, Theratechnologies submitted a New Drug
Application to the U.S. Food and Drug Administration (FDA), seeking approval of tesamorelin
for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The
Companys growth strategy is centered on the commercialization of tesamorelin in the United
States through an agreement with EMD Serono, Inc. for HIV-associated lipodystrophy. Moreover,
Theratechnologies growth will also derive from the commercialization of tesamorelin in other
markets for HIV-associated lipodystrophy, as well as the development of clinical programs for
tesamorelin in other medical conditions.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information
includes, but is not limited to: information regarding the growth of Theratechnologies through
the development of tesamorelin and additional clinical programs.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control, that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. The assumptions made include the assumption, among others, that the FDA will
approve tesamorelin for commercial sale in the United States, the Company will enter into
agreements with partners in geographies other than the United States and that results from
additional clinical programs will be positive. These risks and uncertainties include, but are
not limited to: the risk that tesamorelin is not approved by the FDA for commercial sale in the
United States, the risk that the Company is unable to conclude agreements with partners relating
to tesamorelin in geographies other than the Unites States, or the risk that the design of
clinical programs may not be begun or, if begun, must be suspended.
The Company refers potential investors to the Risks and Uncertainties section of its Annual
Information Form (the AIF) dated February 23, 2010. The AIF is available at www.sedar.com
under the Companys public filings. The reader is cautioned to consider these and other risks
and uncertainties carefully and not to put undue reliance on forward-looking statements.
Forward-looking information reflects current expectations regarding future events and speaks
only as of the date of this press release and represents the Companys expectations as of that
date.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
-30-
Contact:
Andrea Gilpin
Vice president, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
ex-99.62
Exhibit 99.62
News Release
THERATECHNOLOGIES: TESAMORELIN DATA PRESENTED AT THE
INTERSCIENCE CONFERENCE ON ANTIMICROBIAL AGENTS AND
CHEMOTHERAPY 50TH ANNUAL MEETING
Montréal, Canada September 13, 2010 Theratechnologies (TSX: TH) presented two scientific
posters regarding tesamorelin, an investigational growth hormone-releasing factor being
evaluated for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
and currently under regulatory review by the U.S. Food and Drug Administration, at the
50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy
(ICAAC) meeting, in Boston, from Sunday, September 12, to Wednesday, September 15.
The first poster is entitled Reduction in Visceral Adipose Tissue (VAT) with Tesamorelin
Correlates with Changes in Anthropometric, and Patient-Reported Outcome Parameters in
HIV-infected Patients with Excess Abdominal Fat and describes the correlations between VAT,
waist circumference and body image parameters in tesamorelin-treated patients.
The second poster is entitled Efficacy and Long-Term Safety of Tesamorelin, a Growth
Hormone-Releasing Factor Analogue, in Sub-Populations of HIV-Infected Patients with Excess
Abdominal Fat and describes the efficacy and safety of tesamorelin among different
sub-populations of HIV-infected patients with excess abdominal fat.
Both posters were presented at the ICAAC poster session which took place on Sunday, September
12, from 11:30 a.m. to 1:30 p.m., and are now available on Theratechnologies website at
www.theratech.com
About HIV-Associated Lipodystrophy
Several factors including a patients antiretroviral drug regimen and the HIV virus itself are
thought to contribute to HIV-associated lipodystrophy, which is characterized by body
composition changes. The changes in body composition may include excess abdominal fat
accumulation, which is known as abdominal lipohypertrophy. There is currently no approved
treatment available for excess abdominal fat in HIV-infected patients with lipodystrophy.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The
Company targets unmet medical needs in specialty markets where it can retain all or part of the
commercial rights to its products. Its most advanced compound, tesamorelin, is an analogue of
the human growth hormone releasing factor. In 2009, Theratechnologies submitted a New Drug
Application to the U.S. Food and Drug Administration (FDA), seeking approval of tesamorelin
for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The
Companys growth strategy is centered on the commercialization of tesamorelin in the United
States through an agreement with EMD Serono, Inc. for HIV-associated lipodystrophy. Moreover,
Theratechnologies growth will also derive from
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
the commercialization of tesamorelin in other markets for HIV-associated lipodystrophy, as
well as the development of clinical programs for tesamorelin in other medical conditions.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information
includes, but is not limited to: information regarding the growth of Theratechnologies through
the development of tesamorelin and additional clinical programs.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control, that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. The assumptions made include the assumption, among others, that the FDA will
approve tesamorelin for commercial sale in the United States, the Company will enter into
agreements with partners in geographies other than the United States and that results from
additional clinical programs will be positive. These risks and uncertainties include,
but are not limited to: the risk that tesamorelin is not approved by the FDA for commercial sale
in the United States, the risk that the Company is unable to conclude agreements with partners
relating to tesamorelin in geographies other than the Unites States, or the risk that the design
of clinical programs may not be begun or, if begun, must be suspended.
The Company refers potential investors to the Risks and Uncertainties section of its Annual
Information Form (the AIF) dated February 23, 2010. The AIF is available at www.sedar.com
under the Companys public filings. The reader is cautioned to consider these and other risks
and uncertainties carefully and not to put undue reliance on forward-looking statements.
Forward-looking information reflects current expectations regarding future events and speaks
only as of the date of this press release and represents the Companys expectations as of that
date.
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514-336-7800 x 205
communications@theratech.com
ex-99.63
Exhibit 99.63
News Release
Theratechnologies is pleased to announce the appointment of a new president and CEO
Montréal, Canada September 1, 2010 Theratechnologies (TSX: TH) announced today the
appointment of Mr. John-Michel T. Huss as President and Chief Executive Officer of the Company.
Mr. Huss will assume his responsibilities in the coming months.
Until recently, Mr. Huss was Chief of Staff, Office of the CEO, of Sanofi-Aventis in Paris. Mr.
Huss has over 20 years experience in the pharmaceutical industry in various international positions
and was responsible for various disease areas including diabetes and metabolism. Mr. Huss began his
career in 1990, at Merck & Co., Inc. primarily in sales and marketing in the U.S., Germany and
Switzerland. In 1996, he was offered a position with F. Hoffman-La Roche as an Internal Product
Manager at their Basel headquarters in Switzerland. In 1999, he joined Sanofi-Synthélabo GmbH, as
Business Unit Director and has held various positions of increasing responsibility in marketing and
sales. He became General Manager in Switzerland in 2007. During his tenure at Sanofi-Aventis
(Sanofi-Synthélabo merged with Aventis in 2004) he held positions in Germany, Canada, Switzerland
and France. Mr. Huss completed his first University degree in Applied Linguistics in Germany and
then received an MBA in the U.S., specializing in International Business.
I am honoured to have been chosen as Theratechnologies President and CEO. The Company has done an
outstanding job of developing an exciting new compound, tesamorelin, and navigating it through the
final regulatory stages of the drug development process, commented Mr. Huss. I very much look
forward to joining Theratechnologies at this stage of development in order to grow it into a
significant biopharmaceutical company, he concluded.
Mr. Huss is a highly accomplished leader that will complement the existing management team very
nicely, commented Mr. Paul Pommier, Chairman of the Board of Directors of Theratechnologies. We
are delighted to welcome Mr. Huss to Theratechnologies management team and look forward to
supporting him as he takes the business forward, capitalizing on his wealth of commercialization
experience. The appointment marks a new exciting era for Theratechnologies as we look to grow the
Company to the next level, concluded Mr. Pommier.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company
targets unmet medical needs in financially attractive specialty markets where it can retain all or
part of the commercial rights to its products. Its most advanced compound, tesamorelin, is an
analogue of the human growth hormone releasing factor. In 2009, Theratechnologies submitted a New
Drug Application to the U.S. Food and Drug Administration (FDA), seeking approval of tesamorelin
for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The
Companys growth strategy is centered on the commercialization of tesamorelin in the United States
and in other markets for HIV-associated lipodystrophy, as well as the development of clinical
programs for tesamorelin in other medical conditions.
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514-336-7800 x 205
communications@theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
ex-99.64
Exhibit 99.64
News Release
Theratechnologies to present at both BMO and Canaccord Genuity Conferences
Montréal, Canada August 2, 2010 - Theratechnologies (TSX: TH) announced today that the
Company will present corporate overviews at the BMO Capital Markets Focus on Healthcare
Conference and the 30th Annual Canaccord Genuity Global Growth Conference, both
being held in the coming weeks.
The BMO presentation will be made by Dr. Andrea Gilpin, Theratechnologies Vice President,
Investor Relations and Communications, and will take place on August 5, at 1:15 p.m., at the
Sheraton New York Hotel & Towers in New York City. The Canaccord Genuity presentation will be
made by Mr. Yves Rosconi, Theratechnologies President and Chief Executive Officer, and will
take place on August 11, at 5:00 p.m., at the InterContinental in Boston.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and
develops innovative therapeutic products, with an emphasis on peptides, for commercialization.
The Company targets unmet medical needs in financially attractive specialty markets where it
can retain all or part of the commercial rights to its products. Its most advanced compound,
tesamorelin, is an analogue of the human growth hormone releasing factor. In 2009,
Theratechnologies submitted a New Drug Application to the U.S. Food and Drug Administration,
seeking approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. The Companys growth strategy is centered on the
commercialization of tesamorelin in the United States and in other markets for HIV-associated
lipodystrophy, as well as the development of clinical programs for tesamorelin in other
medical conditions.
- 30 -
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514-336-7800 x 205
communications@theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: (514) 336-7800 Fax: (514) 336-7242 www.theratech.com
ex-99.65
Exhibit 99.65
News Release
Theratechnologies receives a motion of authorization
to institute a class action
Montréal, Canada July 26, 2010 - Theratechnologies (TSX: TH) announced today that it has
received from 121851 Canada Inc., formerly a shareholder of the Company, a motion of
authorization to institute a class action against the Company and certain of its executive
officers. This motion was filed in the Superior Court of Quebec, district of Montreal. This
person intends to initiate a class action to represent the class of persons who were
shareholders at May 21, 2010 and who sold their common shares of the Company on May 25 or 26,
2010. This person alleges that Theratechnologies did not comply with its continuous disclosure
obligations as a reporting issuer by failing to disclose a material change. Theratechnologies
is of the view that the allegations contained in the motion are frivolous and entirely without
merit and intends to take all appropriate actions to vigorously defend its position.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and
develops innovative therapeutic products, with an emphasis on peptides, for commercialization.
The Company targets unmet medical needs in financially attractive specialty markets where it
can retain all or part of the commercial rights to its products. Its most advanced compound,
tesamorelin, is an analogue of the human growth hormone releasing factor. In 2009,
Theratechnologies submitted a New Drug Application to the U.S. Food and Drug Administration,
seeking approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. The Companys growth strategy is centered on the
commercialization of tesamorelin in the United States and in other markets for HIV-associated
lipodystrophy, as well as the development of clinical programs for tesamorelin in other
medical conditions.
-30-
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514-336-7800 x 205
communications@theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: (514) 336-7800 Fax: (514) 336-7242 www.theratech.com
ex-99.66
Exhibit 99.66
News Release
Update on timeline for FDA Action Date for Theratechnologies
tesamorelin New Drug Application
Montréal, Canada July 20, 2010 - Theratechnologies (TSX: TH) announced today that it
has received feedback from the U.S. Food and Drug Administration (FDA or the Agency)
regarding the timeline to review tesamorelins New Drug Application for the treatment of
excess abdominal fat in HIV-infected patients with lipodystrophy. The FDA has indicated that
the review is progressing well. The Company now expects to have an official response in the
fourth quarter of 2010. Theratechnologies and the Agency continue the positive and
constructive dialogue regarding the regulatory process for tesamorelin.
About HIV-Associated Lipodystrophy
Several factors including a patients antiretroviral drug regimen and the HIV virus itself are
thought to contribute to HIV-associated lipodystrophy, which is characterized by body
composition changes, dyslipidemia and glucose intolerance. The changes in body composition
include excess abdominal fat accumulation. There is currently no approved treatment available
for the excess abdominal fat in HIV-infected patients with lipodystrophy.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and
develops innovative therapeutic products, with an emphasis on peptides, for commercialization.
The Company targets unmet medical needs in financially attractive specialty markets where it
can retain all or part of the commercial rights to its products. Its most advanced compound,
tesamorelin, is an analogue of the human growth hormone releasing factor. In 2009,
Theratechnologies submitted a New Drug Application to the U.S. Food and Drug Administration,
seeking approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. The Companys growth strategy is centered on the
commercialization of tesamorelin in the United States and in other markets for HIV-associated
lipodystrophy, as well as the development of clinical programs for tesamorelin in other
medical conditions.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking
information within the meaning of applicable securities legislation. This forward-looking
information includes, but is not limited to, information regarding approval of tesamorelin for
the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy by the FDA
and the timeline by which a response will be provided by the FDA to the Company regarding its
New Drug Application. Forward-looking information is based upon a number of assumptions and is
subject to a number of risks and uncertainties, many of which are beyond the Companys control
that could cause actual results to differ materially from those that are disclosed in or
implied by such forward-looking information. These risks and uncertainties include the risk
that the FDA does not approve tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy or that the timeline regarding an official response
be delayed. Certain assumptions made in preparing the forward-looking information include,
among others, that the Company and the FDA will review on a timely basis the exchange of
information between each of them, that the discussions will remain positive and that the FDA
will approve tesamorelin. All of the
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: (514) 336-7800 Fax: (514) 336-7242 www.theratech.com
-2-
forward-looking information is qualified by the foregoing
cautionary statements, and there
can be no guarantee that the results or developments anticipated by the Company will be
realized. Forward-looking information reflects current expectations regarding future events
only as of the date of release of this press release. Investors are referred to the Companys
public filings available at www.sedar.com. In particular, further details on these
risks and descriptions of these risks are disclosed in the Risk and Uncertainties section of
the Companys Annual Information Form, dated February 23, 2010, for the year ended November
30, 2009.
-30-
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514-336-7800 x 205
communications@theratech.com
ex-99.67
Exhibit 99.67
Second Quarter 2010: Theratechnologies Reports Lower Burn Rate and Good Financial Position
Montréal, Canada July 7, 2010 - Theratechnologies (TSX: TH) today announced its financial
results for the second quarter ended May 31, 2010. For reference, the complete Managements
Discussion and Analysis with the associated Financial Statements can be found at
www.theratech.com/en/investor-relations/financial-reports-theratechnologies.php or www.sedar.com.
Second quarter financial highlights included:
|
Ø |
|
Consolidated revenues of $2,226,000 |
|
|
Ø |
|
Burn rate of $4,387,000, a year-over-year decrease of 12% (adjusted burn rate of $6,098,000) |
|
|
Ø |
|
Liquidity of $51,050,000 at May 31, 2010 |
Operating and financial results are in line with the objectives of the Company, noted Mr. Luc
Tanguay, Senior Executive Vice President & CFO of Theratechnologies. With liquidities in excess of
$50 million and a lower burn rate over the previous year, we are in a good position to pursue our
business plan, Mr. Tanguay added.
Financial Highlights
For the three-month and six-month periods ending May 31, 2010:
Ø |
|
Consolidated revenues amounted to $2,226,000 for the quarter and $4,521,000 for the
six-month period, compared to $2,317,000 and $4,326,000 for the corresponding periods in
2009. |
|
Ø |
|
Research and development (R&D) expenses are significantly lower than those of the previous
year, reflecting the completion of the tesamorelin Phase 3 clinical program in 2009. Before tax
credits, R&D expenses totalled $4,259,000 for the quarter and $8,368,000 for the six-month
period, compared to $5,696,000 and $12,011,000 for the corresponding periods in 2009,
representing decreases of 25% and 30% respectively. The R&D expenses incurred in the second
quarter of 2010 are mainly related to the primary objective of the Company, which involves the
regulatory activities connected with the preparation for the U.S. Food and Drug Administration
(FDA) Advisory Committee meeting. |
|
Ø |
|
General and administrative expenses amounted to $2,057,000 for the quarter and $3,858,000
for the six-month period, compared to $1,857,000 and $4,178,000 for the corresponding
periods in 2009. |
|
Ø |
|
Selling and market development expenses amounted to $764,000 for the quarter and $1,380,000 for
the six-month period compared to $540,000 and $1,021,000 for the corresponding periods in 2009.
The increase in the selling and market development expenses is principally due to business
development and market research expenses for territories outside the United States. These
expenses also include activities associated with the management of the collaboration and
licensing agreement with EMD Serono, Inc. (EMD Serono). |
|
Ø |
|
Net loss: The Company recorded a net loss of $4,823,000 ($0.08 per share) for the
quarter and $9,090,000 ($0.15 per share) for the six-month period compared to net losses of
$5,430,000 ($0.09 per share) and $16,184,000 ($0.27 per share) for the corresponding
periods in 2009. |
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
|
o |
|
At May 31, 2010, liquidities, which include cash and bonds, amounted to $49,048,000, and tax
credits receivable amounted to $2,002,000, for a total of $51,050,000. |
|
|
o |
|
The burn rate from operating activities, excluding changes in operating assets and
liabilities, was $4,387,000 in the quarter and $8,248,000 for the six-month period compared to
$4,988,000 and $15,400,000 for the corresponding periods in 2009. Excluding the revenues and
fees associated with the agreement with EMD Serono, the adjusted burn rate from operating
activities, excluding changes in operating assets and liabilities, was $6,098,000 in the
quarter and $11,671,000 for the six-month period compared to $6,699,000 and $14,268,000 for
the corresponding periods in 2009. |
|
|
o |
|
In the event of approval of tesamorelin, the anticipated 2010 adjusted burn rate of
$24,000,000 could be increased by 5 to 10%. Principal components of the potential increase in
spending include the qualification of back-up suppliers for tesamorelin and the drugs fill
and finish operation, as well as preparations for the filing of a New Drug Submission in
Canada. Most of these costs would be associated to projects that are non-repetitive in nature
and would be related to the acceleration of activities in the current business plan. |
Non-GAAP Measures
The Company uses measures that do not conform to generally accepted accounting principles (GAAP)
to assess its operating performance. Securities regulators require that companies caution readers
that earnings and other measures adjusted to a basis other than GAAP do not have standardized
meanings and are unlikely to be comparable to similar measures used by other companies.
Accordingly, these measures should not be considered in isolation. The Company uses non-GAAP
measures such as adjusted net loss and the adjusted burn rate from operating activities before
changes in operating assets and liabilities, to measure its performance from one period to the next
without including changes caused by certain items that could potentially distort the analysis of
trends in its operating performance, and because such measures provide meaningful information on
the Companys financial condition and operating results. Please refer to the Managements
Discussion and Analysis for the three-month and six-month periods ended May 31, 2010 for more
details on how these non-GAAP measures are calculated.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company
targets unmet medical needs in financially attractive specialty markets where it can retain all or
part of the commercial rights to its products. Its most advanced compound, tesamorelin, is an
analogue of the human growth hormone releasing factor. In 2009, Theratechnologies submitted a New
Drug Application to the U.S. Food and Drug Administration, seeking approval of tesamorelin for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The Companys growth
strategy is centered on the commercialization of tesamorelin in the United States and in other
markets for HIV-associated lipodystrophy, as well as the development of clinical programs for
tesamorelin in other medical conditions.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Companys website at
www.theratech.com. Additional information, including the Annual Information Form and the Annual
Report, is also available on SEDAR at www.sedar.com.
2
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information includes,
but is not limited to, information regarding approval of tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy by the FDA, the receipt of milestone
payments and/or royalties under the agreement entered into with EMD Serono, the filing of a New
Drug Submission in Canada, and the potential increase in the adjusted burn rate. Furthermore, the
words will, may, could, should, outlook, believe, plan, envisage, anticipate,
expect and estimate, or variations of them denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties include, but are not limited to, the risk that the FDA
does not approve tesamorelin for the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy, the risk that the payment of milestones is delayed or not received or that the
royalties from the sale of tesamorelin are not received, the risk that the preparation of a New
Drug Submission in Canada is delayed or is not completed, and the risk that the Company is unable
to enter into commercial agreements with third parties to qualify back-up suppliers of tesamorelin.
Although the forward-looking information contained herein is based upon what the Company believes
are reasonable assumptions, investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking information. Certain assumptions
made in preparing the forward-looking information and the Companys objectives include the
assumption, among others, that the FDA will approve tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy, sales of tesamorelin in the United
States will be successful, no issue will occur in the preparation of a New Drug Submission in
Canada, and the Company will be able to enter into commercial agreements with third parties to
qualify back-up suppliers of tesamorelin.
Consequently, all of the forward-looking information is qualified by the foregoing cautionary
statements, and there can be no guarantee that the results or developments anticipated by the
Company will be realized or, even if substantially realized, that they will have the expected
consequences or effects on the Company, its business, its financial condition or its results of
operation. Furthermore, the forward-looking information reflects current expectations regarding
future events only as of the date of release of this press release.
Investors
are referred to the Companys public filings available at
www.sedar.com. In particular,
further details on these risks and descriptions of these risks are disclosed in the Risk and
Uncertainties section of the Companys Annual Information Form, dated February 23, 2010, for the
year ended November 30, 2009.
- 30 -
Information:
Andrea Gilpin
Vice President, IR & Communications
Phone: 514-336-7800, ext. 205
communications@theratech.com
Luc Tanguay
Senior Executive Vice President and
Chief Financial Officer
Phone: 514-336-7800, ext. 204
ltanguay@theratech.com
3
ex-99.68
Exhibit 99.68
News Release
Theratechnologies added to the Russell Global Index
Montréal, Canada June 29, 2010- Theratechnologies (TSX: TH) announced today that
it has been added to the Russell Global Index as part of Russell Investments recent
reconstitution of its comprehensive set of global equity indexes which occurred at market
closing on June 25. The complete list is posted on www.russell.com.
Membership in the Russell Global Index, which remains in place for one year, means automatic
inclusion in the appropriate large-cap, small-cap, all-cap indexes as well as the applicable
style, sector and country indexes. The index consists of more than 10,000 securities in 70
countries and offers over 300 key subindexes. The index is reconstituted annually and all
sub-indexes are recalibrated simultaneously to accurately measure current market realities
for each market segment.
We are pleased with this recognition, which will increase our profile in the investment
community. The addition to the Russell Global Index demonstrates the growing participation
that Theratechnologies has in the capital markets outside Canada, said Luc Tanguay, Senior
Executive Vice President & CFO of Theratechnologies.
About Russell
Russell Investments has $179 billion in assets under management as of March 31, 2010, and
serves individual, institutional and advisor clients in more than 40 countries. Founded in
1936, Russell is a subsidiary of The Northwestern Mutual Life Insurance Company.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and
develops innovative therapeutic products, with an emphasis on peptides, for
commercialization. The Company targets unmet medical needs in financially attractive
specialty markets where it can retain all or part of the commercial rights to its products.
Its most advanced compound, tesamorelin, is an analogue of the human growth hormone releasing
factor. In 2009, Theratechnologies submitted a New Drug Application to the U.S. Food and Drug
Administration, seeking approval of tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy. The Companys growth strategy is centered on the
commercialization of tesamorelin in the United States and in other markets for HIV-associated
lipodystrophy, as well as the development of clinical programs for tesamorelin in other
medical conditions.
-30-
Contact:
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: (514) 336-7800 Fax: (514) 336-7242 www.theratech.com
ex-99.69
Exhibit 99.69
News Release
Theratechnologies Announces Publication of Combined Tesamorelin
Phase 3 Results in JCEM
Montreal, Canada June 24, 2010 Theratechnologies (TSX: TH) today announced that the
article entitled, Effects of Tesamorelin (TH9507), a Growth Hormone-Releasing Factor Analog,
in Human Immunodeficiency Virus-Infected Patients with Excess Abdominal Fat: A Pooled Analysis
of Two Multicenter, Double-Blind Placebo-Controlled Phase 3 Trials with Safety Extension Data,
has been made available on the web site of the Journal of Clinical Endocrinology & Metabolism
(http://jcem.endojournals.org) prior to its print publication. The article outlines, in
detail, a pooled analysis of two Phase 3 studies of tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy.
Dr. Steven Grinspoon, MD, one of the authors of the article and a researcher at Massachusetts
General Hospital and Harvard Medical School, provided a summary of the results during an oral
presentation at ENDO 2010, The Endocrine Societys annual meeting held this week in San Diego,
California. The presentation was entitled: Effects of Tesamorelin, a Growth Hormone-Releasing
Analog, over 52 Weeks in HIV-Infected Patients with Excess Abdominal Fat: A Pooled Analysis of
2 Multicenter, Randomized, Placebo-Controlled Phase 3 Trials.
About HIV-Associated Lipodystrophy
Several factors including a patients antiretroviral drug regimen and the HIV virus itself are
thought to contribute to HIV-associated lipodystrophy, which is characterized by body
composition changes, dyslipidemia and glucose intolerance. The changes in body composition
include excess abdominal fat accumulation. There is currently no approved treatment available
for the excess abdominal fat in HIV-infected patients with lipodystrophy.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The
Company targets unmet medical needs in financially attractive specialty markets where it can
retain all or part of the commercial rights to its products. Its most advanced compound,
tesamorelin, is an analogue of the human growth hormone releasing factor. In 2009,
Theratechnologies submitted a New Drug Application to the U.S. Food and Drug Administration,
seeking approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. The Companys growth strategy is centered on the commercialization
of tesamorelin in the United States and in other markets for HIV-associated lipodystrophy, as
well as the development of clinical programs for tesamorelin in other medical conditions.
-30-
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
Phone: 514 336-7800, ext. 205
communications@theratech.com
ex-99.70
Exhibit 99.70
News
Release
Theratechnologies to present at both Jefferies and Needham conferences
Montréal, Canada June 8, 2010 - Theratechnologies (TSX: TH) announced today that
Yves Rosconi, President and Chief Executive Officer of the Company, will present corporate
overviews at the Jefferies Global Life Sciences Conference and the Annual Needham Healthcare
Conference, both being held this week in New York City.
The Jefferies presentation will take place on June 9, at 3:30 p.m., at the Grand Hyatt Hotel
in New York City, and the Needham presentation, on June 10, at 1:20 p.m., at the New York
Palace Hotel in New York City.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and
develops innovative therapeutic products, with an emphasis on peptides, for
commercialization. The Company targets unmet medical needs in financially attractive
specialty markets where it can retain all or part of the commercial rights to its products.
Its most advanced compound, tesamorelin, is an analogue of the human growth hormone releasing
factor. In 2009, Theratechnologies submitted a New Drug Application to the U.S. Food and Drug
Administration, seeking approval of tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy. The Companys growth strategy is centered on the
commercialization of tesamorelin in the United States and in other markets for HIV-associated
lipodystrophy, as well as the development of clinical programs for tesamorelin in other
medical conditions.
-30-
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: (514) 336-7800 Fax: (514) 336-7242 www.theratech.com
ex-99.71
Exhibit 99.71
News Release
YVES ROSCONI, PRESIDENT AND CEO OF THERATECHNOLOGIES,
WILL RETIRE ON DECEMBER 31, 2010
MONTREALJune 2, 2010Theratechnologies Inc. (the Company) (TSX: TH) today announced that Yves
Rosconi, its president and CEO, has informed the Board of Directors yesterday of his decision to
retire on December 31, 2010. Mr. Rosconi had been considering this prospect for several years, but
decided to defer his decision until the Companys lead product, tesamorelin, was in the final
stages of the approval process. Mr. Rosconi indicated that his decision was made following, among
other things, the positive outcome from the Advisory Committee of the US Food and Drug
Administrations (FDA) Division of Metabolism and Endocrinology Products, which was delivered on
Thursday May 27, 2010.
Yves Rosconi has played a key role in transforming Theratechnologies from a company that was
focussed on research and development into one that today has product commercialization in its
sights, said Paul Pommier, Chairman of the Companys Board of Directors. Under his leadership,
our Company accomplished a number of steps leading up to the unanimous recommendation from the
FDAs advisory committee. From the moment that Mr. Rosconi joined Theratechnologies he has had a
positive influence on our Company, our employees and our shareholders.
Since joining Theratechnologies in November 2004 as president and CEO, Yves Rosconi has attained
many of the Companys key objectives. Among his most notable achievements was the addition of
experienced individuals to the executive management team, choosing the appropriate clinical program
for tesamorelin, advancing tesamorelin through the final stages of development and regulatory
approval in the United States, and the signing of a major partnership agreement for the
commercialization of tesamorelin in that country. He also expanded and diversified the Companys
shareholder base in order to support it throughout these crucial years of development.
The Strategic Committee of the Board of Directors will begin immediately the formal search for a
new President and CEO. The Company is seeking to recruit a person with the requisite experience to
pursue Theratechnologies business plan and its growth.
I am extremely proud of what we have accomplished at Theratechnologies in recent years, said
Mr. Rosconi. We have worked very hard to get our lead product, tesamorelin, to where it is today.
The team and I remain fully engaged in obtaining FDA approval for tesamorelin.
The FDA has indicated that the expected date for completing the review of the New Drug Application
for tesamorelin is July 27, 2010.
Theratechnologies Inc.
2310, boul. Alfred-Nobel, Montréal (Québec) Canada H4S 2B4
Téléphone : 514 336-7800 Télécopieur : 514336-7242 www.theratech.com
1
Yves passion and determination have made Theratechnologies a major player in the biotechnology
sector in Canada, concluded Mr. Pommier. The Board of Directors thanks him for his keen sense of
responsibility, which will enable the Company to pursue its business plan and ensure a smooth
transition to the new President and CEO.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company
targets unmet medical needs in financially attractive specialty markets where it can retain all or
part of the commercial rights to its products. Its most advanced compound, tesamorelin, is an
analogue of the human growth hormone releasing factor. In 2009, Theratechnologies submitted a New
Drug Application to the US Food and Drug Administration, seeking approval of tesamorelin for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The Companys growth
strategy is centered on the commercialization of tesamorelin in the United States and in other
markets for HIV-associated lipodystrophy, as well as the development of clinical programs for
tesamorelin in other medical conditions.
INFORMATION:
Andrea Gilpin
Vice-president, Investor Relations and Communications
Theratechnologies Inc.
514-336-7800, ext. 205
communications@theratech.com
Theratechnologies Inc.
2310, boul. Alfred-Nobel, Montréal (Québec) Canada H4S 2B4
Téléphone : 514 336-7800 Télécopieur : 514336-7242 www.theratech.com
2
ex-99.72
Exhibit 99.72
News
Release
Theratechnologies announces positive vote by FDA Advisory Committee for tesamorelin
Montreal, Canada May 27, 2010 Theratechnologies (TSX:TH) today announced that the U.S.
Food and Drug Administration (FDA or the Agency) Endocrinologic and Metabolic Drugs
Advisory Committee recommended by a 16 to 0 unanimous vote that tesamorelin, a growth hormone
releasing factor, should be granted marketing approval by the FDA for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy, based on a favorable benefit-risk
profile.
We are pleased with the outcome of the Advisory Committee. This recommendation reinforces our
belief that the tesamorelin benefit-risk profile seen in clinical trials in HIV-patients with
excess visceral abdominal fat supports approval for this indication, commented Mr. Yves
Rosconi, President and Chief Executive Officer of Theratechnologies. The Advisory Committee
recommendation is another important step forward for the Company. It is especially significant
for those patients who suffer from this serious metabolic complication, where today no
treatment option exists, Mr. Rosconi concluded.
Although advisory committees provide their recommendations to the Agency, the final decisions
on marketing approvals are made by the FDA. The FDA has indicated that the action goal date,
which is the target date for the FDA to complete its review of the tesamorelin New Drug
Application, will be July 27, 2010.
In 2008, Theratechnologies entered into a collaboration and licensing agreement with EMD
Serono, Inc. (an affiliate of Merck KGaA, Darmstadt, Germany), for the exclusive
commercialization rights to tesamorelin in the United States for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy.
About HIV-Associated Lipodystrophy
Several factors including a patients antiretroviral drug regimen and the HIV virus itself are
thought to contribute to HIV-associated lipodystrophy, which is characterized by body
composition changes, dyslipidemia and glucose intolerance. The changes in body composition
include excess abdominal fat accumulation. There is currently no approved treatment available
for the excess abdominal fat in HIV-infected patients with lipodystrophy.
About tesamorelin
Tesamorelin is a novel, stabilized analogue of growth hormone releasing factor (GRF). GRF is a
hypothalamic peptide that acts on the pituitary cells in the brain to stimulate the synthesis
and pulsatile release of endogenous growth hormone (GH).
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that
discovers and develops innovative therapeutic products, with an emphasis on peptides, for
commercialization. The Company targets unmet medical needs in financially attractive specialty
markets where it can retain all or part of the commercial rights to its products. Its most
advanced compound, tesamorelin, is an analogue of the
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
human growth hormone releasing factor. In
2009, Theratechnologies submitted a New Drug Application to the U.S. Food and Drug
Administration, seeking approval of tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy. The Companys growth strategy is centered on the
commercialization of tesamorelin in the United States and in other markets for HIV-associated
lipodystrophy, as well as the development of clinical programs for tesamorelin in other medical
conditions.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking
information within the meaning of applicable securities legislation. This forward-looking
information includes, but is not limited to: information regarding the growth of
Theratechnologies through the development of tesamorelin and additional clinical programs.
Words such as will, may, could, should, outlook, believe, plan, envisage,
anticipate, expect and estimate, or the variations of them denote forward-looking
information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control, that could cause
actual results to differ materially from those that are disclosed in or implied by such
forward-looking information. These risks and uncertainties include, but are not limited to: the
inability of Theratechnologies to further develop tesamorelin as a result of serious adverse
events related to its administration or non-conclusive results from additional development
programs. The Company refers potential investors to the Risks and Uncertainties section of
its Annual Information Form (the AIF) dated February 23, 2010. The AIF is available at
www.sedar.com under the Companys public filings. The reader is cautioned to consider these and
other risks and uncertainties carefully and not to put undue reliance on forward-looking
statements.
Forward-looking information reflects current expectations regarding future events and speaks
only as of the date of this press release and represents the Companys expectations as of that
date. The Company does not undertake to update or amend such forward-looking information
whether as a result of new information, future events or otherwise, except as may be required
by applicable law.
-30-
Contact:
Investor relations contact
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514-331-4320
communications@theratech.com
Page 2 of 3
Media contacts
Media in Canada, please contact:
Roch Landriault
National Public Relations
Phone: 514-843-2345
rlandriault@national.ca
Media in the United States, please contact:
Becky Lauer
MS&L Group
Mobile: 917-304-6138
Office: 212-468-4125
becky.lauer@mslworldwide.com
Page 3 of 3
ex-99.73
Exhibit 99.73
News Release
THERATECHNOLOGIES TO PRESENT AT BIOFINANCE 2010 CONFERENCE
Montréal, Canada, April 5, 2010 Theratechnologies (TSX: TH) announced today that
Yves Rosconi, President and Chief Executive Officer, will present an overview of the Company at
the BioFinance 2010 Conference, being held this week in Toronto. Mr. Rosconi will be speaking at
11:00 a.m., on Wednesday, April 7, in the Trinity II Room of the Toronto Marriott Eaton Centre.
BioFinance is the Canadian life science industrys leading investor conference that brings
together key industry players to consider investment opportunities and issues affecting companies
in biotechnology.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The
Company targets unmet medical needs in financially attractive specialty markets where it can
retain all or part of the commercial rights to its products. Its most advanced compound,
tesamorelin, is an analogue of the human growth hormone releasing factor. In 2009,
Theratechnologies submitted a New Drug Application to the U.S. Food and Drug Administration,
seeking approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. The Companys growth strategy is centered on the commercialization
of tesamorelin in the United States and in other markets for HIV-associated lipodystrophy, as
well as the development of clinical programs for tesamorelin in other medical conditions.
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
ex-99.74
Exhibit 99.74
News Release
THERATECHNOLOGIES REPORTS POSITIVE OUTCOME AT ITS
ANNUAL AND SPECIAL MEETING OF SHAREHOLDERS
Montreal, Canada March 25, 2010 Theratechnologies Inc. (TSX:TH) is pleased to announce
that it held its annual and special meeting of shareholders in Montreal today. At the meeting,
the shareholders of the Company re-elected the current members of the Board of Directors to act
as directors, designated KPMG LLP to act as auditors of the Company for the ensuing year and
approved the Shareholder Rights Plan. The Shareholder Rights Plan is designed to provide
adequate time for the Board of Directors and the shareholders to assess an unsolicited takeover
bid for Theratechnologies.
Speaking to the shareholders, Mr. Paul Pommier, Chairman of the Board of Theratechnologies,
indicated that the submission of the New Drug Application (NDA) to the Food and Drug
Administration (FDA) in the United States, and its acceptance for review, was a major
accomplishment in 2009. He continued by saying that, every step is one closer to
Theratechnologies becoming a revenue-generating company.
Mr. Pommier assured shareholders that, in 2010, the focus will continue to be on the
development of the tesamorelin asset to maximize shareholder value. He noted that
Theratechnologies will work together with its existing partner, and/or any future partners, to
take full advantage of the commercial opportunities that exist for tesamorelin in the U.S. and
in other geographies.
Following Mr. Pommiers remarks, Mr. Yves Rosconi, President and Chief Executive Officer of
Theratechnologies, offered an overview of the Companys accomplishments over the last year.
With the major corporate objective of submitting the NDA being met, Mr. Rosconi stated: The
fact that our file was accepted for review by the FDA without requiring further modifications
speaks to the quality of the work presented in our file. In addition, he noted, I believe
that the regulatory review process is moving in the right direction.
Mr. Rosconi reminded shareholders that the public meeting before the Advisory Committee of the
FDA was now confirmed for May 27th, and that internal teams at Theratechnologies were actively
working to prepare for this meeting. Mr. Rosconi added, With a partner in hand, who is
responsible for commercialization in the U.S., we are now working towards entering into
agreements with qualified partners in additional geographies.
Mr. Rosconi concluded his remarks for the current year by citing important targeted milestones
to be achieved by the Company. These include: approval for tesamorelin in the United States,
the signing of partnerships for additional geographies, as well as the design of additional
clinical programs with tesamorelin.
Theratechnologies Senior Executive Vice-President and Chief Financial Officer, Mr. Luc
Tanguay, provided an overview of the Companys financial position. Commenting on results made
public earlier this week, Mr. Tanguay said that Theratechnologies had completed the first
quarter 2010 with $57 million in liquidities and reduced its burn rate. He added that this
situation was due mainly to payments received from its commercial partner, combined with a
decrease in expenses. With additional potential milestone payments and a lower burn-rate of
approximately $24 million in 2010, we should expect to be in a good cash position at the end of
this year, noted Mr. Tanguay.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The
Company targets unmet medical needs in financially attractive specialty markets where it
can retain all or part of the commercial rights to its products. Its most advanced compound,
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
tesamorelin, is an analogue of the human growth hormone releasing factor. In 2009,
Theratechnologies submitted a New Drug Application to the U.S. Food and Drug Administration,
seeking approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. The Companys growth strategy is centered on the commercialization
of tesamorelin in the United States and in other markets for HIV-associated lipodystrophy, as
well as the development of clinical programs for tesamorelin in other medical conditions.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking
information within the meaning of applicable securities legislation. This forward-looking
information includes, but is not limited to, information regarding the potential revenues to be
generated by the Company, the entering into of strategic alliance agreements with partners in
geographies other than the United States, the initiation of clinical programs with tesamorelin
and the receipt of milestone payments. Furthermore, the words will, may, could, should,
outlook, believe, plan, envisage, anticipate, expect and estimate, or variations
of them denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such
forward-looking information. These risks and uncertainties include, but are not limited to, the
risk that tesamorelin is not approved by the FDA for commercial sale in the United States, the
risk that the Company is unable to conclude agreements with partners relating to tesamorelin in
geographies other than the Unites States, the risk that the design of clinical programs be
delayed and the risk that no payment is received if the Company does not meet its milestones.
Although the forward-looking information contained herein is based upon what the Company
believes are reasonable assumptions, investors are cautioned against placing undue reliance on
this information since actual results may vary from the forward-looking information. Certain
assumptions made in preparing the forward-looking information and the Companys objectives
include the assumption, among others, that the FDA will approve tesamorelin for commercial sale
in the United States, the Company will enter into agreements with partners in geographies other
than the United States and the Company will meet its milestones and receive the payments
related thereto.
Consequently, all of the forward-looking information is qualified by the foregoing cautionary
statements, and there can be no guarantee that the results or developments anticipated by the
Company will be realized or, even if substantially realized, that they will have the expected
consequences or effects on the Company, its business, its financial condition or its results of
operation. Furthermore, the forward-looking information reflects current expectations regarding
future events only as of the date of release of this press release.
Investors are referred to the Companys public filings available at www.sedar.com. In
particular, further details and descriptions of these risks are disclosed in the Risk and
Uncertainties section of the Companys Annual Information Form, dated February 23, 2010, for
the year ended November 30, 2009.
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
2
ex-99.75
Exhibit 99.75
News Release
THERATECHNOLOGIES ANNOUNCES FINANCIAL RESULTS AND CLOSES THE FIRST
QUARTER IN A STRONG FINANCIAL POSITION
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$57 M liquidity position and lower R&D expenses |
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New date set for FDA Advisory Committee meeting |
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Results from the second Phase 3 trial published in the medical journal JAIDS |
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|
Patents granted for tesamorelin in Brazil and Australia |
Montréal, Canada March 23, 2010 - Theratechnologies (TSX: TH) today announced its financial
results for the first quarter ended February 28, 2010.
We finished the first quarter of 2010 with a solid balance sheet including $57 million of
liquidity, which positions us well to pursue our business plan, noted Mr. Luc Tanguay, Senior
Executive Vice President and CFO of Theratechnologies. Furthermore, our research and development
expense decreased by 35% compared to the first quarter of 2009. This planned expense reduction
helped to reduce the first quarter loss compared to the same period in 2009, Mr. Tanguay
concluded.
The first quarter of 2010 was devoted to preparing for our participation in the public hearing of
the FDAs Endocrinologic and Metabolic Drugs Advisory Committee, stated Yves Rosconi, President
and CEO of Theratechnologies. Concurrently with these preparations, we continued to seek out
partners for tesamorelin in additional markets and these efforts are going well, he added. We
will be presenting an overview of our activities and strategic initiatives to shareholders at the
annual and special meeting of shareholders this week at the Centre Mont-Royal, Mr. Rosconi
concluded.
Reminder: Theratechnologies will be holding its annual and special meeting of shareholders this
Thursday, the 25th of March, in the Salon International of the Centre Mont-Royal, 2200
rue Mansfield, Montréal.
Highlights
New date for the FDA Advisory Committee meeting
The U.S. Food and Drug Administration (FDA) has set a new date of May 27, 2010 for the
Endocrinologic and Metabolic Drugs Advisory Committee meeting. The purpose of the meeting is to
review Theratechnologies New Drug Application (NDA) for tesamorelin, which was submitted on May
29, 2009. The Advisory Committee meeting was originally scheduled for February 24, 2010 but was
postponed due to administrative delays at the FDA. As a result of this postponement, the FDA has
indicated that the action goal date, which is the target date for the FDA to complete its review of
the tesamorelin NDA, will be July 27, 2010.
The role of the Advisory Committee is to provide the FDA with advice from independent experts and
other interested parties on the use of tesamorelin. Even though advisory committees address
questions posed to them through public meetings, the final decision on the approval of a product
remains solely with the FDA.
Results from the second Phase 3 trial published in the medical journal JAIDS
An article entitled, Effects of Tesamorelin, a Growth Hormone-Releasing Factor, in HIV-Infected
Patients With Abdominal Fat Accumulation: A Randomized Placebo-Controlled Trial With a Safety
Extension, has been published in the March 1st issue of The Journal of Acquired Immune Deficiency
Syndromes (JAIDS). The article outlines, in detail, the 52-week data of the second Phase 3 trial,
in evaluating tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy. Top-line results of the study were first disclosed in December 2008.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
Patents granted for tesamorelin in Brazil and Australia
On February 25, 2010, the Australian Patent Office granted Theratechnologies patent number
2003229222 entitled GRF Analogue Compositions and their Use covering the pharmaceutical
formulation and the method of treating HIV-associated lipodystrophy with tesamorelin. Obtaining
this patent provides protection for tesamorelin in Australia until May 2013. On December 29, 2009,
the Brazil Patent and Trademark Office issued a patent to Theratechnologies for tesamorelin
granting protection in that territory until December 2019.
MANAGEMENTS DISCUSSION AND ANALYSIS FOR THE FIRST QUARTER
Revenues
Consolidated revenues for the three-month period ended February 28, 2010, amounted to $2,295,000
compared to $2,009,000 for 2009. The increased revenues in 2010 are related to a longer
amortization period (3 months in 2010 versus 2.5 months in 2009) for the initial payment of the
collaboration and licensing agreement with EMD Serono, Inc. (EMD Serono).
The initial payment of $27,097,000 has been deferred and is being amortized over its estimated
service period on a straight-line basis. This period may be modified in the future based on
additional information that the Company may receive. For the three-month period ended February 28,
2010, an amount of $1,711,000 ($1,426,000 for the same period in 2009) related to this transaction
was recognized as revenue. At February 28, 2010, the deferred revenues related to this transaction
recorded on the balance sheet amounted to $18,826,000.
R&D Activities
Research and development (R&D) expenditures, before tax credits, totalled $4,109,000 for the
first quarter of 2010, compared to $6,315,000 in 2009. The R&D expenses incurred in the first
quarter of 2010 are mainly related to the primary objective of the Company, which encompasses the
regulatory activities connected with the preparation for the FDA Advisory Committee meeting. This
explains the planned reduction in R&D expenses. The research and development expenses incurred in
the first quarter of 2009 are essentially related to closing activities for the confirmatory Phase
3 study.
Other Expenses
For the first quarter of 2010, general and administrative expenses amounted to $1,801,000, compared
to $2,321,000 for the same period in 2009. These expenses are comparable to those of 2009, with the
exception of exchange loss and the costs associated with revising the Companys business plan in
2009.
Selling and market development costs amounted to $616,000 for the first quarter of 2010, compared
to $481,000 for the same period in 2009. The sales and market development expenses are principally
composed of business development and market research expenses outside the United States and the
costs of managing the agreement with EMD Serono.
In the first quarter of 2010, patents amounted to $204,000 and were principally related to costs
associated with patents for the preclinical programs.
In 2009, the Company incurred expenses of $4,269,000 associated with the closing of the
agreement with EMD Serono.
Net Results
Taking into account the revenues and expenses described above, the Company recorded a first
quarter 2010 net loss of $4,267,000 ($0.07 per share), compared to a net loss of $10,754,000
($0.18 per share) for the same period in 2009.
2
The net loss in 2010 includes revenues of $1,711,000 related to the agreement with EMD Serono.
Excluding this item, the adjusted net loss (see Annex A) amounted to $5,978,000 in 2010, a decrease
of 24.4% compared to the same period in 2009.
Quarterly Financial Information
The selected financial information provided below is derived from the Companys unaudited quarterly
financial statements for each of the last eight quarters. This information has been restated
following the adoption of the Canadian Institute of Chartered Accountants (CICA) Handbook Section
3064, Goodwill and Intangible Assets.
(in thousands of Canadian dollars, except per share amounts)
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2010 |
|
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2009 |
|
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|
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2008 |
|
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|
|
Q1 |
|
|
Q4 |
|
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Q3 |
|
|
Q2 |
|
|
Q1 |
|
|
Q4 |
|
|
Q3 |
|
|
Q2 |
|
|
Revenues |
|
$ |
2,295 |
|
|
$ |
2,246 |
|
|
$ |
13,148 |
|
|
$ |
2,317 |
|
|
$ |
2,009 |
|
|
$ |
616 |
|
|
$ |
710 |
|
|
$ |
716 |
|
Net (loss)
earnings |
|
$ |
(4,267 |
) |
|
$ |
(4,698 |
) |
|
$ |
5,824 |
|
|
$ |
(5,430 |
) |
|
$ |
(10,754 |
) |
|
$ |
(15,145 |
) |
|
$ |
(11,220 |
) |
|
$ |
(11,382 |
) |
Basic and
diluted
(loss)
earnings
per share |
|
$ |
(0.07 |
) |
|
$ |
(0.08 |
) |
|
$ |
0.10 |
|
|
$ |
(0.09 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.20 |
) |
|
As described above, the increased revenues in 2010 and 2009 are related to the amortization of
the initial payment received at the closing of the agreement with EMD Serono, as well as the
milestone payment of $10,884,000 recorded in August 2009. The increase in the fourth quarter net
loss in 2008 is due to impairment charges for intellectual property.
Financial Position
At February 28, 2010, liquidities, which include cash and bonds, amounted to $55,289,000, and tax
credits receivable amounted to $1,834,000 for a total of $57,123,000.
For the three-month period ended February 28, 2010, the burn rate from operating activities,
excluding changes in operating assets and liabilities, was $3,861,000, compared to $10,412,000 in
2009. Excluding the revenue of $1,711,000 related to the agreement with EMD Serono, the adjusted
burn rate from operating activities, excluding changes in operating assets and liabilities (see
Annex A), was $5,572,000 for the quarter ended February 28, 2010, compared to $7 569 000 for the
first quarter of 2009, a decrease of 26.4%.
New Accounting Policies
In February 2008, the Accounting Standards Board of Canada (AcSB) announced that accounting
standards in Canada, as used by public companies, will converge with International Financial
Reporting Standards (IFRS). The Companys changeover date from current Canadian generally
accepted accounting principles (GAAP) to IFRS applies to the interim and annual financial
statements of the fiscal year beginning December 1, 2011, when the Company will report financial
information for both the first quarter and comparative period using IFRS.
IFRS uses a conceptual framework similar to Canadian GAAP, but there are significant differences in
recognition, measurement and disclosures.
The Companys IFRS convergence project includes four steps: diagnostic and planning, detailed
analysis, design, and implementation.
Phase One: Diagnostic Phase - This phase involves establishing a project plan for IFRS
convergence and the initial identification of differences between Canadian GAAP and IFRS.
3
The Company is currently assessing the conversion of its consolidated financial statements to IFRS
and expects to complete this phase in the next quarter. It is not presently possible to determine
the impact of converting to IFRS on the consolidated financial statements or on the Companys
business because the diagnostic phase has not been completed. Once it is completed, the Company
will be in a position to confirm the schedule for the following phases.
Phase Two: Detailed Analysis This phase involves a comprehensive assessment of the differences
between IFRS and the Companys current accounting policies in order to evaluate the impact on the
Company. In addition, the detailed analysis will identify training requirements, and determine
eventual changes to business processes and information systems.
Phase Three: Design This phase consists of an analysis of the available accounting options under
IFRS, notably the exceptions, exemptions and actual choices available for the transition and the
preparation of draft IFRS financial statements and the accompanying notes. In addition, it is
during this phase that changes to the business processes and the information systems are designed.
Phase Four: Implementation This phase involves implementing changes to systems, business
processes and internal controls, determining the opening IFRS transition balance sheet and the
impact on taxation, parallel accounting under Canadian GAAP and IFRS and preparing detailed
reconciliations between Canadian GAAP and IFRS financial statements.
Outstanding Share Data
On March 22, 2010, the number of shares issued and outstanding was 60,450,890, while
outstanding options granted under the stock option plan were 2,883,636.
Contractual Obligations
There were no material changes in contractual obligations during the quarter, other than in the
ordinary course of business.
Economic and Industry Factors
Economic and industry factors were substantially unchanged from those reported in the Companys
2009 Annual Report.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company
targets unmet medical needs in financially attractive specialty markets where it can retain all or
part of the commercial rights to its products. Its most advanced compound, tesamorelin, is an
analogue of the human growth hormone releasing factor. In 2009, Theratechnologies submitted a New
Drug Application to the U.S. Food and Drug Administration, seeking approval of tesamorelin for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The Companys growth
strategy is centered on the commercialization of tesamorelin in the United States and in other
markets for HIV-associated lipodystrophy, as well as the development of clinical programs for
tesamorelin in other medical conditions.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Companys website at
www.theratech.com. Additional information, including the Annual Information Form and the Annual
Report, is also available on SEDAR at www.sedar.com.
Forward-Looking Information
This press release and the Managements Discussion and Analysis for the first quarter incorporated
therein contain certain statements that are considered forward-looking information within the
meaning of applicable securities legislation. This forward-looking information includes, but is not
limited to, information regarding the pursuit of the Companys business plan with the funds that it
has available, the search for partners in new markets and the completion of a transition plan for
4
IFRS. Furthermore, the words will, may, could, should, outlook, believe, plan,
envisage, anticipate, expect and estimate, or variations of them denote forward-looking
information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties include, but are not limited to, the risk that the
Companys funding needs may change, that the Company is unable to conclude agreements with partners
in new markets for tesamorelin and that the timeline for preparing a transition plan for IFRS is
not met.
Although the forward-looking information contained herein is based upon what the Company believes
are reasonable assumptions, investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking information. Certain assumptions
made in preparing the forward-looking information and the Companys objectives include the
assumption, among others, that the operating activities of the Company will conform to its business
plan, the Company will reach agreements with partners in new markets for tesamorelin and the
Company will not experience any difficulties in preparing a transition plan for IFRS.
Consequently, all of the forward-looking information is qualified by the foregoing cautionary
statements, and there can be no guarantee that the results or developments anticipated by the
Company will be realized or, even if substantially realized, that they will have the expected
consequences or effects on the Company, its business, its financial condition or its results of
operation. Furthermore, the forward-looking information reflects current expectations regarding
future events only as of the date of release of this press release.
Investors are referred to the Companys public filings available at www.sedar.com. In
particular, further details on these risks and descriptions of these risks are disclosed in the
Risk and Uncertainties section of the Companys Annual Information Form, dated February 23, 2010,
for the year ended November 30, 2009.
Information:
Andrea Gilpin
Vice President, IR & Communications
Phone: 514-336-7800, ext. 205
communications@theratech.com
Luc Tanguay
Senior Executive Vice President and
Chief Financial Officer
Phone: 514-336-7800, ext. 204
ltanguay@theratech.com
5
ANNEX A
Non-GAAP measures
The Company uses measures that do not conform to generally accepted accounting principles (GAAP)
to assess its operating performance. Securities regulators require that companies caution readers
that earnings and other measures adjusted to a basis other than GAAP do not have standardized
meanings and are unlikely to be comparable to similar measures used by other companies.
Accordingly, these measures should not be considered in isolation. The Company uses non-GAAP
measures such as adjusted net loss and the adjusted burn rate from operating activities before
changes in operating assets and liabilities, to measure its performance from one period to the next
without including changes caused by certain items that could potentially distort the analysis of
trends in its operating performance, and because such measures provide meaningful information on
the Companys financial condition and operating results.
Definition and reconciliation of non-GAAP measures
In order to measure performance from one period to another, without accounting for changes related
to revenues and fees associated with the collaboration and license agreement with EMD Serono,
management uses adjusted net loss and adjusted burn rate from operating activities before changes
in operating assets and liabilities. These items are excluded because they affect the comparability
of the financial results and could potentially distort the analysis of trends in the Companys
operating performance. The exclusion of these items does not necessarily indicate that they are
non-recurring.
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First Quarter |
(Thousands of dollars) |
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2010 |
|
2009 |
Adjusted net loss |
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Net loss, per the financial statements |
|
$ |
(4,267 |
) |
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$ |
(10,754 |
) |
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Adjustments: |
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Revenues associated with a collaboration and license agreement
(note 6 to the consolidated financial statements) |
|
$ |
(1,711 |
) |
|
$ |
(1,426 |
) |
Fees associated with collaboration and license agreement |
|
|
|
|
|
$ |
4,269 |
|
|
|
|
Adjusted net loss |
|
$ |
(5,978 |
) |
|
$ |
(7,911 |
) |
|
|
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|
|
|
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|
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|
First Quarter |
|
|
2010 |
|
2009 |
Adjusted burn rate before changes in operating assets and liabilities |
|
|
|
|
|
|
|
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Burn rate before changes in operating assets and liabilities, per the
financial statements |
|
$ |
(3,861 |
) |
|
$ |
(10,412 |
) |
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Adjustments: |
|
|
|
|
|
|
|
|
Revenues associated with a collaboration and license agreement
(note 6 to the consolidated financial statements) |
|
$ |
(1,711 |
) |
|
$ |
(1,426 |
) |
Fees associated with collaboration and license agreement |
|
|
|
|
|
$ |
4,269 |
|
|
|
|
Adjusted burn rate before changes in operating assets and liabilities |
|
$ |
(5,572 |
) |
|
$ |
(7,569 |
) |
|
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|
6
ex-99.76
Exhibit 99.76
News
Release
THERATECHNOLOGIES: ANNUAL AND SPECIAL MEETING OF SHAREHOLDERS
Montréal, Canada, March 22, 2010 Mr. Paul Pommier, Chairman of the Board of
Theratechnologies (TSX:TH) and Mr. Yves Rosconi, President and Chief Executive Officer,
invite shareholders to Theratechnologies Annual and Special Meeting that will be held on
Thursday, March 25, 2010, at 10:00 a.m., at the Centre Mont-Royal, 2200 Mansfield, in
Montréal.
|
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What:
|
|
Theratechnologies Annual and Special Meeting of Shareholders |
|
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When:
|
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Thursday, March 25, 2010 at 10:00 a.m. |
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Where:
|
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Centre Mont-Royal |
|
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2200 Mansfield, Montréal |
|
|
International Room |
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and
develops innovative therapeutic products, with an emphasis on peptides, for
commercialization. The Company targets unmet medical needs in financially attractive
specialty markets where it can retain all or part of the commercial rights to its products.
Its most advanced compound, tesamorelin, is an analogue of the human growth hormone
releasing factor. In 2009, Theratechnologies submitted a New Drug Application to the U.S.
Food and Drug Administration, seeking approval of tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy. The Companys growth strategy is
centered on the commercialization of tesamorelin in the United States and in other markets
for HIV-associated lipodystrophy, as well as the development of clinical programs for
tesamorelin in other medical conditions.
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2A4
Phone: (514) 336-7800 Fax: (514) 336-7242 www.theratech.com thera@theratech.com
ex-99.77
Exhibit 99.77
News
Release
FDA Confirms Date for Advisory Committee Review of the Tesamorelin New Drug Application
Montreal, Canada March 22, 2010 Theratechnologies (TSX:TH) today announced that the U.S.
Food and Drug Administration (FDA) has confirmed that the Endocrinologic and Metabolic Drugs
Advisory Committee will meet to review Theratechnologies New Drug Application (NDA) for
tesamorelin on Thursday, May 27, 2010. The meeting will take place at The Inn and Conference
Center, University of Maryland University College (3501 University Blvd. East, Adelphi,
Maryland). Information related to the meeting is available on The Office of the Federal
Register web site at: www.federalregister.gov
Theratechnologies submitted an NDA to the FDA on May 29, 2009, for tesamorelin, an analogue of
the human growth hormone releasing factor proposed for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy. The FDA filed the NDA on August 12, 2009, which
initiated a substantive review of the application. The Advisory Committee meeting was
originally scheduled for February 24, 2010, but was postponed due to administrative delays at
the FDA. As a result of this postponement, the FDA has indicated that the action goal date,
which is the target date for the FDA to complete its review of the tesamorelin NDA, will be
extended to July 27, 2010.
About HIV-Associated Lipodystrophy
Several factors including a patients antiretroviral drug regimen and the HIV virus itself are
thought to contribute to HIV-associated lipodystrophy, which is characterized by body
composition changes, dyslipidemia and glucose intolerance. The changes in body composition
include excess abdominal fat accumulation. There is currently no approved treatment available
for the excess abdominal fat related to HIV-associated lipodystrophy.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The
Company targets unmet medical needs in financially attractive specialty markets where it can
retain all or part of the commercial rights to its products. Its most advanced compound,
tesamorelin, is an analogue of the human growth hormone releasing factor. In 2009,
Theratechnologies submitted a New Drug Application to the U.S. Food and Drug Administration,
seeking approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. The Companys growth strategy is centered on the commercialization
of tesamorelin in the United States and in other markets for HIV-associated lipodystrophy, as
well as the development of clinical programs for tesamorelin in other medical conditions.
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
ex-99.78
Exhibit 99.78
News
Release
Theratechnologies Announces Publication of Second Phase 3 Results in JAIDS
Montreal, Canada March 1, 2010 Theratechnologies (TSX: TH) today announced that the
article entitled, Effects of Tesamorelin, a Growth Hormone-Releasing Factor, in HIV-Infected
Patients With Abdominal Fat Accumulation: A Randomized Placebo-Controlled Trial With a Safety
Extension, has been published in the March 1st issue of JAIDS Journal of Acquired Immune
Deficiency Syndromes (Volume 53: pages 311-322)
(http://journals.lww.com/jaids/pages/default.aspx).The article outlines, in detail, the 52-week
data of the second Phase 3 trial, in evaluating tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy. Top-line results were initially
disclosed in December 2008.
We are proud to have data from our Phase 3 clinical program published in another recognized
scientific publication, commented Mr. Yves Rosconi, President and Chief Executive Officer of
Theratechnologies. This publication in JAIDS demonstrates, once again, a great interest on the
part of the scientific community for tesamorelin, concluded Mr. Rosconi.
About HIV-Associated Lipodystrophy
Several factors including a patients antiretroviral drug regimen and the HIV virus itself are
thought to contribute to HIV-associated lipodystrophy, which is characterized by body
composition changes, dyslipidemia and glucose intolerance. The changes in body composition
include excess abdominal fat accumulation. There is currently no approved treatment available
for the excess abdominal fat related to HIV-associated lipodystrophy.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The
Company targets unmet medical needs in financially attractive specialty markets where it can
retain all or part of the commercial rights to its products. Its most advanced compound,
tesamorelin, is an analogue of the human growth hormone releasing factor. In 2009,
Theratechnologies submitted a New Drug Application to the U.S. Food and Drug Administration,
seeking approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. The Companys growth strategy is centered on the commercialization
of tesamorelin in the United States and in other markets for HIV-associated lipodystrophy, as
well as the development of clinical programs for tesamorelin in other medical conditions.
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
ex-99.79
Exhibit 99.79
News
Release
THERATECHNOLOGIES ANNOUNCES A TENTATIVE NEW DATE FOR THE FDA
ADVISORY COMMITTEE REVIEW OF THE TESAMORELIN NEW DRUG APPLICATION
Montreal, Canada February 25, 2010 Theratechnologies (TSX:TH) today announced that the U.S.
Food and Drug Administration (FDA) has set a tentative new date of May 27, 2010 for the
Endocrinologic and Metabolic Drugs Advisory Committee meeting to review Theratechnologies New
Drug Application (NDA) for tesamorelin. This information will be confirmed in the coming
weeks once it is published on the Office of the Federal Register web site at:
www.federalregister.gov.
Theratechnologies submitted an NDA to the FDA on May 29, 2009, for tesamorelin, an analogue of
the human growth hormone releasing factor proposed for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy. The FDA filed the NDA on August 12, 2009, which
initiated a substantive review of the application. The Advisory Committee meeting was
originally scheduled for February 24, 2010, but was postponed due to administrative delays at
the FDA. As a result of this postponement, the FDA has indicated that the action goal date,
which is the target date for the FDA to complete its review of the tesamorelin NDA, will be
extended to July 27, 2010.
About HIV-Associated Lipodystrophy
Several factors including a patients antiretroviral drug regimen and the HIV virus itself are
thought to contribute to HIV-associated lipodystrophy, which is characterized by body
composition changes, dyslipidemia and glucose intolerance. The changes in body composition
include excess abdominal fat accumulation. There is currently no approved treatment available
for the excess abdominal fat related to HIV-associated lipodystrophy.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products, with an emphasis on peptides, for commercialization. The
Company targets unmet medical needs in financially attractive specialty markets where it can
retain all or part of the commercial rights to its products. Its most advanced compound,
tesamorelin, is an analogue of the human growth hormone releasing factor. In 2009,
Theratechnologies submitted a New Drug Application to the U.S. Food and Drug Administration,
seeking approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected
patients with lipodystrophy. The Companys growth strategy is centered on the commercialization
of tesamorelin in the United States and in other markets for HIV-associated lipodystrophy, as
well as the development of clinical programs for tesamorelin in other medical conditions.
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
ex-99.80
Exhibit 99.80
News Release
MILESTONES MET IN 2009 LEAD TO OPTIMISTIC OUTLOOK FOR THERATECHNOLOGIES
Theratechnologies announces financial results for the fourth quarter
and reviews highlights for the year 2009
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Conclusion of an agreement with EMD Serono |
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Filing of a New Drug Application with the FDA |
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Receipt of a US $10 M milestone payment |
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Invitation to appear before a FDA Advisory Committee |
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Granting of a patent for tesamorelin in Brazil |
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$65 M liquidity position |
Montréal, Canada February 10, 2010 - Theratechnologies (TSX: TH) today announced its
financial results for the fourth quarter ended November 30, 2009, and reviewed the years
highlights.
Theratechnologies had another great year in 2009, stated Yves Rosconi, President and CEO of
Theratechnologies. The year started off with the conclusion of the agreement with EMD Serono. Our
first priority under the terms of the agreement was to submit our New Drug Application to the FDA.
I am pleased to say that Theratechnologies was able to overcome this challenge and meet its set
objectives, continued Mr. Rosconi. Our regulatory filing is currently in the process of being
evaluated by the FDA and we are on the right track to achieving our principal objective, which is
to obtain approval for tesamorelin in the United States. Evidently, there is still work to do, and
our accomplishments in 2009 will allow us to view the year 2010 with optimism, concluded Mr.
Rosconi.
We ended the financial year, which was marked by a planned decrease in expenditures and by the
receipt of payments associated with the EMD Serono agreement, with over $65 M in cash, noted Mr.
Luc Tanguay, Senior Executive Vice President and CFO of Theratechnologies. With two potential
milestone payments associated with the approval of tesamorelin, we are well positioned to maintain
a solid balance sheet in 2010, Mr. Tanguay concluded.
Highlights
Agreement signed with EMD Serono
On December 15, 2008, Theratechnologies completed the transaction related to the collaboration and
licensing agreement with EMD Serono, Inc. (EMD Serono), an affiliate of Merck KGaA, of Darmstadt,
Germany. Under the terms of the agreement, Theratechnologies received US $30 M (CAD $37.0 M) which
included an initial payment of US $22 M (CAD $27.1 M) from EMD Serono and a subscription totalling
US $8 M (CAD $9.9 M) for common shares in the Company by Merck KGaA. Under the agreement,
Theratechnologies may receive up to US $215 M including the initial payment as well as payments
based on the achievement of certain development, regulatory and sales milestones. Furthermore,
Theratechnologies will be entitled to receive increasing royalties on annual net sales of
tesamorelin in the United States.
Submission of a New Drug Application to the FDA
On May 29, 2009, Theratechnologies submitted a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA), for the approval of tesamorelin, an analogue of the human growth
hormone releasing factor, in the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
Receipt of a US $10 M milestone payment
In accordance with the terms of the Companys collaboration and licensing agreement with EMD
Serono, Theratechnologies received a milestone payment of US $10 M (CAN $10.9 M) associated with
the FDAs acceptance of the NDA for tesamorelin. The acceptance of the NDA, which occurred August
12, 2009, marked the continuance of the review by the FDA of the application submitted by
Theratechnologies.
Invitation to appear before a FDA Advisory Committee
As part of the review of its regulatory filing, Theratechnologies is preparing for a public meeting
before the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA. Initially scheduled
for February 24, 2010, the meeting was postponeddue to administrative delays at the FDAuntil a
later date which has not yet been determined. The role of the Advisory Committee is to provide the
FDA with advice from independent experts and other interested parties on the use of tesamorelin.
Even though advisory committees address questions posed by the regulatory authorities through
public meetings, the final decision on the approval of a product remains solely with the FDA.
Issuance of a patent for tesamorelin in Brazil
On December 29, 2009, the Brazil Patent and Trademark Office issued Patent Number PI 9608799-4
entitled Chimeric fatty body-pro-GRF analog with increased biological potency and pharmaceutical
formulation for tesamorelin. The granting of this patent provides protection in Brazil until
December 2019.
MANAGEMENTS DISCUSSION AND ANALYSIS FOR THE FOURTH QUARTER
Revenues
Consolidated revenues for the three-month period ended November 30, 2009, amounted to $2,246,000
compared to $616,000 for the same period in 2008. For the year ended November 30, 2009,
consolidated revenues were $19,720,000 compared to $2,641,000 for the same period in 2008.
Royalties, technologies and other
The increased revenues in 2009 are related to the initial payment received on December 15, 2008,
upon the closing of the collaboration and licensing agreement with EMD Serono, Inc. (EMD Serono)
as well as the receipt of a milestone payment of $10,884,000 during the third quarter of 2009.
The payment of US $30,000,000 (CAD $36,951,000) included an initial payment of US $22,000,000 (CAD
$27,097,000) and a subscription for common shares by Merck KGaA at a price of US $3.67 (CAD $4.52)
per share, resulting in gross proceeds of US $8,000,000 (CAD $9,854,000). The initial payment of
$27,097,000 has been deferred and is being amortized over its estimated service period on a
straight-line basis. This period may be modified in the future based on additional information that
the Company may receive related to the estimated service period. For the year ended November 30,
2009, an amount of $6,560,000 related to this transaction was recognized as revenue. At November
30, 2009, the deferred revenues related to this transaction recorded on the balance sheet amounted
to $20,537,000.
The milestone payment of $10,884,000, received during the third quarter under the terms of the
collaboration and licensing agreement with EMD Serono, is associated with the acceptance by the
U.S. Food and Drug Administration (FDA) to review the New Drug Application (NDA) for
tesamorelin that was submitted by Theratechnologies on May 29, 2009. Under the terms of the
collaboration and licensing agreement with EMD Serono, a milestone payment of US $10,000,000 was
associated with the FDAs acceptance to review the NDA for tesamorelin. All milestone payments,
including the aforementioned payment, are recorded as they are earned, upon the achievement of
predetermined milestones specified in the agreement.
Interest
Interest revenues for the three-month period ended November 30, 2009, amounted to $528,000 compared
to $518,000 for the same period in 2008. For the year ended November 30, 2009, interest revenues
were $2,252,000 compared to $2,427,000 for the same period in 2008. The decrease in interest
revenues during the three-month period is associated with lower interest rates during the year,
which translated to a lower return on investment. In the fourth quarter of 2009, this decrease in
interest rates was compensated by an increase in the average level of investments.
R&D Activities
Research and Development (R&D) expenditures, before tax credits, totalled $4,534,000 for the
fourth quarter of 2009, compared to $6,313,000 for the same period in 2008, representing a decrease
of 28.2%. For the year ended November 30, 2009, R&D expenditures were $22,226,000, compared to
$35,326,000 for the same period in 2008, representing a decrease of 37.1%. These lower levels of
R&D expenses are due to the conclusion of the Phase 3 clinical program in the first half of 2009.
The R&D expenses in 2009 include a non-recurring charge of $1,377,000 associated with research
material produced to obtain stability data and to validate the commercial production process as
requested by the FDA. The R&D expenses incurred in the fourth quarter of 2009 are mainly related to
follow up on the regulatory filing notably managing responses to the FDAs questions, a normal part
of the review process, and the preparation for the FDA Advisory Committee meeting as well as the
preparation for larger-scale production of tesamorelin.
Other Expenses
For the fourth quarter of 2009, general and administrative expenses amounted to $1,634,000,
compared to $1,874,000 for the same period in 2008. For the year ended November 30, 2009, general
and administrative expenses amounted to $7,149,000 compared to $6,185,000 for the same period in
2008. The increased expenses in 2009 are principally due to a higher exchange loss as well as costs
associated with revising the Companys business plan in the first quarter. The exchange losses are
due to the conversion of monetary assets and liabilities denominated in foreign currencies into
Canadian dollar equivalents using rates of exchange in effect on the balance sheet date.
Selling and market development costs amounted to $1,067,000 for the fourth quarter of 2009,
compared to $1,124,000 for the same period in 2008. For the year ended November 30, 2009, selling
and market development expenses amounted to $2,583,000, compared to $3,811,000 for the same period
in 2008. The decrease in selling and market development costs is due to the signing of an agreement
with EMD Serono for the U.S. commercialization of tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy. Since the signing of this agreement, the sales and
market development expenses are principally composed of business development expenses outside the
United States and the costs of managing the agreement with EMD Serono.
In the fourth quarter of 2008, Theratechnologies conducted an impairment test on the intellectual
property of the ExoPep platform following a review of the development strategy by Management for
new products. As a consequence, the Company wrote off the carrying amount of this intellectual
property in 2008. The write-off of $4,571,000 is included in Patents, amortization and impairment
of other assets in the consolidated statement of earnings.
In 2008, the Company incurred an impairment of $578,000 related to stock options held in a
publicly-traded company.
Net Results
Taking into account the changes in revenues and expenses described above, the Company recorded a
fourth quarter net loss of $4,698,000 ($0.08 loss per share), compared to a net loss of $15,145,000
($0.26 loss per share) for the same period in 2008. For the year ended November 30, 2009, the net
loss was $15,058,000 ($0.25 loss per share), compared to a net loss of $48,611,000 ($0.85 loss per
share) for the same period in 2008. The net loss in 2008 included the previously described decline
in impairment charges, totalling $5,149,000.
The fourth quarter 2009 net loss includes revenues of $1,711,000 related to the agreement with EMD
Serono. Excluding this item, the adjusted net loss (see Annex A) amounted to $6,409,000, a decrease
of 57.7% compared to the same period in 2008. For the year ended November 30, 2009, the net loss
included revenue of $17,444,000 and a non-recurring charge of $4,269,000 related to the agreement
with EMD Serono. Excluding these two items, the adjusted net loss (see Annex A) amounted to
$28,233,000, a decrease of 41.9% compared to the same period in 2008.
Quarterly Financial Information
The selected financial information provided below is derived from the Companys unaudited quarterly
financial statements for each of the last eight quarters. This information has been restated
following the adoption of the Canadian Institute of Chartered Accountants (CICA) Handbook Section
3064, Goodwill and Intangible Assets.
(in thousands of Canadian dollars, except per share amounts)
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2009 |
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2008 |
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Q4 |
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Q3 |
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Q2 |
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Q1 |
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Q4 |
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Q3 |
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Q2 |
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Q1 |
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Revenues |
|
$ |
2,246 |
|
|
$ |
13,148 |
|
|
$ |
2,317 |
|
|
$ |
2,009 |
|
|
$ |
616 |
|
|
$ |
710 |
|
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$ |
716 |
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$ |
599 |
|
Net earnings (net loss) |
|
$ |
(4,698 |
) |
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$ |
5,824 |
|
|
$ |
(5,430 |
) |
|
$ |
(10,754 |
) |
|
$ |
(15,145 |
) |
|
$ |
(11,220 |
) |
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$ |
(11,382 |
) |
|
$ |
(10,864 |
) |
Basic and
diluted benefit (loss) per share |
|
$ |
(0.08 |
) |
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$ |
0.10 |
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$ |
(0.09 |
) |
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$ |
(0.18 |
) |
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$ |
(0.26 |
) |
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$ |
(0.19 |
) |
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$ |
(0.20 |
) |
|
$ |
(0.20 |
) |
|
As described above, the increased revenues in 2009 are related to the amortization of the
initial payment received at the closing of the agreement with EMD Serono, as well as the milestone
payment of $10,884,000 recorded in August 2009. The increase in the fourth quarter net loss in 2008
is due to impairment charges for intellectual property.
Financial Position
At November 30, 2009, liquidities, which include cash and bonds, amounted to $63,362,000, and tax
credits receivable amounted to $1,666,000 for a total of $65,028,000.
For the three-month period ended November 30, 2009, the burn rate from operating activities,
excluding changes in operating assets and liabilities, was $4,333,000, compared to $9,559,000 for
the same period in 2008. Excluding the revenue of $1,711,000 related to the agreement with EMD
Serono, the adjusted burn rate from operating activities, excluding changes in operating assets and
liabilities (see Annex A), was $6,044,000, a decrease of 36.8%, compared to the corresponding
period in 2008.
For the year ended November 30, 2009, the burn rate from operating activities, excluding changes in
operating assets and liabilities, was $13,547,000, compared to $41,592,000 for the same period in
2008. The decrease in the 2009 burn rate is principally related to the payments received under the
agreement with EMD Serono as well as the decline in R&D expenditures and in selling and market
development costs. Excluding the revenue of $17,444,000 and the non-recurring charge of $4,269,000
related to the agreement with EMD Serono, the adjusted burn rate from operating activities,
excluding changes in operating assets and liabilities (see Annex A), was $26,722,000, a decrease of
35.8%, compared to the corresponding period in 2008.
Subsequent Events
Shareholder rights plan
On February 10, 2010, the Board of Directors of the Company adopted a shareholder rights plan (the
Plan), effective as of such date. The Plan is designed to provide adequate time for the Board of
Directors, and the shareholders, to assess an unsolicited takeover bid for Theratechnologies. In
addition, the Plan provides the Board of Directors with sufficient time to explore and develop
alternatives for maximizing shareholder value if a takeover bid is made, as well as provide
shareholders with an equal opportunity to participate in a takeover bid to receive full and fair
value for their common shares (the Common Shares). The Plan, if approved by the shareholders at
the Companys next Annual and Special Meeting to be held in March 2010, will expire at the close of
the Companys annual meeting of shareholders in 2013.
The rights issued under the Plan will initially attach to and trade with the Common Shares and no
separate certificates will be issued unless an event triggering these rights occurs. The rights
will become exercisable only when a person, including any party related to it, acquires or attempts
to acquire 20 percent or more of the outstanding Common Shares without complying with the
Permitted Bid provisions of the Plan or without approval of the Board of Directors. Should such
an acquisition occur or be announced, each right would, upon exercise, entitle a rights holder,
other than the acquiring person and related persons, to purchase Common Shares at a 50 percent
discount to the market price at the time.
Under the Plan, a Permitted Bid is a bid made to all holders of the Common Shares and which is open
for acceptance for not less than 60 days. If at the end of 60 days at least 50 percent of the
outstanding Common Shares, other than those owned by the offeror and certain related parties have
been tendered, the offeror may take up and pay for the Common Shares but must extend the bid for a
further 10 days to allow other shareholders to tender.
Granting of stock options
On December 8, 2009, the Company granted 265,000 options at an exercise price of $3.84 per share
and cancelled 19,167 options at a weighted exercise price of $2.38 per share in connection with its
stock option plan.
New Accounting Policies
Refer to Note 2 of the Companys unaudited Consolidated Financial Statements for the fourth quarter
of 2009.
The impact of adopting Section 3064, Goodwill and Intangible Assets, of the CICA Handbook was to
increase the opening deficit and to reduce other assets on December 1, 2007 and 2008 by $941,000
and $599,000 respectively. These amounts correspond to adjustments made to patent costs related to
periods prior to these dates. Furthermore, following the adoption of this standard, patents and
amortization of other assets presented in the consolidated statements of earnings were reduced by
$342,000 for the year ended November 30, 2008.
Outstanding Share Data
On February 9, 2010, the number of shares issued and outstanding was 60,449,225, while outstanding
options granted under the stock option plan were 2,891,801.
Contractual Obligations
The Company rents its premises under an operating lease expiring in April 2010. In 2009, the lease
was renewed by the Company and the lessor for a period of 11 years ending April 30, 2021. Refer to
Note 7 of the Companys unaudited Consolidated Financial Statements for the fourth quarter of 2009.
In addition, during and after the year ended November 30, 2009, the Company entered into long-term
supply agreements with third parties in anticipation of the commercialization of tesamorelin.
Certain of these agreements stipulate an obligation to purchase minimum quantities of products in
certain circumstances.
Economic and Industry Factors
Economic and industry factors were substantially unchanged from those reported in the Companys
2008 Annual Report.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products for commercialization. The Company targets unmet medical needs in
financially attractive specialty markets where it can retain all or part of the commercial rights
to its products. Its most advanced compound, tesamorelin, is an analogue of the human growth
hormone releasing factor. In 2009, Theratechnologies submitted a New Drug Application (NDA) to the
United States Food and Drug Administration (FDA), seeking approval of tesamorelin for the treatment
of excess abdominal fat in HIV-infected patients with lipodystrophy. The Companys growth strategy
is centered on the commercialization of tesamorelin in the United States and in other markets for
HIV-associated lipodystrophy as well as the development of clinical programs for tesamorelin in
other medical conditions.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Companys website at
www.theratech.com. Additional information, including the Annual Information Form and the
Annual Report, is also available on SEDAR at www.sedar.com.
Forward-Looking Information
This press release and the Managements Discussion and Analysis for the fourth quarter
incorporated therein contain certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information
includes,
but is not limited to, information regarding the commercialization of tesamorelin in HIV-associated
lipodystrophy, the receipt of royalties related to the commercialisation of tesamorelin, the
development of new markets for tesamorelin, the conclusion of partnership agreements and the
liquidity needs to finance the Companys operations. Furthermore, the words will, may, could,
should, outlook, believe, plan, envisage, anticipate, expect and estimate, or the
negatives of these terms or variations of them and the use of the conditional tense as well as
similar expressions denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties include, but are not limited to, the risk that the
Company may not obtain all required approvals from regulatory agencies to market its products, the
risk that the Companys products may not be accepted by the market, and the delays that may occur
if the Company encounters problems with a third-party supplier of services.
Although the forward-looking information contained herein is based upon what the Company believes
are reasonable assumptions, investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking information. Certain assumptions
made in preparing the forward-looking information and the Companys objectives include the
assumption, among others, that the FDA will approve tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy, that the Companys business plan will
not be substantially modified and that current relationships with the Companys third-party
suppliers of services and products will remain good.
Consequently, all of the forward-looking information is qualified by the foregoing cautionary
statements, and there can be no guarantee that the results or developments anticipated by the
Company will be realized or, even if substantially realized, that they will have the expected
consequences or effects on the Company, its business, its financial condition or its results of
operation. Furthermore, the forward-looking information reflects current expectations regarding
future events only as of the date of release of this press release.
Investors are referred to the Companys public filings available at www.sedar.com. In
particular, further details and descriptions of these risks and other factors are disclosed in the
Risk and Uncertainties section of the Companys Annual Information Form, dated February 24, 2009,
for the year ended November 30, 2008. The Company does not undertake to update or amend such
forward-looking information whether as a result of new information, future events or otherwise,
except as may be required by applicable law.
Information:
Andrea Gilpin
Vice President, IR & Communications
Phone: 514-336-7800, ext. 205
communications@theratech.com
Luc Tanguay
Senior Executive Vice President and
Chief Financial Officer
Phone: 514-336-7800, ext. 204
ltanguay@theratech.com
ANNEX A
Non-GAAP measures
The Company uses measures that do not conform to generally accepted accounting principles (GAAP)
to assess its operating performance. Securities regulators require that companies caution readers
that earnings and other measures adjusted to a basis other than GAAP do not have standardized
meanings and are unlikely to be comparable to similar measures used by other companies.
Accordingly, these measures should not be considered in isolation. The Company uses non-GAAP
measures such as adjusted net loss and the adjusted burn rate from operating activities before
changes in operating assets and liabilities, to measure its performance from one period to the
next without including changes caused by certain items that could potentially distort the analysis
of trends in its operating performance, and because such measures provide meaningful information
on the Companys financial condition and operating results.
Definition and reconciliation of non-GAAP measures
In order to measure performance from one period to another, without accounting for changes related
to revenues and fees associated with the collaboration and license agreement with EMD Serono,
management uses adjusted net loss and adjusted burn rate before changes in operating assets and
liabilities. These items are excluded because they affect the comparability of the financial
results and could potentially distort the analysis of trends in the Companys operating
performance. The exclusion of these items does not necessarily indicate that they are
non-recurring.
(Thousands of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November 30th |
|
|
November 30th |
|
|
|
(3 months) |
|
|
(12 months) |
|
Adjusted net loss |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Net loss, per the financial statements |
|
$ |
(4,698 |
) |
|
$ |
(15,145 |
) |
|
$ |
(15,058 |
) |
|
$ |
(48,611 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues associated with a collaboration and license
agreement (note 7 to the consolidated financial
statements) |
|
|
(1,711 |
) |
|
|
|
|
|
|
(17,444 |
) |
|
|
|
|
Fees associated with collaboration and license
agreement |
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
|
|
|
|
Adjusted net loss |
|
$ |
(6,409 |
) |
|
$ |
(15,145 |
) |
|
$ |
(28,233 |
) |
|
$ |
(48,611 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November 30th |
|
|
November 30th |
|
Adjusted burn rate before changes in operating |
|
(3 months) |
|
|
(12 months) |
|
assets and liabilities |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Burn rate before changes in operating assets and
liabilities, per the financial statements |
|
$ |
(4,333 |
) |
|
$ |
(9,559 |
) |
|
$ |
(13,547 |
) |
|
$ |
(41,592 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues associated with a collaboration and license
agreement (note 7 to the consolidated financial
statements) |
|
|
(1,711 |
) |
|
|
|
|
|
|
(17,444 |
) |
|
|
|
|
Fees associated with collaboration and license
agreement |
|
|
|
|
|
|
|
|
|
|
4,269 |
|
|
|
|
|
|
|
|
Adjusted burn rate before changes in operating
assets and liabilities |
|
$ |
(6,044 |
) |
|
$ |
(9,559 |
) |
|
$ |
(26,722 |
) |
|
$ |
(41,592 |
) |
|
|
|
ex-99.81
Exhibit 99.81
News Release
THERATECHNOLOGIES ADOPTS SHAREHOLDER RIGHTS PLAN
Montreal, Canada February 10, 2010 Theratechnologies Inc. (TSX-TH) announced today that its
Board of Directors has adopted a shareholder rights plan (the Plan), effective as of such date.
The Plan is designed to provide adequate time for the Board of Directors and the shareholders to
assess an unsolicited takeover bid for Theratechnologies, to provide the Board of Directors with
sufficient time to explore and develop alternatives for maximizing shareholder value if a
takeover bid is made, and to provide shareholders with an equal opportunity to participate in a
takeover bid and receive full and fair value for their common shares (the Common Shares). The
Company is not adopting the Plan in response to any specific proposal to acquire control of the
Company, nor is it aware of any such effort.
Shareholders will be asked to approve the Plan at the Companys next annual and special meeting
to be held on March 25, 2010. The Plan, if approved by the shareholders, will expire at the close
of the Companys annual meeting of shareholders in 2013.
The rights issued under the Plan will initially attach to and trade with the Common Shares and no
separate certificates will be issued unless an event triggering these rights occurs. The rights
will become exercisable only when a person, including any party related to it, acquires or
attempts to acquire 20 percent or more of the outstanding Common Shares without complying with
the Permitted Bid provisions of the Plan or without approval of the Board of Directors. Should
such an acquisition occur or be announced, each right would, upon exercise, entitle a rights
holder, other than the acquiring person and related persons, to purchase Common Shares at a 50
percent discount to the market price at the time.
Under the Plan, a Permitted Bid is a bid made to all holders of the Common Shares and which is
open for acceptance for not less than 60 days. If at the end of 60 days at least 50 percent of
the outstanding Common Shares, other than those owned by the offeror and certain related parties
have been tendered, the offeror may take up and pay for the Common Shares but must extend the bid
for a further 10 days to allow other shareholders to tender.
The rights plan is similar to other shareholder rights plans recently adopted by several other
Canadian companies. A material change report and a complete copy of the rights plan will be
filed on the System for Electronic Document Analysis and Retrieval (SEDAR) shortly. The
issuance of Common Shares upon the exercise of the rights is subject to receipt of certain
regulatory approvals.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers and develops
innovative therapeutic products for commercialization. The Company targets unmet medical needs in
financially attractive specialty markets where it can retain all or part of the commercial rights
to its products. Its most advanced compound, tesamorelin, is an analogue of the human growth
hormone releasing factor. In 2009, Theratechnologies submitted a New Drug Application (NDA) to
the United States Food and Drug Administration (FDA), seeking approval of tesamorelin for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The Companys
growth strategy is centered on the commercialization of tesamorelin in the United States and in
other markets for HIV-associated lipodystrophy as well as the development of clinical programs
for tesamorelin in other medical conditions.
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
ex-99.82
Exhibit 99.82
News
Release
Theratechnologies reports that the FDA will reschedule for administrative
reasons the Advisory Committee meeting to review tesamorelins NDA
Montreal, Canada January 25, 2010 Theratechnologies (TSX:TH) today announced that the U.S.
Food and Drug Administration (FDA) will reschedule its meeting of the Endocrinologic and
Metabolic Drugs Advisory Committee to review Theratechnologies New Drug Application (NDA)
for tesamorelin. Originally scheduled for Wednesday, February 24, 2010, the meeting will be
rescheduled due to an administrative delay at the FDA. The FDA informed Theratechnologies that
this delay is entirely procedural and is not related to the tesamorelin NDA. A new meeting
date will be announced shortly in the Federal Register.
Theratechnologies submitted an NDA to the FDA on May 29, 2009, for tesamorelin, an analogue of
the growth hormone releasing factor, proposed for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy. The FDA filed the NDA on August 12, 2009, which
initiated a substantive review of the application. The Prescription Drug User Fee Act (PDUFA)
date, which is the target date for the FDA to complete its review of tesamorelins NDA, is
March 29, 2010.
About HIV-Associated Lipodystrophy
Several factors including a patients antiretroviral drug regimen and the HIV virus itself are
thought to contribute to HIV-associated lipodystrophy, which is characterized by body
composition changes, dyslipidemia and glucose intolerance. The changes in body composition
include excess abdominal fat accumulation. There is currently no approved treatment available
for the excess abdominal fat related to HIV-associated lipodystrophy, a condition that can
stigmatize patients.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company with core expertise in
peptide-based therapeutics. Its most advanced compound, tesamorelin, is an analogue of the
human growth hormone releasing factor.
In late 2008, Theratechnologies completed its Phase 3 clinical program which was designed to
evaluate tesamorelin in treating excess abdominal fat in HIV-infected patients with
lipodystrophy. Theratechnologies signed a collaboration and licensing agreement with EMD
Serono, Inc., for the commercialization of tesamorelin in the United States.
With a New Drug Application filed with the U.S. authorities in May 2009, Theratechnologies
growth strategy is firmly focused on the development of tesamorelin in the United States and in
other potential HIV-associated lipodystrophy markets, as well as through additional clinical
programs for other medical conditions.
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
ex-99.83
Exhibit 99.83
News
Release
Theratechnologies reports date for FDA Advisory Committee Review of the
Tesamorelin New Drug Application
Montreal, Canada January 18, 2010 Theratechnologies (TSX:TH) today announced that the U.S.
Food and Drug Administration (FDA) has confirmed that the Endocrinologic and Metabolic Drugs
Advisory Committee will meet to review Theratechnologies New Drug Application (NDA) for
tesamorelin on Wednesday, February 24, 2010. The meeting will take place at the Hilton
Washington DC/Silver Spring (8727 Colesville Road, Silver Spring, Maryland). Information
related to the meeting is available on The Office of the Federal Register web site at:
www.federalregister.gov
Theratechnologies submitted an NDA to the FDA on May 29, 2009, for tesamorelin, an analogue of
the growth hormone releasing factor proposed for the treatment of excess abdominal fat in HIV
patients with lipodystrophy. The FDA filed the NDA on August 12, 2009, which initiated a
substantive review of the application. The Prescription Drug Fee Act (PDUFA) date, which is
the target date for the FDA to complete its review of tesamorelin NDA, is March 29, 2010.
About HIV-Associated Lipodystrophy
Several factors including a patients antiretroviral drug regimen and the HIV virus itself are
thought to contribute to HIV-associated lipodystrophy, which is characterized by body
composition changes, dyslipidemia and glucose intolerance. The changes in body composition
include excess abdominal fat accumulation. There is currently no approved treatment available
for the excess abdominal fat related to HIV-associated lipodystrophy, a condition that can
stigmatize patients.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company with core expertise in
peptide-based therapeutics. Its most advanced compound, tesamorelin, is an analogue of the
human growth hormone releasing factor.
In late 2008, Theratechnologies completed its Phase 3 clinical program which was designed to
evaluate tesamorelin in treating excess abdominal fat in HIV patients with lipodystrophy.
Theratechnologies signed a collaboration and licensing agreement with EMD Serono, Inc., for the
commercialization of tesamorelin in the United States.
With a New Drug Application filed with the U.S. authorities in May 2009, Theratechnologies
growth strategy is firmly focused on the development of tesamorelin in the United States and in
other potential HIV-associated lipodystrophy markets, as well as through additional clinical
programs for other medical conditions.
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
ex-99.84
Exhibit 99.84
News Release
Theratechnologies to present at Biotech Showcase 2010
Montréal, Canada January 11, 2010 Theratechnologies (TSX: TH) announced today that Yves
Rosconi, President and Chief Executive Officer of the Company, will be presenting an overview of
Theratechnologies at Biotech Showcase 2010, which will take place at the Marines Memorial Club &
Hotel, in San Francisco. During his presentation scheduled tomorrow at 3:20 p.m., Mr. Rosconi
will review the 2009 operational accomplishments and will discuss Theratechnologies strategy and
growth opportunities for the year to come.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company with core expertise in
peptide-based therapeutics. Its most advanced compound, tesamorelin, is an analogue of the human
growth hormone releasing factor.
In late 2008, Theratechnologies completed its Phase 3 clinical program which was designed to
evaluate tesamorelin in treating excess abdominal fat in HIV patients with lipodystrophy.
Theratechnologies also signed a collaboration and licensing agreement with EMD Serono, Inc., for
the commercialization of tesamorelin in the United States.
With a New Drug Application filed with the U.S. authorities in May 2009, Theratechnologies growth
strategy is firmly focused on the development of tesamorelin in the United States and in other
potential HIV-associated lipodystrophy markets, as well as through additional clinical programs
for other medical conditions.
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
ex-99.85
Exhibit 99.85
News Release
THERATECHNOLOGIES RECEIVES PATENT PROTECTION IN BRAZIL FOR TESAMORELIN
Montreal, Canada December 29, 2009 Theratechnologies (TSX:TH) today announced that the Brazil
Patent and Trademark Office has issued Patent Number 9608799-4 entitled Chimeric fatty
body-pro-GRF analog with increased biological potency and pharmaceutical formulation for its
lead-compound, tesamorelin. The granting of this patent provides protection in Brazil until
December 2019.
This patent aligns us well in executing one of our top priorities, which is to expand
commercialization into various geographies for tesamorelin in HIV-associated lipodystrophy,
commented Mr. Yves Rosconi, President and Chief Executive Officer of Theratechnologies. Brazil is
a country where there are patients in need and where we can leverage the work already completed for
the U.S. regulatory agency. The patent announced today solidifies our approach and reinforces
Brazil as an attractive territory for potential partners, concluded Mr. Rosconi.
About HIV-Associated Lipodystrophy
Several factors including the antiretroviral drug regimen and the virus itself are thought to
contribute to HIV-associated lipodystrophy, which is characterized by body composition changes,
dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat
accumulation. There is currently no approved treatment available for the excess abdominal fat
related to HIV-associated lipodystrophy, a condition that can stigmatize patients and discourage
HIV treatment adherence.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company with core expertise in
peptide-based therapeutics. Its most advanced compound, tesamorelin, is an analogue of the human
growth hormone-releasing factor.
In late 2008, Theratechnologies completed its Phase 3 clinical program evaluating tesamorelin in
treating excess abdominal fat in HIV-infected patients with lipodystrophy. In addition, the Company
signed a collaboration and licensing agreement with EMD Serono, Inc., for the commercialization of
tesamorelin in the United States.
With a New Drug Application recently filed with the U.S. authorities, Theratechnologies growth
strategy is firmly focused on the development of tesamorelin, in the United States and in other
potential HIV-associated lipodystrophy markets, as well as through additional clinical programs for
other medical conditions.
Forward-Looking Information
This press release contains certain statements that are considered forward-looking information
within the meaning of applicable securities legislation. This forward-looking information includes,
but is not limited to information regarding the expansion of the commercialization of tesamorelin
in other geographies and information regarding the ability to find partners in Brazil. Words such
as will, may, could, should, outlook, believe, plan, envisage, anticipate,
expect and estimate, or the variations of them denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is subject to a number of
risks and uncertainties, many of which are beyond the Companys control, that could cause actual
results to differ materially from those that are disclosed in or implied by such forward-looking
information. These risks and uncertainties include, but are not limited to: the risk that
tesamorelin for the treatment of HIV-associated lipodystrophy does not receive regulatory approval
for commercialization and the risk that Theratechnologies does not find any partner to
commercialize tesamorelin in Brazil or in any other country. The Company refers potential investors
to the Risks and Uncertainties section of its Annual Information Form (the AIF) dated February
24, 2009. The
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
AIF is
available at www.sedar.com under the Companys public filings. The reader is cautioned to
consider these and other risks and uncertainties carefully and not to put undue reliance on
forward-looking statements.
Forward-looking information reflects current expectations regarding future events and speaks only
as of the date of this press release and represents the Companys expectations as of that date.
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
ex-99.86
Exhibit 99.86
EXECUTION COPY
SHAREHOLDER RIGHTS PLAN AGREEMENT
DATED AS OF FEBRUARY 10, 2010
Between
THERATECHNOLOGIES INC.
and
COMPUTERSHARE TRUST COMPANY OF CANADA
as Rights Agent
Fasken Martineau DuMoulin LLP
Stock Exchange Tower
Suite 3400, Box 242
800 Place Victoria
Montreal, Québec H4Z 1E9
New Rights Plan
TABLE OF CONTENTS
|
|
|
|
|
|
|
Page |
|
ARTICLE 1 INTERPRETATION |
|
|
2 |
|
1.1 Certain Definitions |
|
|
2 |
|
1.2 Currency |
|
|
15 |
|
1.3 Descriptive Headings |
|
|
15 |
|
1.4 References to Agreement |
|
|
15 |
|
1.5 Calculation of Number and Percentage of Beneficial Ownership of |
|
|
|
|
Outstanding Common Shares |
|
|
16 |
|
1.6 Acting Jointly or in Concert |
|
|
16 |
|
1.7 Application of Statutes, Regulations and Rules |
|
|
16 |
|
ARTICLE 2 THE RIGHTS |
|
|
16 |
|
2.1 Legend on Certificates |
|
|
16 |
|
2.2 Execution, Authentication, Delivery and Dating of Rights Certificates |
|
|
17 |
|
2.3 Registration, Registration of Transfer and Exchange |
|
|
18 |
|
2.4 Mutilated, Destroyed, Lost and Stolen Rights Certificates |
|
|
18 |
|
2.5 Persons Deemed Owners of Rights |
|
|
19 |
|
2.6 Delivery and Cancellation of Certificates |
|
|
19 |
|
2.7 Agreement of Rights Holders |
|
|
20 |
|
2.8 Rights Certificate Holder Not Deemed a Shareholder |
|
|
20 |
|
ARTICLE 3 EXERCISE OF THE RIGHTS |
|
|
21 |
|
3.1 Initial Exercise Price, Exercise of Rights, Detachment of Rights |
|
|
21 |
|
3.2 Adjustments to Exercise Price, Number of Rights |
|
|
24 |
|
3.3 Date on Which Exercise is Effective |
|
|
30 |
|
ARTICLE 4
ADJUSTMENTS TO THE RIGHTS IN THE EVENT OF CERTAIN TRANSACTIONS |
|
|
30 |
|
4.1 Flip-in Event |
|
|
30 |
|
ARTICLE 5 THE RIGHTS AGENT |
|
|
32 |
|
5.1 General |
|
|
32 |
|
5.2 Merger or Amalgamation or Change of Name of Rights Agent |
|
|
33 |
|
5.3 Duties of Rights Agent |
|
|
34 |
|
5.4 Change of Rights Agent |
|
|
36 |
|
ARTICLE 6 MISCELLANEOUS |
|
|
36 |
|
6.1 Redemption and Waiver |
|
|
36 |
|
6.2 Expiration |
|
|
38 |
|
6.3 Issuance of New Rights Certificate |
|
|
39 |
|
6.4 Fractional Rights and Fractional Shares |
|
|
39 |
|
6.5 Supplements and Amendments |
|
|
39 |
|
6.6 Rights of Action |
|
|
41 |
|
1
TABLE OF CONTENTS (contd.)
|
|
|
|
|
|
|
Page |
|
6.7 Notice of Proposed Actions |
|
|
41 |
|
6.8 Notices |
|
|
42 |
|
6.9 Costs of Enforcement |
|
|
42 |
|
6.10 Successors |
|
|
43 |
|
6.11 Benefits of this Agreement |
|
|
43 |
|
6.12 Governing Law |
|
|
43 |
|
6.13 Counterparts |
|
|
43 |
|
6.14 Severability |
|
|
43 |
|
6.15 Effective Date |
|
|
43 |
|
6.16 Determinations and Actions by the Board of Directors |
|
|
44 |
|
6.17 Time of the Essence |
|
|
44 |
|
6.18 Regulatory Approvals |
|
|
44 |
|
6.19 Language |
|
|
44 |
|
2
MEMORANDUM OF AGREEMENT made as of the 10th day of February, 2010.
|
|
|
BETWEEN:
|
|
THERATECHNOLOGIES INC., a company
existing under the laws of Québec, |
|
|
|
|
|
(hereinafter called the Company), |
|
|
|
|
|
OF THE FIRST PART, |
|
|
|
AND:
|
|
COMPUTERSHARE TRUST COMPANY
OF CANADA, a trust company existing
under the laws of Canada, as
rights agent, |
|
|
|
|
|
(hereinafter called the Rights Agent), |
|
|
|
|
|
OF THE SECOND PART. |
WHEREAS the Board of Directors of the Company has determined that it is advisable that the
Company adopt a shareholder rights plan to take effect on the Effective Date (as hereinafter
defined), subject to approval by the Independent Shareholders (as hereinafter defined) at the
annual and special meeting of shareholders of the Company scheduled to be held on March 25, 2010,
to ensure fair and equal treatment of all the Companys shareholders in the event of a take-over
bid, to protect shareholders from coercive take-over tactics and to allow the Board of Directors
and Shareholders of the Company adequate time to assess the bid and consider alternatives to
enhance value for Shareholders (the Rights Plan);
AND WHEREAS in order to implement the Rights Plan the Board of Directors of the Company has:
(a) authorized the issuance of one right (a Right) in respect of each Common Share (as
hereinafter defined) outstanding at the Record Time (as hereinafter defined); and
(b) authorized the issuance of one Right in respect of each Common Share issued after the Record
Time and prior to the earlier of the Separation Time (as hereinafter defined) and the Expiration
Time (as hereinafter defined);
AND WHEREAS each Right entitles the holder thereof, after the Separation Time, to purchase
Common Shares of the Company, pursuant to the terms and subject to the conditions set forth herein;
AND WHEREAS the Company desires to appoint the Rights Agent to act on behalf of the Company
and holders of Rights, and the Rights Agent is willing so to act, in connection with
New Rights Plan
the issuance, transfer, exchange and replacement of Rights Certificates (as hereinafter
defined), the exercise of Rights and other matters referred to herein;
NOW THEREFORE, in consideration of the premises and the respective covenants and agreements
set forth herein the parties hereby agree as follows:
ARTICLE 1
INTERPRETATION
1.1 Certain Definitions
For the purposes of this Agreement, the following terms have the meanings indicated:
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(a) |
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1933 Securities Act shall mean the Securities Act of 1933 of the United States, as
amended, and the regulations thereunder, and any comparable or successor regulations
thereto; |
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(b) |
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1934 Exchange Act shall mean the Securities Exchange Act of 1934 of the United States,
as amended, and the regulations thereunder, and any comparable or successor regulations
thereto; |
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(c) |
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Acquiring Person shall mean any Person who is the Beneficial Owner of 20% or more of
the outstanding Common Shares of the Company. Notwithstanding the foregoing, the term
Acquiring Person shall not include: |
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(i) |
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the Company or any Subsidiary of the Company; |
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(ii) |
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any Person who becomes the Beneficial Owner of 20% or more of the outstanding
Common Shares of the Company as a result of any one or any combination of: |
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(a) |
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an acquisition and cancellation or redemption by the Company or a
Subsidiary of the Company of Common Shares which, by reducing the number of
Common Shares outstanding, increases the percentage of outstanding Common
Shares Beneficially Owned by such Person to 20% or more of the Common Shares
outstanding (a Share Reduction); |
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(b) |
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an acquisition of Common Shares made pursuant to a Permitted Bid or a
Competing Permitted Bid (a Permitted Bid Acquisition); |
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(c) |
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an acquisition of Common Shares in respect of which the Board of
Directors has waived the application of section 4.1 pursuant to the
provisions of section 6.1 (an Exempt Acquisition); |
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(d) |
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a Convertible Security Acquisition; or |
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(e) |
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a Permitted Acquisition; |
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provided, however, that if a Person shall become the Beneficial Owner of 20%
or more of the Common Shares of the Company then outstanding by reason of one
or any combination of a Share Reduction, a Permitted Bid Acquisition, an
Exempt Acquisition, a Convertible Security Acquisition or a Permitted
Acquisition and thereafter such Person, while such Person is the Beneficial
Owner of 20% or more of the Common Shares of the Company then outstanding,
increases the number of Common Shares of the Company beneficially owned by
such Person by more than 1% of the number of Common Shares outstanding (other
than pursuant to one or any combination of a Share Reduction, a Permitted Bid
Acquisition, an Exempt Acquisition, a Convertible Security Acquisition or a
Permitted Acquisition) then, as of the date such Person becomes the Beneficial
Owner of such additional outstanding Common Shares of the Company, such Person
shall be an Acquiring Person; |
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(iii) |
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for a period of 10 days after the Disqualification Date
(as hereinafter defined), any Person who becomes the Beneficial Owner of
20% or more of the outstanding Common Shares of the Company as a result
of such Person becoming disqualified from relying on clause 1.1(f)(v)
hereof because such Person makes or announces an intention to make a
Take-over Bid in respect of the Common Shares of the Company alone or by
acting jointly or in concert with any other Person and, for this purpose,
Disqualification Date means the first date of public announcement of
facts indicating that such Person is making or intends to make a
Take-over Bid; |
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(iv) |
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an underwriter or member of a banking or selling group acting in such capacity
that becomes the Beneficial Owner of 20% or more of the Common Shares of the Company
in connection with a distribution of securities of the Company; or |
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(v) |
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a Person (a Grandfathered Person) who is the Beneficial Owner of more than 20%
of the outstanding Common Shares of the Company determined as of the Record Time;
provided, however, that this exemption shall not be, and shall cease to be, applicable
to a Grandfathered Person in the event that such Grandfathered Person shall, after the
Record Time, become the Beneficial Owner of additional Common Shares of the Company
that increases its Beneficial Ownership by more than 1% of the number of Common Shares
of the Company outstanding (other than through one or any combination of a Share
Reduction, a Permitted Bid Acquisition, an Exempt Acquisition, a Convertible Security
Acquisition or a Permitted Acquisition); |
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(d) |
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Affiliate, when used to indicate a relationship with a specified corporation, means a
Person who directly, or indirectly through one or more controlled |
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intermediaries, controls, or is controlled by, or is under common control with,
such specified corporation; |
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(e) |
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Associate of a specified Person shall mean any Person to whom such specified Person is
married or with whom such specified Person is living in a conjugal relationship outside
marriage, or any relative of such specified Person, said spouse or other Person who has the
same home as such specified Person; |
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(f) |
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a Person shall be deemed the Beneficial Owner of, and to have Beneficial Ownership
of, and to Beneficially Own: |
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(i) |
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any securities as to which such Person or any of such Persons Affiliates
or Associates is the owner at law or equity; |
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(ii) |
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any securities as to which such Person or any of such Persons Affiliates
or Associates has the right to acquire (where such right is exercisable within a
period of 60 days, or upon the occurrence of a contingency) (a) upon the exercise
of any Convertible Securities (other than a Right) or (b) pursuant to any
agreement, arrangement, pledge or understanding, whether or not in writing (other
than customary agreements with and between underwriters or banking group or
selling group members with respect to a distribution of securities and other than
pledges or hypothecs of securities in the ordinary course of business); and |
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(iii) |
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any securities which are Beneficially Owned within the meaning of the foregoing
provisions of this subsection 1.1(f) by any other Person with whom such Person is
acting jointly or in concert; |
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provided, however, that a Person shall not be deemed the Beneficial Owner of or to
have Beneficial Ownership of, or to Beneficially Own, any security because: |
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(iv) |
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such security has been agreed to be deposited or tendered pursuant to a Lock-up
Agreement or is otherwise deposited or tendered pursuant to any Take-over Bid made by
such Person, made by any of such Persons Affiliates or Associates or made by any
Person acting jointly or in concert with such Person until such deposited security has
been taken up or paid for, whichever shall occur first; |
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(v) |
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such Person holds such security, provided that: |
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(a) |
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the ordinary business of such Person (an Investment Manager) includes
the management of mutual funds or investment funds for others (which others,
for greater certainty, may include or be limited to one or more employee
benefit plans or pension plans) and such security is held by the Investment
Manager in the ordinary course of such business in the performance of such
Investment Managers duties for the account of any other Person or |
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Persons (a Client) including non-discretionary accounts held
on behalf of a broker or dealer registered under applicable laws; or |
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(b) |
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such Person (a Trust Company) is licensed to carry on the business of a
trust company under applicable laws and, as such, acts as trustee or
administrator or in a similar capacity in relation to the estates of deceased
or incompetent Persons (Estate Accounts) or in relation to other accounts
(Other Accounts) and holds such security in the ordinary course of such
duties for the estate of any such deceased or incompetent Person or for such
Estate Accounts or Other Accounts; or |
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(c) |
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such Person (an Administrator) is the administrator or the trustee of
one or more pension funds or plans (each a Plan) or is a Plan registered
under applicable laws and holds such security in the ordinary course of such
duties for such Plan; or |
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(d) |
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such Person is a Plan or is a Person established by statute (the
Statutory Body) for purposes that include, and the ordinary business or
activity of such Person includes, the management of investment funds for
employee benefit plans, pension plans, insurance plans (other than plans
administered by insurance companies) of various public bodies and the
Statutory Body holds such security for the purposes of its activities as such;
or |
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(e) |
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such Person is a Crown agent or agency; |
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provided that the Investment Manager, Trust Company, Administrator, the Plan,
the Statutory Body or the Crown agent or agency, as the case may be, is not
then making or has not announced a current intention to make a Take-over Bid,
alone or acting jointly or in concert with any other Person (other than an
Offer to Acquire Shares of the Company by means of a distribution by the
Company or by means of ordinary market transactions (including pre-arranged
trades) executed through the facilities of a stock exchange or organized
over-the-counter market); |
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(vi) |
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such Person, any of such Persons Affiliates or Associates or any Person acting
jointly or in concert with such Person is a Client of the same Investment Manager as
another Person on whose account the Investment Manager holds such security, or by
reason of such Person being an Estate Account or an Other Account of the same Trust
Company as another Person on whose account the Trust Company holds such security or
by reason of such Person being a Plan which has an Administrator which is also a
trustee for another Plan on whose account the Trustee holds such security; |
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(vii) |
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such Person is (i) a Client of an Investment Manager and such security is
owned at law or in equity by the Investment Manager, or (ii) an account of a Trust
Company and such security is owned at law or in equity by the Trust Company, or (iii)
a Plan and such security is owned at law or in equity by the Administrator thereof; or |
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(viii) |
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such Person is the registered holder of securities as a result of carrying on
the business of a securities depositary or as a result of being a nominee holder of
such securities. |
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(g) |
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Board of Directors shall mean the board of directors of the Company or, if duly
constituted and whenever duly empowered, the executive committee of the board of directors of
the Company; |
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(h) |
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Business Day shall mean any day other than a Saturday, a Sunday or a day on which
banking institutions in Montreal, Québec are authorized or obligated by law to close; |
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(i) |
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Canadian Dollar Equivalent of any amount which is expressed in United States dollars
shall mean on any date the Canadian dollar equivalent of such amount determined by
multiplying such amount by the U.S.-Canadian Exchange Rate in effect on such date; |
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(j) |
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Canadian-U.S. Exchange Rate shall mean on any date the inverse of the U.S.-Canadian
Exchange Rate; |
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(k) |
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Close of Business on any date shall mean the time on such date (or, if such date is not
a Business Day, the time on the next succeeding Business Day) at which the offices of the
transfer agent for the Shares (or, after the Separation Time, the offices of the Rights Agent
in Montreal, Québec) are closed to the public in the city in which such transfer agent or
Rights Agent has an office for the purposes of this Agreement; |
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(l) |
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Common Share when used with reference to the Company, shall mean the Common Shares
and/or any other shares entitled to vote generally in the election of directors, as the
context requires, and, when used with reference to any Person other than the Company, shall
mean shares of capital stock of such other Person entitled to vote generally in the election
of the directors of such other Person. |
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(m) |
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Companies Act shall mean the Companies Act (Québec), as amended, and the regulations
made thereunder, and any comparable or successor laws or regulations thereto; |
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(n) |
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Competing Permitted Bid means a Take-over Bid that is made by means of a Take-over Bid
circular and which also complies with the following additional provisions: |
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(i) |
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the Take-over Bid is made after a Permitted Bid has been made and
prior to the expiry of the Permitted Bid or of any other Competing Permitted
Bids (in this definition the Prior Bids); |
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(ii) |
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the Take-over Bid satisfies all components of the definition of a Permitted Bid
other than the requirements set out in clause (ii) of such definition; and |
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(iii) |
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the Take-over Bid contains, and the take-up and payment for Common Shares
tendered or deposited thereunder are subject to, irrevocable and unqualified
conditions that no Common Shares will be taken up and paid for pursuant to such
Take-over Bid (x) prior to the Close of Business on a date that is no earlier than the
later of (1) the earliest date on which Common Shares may be taken up and paid for
under any Prior Bids in existence when the Take-over Bid is made and (2) 35 days after
the date of such Take-over Bid constituting the Competing Permitted Bid, and (y)
unless, at the time that the Common Shares are to be taken up, more than 50% of the
then outstanding Common Shares held by Independent Shareholders, have been deposited
or tendered pursuant to such Take-over Bid and not withdrawn; |
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(o) |
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controlled: a corporation is controlled by another Person or two or more Persons,
acting jointly or in concert, if: |
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(i) |
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securities entitled to vote in the election of directors carrying more than 50% of
the votes for the election of the directors are held, directly or indirectly, by or
for the benefit of the other Person or Persons acting jointly or in concert; and |
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(ii) |
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the votes carried by such securities are entitled, if exercised, to elect a
majority of the board of directors of such corporation; |
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and controls, controlling and under common control with shall be interpreted
accordingly; |
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(p) |
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Convertible Securities means at any time any securities issued by the Company from time
to time (other than the Rights) carrying any exercise, conversion or exchange right pursuant
to which the holder thereof may acquire Common Shares or other securities which are
convertible into exercisable or exchangeable for Common Shares. |
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(q) |
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Convertible Securities Acquisition means the acquisition of Common Shares upon the
exercise of a Convertible Security received by a Person pursuant to a Permitted Bid
Acquisition, an Exempt Acquisition or a Permitted Acquisition. |
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(r) |
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dividends paid in the ordinary course shall mean cash dividends paid at regular
intervals in any financial year of the Company to the extent that such cash dividends do not
exceed, in the aggregate, the greatest of: |
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(i) |
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200% of the aggregate amount of cash dividends declared payable by the
Company on its Shares in its immediately preceding financial year; |
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(ii) |
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300% of the arithmetic average of the aggregate amounts of cash dividends
declared payable by the Company on its Shares in its three immediately preceding
financial years; |
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(iii) |
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100% of the aggregate consolidated net income of the Company, before
extraordinary items, for its immediately preceding financial year; and |
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(iv) |
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100% of the aggregate consolidated net income of the Company, before
extraordinary items, for its current financial year; |
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(s) |
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Effective Date shall mean the time at which the annual and special meeting of the
holders of Common Shares scheduled to be held on March 25, 2010 terminates; |
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(t) |
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Election to Exercise shall have the meaning ascribed thereto in clause 3.1(e)(ii); |
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(u) |
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Exempt Acquisition shall have the meaning ascribed thereto in subclause 1.1(c)(ii)(c); |
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(v) |
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Exercise Price shall mean, as of any date, the price at which a holder of a Right may
purchase Common Shares issuable upon exercise of such Right. Subject to adjustment thereof in
accordance with the terms hereof, the Exercise Price for each Right shall be $25.00; |
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(w) |
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Expiration Time shall mean the earlier of: |
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(i) |
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the Termination Time; |
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(ii) |
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the termination of the annual meeting of the shareholders of the Company in the
year 2013; and |
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(iii) |
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the Close of Business on the date this Agreement becomes void pursuant to the
provisions of section 6.15; |
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(x) |
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Flip-in Event shall mean a transaction in or pursuant to which any Person shall become
an Acquiring Person provided, however, that a Flip-in Event shall be deemed to occur at the
Close of Business on the tenth day (or on such later day as the Board of Directors shall
determine) after a Stock Acquisition Date; |
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(y) |
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Grandfathered Person shall have the meaning ascribed thereto in clause 1.1(c)(v); |
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(z) |
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Independent Shareholders shall mean all holders of Common Shares of the Company, other
than (i) any Acquiring Person, (ii) any Offeror other than a |
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Person described in paragraph (v) of the definition of Beneficial Owner, (iii) any
Affiliate or Associate of any Acquiring Person or Offeror, (iv) any Person acting
jointly or in concert with any Acquiring Person or Offeror, and (v) any Person who is
an administrator or trustee of any employee benefit plan, deferred profit sharing
plan, stock participation plan or any similar plan or trust for the benefit of
employees of the Company or a wholly-owned Subsidiary of the Company, unless the
beneficiaries of such plan or trust direct the manner in which such Common Shares are
to be voted or direct whether the Common Shares are to be tendered to a Take-over Bid; |
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(aa) |
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Lock-up Agreement means an agreement between an Offeror, any of its Affiliates or
Associates or any other Person acting jointly or in concert with the Offeror and a Person
(the Locked-up Person) who is not an Affiliate or Associate of the Offeror or a Person
acting jointly or in concert with the Offeror whereby the Locked-up Person agrees to deposit
or tender the Common Shares by the Locked-up Person to the Offerors Take-over Bid or to any
Take-over Bid made by any of the Offerors Affiliates or Associates or made by any other
Person acting jointly or in concert with the Offeror (the Subject Bid), where (A) in the
context of a Subject Bid that is supported by the Company, the agreement shall terminate
automatically or may be terminated by the Locked-up Person upon termination, in accordance
with its terms, of the agreement between the Offeror, any of its Affiliates or Associates or
any other Person acting jointly or in concert with the Offeror and the Company, under which
it was agreed that the Offeror or any Affiliates or Associates or any other Person acting
jointly or in concert with the Offeror would acquire all of the Common Shares outstanding in
accordance with the terms of the agreement, (B) in the context of a Subject Bid that is not
supported by the Company, where the agreement: |
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(i) |
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permits the Locked-up Person to withdraw the Common Shares from the agreement in
order to tender or deposit the Common Shares to another Take-over Bid or to support
another transaction that in either case will provide greater value to the Locked-up
Person than the Subject Bid; or |
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(ii) |
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(a) permits the Locked-up Person to withdraw the Common Shares from the agreement
in order to tender or deposit the Common Shares to another Take-over Bid or to support
another transaction that contains an offering price for each Common Share that exceeds
by as much as or more than a specified amount (the Specified Amount) the offering
price for each Common Share contained in or proposed to be contained in the Subject
Bid; and (b) does not by its terms provide for a Specified Amount that is greater than
7% of the offering price contained in or proposed to be contained in the Subject Bid;
and |
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(iii) |
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does not provide for any break-up fees, top-up fees, penalties, expenses or
other amounts that exceed in the aggregate the greater of: |
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(a) |
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the cash equivalent of 2.5% of the price or value payable under the
Take-over Bid to a Locked-up Person; and |
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(b) |
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50% of the amount by which the price or value payable under another
Take-over Bid or transaction to a Locked-up Person exceeds the price or value
of the consideration that such Locked-up Person would have received under the
Take-over Bid; |
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which shall be payable by a Locked-up Person pursuant to the Lock-up Agreement
in the event a Locked-up Person fails to deposit or tender Common Shares to
the Take-over Bid or withdraws Common Shares in order to accept the other
Take-over Bid or support another transaction; |
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and for a greater clarity an agreement may contain a right of first refusal or require
a period of delay to give an offeror an opportunity to match a higher price in another
Take-over Bid or other similar limitation on a Locked-up Person as
long as the Locked-up
Person can accept another bid or tender to another transaction; |
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(bb) |
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Market Price per share of any securities on any date of determination shall mean the
weighted average trading price per share of such securities (determined as described below)
for the 20 consecutive Trading Days through and including the Trading Day immediately
preceding such date; provided, however, that if an event of a type analogous to any of the
events described in section 3.2 shall have caused the sale prices in respect of any Trading
Day used to determine the Market Price not to be fully comparable with the sale prices on
such date of determination or, if the date of determination is not a Trading Day, on the
immediately preceding Trading Day, each such sale price so used shall be appropriately
adjusted in a manner analogous to the applicable adjustment provided for in section 3.2 in
order to make it fully comparable with the sale price on such date of determination or, if
the date of determination is not a Trading Day, on the immediately preceding Trading Day.
The weighted average trading price per share of any securities on any date shall be
determined by dividing the aggregate sale price of all securities sold on the principal stock
exchange in Canada on which such securities are listed and posted for trading divided by the
total number of securities so sold; and |
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(i) |
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if for any reason such prices are not available on such day or the securities are
not listed and posted for trading on any stock exchange in Canada, the Market Price
shall be calculated using the sale prices for such securities as reported in the
principal consolidated transaction reporting system with respect to securities listed
or admitted to trading on the principal national securities exchange in the United
States on which such securities are listed or admitted to trading; |
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(ii) |
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if for any reason such prices are not available on such day or the securities are
not listed and posted for trading on a stock exchange in Canada or a |
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national securities exchange in the United States, the Market Price
shall be calculated using the average of the high bid and low asked prices of
each share of such securities in the over-the-counter market, as reported by
The National Association of Securities Dealers, Inc. or such other comparable
system then in use; or |
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(iii) |
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if on any such date the securities are not quoted by any such organization, the
Market Price shall be calculated using the average of the closing bid and asked prices
as furnished by a professional market maker making a market in the securities; |
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provided, however, that if on any such date the securities are not traded on any
exchange or in the over-the-counter market and the price referred to in clause
1.1(aa)(iii) is not available, the closing price per share of such securities on such
date shall mean the fair value per share of such securities on such date as determined
by a nationally or internationally recognized investment dealer or investment banker
with respect to the fair value per share of such securities. The Market Price shall be
expressed in Canadian dollars and if initially determined in respect of any day
forming part of the 20 consecutive Trading Day period in question in United States
dollars, such amount shall be translated into Canadian dollars on such date at the
Canadian Dollar Equivalent thereof; |
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(cc) |
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Offer to Acquire shall include: |
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(i) |
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an offer to purchase, or a solicitation of an offer to sell Common Shares; and |
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(ii) |
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an acceptance of an offer to sell Common Shares, whether or not such offer to
sell has been solicited; |
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or any combination thereof, and the Person accepting an offer to sell shall be deemed
to be making an Offer to Acquire to the Person who made the offer to sell; |
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(dd) |
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Offeror shall mean a Person who has announced a current intention to make or who is
making a Take-over Bid (including a Permitted Bid or a Competing Permitted Bid) but only so
long as the Take-over Bid so made or announced has not been withdrawn or terminated or has
not expired; |
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(ee) |
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Permitted Acquisition shall mean an acquisition of Common Shares of the Company by a
Person |
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(i) |
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as a result of a stock dividend, a stock split or other event pursuant to which
such Person receives or acquires Common Shares of the Company or Convertible
Securities on the same pro rata basis as all other holders of Common Shares, or |
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(ii) |
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pursuant to a regular dividend reinvestment or other plan of the Company
made available by the Company to the holders of Common Shares of the Company, or |
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(iii) |
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pursuant to the receipt and/or exercise of rights issued by the Company to all
of the holders of Common Shares of the Company to subscribe for or purchase Common
Shares of the Company or Convertible Securities, provided that such rights are
acquired directly from the Company and not from any other Person, provided that the
Person does not thereby acquire a greater percentage of Common Shares than the
Persons percentage of Common Shares Beneficially Owned immediately prior to such
acquisition or exercise; or |
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(iv) |
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pursuant to a distribution to the public by the Company of Common Shares, or
securities convertible into or exchangeable for Common Shares or Convertible
Securities, pursuant to a prospectus, provided that the Person does not thereby
acquire a greater percentage of such Common Shares or Convertible Securities or
securities convertible into or exchangeable for Common Shares or Convertible
Securities, so offered than the Persons percentage of Common Shares Beneficially
Owned immediately prior to such acquisition or to an amalgamation, merger or other
statutory procedure requiring shareholders approval; or |
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(v) |
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pursuant to a distribution by the Company of Common Shares or Convertible
Securities by way of a private placement by the Company or upon the exercise by an
individual employee of stock options granted under a stock option plan of the Company
or rights to purchase securities granted under a share purchase plan of the Company,
provided that (1) all necessary stock exchange approvals for such private placement,
stock option plan or share purchase plan have been obtained and such private
placement, stock option plan or share purchase plan complies with the terms and
conditions of such approvals and (2) such Person does not become the Beneficial Owner
of more than 25% of the Common Shares outstanding immediately prior to the
distribution, and in making this determination the Common Shares to be issued to such
Person in the distribution shall be deemed to be held by such Person but shall not be
included in the aggregate number of outstanding Common Shares immediately prior to the
distribution; |
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(ff) |
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Permitted Bid means a Take-over Bid that is made by means of a Take-over Bid circular
and that also complies with the following additional provisions: |
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(i) |
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the Take-over Bid is made to all holders of Common Shares of the Company as
registered on the books of the Company, other than the Offeror; |
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(ii) |
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the Take-over Bid contains, and the take-up and payment for Common
Shares tendered or deposited thereunder are subject to, an irrevocable and
unqualified condition that no Common Shares shall be taken up and paid for
pursuant to the Take-over Bid prior to the Close of Business on the date
which is not less than 60 days after the date of the Take-over Bid and only
if at such date more than 50% of the Common Shares then outstanding held by
Independent Shareholders, shall have been deposited or tendered pursuant to
the Take-over Bid and not withdrawn; |
|
|
(iii) |
|
the Take-over Bid contains an irrevocable and unqualified provision that, unless
the Take-over Bid is withdrawn, Common Shares may be deposited pursuant to such
Take-over Bid at any time during the period of time between the date of the Take-over
Bid and the date on which the Common Shares may be taken up and paid for and that any
such shares deposited pursuant to the Take-over Bid may be withdrawn until taken up
and paid for; and |
|
|
(iv) |
|
the Take-over Bid contains an irrevocable and unqualified provision that
in the event that more than 50% of the Common Shares then outstanding held by
Independent Shareholders shall have been deposited to the Take-over Bid as at the
date of first take-up or payment for Common Shares under the Take-over Bid, the
Offeror will make a public announcement of that fact and the Take-over Bid will
remain open for deposits and tenders of Common Shares for not less than 10
Business Days from the date of such public announcement; |
|
(gg) |
|
Permitted Bid Acquisition shall have the meaning ascribed thereto in subclause
1.1(c)(ii)(b); |
|
|
(hh) |
|
Person shall include any individual, body corporate, firm, partnership, association,
cooperative, trust, trustee, executor, administrator, legal personal representative, group,
unincorporated organization, syndicate, government or governmental agency or instrumentality,
or any other entity; |
|
|
(ii) |
|
Record Time shall mean 6:00 p.m. (Montreal time) on February 9,
2010; |
|
|
(jj) |
|
Right shall have the meaning ascribed thereto in the
recitals hereto; (kk) Rights Agent shall mean Computershare Trust
Company of Canada; |
|
|
(ll) |
|
Rights Certificates shall mean the certificates representing the Rights after the
Separation Time, which shall be in the form attached hereto as Exhibit A; |
|
|
(mm) |
|
Rights Register and Rights Registrar shall have the respective meanings ascribed
thereto in subsection 2.3(a); |
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|
(nn) |
|
Securities Act (Ontario) shall mean the Securities Act, R.S.O. 1990, c.
S.5, as amended, and the regulations thereunder, and any comparable or successor laws or
regulations thereto; |
|
|
(oo) |
|
Securities Act (Québec) shall mean the Securities Act, R.S.Q. c. V-1.1, as amended,
and the regulations thereunder, and any comparable or successor laws or regulations thereto; |
|
|
(pp) |
|
Separation Time shall mean, subject to subsection 6.1(f), the Close of Business on the
tenth Business Day after the earlier of: |
|
(i) |
|
the Stock Acquisition Date; |
|
|
(ii) |
|
the date of the commencement of, or first public announcement of the intent of
any Person (other than the Company or any Subsidiary of the Company) to commence a
Take-over Bid (other than a Permitted Bid or a Competing Permitted Bid, as the case
may be); and |
|
|
(iii) |
|
the date on which a Permitted Bid or Competing Permitted Bid ceases to qualify
as such; |
|
|
|
or such later time as may be determined by the Board of Directors acting in good
faith; provided that if the Take-over Bid expires, or is cancelled, terminated or
otherwise withdrawn prior to the Separation Time, such Take-over Bid shall be deemed,
for the purposes of this subsection 1.1(mm), never to have been made and provided
further that if the Board of Directors determines pursuant to section 6.1 hereof to
waive the application of section 4.1 to a Flip-in Event, the Separation Time in
respect of such Flip-in Event shall be deemed never to have occurred; |
|
|
(qq) |
|
Shares shall mean the shares in the capital of the Company; |
|
|
(rr) |
|
Share Reduction shall have the meaning ascribed thereto in subclause 1.1(c)(ii)(a); |
|
|
(ss) |
|
Stock Acquisition Date shall mean the date of the first public announcement (which for
the purposes of this definition shall include, without limitation, the filing of a report
pursuant to the Securities Act (Ontario) or pursuant to the Securities Act (Québec) or
section 13(d) under the the 1934 Exchange Act) by the Company or an Acquiring Person of facts
indicating that a Person has become an Acquiring Person; |
|
|
(tt) |
|
Subsidiary of a Person shall have the meaning ascribed thereto in the Securities Act
(Ontario); |
|
|
(uu) |
|
Take-over Bid shall mean an Offer to Acquire Common Shares of the Company or other
securities convertible into Common Shares of the Company, where the Common Shares or other
securities of the Company subject to the Offer |
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|
|
|
to Acquire are acquired at the date of such Offer to Acquire by the Person
making such Offer to Acquire, together with the Common Shares Beneficially Owned by
the Person making the Offer to Acquire would constitute in the aggregate 20% or more
of the outstanding Common Shares of the Company; |
|
|
(vv) |
|
Termination Time shall mean the time at which the right to exercise Rights shall
terminate pursuant to subsection 6.1(e) or section 6.15; |
|
|
(ww) |
|
Trading Day, when used with respect to any securities, shall mean a day on which the
principal United States or Canadian securities exchange on which such securities are listed
or admitted to trading is open for the transaction of business or, if the securities are not
listed or admitted to trading on any United States or Canadian securities exchange, a
Business Day; |
|
|
(xx) |
|
US.-Canadian Exchange Rate shall mean on any date: |
|
(i) |
|
if on such date the Bank of Canada sets an average noon spot rate of exchange
for the conversion of one United States dollar into Canadian dollars, such rate; and |
|
|
(ii) |
|
in any other case, the rate for such date for the conversion of one United
States dollar into Canadian dollars which shall be calculated in the manner
determined by the Board of Directors from time to time acting in good faith; |
|
(yy) |
|
US. Dollar Equivalent of any amount which is expressed in Canadian dollars shall mean
on any date the United States dollar equivalent of such amount determined by multiplying
such amount by the Canadian-U.S. Exchange Rate in effect on such date. |
1.2 Currency
All sums of money which are referred to in this Agreement are expressed in lawful money of Canada,
unless otherwise specified.
1.3 Descriptive Headings
Descriptive headings appear herein for convenience only and shall not control or affect the meaning
or construction of any of the provisions hereof.
1.4 References to Agreement
References to this Agreement, hereto, herein hereby hereunder, hereof and similar
expressions refer to this Agreement, as amended or supplemented from time to time, and not to any
particular Article, section, subsection, clause, subclause, subdivision or other portion hereof and
include any and every instrument supplemental or ancillary hereto.
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- 15 -
1.5 |
|
Calculation of Number and Percentage of Beneficial Ownership of Outstanding Common
Shares |
|
(a) |
|
For the purposes of this Agreement, in determining the percentage of the outstanding
Common Shares of the Company with respect to which a Person is or is deemed to be the
Beneficial Owner, all unissued Common Shares of the Company of which such Person is deemed
to be the Beneficial Owner shall be deemed to be outstanding. |
|
|
(b) |
|
The percentage of outstanding Common Shares of the Company Beneficially Owned by any
Person shall, for the purposes of this Agreement, be and be deemed to be the product
determined by the formula: |
|
|
|
|
100 x A B |
|
where: A = |
|
the number of votes for the election of all directors generally attaching
to the Common Shares Beneficially Owned by such Person; and |
|
|
B = |
|
the number of votes for the election of all directors generally attaching
to all outstanding Common Shares of the Company. |
1.6 |
|
Acting Jointly or in Concert |
For purposes of this Agreement, a Person shall be acting jointly or in concert with another
Person if such Person has any agreement, arrangement or understanding (whether formal or informal
and whether or not in writing) with such other Person to acquire, or Offer to Acquire any Common
Shares of the Company (other than customary agreements with and between underwriters and banking
group or selling group members with respect to a distribution of securities by way of a prospectus
or by way of a private placement or pursuant to a pledge of securities in the ordinary course of
business).
1.7 |
|
Application of Statutes, Regulations and Rules |
Where a statute, regulation or rule is referred to in a definition or other provision of this
Agreement, it shall be conclusively deemed to have application in the contemplated circumstances
notwithstanding that such statute, regulation or rule might not, but for the provisions of this
section 1.7 have application for want of jurisdiction or otherwise.
ARTICLE 2
THE RIGHTS
2.1 |
|
Legend on Certificates |
Certificates for Common Shares issued after the Record Time but prior to the Close of Business
on the earlier of the Separation Time and the Expiration Time shall evidence, one Right
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for each Common Share evidenced thereby and shall have impressed on, printed on, written on or
otherwise affixed to them the following legend:
|
|
UNTIL THE SEPARATION TIME (AS DEFINED IN THE RIGHTS AGREEMENT REFERRED TO BELOW), THIS
CERTIFICATE ALSO EVIDENCES AND ENTITLES THE HOLDER HEREOF TO CERTAIN RIGHTS AS SET FORTH IN
A SHAREHOLDER RIGHTS PLAN AGREEMENT, DATED AS OF THE 10th DAY OF FEBRUARY, 2010
(THE RIGHTS AGREEMENT) BETWEEN THERATECHNOLOGIES INC. (THE COMPANY) AND COMPUTERSHARE
TRUST COMPANY OF CANADA, AS RIGHTS AGENT, (AS THE SAME MAY BE AMENDED OR SUPPLEMENTED FROM
TIME TO TIME IN ACCORDANCE WITH THE TERMS THEREOF) THE TERMS OF WHICH ARE HEREBY
INCORPORATED HEREIN BY REFERENCE AND A COPY OF WHICH MAY BE INSPECTED DURING NORMAL BUSINESS
HOURS AT THE HEAD OFFICE OF THE COMPANY. UNDER CERTAIN CIRCUMSTANCES, AS SET FORTH IN THE
RIGHTS AGREEMENT SUCH RIGHTS MAY BE TERMINATED, MAY EXPIRE, MAY BECOME VOID (IF, IN CERTAIN
CASES, THEY ARE BENEFICIALLY OWNED BY AN ACQUIRING PERSON, AS SUCH TERMS ARE DEFINED IN
THE RIGHTS AGREEMENT, WHETHER CURRENTLY HELD BY OR ON BEHALF OF SUCH PERSON OR ANY
SUBSEQUENT HOLDER) OR MAY BE EVIDENCED BY SEPARATE CERTIFICATES AND MAY NO LONGER BE
EVIDENCED BY THIS CERTIFICATE. THE COMPANY WILL MAIL OR ARRANGE FOR THE MAILING OF A COPY
OF THE RIGHTS AGREEMENT TO THE HOLDER OF THIS CERTIFICATE WITHOUT CHARGE AS SOON AS IS
PRACTICABLE UPON RECEIPT OF A WRITTEN REQUEST THEREFOR. |
Certificates representing Common Shares that are issued and outstanding at the Record Time
shall evidence one Right for each Common Share evidenced thereby, notwithstanding the absence of
the foregoing legend until the earlier of the Separation Time and the Expiration Time.
2.2 |
|
Execution, Authentication, Delivery and Dating of Rights Certificates |
|
(a) |
|
The Rights Certificates shall be executed on behalf of the Company by any of the
Chairman of the Board, the President and Chief Executive Officer or the Vice President,
Finance and Chief Financial Officer, together with any other of such persons or together
with any one of the Secretary or any other officer of the Company. The signature of any
such officers of the Company on the Rights
Certificates may be manual or facsimile. Rights Certificates bearing the manual or
facsimile signatures of individuals who were at any time the proper officers of the
Company shall bind the Company, notwithstanding that such individuals or any of them
have ceased to hold such offices prior to the countersignature and delivery of such
Rights Certificates. |
|
|
(b) |
|
Promptly after the Company learns of the Separation Time, the Company will notify the
Rights Agent of such Separation Time and will deliver Rights Certificates executed by the
Company to the Rights Agent for countersignature and disclosure statement describing the
Rights, and the Rights Agent shall |
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- 17 -
|
|
|
manually (or by facsimile signature in a manner satisfactory to the Company)
countersign and deliver such Rights Certificates to the holders of the Rights
pursuant to subsection 3.1(d). No Rights Certificate shall be valid for any purpose
until countersigned by the Rights Agent as aforesaid. |
|
|
(c) |
|
Each Rights Certificate shall be dated the date of the countersignature thereof. |
2.3 |
|
Registration, Registration of Transfer and Exchange |
|
(a) |
|
After the Separation Time, the Company will cause to be kept a register (the Rights
Register) in which, subject to such reasonable regulations as it may prescribe, the Company
will provide for the registration and transfer of Rights.
The Rights Agent is hereby appointed the Rights Registrar for the purpose of
maintaining the Rights Register for the Company and registering Rights and transfers
of rights as herein provided. In the event that the Rights Agent shall cease to be
the Rights Registrar, the Rights Agent will have the right to examine the Rights
Register at all reasonable times. After the Separation Time and prior to the
Expiration Time, upon surrender for registration of transfer or exchange of any
Rights Certificate, and subject to the provisions of subsection 2.3(c), the Company
will execute, and the Rights Agent will countersign, register and deliver, in the
name of the holder or the designated transferee or transferees, as required pursuant
to the holders instructions, one or more new Rights Certificates evidencing the
same aggregate number of Rights as did the Rights Certificates so surrendered. |
|
|
(b) |
|
All Rights issued upon any registration of transfer or exchange of Rights Certificates
shall be valid obligations of the Company, and such Rights shall be entitled to the same
benefits under this Agreement as the Rights surrendered upon such registration of transfer
or exchange. |
|
|
(c) |
|
Every Rights Certificate surrendered for registration of transfer or exchange shall be
duly endorsed, or be accompanied by a written instrument of transfer in form satisfactory to
the Company or the Rights Agent, as the case may be, duly executed by the holder thereof or
such holders attorney duly authorized in writing. As a condition to the issuance of any new
Rights Certificate under this section 2.3, the Company may require the payment of a sum
sufficient to cover any tax or other governmental charge that may be imposed in relation
thereto and any other expenses (including the fees and expenses of the Rights Agent) in
connection therewith. |
2.4 |
|
Mutilated, Destroyed, Lost and Stolen Rights Certificates |
|
(a) |
|
If any mutilated Rights Certificate is surrendered to the Rights Agent prior to the
Expiration Time, the Company shall execute and the Rights Agent shall manually countersign
and deliver in exchange therefor a new Rights Certificate evidencing the same number of
Rights as the Rights Certificate so surrendered. |
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|
(b) |
|
If there shall be delivered to the Company and the Rights Agent prior to the Expiration
Time: (i) evidence to their satisfaction of the destruction, loss or theft of any Rights
Certificate; and (ii) such security or indemnity as may be required by each of them to save
each of them and any of their agents harmless, then, in the absence of notice to the Company
or the Rights Agent that such Rights Certificate has been acquired by a bona fide purchaser,
the Company shall execute and upon its request the Rights Agent shall countersign and
deliver, in lieu of any such destroyed, lost or stolen Rights Certificate, a new Rights
Certificate evidencing the same number of Rights as did the Rights Certificate so destroyed,
lost or stolen. |
|
|
(c) |
|
As a condition to the issuance of any new Rights Certificate under this section 2.4, the
Company may require the payment of a sum sufficient to cover any tax or other governmental
charge that may be imposed in relation thereto and any other expenses (including the fees
and expenses of the Rights Agent) in connection therewith. |
|
|
(d) |
|
Every new Rights Certificate issued pursuant to this section 2.4 in lieu of any
destroyed, lost or stolen Rights Certificate shall evidence the contractual obligation of
the Company, whether or not the destroyed, lost or stolen Rights Certificate shall be at any
time enforceable by anyone, and shall be entitled to all the benefits of this Agreement
equally and proportionately with any and all other Rights duly issued by the Company. |
2.5 |
|
Persons Deemed Owners of Rights |
Prior to due presentment of a Rights Certificate, the Company, the Rights Agent and any agent
of the Company or the Rights Agent may deem and treat the Person in whose name such Rights
Certificate (or, prior to the Separation Time, the associated Common Share certificate) is
registered as the absolute owner thereof and of the Rights evidenced thereby, for all purposes
whatsoever. As used in this Agreement, unless the context otherwise requires, the term holder of
any Rights shall mean the registered holder of such Rights (or, prior to the Separation Time, the
associated Common Shares).
2.6 |
|
Delivery and Cancellation of Certificates |
All Rights Certificates surrendered upon exercise or for redemption, registration of transfer
or exchange shall, if surrendered to any Person other than the Rights Agent, be delivered to the
Rights Agent and, in any case, shall be promptly cancelled by the Rights Agent. The Company may at
any time deliver to the Rights Agent for cancellation any Rights Certificates previously
countersigned and delivered hereunder which the Company may have acquired in any manner whatsoever,
and all Rights Certificates so delivered shall be promptly cancelled by the Rights Agent. No
Rights Certificate shall be countersigned in lieu of or in exchange for any Rights Certificates
cancelled as provided for in this section 2.6, except as expressly permitted by this Agreement. The
Rights Agent shall, subject to applicable law, destroy all cancelled Rights Certificates and
deliver a certificate of destruction to the Company upon request.
New Rights Plan
- 19 -
2.7 |
|
Agreement of Rights Holders |
Every holder of Rights by accepting such Rights consents and agrees with the Company and the
Rights Agent and with every other holder of Rights:
|
(a) |
|
to be bound by and subject to the provisions of this Agreement, as amended from time to
time in accordance with the terms hereof, in respect of the Rights held; |
|
|
(b) |
|
that prior to the Separation Time, each Right will be transferable only together with,
and will be transferred by a transfer of, the associated Common Share; |
|
|
(c) |
|
that after the Separation Time, the Rights Certificates will be transferable only upon
registration of the transfer on the Rights Register as provided herein; |
|
|
(d) |
|
that prior to due presentment of a Rights Certificate (or, prior to the Separation Time,
the associated Common Share certificate) for registration of transfer, the Company, the
Rights Agent and any agent of the Company or the Rights Agent may deem and treat the Person
in whose name the Rights Certificate (or, prior to the Separation Time, the associated
Common Share certificate) is registered as the absolute owner thereof and of the Rights
evidenced thereby (notwithstanding any notations of ownership or writing on such Rights
Certificate or the associated Common Share certificate, made by anyone other than the
Company or the Rights Agent) for all purposes whatsoever, and neither the Company nor the
Rights Agent shall be affected by any notice to the contrary; |
|
|
(e) |
|
that such holder of Rights is not entitled to receive any fractional Rights or any
fractional Common Shares upon exercise of a Right (except as provided herein); |
|
|
(f) |
|
that without the approval of any holder of Rights and upon the sole authority of the
Board of Directors acting in good faith, this Agreement may be supplemented or amended from
time to time pursuant to and as provided herein; and |
|
|
(g) |
|
notwithstanding anything in this Agreement to the contrary, neither the Company nor the
Rights Agent and their respective directors and officers shall have any liability to any
holder of a Right or any other Person as a result of its inability to perform any of its
obligations under this Agreement by reason of any preliminary or permanent injunction or
other order, decree or ruling issued by a court of competent jurisdiction or by a
governmental, regulatory or administrative agency or commission or any statute, rule,
regulation or executive order promulgated or enacted by such governmental or regulatory
authority, prohibiting or otherwise restraining performance of such obligation. |
2.8 |
|
Rights Certificate Holder Not Deemed a Shareholder |
No holder, as such, of any Right or Rights Certificate shall be entitled to vote, receive
dividends or be deemed for any purpose whatsoever the holder of any Common Share which may at any
time be issuable on the exercise of such Right, nor shall anything contained herein or in any
Rights Certificate be construed or deemed to confer upon the holder of any Right or
New Rights Plan
- 20 -
Rights Certificate, as such, any of the rights, titles, benefits or privileges of a shareholder of
the Company or any right to vote at any meeting of shareholders of the Company whether for the
election of directors or otherwise or upon any matter submitted to holders of any Shares at any
meeting thereof, or to give or withhold consent to any action of the Company, or to receive notice
of any meeting or other action affecting any shareholder of the Company except as expressly
provided herein, or to receive dividends, distributions or subscription rights, or otherwise, until
the Right or Rights evidenced by any Rights Certificate shall have been duly exercised in
accordance with the terms and provisions hereof.
ARTICLE 3
EXERCISE OF THE RIGHTS
3.1 |
|
Initial Exercise Price, Exercise of Rights, Detachment of Rights |
|
(a) |
|
Subject to adjustment as herein set forth, from and after the Separation Time and prior
to the Expiration Time, each Right will entitle the holder thereof to purchase one Common
Share for the Exercise Price (or its U.S. Dollar Equivalent) as at the Close of Business on
the day immediately preceding the date of the exercise of the Right (which Exercise Price
and number of Common Shares are subject to adjustment as set forth below). Notwithstanding
any other provision of this Agreement, any Rights held by the Company or any of its
Subsidiaries shall be void. |
|
|
(b) |
|
Until the Separation Time: |
|
(i) |
|
the Rights shall not be exercisable and no Right may be exercised; and |
|
|
(ii) |
|
each Right will be evidenced by the certificate for the associated Common Share
registered in the name of the holder thereof (which certificate shall also be deemed
to be a Rights Certificate) and will be transferable only together with, and will be
transferred by a transfer of, such associated Common Share. |
|
(c) |
|
From and after the Separation Time and prior to the Expiration Time: |
|
(i) |
|
the Rights shall be exercisable; and |
|
|
(ii) |
|
the registration and transfer of the Rights shall be separate from and
independent of the Common Shares. |
|
(d) |
|
Promptly following the Separation Time, the Company will prepare and the Rights Agent
will mail to each holder of record of Common Shares as of the Separation Time (other than an
Acquiring Person and other than, in respect of any Rights Beneficially Owned by such
Acquiring Person which are not held of record by such Acquiring Person, the holder of record
of such Rights (a Nominee)), at such holders address as shown by the records of the
Company (and the Company hereby agrees to furnish copies of such records to the Rights Agent
for this purpose): |
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|
(i) |
|
a Rights Certificate representing the number of Rights held by such holder at the
Separation Time in substantially the form of Exhibit A hereto, appropriately completed
and having such marks of identification or designation and such legends, summaries or
endorsements printed thereon as the Company may deem appropriate and as are not
inconsistent with the provisions of this Agreement, or as may be required to comply
with any law, rule, regulation or judicial or administrative order or with any rule or
regulation made pursuant thereto or with any rule or regulation of any stock exchange
or quotation system on which the Rights may from time to time be listed or traded, or
to conform to usage; and |
|
|
(ii) |
|
a disclosure statement describing the Rights; |
|
|
|
provided that a Nominee shall be sent the materials provided for in clauses 3.1(d)(i)
and 3.1(d)(ii) only in respect of all Common Shares held of record by it which are not
Beneficially Owned by an Acquiring Person. |
|
|
(e) |
|
Rights may be exercised in whole or in part on any Business Day after the Separation Time
and prior to the Expiration Time by submitting to the Rights Agent: |
|
(i) |
|
the Rights Certificate evidencing such Rights; |
|
|
(ii) |
|
an election to exercise such Rights (an Election to Exercise), substantially in
the form attached to the Rights Certificate, duly completed and executed by the holder
or his executors or administrators or other personal representatives or his or their
legal attorney duly appointed by an instrument in writing in form and executed in a
manner satisfactory to the Rights Agent; and |
|
|
(iii) |
|
payment by certified cheque, bankers draft or money order payable to the order
of the Rights Agent, of a sum equal to the applicable Exercise Price multiplied by the
number of Rights being exercised and a sum sufficient to cover any transfer or charge
which may be payable in respect of any transfer involved in the transfer or delivery
of Rights Certificates or the issuance or delivery of certificates for the relevant
Common Shares in a name other than that of the holder of the Rights being exercised.
The Rights Agent may retain any cash balance held in connection with this Agreement
and may, but need not, hold same in its deposit department or the deposit department
of one of its Affiliates; but the Rights Agent and its Affiliates shall not be liable
to account for any profit to the Company or any other person or entity other than at a
rate, if any, established from time to time by the Rights Agent or one of its
Affiliates. |
|
(f) |
|
Upon receipt of the Rights Certificate which is accompanied by a completed Election to
Exercise (provided that such Right is not null and void pursuant to subsection 4.1(b)) and
payment as set forth in clause 3.1(e)(iii), the Rights Agent |
New Rights Plan
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|
|
|
(unless otherwise instructed in writing by the Company in the event that the Company
is of the opinion that the Rights cannot be exercised in accordance with this
Agreement) will thereupon promptly: |
|
(i) |
|
requisition from the transfer agent for the Common Shares certificates
representing the number of such Common Shares to be purchased (the Company hereby
irrevocably authorizing its transfer agents to comply with all such requisitions); |
|
|
(ii) |
|
when appropriate, requisition from the Company the amount of cash to be paid in
lieu of issuing fractional Common Shares; |
|
|
(iii) |
|
after receipt of such Common Share certificate referred to in clause 3.1(f)(i),
deliver the same to or to the order of the registered holder of such Rights
Certificate, registered in such name or names as may be designated by such holder; |
|
|
(iv) |
|
when appropriate, after receipt, deliver such cash referred to in clause
3.1(f)(ii) to or to the order of the registered holder of the Rights Certificate; and |
|
|
(v) |
|
tender to the Company all payments received on exercise of the Rights. |
|
(g) |
|
In case the holder of any Rights shall exercise less than all the Rights evidenced by
such holders Rights Certificate, a new Rights Certificate evidencing the Rights remaining
unexercised will be issued by the Rights Agent to such holder or to such holders duly
authorized assigns. |
|
|
(h) |
|
The Company covenants and agrees that it will: |
|
(i) |
|
take all such reasonable action as may be necessary and within its power to ensure
that all Common Shares delivered upon exercise of Rights shall, at the time of
delivery of the certificates representing such Common Shares (subject to payment of
the Exercise Price), be duly and validly authorized, issued and delivered as fully
paid and non-assessable; |
|
|
(ii) |
|
take all such actions as may be necessary and within its power to comply with any
applicable requirements of the Companies Act, the Securities Act (Ontario), the
Securities Act (Québec) and the securities act or comparable legislation of each of
the other provinces of Canada, the 1933 Securities Act and the 1934 Exchange Act (if
applicable) and any other applicable law, rule or regulation, in connection with the
issuance and delivery of the Rights Certificates and the issuance of any Common Shares
upon exercise of Rights; |
|
|
(iii) |
|
use reasonable efforts to cause all Common Shares issued upon exercise of Rights
to be listed on the principal exchanges on which the Common Shares were traded
immediately prior to the Stock Acquisition Date; |
New Rights Plan
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|
(iv) |
|
cause to be reserved and kept available out of its authorized and unissued
Common Shares the number of Common Shares that, as provided in this Agreement, will
from time to time be sufficient to permit the exercise in full of all outstanding
Rights; and |
|
|
(v) |
|
pay when due and payable any and all federal and provincial transfer taxes (for
greater certainty not including any income taxes of the holder or exercising holder
or any liability of the Company to withhold tax) which may be payable in respect of
the original issuance or delivery of the Rights Certificates, provided that the
Company shall not be required to pay any transfer tax or charge which may be payable
in respect of any transfer involved in the transfer or delivery of Rights
Certificates or the issuance or delivery of certificates for Common Shares in a name
other than that of the holder of the Rights being transferred or exercised. |
3.2 |
|
Adjustments to Exercise Price, Number of Rights |
The Exercise Price, the number of Common Shares (or other securities) subject to purchase upon
the exercise of each Right and the number of Rights outstanding are subject to adjustment from time
to time as provided in this section 3.2.
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(a) |
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In the event the Company shall at any time after the Record Time and prior to the
Expiration Time: |
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(i) |
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declare or pay a dividend on the Common Shares payable in Common Shares (or
other securities exchangeable for or convertible into or giving a right to acquire
Common Shares or other capital stock of the Company) other than pursuant to any
dividend reinvestment program; |
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(ii) |
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subdivide or change the outstanding Common Shares of any class into a greater
number of Common Shares; or |
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(iii) |
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combine or change the outstanding Common Shares of any class into a smaller
number of Common Shares; or |
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(iv) |
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issue any new Common Shares (or other securities exchangeable for or
convertible into or giving a right to acquire Common Shares) in respect of, in lieu
of or in exchange for existing Common Shares, in a reclassification, amalgamation,
merger, statutory arrangement or consolidation, |
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the Exercise Price and the number of Rights outstanding, or, if the payment or
effective date therefor shall occur after the Separation Time, the securities
purchasable upon exercise of Rights shall be adjusted in the manner set forth below. |
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If the Exercise Price and the number of Rights outstanding are to be adjusted: |
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(i) |
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the Exercise Price in effect after such adjustment will be equal to the Exercise
Price in effect immediately prior to such adjustment divided by the number of Common
Shares (or other capital stock) (the Expansion Factor) that a holder of one Common
Share immediately prior to such dividend, subdivision, change, consolidation or
issuance would hold thereafter as a result thereof (assuming the exercise of all such
exchange or conversion rights, if any); and |
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(ii) |
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each Right held prior to such adjustment will become that number of Rights equal
to the Expansion Factor, |
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and the adjusted number of Rights will be deemed to be distributed among the Common
Shares with respect to which the original Rights were associated (if they remain
outstanding) and the Common Shares issued in respect of such dividend, subdivision,
change, consolidation or issuance, so that each such Common Share (or other capital
stock) will have exactly one Right associated with it. |
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If the securities purchasable upon exercise of Rights are to be adjusted, the
securities purchasable upon exercise of each Right after such adjustment will be the
securities that a holder of the securities purchasable upon exercise of one Right
immediately prior to such dividend, subdivision, change, consolidation or issuance
would hold immediately thereafter as a result thereof. To the extent that such rights
of exchange, conversion or acquisition are not exercised prior to the expiration
thereof, the Exercise Price shall be readjusted to the Exercise Price which would then
be in effect based on the number of Common Shares (or securities convertible into or
exchangeable for Common Shares) actually issued upon the exercise of such rights. |
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If an event occurs which would require an adjustment under both this section 3.2 and
section 4.1, the adjustment provided for in this section 3.2 shall be in addition to,
and shall be made prior to, any adjustment required under section 4.1. |
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If the Company shall at any time after the Record Time and prior to the Separation
Time issue any Common Shares otherwise than in a transaction referred to in this
subsection 3.2(a), each such Common Share so issued shall automatically have one new
Right associated with it, which Right shall be evidenced by the certificate
representing such Common Share. |
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(b) |
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In case the Company shall at any time after the Record Time and prior to the Separation
Time fix a record date for the issuance of rights, options or warrants to all holders of
Common Shares entitling them to subscribe for or purchase (for a period expiring within 45
calendar days after such record date) Common Shares (or shares having the same rights,
privileges and preferences as Common Shares (equivalent Common Shares)) or securities
convertible into Common Shares or equivalent Common Shares at a price per Common Share or per
equivalent Common Share (or having a conversion price per share, if a security convertible
into Common Shares or equivalent Common Shares) less than 90% of the Market |
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Price per Common Share on such record date, the Exercise Price in respect of the
Rights to be in effect after such record date shall be determined by multiplying the
Exercise Price in respect of the Rights in effect immediately prior to such record
date by a fraction: (i) the numerator of which shall be the number of Common Shares
outstanding on such record date, plus the number of Common Shares that the aggregate
offering price of the total number of Common Shares and/or equivalent Common Shares so
to be offered (and/or the aggregate initial conversion price of the convertible
securities so to be offered) would purchase at such Market Price per Common Share; and
(ii) the denominator of which shall be the number of Common Shares outstanding on such
record date, plus the number of additional Common Shares and/or equivalent Common
Shares to be offered for subscription or purchase (or into which the convertible
securities so to be offered are initially convertible). In case such subscription
price may be paid by delivery of consideration, part or all of which may be in a form
other than cash, the value of such consideration shall be as determined in good faith
by the Board of Directors, whose determination shall be described in a statement filed
with the Rights Agent and shall be binding on the Rights Agent and the holders of the
Rights. Such adjustment shall be made successively whenever such a record date is
fixed and, in the event that such rights or warrants are not so issued, the Exercise
Price in respect of the Rights shall be readjusted to be the Exercise Price which
would then be in effect if such record date had not been fixed. To the extent that
such rights of conversion, exchange or purchase are not exercised prior to the
expiration thereof, the Exercise Price shall be readjusted to the Exercise Price which
would then be in effect based on the number of Common Shares (or securities
convertible into or exchangeable or exercisable for Common Shares) actually issued
upon the exercise of such rights. |
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(c) |
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For purposes of this Agreement, the granting of the right to purchase Common Shares
(whether from treasury or otherwise) pursuant to a dividend or interest reinvestment plan or
any Common Share purchase plan providing for the reinvestment of dividends or interest
payable on the securities of the Company or the investment of periodic optional payments or
any employee benefit, stock option or similar plans shall be deemed not to constitute an
issue of rights, options or warrants by the Company; provided, however, that in all such
cases the right to purchase Common Shares is at a price per share of not less than 90% of the
current market price per share (determined as provided in such plans) of Common Shares. |
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(d) |
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In case the Company shall at any time after the Record Time and prior to the Separation
Time fix a record date for a distribution to all holders of Common Shares (including any such
distribution made in connection with a merger in which the Company is the continuing Company)
of evidences of indebtedness or assets, including cash (other than a dividend paid in the
ordinary course or a dividend paid in Common Shares, but including any dividend payable in
securities other than Common Shares), or subscription rights or warrants entitling them to
subscribe for or purchase Common Shares (excluding those referred to in subsection 3.2(b)) at
a price per Common Share that is less than 90% of the |
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Market Price per Common Share on such record date, the Exercise Price in respect of
the Rights to be in effect after such record date shall be determined by multiplying
the Exercise Price in respect of the Rights in effect immediately prior to such record
date by a fraction: (i) the numerator of which shall be the Market Price per Common
Share on such record date, less the fair market value (as determined in good faith by
the Board of Directors, whose determination shall be described in a statement filed
with the Rights Agent and shall be binding on the Rights Agent and the holders of the
Rights) of the portion of the cash, assets or evidences of indebtedness so to be
distributed or of such subscription rights or warrants applicable to a Common Share;
and (ii) the denominator of which shall be such Market Price per Common Share. Such
adjustments shall be made successively whenever such a record date is fixed and, in
the event that such distribution is not so made, the Exercise Price in respect of the
Rights shall be adjusted to be the Exercise Price in respect of the Rights which would
have been in effect if such record date had not been fixed. |
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(e) |
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Notwithstanding anything herein to the contrary, no adjustment in an Exercise Price shall
be required unless such adjustment would require an increase or decrease of at least 1% in
such Exercise Price; provided, however, that any adjustments which by reason of this
subsection 3.2(e) are not required to be made shall be carried forward and taken into account
in any subsequent adjustment. All calculations under this section 3.2 shall be made to the
nearest cent or to the nearest ten-thousandth of a Common Share or other share, as the case
may be.
Notwithstanding the first sentence of this subsection 3.2(e), any adjustment required
by this section 3.2 shall be made no later than the earlier of (i) three years from
the date of the transaction which mandates such adjustment and (ii) the Expiration
Time. |
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(f) |
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Subject to the prior consent of the holders of Common Shares or Rights obtained in
accordance with the provisions of Article 6, as applicable, in the event the Company shall at
any time after the Record Time and prior to the Separation Time issue any shares of capital
stock (other than Common Shares), or rights or warrants to subscribe for or purchase any such
capital stock, or securities convertible into or exchangeable for any such capital stock, in
a transaction referred to in clauses 3.2(a)(i) or 3.2(a)(iv), if the Board of Directors
acting in good faith determines that the adjustments contemplated by subsections 3.2(a),
3.2(b) and 3.2(c) above in connection with such transaction will not appropriately protect
the interests of the holders of Rights, the Company may determine what other adjustments to
the Exercise Price, number of Rights or securities purchasable upon exercise of Rights would
be appropriate and, notwithstanding subsections 3.2(a), 3.2(b) and 3.2(c) above, such
adjustments (rather than the adjustment contemplated by subsections 3.2(a), 3.2(b) and
3.2(c)), shall be made.
The Company and the Rights Agent at the written direction of the Company shall amend
this Agreement as appropriate to provide for such adjustments. |
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(g) |
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If, as a result of an adjustment made pursuant to section 4.1, the holder of any Right
thereafter exercised shall become entitled to receive any Shares other than |
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Common Shares, thereafter the number of such other Shares so receivable upon exercise
of any Right and the applicable Exercise Price thereof shall be subject to adjustment
from time to time in a manner and on terms as nearly equivalent as is practicable to
the provisions with respect to the Common Shares contained in this section 3.2, and
the provisions of this Agreement with respect to the Common Shares shall apply on like
terms to any such other Shares. |
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(h) |
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All Rights originally issued by the Company subsequent to any adjustment made to an
Exercise Price hereunder shall evidence the right to purchase, at the adjusted Exercise
Price, that number of Common Shares purchasable from time to time hereunder upon exercise of
the Rights, all subject to further adjustment as provided herein. |
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(i) |
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Unless the Company shall have exercised its election as provided in subsection 3.2(j),
upon each adjustment of an Exercise Price as a result of the calculations made in subsections
3.2(b) and 3.2(d), each Right outstanding immediately prior to the making of such adjustment
shall thereafter evidence the right to purchase, at the adjusted Exercise Price, that number
of Common Shares (calculated to the nearest one ten-thousandth) determined by: |
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(a) |
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the number of such Common Shares which would have been issuable upon the
exercise of a Right immediately prior to this adjustment; by |
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(b) |
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the relevant Exercise Price in effect immediately prior to such adjustment
of the Relevant Exercise Price; and |
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(ii) |
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dividing the product so obtained by the relevant Exercise Price in effect
immediately after such adjustment of the relevant Exercise Price. |
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(j) |
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The Company may elect on or after the date of any adjustment of an Exercise Price to
adjust the number of Rights, in lieu of any adjustment in the number of Common Shares
purchasable upon the exercise of a Right. Each of the Rights outstanding after the
adjustment in the number of Rights shall be exercisable for the number of Common Shares for
which such a Right was exercisable immediately prior to such adjustment. Each Right held of
record prior to such adjustment of the number of Rights shall become that number of Rights
(calculated to the nearest one ten-thousandth) obtained by dividing the relevant Exercise
Price in effect immediately prior to adjustment of the relevant Exercise Price by the
relevant Exercise Price in effect immediately after adjustment of the relevant Exercise
Price. The Company shall make a public announcement of its election to adjust the number of
Rights, indicating the record date for the adjustment, and, if known at the time, the amount
of the adjustment to be made.
This record date may be the date on which the relevant Exercise Price is adjusted or
any day thereafter, but, if the Rights Certificates have been issued, shall be at |
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least 10 days later than the date of the public announcement. If Rights Certificates
have been issued, upon each adjustment of the number of Rights pursuant to this
subsection 3.2(j), the Company shall, as promptly as is practicable, cause to be
distributed to holders of record of Rights Certificates on such record date, Rights
Certificates evidencing, subject to section 6.4, the additional Rights to which such
holders shall be entitled as a result of such adjustment, or, at the option of the
Company, shall cause to be distributed to such holders of record in substitution and
replacement for the Rights Certificates held by such holders prior to the date of
adjustment, and upon surrender thereof, if required by the Company, new Rights
Certificates evidencing all the Rights to which such holders shall be entitled after
such adjustment. Rights Certificates to be so distributed shall be issued, executed
and countersigned in the manner provided for herein and may bear, at the option of the
Company, the relevant adjusted Exercise Price and shall be registered in the names of
holders of record of Rights Certificates on the record date specified in the public
announcement. |
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(k) |
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Irrespective of any adjustment or change in an Exercise Price or the number of Common
Shares issuable upon the exercise of the Rights, the Rights Certificates theretofore and
thereafter issued may continue to express the relevant Exercise Price per Common Share and
the number of Common Shares which were expressed in the initial Rights Certificates issued
hereunder. |
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(l) |
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In any case in which this section 3.2 shall require that an adjustment in an Exercise
Price be made effective as of a record date for a specified event, the Company may elect to
defer, until the occurrence of such event, the issuance to the holder of any Right exercised
after such record date of the number of Common Shares and other securities of the Company, if
any, issuable upon such exercise over and above the number of Common Shares and other
securities of the Company, if any, issuable upon such exercise on the basis of the relevant
Exercise Price in effect prior to such adjustment; provided, however, that the Company shall
deliver to such holder a due bill or other appropriate instrument evidencing such holders
right to receive such additional Common Shares (fractional or otherwise) or other securities
upon the occurrence of the event requiring such adjustment. |
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(m) |
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Notwithstanding anything in this section 3.2 to the contrary, the Company shall be
entitled to make such reductions in each Exercise Price in addition to those adjustments
expressly required by this section 3.2, as and to the extent that in its good faith judgment
the Board of Directors shall determine to be advisable in order that any: (i) consolidation
or subdivision of Common Shares; (ii) issuance wholly for cash of any Common Share or
securities that by their terms are convertible into or exchangeable for Common Shares; (iii)
stock dividends; or (iv) issuance of rights, options or warrants referred to in this section
3.2 hereafter made by the Company to holders of its Common Shares shall not be taxable to
such shareholders. |
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(n) |
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The Company covenants and agrees that, after the Separation Time, it will not, except as
permitted by section 6.1 or 6.5, take (or permit any Subsidiary of the Company to take) any
action if at the time such action is taken it is reasonably foreseeable that such action
will diminish substantially or otherwise eliminate the benefits intended to be afforded by
the Rights. |
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(o) |
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Whenever an adjustment to the Exercise Price or a change in the securities purchasable
upon exercise of the Rights is made at any time after the Separation Time pursuant to this
Section 3.2, the Company shall promptly: |
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(i) |
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File with the Rights Agent and with the transfer agent for the Common Shares a
certificate specifying the particulars of such adjustment or change; and |
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(ii) |
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Cause notice of the particulars of such adjustment or change to be given to the
holders of the Rights; provided that failure to file such certificate or cause such
notice to be given as aforesaid, or any defect therein, shall not affect the
validity of any such adjustment or change. |
3.3 |
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Date on Which Exercise is Effective |
Each Person in whose name any certificate for Common Shares is issued upon the exercise of
Rights shall for all purposes be deemed to have become the holder of record of the Common Shares
represented thereby on, and such certificate shall be dated, the date upon which the Rights
Certificate evidencing such Rights was duly surrendered (together with a duly completed Election to
Exercise) and payment of the relevant Exercise Price for such Rights (and any applicable transfer
taxes and other governmental charges payable by the exercising holder hereunder) was made;
provided, however, that if the date of such surrender and payment is a date upon which the relevant
Common Share transfer books of the Company are closed, such Person shall be deemed to have become
the holder of record of such Common Shares on, and such certificate shall be dated, the next
succeeding Business Day on which the relevant Common transfer books of the Company are open.
ARTICLE 4
ADJUSTMENTS TO THE RIGHTS
IN THE EVENT OF CERTAIN TRANSACTIONS
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(a) |
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Subject to subsection 4.1(b) and subsections 6.1(f), 6.1(g) and 6.1(h), in the event
that prior to the Expiration Time a Flip-in Event shall occur, each Right shall constitute,
effective on and after the later of its date of issue and the Close of Business on the tenth
Trading Day following the Stock Acquisition Date, the right to purchase from the Company,
upon payment of the relevant Exercise Price and otherwise exercising such Right in
accordance with the terms hereof, that number of Common Shares having an aggregate Market
Price on the date of consummation or occurrence of such Flip-in Event equal to twice the
relevant Exercise Price for an amount in cash equal to the relevant Exercise Price (such |
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right to be appropriately adjusted in a manner analogous to the applicable adjustments
provided for in section 3.2 upon each occurrence after the Stock Acquisition Date of
any event analogous to any of the events described in section 3.2). |
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(b) |
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Notwithstanding anything in this Agreement to the contrary, upon the occurrence of any
Flip-in Event, any Rights that are or were Beneficially Owned on or after the earlier of the
Separation Time and the Stock Acquisition Date by: (i) an Acquiring Person (or any Affiliate
or Associate of an Acquiring Person or any Person acting jointly or in concert with an
Acquiring Person or any Affiliate or Associate of an Acquiring Person); or (ii) a transferee
or other successor in title, directly or indirectly, (a Transferee) of Rights held by an
Acquiring Person (or any Affiliate or Associate of an Acquiring Person or any Person acting
jointly or in concert with an Acquiring Person or any Affiliate or Associate of an Acquiring
Person) who becomes a Transferee concurrently with or subsequent to the Acquiring Person
becoming an Acquiring Person in a transfer that the Board of Directors has determined is part
of a plan, arrangement or scheme of an Acquiring Person (or any Affiliate or Associate of an
Acquiring Person or any Person acting jointly or in concert with an Acquiring Person or any
Affiliate or Associate of an Acquiring Person), that has the purpose of avoiding the effect
of this subsection 4.1(b) shall become null and void without any further action, and any
holder of such Rights (including any Transferee) shall not have any right whatsoever to
exercise such Rights under any provision of this Agreement and shall not have thereafter any
other rights whatsoever with respect to such Rights, whether under any provision of this
Agreement or otherwise. The holder of any
Rights represented by a Rights Certificate which is submitted to the Rights Agent upon
exercise or for registration of transfer or exchange which does not contain the
necessary certifications set forth in the Rights Certificate establishing that such
Rights are not void under this subsection 4.1(b) shall be deemed to be an Acquiring
Person for the purposes of this subsection 4.1(b) and such Rights shall become null
and void. |
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(c) |
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In the event that there shall not be sufficient Common Shares authorized for issuance to
permit the exercise in full of the Rights in accordance with this section 4.1 the Company
shall take all such action as may be necessary to authorize additional Common Shares for
issuance upon the exercise of the Rights. |
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(d) |
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From and after the Separation Time, the Company shall do all such acts and things as
shall be necessary and within its power to ensure compliance with the provisions of this
section 4.1 including, without limitation, all such acts and things as may be required to
satisfy the requirements of the Companies Act, the Securities Act (Ontario), the Securities
Act (Québec) or comparable legislation of each of the provinces of Canada, and of the United
States and each of the states thereof, if necessary, in respect of the issue of Common Shares
upon the exercise of Rights in accordance with this Agreement. |
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(e) |
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Any Rights Certificate that represents Rights Beneficially Owned by a
Person described in subsection 4.1(b) or transferred to any nominee of any such Person, and
any Rights Certificate issued upon transfer, exchange, replacement or adjustment of any
other Rights Certificate referred to in this sentence, shall contain the following legend: |
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The Rights represented by this Certificate were issued to a Person
who was an Acquiring Person or an Affiliate or an Associate of an
Acquiring Person (as such terms are defined in the Rights Agreement)
or a Person acting jointly or in concert with any of them. This
Rights Certificate and the Rights represented hereby shall become void
in the circumstances specified in subsection 4.1(b) of the Rights
Agreement. |
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provided that the Rights Agent shall not be under any responsibility to ascertain
the existence of facts that would require the imposition of such legend but shall be
required to impose such legend only if instructed to do so by the Company in writing
or if a holder fails to certify upon transfer or exchange in the space provided on
the Rights Certificate that such holder is not a Person described in such legend. |
ARTICLE
5
THE RIGHTS AGENT
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(a) |
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The Company hereby appoints the Rights Agent to act as agent for the Company
and the holders of Rights in accordance with the terms and conditions hereof, and the
Rights Agent hereby accepts such appointment. The Company may from time to time appoint
one or more Co-Rights Agents as it may deem necessary or desirable subject to the
approval of the Rights Agent. In the event the Company appoints one or more Co-Rights
Agents, the respective duties of the Rights Agents and Co-Rights Agents shall be as the
Company may determine with the approval of the Rights Agent. The Company agrees to pay
to the Rights Agent reasonable compensation for all services rendered by them from time
to time, its reasonable expenses and counsel fees and other disbursements incurred in
the administration and execution of this Agreement and the exercise and performance of
its duties hereunder. The Company also agrees to indemnify the Rights Agent, its
offices, directors and employees for, and to hold them harmless against, any loss,
liability or expense, incurred without negligence, bad faith or wilful misconduct on
the part of the Rights Agent, for anything done or omitted by the Rights Agent in
connection with the acceptance and administration of this Agreement, including the
costs and expenses of defending against any claim of liability, which right to
indemnification will survive the termination of this Agreement or the resignation or
removal of the Rights Agent. |
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(b) |
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The Rights Agent shall be protected and shall incur no liability for or in
respect of any action taken, suffered or omitted by it (without negligence, bad
faith or wilful misconduct on the part of the Rights Agent) in connection with its
administration of this Agreement in reliance upon any certificate for Common Shares,
Rights Certificate, certificate for Shares of the Company, instrument of assignment
or transfer, power of attorney, endorsement, affidavit, letter, notice, direction,
consent, certificate, statement or other paper or document believed by it to be
genuine and to be signed, executed and, where necessary, verified or acknowledged,
by the proper Person or Persons. |
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(c) |
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The Company shall inform the Rights Agent in a reasonably timely manner of
events which may materially affect the administration of this Agreement by the Rights
Agent and shall, at any time, upon request by the Rights Agent provide to the Rights
Agent an incumbency certificate certifying the then current officers of the Company. |
5.2 |
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Merger or Amalgamation or Change of Name of Rights Agent |
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(a) |
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Any Company into which the Rights Agent or any successor Rights Agent may be
merged or amalgamated or with which it may be consolidated, or any Company resulting
from any merger, amalgamation or consolidation to which the Rights Agent or any
successor Rights Agent is a party, or any Company succeeding to the shareholder or
stockholder services business of the Rights Agent or any successor Rights Agent, will
be the successor to the Rights Agent under this Agreement without the execution or
filing of any paper or any further act on the part of any of the parties hereto,
provided that such Company would be eligible for appointment as a successor Rights
Agent under the provisions of section 5.4. In case at the time such successor Rights
Agent succeeds to the agency created by this Agreement any of the Rights Certificates
have been countersigned but not delivered, any such successor Rights Agent may adopt
the countersignature of the predecessor Rights Agent and deliver such Rights
Certificates so countersigned; and in case at that time any of the Rights Certificates
have not been countersigned, any successor Rights Agent may countersign such Rights
Certificates either in the name of the predecessor Rights Agent or in the name of the
successor Rights Agent; and in all such cases such Rights Certificates will have the
full force provided in the Rights Certificates and in this Agreement. |
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(b) |
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In case at any time the name of the Rights Agent is changed and at such time
any of the Rights Certificates shall have been countersigned but not delivered, the
Rights Agent may adopt the countersignature under its prior name and deliver Rights
Certificates so countersigned; and in case at that time any of the Rights Certificates
shall not have been countersigned, the Rights Agent may countersign such Rights
Certificates either in its prior name or in its changed name; and in all such cases
such Rights Certificates shall have the full force provided in the Rights Certificates
and in this Agreement. |
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5.3 |
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Duties of Rights Agent |
The Rights Agent undertakes the duties and obligations imposed by this Agreement upon the
following terms and conditions, by all of which the Company and the holders of Rights Certificates,
by their acceptance thereof, shall be bound:
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(a) |
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the Rights Agent may retain and consult with legal counsel (who may be legal
counsel for the Company) and the opinion of such legal counsel will be full and
complete authorization and protection to the Rights Agent as to any action taken or
omitted by it in good faith and in accordance with such opinion; the Rights Agent may
also, with the approval of the Company (where such approval may reasonable be obtained
and such approval not be unreasonably withheld), consult with such other experts as the
Rights Agent shall consider necessary or appropriate to properly carry out the duties
and obligations imposed under this Agreement (at the Companys expense, which expenses
must be reasonable in the circumstances) and the Rights Agent shall be entitled to act
and rely in good faith on the advice of any such expert; |
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(b) |
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whenever in the performance of its duties under this Agreement the Rights Agent
deems it necessary or desirable that any fact or matter be proved or established by the
Company prior to taking or refraining from taking any action hereunder, such fact or
matter (unless other evidence in respect thereof be herein specifically prescribed) may
be deemed to be conclusively proved and established by a certificate signed by a Person
believed by the Rights Agent to be the Chairman of the Board, the President or any
Vice-President and by the Treasurer or any Assistant-Treasurer or the Secretary or any
Assistant-Secretary of the Company and delivered to the Rights Agent and such
certificate shall be full authorization to the Rights Agent for any action taken or
suffered in good faith by it under the provisions of this Agreement in reliance upon
such certificate; |
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(c) |
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the Rights Agent will be liable hereunder only for its own negligence, bad
faith or wilful misconduct; |
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(d) |
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the Rights Agent will not be liable for or by reason of any of the statements
of fact or recitals contained in this Agreement or in the certificates for Shares or
the Rights Certificates (except its countersignature thereof) or be required to verify
the same, but all such statements and recitals are and will be deemed to have been made
by the Company only; |
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(e) |
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the Rights Agent will not be under any responsibility in respect of the
validity of this Agreement or the execution and delivery hereof (except the due
authorization, execution and delivery hereof by the Rights Agent) or in respect of the
validity or execution of any Share certificate or Rights Certificate (except its
countersignature thereof); nor will it be responsible for any breach by the Company of
any covenant or condition contained in this Agreement or in any Rights Certificate, nor
will it be responsible for any change in the exercisability of the Rights (including
the Rights becoming void pursuant to subsection 4.1(b)) or |
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any adjustment required under the provisions of section 3.2 or responsible for the
manner, method or amount of any such adjustment or the ascertaining of the
existence of facts that would require any such adjustment (except with respect to
the exercise of Rights after receipt of the certificate contemplated by section
3.2 describing any such adjustment); nor will it by any act hereunder be deemed to
make any representation or warranty as to the authorization of any Common Shares
to be issued pursuant to this Agreement or any Rights or as to whether any Shares
will, when issued, be duly and validly authorized, executed, issued and delivered
as fully paid and non-assessable; |
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(f) |
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the Company agrees that it will perform, execute, acknowledge and deliver
or cause to be performed, executed, acknowledged and delivered all such further
and other acts, instruments and assurances as may reasonably be required by the
Rights Agent for the carrying out or performing by the Rights Agent of the
provisions of this Agreement; |
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(g) |
|
the Rights Agent is hereby authorized and directed to accept instructions
with respect to the performance of its duties hereunder from any Person believed
by the Rights Agent to be the Chairman of the Board, the President and Chief
Executive Officer, any Vice-President or the Secretary or any Assistant-Secretary
or the Treasurer or any Assistant-Treasurer of the Company, and to apply to such
Persons for advice or instructions in connection with its duties, and it shall
not be liable for any action taken or suffered by it in good faith in accordance
with instructions of any such Person; it is understood that instructions to the
Rights Agent will, except where circumstances make it impracticable or the Rights
Agent otherwise agrees, be given in writing and, where not in writing, such
instructions will be confirmed in writing as soon as reasonably possible after
the giving of such instructions. |
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(h) |
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the Rights Agent and any shareholder or stockholder, director, officer or
employee of the Rights Agent may buy, sell or deal in Shares, Rights or other
securities of the Company or become pecuniarily interested in any transaction in
which the Company may be interested, or contract with or lend money to the
Company or otherwise act as fully and freely as though it were not the Rights
Agent under this Agreement. Nothing herein shall preclude the Rights Agent from
acting in any other capacity for the Company or for any other legal entity; |
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(i) |
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the Rights Agent may execute and exercise any of the rights or powers
hereby vested in it or perform any duty hereunder either itself or by or through
its attorneys or agents, and the Rights Agent will not be answerable or
accountable for any act, default, neglect or misconduct of any such attorneys or
agents or for any loss to the Company resulting from any such act, default,
neglect or misconduct, provided reasonable care was exercised in the selection
and continued employment thereof; and |
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(j) |
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the Rights Agent may retain any cash balance held in connection with this
Agreement and may, but need not, hold same in its deposit department or the |
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deposit department of one of its Affiliates; but the Rights Agent and its Affiliates
shall not be liable to account for any profit to the Company or any other person or
entity other than at a rate, if any, established from time to time by the Rights
Agent or one of its Affiliates. |
5.4 |
|
Change of Rights Agent |
The Rights Agent may resign and be discharged from its duties under this Agreement upon 90
days prior written notice (or such lesser notice as is acceptable to the Company) mailed to the
Company and to each transfer agent of Shares by registered or certified mail, and to the holders of
the Rights in accordance with section 6.8. The Company may remove the Rights Agent upon 30 days
prior written notice, mailed to the Rights Agent and to each transfer agent of the Shares by
registered or certified mail, and to the holders of the Rights in accordance with section 6.8. If
the Rights Agent should resign or be removed or otherwise become incapable of acting, the Company
will appoint a successor to the Rights Agent. If the Company fails to make such appointment within
a period of 30 days after such removal or after it has been notified in writing of such resignation
or incapacity by the resigning or incapacitated Rights Agent or by the holder of any Rights (which
holder shall, with such notice, submit such holders Rights Certificate for inspection by the
Company), then by prior written notice to the Company, the Rights Agent (at the Companys expense,
which expenses must be reasonable in the circumstances) or the holder of any Rights may apply to
any court of competent jurisdiction for the appointment of a new Rights Agent. Any successor Rights
Agent, whether appointed by the Company or by such a court, shall be a Company incorporated under
the laws of Canada or a province thereof authorized to carry on the business of a trust company in
the Province of Québec. After appointment, the successor Rights Agent will be vested with the same
powers, rights, duties and responsibilities as if it had been originally named as Rights Agent
without further act or deed; but the predecessor Rights Agent, upon payment by the Company to the
predecessor Rights Agent of all outstanding fees and expenses owed by the Company to the
predecessor Rights Agent pursuant to this Agreement, shall deliver and transfer to the successor
Rights Agent any property at the time held by it hereunder and execute and deliver any further
assurance, conveyance, act or deed necessary for the purpose. Not later than the effective date of
any such appointment, the Company will file notice thereof in writing with the predecessor Rights
Agent and each transfer agent of the Shares, and mail a notice thereof in writing to the holders of
the Rights. Failure to give any notice provided for in this section 5.4, however, or any defect
therein, shall not affect the legality or validity of the resignation or removal of the Rights
Agent or the appointment of the successor Rights Agent, as the case may be.
ARTICLE 6
MISCELLANEOUS
6.1 |
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Redemption and Waiver |
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(a) |
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Subject to the prior consent of the holders of Common Shares or Rights obtained in
accordance with subsection 6.5(b) or 6.5(c), as applicable, and prior to the occurrence of a
Flip-in Event as to which the application of section 4.1 has not been waived pursuant to
this section 6.1, the Board of Directors may, acting in good faith, elect to redeem all but
not less than all of the then outstanding Rights |
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|
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at a redemption price of $0.0001 per Right, appropriately adjusted in a manner
analogous to the applicable adjustment provided for in section 3.2, if an event of the
type analogous to any of the events described in section 3.2 shall have occurred (such
redemption price being herein referred to as the Redemption Price). |
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(b) |
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If a Person acquires pursuant to a Permitted Bid, a Competing Permitted Bid or an Exempt
Acquisition outstanding Common Shares other than Common Shares Beneficially Owned by such
Person at the date of the Permitted Bid, the Competing Permitted Bid or such Exempt
Acquisition, the Board of Directors of the Company shall, immediately upon such acquisition
and without further formality be deemed to have elected to redeem the Rights at the
Redemption Price. |
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(c) |
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Where a Take-over Bid that is not a Permitted Bid or a Competing Permitted Bid is
withdrawn or otherwise terminated after the Separation Time has occurred and prior to the
occurrence of a Flip-in Event, the Board of Directors may elect to redeem all the outstanding
Rights at the Redemption Price. |
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(d) |
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Within 10 Business Days after the Board of Directors electing or being deemed to have
elected to redeem the Rights or, if subsection 6.1(a) is applicable, within 10 Business Days
after the holders of Common Shares or the holders of Rights have approved a redemption of
Rights in accordance with subsection 6.5(b) or 6.5(c), as applicable, the Company shall give
notice of such redemption to the holders of the then outstanding Rights by mailing such
notice to each such holder at his last address as it appears on the Rights Register or, prior
to the Separation Time, on the register of Common Shares maintained by the Companys transfer
agent. Each such notice of redemption shall state the method by which the payment of the
Redemption Price shall be made. The Company may not redeem, acquire or purchase for any value
any Rights at any time in any manner other than that specifically set forth in this section
6.1 or in connection with the purchase of Common Shares prior to the Separation Time. |
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(e) |
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If the Board of Directors elects to or is deemed to have elected to redeem the Rights
and, in circumstances where subsection 6.1(a) is applicable, such redemption is approved by
the holders of Common Shares or the holders of Rights in accordance with subsection 6.5(b) or
6.5(c), as applicable, (i) the right to exercise the Rights will thereupon without further
action and without notice terminate and the only right thereafter of the holder of a Right
shall be to receive the Redemption Price, and (ii) no further Rights shall thereafter be
issued. |
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(f) |
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Upon written notice to the Rights Agent, the Board of Directors may, in respect of any
Flip-in Event waive the application of section 4.1 in respect of that Flip-in Event, provided
that both of the following conditions are satisfied: (i) the Board of Directors had
determined, within 10 Business Days following a Stock Acquisition Date, that the Person
became an Acquiring Person by inadvertence and without any intent to become, or knowledge
that it would become, an |
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|
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Acquiring Person; and (ii) such Acquiring Person, within 14 days after such
determination or such earlier or later period as the Board of Directors may
determine (the Disposition Date) has reduced its Beneficial Ownership of Common
Shares such that at the time of waiver pursuant to this subsection 6.1(f) it is no
longer an Acquiring Person; if the Acquiring Person remains an Acquiring Person at
the close of business on the Disposition Date, the Disposition Date shall be deemed
to be the date of occurrence of a further Stock Acquisition Date and section 4.1
shall apply thereto. In the event of any such waiver pursuant to this subsection
6.1(g), for the purposes of this Agreement, such Flip-in Event shall be deemed not
to have occurred and the Separation Time shall be deemed not to have occurred as a
result of such Person having inadvertently become an Acquiring Person. |
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(g) |
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The Board of Directors may, until a Flip-in Event shall have occurred, upon written
notice delivered to the Rights Agent, determine to waive the application of section 4.1 to a
Flip-in Event but only if such Flip-in Event occurs by reason of a Take-over Bid made by way
of a take-over bid circular to all holders of record of the Common Shares of the Company
which are subject to the Take-over Bid (which, for greater certainty, does not include the
circumstances described in subsection 6.1(f)); provided however, that if the Board of
Directors waives the application of section 4.1 to a particular Flip-in Event pursuant to
this subsection 6.1(g), the Board of Directors shall be deemed to have waived the
application of section 4.1 to any other Flip-in Event occurring by reason of any Take-over
Bid which is made by means of a take-over bid circular to all holders of record of Common
Shares prior to the expiry of any Take-over Bid in respect of which a waiver is, or is
deemed to have been, granted under this subsection 6.1(g). |
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(h) |
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The Board of Directors may, with the prior consent of the holders of Common Shares given
in accordance with subsection 6.5(b), determine, at any time prior to the occurrence of a
Flip-in Event as to which the application of section 4.1 has not been waived pursuant to
this section 6.1, if such Flip-in Event would occur by reason of an acquisition of Common
Shares otherwise than pursuant to a Take-over Bid made by means of a Take-over Bid circular
to all holders of record of Common Shares and otherwise than in the circumstances set forth
in subsection 6.1(f), to waive the application of section 4.1 to such Flip-in Event. In the
event that the Board of Directors proposes such a waiver, the Board of Directors shall
extend the Separation Time to a date subsequent to and not more than 10 Business Days
following the meeting of shareholders called to approve such waiver. |
No Person shall have any rights pursuant to this Agreement or in respect of any Right after
the Expiration Time, except the Rights Agent as specified in section 5.1.
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6.3 |
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Issuance of New Rights Certificate |
Notwithstanding any of the provisions of this Agreement or of the Rights to the contrary, the
Company may, at its option, issue new Rights Certificates evidencing Rights in such form as may be
approved by the Board of Directors to reflect any adjustment or change in the number or kind or
class of shares purchasable upon exercise of Rights made in accordance with the provisions of this
Agreement.
6.4 |
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Fractional Rights and Fractional Shares |
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(a) |
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The Company shall not be required to issue fractions of Rights or to distribute Rights
Certificates which evidence fractional Rights. In lieu of such fractional Rights, there
shall be paid to the registered holders of the Rights Certificates with regard to which such
fractional Rights would otherwise be issuable, an amount in cash equal to the fraction of
the Market Price of a whole Right that the fraction of a Right which would otherwise be
issuable is of one whole Right at the date of such issuance. |
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(b) |
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The Company shall not be required to issue fractions of Common Shares upon exercise of
the Rights or to distribute certificates which evidence fractional Common Shares. In lieu
of issuing fractional Common Shares, the Company shall pay to the registered holders of
Rights Certificates, at the time such Rights are exercised as herein provided, an amount in
cash equal to the fraction of the Market Price of a whole Common Shares that the fraction of
a Common Share which would otherwise be issuable upon the exercise of such right is of one
whole Common Share at the date of such exercise. |
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(c) |
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The Rights Agent shall have no obligation to make any payments in lieu of issuing
fractions of Rights or Common Shares pursuant to paragraph (a) or (b), respectively, unless
and until the Company shall have provided to the Rights Agent the amount of cash to be paid
in lieu of issuing such fractional Rights or Common Shares. |
6.5 |
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Supplements and Amendments |
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(a) |
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The Company may make, without the approval of the holders of Rights or Common Shares,
any amendments to this Agreement (i) to correct any clerical or typographical error or (ii)
which are required to maintain the validity and effectiveness of the Agreement as a result
of any change in any applicable laws, rules or regulatory requirements. The Company may,
prior to the due date of the shareholders meeting referred to in section 6.15, supplement,
amend, vary, rescind or delete any of the provisions of this Agreement without the approval
of any holders of Rights or Common Shares (whether or not such action would materially
adversely affect the interest of the holders of Rights generally) where the Board of
Directors acting in good faith deems such action necessary or desirable. Notwithstanding
anything in this section 6.5 to the contrary, no |
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amendment shall be made to the provisions of Article 5 except with the written
concurrence of the Rights Agent to such supplement or amendment. |
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(b) |
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Subject to subsection 6.5(a), the Company may, with the prior consent of the holders of
Common Shares obtained as set forth below, at any time before the Separation Time, amend,
vary or rescind any of the provisions of this Agreement and the Rights (whether or not such
action would materially adversely affect the interests of the holders of Rights generally).
Such consent shall be deemed to have been given if provided by the holders of Common Shares
at a special meeting called and held in compliance with applicable laws, rules and regulatory
requirements and the requirements in the articles and by-laws of the Company. Subject to
compliance with any requirements imposed by the foregoing, consent shall be given if the
proposed amendment, variation or rescission is approved by the affirmative vote of a majority
of the votes cast by Independent Shareholders represented in person or by proxy at the
special meeting. |
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(c) |
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Subject to subsection 6.5(a), the Company may, with the prior consent of the holders of
Rights obtained as set forth below, at any time after the Separation Time and before the
Expiration Time, amend, vary or rescind any of the provisions of this Agreement and the
Rights (whether or not such action would materially adversely affect the interests of the
holders of Rights generally). Such consent shall be deemed to have been given if provided by
the holders of Rights at a special meeting of holders of Rights called and held in compliance
with applicable laws and regulatory requirements and, to the extent possible, with the
requirements in the articles and by-laws of the Company applicable to meetings of holders of
Common Shares, applied mutatis mutandis. Subject to compliance with any requirements imposed
by the foregoing, consent shall be given if the proposed amendment, variation or rescission
is approved by the affirmative vote of a majority of the votes cast by holders of Rights
(other than holders of Rights whose Rights have become null and void pursuant to subsection
4.1(b)), represented in person or by proxy at the special meeting. |
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(d) |
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Any amendments made by the Company to this Agreement pursuant to subsection 6.5(a) which
are required to maintain the validity and effectiveness of this Agreement as a result of any
change in any applicable laws, rules or regulatory requirements shall: |
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(i) |
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if made before the Separation Time, be submitted to the holders of Common Shares
of the Company at the next meeting of shareholders and the shareholders may, by the
majority referred to in subsection (b), confirm or reject such amendment; and |
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(ii) |
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if made after the Separation Time, be submitted to the holders of Rights at a
meeting to be called for on a date not later than immediately following the next
meeting of shareholders of the Company and the holders of Rights may, by resolution
passed by the majority referred to in subsection 6.5(c), confirm or reject such
amendment. |
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|
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Any such amendment shall be effective from the date of the resolution of the Board
of Directors adopting such amendment, until it is confirmed or rejected or until it
ceases to be effective (as described in the next sentence) and, where such amendment
is confirmed, it continues in effect in the form so confirmed. If such amendment is
rejected by the shareholders of the Company or the holders of Rights or is not
submitted to the shareholders of the Company or holders of Rights as required, then
such amendment shall cease to be effective from and after the termination of the
meeting at which it was rejected or to which it should have been but was not
submitted or from and after the date of the meeting of holders of Rights as the case
may be. |
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(e) |
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The Company shall give notice in writing to the Rights Agent of any supplement,
amendment, deletion, variation or rescission to this Agreement pursuant to Section 6.5
within five Business Days of the date of any such supplement, amendment, deletion, variation
or rescission, provided that failure to give such notice, of any defect therein, shall not
affect the validity of any such supplement, amendment, deletion, variation or rescission. |
Subject to the terms of this Agreement, all rights of action in respect of this Agreement,
other than rights of action vested solely in the Rights Agent, are vested in the respective holders
of the Rights; and any holder of any Rights, without the consent of the Rights Agent or of the
holder of any other Rights, may, on such holders own behalf and for such holders own benefit and
the benefit of other holders of Rights, enforce, and may institute and maintain any suit, action or
proceeding against the Company to enforce, or otherwise act in respect of, such holders right to
exercise such holders Rights in the manner provided in such holders Rights Certificate and in
this Agreement. Without limiting the foregoing or any remedies available to the holders of Rights,
it is specifically acknowledged that the holders of Rights would not have an adequate remedy at law
for any breach of this Agreement and will be entitled to specific performance of the obligations
of, and injunctive relief against actual or threatened violations of the obligations of, any Person
subject to this Agreement.
6.7 |
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Notice of Proposed Actions |
If after the Separation Time and prior to the Expiration Time:
|
(a) |
|
there shall occur an adjustment to the Rights pursuant to section 4.1 as a result of the
occurrence of a Flip-in Event; or |
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(b) |
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the Company proposes to effect the liquidation, dissolution or winding-up of
the Company or the sale of all or substantially all of the Companys assets; |
then, in each such case, the Company shall give to each holder of a Right, in accordance with
section 6.8, a notice of such proposed action, which shall specify the date on which such
adjustment to the Rights, liquidation, dissolution or winding-up occurred or is to take place, and
such notice shall be so given at least 10 Business Days after the occurrence of an
adjustment to the Rights or at least 20 Business Days prior to the date of taking such proposed
action.
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Notices or demands authorized or required by this Agreement to be given or made by the Rights
Agent or by the holder of any Rights to or on the Company shall be sufficiently given or made if
delivered or sent by first-class mail, postage prepaid, addressed (until another address is filed
in writing with the Rights Agent) as follows:
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Theratechnologies Inc.
2310 Alfred-Nobel Boulevard
Montreal, Québec
H4S 2B4 |
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Attention: General Counsel and Corporate Secretary
Facsimile: 514 331 9691 |
Any notice or demand authorized or required by this Agreement to be given or made by the Company or
by the holder of any Rights to or on the Rights Agent shall be sufficiently given or made if
delivered or sent by first-class mail, postage prepaid, addressed (until another address is filed
in writing with the Company) as follows:
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Computershare Trust Company of Canada
1500 University Street
Suite 700
Montreal, Québec
H3A 3S8 |
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Attention: Manager, Client Services
Facsimile: 514 982 7580 |
Notices or demands authorized or required by this Agreement to be given or made by the Company or
the Rights Agent to or on the holder of any Rights shall be sufficiently given or made if delivered
or sent by first-class mail, postage prepaid, addressed to such holder at the address of such
holder as it appears upon the registry books of the Rights Agent or, prior to the Separation Time,
on the registry books of the Company for the Common Shares. Any notice which is mailed in the
manner herein provided shall be deemed given, whether or not the holder receives the notice.
The Company agrees that if the Company fails to fulfil any of its obligations pursuant to this
Agreement, then the Company will reimburse the holder of any Rights for the costs and expenses
(including reasonable legal fees) incurred by such holder in actions to enforce his rights pursuant
to any Rights or this Agreement.
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All the covenants and provisions of this Agreement by or for the benefit of the Company or the
Rights Agent shall bind and enure to the benefit of their respective successors and assigns
hereunder.
6.11 |
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Benefits of this Agreement |
Nothing in this Agreement shall be construed to give to any Person other than the Company, the
Rights Agent and the holders of the Rights any legal or equitable right, remedy or claim under this
Agreement, and this Agreement shall be for the sole and exclusive benefit of the Company, the
Rights Agent and the holders of the Rights.
This Agreement and each Right issued hereunder shall be deemed to be a contract made under the
laws of the Province of Québec and for all purposes shall be governed by and construed in
accordance with the laws of such province applicable to contracts to be made and performed entirely
within such province.
This Agreement may be executed in any number of counterparts and each of such counterparts
shall for all purposes be deemed to be an original, and all such counterparts shall together
constitute one and the same instrument.
If any section, subsection, clause, subclause, term or provision hereof or the application
thereof to any circumstance shall, in any jurisdiction and to any extent, be invalid or
unenforceable, such section, subsection, clause, subclause, term or provision shall be ineffective
as to such jurisdiction to the extent of such invalidity or unenforceability without invalidating
or rendering unenforceable the remaining sections, subsections, clauses, subclauses, terms and
provisions hereof or the application of such section, subsection, clause, subclause, term or
provision to circumstances other than those as to which it is held invalid or unenforceable.
|
(a) |
|
Notwithstanding its amendment and restatement as at the date hereof, and subject to
subsection 6.15(b), this Agreement: |
|
(i) |
|
shall be effective and in full force and effect in accordance with its terms
from and after the Effective Date and shall replace and supersede the Original Plan
and shall constitute the entire agreement between the parties pertaining to the
subject matter hereof as of the Effective Date; and |
|
(ii) |
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shall expire and be of no further force or effect from and after the Expiration
Time. |
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|
(b) |
|
Notwithstanding subsection 6.15(a), if the Agreement is not approved by a resolution
passed by a majority of the votes cast by Independent Shareholders who vote in respect of
approval of this Agreement at the annual and special meeting of the holders of Common Shares
scheduled to be held on March 25, 2010, then the Plan and all outstanding Rights shall
terminate and be null and void and of no further force and effect from and after the
Effective Date. |
6.16 |
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Determinations and Actions by the Board of Directors |
All actions, calculations and determinations (including any omissions with respect thereto)
made or done by the Board of Directors in good faith for the purposes hereof shall not subject the
Board of Directors, or any director of the Company, to any liability to the holders of Rights.
|
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Time shall be of the essence in this Agreement. |
6.18 |
|
Regulatory Approvals |
Any obligation of the Company or action contemplated by this Agreement shall be subject to the
receipt of any requisite approval or consent from any applicable regulatory authority including,
without limiting the generality of the foregoing, any necessary approvals of any stock exchanges on
which any securities of the Company are listed.
Les parties aux présentes ont exigé que la présente convention ainsi que tous les documents et
avis qui sy rattachent et/ou qui en découleront soient rédigés en langue anglaise. The parties
hereto have required that this Agreement and all documents and notices related thereto and/or
resulting therefrom be drawn up in the English language.
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IN WITNESS WHEREOF the parties hereto have caused this Agreement to be duly executed as of the
date first above written.
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THERATECHNOLOGIES INC.
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By: |
(signed) Yves Rosconi
|
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President and Chief Executive Officer |
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COMPUTERSHARE TRUST
COMPANY OF CANADA
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By: |
(signed) Martine Gauthier
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Professional, Client Services |
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(signed) Julien Lavallière |
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Professional, Client Services |
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EXHIBIT A
FORM OF RIGHTS CERTIFICATE
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Certificate No. ______
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___Rights |
RIGHTS CERTIFICATE
THE RIGHTS ARE SUBJECT TO REDEMPTION, AT THE OPTION OF THE COMPANY, ON THE TERMS SET FORTH IN THE
RIGHTS AGREEMENT. UNDER CERTAIN CIRCUMSTANCES (SPECIFIED IN SECTION 4.1(b) OF THE RIGHTS
AGREEMENT), RIGHTS BENEFICIALLY OWNED BY AN ACQUIRING PERSON OR ITS AFFILIATES OR ASSOCIATES OR ANY
PERSON ACTING JOINTLY OR IN CONCERT WITH ANY OF THEM OR SUCH PERSONS ASSOCIATES OR AFFILIATES (AS
SUCH TERMS ARE DEFINED IN THE RIGHTS AGREEMENT) OR TRANSFEREES OF ANY OF THE FOREGOING WILL BECOME
VOID WITHOUT FURTHER ACTION.
This certifies that _____________________________, or registered assigns, is the registered
holder of the number of Rights set forth above, each of which entitles the registered holder
thereof, subject to the terms, provisions and conditions of the Shareholder Rights Plan Agreement,
as the same may be amended or supplemented from time to time, made as of February 10, 2010 (the
Rights Agreement) between Theratechnologies Inc., a company existing under the laws of Québec
(the Company) and Computershare Trust Company of Canada, a trust company existing under the laws
of Canada, as rights agent (the Rights Agent, which term shall include any successor Rights Agent
under the Rights Agreement) to purchase from the Company at any time after the Separation Time and
prior to the Expiration Time (as such terms are defined in the Rights Agreement), one fully paid
Common Share of the Company (a Share), at the Exercise Price referred to below, upon presentation
and surrender of this Rights Certificate together with the Form of Election to Exercise duly
executed and submitted to the Rights Agent at its principal office in any of the cities of
Vancouver, Calgary, Winnipeg, Toronto, Montreal and Halifax. The Exercise Price shall initially be
$25.00 Canadian per Right and shall be subject to adjustment in certain events as provided in the
Rights Agreement.
This Rights Certificate is subject to all of the terms, provisions and conditions of the
Rights Agreement which terms, provisions and conditions are hereby incorporated herein by reference
and made a part hereof and to which Rights Agreement reference is hereby made for a full
description of the rights, limitations of rights, obligations, duties and immunities thereunder of
the Rights Agent, the Company and the holders of the Rights Certificates. Copies of the Rights
Agreement are on file at the registered office of the Company and are available upon written
request.
This Rights Certificate, with or without other Rights Certificates, upon surrender at any of
the offices of the Rights Agent designated for such purpose, may be exchanged for another Rights
Certificate or Rights Certificates of like tenor and date evidencing an aggregate number of Rights
equal to the aggregate number of Rights evidenced by the Rights Certificate or Rights Certificates
surrendered. If this Rights Certificate shall be exercised in part, the registered holder
New Rights Plan
shall be entitled to receive, upon surrender hereof, another Rights Certificate or Rights
Certificates for the number of whole Rights not exercised.
Subject to the provisions of the Rights Agreement, the Rights evidenced by this Rights
Certificate (i) may be, and under certain circumstances are required to be, redeemed by the
Company at a redemption price of $0.0001 per Right and (ii) may be exchanged at the option of the
Company for cash, debt or equity securities or other assets of the Company.
No fractional Common Shares will be issued upon the exercise of any Right or Rights evidenced
hereby, but in lieu thereof a cash payment will be made, as provided in the Rights Agreement.
No holder of this Rights Certificate, as such, shall be entitled to vote or receive dividends or
be deemed for any purpose the holder of Common Shares or of any Shares of the Company which may
at any time be issuable upon the exercise hereof, nor shall anything contained in the Rights
Agreement or herein be construed to confer upon the holder hereof, as such, any of the rights of
a shareholder of the Company or any right to vote for the election of directors or upon any
matter submitted to shareholders of the Company at any meeting thereof, or to give or withhold
consent to any corporate action, or to receive notice of meetings or other actions affecting
shareholders of the Company, or to receive dividends or subscription rights, or otherwise, until
the Rights evidenced by this Rights Certificate shall have been exercised as provided in the
Rights Agreement.
This Rights Certificate shall not be valid or obligatory for any purpose until it shall have been
countersigned by the Rights Agent.
WITNESS the facsimile signature of the proper officers of the Company and its corporate
seal.
Date: _____________________
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THERATECHNOLOGIES INC.
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By: |
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By: |
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Countersigned:
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COMPUTERSHARE TRUST COMPANY OF CANADA
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By: |
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New Rights Plan
- A-2 -
FORM OF ELECTION TO EXERCISE
TO: COMPUTERSHARE TRUST COMPANY OF CANADA
The undersigned hereby irrevocably elects to exercise ____________________________ whole
Rights represented by the attached Rights Certificate to purchase Common Shares (the Shares)
issuable upon the exercise of such Rights and requests that certificates for such Shares to be
issued to:
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City and Province |
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Social Insurance, Social Security Number or other taxpayer identification number |
If such number of Rights shall not be all the Rights evidenced by this Rights Certificate, a new
Rights Certificate for the balance of such Rights shall be registered in the name of and delivered
to:
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Social Insurance, Social Security Number or other taxpayer identification number |
Dated: _____________________
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Signature |
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Signature Guaranteed:
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(Signature must correspond to name as written upon the face of this Rights
Certificate in every particular, without alteration or enlargement or any change whatsoever) |
New Rights Plan
- A-3 -
Note: Signature must be guaranteed by a major Canadian trust company, a Schedule 1 Canadian
chartered bank, or a member of a recognized Medallion Guarantee program.
(To be completed if true)
The undersigned hereby represents, for the benefit of the Company and all holders of Rights
and of Shares of the Company, that the Rights evidenced by this Rights Certificate are not, and, to
the knowledge of the undersigned, have never been, Beneficially Owned by an Acquiring Person or an
Affiliate or Associate thereof or any Person acting jointly or in concert with any of the foregoing
(as such terms are defined in the Rights Agreement).
New Rights Plan
- A-4 -
FORM OF ASSIGNMENT
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hereby sells, assigns and transfers unto |
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(Please print name and address of transferee) |
the Rights represented by this Rights Certificate, together with all right, title and interest
therein.
Dated: _____________________
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Signature Guaranteed:
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(Signature must correspond to name as written upon the face of this Rights
Certificate in every particular, without alteration or enlargement or any change whatsoever) |
Note: Signature must be guaranteed by a major Canadian trust company, a Schedule 1 Canadian
chartered bank, or a member of a recognized Medallion Guarantee program..
(To be completed if true)
The undersigned hereby represents, for the benefit of the Company and all holders of Rights and of
Shares of the Company, that the Rights evidenced by this Rights Certificate are not, and, to the
knowledge of the undersigned, have never been, Beneficially Owned by an Acquiring Person or an
Affiliate or Associate thereof or any Person acting jointly or in concert with any of the foregoing
(as defined in the Rights Agreement).
New Rights Plan
- A-5 -
NOTICE
In the event the certification set forth above in the Forms of Assignment and Election to
Exercise is not completed, the Company will deem the Beneficial Owner of the Rights evidenced by
this Rights Certificate to be an Acquiring Person or an Affiliate or Associate thereof (as defined
in the Rights Agreement) and accordingly such Rights will be null and void.
New Rights Plan
- A-6 -
ex-99.87
Exhibit 99.87
SUPPLY AGREEMENT
This
Supply Agreement (hereafter the Agreement ) is
made as of this 5th day of January, 2010 (hereafterEffective Date) by and between
Theratechnologies Inc., having a principal place of business at 2310
Alfred-Nobel Boulevard, Montreal, Quebec, H4S 2B4, Canada (hereafterThera) and Gruppo
Cartotecnico Abar litofarma srl, having a principal place of business at Via
Pusiano, 4 Sesto Ulteriano 20098, San Giuliano, Milan, Italy (hereafter
GCAL).
Whereas , Thera owns rights to the compound, tesamorelin, a stabilised synthetic
analogue of the growth hormone-releasing factor (GRF) (hereafter
Tesamorelin);
Whereas, Thera intends to commercialize Tesamorelin for the treatment of HIV-associated lipodystrophy in the United States;
Whereas, Thera wishes to purchase from GCAL pharmaceutical mass market folding
boxes comprising the [Redacted: Name] Supergraph for the commercialization of Tesameorelin in the
United States.
Now,
Therefore, in consideration of the premises and the mutual
promises and agreements contained herein, Thera and GCAL agree as follows:
Article 1. Definitions
The following words and phrases when used herein with capital letters shall have the
meanings set forth or referenced below:
1.1
Affiliate shall mean any corporation or non-corporate business entity which controls,
is controlled by, or is under common control with a party to this Agreement. A corporation or non-corporate business entity shall be regarded as in control of another corporation or non-corporate
business entity if it owns, or directly or indirectly controls, in excess of fifty percent (50%) of
the voting stock of the other corporation, or (a) in the absence of the ownership of in excess of
fifty percent (50%) of the voting stock of a corporation or (b) in the case of a non-corporate
business entity, if it possesses, directly or indirectly, the power to direct or cause the
direction of the management and policies of such corporation or non-corporate business entity, as
applicable.
1.2 Artworkshall mean the logos, trade dress, Trademark, trade names and other design
printed on the Product.
1.3 Confidential Information shall have the meaning ascribed thereto in the non-disclosure
and non-use agreement attached hereto as Exhibit 8.1.
1.4 [Redacted: Name] Supergraph shall mean the hologram developed by [Redacted: Name] and
affixed on the pharmaceutical mass market folding boxes manufactured by GCAL.
1.5 Product shall mean GCALs pharmaceutical mass market folding boxes manufactured in
accordance with industry standards and the Product Specifications.
1.6 Product Specifications shall mean the specifications of the Product comprising the
[Redacted: Name] Supergraph and the Artwork and
attached hereto as Exhibit 1.6.
1.7
Purchase Order shall mean the purchase order
attached hereto as Exhibit 1.7.
1.8 Third Party shall mean a party other than GCAL or Thera and their respective
Affiliates.
1.9 Trademark shall mean [Redacted: Name] , its logo and colour scheme, all of which are
proprietary to Thera.
Article 2. Supply of Product
2.1 Supply of Product. Pursuant to the terms and conditions of this Agreement and for the
duration of this Agreement and upon receipt of a Purchase Order from Thera, GCAL shall supply the
Product to Thera, and Thera shall take delivery of the Product from GCAL. GCAL shall supply the
Product in accordance with the Product Specifications.
2.2 Product Artwork .Thera shall supply GCAL with the Artwork to be printed on the Product.
2.3
Changes in Product Specifications. Product Specifications shall not be changed without
Theras express written consent. Changes to Product Specifications which relate directly to the
Trademark shall be made at Theras cost. Any other changes to Product Specifications authorised by
Thera, including changes to the [Redacted: Name] Supergraph, shall be made at GCALs cost.
2.5 Delivery of Product. GCAL shall deliver the Product to Thera, [Redacted: Delivery Terms]
at the location specified by Thera in each Purchase Order issued to GCAL. Shipment shall be via a
carrier designated by GCAL. [Redacted: Transfer of
Risk]. GCAL shall pay [Redacted: Description of
Costs]. GCAL shall give Thera sufficient notice as to when the Product shall be shipped to the
location specified by Thera. GCAL shall provide the Product with a packing list and bill of lading
consigned to Thera.
2.6
Price and Payment. GCAL shall invoice Thera for the Product at the prices set forth on
Exhibit 2.6 attached hereto. Thera shall make payment [Redacted: Term] from the later of the date
of receipt of GCALs invoice or the date on which the Product is delivered to Thera as per the
terms of Section 2.5 above.
2.7
Non-Conforming Product. In the event Thera or [Redacted: Name] determines that the
Product is not in compliance with the Product Specifications, Thera shall notify GCAL and provide
GCAL with a sample of the non-conforming Product. Any and all Product that does not comply with
the Product Specifications shall be returned to GCAL at GCALs cost, Ex Works Theras designated
facility or [Redacted: Name] s facility.
2.8 Replacement of Non-Conforming Product. GCAL shall replace at no cost to Thera on an
expedited basis all Products delivered to Thera which do not comply with the Product
Specifications.
2.9 Audits
(a) GCAL hereby grants Thera (or its Third Party designees) the right to conduct audits of
GCALs or its subcontractors packaging facilities.
(b) Thera shall notify GCAL in writing of its intent to audit GCAL. Thera and GCAL will
determine mutually acceptable dates for the audit. Any auditors who are not employees of Thera
shall be required to enter into confidentiality agreements with GCAL or its subcontractors and
Thera containing terms of non-disclosure and non-use at least as stringent as those set forth in
Article 8 herein. Auditors shall abide by GCALs or its sub-contractors visitor policies. GCAL
or its subcontractors shall have the right to protect the confidential information of its other
clients and products and to limit the audit to such areas of the production facility that are
relevant to the Product.
(c) The auditors shall issue a written report of their findings within [Redacted: Term] of the
audit. Thera shall provide to GCAL a written report of its findings as soon as possible, or within
[Redacted: Term] after the conclusion of the audit. GCAL shall promptly address the audit findings,
but in no event later than [Redacted: Term] of receiving the report.
Article 3. Purchase Orders
3.1 Purchase Order Terms. GCAL shall supply the Product to Thera in accordance with
Theras Purchase Orders within [Redacted: Term] of the receipt by GCAL of Theras Purchase Order.
Each Purchase Order or any acknowledgment thereof, whether printed, stamped, typed, or written
shall be governed by the terms of this Agreement and none of the provisions of such Purchase Order
shall be applicable except those specifying Product and quantity ordered, delivery dates, shipping
instructions and invoice information.
Article 4. Warranties; Covenants and Indemnification
4.1 Theras Warranties.
(a) Thera represents and warrants that it will abide by all applicable laws and regulations in
performing its obligations under this Agreement.
(b) Thera also represents and warrants to GCAL that Theras performance of its obligations
under this Agreement will not result in a material violation or breach of any agreement, contract,
commitment or obligation to which Thera is a party or by which it is bound and will not conflict
with or constitute a default under its corporate charter or bylaws.
4.2 GCALs Warranties and Covenants.
(a) GCAL represents and warrants to Thera that the Product GCAL delivers to Thera pursuant to
this Agreement shall, at the time of delivery, be free from defects in material and workmanship and
shall be manufactured: (i) in accordance and in conformity with the Product Specifications; and
(ii) in compliance with all applicable statutes, laws, rules or regulations, including those
relating to the environment, food or drugs and occupational health and safety, including, without
limitation, those enforced or promulgated by the FDA.
(b) GCAL represents and warrants to Thera that it has the capacity to manufacture at least
[Redacted: Quantity] Products annually.
(c) GCAL
represents and warrants to Thera that GCALs performance of its obligations under
this Agreement will not result in a material violation or breach of any agreement, contract,
commitment or obligation to which GCAL is a party or by which it is bound and will not conflict
with or constitute a default under its Certificate of Incorporation or corporate bylaws.
(d) GCAL represents and warrants to Thera that the manufacture and supply of the Product in
accordance with the Product Specifications does not infringe, and does not constitute
misappropriation of, any Third Parties intellectual property.
(e) GCAL represents and warrants to Thera that it has the right to use the [Redacted: Name]
Supergraph on the Product and that GCAL has not been notified to cease using or manufacturing the
Product with the [Redacted: Name] Supergraph.
(f) GCAL hereby agrees to promptly notify Thera of any notice it receives from a Third Party
alleging (i) the infringement of such Third Partys intellectual property or (ii) that it must
cease using the [Redacted: Name] Supergraph.
Article 5. Indemnification
5.1 Indemnification by GCAL. GCAL shall indemnify and hold harmless Thera, its
Affiliates, officers, directors and employees from and against any and all claims, causes of
action, suits, costs and expenses (including reasonable attorney fees), losses or liabilities of
any kind related to this Agreement and asserted by Third Parties to the extent such arise out of or
are attributable to: (a) GCALs breach of any
representation or warranty set forth in Section 4.2;
(b) any violation of any proprietary right of any Third Party
relating to GCALs manufacturing
processes of the Product pursuant to this Agreement; or (c) any negligent or wrongful act or
omission on the part of GCAL, its employees, agents or
representatives and which relate to GCALs
performance hereunder.
5.2
Conditions of Indemnification. If Thera seeks indemnification hereunder from GCAL, Thera
shall promptly give notice to GCAL of any such claim or suit threatened, made or filed against it
which forms the basis for such claim of indemnification and shall cooperate fully with GCAL in the
investigation and defense of all such claims or suits. GCAL shall have the option to assume Theras defense in any such claim or suit with counsel reasonably satisfactory to Thera. No settlement
or compromise shall be binding on Thera without its prior written consent, such consent not to be
unreasonably withheld, provided, however that consent shall not be required from Thera for any
settlement or compromise involving a monetary payment at the time of such settlement or compromise
and further provided that such payment does not trigger the liability of Thera.
Article 6. Intellectual Property Rights
6.1 GCALs Proprietary Rights. GCAL has granted no license, express or implied, to Thera
to use GCAL proprietary technology, know-how or other proprietary rights, other than for the
purposes of this Agreement.
6.2
Theras Proprietary Rights. Thera has granted no license, express or implied, to GCAL to
use Theras compound, proprietary technology, know-how or other proprietary rights, other than
for the purposes of this Agreement.
Article 7. Term and Termination
7.1 Term. This Agreement shall commence on the Effective Date and, unless earlier
terminated as provided below, shall expire [Redacted: Term] after the Effective Date (hereafter the
Initial Term). Unless otherwise terminated in accordance with this Article 7, this Agreement
shall be automatically extended for additional and successive terms of [Redacted: Term] each (each,
a Renewal Term) unless either party gives the other party no less than [Redacted: Term] written
notice of its intention not to renew prior to the expiry of the Initial Term. During any Renewal
Term, either party may give notice of its intention not to renew the current Renewal Term by
providing the other party with no less than [Redacted: Term] written notice of its intention not to
renew prior to the expiry of the relevant Renewal Term.
7.2 General Termination Rights. Either party may terminate this Agreement as follows: (i)
immediately by providing written notice upon the bankruptcy or the insolvency of the other party;
or (ii)upon the expiry of a [Redacted: Term] period following a prior written notice has been given
by a party to the other party upon the breach of any representation, warranty, covenant or any
other material provision of this Agreement by the other party if the breach is not cured within
that [Redacted: Term] period.
7.3 Termination by Thera. Thera shall have the right to terminate this Agreement with or
without cause; provided, however, that Thera gives GCAL no less than [Redacted: Term] prior
written notice during the Initial Term and during any Renewal Term.
7.4 Accrued Payment Obligations. Upon termination pursuant to this Article 7, except by
reason of breach by GCAL, Thera shall reimburse GCAL for [Redacted: Cost]. GCAL
shall invoice Thera for all amounts due hereunder. Payment shall be made pursuant to Section 2.6
herein.
7.5 Survival. Expiration or early termination of this Agreement shall not relieve either party
of any obligations that it may have incurred prior to expiration or early termination, in
particular those covenants and agreements contained in Articles 4, 5, 6, 8 and 9, which will
continue in full force and effect for a period of [Redacted: Term] unless a different time period
is provided for herein.
Article 8. Confidential Information
8.1 Nondisclosure. The terms and conditions contained in the non-disclosure and non-use
agreement dated January 5, 2010 between the parties and attached hereto as Exhibit 8.1 shall govern
the disclosure of Confidential Information by either party under this Agreement.
8.2 Public Announcements. Neither party shall make any public announcement concerning the
transactions contemplated herein, or make any public statement which includes the name of the
other party or any of its Affiliates, or otherwise use the name of the other party or any of its
Affiliates in any public statement or document, except as may be required by law or judicial order,
without the written consent of the other party, which consent shall not be unreasonably withheld.
Subject to any legal or judicial disclosure obligation, any such public announcement proposed by a
party that names the other party shall first be provided in draft to the other party. GCAL
acknowledges that Thera is a publicly traded company with continuous disclosure obligations.
Accordingly, Thera may have to disclose in a press release, a material change report, its
financial statements or in its other continuous disclosure documents the execution of this
Agreement and the material terms thereof. In addition, GCAL acknowledges that Thera may have to
file this Agreement with the Canadian securities regulatory authorities in order to fulfill its
continuous disclosure obligations in Canada.
8.3 Injunctive Relief. The parties acknowledge that either partys breach of this Article 8
may cause the other party irreparable injury for which it would not have an adequate remedy at law.
In the event of a breach, the non-breaching party may be entitled to injunctive relief in addition
to any other remedies it may have at law or in equity.
Article 9. Miscellaneous
9.1 Notices. All notices hereunder shall be delivered as follows: (a) personally; (b) by
facsimile and confirmed by first class mail (postage prepaid); (c) by registered or certified mail
(postage prepaid); or (d) by overnight courier service, to the following addresses of the
respective parties:
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If to Theratechnologies:
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If to Gruppo Cartotecnico Abar Litofarma |
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SRL: |
2310 Alfred-Nobel Boulevard
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Via Pusiano, 4Sesto Ulteriano 20098, |
Montreal,
Québec, Canada
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San Giuliano, Milan, Italy |
H4S 2B4 |
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Attention: Vice President
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Attention: Sales Office |
Pharmaceutical Development
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Messima Piero |
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Facsimile: (514) 331-7321
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Facsimile: 39 0298 839290 |
Notices shall be effective upon receipt if personally delivered or delivered by facsimile and
confirmed by first class mail, on the third business day following the date of registered or
certified mailing or on the first business day following the date of or delivery to the overnight
courier. A party may change its address listed above by written notice to the other party.
9.3 Governing Law. This Agreement shall be construed, interpreted and governed by the laws of
the State of New York excluding the Vienna Convention on the International Sale of Goods and the
Parties hereby submit to the exclusive jurisdiction of the courts of New York to settle any
dispute, litigation or interpretation issues arising from or under the Agreement, including issues
relating to its validity and formation.
9.4 Assignment. Neither party shall assign this Agreement nor any part thereof without the
prior written consent of the other party; provided, however: (a) either party may assign this
Agreement to one of its wholly-owned subsidiaries or its parent corporation without such consent;
and (b) either party, without such consent, may assign this Agreement in connection with the
transfer, sale or divestiture of substantially all of its business to which this Agreement pertains
or in the event of its merger or consolidation with another company. Notwithstanding the
foregoing, Thera, without such consent, shall have the right to assign this Agreement to its
collaboration development partner, [Redacted: Name]. Any permitted assignee shall assume all
obligations of its assignor under this Agreement. No assignment shall relieve any party of
responsibility for the performance of any accrued obligation which such party then has hereunder.
9.6 Entire Agreement. This Agreement, together with the Exhibit(s) referenced and incorporated
herein, constitute the entire agreement between the parties concerning the subject matter hereof
and supersede all written or oral prior agreements or understandings with respect thereto.
9.7 Severability. This Agreement is subject to the restrictions, limitations, terms and
conditions of all applicable governmental regulations, approvals and clearances. If any term or
provision of this Agreement shall for any reason be held invalid, illegal or unenforceable in any
respect, such invalidity, illegality or unenforceability shall not affect any other term or
provision hereof, and this Agreement shall be interpreted and construed as if such term or
provision, to the extent the same shall have been held to be invalid, illegal or unenforceable, had
never been contained herein.
9.8 Waiver-Modification of Agreement. No waiver or modification of any of the terms of this
Agreement shall be valid unless in writing and signed by authorised representatives of both
parties. Failure by either party to enforce any such rights under this Agreement shall not be
construed as a waiver of such rights, nor shall a waiver by either party in one or more instances
be construed as constituting a continuing waiver or as a waiver in other instances.
9.9
Insurance. GCAL will procure and maintain, at its own expense, for the duration of the
Agreement, (a) Commercial General Liability including premises operations, products & completed
operations, blanket contractual liability, personal injury and advertising injury including fire
legal liability for bodily injury and property damage; and (b) Excess Liability, including product
liability with a combined single limit. Upon request, GCAL shall provide to Thera a certificate
evidencing the insurance GCAL is required to obtain and keep in force pursuant to this Section 9.9.
In
Witness Whereof, the parties intending to be bound by the
terms and conditions hereof have caused this Agreement to be signed by their duly authorised
representatives as of the date first above written.
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THERATECHNOLOGIES INC. |
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GRUPPO CARTOTECNICO ABAR LITOFARMA SRL |
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By: (Signed) Luc
Tanguay |
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By: (Signed) Carmelo
Lo Duca |
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Name:
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Luc Tanguay
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Name:
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Carmelo Lo Duca |
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Title:
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Senior Executive Vice President
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Title:
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President |
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and Chief Financial Officer |
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By: (Signed) Pierre
Perazzelli |
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Name:
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Pierre Perazzelli |
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Title:
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Vice President, Pharmaceutical |
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Development |
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GCAL Supply Agreement Redacted final |
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Exhibit 1.6
Product Specifications
[Redacted: Product Specifications]
Exhibit 1.7
Form of Purchase Order
[Redacted: Purchase Order]
Exhibit 2.6
Product Prices
[Redacted:
Product Prices]
Exhibit 8.1
Non-Disclosure and Non-Use Agreement
[Redacted: The Agreement]
ex-99.88
Exhibit 99.88
BECTON DICKINSON CANADA INC.
OEM AGREEMENT
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This agreement between Becton Dickinson Canada Inc. (BD) and Theratechnologies Inc.
(Buyer) shall govern Buyers purchase of products from BD including but not limited to the
products identified on Exhibit A (the Products), which exhibit is attached and incorporated
to this original equipment agreement (the Agreement). Pricing for additional products will
be provided, upon request, by your Regional Business Manager, Kevin Egesborg at (800) 268-5430 ext. 6157. |
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This Agreement shall remain in effect for a period of [Redacted: Term] (the Term)
commencing on the date on which the parties execute this Agreement
(the Effective Date) unless terminated earlier pursuant to the terms hereof. The Term shall be extended for
consecutive [Redacted: Term] periods, the first such
period commencing on the first anniversary
of the Effective Date, unless either party provides the other notice of its intent not to
extend the Term within [Redacted: Term] prior to the anniversary of the Effective Date or any
renewal term. |
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Buyer agrees that it will not use, sell, or distribute the Products for any application or
use that is inconsistent with the instructions, if any, for the Products or the uses for which
the Products are approved by BD. |
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Buyer agrees to the following limitations regarding its purchase of Products: |
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4.1. |
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The Products shall be used, sold, and distributed by Buyer exclusively for the following
purposes (the Permitted Product Uses): |
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4.1.1. |
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in procedural kits and trays; |
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4.1.2. |
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for the marketing, sale and distribution of the Buyers growth hormone-releasing
factor GRF (tesamorelin); |
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4.2. |
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Buyer shall provide adequate support and information to its
customers to enable them to
properly use the Products. Such support shall include but not be limited to supplying its
customers with the package inserts and instructions for use provided for the Products to Buyer by
BD. If such package inserts and/or product instructions have not been provided, Buyer shall
request that BD provide same. |
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Absent written agreement by BD, Buyer shall not sell, market, advertise, ship, distribute,
transfer or make the Products available in any manner outside of the Territory, which shall be
the United States and any possessions thereof. |
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Buyer acknowledges that BD is the owner of all the trademarks, trade names, brands,
designs, copyrights, intellectual property, and other indicia of
manufacturing origin, quality, and
inventorship used on, about, or embodied by the Products (collectively the Proprietary
Rights), and all of the goodwill attributable to the Proprietary Rights. Buyer acknowledges
that nothing in this Agreement gives it any right, title, or interest in or to the Proprietary
Rights. Buyer will make no contrary representations. Buyer shall acknowledge and accurately
reflect in all advertising, marketing materials, packaging and labeling for all Permitted Product
Uses BDs Proprietary Rights including but not limited to BD trademarks, trade names, and
branding. In addition, Buyer shall not without the prior written
consent of BD alter, deface,
remove, cover, mutilate, or modify in any manner any indications of BDs Proprietary Rights
placed, attached, or affixed by BD on the Products or their packaging, including but not limited
to trademarks, trade names, branding, serial or model numbers. Buyer shall provide a copy of
all advertising, marketing materials, packaging, and labeling for all Permitted Product Uses so
that BD may review such materials for consistency with this
Section 4.4. BD may require Buyer
to, and Buyer shall, edit all such materials or cease disseminating such materials if such
materials, in BDs sole determination, are not consistent with
this Section 4.4. |
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4.5. |
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If Buyer uses, sells, or distributes the Products in any manner inconsistent with the
foregoing limitations, BD may in its sole discretion terminate this Agreement with an advance
written notice if Buyer has not remedied said breach within [Redacted: Term] from the receipt
of the notice from BD and without any penalty or liability from BD to Buyer. |
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BD shall package and supply the Products to Buyer, and Buyer shall take delivery of the
Products from BD in accordance with the terms of this Agreement. |
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5.1. |
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BD shall package and supply the Products within [Redacted: Term] from the receipt of
Buyers purchase order and in accordance with the packaging and labeling specifications of the
Products as established between the parties (the Packaging Specifications)and the quality
system regulation as set forth in 21 C.F.R. Part 820 (or any successor law or regulation
thereof), as applicable, regarding medical devices and |
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all applicable rules and regulations promulgated by the Food and Drug Administration (the
Product Specifications). |
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5.2. |
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BD shall label the Products in accordance with the Packaging Specifications. |
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5.3. |
|
BD shall provide the packaging which is required for the transport of the Products as set
forth in the Packaging Specifications on Exhibit B, which Exhibit is attached to this Agreement
and hereby incorporated by reference. The Packaging Specifications shall not be changed without
Buyers express written consent. |
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5.4. |
|
If changes occur in the Product Specifications, or if
technical difficulties require BD to
perform either additional work or repeat work, and such additional work or repeat work is not
due to BDs fault or negligence, then BD shall provide Buyer with cost estimates for such work.
If Buyer approves such costs in writing, BD shall perform such work. Buyer shall pay BDs
additional costs for such work within [Redacted: Term] of the receipt of the invoice for such
work. |
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|
5.5. |
|
Buyer shall have a period of [Redacted: Term]
from the date of its receipt of a shipment of
Products to inspect and reject such shipment for nonconformance with the Product Specifications
and/or Packaging Specifications. If Buyer rejects such shipment, it shall promptly so notify BD
and provide to BD samples of the Products for verification. |
|
5.5.1. |
|
If BD confirms that such shipment did not meet the Product Specifications and/or
Packaging Specifications, BD shall replace, at no cost to Buyer, that portion of the Product
shipment which does not conform to the Product Specifications and/or Packaging
Specifications, and shall bear all expenses of shipping and
verification of the shipment of
Products. Any nonconforming portion of any shipment shall be disposed of as directed by BD,
at BDs expense. |
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5.5.2. |
|
If BD verifies such shipment and determines that it did conform to the Product
Specifications and/or Packaging Specifications, and Buyer does not agree with this
assessment, then, either party may, by written notice to the other party, request that such
dispute be referred to each partys respective Chief Executive Officer (or an executive
officer of each party as designated by the CEO) (the Executive Officers) for
resolution. The Executive Officers shall meet within [Redacted: Term] of such other partys
receipt of written notice of such dispute. If the Executive Officers cannot resolve such
dispute within [Redacted: Term] of written notice of such dispute, then, at any time after
such [Redacted: Term] period, either party may bring an action in a court of competent
jurisdiction in the district of Toronto. Each party shall bear the cost of [Redacted:
Description of Costs]. Either party may proceed to enforce any and all of its rights with
respect to such dispute. |
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5.5.3. |
|
Any Products that Buyer does not reject pursuant to this
Section 5.5.3 shall be deemed
accepted, and all claims with respect to the Products not conforming with Product
Specifications and/or Packaging Specifications shall be deemed waived by Buyer, except as
to defects which are not reasonably discoverable or render the Products non-conforming to
Product Specifications and/or Packaging Specifications, as applicable. |
6. |
|
Buyer agrees that it will purchase the Products for resale in
accordance with this Agreement.
For further clarity, nothing contained in this Agreement shall be construed as to granting any
exclusivity to BD in supplying and/or packaging the Products to Buyer. |
|
7. |
|
Buyer shall only resell the Products in accordance with the
provisions of Section 4 of this
Agreement and in the same form and packaging as supplied by BD. |
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8. |
|
Buyer shall not, without BDs prior written consent, use BDs name, trademarks, trade names,
branding, lot numbers or anything alike in any advertising or marketing materials, or on
packaging of the Products to the extent such markings were not placed on the packaging or the
Products by BD. |
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9. |
|
The Products purchased by Buyer pursuant to this Agreement
are not eligible for rebates and
Buyer shall not submit rebate requests for any Products purchased pursuant to this Agreement. |
|
10. |
|
As of [Redacted: Date] and during the Term
thereafter, BD may request that Buyer provide, and
Buyer shall provide, on a [Redacted: Term] basis, [Redacted: Term] forecasts of its estimated
purchases of the Products to better enable BD to supply Buyers needs, provided, however, that such
forecasts may be changed at all times by Buyer. BD shall not be
liable for any incremental costs
incurred by Buyer as a result of any backorder of Products. |
|
11. |
|
Buyer shall not promote or sell any products that, in BDs sole judgment, are imitative of or
may be passed off as Products, and Buyer shall not promote or sell any products bearing a name or
trademark that may, as |
Page 2
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determined by BD, infringe or imitate trademarks owned by BD, or any other trademarks, designs
or slogans used in promoting, advertising or selling the Products. |
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12. |
|
Upon receipt of a complaint or receipt of a reported adverse event that explicitly references
any of the Products or may be associated with any of the Products, Buyer shall forthwith forward
the complaint, including BD catalogue/product number, BD product name, description of the incident
and complainant contact information to BD but in any event no later than [Redacted : Term] from
receipt thereof. If the reported adverse event is related or associated in any manner to the
Products, then BD shall be copied on all subsequent correspondence between Buyer and the
complainant. If the reported adverse event is solely related to the Products, then BD shall be the
primary contact with respect to such correspondence. BD, upon receipt of the Product complaint
information and materials will investigate the complaint and retain on file all related
information, in addition to any corrective and preventative actions that are either planned or
taken. At the request of Buyer, BD will provide an acknowledgement of receipt of the Product
complaint and that the complaint investigation has been closed. If a medical device report is deemed to be required for a Product, BD is to assume responsibility for the filing any such report. Records of the complaint investigation and associated documents will be made available to Buyer
if specifically requested during a regulator audit (e.g. U.S. F.D.A. drug G.M.P. inspection).BD
shall inform Buyer forthwith about any notice received by a Regulatory Authority that would
potentially hinder or prevent BD from packaging or supplying the Product to Buyer according to this
Agreement. Regulatory Authority means federal,
provincial,state or local regulatory agency,
department, bureau or other governmental entity of Canada or the United States, including the
F.D.A., which is responsible for issuing approvals, licenses,
registrations or authorizations
necessary for the manufacture, use, storage, transport or sale of the Products in Canada and in the
United States and any possession thereof. |
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13. |
|
In the event: (a) any Regulatory Authority or other national government authority issues a
request, directive or order that the Products be recalled; (b) a court of competent jurisdiction
orders such a recall; or (c) Buyer or BD reasonably determines that the Products should be
recalled, the parties shall take all appropriate corrective actions, and shall cooperate in any
governmental investigations surrounding the recall. In the event that such recall results from the
breach by BD of the terms of this Agreement, BD shall be responsible for promptly replacing the
quantity of the Products that were recalled at no cost to Buyer or at its sole option reimburse
Buyer for the cost of the Products that were recalled. BD shall be responsible for all commercially
reasonable costs and expenses related to the recall. In the event that the recall does not result
from the breach by BD of terms of this Agreement, Buyer shall be
responsible for all commercially reasonable costs and expenses of the recall. For purposes of this Agreement, commercially
reasonable expenses of the recall include expenses of notification and destruction or return of the
recalled Products and any costs associated with the distribution of the replacement Products, but
shall not include lost profits of either party. For purposes of this Agreement, a recall shall
include any market withdrawal, communication (informing the end-user of a real or potential
Product quality, safety or performance issue) or instructions issued by BD or Buyer to an end-user
that provides instructions regarding handling and storage, that is not provided or included on
Product labeling. Any correspondence with a Regulatory Authority
pertaining to a recall and regarding
or impacting the Products, shall be directed to BD and BD shall be the primary contact in
connection thereto. |
|
14. |
|
Buyer shall not market, em ploy any sales practice, or issue or display any advertisement
which in BDs sole opinion, acting reasonably, is detrimental to the reputation, image, or
positioning of BD or the Products and BD shall be entitled to require Buyer to cease any such
practice or withdraw any such advertisement. |
|
15. |
|
The parties agree that throughout the Term they will remain
in compliance with all applicable
United States and Canadian laws and regulations. |
|
16. |
|
U.S. law regulates the export, re-export or other transfer of the Products. Any required U.S.
and non-U.S. government authorization (specifically including Canada) must be obtained prior
to shipment, and diversion contrary to U.S. and non-U.S. law is
prohibited. By ordering the
Products from BD, Buyer agrees to comply fully with all applicable export control laws and
regulations of the United States and Canada, and expressly assumes responsibility for determining
whether a subsequent transaction requires U.S. and Canadian government authorization and, if so,
for obtaining such authorization before shipping or otherwise transferring the Products to another
party. |
|
17. |
|
Buyer agrees to comply with all standard conditions and destination control statements set
forth on the invoice, bill of lading or other documents accompanying the shipment of the Products. |
|
18. |
|
Buyer affirms that it will not knowingly use, resell or distribute Products directly or
indirectly, for the development, production or proliferation of weapons of mass destruction
(nuclear, chemical, or biological)or missile delivery systems, and/or for terrorist activities. |
|
19. |
|
BD shall deliver the Products to Buyer on the requested shipping date as set out on the
purchase order, [Redacted: Delivery Terms] at [Redacted: Location] or such other facility as may be
agreed upon in writing by |
Page 3
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the parties. Shipment shall be via a carrier designated by Buyer. Title and risk of loss shall
pass to Buyer [Redacted: Title and Risk of Loss Conditions] at [Redacted: Location]. BD shall pay all costs
relating to the Products until such time as it has been placed at the disposal of Buyer at the
[Redacted: Location]. BD shall give Buyer at least [Redacted: Term] notice as to when the
Products will be placed at its disposal. BD shall provide the Products with a packing list and
bill of lading consigned to Buyer. BD shall pay all costs of checking operations such as,
checking quality, measuring, weighing and counting, which are necessary for the purpose of
placing the Products at Buyers disposal. |
|
20. |
|
Items ordered by Buyer that are special non-stock products, which orders have been
accepted by BD and shipping dates given may not be canceled or returned to BD for credit. |
|
21. |
|
Unless otherwise agreed, BD specifications and quality requirements shall apply to all
Products purchased under this Agreement. |
|
22. |
|
WARRANTY. BD represents and warrants that the Products shall be free from material defects,
shall meet the Product Specifications and Packaging Specifications and that the Proprietary Rights
do not infringe or constitute a misappropriation of any third partys Proprietary Rights. THE
WARRANTIES SET FORTH IN THIS PARAGRAPH ARE EXCLUSIVE REGARDING THE PRODUCTS AND IN LIEU OF ALL
OTHER REPRESENTATIONS, WARRANTIES AND CONDITIONS EXPRESS, IMPLIED OR STATUTORY, INCLUDING ANY
IMPLIED REPRESENTATION, WARRANTY OR CONDITION OF MERCHANTABILITY. ALL OTHER REPRESENTATIONS,
WARRANTIES AND CONDITIONS WHETHER EXPRESS OR IMPLIED BY STATUTES OR OTHERWISE ARE HEREBY
EXPRESSLY DISCLAIMED. In the event of a breach of this warranty, Buyers remedy shall be the
replacement of the allegedly defective Products by BD with BD Products or a credit or refund of the
funds paid by Buyer for the affected Products, at Buyers option. In no event shall BD be liable for
any indirect or consequential damages, including but not limited to lost profits. |
|
23. |
|
Intentionally omitted. |
|
24. |
|
BD hereby disclaims any liability for the safety and efficacy of any Products which would be reconfigured, repackaged or re-sterilized by Buyer and ultimately sold to third parties by Buyer, and
the sale of Products to Buyer under this Agreement shall not be construed as an endorsement by BD
of any ultimate Products sold by Buyer. |
|
25. |
|
Buyer is responsible for assuring the sterility,if applicable, of any Products ultimately sold
by Buyer to third parties. Buyer is also responsible for obtaining any necessary regulatory
approvals and/or clearances necessary for any Products ultimately sold by Buyer to third parties. |
|
26. |
|
Buyer agrees to and does indemnify and hold harmless BD, its directors, officers, agents and employees from and against any and all liabilities, demands, claims, suits,losses, damages, causes of
action, or judgments including costs, attorney fees, and expenses incident thereto which may be
suffered directly by reason of any loss, damage, death or bodily injury arising out of or in
connection with (i) Buyers negligent or wrongful willful acts in connection with this Agreement or
(ii) Buyers breach of or failure to comply with any provision of this Agreement. This indemnification shall not extend to indirect, special,or consequential damages, including, without
limitation, lost profits whether foreseeable or communicated to the other party. |
|
27. |
|
BD agrees to and does indemnify and hold harmless Buyer, its directors, officers, agents and employees from and against any and all liabilities, demands, claims, suits,losses, damages, causes of
action, or judgments including costs, attorney fees, and expenses incident thereto which may be
suffered directly by reason of any loss, damage, death or bodily injury arising out of or in
connection with (i) BDs negligent or wrongful willful acts in connection with this Agreement or
(ii) the Products furnished to Buyer pursuant to this Agreement or any purchase order issued
pursuant to this Agreement or (iii) BDs breach of the warranties contained herein or failure
to comply with any provision of this Agreement. This Indemnification shall not extend to
indirect,special, or consequential damages, including, without limitation, lost profits whether
foreseeable or communicated to the other party. |
|
28. |
|
If either party seeks indemnification from the other hereunder, it shall promptly give notice to
the other party of any such claim or suit threatened, made or filed against it which forms the
basis for such claim of indemnification and shall cooperate fully with the other party in the
investigation and defense of all such claims or suits. The indemnifying party shall have the option
to assume the other partys defense in any such claim or suit with counsel reasonably
satisfactory to the other party. No settlement or compromise shall [Redacted: Settlement Conditions]
. |
|
29. |
|
Buyer will maintain and keep in force during the Term ,
general public liability, and property
damage insurance against any insurable claim or claims, which might or could arise regarding
Products purchased from BD.Such |
Page 4
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insurance will contain a minimum combined single limit of
liability for bodily injury and property
damage in the amounts of not less than [Redacted: Amount] and [Redacted: Amount]. |
|
30. |
|
BD will maintain and keep in force during the Term, general public liability,and property
damage insurance against any insurable claim or claims, which might or could arise regarding
Products purchased from BD. Such insurance will contain a minimum
combined single limit of
liability for bodily injury and property damage in the amounts of not
less than [Redacted: Amount]
and [Redacted: Amount]. |
|
31. |
|
At any time, either Buyer or BD may terminate this Agreement for any reason upon [Redacted:
Term] written notice to the other or as otherwise agreed in writing by the Buyer and BD, provided
that Buyer complies at all times with its payment obligations under this Agreement. In the event
that during the notice period Buyer fails to comply with its payment obligations hereunder, the
provisions of Section 32.1 will apply. |
|
32. |
|
Notwithstanding anything to the contrary, this Agreement may be terminated by either party
giving notice to the other effective the date of receipt of written notice thereof: |
|
32.1. |
|
if the other party breaches any term, condition or provision of this Agreement, and such
breach is not cured to the reasonable satisfaction of the other party within [Redacted: Term] of
receipt of written notice of breach thereof, or as otherwise agreed upon by the parties in
writing; |
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|
32.2. |
|
if a party takes any action in respect of liquidation or winding up, or make an assignment
for the benefit of creditors, or makes any proposal under the Bankruptcy Act or any comparable
statute of any applicable jurisdiction, or a judgment or order is entered by any court of
competent jurisdiction approving any such petition,or if a custodian or receiver or receiver and
manager or any other official with similar powers be appointed for such party; and if such party
ceases to do business as a going concern; |
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32.3. |
|
in the event of any allegation of infringement being made against either BD or Buyer for
infringement of a third party intellectual property right in
consequence of the sale of the
Products; and |
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|
32.4. |
|
in the event of a Change of Control (as defined in Section 35) where the person acquiring
control is a competitor of BD or any of its Affiliates. In this case, Buyer shall take any and
all action reasonably requested by BD to protect any Confidential Information of BD from
disclosure to or use by any Affiliate of the transferee or the Buyer in the case of a Change of
Control. |
33. |
|
Termination of this Agreement by a party shall not deprive such party of any of
its rights, remedies or actions against the other party for damages or equitable remedies. |
|
34. |
|
Upon termination, except by reason of breach by BD, Buyer shall reimburse BD for BDs cost of
all supplies purchased and on hand or on order, if such supplies were ordered by BD based on
Buyers firm purchase order, and such supplies cannot be reasonably used by BD for other purposes,
and for Products manufactured or delivered until the notice of termination. |
|
35. |
|
In the event of a Change of Control of the Buyer, Buyer shall provide BD with a notice within
[Redacted: Term] prior to the effective date of the Change of Control. Upon receipt of the notice,
BD shall have an additional period of [Redacted: Term] to provide notice to Buyer of acceptance of
Change of Control or refusal to Change of Control, in which case, this Agreement shall be
terminated by the end of an additional period of [Redacted: Term] . Change of Control means (a)
the direct or indirect sale, transfer, conveyance, lease or other disposition (other than by way of
consolidation, amalgamation or merger), in one or a series of related transactions, of all or
substantially all of the property and assets of Buyer to any person or group of persons acting
jointly or in concert for purposes of such transaction; or (b) the consummation of any transaction
including any consolidation, amalgamation, merger or issue of voting shares, the result of which
is that any person or group of person acting jointly or in concert for purposes of such transaction
becomes the beneficial owner, directly or indirectly, of more than 50% of the voting shares of the
Buyer, measured by voting power rather than number of shares. |
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36. |
|
BD hereby grants Buyer (or its third party designees), the right to conduct for cause audits
of BDs or its subcontractors packaging facilities to
address significant Product or safety concerns
as discovered through adverse drug events or customer complaints related to Product failures. |
|
36.1. |
|
Buyer shall notify BD in writing of its intent to audit. Buyer and BD will determine
mutually acceptable dates for the audit. Any auditors who are not employees of Buyer shall be
required to enter into confidentiality agreements with BD or its subcontractor and Buyer
containing terms of non-disclosure and non-use at least as stringent as those set forth in
Section 38. Auditors shall abide by BDs or its
sub-contractors visitor policies. BD or its
subcontractor shall have the right to protect the confidential
information of its other clients
and products and to limit the audit to such areas of the production facility that are relevant
to the Products. |
Page 5
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36.2. |
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The auditors shall issue a written report of their findings within [Redacted: Term] of the
audit. Buyer shall provide to BD a written report of its findings as soon as possible, or within
[Redacted: Term] after the conclusion of the audit. BD shall promptly address the audit findings,
but in no event later than [Redacted: Term] of receiving the report. |
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36.3. |
|
Any dispute in connection with a written report or findings by auditors shall be dealt with
in accordance with the provisions of Section 5.5.2. |
37. |
|
Each purchase order or any acknowledgment thereof, whether printed, stamped, typed, or written
shall be governed by the terms of this Agreement and none of the provisions of such purchase
order or acknowledgment shall be applicable except those specifying Products and quantity ordered,
delivery dates, special shipping instructions and invoice information. Buyer shall place the
purchase orders no less than [Redacted: Term] prior to the requested shipping date. |
|
38. |
|
It is contemplated that in the course of the performance of this Agreement each party may, from
time to time, disclose Confidential Information to the other. Confidential Information means
all information disclosed hereunder in writing or orally, visually or through some other media, except any portion thereof which: (a) is known to the recipient at the time of the disclosure, as
evidenced by its written records or other competent evidence; (b) is disclosed to the recipient by a
third person lawfully in possession of such information and not under an obligation of nondisclosure;
(c) is or becomes patented, published or otherwise part of the
public domain through no fault of
the recipient; (d) is developed by or for the recipient independently of Confidential Information
disclosed hereunder as evidenced by the recipients written records or other competent evidence;
or (e) is required by law to be disclosed by the recipient, provided that the recipient gives the
disclosing party hereto prompt notice of such legal requirement such that the disclosing party
shall have the opportunity to apply for confidential treatment of such Confidential Information. The
burden of proof for these exceptions lies with recipient. Each party agrees that, except as
expressly provided in this Agreement, it shall not disclose Confidential Information received from
the other party, and shall not use Confidential Information disclosed to it by the other party, for
any purpose other than to fulfill each parties obligations under this Agreement.
Notwithstanding the foregoing, Buyer shall be entitled to disclose Confidential Information to
its distributor in the United States, including its territories and possessions. |
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38.1. |
|
Notwithstanding the above, nothing contained in this Agreement shall preclude Buyer from
using Confidential Information as may be necessary for obtaining governmental marketing
approvals pursuant to the terms and conditions of this Agreement, or for either party to comply
with applicable governmental laws and regulations or court orders (provided that the party
disclosing such information uses reasonable efforts to seek confidential treatment of such
information, except as required to file and prosecute such patent
applications). The obligations
of the parties relating to Confidential Information shall survive for a period of ten (10) years
after the expiry or earlier termination of this Agreement. |
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38.2. |
|
Neither party shall make any public announcement concerning the transactions
contemplated herein, or make any public statement which includes the name of the other party or
any of its affiliates, or otherwise use the name of the other party or any of its affiliates in
any public statement or document, except as may be required by law or
judicial order, without
the written consent of the other party, which consent shall not be unreasonably withheld.
Subject to any legal or judicial disclosure obligation, any such public announcement proposed
by a party that names the other party shall first be provided in
draft to the other party. BD
acknowledges that Buyer is a publicly traded company with continuous disclosure obligations.
Accordingly, Buyer may have to disclose in a press release, a material change report, its
financial statements or in its other continuous disclosure documents the execution of this
Agreement and the material terms thereof. BD acknowledges that Buyer
may have to file this
Agreement with the Canadian securities regulatory authorities in order to fulfill its
continuous disclosure obligations in Canada. |
39. |
|
BD shall not be responsible for any delay of production for delivery of Products attributable
to [Redacted: Description of events], and any other circumstance beyond the control of BD. |
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40. |
|
The terms of this Agreement are severable and if for any reason any terms should be
unenforceable or invalid, the rest of the Agreement shall remain in
full force and effect. No delay
or omission by either party in exercising any right or remedy shall operate as a waiver. |
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41. |
|
This Agreement cancels and supersedes any previous agreement between Buyer and BD or its
predecessors in title in relation to the Products. |
|
42. |
|
This Agreement is personal to each party and its rights and obligations herein shall not be
assigned or transferred without the prior written consent of the
other party. However, either party
may assign this Agreement to one of its wholly-owned subsidiaries or its parent corporation without
such consent. Notwithstanding the foregoing, Buyer, without such consent, shall have the right to
assign this Agreement to [Redacted: Name]. Any |
Page 6
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permitted assignee shall assume all obligations of its assignor under this Agreement. No
assignment shall relieve any party of responsibility for the performance of any accrued
obligation which such party then has hereunder. |
|
43. |
|
The parties relationship hereunder is that of independent contractors. This Agreement does not
create any employment, agency, franchise, joint venture, partnership or other similar legal
relationship between BD and Buyer. Buyer shall make no warranty concerning the Products except as
expressly approved by BD. Buyer shall have no right or authority to assume or claim any obligation
of any kind, express or implied, by or on behalf of BD, or to bind BD or any way whatsoever. |
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44. |
|
No variation, modification or waiver of any of the terms of
this Agreement shall be valid unless
made in writing and signed on behalf of both parties. This Agreement and the Exhibits and other
attachments to this Agreement set out the entire understanding between the parties with respect to
the rights and duties of the parties and no party has relied on any representation that is not
expressly set out or referred to in this Agreement. |
|
45. |
|
In order to be effective, any notice must be in writing. A notice is effective if it is
delivered (i) personally, either to the individual designated below for such party, or to an
individual having apparent authority to accept deliveries on behalf of such individual at its
address set out below; (ii) by fax, (iii) by registered mail at or to the applicable addresses set
out opposite the partys name below or at or to such other address for a party as such party from
time to time designates to the other parties in the same manner : |
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|
|
Technical Information:
|
|
For technical information, please call Claudine Keats, Product |
|
|
Manager, 1-800-268-5430, Extension 6170 |
|
|
|
Product Certifications:
|
|
By acceptance of this Agreement,
Buyer acknowledges that BD will provide an Annual Certification of
Compliance and Biosafety (Sterility, Non-Toxicity, Non-Pyrogenicity
as applicable) for all Products purchased or shipped under this Agreement. |
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|
|
Customer Service: |
|
|
|
|
|
By Phone:
|
|
1-866-979-9408 / 1-888-259-0187 |
|
|
|
By Fax:
|
|
1-800-565-0897 |
|
|
|
Notices to BD: |
|
|
By Mail:
|
|
Becton Dickinson Canada Inc., |
|
|
2100 Derry Road West, Suite 100, |
|
|
Mississauga, Ontario, L5N 0B3 |
|
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|
|
|
Attention:Kevin Egesborg |
|
|
Regional Business Manager |
|
|
|
Notices to Buyer: |
|
|
By Mail:
|
|
Theratechnologies Inc., |
|
|
2310 Alfred-Nobel Blvd. |
|
|
Montreal , Quebec, H4S 2B4 |
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|
|
|
Attention:Pierre Perazzelli |
|
|
Vice President, Pharmaceutical Development |
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|
|
Payment:
|
|
BD shall invoice Buyer for the
Products [Redacted: Timing
of Payment] at the prices set forth on Exhibit C, which
Exhibit is hereby incorporated by reference. Buyer shall
make payment [Redacted: Term] from the date of receipt of
BDs invoice. |
|
|
|
Minimum Orders:
|
|
The minimum order quantity for the Products shall be
[Redacted: Quantity] kits. For greater clarity, one (1) kit
is comprised of the following: |
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|
|
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[Redacted: Quantity]; |
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[Redacted: Quantity]; and, |
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[Redacted: Quantity]. |
Page 7
47. |
|
This Agreement may be executed in any number of counterparts, each of which shall be deemed to
be an original and all of which together shall be deemed to be one and the same instrument. |
|
48. |
|
This Agreement is governed by, and is to be interpreted, construed and enforced in accordance
with, the laws of Ontario and the laws of Canada applicable in Ontario, excluding any rule or
principle of conflicts of law that may provide otherwise. |
|
49. |
|
The parties irrevocably attorn to the jurisdiction of the courts of Ontario, which will have non-exclusive jurisdiction over any matter arising out of this Agreement. |
IN WITNESS WHEREOF, the undersigned duly authorized representatives of the parties have executed
this agreement as of the last date below written.
|
|
|
THERATECHNOLOGIES INC.
|
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BECTON DICKINSON CANADA INC. |
|
|
|
Pierre Perazzelli
|
|
Doug Johnstone |
|
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|
Name
|
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Name |
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|
|
V.P. Pharmaceutical Development
|
|
Director, Distributor RE |
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Title
|
|
Title |
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(signed) Pierre Perazzelli
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(signed) Doug Johnstone |
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Signature
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Signature |
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November 2, 2009
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November 6, 2009 |
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Date Signed
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Date Signed |
OEM Canadian Agreement BD & Thera FINAL - Redacted final
Page 8
EXHIBIT A
Products
[Redacted: Description and amount of products]
EXHIBIT B
Packaging Specifications
[Redacted: Specifications]
Page 10
EXHIBIT C
Price List
[Redacted: Pricing]
ex-99.89
Exhibit 99.89
DEVELOPMENT AND SUPPLY AGREEMENT
This Development and Supply Agreement (this Agreement) is made as of this 26 th day
of March, 2009 (Effective Date) by and between Theratechnologies Inc., having a
principal place of business at 2310 Alfred-Nobel Boulevard, Montreal, P.Q., H4S 2B4, Canada
(Theratechnologies) and Hospira Worldwide, Inc., having a principal place of business at 275
North Field Drive, Lake Forest, Illinois, 60045, U.S.A. (Hospira).
Witnesseth:
Whereas, Theratechnologies owns rights to the compound, tesamorelin, a stabilized
synthetic analogue of the growth hormone-releasing factor (GRF);
Whereas, Theratechnologies intends to market, promote and sell the tesamorelin for
the treatment of HIV-associated lipodystrophy (Tesamorelin) product in the United States;
Whereas, Theratechnologies wishes to have Hospira manufacture for it a non-standard
version of its standard sterile water for injection diluent;
Whereas, Hospira has available for manufacture and sale such non-standard version of
sterile water for injection and has received approval from the US Food and Drug Administration on
its New Drug Application (NDA) for sterile water for injection filled and finished in a 10 mL
plastic vial with [Redacted: Term] expiry dating; and
Whereas, the parties desire that Hospira manufacture and sell to Theratechnologies
its total U.S. requirements of the non-standard version of its regular sterile water for injection
diluent.
Now, Therefore, in consideration of the premises and the mutual promises and
agreements contained herein, Theratechnologies and Hospira agree as follows:
Article 1. Definitions
The following words and phrases when used herein with capital letters shall have the meanings
set forth or referenced below:
1.1 Affiliate shall mean any corporation or non-corporate business entity which controls, is
controlled by, or is under common control with a party to this Agreement. A corporation or
non-corporate business entity shall be regarded as in control of another corporation or
non-corporate business entity if it owns, or directly or indirectly controls, in excess of fifty
percent (50%) of the voting stock of the other corporation, or (a) in the absence of the ownership
of in excess of fifty percent (50%) of the voting stock of a corporation or (b) in the case of a
non-corporate business entity, if it possesses, directly or indirectly, the power to direct or
cause the direction of the management and policies of such corporation or non-corporate business
entity, as applicable.
1.2 cGMP shall mean the current good manufacturing practices as set forth in 21 C.F.R. Part
210 and Part 211, as applicable.
1.3 Confidential Information shall mean all information disclosed hereunder in writing and
identified as being confidential or, if disclosed orally, visually or through some other media, is
identified as confidential at the time of disclosure and is summarized in writing within [Redacted:
Term] of such disclosure and identified as being confidential, except any portion thereof which:
(a) is known to the recipient at the time of the disclosure, as evidenced by its written
records or other competent evidence;
(b) is disclosed to the recipient by a third person lawfully in possession of such information
and not under an obligation of nondisclosure;
(c) is or becomes patented, published or otherwise part of the public domain through no fault
of the recipient;
(d) is developed by or for the recipient independently of Confidential Information disclosed
hereunder as evidenced by the recipients written records or other competent evidence; or
(e) is required by law to be disclosed by the recipient, provided that the recipient gives the
other party hereto prompt notice of such legal requirement such that such other party shall have
the opportunity to apply for confidential treatment of such Confidential Information.
1.4 Minimum Purchase Requirement shall have the meaning provided in Section 5.7.
1.5 NDA shall mean a New Drug Application filed pursuant to the requirements of the FDA, as
more fully defined in 21 C.F.R. § 314.3 et seq., as the same may be amended from time to time, a
Biologics License Application filed pursuant to the requirements of the FDA, as more fully defined
in 21 C.F.R. §601, as the same may be amended from time to time, and any equivalent application
filed, together, in each case, with all additions, deletions or supplements thereto.
1.6 NDA Acceptance shall mean the receipt of written notice from the FDA that the filing of
an NDA for Tesamorelin has been accepted pursuant to and in accordance with 21 C.F.R. §314.101, as
the same may be amended from time to time.
1.7 Packaging Specifications shall mean those packaging and labeling specifications of the
Product for the special tray labeling and artwork, vial labeling and artwork and corrugate
packaging labeling and artwork, which are attached on Exhibit 1.7.
Theratechnologies
Hospira Diluent Agreement
Page 2 of 22
1.8 Product shall mean Hospiras non-standard version of Hospiras sterile water for
injection diluent (Hospira List 4887-10), packaged in a 10 mL plastic vial with flip-top cap, with
[Redacted: Term] expiry dating and meeting the Product Specifications.
1.9 Product Specifications shall be substantially in the form of Hospiras Certificate of
Analysis, which form will certify the Products [Redacted: Term] expiry dating and confirming that
the Product has been manufactured in accordance with all cGMP and all rules and regulations
promulgated by the FDA, a form of such Certificate of Analysis is attached on Exhibit1.9.
1.10 Regulatory Approval shall mean the approval of Tesamorelin for sale to the public in
the United States markets by a relevant Regulatory Authority.
1.11 Regulatory Authority shall mean any federal, state or local regulatory agency,
department, bureau or other governmental entity of the United States, including the FDA, which is
responsible for issuing approvals, licenses, registrations or authorizations necessary for the
manufacture, use, storage, transport or sale of Product in the United States.
1.12 Third Party shall mean a party other than Hospira or Theratechnologies and their
respective Affiliates.
Article 2. Product Development Project
2.1 General. Promptly following the Effective Date and upon receipt of a written purchase
order from Theratechnologies, Hospira shall undertake a product development project (the Project)
consisting of the bulk packaging container design activities set forth in Exhibit 2.1. The
price for the activities to be undertaken and completed in the Project shall be [Redacted: Price],
payable no later than [Redacted: Term] after the date of Hospiras invoice therefor. The purchase
order shall be issued by Theratechnologies within [Redacted: Term] from the delivery to
Theratechnologies of the Letters of Authorization (as defined below).
2.2 Commercially Reasonable Efforts. Hospira shall use its commercially reasonable efforts
successfully to complete the Project by no later than [Redacted: Date], unless the parties mutually
agree to extend this date.
2.3 Changes in Project Scope. If changes occur in the Project or Product Specifications, or if
technical difficulties require that Hospira perform either additional work or repeat work, and such
additional work or repeat work is not required due to Hospiras fault or negligence, Hospira shall
provide Theratechnologies with cost estimates for such work. Only if Theratechnologies approves
such costs in writing, Hospira shall perform such work and Theratechnologies shall pay Hospiras
costs for such work within [Redacted: Term] of completion of such work. Reimbursement for such
additional work or repeat work shall be at the hourly rates set forth in Exhibit 2.3, plus
[Redacted: Description of Costs].
Theratechnologies
Hospira Diluent Agreement
Page 3 of 22
Article 3. Theratechnologiess Regulatory Submissions
3.1 Access to NDA. Hospira shall grant Theratechnologies reference rights to Hospiras
NDA for the Product. To affect this, Hospira shall execute certain documentation (Letters of
Authorization) no later than [Redacted: Term] after the Effective Date which shall be delivered to
Theratechnologies and the appropriate Regulatory Authorities permitting such Regulatory Authorities
to consult Hospiras NDA in their review of Theratechnologiess marketing applications. Hospira
shall send copies of such Letters of Authorization to Theratechnologies. Hospira shall inform
Theratechnologies in advance of any prior approval or changes being effected, amendments or
modifications thereto in order to permit Theratechnologies to amend or supplement any effected
regulatory applications and filings.
Article 4. Manufacture And Supply Of Product
4.1 Purchase and Sale of Product. Pursuant to the terms and conditions of this Agreement
and for the duration of this Agreement, Hospira shall manufacture, sell and deliver the Product to
Theratechnologies, and Theratechnologies shall purchase and take delivery of its total U.S.
requirements of the Product exclusively from Hospira for sales of Tesamorelin in the United States.
Hospira shall manufacture Product in accordance with the Product Specifications.
4.2 Product Labeling. Hospira shall label Product in accordance with the Packaging
Specifications.
4.3 Packaging Specifications. The Packaging Specifications shall not be changed without
Theratechnologiess express written consent.
4.4 Delivery. Hospira shall deliver the Product to Theratechnologies, [Redacted: Delivery
Terms] from [Redacted: Place] or such other facility as may be agreed upon in writing by the
parties. Shipment shall be via a carrier designated by Theratechnologies. [Redacted: Transfer of
Risk]
4.5 Price and Payment.
(a) Price. Hospira shall invoice Theratechnologies for the Product at the prices set forth on
Exhibit 4.5. Prices are firm through [Redacted: Date]. Beginning [Redacted: Date] and on
each succeeding [Redacted: Date] during the term hereof, prices may be increased by Hospira.
Hospira will notify Theratechnologies by [Redacted: Date] of the then current calendar year of any
price increase to be effective for the ensuing calendar year. Price increases shall be effective
for deliveries beginning [Redacted: Date] of each calendar year. Such increases shall not exceed
[Redacted: Price Increase Calculation].
(b) Payment. Hospira shall invoice Theratechnologies upon shipment of Product.
Theratechnologies shall make payment net [Redacted: Term] from the date of receipt of Hospiras
invoice.
Theratechnologies
Hospira Diluent Agreement
Page 4 of 22
(c) Taxes. Any federal, state, county or municipal sales or use tax, excise, customs charges,
duties or similar charge, or any other tax assessment (other than that assessed against income),
license, fee or other charge lawfully assessed or charged on the manufacture, sale or
transportation of Product sold pursuant to this Agreement, shall be paid by Theratechnologies.
4.6 Replacement of Nonconforming Shipment. Hospira will include a Certificate of Analysis with
each batch of Product confirming that the Product has been manufactured in conformity with all
applicable quality standards and practices. Theratechnologies shall have a period of [Redacted:
Term] from the date of its receipt of a shipment of Product to inspect and reject such shipment for
nonconformance with the Product Specifications. Theratechnologies will refer to applicable sections
of the United States Pharmacopeia (USP) for testing instructions with reference to Product. Hospira
will confirm appropriate interpretation by Theratechnologies of USP test procedures if requested.
If Theratechnologies rejects such shipment, it shall promptly so notify Hospira and provide to
Hospira samples of such shipment for testing. If Hospira tests such shipment and determines that it
did conform to the Product Specifications, the parties shall submit samples of such shipment to a
mutually acceptable independent laboratory for testing. If such independent laboratory determines
that the shipment conformed to the Product Specifications, Theratechnologies shall bear all
expenses of shipping and testing such shipment samples. If Hospira or such independent laboratory
confirms that such shipment did not meet the Product Specifications, Hospira shall replace, at no
cost to Theratechnologies, that portion of the Product shipment which does not conform to the
Product Specifications, and shall bear all expenses of shipping and testing the shipment samples.
Any nonconforming portion of any shipment shall be disposed of as directed by Hospira,[Redacted:
Expense]. Any Product that Theratechnologies does not reject pursuant to this Section 4.6
shall be deemed accepted, and all claims with respect to Product not conforming with Product
Specifications shall be deemed waived by Theratechnologies, except as to latent defects which are
not reasonably discoverable, render the Product not conforming to Product Specifications, and are
solely caused by Hospira.
4.7 Audit Rights
(a) Hospira hereby grants Theratechnologies (or its Third Party designees), the right to
conduct for cause audits of Hospiras manufacturing facility to address significant Product or
safety concerns as discovered through adverse drug events or customer complaints related to Product
failures and attributed to Hospiras manufacture of the Product. Product failures would include
issues related to stability out of specification, sterilization, labelling, and container
integrity.
(b) Theratechnologies shall notify Hospira in writing of the intent to audit for cause. The
audit shall be limited to no more than [Redacted: Quantity] auditors for no more than [Redacted:
Term]. Theratechnologies and Hospira will determine mutually acceptable dates for the audit. Any
auditors that are not employees of Theratechnologies shall be required to enter into
confidentiality agreements with Hospira and Theratechnologies containing terms of non-disclosure
and non-use at least as stringent as those set forth in Article 10. Auditors shall abide by
Hospiras visitor policies. Hospira shall have the right to protect the confidential information of
its other clients and products and to limit the audit to such areas of the production facility that
are relevant to the Product.
Theratechnologies
Hospira Diluent Agreement
Page 5 of 22
(c) An exit meeting will be held with representatives from Hospira and Theratechnologies.
(d) The auditors shall issue a written report of findings within [Redacted: Term] of the
audit. Theratechnologies shall provide to Hospira a written report of findings as soon as possible,
or within [Redacted: Term] after conclusion of audit. Hospira shall promptly address the audit
findings, but in no event later than [Redacted: Term] of receiving the report.
Article 5. Orders And Forecasts
5.1 Rolling Forecasts. No later than [Redacted: Term] after NDA Acceptance,
Theratechnologies shall provide to Hospira an [Redacted: Term] forecast of its requirements of the
Products (Rolling Forecast) for the [Redacted: Term] period immediately thereafter. Each Rolling
Forecast shall be updated on a [Redacted: Term] basis. The [Redacted: Term] of each Rolling
Forecast shall be considered a binding commitment upon Theratechnologies to purchase quantities
described therein and a binding commitment upon Hospira to produce and deliver such quantities on
the delivery dates described therein (Firm Order). Upon submission of each such forecast to
Hospira, Theratechnologies shall furnish Hospira with a binding purchase order to purchase such
quantities of Products as are set forth in the forecast for the most recent [Redacted: Term]. The
[Redacted: Term] of each Rolling Forecast shall be non-binding upon the parties.
5.2 Firm Orders. Each Firm Order shall specify the quantity of Products to be purchased,
shipping dates and any other relevant information; provided, however, that no shipping date shall
be less than [Redacted: Term] from the date of Hospiras receipt of such Firm Order. Subject to the
previous sentence, Hospira shall supply Products within the time frame requested by
Theratechnologies in its Firm Orders.
5.3 Firm Order Acceptance. Within [Redacted: Term] after receipt of a Firm Order issued in
accordance with Section 5.2, Hospira shall confirm to Theratechnologies its acceptance of
the purchase order, delivery date(s) and quantity of Products ordered by Theratechnologies. Hospira
may not reject a Firm Order if it is issued in accordance with Section 5.2. Hospira shall
not be obligated to, but shall at all times use commercially reasonable efforts to meet the
delivery dates where the Firm Order is not issued in accordance with Section 5.2.
5.4 Additional Quantities. Hospira shall supply Theratechnologies up to [Redacted: Quantity]
more Product (rounded up to the next full batch size of [Redacted: Quantity] units of Product) than
previously ordered in the Firm Order period if requested by Theratechnologies. Hospira shall not be
obligated to deliver additional quantities over and above the [Redacted: Quantity] excess, but
shall use all reasonable commercial efforts to produce and deliver to Theratechnologies such
additional quantities within [Redacted: Term] of issuance of the Firm Order.
5.5 Firm Order Changes or Cancellations. If, due to unforeseen circumstances,
Theratechnologies requests changes to Firm Orders of Products within the Firm Order period, Hospira
shall use reasonable commercial efforts to accommodate the changes, other than as
Theratechnologies
Hospira Diluent Agreement
Page 6 of 22
specified in
Section 5.4, within reasonable manufacturing capabilities and efficiencies. If Hospira can
accommodate such change, Hospira shall advise Theratechnologies of the costs, if any, associated
with making any such change and Theratechnologies shall be deemed to have accepted the obligation
to pay Hospira for such costs if Theratechnologies indicates in writing to Hospira that Hospira
should proceed to make the change. If Hospira cannot accommodate such change, Theratechnologies
shall be bound to the original Firm Order. If Theratechnologies cancels a Firm Order, [Redacted:
Payment Obligations].
5.6 Purchase Order Terms. Each purchase order or any acknowledgment thereof, whether printed,
stamped, typed, or written shall be governed by the terms of this Agreement and none of the
provisions of such purchase order or acknowledgment shall be applicable except those specifying
Product and quantity ordered, delivery dates, special shipping instructions and invoice
information.
5.7 Minimum Purchase Requirement. [Redacted: Term] of this Agreement, Theratechnologies shall
purchase a minimum of [Redacted: Quantity] batches of Product (Minimum Purchase Requirement)
after Regulatory Approval. If Regulatory Approval is obtained after [Redacted: Date] in any
calendar year, then the Minimum Purchase Requirement shall be applied to the [Redacted: Term]. For
purposes of this Section 5.7, a batch size shall be [Redacted: Quantity] units of Product.
In lieu of Theratechnologies taking delivery of each Minimum Purchase Requirement of Product,
Theratechnologies shall have the option to pay an amount equal to [Redacted: Amount] of that
portion of its Minimum Purchase Requirement it has not or will not meet, at the prices set forth in
Exhibit 4.4 and waive Hospiras manufacture and delivery obligations for the unmet Minimum
Purchase Requirement. In the latter event, Hospira shall invoice Theratechnologies for the amount
payable, and Theratechnologies shall pay Hospira within [Redacted: Term] after receipt of Hospiras
invoice.
Article
6. Product Complaints; Recalls
6.1 Notification of Complaints. Theratechnologies shall notify Hospira promptly of any
Product complaints involving Hospiras manufacture or packaging of the Product in sufficient time
to allow Hospira to evaluate the complaints and assist Theratechnologies in responding to such
complaints. Hospira shall investigate Product complaints according to Hospira procedures. Hospira
shall inform Theratechnologies forthwith about any notice received by a Regulatory Authority that
would potentially hinder or prevent Hospira from manufacturing or delivering the Product to
Theratechnologies according to this Agreement.
6.2
Product Recalls. In the event: (a) any Regulatory Authority or other national government
authority issues a request, directive or order that the Product be recalled; (b) a court of
competent jurisdiction orders such a recall; or (c) Theratechnologies or Hospira reasonably
determines that the Product should be recalled, the parties shall take all appropriate corrective
actions, and shall cooperate in any governmental investigations surrounding the recall.
In the
event that such recall results from [Redacted: Description of Obligation] of this Agreement,
Hospira shall be responsible for promptly replacing the quantity of Products that were recalled at
no cost to Theratechnologies or reimbursing Theratechnologies for the cost of the Products that
were recalled. In addition, Hospira shall be responsible for all administrative expenses of the
recall.
Theratechnologies
Hospira Diluent Agreement
Page 7 of 22
In the event that the recall does not result from [Redacted: Description of Obligation]
this Agreement, Theratechnologies shall be responsible for the expenses of the recall. For purposes
of this Agreement, [Description of Expenses].
Article 7. Warranties; Covenants and Indemnification
7.1 Theratechnologiess Warranties.
(a) Theratechnologies represents and warrants that it will abide by all applicable laws and
regulations in performing its obligations under this Agreement.
(b) Theratechnologies also represents and warrants to Hospira that Theratechnologiess
performance of its obligations under this Agreement will not result in a material violation or
breach of any agreement, contract, commitment or obligation to which Theratechnologies is a party
or by which it is bound and will not conflict with or constitute a default under its corporate
charter or bylaws.
(c) Theratechnologies further represents and warrants that it will only sell the Product in
the United States and only in conjunction with its Tesamorelin product.
7.2 Hospiras Warranties and Covenants.
(a) Hospira represents and warrants to Theratechnologies that the Product Hospira delivers to
Theratechnologies pursuant to this Agreement shall, at the time of delivery, not be adulterated or
misbranded within the meaning of the Federal Food, Drug and Cosmetic Act, as amended (the Act),
or within the meaning of any applicable state or municipal law in which the definitions of
adulteration and misbranding are substantially the same as those contained in the Act, as the Act
and such laws are constituted and effective at the time of delivery and will not be an article
which may not under the provisions of Sections 404 and 505 of the Act be introduced into interstate
commerce.
(b) Hospira further represents and warrants to Theratechnologies that Product Hospira delivers
to Theratechnologies pursuant to this Agreement shall, at the time of delivery, be free from
defects in material and workmanship and shall be manufactured: (i) in accordance and conformity
with the Product Specifications; and (ii) in compliance with all applicable statutes, laws, rules
or regulations, including those relating to the environment, food or drugs and occupational health
and safety, including, without limitation, those enforced or promulgated by the FDA (including,
without limitation, compliance with cGMPs).
(c) Hospira further represents and warrants to Theratechnologies that Hospiras performance of
its obligations under this Agreement will not result in a material violation or breach of any
agreement, contract, commitment or obligation to which Hospira is a party or by which it is
bound and will not conflict with or constitute a default under its Certificate of Incorporation or
corporate bylaws.
Theratechnologies
Hospira Diluent Agreement
Page 8 of 22
(d) HOSPIRA MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO PRODUCT.
ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY DISCLAIMED BY HOSPIRA.
7.3 Indemnification by Hospira. Hospira shall indemnify and hold harmless
Theratechnologies, its Affiliates, officers, directors and employees from and against all claims,
causes of action, suits, costs and expenses (including reasonable attorneys fees), losses or
liabilities of any kind related to this Agreement and asserted by third parties to the extent such
arise out of or are attributable to: (a) Hospiras breach of any representation or warranty set
forth in [Redacted: Description of Breach] ; (b) any violation of any proprietary right of any
Third Party relating to Hospiras manufacturing processes used in the manufacture of Product
pursuant to this Agreement; or (c) any negligent or wrongful act or omission on the part of
Hospira, its employees, agents or representatives and which relate to Hospiras performance
hereunder.
7.4 Indemnification by Theratechnologies. Theratechnologies shall indemnify and hold harmless
Hospira, its Affiliates, officers, directors and employees harmless from and against all claims,
causes of action, suits, costs and expenses (including reasonable attorneys fees), losses or
liabilities of any kind related to this Agreement and asserted by third parties to the extent such
arise out of or are attributable to: (a) Theratechnologiess breach of any representation or
warranty set forth in [Redacted: Description of Breach] (b) the use of or lack of safety or
efficacy of Tesamorelin (unless caused by the Product); or (c) any negligent or wrongful act or
omission on the part of Theratechnologies, its employees, agents or representatives and which
relate to Theratechnologiess performance hereunder.
7.5 Conditions of Indemnification. If either party seeks indemnification from the other
hereunder, it shall promptly give notice to the other party of any such claim or suit threatened,
made or filed against it which forms the basis for such claim of indemnification and shall
cooperate fully with the other party in the investigation and defense of all such claims or suits.
The indemnifying party shall have the option to assume the other partys defense in any such claim
or suit with counsel reasonably satisfactory to the other party. No settlement or compromise
[Redacted: Settlement Conditions].
Theratechnologies
Hospira Diluent Agreement
Page 9 of 22
7.6 No Consequential Damages. NEITHER PARTY SHALL BE LIABLE TO THE
OTHER FOR INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY OR
CONSEQUENTIAL DAMAGES RESULTING FROM ANY BREACH OF THIS AGREEMENT EVEN IF THE PARTY HAS
BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THIS LIMITATION ON LIABILITY SHALL NOT APPLY TO
ANY DAMAGES OR CLAIMS FOR WHICH EITHER PARTY IS OBLIGATED TO INDEMNIFY THE OTHER PARTY PURSUANT TO
THIS ARTICLE 7.
Article
8. Intellectual Property Rights
8.1 Hospiras Proprietary Rights. Hospira has granted no license, express or implied, to
Theratechnologies to use Hospira proprietary technology, know-how or other proprietary rights other
than for the purposes of this Agreement.
8.2 Theratechnologiess Proprietary Rights. Theratechnologies has granted no license, express
or implied, to Hospira to use Theratechnologiess proprietary technology, know-how or other
proprietary rights.
Article 9. Term And Termination
9.1 Term. This Agreement shall commence on the Effective Date and, unless earlier
terminated as provided below, shall expire [Redacted: Term] years after the Effective Date (the
Initial Term). Unless otherwise terminated in accordance with this Article 9, this
Agreement shall be automatically extended for additional and successive terms of [Redacted: Term]
each (each, a Renewal Term) unless either party gives the other party no less than [Redacted:
Term] written notice of its
intention not to renew prior to the expiry of the Initial Term. During any Renewal Term,
either party may give notice of its intention not to renew the current Renewal Term by providing
the other party with no less than [Redacted: Term] written notice of its intention not to renew
prior to the expiry of the relevant Renewal Term.
9.2 Failure to Obtain Regulatory Approval. Either party may terminate this Agreement by giving
to the other party [Redacted: Term] prior written notice if Tesamorelin has not received FDA
regulatory approval by [Redacted: Date].
9.3 General Termination Rights. Either party may terminate this Agreement as follows:
(a) Immediately by providing written notice upon the bankruptcy or the insolvency of the other
party; or
(b) Upon the expiry of [Redacted: Term] prior written notice given by a party upon the breach
of any warranty or any other material provision of this Agreement by the other party if the breach
is not cured within that [Redacted: Term] period.
Theratechnologies
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9.4 Hospira Termination. If, in any [Redacted: Term], Theratechnologies waives Hospiras
manufacturing and delivery obligations pursuant to Section 5.7, Hospira may terminate this
Agreement upon [Redacted: Term] prior written notice to Theratechnologies.
9.5 Theratechnologies Termination.
(a) Theratechnologies shall have the right to terminate this Agreement by giving [Redacted:
Term], prior written notice to Hospira if such notice is given prior to its obtaining Regulatory
Approval together with payment of [Redacted: Amount], provided, however, that such amount shall be
payable only if Theratechnologies has not purchased at least [Redacted: Quantity] batch of Product
prior to its obtaining Regulatory Approval. In the [Redacted: Name] and Hospira enter into a
commercial Development and Supply Agreement [Redacted: Purpose of Agreement].
(b) Additionally, Theratechnologies shall have the right to terminate this Agreement upon
[Redacted: Term] prior written notice to Hospira in the event that Theratechnologies is required
definitively to remove Tesamorelin from the United States market pursuant to an order issued by the
FDA.
9.6 Mutual Termination. Either party shall have the right to terminate this Agreement
[Redacted: Description of Cause] ; provided, however, that the party wishing to terminate gives the
other party no less than [Redacted: Term] prior written notice during the Initial Term and
[Redacted: Term] prior written notice during any Renewal Term.
9.7 Accrued Payment Obligations. Upon termination pursuant to this Article 9, except
by reason of breach by Hospira, Theratechnologies shall reimburse Hospira for Hospiras cost of all
supplies purchased and on hand or on order, if such supplies were ordered by Hospira based on firm
purchase orders or Theratechnologiess estimates of its requirements of Product, and such supplies
cannot be reasonably used by Hospira for other purposes. Hospira shall invoice Theratechnologies
for all amounts due hereunder. Payment shall be made pursuant to Section 4.5(b).
9.8 Survival. Expiration or early termination of this Agreement shall not relieve either party
of any obligations that it may have incurred prior to expiration or early termination in
particular those covenants and agreements contained in Articles 4 (excluding Section
4.1), 6, 7 and 11, which will continue in full force and effect for a period of
[Redacted: Term] unless a different time period is indicated in this Agreement.
Article 10. Confidential Information
10.1 Nondisclosure. It is contemplated that in the course of the performance of this Agreement
each party may, from time to time, disclose Confidential Information to the other. Hospira agrees
that, except as expressly provided herein, it shall not disclose Confidential Information received
from Theratechnologies, and shall not use Confidential Information disclosed to it by
Theratechnologies, for any purpose other than to fulfill Hospiras obligations hereunder.
Theratechnologies agrees that, except as expressly provided herein, it shall not disclose
Theratechnologies
Hospira Diluent Agreement
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Confidential Information received from Hospira, and shall not use Confidential Information
disclosed to it by Hospira, for any purpose other than to fulfill Theratechnologiess obligations
hereunder.
10.2 Exceptions to Duty of Nondisclosure. Notwithstanding the above, nothing contained in this
Agreement shall preclude Theratechnologies from utilizing Confidential Information as may be
necessary to obtaining governmental marketing approvals pursuant to the terms and conditions of
this Agreement, or for either party to comply with applicable governmental laws and regulations or
court orders (provided that the party disclosing such information uses reasonable efforts to seek
confidential treatment of such information, except as required to file and prosecute such patent
applications). The obligations of the parties relating to Confidential Information shall survive
for a period of [Redacted: Term] after the expiry or earlier termination of this Agreement.
10.3 Public Announcements. Neither party shall make any public announcement concerning the
transactions contemplated herein, or make any public statement which includes the name of the other
party or any of its Affiliates, or otherwise use the name of the other party or any of its
Affiliates in any public statement or document, except as may be required by law or judicial order,
without the written consent of the other party, which consent shall not be unreasonably withheld.
Subject to any legal or judicial disclosure obligation, any such public announcement proposed by a
party that names the other party shall first be provided in draft to the other party. Hospira
acknowledges that Theratechnologies is a publicly traded company with continuous disclosure
obligations. Accordingly, Theratechnologies may have to disclose in a press release, a material
change report, its financial statements and its other continuous disclosure documents the execution
of this agreement and the material terms thereof. In addition, Hospira acknowledges that
Theratechnologies may have to file this Agreement with the Canadian securities regulatory
authorities in order to fulfill its continuous disclosure obligations in Canada.
10.4 Injunctive Relief. The parties acknowledge that either partys breach of this Article
10 may cause the other party irreparable injury for which it would not have an adequate remedy
at law. In the event of a breach, the non-breaching party may be entitled to injunctive relief in
addition to any other remedies it may have at law or in equity.
Article 11. Miscellaneous
11.1 Force Majeure.
(a) Excusable Delay. Any delay in the performance of any of the duties or obligations of
either party hereto (except the payment of money) shall not be considered a breach of this
Agreement and the time required for performance shall be extended for a period equal to the period
of such delay, provided that such delay has been caused by or is the result of any acts of
[Redacted: Description of Events], or other unforeseeable causes beyond the control and without the
fault or negligence of the party so affected. The affected party shall give prompt notice to the
other party of such cause, and shall take promptly whatever reasonable steps are necessary to
relieve the effect of such cause.
Theratechnologies
Hospira Diluent Agreement
Page 12 of 22
(b) Transfer of Production. If Hospira becomes subject to an event of force majeure which
interferes with production of Product at Hospiras Rocky Mount, North Carolina facility, the
parties shall mutually agree on implementation of an agreed-upon action plan to transfer production
of Product to another Hospira facility. The parties shall, after the execution of this Agreement
and at the request of either party, meet to discuss and define such an action plan.
11.2 Notices. All notices hereunder shall be delivered as follows: (a) personally; (b) by
facsimile and confirmed by first class mail (postage prepaid); (c) by registered or certified mail
(postage prepaid);
or (d) by overnight courier service, to the following addresses
of the respective parties:
If
to Theratechnologies:
2310 Alfred-Nobel Boulevard
Montreal, PQ
H4 2A4 Canada
Attention: Vice President
Pharmaceutical Development
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Facsimile: (514) 331-7321 |
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If to Hospira:
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With copy to: |
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Hospira Worldwide, Inc.
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Hospira Worldwide, Inc. |
275
North. Field Drive
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Building H1; Department NLEG |
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275 N. Field Drive |
Attention General Manager, Contract
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Lake Forest, IL 60045 |
Manufacturing
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Attention: General Counsel |
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Facsimile: (224) 212-3210
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Facsimile: (224) 212-2086 |
Notices shall be effective upon receipt if personally delivered or delivered by facsimile and
confirmed by first class mail, on the third business day following the date of registered or
certified mailing or on the first business day following the date of or delivery to the overnight
courier. A party may change its address listed above by written notice to the other party.
11.3 Choice of Law. This Agreement shall be construed, interpreted and governed by the laws of
the State of New York, excluding its choice of law provisions. The United Nations Convention on the
International Sale of Goods is hereby expressly excluded.
11.4 Alternative Dispute Resolution. The parties recognize that bona fide disputes may arise
which relate to the parties rights and obligations under this Agreement. The parties agree that,
except as provided in Section 4.6 and for Third Party claims for which a party has a claim
under this Agreement, all such disputes resulting from or arising under this Agreement shall be
resolved by alternative dispute resolution in accordance with the procedure set forth in
Exhibit 11.4. Notwithstanding the foregoing, nothing in this Agreement shall prevent either
party from
Theratechnologies
Hospira Diluent Agreement
Page 13 of 22
bringing proceedings in a court of competent jurisdiction in order to obtain a
preliminary injunction or other equitable relief or to enforce an award of the tribunal constituted
pursuant to this Section 11.4.
11.5 Assignment. Neither party shall assign this Agreement nor any part thereof without the
prior written consent of the other party; provided, however: (a) either party may assign this
Agreement to one of its wholly-owned subsidiaries or its parent corporation without such consent;
and (b) either party, without such consent, may assign this Agreement in connection with the
transfer, sale or divestiture of substantially all of its business to which this Agreement pertains
or in the event of its merger or consolidation with another company. Notwithstanding the foregoing,
Theratechnologies, without such consent, shall have the right to assign this Agreement to
[Redacted: Name]. Any permitted assignee shall assume all obligations of its assignor under this
Agreement. No assignment shall relieve any party of responsibility for the performance of any
accrued obligation which such party then has hereunder.
11.6 Entire Agreement. This Agreement, together with the Exhibits referenced and incorporated
herein, constitute the entire agreement between the parties concerning the subject matter hereof
and supersede all written or oral prior agreements or understandings with respect thereto.
11.7 Severability. This Agreement is subject to the restrictions, limitations, terms and
conditions of all applicable governmental regulations, approvals and clearances. If any term or
provision of this Agreement shall for any reason be held invalid, illegal or unenforceable in any
respect, such invalidity, illegality or unenforceability shall not affect any other term or
provision hereof, and this
Agreement shall be interpreted and construed as if such term or provision, to the extent the
same shall have been held to be invalid, illegal or unenforceable, had never been contained herein.
11.8 Waiver-Modification of Agreement. No waiver or modification of any of the terms of this
Agreement shall be valid unless in writing and signed by authorized representatives of both
parties. Failure by either party to enforce any such rights under this Agreement shall not be
construed as a waiver of such rights, nor shall a waiver by either party in one or more instances
be construed as constituting a continuing waiver or as a waiver in other instances.
11.9 Insurance. Hospira will procure and maintain, at its own expense, for the duration of the
Agreement, and for [Redacted: Term] thereafter if written on a claims made or occurrence reported
form, the types of insurance specified below with carriers rated [Redacted: Rating] with A. M. Best
or like rating agencies.
(a) Workers Compensation accordance with applicable statutory requirements and shall provide
a waiver of subrogation in favor of the other party;
(b) Commercial General Liability including premises operations, products & completed
operations, blanket contractual liability, personal injury and advertising injury including fire
legal liability for bodily injury and property damage in an amount not less than [Redacted: Amount]
and [Redacted: Amount] ; and
Theratechnologies
Hospira Diluent Agreement
Page 14 of 22
(c) Excess Liability, including products liability with a combined single limit in an
amount of not less than [Redacted: Amount] ;
Hospira may, at its option, satisfy, in whole or in part, its obligations under this
Section 11.9 through its self- insurance program.
11.10
Exhibits. All Exhibits referred to herein are hereby incorporated by reference.
11.11 Debarment Warranty. Hospira and Theratechnologies represent and warrant that neither
party uses nor will use in the future use
in any capacity the services of any person debarred under
Section (a) or (b) of 21 U.S.C. Section 335a.
REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK
SIGNATURE PAGE FOLLOWS
Theratechnologies Hospira Diluent Agreement
Page 15 of 22
In Witness Whereof, the parties intending to be bound by the terms and
conditions hereof have caused this Agreement to be signed by their duly authorized representatives
as of the date first above written.
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HOSPIRA WORLDWIDE, INC. |
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THERATECHNOLOGIES, INC |
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By: |
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(signed) Anthony Cacich |
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By: |
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(signed) Luc Tanguay |
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Name:
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Anthony Cacich
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Name:
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Luc Tanguay |
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Title:
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Vice President & General Manager,
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Title:
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Senior Executive Vice President and |
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Contract Manufacturing
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Chief Financial Officer |
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By: |
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(signed) Pierre Perazzelli |
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Name:
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Pierre Perazzelli |
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Title:
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Vice President, Pharmaceutical Development |
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Diluent Development and Supply Agreement- Redacted final
Theratechnologies Hospira Diluent Agreement
Page 16 of 22
Exhibit
1.7
Packaging Specifications
[Redacted: Packaging Specifications]
Exhibit 1.9
Product Specifications
[Redacted: Product Specifications]
Exhibit 2.1
Development of Bulk Packaging Container Activities
[Redacted: Description of Activities]
Exhibit 2.3
Hourly Rates
[Redacted: Rates]
Exhibit 4.5
Product Prices
[Redacted: Prices]
Exhibit 11.4
Alternative Dispute Resolution
[Redacted: Dispute Resolution]
ex-99.90
Exhibit 99.90
MANUFACTURING AND SUPPLY AGREEMENT
ENTERED INTO on the 11th day of March, 2009
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BETWEEN:
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Theratechnologies Inc., a company incorporated
pursuant to the laws of the Province of Quebec, having its head office
and principal place of business at 2310 Alfred-Nobel Boulevard, in the
City of Montreal, Province of Quebec, Canada, H4S 2B4 |
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(hereinafter referred to as Thera) |
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AND:
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Bachem Americas Inc., a company incorporated
pursuant to the laws of the State of California, having its head office
and principal place of business at 3132 Kashiwa Street, in the City of
Torrance, State of California, United States of America, 90505 |
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(hereinafter referred to as Americas) |
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AND:
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Bachem, Inc., a company incorporated pursuant to the
laws of the State of California, having its head office and principal
place of business at 3132 Kashiwa Street, in the City of Torrance, State
of California, United States of America, 90505 |
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(hereinafter referred to as Inc.) |
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(Americas and Inc. are hereinafter collectively referred to as Bachem) |
WHEREAS Thera is a biopharmaceutical company which specializes in the research and the development
of therapeutic peptides;
WHEREAS Bachem is a company which specializes in the manufacturing of therapeutic peptides;
WHEREAS on November 6, 2001, Peptix Inc., the manufacturing subsidiary of Thera, and Inc. entered
into a Collaborative Development and Manufacturing Agreement (hereinafter referred to as the
CDMA) pursuant to which Inc., jointly with Peptix, developed a large scale manufacturing process
for Theras proprietary peptide, TH9507 or tesamorelin (hereinafter referred to as the Active
Ingredient);
WHEREAS on November 29, 2006, Peptix ceased its activities and transferred all of its assets and
liabilities, including those pursuant to the CDMA, to Thera, its sole shareholder;
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Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
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Page 1 |
WHEREAS under the CDMA, the process for the manufacturing of [Redacted: Quantity] Lots (as
hereinafter defined) of Active Ingredient remains subject to validation;
WHEREAS during the term of the CDMA, the requirements for the Active Ingredient changed, and future
requirements are now more clearly defined as the commercial launch of a Finished Product (as
hereinafter defined) approaches; and
WHEREAS the parties now wish to terminate the CDMA and enter into a new agreement to define their
respective obligations with respect to the validation of the [Redacted: Quantity] manufacturing
process, and the development and validation of a manufacturing process for the production of
[Redacted: Quantity] Lots of Active Ingredient.
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the parties agree as follows:
ARTICLE 1
DEFINITIONS AND INTERPRETATION
1.1 |
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Definitions In this Agreement, unless the context clearly indicates to the
contrary, the following words shall have the meanings set out hereunder: |
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1.1.1 |
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[Redacted: Quantity] Lot Manufacturing Process shall mean the manufacturing
process which meets cGMPs and Applicable Laws for the production of a nominal
[Redacted: Quantity] Lots of Active Ingredient, developed pursuant to Article 3 of the
CDMA and the letter of agreement entered into on November 19, 2007 between Thera and
Bachem. For the purposes of this agreement, reference to a Lot of [Redacted: Quantity]
shall be interpreted to mean the yield of a Lot of [Redacted: Quantity] which may be
less or more than [Redacted: Quantity]. |
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1.1.2 |
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Acquisition of Control of Thera shall mean the acquisition (whether by
take-over bid, share exchange, amalgamation, merger, plan of arrangement,
reorganization or subscription of securities) of voting securities of Thera by a
Person, whether acting alone or jointly or in concert with other Persons, resulting in
his holding of more than fifty percent (50%) of Theras voting securities, or the sale,
lease, licensing, transfer or disposal (whether voluntary or involuntary) of all, or
substantially all, of the assets of Thera to a Person. For the purposes of this
definition, it is a question of fact as to whether a Person is acting jointly or in
concert with an other Person but a Person who, pursuant to an agreement, commitment or
understanding, whether formal or informal, acquires securities of Thera or who intends
to exercise the voting rights attached to the securities of Thera in concert with an
other Person shall be presumed to be acting jointly or in concert with such other
Person. |
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Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
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Page 2 |
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1.1.3 |
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Active Ingredient shall mean the growth hormone-releasing factor analogue
peptide developed by Thera, tesamorelin acetate, scientifically referred to as
[Redacted: Chemical Formula]. |
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1.1.4 |
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Affiliate shall mean a Person directly or indirectly controlling, or
controlled by, or under common control with an other Person, with control meaning
direct or indirect ownership of more than 50% of the voting securities or similar
rights of interests of such Person or the power, direct or indirect, to cause or direct
the management or policies of an other Person. |
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1.1.5 |
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Agreement shall mean this manufacturing and supply agreement together with
the Quality Agreement. |
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1.1.6 |
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Applicable Laws shall mean all laws, statutes, ordinances codes, rules,
regulations, guidelines and procedures which have been enacted by Regulatory
Authorities and are in effect during the Term hereof in each case to the extent
applicable to the performance by the parties of their respective obligations hereunder
or otherwise to the subject matter of this Agreement. |
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1.1.7 |
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Bachem Know-How shall mean all of the manufacturing information, analytical
methods and validation, technical information, know-how and inventions, patentable and
non-patentable, relating to the manufacturing of molecules and developed by Bachem. For
the avoidance of doubt, Bachem Know-How does not include any element of the Thera
Know-How. |
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1.1.8 |
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Breaching Party shall have the meaning ascribed thereto in Section 13.2
hereof. |
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1.1.9 |
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cGMPs shall mean current Good Manufacturing Practices, as required for
active pharmaceutical ingredients in accordance with the U.S. FDA guidance for industry
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, as the
same may be amended or re-enacted from time to time, and all equivalent guidelines and
regulations as promulgated by the Regulatory Authorities. |
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1.1.10 |
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Calendar Year shall mean the period beginning on January 1st of one year
and ending on December 31st of that same year. |
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1.1.11 |
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CDMA shall have the meaning ascribed thereto in the preamble of this Agreement. |
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1.1.12 |
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Certificate of Analysis and Conformity shall mean the certificate of analysis
confirming the identity, quality and purity of a Lot of Active Ingredient to which it
pertains together with the certificate of conformity confirming that the same Lot of
Active Ingredient was manufactured, tested, stored and supplied in compliance with
cGMPs and Applicable Laws, each such certificate signed by an authorized employee of
Bachem. |
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Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
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Page 3 |
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1.1.13 |
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Confidential Information shall mean all data and information in oral, written,
graphic, photographic, electronic, recorded or other form hereafter disclosed by either
party (the Disclosing Party) to the other party (the Recipient) during the term of
the CDMA and during the Term of this Agreement, including the Drug Master File,
business plans, regulatory and product strategies and the Know-How, except for (i)
information which, at the time of disclosure, is, or thereafter becomes, public
knowledge through no breach of this Agreement, (ii) documented information which is
rightfully in the Recipients possession prior to the date of the CDMA; (iii)
information which is disclosed to the Recipient by a Person (other than the Disclosing
Party) which is rightfully in possession of same and is not bound by confidentiality
provisions, (iv) information which is disclosed with the prior written approval of the
Disclosing Party; (v) information which is independently developed by Recipient without
benefit of the Confidential Information as evidenced by written records or (vi)
information which the Recipient is required under any Applicable Laws or legal process
to disclose to any competent judicial or Regulatory Authority; provided, however, that
in the event that a disclosure is required under (vi), the Recipient has complied with
the terms of Section 10.6. |
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1.1.14 |
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Disclosing Party shall have the meaning ascribed thereto in Subsection 1.1.13
hereof. |
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1.1.15 |
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Drug Master File shall mean all the documentation detailing information about
facilities, processes or articles used in the manufacturing, processing, packaging and
storing of the Active Ingredient, including the analytical test methods for the Active
Ingredient. |
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1.1.16 |
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EMEA shall mean the European Medicine Evaluation Agency or any successor entity
thereto. |
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1.1.17 |
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Executed Batch Record shall mean the record prepared from the approved Master Batch
Record, containing complete information relating to the production and control of a
Lot. |
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1.1.18 |
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FDA shall mean the United States Food and Drug Administration or any successor
entity thereto. |
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1.1.19 |
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Finished Product shall mean a product based on, or containing, the Active
Ingredient and that is approved by a Regulatory Authority. |
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1.1.20 |
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Firm Order shall have the meaning ascribed thereto in Section 7.6. |
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1.1.21 |
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Gram or g shall mean a gram of net peptide content. For the purposes of this
definition, net peptide content shall mean the peptide content obtained using the
elemental analysis method, or any other method mutually agreed to between the parties
hereto. |
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1.1.22 |
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Indemnified Party shall have the meaning ascribed thereto in Section
12.3 hereof. |
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Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
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Page 4 |
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1.1.23 |
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Indemnifying Party shall have the meaning ascribed thereto in Section 12.3 hereof. |
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1.1.24 |
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Liabilities shall have the meaning ascribed thereto in Section 12.1 hereof. |
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1.1.25 |
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Lot shall mean a specific quantity of Active Ingredient produced pursuant to the
[Redacted: Quantity] Lot Manufacturing Process or the [Redacted: Quantity] Lot
Manufacturing Process. |
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1.1.26 |
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Manufacturing Cost shall mean the cost of manufacturing the Active Ingredient. It
shall be comprised of the following items: [Redacted: Items]. |
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1.1.27 |
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Manufacturing Processes shall mean the [Redacted: Quantity] Lot Manufacturing
Process and the [Redacted: Quantity] Lot Manufacturing Process. |
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1.1.28 |
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Master Batch Record shall mean the document containing formulas and manufacturing
process for the Active Ingredient. |
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1.1.29 |
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Minimum Purchase Obligation shall have the meaning ascribed thereto in Section 7.2. |
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1.1.30 |
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mmole shall mean millimole. |
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1.1.31 |
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Non-Breaching Party shall have the meaning ascribed thereto in Section 13.2 hereof. |
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1.1.32 |
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Notice shall have the meaning ascribed thereto in Section 15.1 hereof. |
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1.1.33 |
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[Redacted: Quantity] Lot Manufacturing Process shall mean the manufacturing process
which meets cGMPs and Applicable Laws for the production of a nominal [Redacted:
Quantity] Lot of Active Ingredient, developed pursuant to Section 4.2 hereof. For the
purposes of this Agreement, reference to a Lot of [Redacted: Quantity] or [Redacted:
Quantity] shall be interpreted to mean the yield of a Lot of [Redacted: Quantity] which
may be less or more than [Redacted: Quantity]. |
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1.1.34 |
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Permitted Assignee shall mean a Person to whom this Agreement, together with the
Quality Agreement, is assigned by Thera pursuant to Section 18.6. |
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1.1.35 |
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Person shall mean an individual, a body corporate, a sole proprietorship, a
partnership, a trust, a fund, an association, a syndicate, an organization or other
organized group of persons, whether constituted or not as a legal person, or whether
incorporated or not, and an individual or other person in that persons capacity as a
trustee, executor, administrator or personal or other legal representative, and any
Regulatory Authority. |
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1.1.36 |
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Purchase shall mean the issuance by Thera of a purchase order for the manufacture
of one or more Lots of Active Ingredient, the acceptance |
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Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
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Page 5 |
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thereof by Bachem and the release by Bachem of the Active Ingredient referred to in such purchase order. |
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1.1.37 |
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Qualification Batch shall mean a Lot of Active Ingredient that meets Specifications
and is manufactured following a work plan and in compliance with cGMPs and Applicable
Laws to assess the critical parameters and test the proper functioning of a
manufacturing process. |
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1.1.38 |
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Quality Agreement shall mean the Quality Agreement attached hereto as Schedule 1.1.38. |
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1.1.39 |
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Quarter shall mean a three-month period starting on the first day of each of
January, April, July and October. |
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1.1.40 |
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Recipient shall have the meaning ascribed thereto in Subsection 1.1.13 hereof. |
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1.1.41 |
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Regulatory Authorities shall mean the FDA, the TPD and the EMEA and any other
regulatory authority having jurisdiction over the manufacture, packaging, marketing,
sale and distribution of the Active Ingredient. |
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1.1.42 |
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Related Party shall mean any Person who (i) owns 10% or more of the outstanding
shares of Thera or (ii) is a subsidiary of Thera or (iii) is the partner of Thera in a
strategic alliance or licensing deal to develop and/or commercialize a product
containing the Active Ingredient. |
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1.1.43 |
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Specifications shall mean those specifications set forth in Schedule 1.1.43A and
Schedule 1.1.43B attached hereto, as may be modified from time to time by mutual
agreement of the parties hereto. |
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1.1.44 |
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Term shall mean the term of this Agreement as stipulated in Section 13.1 or any
shorter term if terminated prematurely for any reason. |
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1.1.45 |
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Theras Annual Requirement(s) shall mean the direct ordering by Thera of Active
Ingredient to fulfill its needs in Active Ingredient during a Calendar Year for the
sale by Thera of a Finished Product. |
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1.1.46 |
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Thera Know-How shall mean all of the manufacturing information, analytical methods
and validation, technical information, Master Batch Record, regulatory information,
know-how and inventions, patentable and non-patentable relating to the Manufacturing
Processes but shall exclude (i) information which is now in the public domain or
subsequently becomes such through no breach of this Agreement and then only from said
latter date or (ii) documented information which is rightfully in Bachems possession
prior to the date of the CDMA or subsequently independently developed by Bachem. |
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1.1.47 |
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Third-Party Contract Manufacturer shall mean a company marketing its contract
manufacturing capabilities and/or producing bulk active pharmaceutical ingredient. |
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Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
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Page 6 |
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1.1.48 |
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TPD shall mean the Therapeutic Products Directorate of Health Canada or any
successor entity thereto. |
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1.1.49 |
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Validation Lots shall have the meaning ascribed thereto in Section 5.3 hereof. |
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1.1.50 |
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Validation Process shall mean all activities related to process validation
including, but not limited to, In-Process HPLC Method Validation, manufacturing of
[Redacted: Quantity] Validation Lots and performing stability testing on each of the
[Redacted: Quantity] Validation Lots. |
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1.1.51 |
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Validation Process Costs shall have the meaning ascribed thereto in Section 5.4
hereof. |
1.2 |
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Interpretation This Agreement shall be governed by the following provisions: |
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1.2.1 |
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Should any provision of this Agreement be null or without effect or deemed
unwritten, it or they shall not render the other provisions, terms and conditions
hereof invalid as this Agreement is not an indivisible whole. |
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1.2.2 |
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The parties acknowledge that each provision of this Agreement was negotiated
in good faith, understood and for good and valuable consideration, agreed to by them
and that the agreement does not constitute an adhesion contract for it. |
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1.2.3 |
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Time shall be of the essence of this Agreement and every part thereof. |
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1.2.4 |
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The division of this Agreement into Articles, Sections, Subsections and other
subdivisions and the insertions of headings are for convenience of reference only and
shall not affect or be utilized in the construction or the interpretation hereof. |
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1.2.5 |
|
Where required herein, the singular shall comprise the plural and vice versa,
the masculine shall include the feminine and vice versa while the neuter shall comprise
both the masculine and the feminine. |
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1.2.6 |
|
This Agreement shall be governed by and construed in accordance with the laws
of the Province of Quebec and the laws of Canada applicable therein without giving
effect to the conflict of law principles thereof. Each party agrees to submit to the
non-exclusive jurisdiction of the courts of the Province of Quebec with respect to any
matter arising in relation to this Agreement. |
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1.2.7 |
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The schedules annexed to this Agreement are incorporated by reference herein
and form a part hereof. |
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1.2.8 |
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Unless otherwise indicated herein, all references to dollars in this Agreement
shall be to United States dollars. |
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Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated March 11, 2009
|
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Page 7 |
ARTICLE 2
TERMINATION OF CDMA
2.1 |
|
The parties hereby terminate the CDMA, as of the date hereof, which shall thereafter become
void and without effect, except for the obligations described in Section 11.4 of the CDMA and
those listed in Schedule 2.1 hereto which shall survive its termination. |
2.2 |
|
The parties acknowledge and agree that the large scale manufacturing process that was
developed pursuant to Article 3 of the CDMA was for batches of [Redacted: Quantity] and not
for [Redacted: Quantity] batches, as it was initially provided for in the CDMA, and that such
process is referred to in this Agreement as the [Redacted: Quantity] Lot Manufacturing
Process. |
2.3 |
|
Neither party shall have any liability or obligation towards the other in respect of the
termination of the CDMA, other than as described in Section 2.1 herein. |
ARTICLE 3
[REDACTED: QUANTITY] LOT MANUFACTURING PROCESS
VALIDATION
3.1 |
|
The parties acknowledge that the [Redacted: Quantity] Lot Manufacturing Process has not been
validated under the CDMA and is currently under validation. |
3.2 |
|
Bachem agrees to validate the [Redacted: Quantity] Lot Manufacturing Process ([Redacted:
Quantity]) and shall, in cooperation with Thera, obtain the approvals of the Regulatory
Authorities in relation thereto. |
3.3 |
|
Bachem shall be responsible for the work in relation to the validation of the [Redacted:
Quantity] Lot Manufacturing Process and shall carry out such work at its facilities in
Torrance, California. The cost associated with such work is covered by the purchase order
number [Redacted: Number] described in Schedule 2.1 hereto. |
3.4 |
|
As part of the validation of the [Redacted: Quantity] Lot Manufacturing Process, Bachem shall
manufacture [Redacted: Quantity] Lots of Active Ingredient, each comprised of [Redacted:
Quantity] of Active Ingredient and each meeting the Specifications as defined in Schedule
1.1.43B. Such [Redacted: Quantity] Lots shall be delivered to Thera before [Redacted: Date].
Article 7 of this Agreement shall apply to the manufacturing, analysis, delivery and payment
of such Lots unless otherwise provided for herein. |
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Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
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Page 8 |
ARTICLE 4
[REDACTED: QUANTITY] LOT MANUFACTURING PROCESS
4.1 |
|
Upon written request from Thera and provision of a valid purchase order as described in
Schedule 4.2 (Sections 1, 2, 3, and 5), Bachem shall develop and modify the [Redacted:
Quantity] Lot Manufacturing Process to a cGMP-compliant manufacturing process for the
production of Lots of [Redacted: Quantity] of Active Ingredient. |
4.2 |
|
The [Redacted: Quantity] Lot Manufacturing Process shall follow the draft work plan described
in Schedule 4.2 hereto and comply with the Specifications defined in Schedule 1.1.43A. |
4.3 |
|
The parties agree to use their commercial best efforts to finalize the draft work plan
described in Schedule 4.2 hereof within [Redacted: Term] from the date of execution of this
Agreement. |
4.4 |
|
The Manufacturing Processes and Thera Know-How shall be the sole and exclusive property of
Thera. However, during the Term of this Agreement, Thera agrees not to disclose information
relating to Bachem Know-How, without the prior written approval of Bachem, to a Third-Party
Contract Manufacturer, unless such Third-Party Contract Manufacturer is a Related Party, or to
disclose the information in any publication or public presentation. |
4.5 |
|
The [Redacted: Quantity] Lot Manufacturing Process shall be deemed completed (i) upon release
by Thera and Bachem of the Qualification Batch and (ii) upon successful completion of the
validation plan/protocol. If the Qualification Batch does not meet Specifications and/or no
validation plan/protocol can be derived from the results obtained following the execution of
the draft work plan described in Schedule 4.2, the [Redacted: Quantity] Lot Manufacturing
Process shall be deemed unsuccessful and Bachem shall continue working, developing and
optimizing the [Redacted: Quantity] Lot Manufacturing Process at no cost to Thera until a
Qualification Batch is released and the validation plan/protocol successfully completed. In
the event that Bachem is unable to successfully develop the [Redacted: Quantity] Manufacturing
Process, Bachem shall provide written notice of same to Thera and shall discontinue its
development efforts. Upon notification to Thera, all references to the [Redacted: Quantity]
Lot Manufacturing Process contained within this Agreement shall become null and void while all
other provisions of the Agreement shall remain in effect. |
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Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
|
Page 9 |
ARTICLE 5
[REDACTED: QUANTITY] LOT MANUFACTURING PROCESS VALIDATION
5.1 |
|
Validation of the [Redacted: Quantity] Lot Manufacturing Process may be initiated only after
the approval of the Qualification Batch and the approval of the plan/protocol as described in
Article 4. Upon written request from Thera and provision of a valid purchase order according
to the pricing listed in Schedule 4.2 (Section 4), Bachem shall validate the [Redacted:
Quantity] Lot Manufacturing Process and shall, in cooperation with Thera, obtain the approvals
of the Regulatory Authorities in relation thereto. Following the date of the successful
completion of the [Redacted: Quantity] Lot Manufacturing Process, the [Redacted: Quantity] Lot
Manufacturing Process shall be validated on the earlier of (i) a date that is within
[Redacted: Term] from the date of receipt by Bachem of a purchase order for the manufacture of
[Redacted: Quantity] Validation Lot and (ii) a date that is within [Redacted: Term] from the
date of Regulatory Approval of a Finished Product. For the avoidance of doubt, Thera shall
provide purchase orders as are necessary for Bachem to complete the Validation Process in
accordance with this timeline. |
5.2 |
|
Bachem shall be responsible for the work in relation to the Validation Process and shall
carry out such work at its facilities in Torrance, California. |
5.3 |
|
As part of the Validation Process, Bachem shall manufacture [Redacted: Quantity] Lots of
Active Ingredient, each comprised of [Redacted: Quantity] of Active Ingredient (the
Validation Lots). The first Validation Lot shall be delivered within [Redacted: Term] of the
date of a written purchase order issued by Thera with confirmed receipt by Bachem. Subsequent
Validation Lots shall be delivered as agreed between the parties. The [Redacted: Quantity]
Validation Lots shall be delivered within the time period described in Section 5.1. |
5.4 |
|
Thera shall pay Bachem for the Hex-GRF Process Development and Validation Process a total
amount of [Redacted: Amount] according to the work plan described in Schedule 4.2 hereto
(hereinafter referred to as Validation Process Costs). The Validation Process Costs and the
Validation Lots shall be payable upon the terms set forth in Section 7.15 hereunder. |
5.5 |
|
Both Bachem and Theras Quality Assurance Departments shall approve in writing the protocols
prior to commencement of the Validation Process. Sections 7.9 to 7.25 hereunder shall apply to
the manufacturing and delivery of the Validation Lots. |
5.6 |
|
If the Manufacturing Processes are not approved by the Regulatory Authorities and such
refusal is attributable to the work done by Bachem, Bachem shall have [Redacted: Term] to
correct all deficiencies, at its own costs, without any further payment by Thera. If the
Manufacturing Processes are still not approved after |
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Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
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Page 10 |
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|
such [Redacted: Term] period and the delay is attributable to Bachem, Thera shall have the right to terminate this Agreement upon a
[Redacted: Term] prior notice. |
|
5.7 |
|
The Drug Master File regarding the manufacturing of the Active Ingredient at Bachems
facilities shall be the sole and exclusive property of Bachem and shall be deemed Confidential
Information. The Drug Master File may not be sold, transferred, assigned or disclosed to a
Person unless Thera consents in writing to such sale, transfer, assignment or disclosure,
except as described in this Section. Prior to the expiry of US patent No. 5,861,379, as such
patent term may be extended by statute or regulation, Bachem shall not give permission to a
third party to refer to the Drug Master File, unless Bachem obtains the prior written consent
of Thera. Bachem shall provide Thera with a copy of the Drug Master File and shall file and
maintain such Drug Master File with the Regulatory Authorities free of charge, during the Term
of this Agreement. Bachem will authorize the Regulatory Authorities to review the Drug Master
File or other pertinent information in support of a product submission filed by Thera, a
successor thereof, a partner or a licensee containing the Active Ingredient. Bachem shall
respond to regulatory inquiries in compliance with the timelines presented by the Regulatory
Authorities. |
5.8 |
|
During the Term of this Agreement, Bachem shall be solely liable for, and shall save, defend,
indemnify and hold harmless Thera from and against any and all suits, claims, actions, awards,
demands, liabilities, expenses and/or losses resulting or arising out of non compliance by
Bachem of regulatory and environmental laws of the United States and any State thereof. |
ARTICLE 6
TRANSFER OF MANUFACTURING PROCESSES
6.1 |
|
Bachem shall transfer to Thera, from time to time and on a timely basis, all of Bachem
Know-How during the Term of this Agreement. |
6.2 |
|
Bachem shall provide Thera with a skilled supervisor to help replicate the Manufacturing
Processes, as validated, at Theras facilities and to train Theras employees to become
skilled in the Manufacturing Processes. |
6.3 |
|
Bachem shall provide such representatives at a charge of [Redacted: Rate] per eight-hour
workday per person, plus all reasonable travel and out-of-pocket expenses. Provision of
representatives shall be limited to two separate occasions of not more than two weeks per
occasion unless otherwise agreed in writing by the parties. |
6.4 |
|
During such transfer, Thera agrees to use the same suppliers as Bachem for solvents and
amino-acids derivatives and coupling reagents; provided, however, that such suppliers prices
are competitive in the market. Bachem shall not be held |
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Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
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Page 11 |
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|
responsible for any manufacturing
failures attributed to raw materials from suppliers which were not approved by Bachem. |
|
6.5 |
|
In the course of the replication of the Manufacturing Processes, Thera shall be solely liable
for, and shall save, defend, indemnify and hold harmless Bachem from and against any and all
suits, claims, actions, awards, demands, liabilities, expenses and/or losses resulting or
arising out of non compliance by Thera of regulatory and environmental laws of Canada and any
Province thereof that may ensue from said replication under this Article 6. |
ARTICLE 7
MANUFACTURING OF ACTIVE INGREDIENT
7.1 |
|
During the Term of this Agreement, Bachem and any Affiliate thereof shall manufacture and
sell the Active Ingredient exclusively to Thera and its Permitted Assignees, in accordance
with the Manufacturing Processes. In the event this Agreement is terminated prior to its Term,
neither Bachem nor any of its Affiliates shall, either alone or in collaboration with any
Person, until the expiry of US patent No. 5,861,379, as such patent term may be extended by
statute or regulation, engage in any activity directed to the process development,
manufacture, supply or commercialization of any product similar to, based on or derived from,
the Active Ingredient. |
7.2 |
|
Subject to the terms and conditions contained herein and subject to the successful completion
of the [Redacted: Quantity] Lot Manufacturing Process or the [Redacted: Quantity] Lot
Manufacturing Process, Thera shall Purchase from Bachem, during each Calendar Year, [Redacted:
Minimum Purchase Formula] (hereinafter the Minimum Purchase Obligation). The Active
Ingredient shall be purchased in Lots of [Redacted: Quantity] or [Redacted: Quantity].
Notwithstanding the foregoing, Thera shall have the right to purchase the Active Ingredient
from third party suppliers. Subject to the following sentence, lots of Active Ingredient
purchased from, and manufactured by, one such third party supplier for the purposes of
qualifying such third party supplier as a supplier of Active Ingredient will not be computed
for the purposes of determining Theras fulfillment of its Minimum Purchase Obligation for one
Calendar Year. Theras obligation to fulfill its Minimum Purchase Obligation will be suspended
in the Calendar Year during which one additional third party supplier will have completed the
validation of [Redacted: Quantity] lots of Active Ingredient if Thera Purchases from Bachem
during that Calendar Year at least [Redacted: Quantity] Lot of Active Ingredient. |
7.3 |
|
The price for the Active Ingredient manufactured in [Redacted: Quantity] Lots shall be based
on the prices described in Schedule 7.3 hereto. In the event that a particular lot yields more
than [Redacted: Quantity] net, Thera will have the right to purchase such quantity above the
targeted [Redacted: Quantity] net at a |
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Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
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Page 12 |
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|
price equal to [Redacted: Percentage] of the price set forth for such Lot in the purchase order used for the Purchase. |
|
7.4 |
|
The price for the Active Ingredient manufactured in Lots of [Redacted: Quantity] shall be
negotiated between the parties after the manufacture of the Qualification Batch and before the
issuance of a purchase order by Thera to Purchase the Validation Lots based on reasonable
commercial terms. If the parties do not agree on the selling price of Lots of [Redacted:
Quantity], Thera shall have no obligation to proceed with the Validation Process and the
Purchase of the Validation Lots. If there occur any disagreement between the parties on the
selling price of Lots of [Redacted: Quantity], the reference in Section 7.2 to [Redacted:
Quantity] shall be reduced to [Redacted: Quantity] . |
7.5 |
|
Notwithstanding Theras Minimum Purchase Obligation hereunder, if Theras Annual Requirements
for the Active Ingredient in any Calendar Year are lower than [Redacted: Quantity] , Thera
shall exclusively order such lower quantity of Active Ingredient from Bachem for any such
Calendar Year; provided, however, that Thera shall be under no such obligation if Bachem is in
breach of this Agreement, is unable to manufacture the Active Ingredient pursuant to the terms
hereof or the delivery date for an order takes longer than what is customary for Bachem. |
7.6 |
|
From the date of commercial launch of a Finished Product, Thera shall furnish Bachem, on the
[Redacted: Term], a rolling forecast of the quantities of Active Ingredient that Thera intends
to Purchase on [Redacted: Term] basis during a [Redacted: Term]. The quantities indicated in
such rolling forecast shall be binding on Thera for [Redacted: Term] and a purchase order
shall accompany the forecast (the Firm Order). The remaining quantities for the following
[Redacted: Term] shall not be binding on Thera and shall be used by Bachem for planning
purposes only. If the date of commercial launch of a Finished Product is a date that is not
the first day [Redacted: Term], the [Redacted: Term] of a Firm Order shall be comprised of (i)
that number of days remaining in the [Redacted: Term] during which the commercial launch
occurs and (ii) the [Redacted: Term]. For the avoidance of doubt, firm orders for [Redacted:
Term] shall be comprised of [Redacted: Term]. |
7.7 |
|
Thera shall place with Bachem written purchase orders for the Active Ingredient to be
delivered hereunder at least [Redacted: Term] prior to the delivery date specified in each
respective purchase order and shall request receipt confirmation by Bachem of the purchase
order within [Redacted: Term] of sending each purchase order. The minimum quantity ordered per
purchase order shall be [Redacted: Quantity] of the Active Ingredient. These purchase orders
shall be binding upon Thera provided Bachem accepts such purchase order and confirms in
writing the delivery date of the Active Ingredient ordered within [Redacted: Term] after its
receipt of a written purchase order. If Bachem does not confirm in writing acceptance of a
purchase order, does not confirm in writing the delivery |
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Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
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Page 13 |
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date or, if it confirms a delivery date and such delivery date is a date that is [Redacted: Term] after its receipt of a purchase
order, or if Bachem does not respond within [Redacted: Term] following a request from Thera
regarding the receipt of a purchase order, then the Firm Order shall no longer be binding on
Thera and the purchase order shall be deemed not accepted. Any quantity of Active Ingredient
purchased from an other supplier shall be computed for the purposes of determining Theras
fulfillment of its Minimum Purchase Obligation; provided however, [Redacted: Conditions].
Bachem shall use its best efforts to accommodate any reasonable requests by Thera to increase
the quantity of Active Ingredient being subject to a purchase order accepted by Bachem. |
|
7.8 |
|
Bachem shall remit to Thera and maintain an approved Master Batch Record prior to
manufacturing any commercial Lot. Modifications to the Master Batch Record shall be approved
by Thera and Bachem. |
|
7.9 |
|
Bachem shall maintain reserve samples of each lot of Active Ingredient sufficient to meet
regulatory requirements and guidelines. |
|
7.10 |
|
Bachem shall perform, or cause to be performed, sample tests on each Lot of Active Ingredient
manufactured pursuant to this Agreement before delivery to Thera. Each test report shall set
forth the items tested, Specifications and test results in the Certificate of Analysis and
Conformity (as defined in Section 1.1.12) for each Lot. Bachem shall send, or cause to be
sent, such Certificates of Analysis and Conformity, a complete Executed Master Batch Record
for each Lot manufactured and released and all other release documents to Thera prior to the
delivery of any manufactured Lot. |
|
7.11 |
|
Upon either partys discovery that a Lot of Active Ingredient, which has previously been
released by Bachem, does not conform to the Specifications, or that the release documentation,
including the Certificate of Analysis and Conformity and any Executed Batch Record, does not
comply with cGMPs or Applicable Laws, or does not contain the quantity of Active Ingredient
being subject to a purchase order accepted by Bachem, other than normal weighing variance as
per scale precision, the discovering party will immediately notify the other party of such
failure to meet the Specifications, the cGMPs or the Applicable Laws, or the shortage in
quantity, as the case may be, and of the nature of such failure or shortage in detail,
including, but not limited to, supplying the other with all investigatory reports, data, and
communications, out-of-specification reports and data and the results of all outside
laboratory testing and conclusions, if any. Bachem shall investigate all such failures
promptly and fully cooperate with Thera in determining the cause for the failure and a
corrective action to prevent future failures. Should the failure be due to shelf-life
expiration, no further action will be required of Bachem. Bachem agrees to [Redacted:
Suppliers Obligations]. However, should the parties disagree as to failure of a Lot to meet
Specifications, the parties shall name an independent third-party laboratory to test the Lot
and the decision of such laboratory shall be binding on |
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Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
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Page 14 |
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both parties. If the parties cannot agree on an independent third-party laboratory, each party shall appoint one independent
third-party laboratory and the two independent third-party laboratories shall appoint a third
independent third-party laboratory which shall test the Lot. The decision of such third
independent third-party laboratory shall be binding on both parties. The costs associated with
these activities shall be paid by the party at fault. The payment of the Lot subject to a
claim will be postponed until the claim has been resolved. |
|
7.12 |
|
Lots of Active Ingredient shall only be released once the Quality Assurance Department of
Bachem has confirmed that the Lots conform to Specifications and that the manufacturing of the
Lots complies with cGMPs and Applicable Laws. |
|
7.13 |
|
Bachem shall be responsible for taking quality control stability samples in support of the
regulatory filings for the Active Ingredient, testing stability samples on a timely basis, and
providing Thera with all reports and data generated therefrom. Upon learning of a stability
test failure, Bachem shall immediately notify Thera. After the commercial launch of a Finished
Product, Bachem shall implement a stability program following the guidelines published from
time to time by the International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use to test the stability of the Active Ingredient
in compliance with post-approval commitments made by Thera to the Regulatory Authorities. For
the avoidance of doubt, any stability testing required will be billed to Thera by Bachem with
agreement on pricing reached before initiation of the study. If the stability test failure
occurs within [Redacted: Term] of the date of manufacture of a Lot, Bachem shall immediately
initiate a stability failure investigation at Bachems expense and cooperate with Thera in
attempting to determine the cause for the failure and corrective action to prevent future
failures. |
|
7.14 |
|
Delivery terms for international deliveries in countries that are a party to the
North-American Free Trade Agreement shall be [Redacted: Delivery Terms] at the location
specified in writing by Thera. A certificate of origin (US) shall be supplied to Thera in
order to classify the Lots of Active Ingredient as part of the North-American Free Trade
Agreement. Delivery terms within the United States of America shall be [Redacted: Delivery
Terms] at the location specified in writing by Thera. The delivery terms in countries other
than those above-mentioned shall be mutually agreed upon by the parties prior to any delivery.
[Redacted: Allocation of Costs] |
|
7.15 |
|
Payment shall be made by cheque or by wire transfer to Bachem. The terms of payment shall be
net [Redacted: Term] following receipt by Thera of each of the Certificate of Analysis and
Conformity, the Executed Batch Record and an invoice for the Lots of Active Ingredient.
Invoices shall only be prepared by Bachem once the Lots have been released by Bachem. A copy
of the Executed Batch Record for each Lot of Active Ingredient being subject to a purchase
order |
|
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|
Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
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Page 15 |
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accepted by Bachem shall be provided to Thera within [Redacted: Term] of release of a
Lot. |
|
7.16 |
|
Bachem represents and warrants that each lot of Active Ingredient manufactured by Bachem and
sold to Thera pursuant to this Agreement will meet the Specifications for such Active
Ingredient in effect at the time title to such Active Ingredient passes from Bachem to Thera.
Thera may amend such Specifications from time to time only with the prior written consent of
Bachem, which consent shall not be unreasonably withheld. |
|
7.17 |
|
Bachem represents and warrants that it has sufficient manufacturing capacity to enable Thera
to fulfill, in each Calendar Year, Theras Minimum Purchase Obligation. |
|
7.18 |
|
Bachem represents and warrants that during the Term, its premises shall be maintained in
accordance with cGMPs and Applicable Laws as will allow Bachem to manufacture the Active
Ingredient pursuant to the terms of this Agreement. |
|
7.19 |
|
Bachem represents and warrants that all Active Ingredient will be manufactured in conformity
with the Manufacturing Processes, cGMPs and Applicable Laws. |
|
7.20 |
|
Bachem shall notify Thera immediately of any material deviations to the Manufacturing
Processes that require further investigation. The proposed deviation must be approved by Thera
prior to implementation unless it is physically impossible to do so. In such cases, the
deviation will be communicated to Thera prior to the release of a Lot. |
|
7.21 |
|
[Redacted: Name] shall be responsible for all costs associated with any recalls or market
withdrawals, whether voluntary or involuntary, of the Active Ingredient or any Finished
Product, provided however that [Redacted: Name] shall reimburse [Redacted: Name] for all costs
(including, without limitation, replacement costs for recalled or withdrawn Active Ingredient
or Finished Product and costs associated with notifying customers, shipment of recalled Active
Ingredient or Finished Product from customers and shipment of replacement Active Ingredient or
Finished Product to those customers) incurred in connection with any recalls associated with
(i) the failure of the Active Ingredient to meet Specifications, cGMPs or Applicable Laws,
(ii) defective manufacture, storage, handling, labeling or packaging by [Redacted: Name],
(iii) any breach by [Redacted: Name] of any representation, warranty or covenant contained in
this Agreement, or (iv) the willful misconduct or negligence of [Redacted: Name]. In the event
that fault for the failure which initiates the recall is split between [Redacted: Name], the
parties shall negotiate in good faith to allocate the costs of the recall according to the
allocation of fault. |
|
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|
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|
Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
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Page 16 |
7.22 |
|
Bachem shall maintain all manufacturing, packaging, analytical and stability records, all
records of shipment, and all validation data relating to the Active Ingredient to the extent
and for the time periods required by Applicable Laws with respect to the Active Ingredient. |
|
7.23 |
|
Bachem shall advise Thera promptly if an authorized agent of any Regulatory Authority visits
the facilities where the Active Ingredient is being manufactured, to conduct an inspection
concerning the Active Ingredient. Upon request, Bachem shall furnish to Thera all material
information supplied to, or supplied by, such Regulatory Authority. |
|
7.24 |
|
Within [Redacted: Term] of receipt thereof, Thera and Bachem shall send and
make available, or cause to be sent or made available, to each other, regulatory
correspondence directly related to the Active Ingredient or Finished Product (to the
extent directly related to the Active Ingredient) or any order, request or directive
of any court or Regulatory Authority concerning the withdrawal of Active Ingredient or
Finished Product (to the extent directly related to the Active Ingredient), and
correspondence bearing on the safety and efficacy of the Active Ingredient or Finished
Product (to the extent directly related to the Active Ingredient). Bachem shall
cooperate with Thera in the event of any recall or withdrawal of the Active Ingredient
or Finished Product and provide such reasonable assistance in connection therewith as
Thera may reasonably request. All other regulatory correspondence or order, request or
directive of any court or Regulatory Authority which could have a material adverse
effect on the manufacture of the Active Ingredient or the Finished Product shall be
sent or made available, or cause to be sent or made available, to each other within
[Redacted: Term] from receipt thereof. |
7.25 |
|
Pursuant to reported complaint and/or adverse drug event, if the nature of the reported
complaint and/or adverse drug event requires testing, Bachem will, at Theras reasonable
request, perform analytical testing of corresponding retention samples and provide the results
thereto to Thera as soon as reasonably practicable; provided, however, that Bachem shall be
responsible for the reasonable costs of such testing and reporting to the Regulatory Agency if
it is determined that Bachem is responsible for such reported complaint and/or adverse drug
event. |
|
7.26 |
|
In the event that the sale or manufacture of the Active Ingredient is suspended or halted
further to a decision of a Regulatory Authority while a purchase order accepted by Bachem is
outstanding, Thera shall have the right to cancel such purchase order. Upon cancellation,
Bachem shall not commence the manufacturing of any Lot and shall cease manufacturing any Lot
of Active Ingredient. Theras only liability shall be to pay to Bachem the [Redacted: Cost]
incurred by Bachem in relation to the Lots being manufactured which are subject to such
cancellation. No [Redacted: Cost] shall be payable to Bachem if it is determined that Bachem
is responsible for the issuance of such suspension or halt. |
|
|
|
|
|
|
Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
|
Page 17 |
7.27 |
|
At the end of the Term, Bachem shall immediately terminate production of the Active
Ingredient and shall transfer to Thera, at Theras expenses, all normal and reasonable
inventory of Active Ingredient and all normal and reasonable inventory of raw materials and
packaging components on hand. Thera hereby agrees to accept such transfer and pay for the
inventory at the price in effect at that time between the parties, and the raw materials and
packaging components at their acquisition cost, plus any costs associated with testing,
storage, handling or delivery to Bachem including, without limitation, freight charges and
associated duties, taxes and clearance charges and Bachem shall provide to Thera the original
invoices as evidence of the costs. |
|
7.28 |
|
During the Manufacturing Processes, Bachem shall keep Thera informed of any difficulty,
irregularity or problem that may have an adverse effect on the Specifications, the volume
of Active Ingredients ordered or the delivery date of the Active Ingredients. If the
information communicated by Bachem to Thera relates to: |
|
7.28.1 |
|
the failure by Bachem to meet the Specifications for a lot of Active Ingredient,
notwithstanding Section 7.2 herein, Thera shall have the right to retain the services
of an other supplier to manufacture a Lot of Active Ingredient and the quantity of
Active Ingredient manufactured by such supplier shall be included as forming part of
Theras Minimum Purchase Obligation. The right of Thera to retain the services of an
other supplier shall not be deemed a waiver of its other rights under this Agreement
or at law against Bachem and no money shall be owed by Thera to Bachem in connection
with the Lot of Active Ingredient that does not meet the Specifications; |
|
|
7.28.2 |
|
the failure by Bachem to meet the volume of Active Ingredient ordered,
notwithstanding Section 7.2 herein, Thera shall have the right to retain the services
of an other supplier to manufacture a Lot of Active Ingredient for the quantity of
Active Ingredient that Bachem is unable to deliver and the quantity of Active
Ingredient manufactured by such supplier shall be included as forming part of Theras
Minimum Purchase Obligation. Thera shall only pay Bachem for the delivered. Theras
rights hereunder shall not be deemed a waiver of its other rights under this Agreement
or at law against Bachem; |
|
|
7.28.3 |
|
the failure by Bachem to meet the delivery date of the Active Ingredient, then Thera
shall have the right to reschedule a delivery date for the Active Ingredient being
subject to a purchase order accepted by Bachem and Thera shall remain liable to Bachem
for the payment of the Lot of Active Ingredient upon delivery thereof on the
rescheduled delivery date. Furthermore, Thera shall have the right to retain the
services of an other supplier to manufacture a lot of Active Ingredient and the
quantity of Active Ingredient manufactured by such manufacturer shall be included as
forming part of Theras Minimum Purchase Obligation. Theras rights |
|
|
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|
|
|
Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
|
Page 18 |
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|
|
hereunder shall not be deemed a waiver of its other rights under this Agreement or at law against
Bachem. |
ARTICLE 8
COVENANTS
8.1 |
|
During the Term of this Agreement, Thera grants Bachem a royalty-free non-exclusive license to
use Thera Know-How for the purposes of this Agreement. Bachem agrees not to use or exploit the
Thera Know-How for any other purpose than as set forth in this Agreement. Bachem shall not
have the right to grant sublicenses and make any publication in any form of the Thera Know-How
without the prior written consent of Thera. |
|
8.2 |
|
Bachem shall manufacture the Active Ingredient at its facilities in Torrance, California. |
|
8.3 |
|
During the Term of this Agreement, the parties agree not to directly or indirectly solicit,
recruit or otherwise seek to induce any employee of the other party to terminate their
employment or violate any agreement with or duty to the other party. |
|
8.4 |
|
Bachem agrees to collaborate with Thera and provide Thera with any documentation necessary in
the filing of an investigational new drug application, new drug submission or application with
a Regulatory Authority. |
|
8.5 |
|
During the Term of this Agreement, Bachem shall maintain an appropriate inventory system in
place and shall provide Thera with monthly inventory reports of the Active Ingredient. |
|
8.6 |
|
During the Term of this Agreement and thereafter, for the period required by Applicable Laws
during which Bachem shall keep documentation and records relating to the manufacture of the
Active Ingredient, Bachem shall give access to the auditors of Thera at its facility(ies)
where the Active Ingredient is manufactured for inventory count purposes. Bachem shall be
provided with a reasonable prior written notice in relation to such inventory count and
access. |
|
8.7 |
|
Bachem shall maintain the Active Ingredient in a cGMP storage area and shall limit the access
to the Active Ingredient to its authorized personnel only. |
|
8.8 |
|
In the event a Regulatory Authority having jurisdiction in a country where Thera sells or
markets a Finished Product requires any change to the Manufacturing Processes and/or the
Specifications, Bachem shall use commercially reasonable efforts to make the required changes
so long as such changes do not conflict with cGMPs. In the event amendments are required to
the Manufacturing Processes and/or the Specifications, Thera and Bachem shall agree on
appropriate amendments or supplements and shall incorporate or include such amendment or |
|
|
|
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|
|
Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
|
Page 19 |
|
|
supplement in or as part of the Master Batch Record. In the event that any changes described
significantly influence the cost of manufacturing, Bachem and Thera shall negotiate in good
faith to adjust pricing. Thera agrees to use reasonable efforts to limit the demand of a
Regulatory Authority in connection with any required changes to the Manufacturing Processes
and /or the Specifications; provided, however, that Thera makes no representation and provides
no warranty in connection with such efforts. |
|
8.9 |
|
Bachem shall not be entitled to subcontract any of its obligations under this Agreement,
except with respect to its purchase of the raw materials to manufacture the Active Ingredient
and with respect to its subcontracting of certain analytical services. |
|
8.10 |
|
Bachem shall follow the instructions of Thera in connection with the packaging, handling,
labeling and shipping of the Active Ingredients. |
ARTICLE 9
QUALITY AUDITING
9.1 |
|
Thera, or any other Person designated by Thera subject to the confidentiality provisions of
this Agreement or similar provisions of a confidentiality agreement executed with Bachem,
shall be allowed to conduct Audits of Bachem facilities. Thera shall send a request to
schedule an Audit with Bachem at least [Redacted: Term] prior to the proposed Audit date.
Thera, or any Person designated by Thera, shall be permitted to conduct [Redacted: Amount]
Audit per Calendar Year, unless an Audit discovers a problem or unsatisfactory conditions. In
the event an Audit discovers a problem or unsatisfactory conditions, Thera, or any Person
designated by Thera, shall be entitled to proceed with as many Audits as it deems necessary
upon reasonable prior written notice to Bachem until such problem or unsatisfactory conditions
are solved. For the purposes of this Section, Audit shall mean a Bachem audit involving the
audit and inspection of all elements and systems of the manufacturing process of the Active
Ingredient and of Bachems records of the elements and systems of the manufacturing process. |
|
9.2 |
|
In addition, with at least [Redacted: Term] prior notice, Thera, or any Person designated by
Thera subject to the confidentiality provisions of this Agreement or similar provisions of a
confidentiality agreement executed with Bachem, shall be permitted to investigate/audit
Bachems facility (ies) and records in the event of any failure of any Lot of Active
Ingredient to meet Specifications, any major deviation from Specifications, Active Ingredient
failure (s) or any regulatory actions, violations or complaints relevant to this Agreement. |
|
9.3 |
|
Thera will issue, or will cause to be issued, to Bachem a confidential audit report
summarizing any and all audit observations within two calendar months of the last Audit day.
Bachem will issue responses to all observations in writing to Thera |
|
|
|
|
|
|
Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
|
Page 20 |
|
|
within [Redacted: Term] of
receipt of the audit report, unless an alternate agreement is reached. Responses that are
deemed not acceptable or incomplete or inadequate, and impact Bachem quality systems, will be
reviewed with the respective quality management and commercial representatives from both Thera
and Bachem for resolution. Any dispute on the responses relating to the quality systems of
Bachem that cannot be resolved will be submitted to arbitration pursuant to the terms of
Article 17. Until settlement of a dispute, Thera shall be entitled to have Lots of Active
Ingredient manufactured by another supplier without being in breach of any provision of this
Agreement. In the event the arbitration ruling is entirely in favour of the Bachem position,
[Redacted: Consequences]. |
|
9.4 |
|
Bachem shall provide reasonable cooperation to Thera, and any other Person designated by
Thera subject to the confidentiality provisions of this Agreement or similar provisions of a
confidentiality agreement executed with Bachem, in connection with Audits, investigations,
other audits or access pursuant to Section 8.6 and this Article 9. |
|
ARTICLE 10
CONFIDENTIALITY |
|
10.1 |
|
The parties hereby agree that any Confidential Information provided to the Recipient by the
Disclosing Party hereunder shall remain the exclusive property of the Disclosing Party. |
|
10.2 |
|
The Recipient agrees that it will maintain all Confidential Information in strict confidence
and that it will not permit the Confidential Information in its possession to be disclosed to
any third party or used for any purpose not agreed upon by the parties. |
|
10.3 |
|
Notwithstanding the above, Thera or Bachem shall be authorized to disclose information
relating to the conclusion of this Agreement and to the details thereof excluding details as
to technical or financial information, (i) in press releases or (ii) to future commercial
partners for the Active Ingredient. Details as to technical or financial information contained
in this Agreement may only be disclosed by a party to a Person with the prior written consent
of the other party which shall not be unreasonably withheld. |
|
10.4 |
|
The Recipient shall not permit any employee, director, officer, agent, representative or
Affiliate to have access to the Confidential Information unless such employee, director,
officer, agent, representative or affiliate (a) needs to know the Confidential Information for
the purposes of this Agreement, (b) has been informed of the confidential nature of the
Confidential Information, and (c) agrees to act in accordance with the terms and conditions
set out in this Article. |
|
|
|
|
|
|
Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
|
Page 21 |
10.5 |
|
The Confidential Information shall not be reproduced in any form without the permission of
the Disclosing Party in writing, except as required for the execution of activities agreed
upon between the parties. |
|
10.6 |
|
In the event that the Recipient is required under Applicable Laws or a legal process to
disclose any of the Confidential Information, the Recipient shall provide the Disclosing Party
with prompt notice of any such requirement to allow the Disclosing Party to seek an
appropriate protective order and/or waive compliance with the provisions of Section 10.2. The
parties agree that if the Disclosing Party does not obtain a protective order or does not
provide the Recipient with a waiver and the Recipient is, nonetheless, in the written opinion
of its outside counsel, compelled to disclose the Confidential information to any competent
judicial or Regulatory Authority, or else to be liable for contempt or suffer other penalty,
the Recipient may disclose only that portion of the Confidential Information which it is
advised by a written opinion of its outside counsel is legally required to such tribunal
without liability hereunder; provided, however, that Recipient gives the Disclosing Party
advance written notice of the Confidential Information to be disclosed as
far in advance of its disclosure as is practical and, at the Disclosing Partys request,
seek to obtain assurances that it will be granted confidential treatment. Notwithstanding
the foregoing and the terms of Section 10.2 hereof, Thera shall be authorized to file a copy
of this Agreement with the securities regulatory authorities having jurisdiction over its
business and affairs and on SEDAR pursuant to applicable securities regulation. |
|
10.7 |
|
Upon termination of this Agreement, in whole or in part, the Recipient shall, upon request,
forthwith return to the Disclosing Party all Confidential Information of the Disclosing Party
in the possession of the Recipient and execute a certificate attesting the complete return of
the Confidential Information, except with respect to one copy which may be retained on file in
a secure location for the purposes of determining obligations related to such Confidential
Information. |
ARTICLE 11
INSURANCE
Throughout the Term and for a period of [Redacted: Term] thereafter, Bachem shall obtain and
maintain comprehensive general liability insurance (including broad form general liability,
completed operations and products liability, warehousing liability, blanket contractual liability
and broad form property damage liability) with limits of not less than [Redacted: Amount] combined
single limit for bodily injury and property damage liability [Redacted: Amount]. With respect to
all insurance coverage required under this clause: (i) Bachem shall, promptly upon Theras request,
furnish Thera with certificates of insurance evidencing such insurance; and (ii) all policies shall
include provisions for at least [Redacted: Term] prior written notice of any material change or
cancellation (whether for non-payment or otherwise).
|
|
|
|
|
|
Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
|
Page 22 |
ARTICLE 12
INDEMNIFICATION
12.1 |
|
Bachem shall indemnify and hold harmless Thera and its Affiliates, and their respective
directors, officers, employees, consultants, agents, customers, successors and assigns from
and against all suits, claims, losses, demands, liabilities, damages, costs and expenses
(collectively, the Liabilities) in connection with any claim, charge, suit, demand, action,
inspection or proceeding of any kind made or brought by any third party (a Third Party
Claim), including any Regulatory Authority and any customer or licensee, to the extent that
such Liabilities arise from or relate to: (a) Bachems failure to follow and execute or to
manufacture, handle, test, label, or store the Active Ingredient in accordance with the Master
Batch Record, the protocol or the Specifications, (b) the negligence, recklessness or willful
misconduct of Bachem, its employees, suppliers or agents, (c) Bachems failure to manufacture
the Active Ingredient in accordance with cGMPs, (d) Bachems failure to comply with all
Applicable Laws, regulatory filings, rules or regulations applicable to its performance under
this Agreement, or (e) breach by Bachem or its suppliers or agents of any representation,
warranty, covenant or agreement made by Bachem contained in the Agreement. |
|
12.2 |
|
Except to the extent that Bachem is obligated to indemnify Thera under Section 12.1 herein,
Thera shall indemnify and hold harmless Bachem and its Affiliates, and their respective
directors, officers, employees, consultants, agents, successors and assigns from and against
all Liabilities in connection with any Third Party Claim to the extent that such Liabilities
arise solely from or relate solely to conformance of the Active Ingredient to the
Specifications. |
|
12.3 |
|
A party that intends to claim indemnification under this Article 12 (Indemnified Party)
shall promptly notify the other party (the Indemnifying Party) of any Liability in respect
of which the Indemnified Party intends to claim such indemnification, and the Indemnifying
Party shall have the right to participate in, and, to the extent the Indemnifying Party so
desires, to assume the defence thereof with counsel selected by the
Indemnifying Party; provided, however, that an Indemnified Party shall have the right to
retain its own counsel, with the fees and expenses to be paid by the Indemnifying Party, if
representation of such Indemnified Party by the counsel retained by the Indemnifying Party
would be inappropriate due to actual or potential differing interests between such
Indemnified Party and any other party represented by such counsel in such proceedings or if
Indemnifying Party fails to act under this Section 12.3 in a reasonably timely manner. The
Indemnifying Party [Redacted: Settlement Conditions]. The Indemnified Party [Redacted:
Settlement Conditions]. The failure to deliver notice to the Indemnifying Party within a
reasonable time after the commencement of any such action shall not relieve the Indemnifying
Party from any obligation under this Article 12 unless (and then only to the extent that)
the Indemnifying Party is prejudiced thereby. The Indemnified Party, its |
|
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|
|
|
|
Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
|
Page 23 |
|
|
employees and
agents, shall at the Indemnifying Partys expense cooperate fully with the Indemnifying
Party and its legal representatives in the investigation of any action, claim or liability
covered by this indemnification. |
ARTICLE 13
TERM AND TERMINATION
13.1 |
|
This Agreement shall be effective as of the date first written above and shall continue in
full force and effect until the expiry of US patent No. 5,861,379, as such patent term may be
extended by statute or regulation. |
|
13.2 |
|
In the event of a breach of any provision of this Agreement, the party that is not in breach
of the Agreement (the Non-Breaching Party) shall have the right to terminate this Agreement
immediately upon written notice to the party being in breach (the Breaching Party) of the
Agreement if the Breaching Party fails to remedy a breach within [Redacted: Term] following
receipt of a written notice from the Non-Breaching Party specifying the breach with reasonably
sufficient particulars; provided, however, that if Thera is the Breaching Party as a result of
the failure to fulfill its Minimum Purchase Obligation in a Calendar Year, Bachem shall not
have the right to terminate this Agreement before the expiry of the Calendar Year following
the Calendar Year in which the breach occurred if Thera Purchases during such following
Calendar Year a quantity of Active Ingredient making up for the shortage in its Minimum
Purchase Obligation for the previous Calendar Year. |
|
13.3 |
|
Either party may terminate this Agreement on notice to the other party in the event the other
party becomes the subject of a petition filed for relief under any bankruptcy or insolvency
law, which is not dismissed within [Redacted: Term] of its filing; any general arrangement
with its creditors; any liquidation, termination or cessation of its business. |
|
13.4 |
|
Thera shall have the right to terminate this Agreement upon a [Redacted: Term] prior written
notice to Bachem in the event of an Acquisition of Control of Thera. |
|
13.5 |
|
Thera shall have the right to terminate this Agreement in the event that the FDA does not
approve a Finished Product. |
|
13.6 |
|
Thera shall have the right to terminate this Agreement in the event that the [Redacted:
Quantity] Lot Manufacturing Process and the [Redacted: Quantity]
Lot Manufacturing Process are not validated. |
|
13.7 |
|
Termination of this Agreement for any reason shall not extinguish the unpaid
obligations of any party that accrued prior to the effective date of termination and
the exclusivity provision of Section 7.1. The obligations of both parties with
respect to confidentiality shall survive termination for any reason. |
|
|
|
|
|
|
Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
|
Page 24 |
ARTICLE 14
FORCE MAJEURE
Each of the parties shall be excused from the performance of its obligations hereunder, in the
event that such performance is prevented by force majeure, provided that each of the parties shall
use its best efforts to complete such performance by other means. For the purpose of this
Agreement, force majeure is defined as follows: [Redacted: Definition of Force Majeure].
ARTICLE 15
NOTICES
15.1 |
|
Any payment, notice or other written communication, including a purchase order, (a Notice)
required or permitted to be made or given hereunder may be made or given by either party by
facsimile at the number mentioned below; by first-class mail (postage prepaid) or by air
courier to the mailing address set out below or to such other respective facsimile numbers or
addresses as either party shall designate to the other party, by Notice, provided that such
Notice shall be effective only upon receipt thereof. Notices shall be deemed to have been
received: (i) if mailed, seven (7) days after being dispatched by mail, postage prepaid; (ii)
if sent by air courier, three (3) days after delivery to the air courier company; or (iii) if
sent by facsimile with confirmed transmission, on the day on which such facsimile was sent if
such day is a business day for the recipient or on the first business day next following its
transmission if the facsimile was sent on a day that is not a business day for the recipient.
For the purposes of this Article, in the case of Notices sent to
Thera, business day shall
mean every day of a week, other than Saturdays, Sundays and statutory holidays in the Province
of Quebec, from 8:30 am to 5:00 pm (Eastern Time); and, in the case of Notices sent to Bachem,
business day shall mean every day of a week, other than Saturdays, Sundays and statutory
holidays in the State of California, from 8:30 am to 5:00 pm (Pacific Time). |
|
|
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|
|
|
Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
|
Page 25 |
15.2 |
|
Notices sent to either party shall be sent to the following address: |
|
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If to Thera:
|
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Theratechnologies Inc. 2310
Alfred-Nobel Blvd. Montréal,
Quebec Canada, H4S 2B4 |
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|
Fax: 514-331-7321 |
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Attention: Vice President, Pharmaceutical Development |
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|
If to Bachem:
|
|
Bachem Americas Inc. 3132
Kashiwa Street Torrance,
California 90505
U.S.A. |
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Fax: 310-539-1570 |
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Attention: President & CEO, Bachem Americas, Inc. |
ARTICLE 16
LIMITATIONS OF LIABILITY
Neither party shall be responsible or liable for injuries to or death of any of the other partys
employees (or for injuries, damage or loss to their property) while at or traveling to and from the
plants, offices or premises of the hosting party, unless due to the negligence or wilful misconduct
of such hosting party.
ARTICLE 17
ARBITRATION
Any dispute between the parties arising under this Agreement, including its interpretation, other
than a dispute where arbitration is already provided for herein and other than a disagreement on
the pricing of a [Redacted: Amount] Lot, shall be conclusively settled by the submission of the
dispute to arbitration. The rules governing arbitration shall be those set forth under Sections 941
to 941.3 (inclusively) and Sections 944 to 945.8 (inclusively) of the Code of Civil Procedures
(Québec). The arbitration shall be held in Montreal, Province of
Québec, Canada.
ARTICLE 18
FINAL PROVISIONS
18.1 |
|
This Agreement shall be binding upon and enure to the benefit of the parties hereto, their
successors and permitted assigns. |
|
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|
|
|
|
Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
|
Page 26 |
18.2 |
|
This Agreement constitutes the entire agreement of the parties with respect to the subject
matter of this Agreement and supersedes all prior and contemporaneous agreements and
understandings in connection therewith. It may not be changed nor modified orally, but only by
agreement in writing signed by a duly authorized representative of each of the parties hereto. |
|
18.3 |
|
Each of the parties upon the request of the other shall do, execute, acknowledge and deliver
or cause to be done, executed, acknowledged or delivered all such further acts, deeds,
documents, assignments, transfers, conveyances, powers of attorney and assurances as may be
reasonably necessary or desirable to effect complete consummation of the transactions
contemplated by this Agreement. |
|
18.4 |
|
Nothing contained herein shall constitute or create a partnership among, or a joint venture
by, all or any of the parties. |
|
18.5 |
|
Neither failure nor delay by either party to exercise any right or remedy provided in this
Agreement or by statute, or law shall operate as a waiver of such right or remedy, nor shall
any single or partial exercise of any such right or remedy preclude any other or further
exercise of any other right or remedy. The rights and remedies set forth in this Agreement are
cumulative and enforcement of one right or remedy shall not preclude subsequent enforcement of
the same or other rights and remedies provided in this Agreement or at law. |
|
18.6 |
|
This Agreement and all rights and obligations hereunder shall not be assigned in whole or in
part by either party to any third party without the prior written consent of the other;
provided, however, that Thera shall be entitled to assign this Agreement in whole only without
the prior written consent of Bachem to a Related Party or in the event of an Acquisition of
Control of Thera and provided further that Bachem shall be entitled to assign this Agreement
in whole only without the prior written consent of Thera in connection with the acquisition or
sale of all or substantially all of the entire company. The party having assigned this
Agreement shall be relieved from any obligation hereunder. In the event Thera assigns this
Agreement, Thera shall continue to have the right to order from Bachem the manufacture of
Active Ingredients pursuant to the prices set forth in Schedule 7.3 and pursuant to the price
to be agreed upon for the manufacture of [Redacted: Amount] of Active Ingredient. |
|
18.7 |
|
The parties hereto have required that the present Agreement and all deeds, documents, or
notices relating thereto be drafted in the English language; les
parties aux présentes ont
exigé que la présente convention et tout autre contrat,
document ou avis afférent ou
subordonné aux présentes soient rédigés en langue anglaise. |
|
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|
Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
|
Page 27 |
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed in two counterparts by
their duly authorized representatives as of the day and year first set forth above.
|
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THERATECHNOLOGIES INC.
|
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Per: |
(signed) Luc Tanguay
|
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|
Luc Tanguay |
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Executive Vice President and Chief Financial Officer |
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Per: |
(signed) Pierre Perazzelli
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Pierre Perazzelli |
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Vice President, Pharmaceutical Development |
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BACHEM AMERICAS INC.
|
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Per: |
(signed) Philip Ottiger
|
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Philip Ottiger |
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President & Chief Executive Officer,
Bachem Americas, Inc. |
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BACHEM, INC.
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Per: |
(signed) Alex Fässler
|
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Alex Fässler |
|
|
|
President & Chief Operating Officer,
Bachem, Inc. |
|
|
Manufacturing and Supply Agreement Redacted Quantity final
|
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|
|
|
|
Manufacturing and Supply Agreement
between Theratechnologies Inc, Bachem Americas Inc. and Bachem, Inc. dated
March 11, 2009
|
|
Page 28 |
SCHEDULE 1.38
QUALITY AGREEMENT
[Redacted]
|
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Schedule 1.1.43A
Specifications Active Ingredient [Redacted: Amount] Kilogram Lot
March 11, 2009
|
|
Page 1 |
Quality Agreement Between
Theratechnologies Inc.
and
Bachem, Inc., Manufacturer of the Bulk Active Pharmaceutical Ingredient
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Schedule 1.1.43A
Specifications Active Ingredient [Redacted: Amount] Lot
March 11, 2009
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SCHEDULE 1.1.43A
SPECIFICATIONS ACTIVE INGREDIENT [REDACTED: AMOUNT] LOT
[Redacted: Specifications]
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Schedule 1.1.43A
Specifications Active Ingredient [Redacted: Amount] Lot
March 11, 2009
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SCHEDULE 1.1.43B
SPECIFICATIONS ACTIVE INGREDIENT [REDACTED: QUANTITY] LOT
[Redacted: Specifications]
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Schedule 1.1.43B
Specifications Active Ingredient [Redacted: Amount] Gram Lot
March 11, 2009
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SCHEDULE 2.1
OBLIGATIONS UNDER THE CDMA
[Redacted: Obligations]
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Schedule 2.1
Obligations under the CDMA
March 11, 2009
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SCHEDULE 4.2
WORK PLAN
[Redacted: Work Plan]
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Schedule 4.2
Work Plan
March 11, 2009
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SCHEDULE 7.3
PRICE FOR [REDACTED:QUANTITY] LOTS
[Redacted: Prices]
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Schedule 7.3
Price for [Redacted: Amount] Lots
March 11, 2009
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Page 1 |
EX-99.91
Exhibit 99.91
MANUFACTURE AND SUPPLY AGREEMENT
BETWEEN
DRAXIS PHARMA GENERAL PARTNERSHIP
By way of its managing partner,
DRAXIS SPECIALTY
PHARMACEUTICALS INC.
AND
THERATECHNOLOGIES INC.
AS OF DECEMBER 23, 2009
CONFIDENTIAL
TABLE OF CONTENTS
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ARTICLE I INTERPRETATION |
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1 |
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1.1 Defined Terms |
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1 |
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1.2 incorporation of Schedules |
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7 |
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1.3 Currency |
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7 |
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1.4 General |
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7 |
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ARTICLE II MANUFACTURING |
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8 |
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2.1 Agreement to Manufacture Products |
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8 |
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2.2 Conformance with Specifications |
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8 |
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2.3 Conformance with cGMP and Applicable Laws |
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8 |
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2.4 Supply of Active Pharmaceutical Ingredients |
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8 |
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2.5 Supply of Materials |
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9 |
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2.6 Third Party Suppliers |
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9 |
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2.7 Costs and Expenses |
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9 |
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2.8 Addition of Products |
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9 |
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ARTICLE III CONSIDERATION |
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9 |
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3.1 Price of Products and Adjustment |
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9 |
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3.2 Annual Minimum Purchases |
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10 |
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3.3 Batch Size |
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10 |
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3.4 Payment |
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10 |
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3.5 Taxes |
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11 |
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3.6 Capital Expenditures |
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11 |
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3.7 Additional Costs |
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11 |
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3.8 Cost of Changes |
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11 |
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ARTICLE IV PRODUCT SUPPLY |
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12 |
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4.1 Forecasts |
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12 |
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4.2 Order Procedures |
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13 |
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4.3 Purchase Orders |
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15 |
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4.4 Standard Forms |
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16 |
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ARTICLE V DELIVERY, TITLE AND ACCEPTANCE |
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16 |
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5.1 Product Storage and Shipment |
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16 |
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5.2 Purchaser Acceptance |
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17 |
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5.3 Recalls |
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19 |
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ARTICLE VI QUALITY ASSURANCE AND CONTROL |
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19 |
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6.1 Form of Quality Agreement |
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19 |
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6.2 Testing |
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19 |
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6.3 Product Batch Release |
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19 |
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6.4 Retention Samples |
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20 |
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6.5 Designated Suppliers Audit |
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20 |
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6.6 Manufacturing Records |
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20 |
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ARTICLE VII REGULATORY MATTERS |
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21 |
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7.1 Audit and Inspection |
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21 |
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7.2 Regulatory Submissions |
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22 |
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ARTICLE VIII REPRESENTATIONS AND WARRANTIES |
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22 |
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8.1 Supplier Representations and Warranties |
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22 |
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- i -
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8.2 Purchaser Representations and Warranties |
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24 |
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8.3 Undertakings Relating to Representations and Warranties |
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24 |
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ARTICLE IX INTELLECTUAL PROPERTY |
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25 |
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9.1 Ownership |
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25 |
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9.2 Reproduction of and Right to use Trademarks |
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26 |
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9.3 Suppliers Ownership of Other Property |
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27 |
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9.4 Infringement by a Third Party |
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27 |
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9.5 Right to not Manufacture |
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27 |
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ARTICLE X INDEMNITIES |
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27 |
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10.1 Indemnity of Supplier |
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27 |
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10.2 Indemnity of Purchaser. |
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28 |
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10.3 Indemnity Proceedings |
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28 |
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10.4 Limitation of Liability |
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30 |
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ARTICLE XI TERM AND TERMINATION |
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30 |
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11.1 Term of Agreement |
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30 |
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11.2 termination of Agreement |
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31 |
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ARTICLE XII MISCELLANEOUS |
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32 |
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12.1 Relationship of the Parties |
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32 |
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12.2 Force Majeure |
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32 |
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12.3 Further Assurances |
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33 |
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12.4 Confidentiality |
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33 |
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12.5 Notices |
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34 |
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12.6 Entire Agreement |
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34 |
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12.7 Waiver |
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34 |
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12.8 Amendment |
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35 |
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12.9 Severability |
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35 |
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12.10 Enurement |
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35 |
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12.11 Assignment |
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35 |
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12.12 Counterparts |
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35 |
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12.13 Contra Proferentum |
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35 |
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12.14 Subcontracting |
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35 |
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12.15 Governing Law |
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36 |
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12.16 Non-Solicitation |
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36 |
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12.17 Survival |
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36 |
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12.18 English Language |
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36 |
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- ii -
MANUFACTURE AND SUPPLY AGREEMENT
THIS AGREEMENT is effective from the 23rd day of December, 2009 (the Effective Date )
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B E T W E E N:
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THERATECHNOLOGIES INC., a corporation incorporated under
the laws of the Province of Québec, having its head
office at 2310 Alfred-Nobel, Montreal , Québec , H4S 2B4; |
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(Purchaser ) |
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AND:
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DRAXIS PHARMA GENERAL PARTNERSHIP, by way
of its managing partner , DRAXIS Specialty Pharmaceuticals
Inc., a partnership constituted under the laws of the
Province of Ontario, having its principal office at 16751
Trans-Canada Highway, Kirkland, Québec, H9H 4J4; |
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(Supplier) |
WHEREAS Purchaser desires to have Supplier manufacture and supply certain lyophilized products;
AND WHEREAS Supplier desires to manufacture and supply Purchaser with certain lyophilized products;
AND WHEREAS the Parties are willing to carry out the foregoing pursuant to the terms and
conditions set forth in this Agreement.
NOW , THEREFORE , in consideration of the mutual covenants and agreements in this Agreement,
Purchaser and Supplier agree with each other as follows:
ARTICLE I INTERPRETATION
1.1 Defined Terms.
As used in this Agreement and in the Quality Agreement (as defined below), the following terms
have the following meanings unless the context clearly requires otherwise:
-1-
Accepted Purchase Order(s) means a Purchase Order issued to order a Batch of a Product in the
Firm Zone, a Purchase Order accepted by Supplier or a Purchase Order deemed to be accepted by
Supplier under the terms of Section 4.3(c) of this Agreement.
Active Pharmaceutical Ingredient means the Product Active Pharmaceutical Ingredient tesamorelin
supplied by Purchaser to Supplier for the Manufacturing of the Products.
Additional Costs means the fees that are not described in this Agreement payable for additional
services performed by Supplier for Purchaser at Purchasers request in accordance with the
provisions of the Proposal. For greater certainty, such fees are payable by Purchaser in addition
to the Prices and the Inventory Carrying Fees with Purchasers prior written approval.
Affiliate has the meaning ascribed thereto in the Canada Business Corporations Act .
Agreement means this Manufacture and Supply Agreement and all schedules and instruments
supplemental to or amending thereto.
Annual
Forecast(s) has the meaning ascribed thereto in Section 4.1(a) of this Agreement.
Annual Minimum Purchase has the meaning ascribed thereto in Section 3.2(b) of this Agreement.
APR has the meaning ascribed thereto in Section 19 of the Quality Agreement.
Batch means a production batch of Products as specified under Batch size and lyophilization
cycle in Schedule C attached hereto.
Business Day or Business Days means any day other than a Saturday, Sunday or a nonjudicial day recognized under Québecs Code of Civil Procedure.
Calendar Year(s) means January 1 to December 31 of any given year or years, as the case may be.
CDA means the Confidential Disclosure Agreement entered into between Supplier and Purchaser on
February 14, 1999, a copy of which is attached hereto as Schedule D, as modified by Section
12.4 of this Agreement.
Certificate of Analysis means a document listing the results of testing a representative sample
drawn from a Batch to be delivered.
CFR means the U.S. Code of Federal Regulations.
Commercial Sale means the sale of a Product by Purchaser to consumers or the sale of a Product
by Purchaser to distributors, wholesalers or licensing partners or to any third party for resale
by any of them to consumers.
-2-
[Redacted: Price Increase Calculation].
Current Good Manufacturing Practices or cGMP means, as applicable in accordance with the
Territory in which the Products will be distributed in, the practices set out in the guidelines
(i)published as the Good Manufacturing Practices for Drug Manufacturers and Importers by the HPFBI,
as amended from time to time, (ii)for the manufacture of pharmaceutical products and the Current
Good Manufacturing Practices as defined in United States 21 CFR 210, et seq., as amended from
time to time, and (iii)the EEC Guide to Good Manufacturing Practices for Medical Products, as amended from time to time.
Delivery means that a Product has been released pursuant to Section 6.3 of this Agreement.
Designated Suppliers has the meaning ascribed thereto in Section 6.2 of the Quality Agreement
and are listed in Schedule F attached hereto, as amended from time to time by mutual agreement of
the Parties.
Designated Suppliers Audit has the meaning ascribed thereto in Section 6.2 of the Quality
Agreement.
[Redacted: Name] means the commercial name for a drug to be Commercially Sold in the Territory
made with tesamorelin and used for the treatment of lipodystrophy in HIV-infected patients or any
other commercial name under which this drug will be Commercially Sold.
Facility means those sections of Suppliers facility located at 16751 Trans-Canada Highway,
Kirkland, Québec, Canada used in the Manufacturing of the Products hereunder and, subject to
Purchasers prior written approval, such other facilities used by Supplier in the Manufacturing of
Products hereunder.
Failure to Supply means [Redacted: Definition].
FDA means the United States Food and Drug Administration, or any successor to it.
Firm Zone has the meaning ascribed thereto in Section 4.2(a) of this Agreement.
Force Majeure has the meaning ascribed thereto in Section 12.2(a) of this Agreement.
Governmental Authority or Regulatory Authority means any court, tribunal, arbitrator, agency,
commission, official or other instrumentality of Canada, any relevant foreign country or territory,
or any domestic or foreign state, province, country, city or other political subdivision thereof.
HPFBI means the Health Products and Food Branch Inspectorate of Health Canada, or any
successor to it.
-3-
Incoterms 2000 means the International Commercial Terms published by the International Chamber
of Commerce, as amended from time to time, codifying the contractual rules for the interpretation
of standardized commercial terms for transactions. Incoterms 2000 shall be deemed to have been
incorporated by reference in this Agreement except in so far as they may conflict with any other
provision of this Agreement, in which case the Agreement provision shall prevail.
Indemnitees means either Party, as the case may be, and that Partys directors, officers,
employees, agents and representatives.
Initial Term has the meaning ascribed thereto in Section 11.1(a) of this Agreement.
Intellectual Property means all (i) trademarks, service marks, trade name, trade dress and logos
and any applications for registrations, registrations and renewal thereof; (ii) patent, patent
rights, industrial and other designs, including any and all applications, divisions,
continuation-in-part, extensions, validations, re-examinations or reissues; (iii) copyright, any
original work or authorship fixed in any tangible medium of expression, including literary works,
all forms and types of computer software, all source code, object code, firmware, development
tools, files, records and data, and all documentation related to any of the foregoing, all musical,
dramatic, pictorial, graphic and artistic works; (iv) trade secrets, technology, discoveries and
improvements, know-how, proprietary rights, formulae, technical information, techniques,
inventions, designs, drawings, procedures, processes, models, manufacturing, manuals and systems,
whether or not patentable or copyrightable, including all biological, chemical, biochemical,
toxicological, pharmacological and metabolic material and information and data relating thereto,
clinical, analytical and stability information and data which have actual or potential commercial
value and are not available in the public domain; and (v) all other intellectual property or
proprietary rights, in each case whether or not subject to statutory registration or protection, in
Canada or in the Territory.
Inventory Carrying Fee(s) has the meaning ascribed thereto in Section 4.2(e) of this Agreement.
Law(s) means any law, statute, rule, regulation, guideline (including Current Good Manufacturing
Practices), ordinance or other pronouncement of any Governmental Authority having the effect of law
in Canada and in the United States.
Licences means the licences, permits, certificates, authorizations or approvals issued to
Supplier by the relevant Governmental Authority in respect of its site of manufacture of the
Products.
Long Lead Time Materials has the meaning ascribed thereto in Section 4.2(d) of this Agreement.
Losses mean [Redacted: Definition].
-4-
Manufacture or Manufactured means to effect the operation required in the manufacture,
processing, filling, testing, packaging, labelling or storage, as the case may be, of the Products
by Supplier.
Manufacturing means any operation required in the manufacture, processing, filling, testing,
packaging, labelling or storage, as the case may be, of the Products by Supplier.
Manufacturing Records has the meaning ascribed thereto in Section 6.6 of this Agreement.
Material Zone has the meaning ascribed thereto in Section 4.2(b) of this Agreement.
Materially Adversely Affect Suppliers Business means a consequence or series of consequences
that have a meaningful negative impact on Suppliers business in any given year, as determined by
Supplier, in its sole discretion, acting reasonably.
Materials mean all materials and ingredients, including the Active Pharmaceutical Ingredient(s),
used in the Manufacturing of Products by Supplier, including raw materials and packaging, shipping
or labelling materials.
New Drug Application means a New Drug Application filed pursuant to the requirements of the
FDA, as more fully defined in 21 C.F.R.§ 314.3 et seq., as the same may be amended from time to
time, a Biologics License Application filed pursuant to the requirements of the FDA, and any
equivalent application filed in the Territory, together, in each case, with all additions,
deletions or supplements thereto.
Ongoing Forecast has the meaning ascribed thereto in Section 4.1(c) of this Agreement.
Open Zone has the meaning ascribed thereto in Section 4.2(c) of this Agreement.
Party means either Purchaser or Supplier, individually; Parties means Purchaser and
Supplier, collectively.
Person means any natural person, entity, corporation, general partnership, limited partnership,
proprietorship, other business organization, trust, union, association or Governmental Authority.
Preferred Basis shall mean the exclusive right to Manufacture Batches of Product for Commercial
Sale during the Term in the following percentage:
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[Redacted: Percentage] until [Redacted: Date]; |
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[Redacted: Percentage] for each Calendar Year of the Term
thereafter. |
Prices or Price means the total aggregate cost of each Product as set out in Schedule C for
Calendar Year 2009 and as adjusted in subsequent years of the Term in accordance with the
provisions of Section 3.1 of this Agreement.
-5-
Proceeding means applicable Third Party action, claim, suit, proceeding, arbitration or
Governmental Authority action, notification, investigation or audit all in writing format.
Product(s) means [Redacted: Name] or any other product(s) as may mutually be agreed in
writing between the Parties in accordance with Section 2.8 of this Agreement.
Product Amendment has the meaning ascribed thereto in Section 2.8 of this Agreement.
Product Developments has the meaning ascribed thereto in Section 9.1(c) of this Agreement.
Proposals
means those proposals made by Supplier on (i) February 9, 2006 and accepted by
Purchaser on February 14, 2006, (ii) October 23, 2008 and accepted by Purchaser on October 27,
2008, (iii) January 18, 2005 and accepted by Purchaser on January 20, 2005, a copy of which are
attached hereto as Schedule E.
Purchase Order(s) has the meaning ascribed thereto in Section 4.3(a) of this Agreement.
Purchaser Intellectual Property means any and all Intellectual Property relating to the Products
or their Manufacturing by Supplier that was (i) owned by Purchaser at the Effective Date or
(ii) developed or acquired by Purchaser after the Effective Date provided that such Intellectual
Property does not utilize nor is based on any Supplier Intellectual Property. Purchaser
Intellectual Property excludes Product Developments.
Quality Agreement means the agreement which sets out the details of the allocation of tasks
between the Parties as related to the Manufacturing of the Product, including responsibilities for
quality assurance and control of Materials, packaging components, bulk Product and finished
Product, a copy of which is attached hereto as Schedule B.
Quality Event has the meaning ascribed thereto in Section 1.3 of the Quality Agreement.
Rejected Batch has the meaning ascribed thereto in Section 5.2(b) of this Agreement.
Rejection Notice has the meaning ascribed thereto in Section 5.2(b) of this Agreement.
Renewal Terms has the meaning ascribed thereto in Section 11.1(b) of this Agreement.
Replacement Batch has the meaning ascribed thereto in Section 5.2(e)(i)B of this Agreement.
Specifications means, with respect to a Product, all specifications for Materials,
Manufacturing procedures, sampling plans for a Product as well as the procedures, requirements
(regulatory or otherwise), standards and other items necessary to Manufacture a Product, as
approved by the Parties and attached hereto as Schedule A.
-6-
Supplier Intellectual Property means (i)all Intellectual Property owned by Supplier at the
Effective Date; (ii)all Intellectual Property developed or acquired by Supplier after the Effective
Date independent of the performance of its obligations under this Agreement, provided that such
Intellectual Property does not utilize nor is based on any Purchaser Intellectual Property or
Product Developments; or (iii)all Intellectual Property conceived, reduced to practice, authored or
otherwise generated or developed in the performance of its obligations under this Agreement,
provided that such Intellectual Property has general applicability to the manufacture of
pharmaceutical products other than the Products.
Term means, collectively, the Initial Term and any Renewal Term, as the case may be.
Territory means the United States of America and its territories, including Puerto Rico and
the District of Columbia.
Third Party or Third Parties means any Person other than Purchaser and Supplier.
Updated Annual Forecast(s) has the meaning ascribed thereto in Section 4.1(a) of this Agreement.
1.2 Incorporation of Schedules.
The terms of the Schedules attached or referred to herein are an integral part of this Agreement.
The following Schedules are attached hereto:
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Schedule A Product Specifications |
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Schedule B Quality Agreement |
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Schedule C Prices |
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Schedule D Confidential Disclosure Agreement |
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Schedule E Proposal |
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Schedule F Designated Suppliers |
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Schedule G Ownership of Machinery and Equipment by Purchaser |
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Schedule H Form of Certificate of Manufacture |
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Schedule I Quarantine Shipment Authorization |
1.3 Currency.
Except as otherwise expressly stated, all dollar amounts referred to in this Agreement are in
Canadian dollars.
1.4 General.
Article headings in this Agreement are for convenience only and shall not be used in interpreting
this Agreement. The Agreement shall be read with such changes in gender or number as the context
requires. The definitions in Article 1 shall apply equally to both the singular and plural forms
of the terms defined. The words include, includes and
-7-
including shall be deemed to be followed by the phrase without limitation. All references
herein to Articles, Sections, paragraphs, clauses and Schedules shall be deemed references to
Articles, Sections, paragraphs and clauses of this Agreement and Schedules to this Agreement
unless the context shall otherwise require.
ARTICLE
II MANUFACTURING
2.1 Agreement to Manufacture Products.
For the Term of this Agreement, Supplier agrees to Manufacture the Products identified in Schedule
A on a Preferred Basis for Purchaser in the Facility and to supply exclusively the Product to
Purchaser in accordance with the terms set out in this Agreement and Purchaser agrees to purchase
the Products identified in Schedule A from Supplier on a Preferred Basis in accordance with the
terms of this Agreement. Notwithstanding the foregoing, Supplier acknowledges that Purchaser will
be entitled to have Manufactured [Redacted: Number of Batches of Product].
2.2 Conformance with Specifications.
Supplier shall Manufacture the Products and use Materials in compliance with the Specifications.
Purchaser shall have the right to request in writing changes to any of the Specifications.
Supplier shall have the right to suggest changes to any of the Specifications to Purchaser in
writing. Supplier shall not implement any change to the Specifications before both Parties have
agreed to such changes in writing.
2.3 Conformance with cGMP and Applicable Laws.
Supplier shall Manufacture the Products in accordance with applicable Good Manufacturing Practices
and applicable Laws. Each Party shall promptly notify the other of knowledge of any new
instructions, specifications, guidelines, Laws or regulations required in order to comply with
Good Manufacturing Practices and applicable Laws and shall cooperate in agreeing on the best means
to comply with any new requirements.
2.4 Supply of Active Pharmaceutical Ingredients.
Purchaser shall, at no cost to Supplier, provide to Supplier adequate quantities of Active
Pharmaceutical Ingredients to Manufacture the number of Batches of Product set out in each Purchase
Order at least [Redacted: Term] prior to the requested Delivery date mentioned in each Purchase
Order. Supplier will be responsible for the proper storage of the Active Pharmaceutical Ingredients
while in its possession provided that Purchaser shall provide Supplier with adequate written
temperature excursions for the storage of the Active Pharmaceutical Ingredient. The storage of the
Active Pharmaceutical Ingredient by Supplier shall comply with cGMP and the specifications for the
Active Pharmaceutical Ingredient.
-8-
2.5 Supply of Materials.
Supplier shall supply all Materials for the Manufacture of the Product. Purchaser shall supply the
Active Pharmaceutical Ingredients necessary for the Manufacturing of the Products as indicated in
the Specifications and the cartons and trays at no cost to Supplier.
2.6 Third Party Suppliers.
Third Party suppliers of Materials must be agreed upon between the Parties, including any changes
thereto during the Term of this Agreement.
2.7 Costs and Expenses.
In addition to any other costs and expenses to be charged to the Purchaser in accordance with the
terms of this Agreement, all expenses associated with the development of the artwork, including but
not limited to expenses associated with the development and purchase of plates, cartons, labels and
inserts, will be billed to Purchaser separately [Redacted: Basis] and payable by Purchaser in
accordance with Section 3.4 of this Agreement. Copies of invoices from suppliers in support of
Suppliers invoice for such work will be provided to Purchaser upon request.
2.8 Addition of Products.
The Parties may add a product to this Agreement from time to time by entering into an amendment to
this Agreement (each a Product Amendment). Each Product Amendment shall form a part of this
Agreement and shall contain a description of the Product to be Manufactured pursuant to the terms
of that Product Amendment and of this Agreement, the Specifications for such Product, the price
payable by Purchaser to Supplier for the Product, territory(ies) in which Purchaser proposes to
distribute same and any additional provisions relating to such Product as the Parties shall agree
to. For greater certainty, the Supplier shall have no obligation to add a Product to the
Agreement. Supplier shall have the sole discretion as to whether or not it agrees to add a Product
to this Agreement.
ARTICLE III CONSIDERATION
3.1 Price of Products and Adjustment.
Price of Products. The price of the Products for the Calendar Year 2009 shall be as set out in
Schedule C (the Price) and is
dependent on the annual volume of Product purchased by Purchaser. The Price payable for the Products shall be the Price in force at the time of delivery of the
Products. On [Redacted: Term] of each subsequent year of the Term, the Price shall be subject to a
once annual increase. The increase will be [Redacted: Price Increase Calculation].Supplier will
provide Purchaser with a written
notice no later than [Redacted: Term] of each Calendar Year of the Term setting forth the Price for
the Products for the following Calendar Year. Supplier will provide
- 9 -
Purchaser [Redacted: Description of Documents] upon written request from Purchaser. The Price
shall also be payable for all samples of Products required to be maintained by Supplier under the
terms of this Agreement or any applicable Law as well as any additional samples which the Purchaser
requires, as the case may be, in addition to shipping and handling costs.
3.2 Annual Minimum Purchases.
(a)
Calendar Year 2010. For the Calendar Year 2010, Purchaser shall purchase from Supplier a
minimum volume of Product equal to [Redacted: Calculation of Minimum Volume].
(b) After Approval of the Product. In the Calendar Year in which the FDA approves the Product for
Commercial Sale in the Territory and for each Calendar Year thereafter during the Term, Purchaser
shall purchase from Supplier a minimum volume of Product equal to [Redacted: Calculation of Minimum
Volume] (Annual Minimum Purchase). Subject to Section 4.3(a), if Purchaser fails to purchase the
Annual Minimum Purchase from Supplier in the Calendar Year in which the FDA approves the Product
for Commercial Sale in the Territory and in any Calendar Year of the Term thereafter, Purchaser
shall pay to Supplier within [Redacted: Term] a penalty payment equal to [Redacted: Penalty]. The
penalty payment shall not be reduced in any way if the Failure to Supply is caused by Purchaser,
including, among others, delays in delivery by Purchaser of any Materials to be provided by
Purchaser or by Designated Suppliers or services or approval or changes requested by Purchaser to
be provided pursuant to this Agreement.
(c)
Materials. Beginning in the Calendar Year 2010 and in each Calendar Year of the Term
thereafter, Purchaser shall be responsible for the cost of obsolete or unused Materials reasonably
procured by Supplier for the purpose of meeting Purchasers demand pursuant to the forecasts
received by Supplier hereunder notwithstanding that Purchaser has no Annual Minimum Purchase
obligation hereunder.
3.3 Batch Size.
Batch size shall be based on the manufacturing Batch size as agreed by the Parties in Schedule C
and as set forth in the Quality Agreement. Batch size may be increased if mutually agreed to
between the Parties in writing.
3.4 Payment.
(a) Payment Terms. Purchaser shall pay Supplier for all Products Manufactured under the terms of
this Agreement within [Redacted: Term] of invoice date. Supplier shall issue invoices in respect
of the Product upon Delivery of the Product pursuant to Section 6.3 hereof unless the Product is
shipped under quarantine as per Schedule H hereto. An
interest at the rate of [Redacted: Percentage] per month ([Redacted: Percentage] per annum) shall be payable on all overdue accounts.
- 10 -
(b)
Advance Payment. If Purchaser does not pay Supplier within [Redacted: Term] period set
forth in Section 3.4(a), Supplier shall have the right, in addition to any other rights it may have
under this Agreement or pursuant to Law, [Redacted:
Description of Rights].
(c)
Outstanding Invoices Limit. The Parties agree that the value of the outstanding invoices issued
by Supplier to Purchaser shall not exceed at any given time [Redacted: Amount]. [Redacted:
Description of the Limit Establishment].
3.5 Taxes.
In addition to the amounts paid by Purchaser pursuant to Section 3.1, Purchaser shall pay to
Supplier all applicable use, consumption, sales or excise taxes of any taxing authority. The amount
of such taxes are not included in the Price and will be added to the Price in effect at the time of
Delivery thereof (unless shipped pursuant to Schedule H hereto) and will be reflected in the
invoices submitted to Purchaser by Supplier pursuant to Section 3.4 hereof. Purchaser shall pay the
amount of such taxes to Supplier in accordance with the payment provisions set forth in Section 3.4
hereof.
3.6 Capital Expenditures.
Any good constituting capital expenditures to Purchaser that Purchaser requests in writing Supplier
to purchase in order to Manufacture the Products will be payable by Purchaser upon the terms and
conditions agreed upon between the Parties and are not included in the Price.
3.7 Additional Costs.
The fees payable for additional services which may be performed by Supplier for Purchaser in
accordance with the provisions of this Agreement or the Proposals, as applicable, including without
limitation test method transfer, cleaning validation, manufacturing documentation, engineering
batches, demonstration/validation batches, process validation (sterilization and depyrogeneration),
analytical method validation, sterile filter validation, broth trial media fill, project
management, stability studies, site registration support and transfer, regulatory affairs and
laboratory support services will be payable by Purchaser within [Redacted: Term] of the invoice
date and are not included in the Price.
3.8 Cost of Changes.
(a)
Changes Requested by Purchaser. In the event that Purchaser desires any change to Materials or
components of the Products, process and other Specifications and/or controls, as well as the
Manufacturing and/or packaging of Products, Purchaser will notify Supplier in writing of any such
proposed change. Supplier shall have [Redacted: Term] to respond in writing to the proposed changes
and provide Purchaser with an estimate of the costs associated with the implementation of such
changes. Purchaser shall provide its written authorization of any change control within [Redacted:
Term] of the date of such response. Supplier reserves the right to cancel any change
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control opened and not authorized by Purchaser after such [Redacted: Term] period and to charge
Purchaser a cancellation fee of [Redacted: Amount] per change request if such change control was
requested by Purchaser. [Redacted: Redacted: Description of Costs]
(b) Changes to Comply with cGMP or Law. Purchaser shall be responsible for all costs and expenses,
associated with changes required in the Manufacturing formula and Specifications of the Products in
order to comply with changes to cGMP or applicable Laws occurring after the date of this Agreement
and not associated with the manufacture of products generally:
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(i) |
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Should the costs and expenses that would be payable by Purchaser pursuant to
the foregoing in order to comply with any such changes within the delay prescribed in
the cGMP or applicable Law exceed [Redacted: Percentage] to be Manufactured by Supplier
based on the last Ongoing Forecast provided to Supplier under Section 4.1 hereof at the
time the changes occurred, Purchaser shall have the right to terminate this Agreement
by giving Supplier a prior written notice within the delay prescribed in the cGMP or
applicable Law to comply with such changes, pursuant to Section 11.2(e) of this
Agreement. |
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(ii) |
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Supplier shall have the right to terminate this Agreement by giving Purchaser
prior written notice within the delay prescribed in the cGMP or applicable Law to
comply with such changes, should the cost and expenses that would be payable by
Supplier pursuant to the foregoing exceed [Redacted: Costs
and Expenses]. |
ARTICLE IV PRODUCT SUPPLY
4.1 Forecasts.
(a) Annual Forecasts. By no later than [Redacted: Term] after acceptance by the FDA of the New Drug
Application for the Product, Purchaser shall provide Supplier with a confirmed written [Redacted:
Term] forecast of its anticipated Product Manufacturing requirements to be Manufactured in
accordance with this Agreement for the upcoming Calendar Year (Annual Forecast). Within
[Redacted: Term] after the FDA has approved the Product for Commercial Sale in the Territory,
Purchaser shall provide Supplier with an updated Annual Forecast (Updated Annual Forecast).
Thereafter, by [Redacted: Date] of each Calendar Year of the Term, Purchaser shall provide Supplier
with a revised Updated Annual Forecast. Purchaser shall provide Supplier with a written
confirmation of such Annual Forecast and Updated Annual Forecasts by an authorized commercial
representative of Purchaser. Subject to Section 3.2(a) hereof, the Annual Forecast shall not be
binding on Purchaser. For greater certainty, Purchasers Annual Forecast, Updated Annual Forecast
and each revised Updated Annual Forecast sent to Supplier shall be presented on a Preferred Basis
proportion.
(b) [Redacted: Manufacturing Obligations].
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(c) Ongoing Forecasts. In addition to the Annual Forecasts, the Updated Annual Forecasts and the
revised Updated Annual Forecasts, at the latest on [Redacted: Term] Purchaser shall provide
Supplier with a copy of its forecast of its anticipated Product Manufacturing requirements for
[Redacted: Term] (the Ongoing Forecast). Each Ongoing Forecast shall provide Delivery dates for
each Firm Zone (as defined in Section 4.2(a)), in addition to quantity and purchase order specifics
for the Firm Zone, the Material Zone and the Open Zone. In the event that an Ongoing Forecast is
not delivered on [Redacted: Term] in accordance with this provision, [Redacted: Term] [Redacted:
Manufacturing Obligations].
4.2 Order Procedures.
(a) Firm Zone. After the approval of the Product by the FDA for its Commercial Sale in the
Territory, product quantities forecasted for [Redacted: Term] of each revised Updated Annual
Forecast and each Ongoing Forecast (Firm Zone) are deemed to be binding orders and as such
Purchaser and Supplier are committed to same. Product quantities forecasted in the Updated Annual
Forecast are deemed to be binding orders from [Redacted: Term]. For example, [Redacted: Term]. The
Parties shall use reasonable best efforts to negotiate any change in the Delivery date of any
binding order; provided, however, that:
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(i) |
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if Purchaser reduces its requirements for Products to be Manufactured in the
Firm Zone of an Ongoing Forecast, Purchaser shall [Redacted: Obligations]; and |
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(ii) |
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if Supplier agrees to Manufacture additional quantities of the Products in the
Firm Zone of an Ongoing Forecast, Purchaser, in addition to the Price, shall reimburse
Supplier for any incremental costs incurred by Supplier in this regard. Supplier shall
submit such incremental costs to Purchaser prior to the Manufacture of such additional
quantities of Products. |
(b) Material Zone. Excluding the Firm Zone, Product quantities forecasted for the [Redacted: Term]
following the Firm Zone of the Updated Annual Forecast, the revised Updated Annual Forecast and any
Ongoing Forecast (Material Zone) are [Redacted: Obligations]. Changes of timing for Delivery of
Products within the Material Zone may be made to respond to changing customer demand; provided,
however, that if any order made by Purchaser for Products to be Delivered during the Material Zone
of the Updated Annual Forecast, the revised Updated Annual Forecast or any Ongoing Forecast is
cancelled, deferred or reduced, so as to result in a lesser quantity of Products ordered by
Purchaser than indicated in the corresponding month of such Material Zone, Purchaser shall be
[Redacted: Obligations]. For greater clarity, [Redacted: Obligations].
(c) Open Zone. Product quantities forecasted for the [Redacted: Term] following the Material Zone
of the Updated Annual Forecast, the revised Updated Annual Forecast and any Ongoing Forecast (Open
Zone) are [Redacted: Obligations] . The Parties
- 13 -
acknowledge and agree that the requirements specified in the Open Zone of the Updated Annual
Forecast, the revised Updated Annual Forecast and any Ongoing Forecast are for the purposes of
Suppliers internal scheduling and planning only and Purchaser shall not be responsible for any
costs of Materials procured or other expenses incurred by Supplier for the purpose of meeting the
requirements specified in the Open Zone, unless related to Long Lead Time Materials as referenced
in Section 4.2(d) or agreed to by both Parties.
(d) Long Lead Time Materials. Any inventory of Materials held by Supplier beyond requirements
necessary for the supply of the Products required under the Firm Zone and the Material Zone or any
safety stock pre-approved by Purchaser (Long Lead Time Materials) is the responsibility of
Supplier. However, if the Parties agree on the purchase or entering into of commitments to purchase
any Long Lead Time Materials based on the Ongoing Forecast for [Redacted: Term] and (i) those Long
Lead Time Materials cannot be used by Supplier for Products or for other Supplier business within
[Redacted: Term] for which those Long Lead Time Materials were purchased, or (ii) if this Agreement
is terminated or expires, whichever occurs first, Purchaser shall pay Supplier for those Long Lead
Time Materials, provided that Supplier shall make commercially reasonable efforts to minimize its
quantities of unusable Long Lead Time Materials.
(e) Inventory Carrying Fees. If Supplier is required to store at the Facility Materials supplied to
it by Purchaser for a period longer than the [Redacted: Term] or store Products for a period longer
than [Redacted: Term] after the Product has passed release Specification criteria, then Purchaser
shall pay to Supplier a reasonable and customary inventory carrying fee, such fee being in addition
to the Price (Inventory Carrying Fee). Said Inventory Carrying Fee is estimated at [Redacted:
Amount] for Calendar Year 2009 and will be determined at the time of storage based on market
conditions. The Inventory Carrying Fee may be increased by Supplier on a yearly basis by giving a
[Redacted: Term] prior written notice to Purchaser. The increase, if any, [Redacted: Price Increase
Calculation]. Notwithstanding anything to the contrary set forth herein, Supplier reserves the
right to refuse such warehousing request if it does not have the necessary additional warehousing
capacity.
(f) Graphic Changes. If there is to be changes to any artwork for any Product, at least [Redacted:
Term] prior to the intended first Delivery date of such Product with such changed artwork,
Purchaser shall provide to Supplier, at no cost, digital artwork in a format acceptable to Supplier
and in compliance with the packaging specifications for such Product.
(g) Safety Stock. Supplier will carry the necessary safety stock of Materials to support the Firm
Zone and Material Zone lead times and to ensure timely Delivery of orders of Products. Any safety
stock of Long Lead Time Materials must be approved in writing by Purchaser pursuant to Section
4.2(d) hereof and is subject to payment by Purchaser of a storage fee to be mutually agreed upon
between the Parties. Supplier shall have the right to build and carry a [Redacted: Term] inventory
of Products at the Facility if each of the following conditions are met: [Redacted: Description of
Conditions]. Notwithstanding the foregoing, Supplier will be responsible for [Redacted:
- 14 -
Costs] [Redacted: Obligation of Supplier] if Supplier provides Purchaser on the requested delivery
date with a Product that does not [Redacted: List of Conditions].
For the purposes of this paragraph 4.2(g) only, the expression requested delivery date
shall be the date requested by Purchaser for the Product to be made available for shipment. Title
and risk to the Product shall pass to Purchaser on such requested delivery date.
4.3 Purchase Orders.
(a) General. Purchaser shall deliver to Supplier purchase orders (each a Purchase Order) for the
aggregate quantity of Batches of Product in each Firm Zone. Each Purchase Order shall specify the
number of Batches of Product ordered, the Price, the requested Delivery date, the shipping
destination of the Batches of Product and Purchasers instructions for such shipping, in accordance
with the provisions of Section 5.1(c) of this Agreement. Purchase Orders shall be delivered at
least [Redacted: Term] in advance of the requested Delivery date.
(b) Transmission. The Purchase Orders may be transmitted electronically or by other means in such
location as Supplier shall designate from time to time. Supplier shall promptly acknowledge receipt
of each Purchase Order by sending to Purchaser electronic (email and/or fax) written notice of
acknowledgement for each Purchase Order within [Redacted: Term] after its receipt.
(c) Rejection and Deemed Acceptance. Notwithstanding anything in this Agreement to the contrary,
Supplier shall be bound by Purchase Orders delivered to Supplier for Product quantities forecasted
within the Firm Zone or which are deemed to be accepted hereunder (Accepted Purchase Order).
However, Supplier reserves the right at its sole discretion to reject without liability the
Manufacturing of Product quantities in any Purchase Order that exceed the quantities forecasted in
the Firm Zone or for reasons of Force Majeure; provided, however, that failure by Supplier to
deliver to Purchaser a written notice objecting to the Manufacture of quantities of Product
exceeding the quantities forecasted in the Firm Zone within [Redacted: Term] after receipt of the
Purchase Order shall constitute Suppliers deemed acceptance of said Purchase Order. If Purchase
Orders for Product quantities which exceed the Product quantities forecasted in the Firm Zone are
rejected by Supplier, the excess Product quantities shall not be included in the calculation of the
Annual Minimum Purchase set forth in Section 3.2.
(d) Failure to Supply.
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(i) |
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In the event that Supplier is not, or anticipates that it will not be, able to
fulfill the terms of an Accepted Purchase Order, Supplier shall promptly notify
Purchaser of that fact and Supplier shall [Redacted: Obligation of Supplier] to
minimize the damage to Purchaser caused by Suppliers inability to comply with the
terms of an Accepted Purchase Order. |
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(ii) |
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[Redacted: Purchasers Rights]. |
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(e) Accommodations. From time to time, due to significant unforeseen circumstances, Purchaser may
deliver to Supplier a Purchase Order for Product volumes in excess of those specified in any Firm
Zone. Supplier shall work with Purchaser on a reasonable commercial basis to assist with delivery
of such volume excesses; provided, however, that:
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(i) |
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Supplier shall not be obliged to use commercially reasonable efforts to deliver
excess volumes of Product exceeding [Redacted: Percentage] of the Product volumes
specified in the Firm Zone for Calendar Year 2009 and until [Redacted: Term] from the
approval of a Product by the FDA for Commercial Sale in the Territory and, thereafter,
[Redacted: Percentage] of the Product volumes specified in the Firm Zone; and |
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(ii) |
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[Redacted: Suppliers Rights]. |
4.4 Standard Forms.
In ordering and delivering the Products pursuant hereto, Supplier and Purchaser may employ their
standard forms, but nothing in those forms shall be construed to modify, amend or supplement the
terms of this Agreement and, in the case of any conflict between those forms and this Agreement,
the terms of this Agreement shall prevail.
ARTICLE V DELIVERY, TITLE AND ACCEPTANCE
5.1 Product Storage and Shipment.
(a) Storage Conditions. The Materials and Products manufactured by Supplier are to be stored and
transported in accordance with the conditions agreed between Purchaser and Supplier and in
accordance with the Specifications and applicable Laws.
(b) Transfer of Title. Title to and risk for the Products Manufactured by Supplier under this
Agreement shall pass to Purchaser [Redacted: Condition to Transfer of Risk]. Except if caused by
Suppliers own fault or negligence, Supplier shall not be liable to Purchaser for the costs of loss
of any kind arising out of or in relation to damage to or loss of a Product, however caused, which
occurs after title to and risk for a Product passes to Purchaser, nor shall any liability of
Purchaser to Supplier under this Agreement be diminished or extinguished by reason of such loss or
damage. For greater certainty, Purchaser shall be liable for all costs and risks of loss [Redacted:
Condition to Transfer of Risk].
(c) Shipment of Products. Shipment of a Product from Suppliers Facility to Purchaser or
Purchasers designee shall be made [Redacted: Delivery Terms] Shipment of a Product shall be made
at Purchasers sole cost and expenses and Purchaser shall be liable for any and all transportation
charges, including without limitation freight, duties and taxes levied in connection with the
shipment of the Products. Supplier shall arrange for the shipment of the Products in accordance
with Purchasers instructions. Purchaser shall select and retain the carrier and insurance company
for shipping of the Products in
- 16 -
accordance with the terms of this Agreement. Purchaser shall provide Supplier with its carriers
name and account number and its insurance company contact information. Supplier will schedule
freight pick up with Purchasers selected carrier and complete the documentation on behalf of
Purchaser for each shipment of Product by using Purchasers account number. All costs and invoices
shall be charged by Purchasers selected carrier directly to Purchaser for all Third Party costs
related to same. If Purchaser wishes the shipment of the Products to be on any unique pallets,
Purchaser shall, at its own cost and expense, make such pallets available to Supplier.
5.2 Purchaser Acceptance.
(a) Quantitative Defects. Purchaser shall inform Supplier in writing of any claim relating to
quantitative defects in shipments of Batches of Product within [Redacted: Term] from the receipt by
Purchaser or Purchasers designee of such Batches of Product and Purchaser shall provide to
Supplier copies of any appropriate documents relating to such defects. Supplier shall at its own
expense, including, notwithstanding Section 5.1(b) hereof, shipment and insurance expenses, provide
Purchaser with any missing quantities of a Product as soon as reasonably possible after receipt of
notice from Purchaser. Any claim for a quantitative defect which is not made within such [Redacted:
Term] period shall be deemed to have been waived by Purchaser. Purchaser shall have the right to
deduct from payment any missing quantity of Product shipped until resolution of the matter pursuant
to this Agreement provided that Purchaser has notified Supplier in writing of its claim pursuant to
this Section 5.2(a).
(b) Qualitative Defects. Purchaser shall have [Redacted: Term] from receipt by Purchaser or
Purchasers designee of each Batch of Product in which to determine by appropriate validated tests
and assays whether or not each Batch Delivered conforms to the Specifications. If Purchaser deems
that a Batch does not conform to the Specifications
(Rejected Batch), [Redacted: List of Conditions] , Purchaser may reject such Batch by giving
written notice to Supplier within [Redacted: Term] after receipt by Purchaser or Purchasers
designee of such Batch of Product (Rejection Notice). Purchaser must specify in reasonable detail
the manner in which such Batch fails to meet the Specifications. Purchaser may withhold payment for
any Batch of Product for which a Rejection Notice has been given to Supplier [Redacted: Term].
Purchaser shall be deemed to have accepted any Batch with respect to which it fails to notify
Supplier as provided in this Section 5.2(b).
(c) Disposition of Rejected Batch. Supplier shall have [Redacted: Term] from the receipt of the
Rejection Notice to accept or reject Purchasers claims and submit a report on the Rejected Batch
indicating the investigation and testing done and the recommended disposition to Purchaser, as the
case may be. Purchaser shall review such report and notify Supplier that Purchaser either requests
additional data, approves the recommended disposition of the Rejected Batch or will otherwise
direct Supplier as to how Purchaser wishes the Rejected Batch to be disposed of. Purchaser shall
have [Redacted: Right of Purchaser] of the Rejected Batch until resolution of the dispute pursuant
to this Agreement.
- 17 -
(d) Dispute of Test Results. If the Parties fail to agree on whether a Batch of Product fails in
whole or in part to meet the Specifications and on the disposition of such Rejected Batch, such
dispute shall be resolved promptly by an independent testing organization of recognized repute
within the pharmaceutical industry of the Territory mutually agreed upon by the Parties. The
appointment of such organization shall not be unreasonably delayed by either Party. The decision of
such testing organization shall be binding on both Parties. The fees and costs of the testing
organization, and storage and handling of the Product during the dispute shall be [Redacted: Cost
Allocation]. If the Parties agree that a Rejected Batch conforms to the Specifications or if the
dispute in this regard has been resolved pursuant to Section 5.2(d) in favour of Supplier,
Purchaser shall provide Supplier with payment for such Rejected Batch forthwith.
(e) Rework, Reprocessing and Replacement of Rejected Batch.
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(i) |
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If the Parties agree that a Rejected Batch fails in whole or in part to conform
to the Specifications, or if the dispute between the Parties in this regard has been
resolved pursuant to Section 5.2(d) in favour of Purchaser, Supplier agrees to use its
commercially reasonable best efforts to either: |
|
A. |
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if possible, rework or reclaim the Rejected Batch, which shall
be returned to Supplier forthwith and Supplier shall assume [Redacted: Costs],
if any, in connection with the shipment of same; or |
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|
B. |
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destroy the Rejected Batch, which Batch shall be returned to
Supplier forthwith and Supplier shall assume [Redacted: Costs], if any, in
connection with the shipment of same and deliver [Redacted: Costs] a
replacement shipment for the Rejected Batch (Replacement Batch), [Redacted:
List of Conditions]; |
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within [Redacted: Term] of the date Supplier accepts Purchasers written Rejection
Notice or the date of the final resolution of the dispute, whichever is the
earliest. The [Redacted: Term] delay is subject to Supplier having all Materials in
inventory, including Long Lead Time Materials. |
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(ii) |
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Notwithstanding the existence of a dispute concerning a Product rejected by
Purchaser, pending resolution of such dispute, Supplier shall, within [Redacted: Term]
of issue by Purchaser of a Purchase Order for additional Batches of Product of the type
and quantity claimed to be rejected as contemplated by Section 5.2(b) hereof, deliver
such additional Batches of Product and Purchaser shall be obligated to pay for such
Batches of Product in accordance with Section 3.4 hereof. The [Redacted: Term] delay is
subject to Supplier having all Materials in inventory, including Long Lead Time
Materials. |
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(iii) |
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Notwithstanding anything to the contrary contained herein, should the Rejected
Batch have failed to meet the Specifications [Redacted: List of Conditions and
Suppliers Obligations]. |
5.3 Recalls.
(a) Each Party shall notify the other in writing within [Redacted: Term] of such Partys receipt of
any order, request or directive of a court or governmental authority relating to the recall or
withdrawal of the Products. Purchaser shall have sole control over the administration of any recall
or withdrawal, whether voluntary or involuntary, of the Products. Supplier shall cooperate with
Purchaser in the event of any recall or withdrawal of the Products in the Territory in connection
with the quality of the Product Manufactured by Supplier and provide such reasonable assistance in
connection therewith as Purchaser may reasonably request. Subject to Article X hereof, the direct
costs of any recall or withdrawal shall be borne by [Redacted: Cost Allocation]
ARTICLE VI QUALITY ASSURANCE AND CONTROL
6.1 Form of Quality Agreement.
The Parties will agree on a Quality Agreement, which will set forth the technical terms of supply
needed to satisfy quality control considerations for Manufacturing by Supplier under this
Agreement. The Parties agree that, if any provisions of the Quality Agreement are inconsistent with
this Agreement, the provisions of this Agreement shall govern to the extent of such inconsistency.
6.2 Testing.
Supplier shall perform the quality control tests and assays identified in the Quality Agreement and
in accordance therewith.
6.3 Product Batch Release.
Supplier shall be responsible for the technical release to Purchaser of each Batch of Product
Manufactured and Purchaser shall be responsible for the release of the Product to the market. A
Batch of Product can be released once Supplier has performed, or has had performed under its
supervision by a Third Party, all customary tests as per the Specifications and the Product meets
the Specifications. In addition to the invoice described under Section 3.4, Supplier will provide a
Batch Certificate of Analysis with representative chromatograms with each Batch of Product upon the
release of such Batch of Product by Supplier. Supplier will also provide, as part of the
Certificate of Analysis, an American equivalent to a Certificate of Manufacture (as defined in
the Canadian good manufacturing practices) in the form attached hereto as Schedule H. This
Certificate of Manufacture will certify that the Batch of Product was Manufactured and tested in
conformance with the Specifications and applicable cGMP and will list deviations and
investigations, as applicable.
- 19 -
[Redacted: Amount] full Batch record (i.e. Certificate of Manufacture, Certificate of Analysis,
list of Quality Events, Manufacturing Records and Packaging Records) will be provided by Supplier
to Purchaser [Redacted: Amount] of any Product and, subsequently, [Redacted: Term] of the Term of
this Agreement per Product and per dosage form. Purchaser may request thereafter full Batch records
with each Batch of Product released to Purchaser subject to payment by Purchaser of [Redacted:
Amount]. [Redacted: Cost] shall be payable by Purchaser to Supplier to have the full Batch records
of a Batch of Product that was released to the market which, thereafter, becomes subject to an
investigation.
Supplier will not ship a Batch of the Product if such Batch is under quarantine (before Suppliers
internal release pursuant to this Agreement), unless on exceptional basis and after receipt of the
other Partys written authorization in the form attached hereto as Schedule I.
Once all the customary testing performed by, or made under the supervision of, the Supplier is
completed pursuant to the Specifications and the Product meets the Specifications, Purchaser agrees
that Supplier shall have the right to Deliver a Product to Purchaser pending the receipt by
Purchaser of test results from any Third Party testing laboratory unless Purchaser sought those
tests in the context of a dispute with Supplier on the quality of a Product.
Purchaser shall be responsible for all changes to the Specifications as a result thereof and
Purchaser shall be solely liable for the release of the finished Products to the market.
6.4 Retention Samples.
Sampling details and schedules must be agreed to by the Parties prior to implementation and
incorporated into the Quality Agreement. The costs of retained samples shall be charged back to
Purchaser [Redacted: Costs], as the case may be, plus shipping and handling costs, if applicable.
6.5 Designated Suppliers Audit.
If Purchaser and Supplier agree that Supplier shall be responsible for the performance of a
Designated Suppliers Audit, Purchaser agrees that such Designated Suppliers Audit shall be
performed at Purchasers sole cost and expense and Purchaser shall indemnify Supplier within
[Redacted: Term] of the invoice date for any such costs and expenses incurred as a result of such
Designated Suppliers Audit. The rate to be charged to Purchaser for the performance of such
Designated Suppliers Audit shall be Suppliers applicable standard rate. Such standard rate is
established at [Redacted: Amount] for Calendar Year 2009. Such standard rate may be increased by
Supplier [Redacted: Price Increase Calculation].
6.6 Manufacturing Records.
Supplier shall maintain true, accurate and complete records regarding the Manufacturing of the
Products as required by applicable Law (Manufacturing Records) including,
- 20 -
without limitation, the information required to be maintained pursuant to the Quality Agreement.
ARTICLE VII REGULATORY MATTERS
7.1 Audit and Inspection.
(a) Purchaser Audit. Supplier grants Purchaser the right to audit or to appoint Third Parties
[Redacted: Description of Third Parties], to audit the Facility and Suppliers documentation on an
annual basis demonstrating Suppliers satisfactory performance of its obligations under this
Agreement and the Quality Agreement. Such audit shall be conducted during normal business hours for
a period not to exceed [Redacted: Term], by a maximum of [Redacted: Amount] auditors. Additional
auditors and/or Business Days may be agreed upon between the Parties subject to payment by
Purchaser of an additional fee of [Redacted: Amount] per additional auditor and per additional
Business Day. Purchaser will notify Supplier in writing at least [Redacted: Term], in advance of
such an audit. Notwithstanding anything to the contrary contained herein, the right to audit
granted to Purchaser herein shall be limited to [Redacted: Amount] per Calendar Year and may only
be exercised during the months of [Redacted: Term], save and except for situations where a single
audit reveals significant concerns from the perspective of Purchaser and [Redacted: Description of
Third-parties], acting reasonably, that require appropriate additional audit follow-up or when an
audit for cause is warranted, in which event, any such additional audit shall not be limited in
time and shall not be subject to the payment of any additional fee to Supplier.
Any Person appointed by Purchaser to perform such an audit shall at all times be bound by the
obligations of confidentiality and non-disclosure of Suppliers confidential information and agree
to disclose to Purchaser only such information as is necessary to determine if Supplier is
performing its obligations under Article II. Such Person shall also agree to disclose to Supplier
the results of its review.
It is furthermore agreed that the on-site availability of Purchaser, or such appointed Person,
shall have no bearing on Suppliers production schedule as Supplier shall be authorized and
entitled to proceed with same in the absence of Purchasers or such appointed Persons
representative.
(b) Inspection by Governmental Authorities. Supplier shall permit inspections of the Facility by
Governmental Authorities of the Territory with respect to the fulfillment of any requirement for
any License during the Term of this Agreement and, if necessary, thereafter.
(c) Inspection Notification. Supplier agrees to promptly notify Purchaser of any inspection by any
Governmental Authority pending as of the date hereof or as notice of same may arise during the
Term, and of any communications to or from any Governmental Authority (including the reporting of
adverse drug experiences or field alerts) which might adversely affect Suppliers ability to
perform its obligations under this Agreement. Supplier shall keep Purchaser informed of the
resolution of the matter
- 21 -
with the relevant Governmental Authority and if responses have a direct impact on the Product,
Supplier shall provide Purchaser with the proposed resolution prior to sending same to the
Governmental Authority. In such circumstances, Supplier shall take into consideration any comments
received from Purchaser prior to such sending.
(d) Order by Governmental Authority. Should the HPFBI or the FDA require Purchaser to stop selling
the Products in the Territory, Purchaser shall have the right to suspend this Agreement and mutual
obligations by sending written notice to Supplier or to terminate this Agreement pursuant to
Section 11.2(e) hereof. Notwithstanding Section 12.2(b) hereof, any such suspension or termination
by Purchaser shall not relieve Purchaser of its obligation to reimburse Supplier for [Redacted:
Reimbursement Obligation] Purchaser shall not be bound to reimburse Supplier for the [Redacted:
Reimbursement Obligation] if such suspension or termination solely arises out of or results from an
event caused by Suppliers negligence or breach of this Agreement.
7.2 Regulatory Submissions.
Supplier shall provide reasonable support for any submissions required to the HPFBI, FDA and other
applicable Governmental Authority to support contract manufacturing of Purchasers Products by
Supplier at the Facility.
The Parties agree that, other than for reasonable regulatory efforts in connection with requests
made by Purchaser for changes to Specifications, all regulatory support services, including without
limitation the gathering of documents in support of a Product submission or APR, notarization of
documents, company registration (such as CoAs and form 2657), auxiliary regulatory services (such
as sterility packages, clarifax, question answering, legalization of document) are not included in
the Price.
All regulatory support services set forth above shall be charged to Purchaser in accordance with
the standard rates established by Supplier for said services from time to time in addition to
notary and legal fees, where applicable. Suppliers rate for regulatory support services is
established at [Redacted: Amount] for Calendar Year 2009. Such standard rate may be increased by
Supplier [Redacted: Term] and notice in writing shall be given to the Purchaser. Such increase
[Redacted: Price Increase Calculation]. Purchaser shall pay Supplier for all regulatory support
services within [Redacted: Term] of invoice date.
ARTICLE VIII REPRESENTATIONS AND WARRANTIES
8.1 Supplier Representations and Warranties.
(a) Representations and Warranties. Supplier represents, warrants and covenants, while
acknowledging that Purchaser is relying on such representations and warranties in entering into
this Agreement, that:
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(i) |
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in performing its services hereunder, Supplier shall comply with all
provincial, state, local and federal Laws and the cGMP applicable to such |
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services and shall hold, and shall continue to hold during the Term of this
Agreement, all Licenses necessary or required for the Manufacturing of the Products
for sale in the Territory and the performance of its obligations hereunder; |
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(ii) |
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the Facility, all equipment and tooling utilized in the Manufacturing of the
Products hereunder, and the procedures and processes (including installation, operation
and performance qualifications) instituted by Supplier in connection herewith are, and
shall continue during the term of this Agreement, to be in material compliance with all
applicable Laws and maintained in good operating condition; |
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(iii) |
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[Redacted: Representation] |
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(iv) |
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[Redacted: Representation] |
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(v) |
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Supplier shall carry and keep in good force during the Term of this Agreement
and for a period of [Redacted: Term] thereafter, a comprehensive general liability,
product liability and commercial property insurance coverage in such form and amount as
a reasonable party in similar circumstances would carry and keep to fulfil its
obligations hereunder (in an amount no less [Redacted: Amount]. Supplier shall submit a
certificate of such insurance (which shall include such information) to Purchaser for
its approval within [Redacted: Term] of the date of signature of this Agreement. If
such certificate is not furnished within [Redacted: Term], Purchaser shall notify
Supplier in writing and give Supplier [Redacted: Term] to cure such breach. If Supplier
fails to provide the certificate during such [Redacted: Term] cure period, Purchaser
may, at its option, immediately terminate this Agreement or any amendment thereof; |
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(vi) |
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the Products Manufactured by Supplier under the terms of this Agreement: |
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A. |
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will comply with the Specifications and applicable Laws,
including cGMP in accordance with general industry practice; |
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B. |
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shall not contain any material that would cause the Products to
be adulterated within the meaning of the Food and Drug Act (Canada) or
adulterated or misbranded within the meaning of Section 404 or 505 of the
Federal Food, Drug and Cosmetic Act as amended, or the regulations issued
thereunder or within the meaning of any provincial, state or local law the
adulteration and misbranding provisions of which are similar to such Act; and |
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C. |
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shall be free from material defects in Materials and
workmanship not otherwise caused by Materials supplied by Purchaser or by any
Designated Suppliers or defect in the Specifications and/or in Purchasers
formula for the Manufacturing of the Product . |
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(vii) |
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Supplier is a general partnership duly constituted, validly existing and in
good standing under the laws of the Province of Ontario; |
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(viii) |
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Supplier has the power and authority to conduct its business as currently being
conducted and as contemplated herein; |
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(ix) |
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Supplier has the power and authority to make, deliver and perform its
obligations under this Agreement by way of its managing partner and has taken all
necessary action to authorize the execution, delivery and performance of this
Agreement. |
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(x) |
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the execution, delivery and performance of this Agreement by Supplier will not
violate any agreement or instrument to which Supplier is a party. |
(b) Exclusions. The warranties with respect to the Products shall not apply to any Product which,
[Redacted: Exclusions].
(c) Limitation. Subject to applicable Law, Supplier makes no other warranty or representation,
express or implied, with respect to the Products, whether as to merchantability, quality or fitness
for a particular purpose.
8.2 Purchaser Representations and Warranties.
(a) Representations and Warranties. Purchaser represents and warrants, while acknowledging that
Supplier is relying on such representations and warranties in entering into this Agreement, that:
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(i) |
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it shall provide all information necessary for Supplier to Manufacture the
Products in accordance with the Specifications and all applicable Laws, including cGMP,
and shall make its employees available on a timely basis to respond to questions
concerning such information; |
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(ii) |
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to the extent that Purchaser supplies any Materials, including the Active
Pharmaceutical Ingredient, or other information to Supplier (including packaging and
labelling requirements) or engages in Manufacturing with respect to any of the Products
(either directly or indirectly through a Third Party), all such Materials or other
information and Manufacturing will comply with the Specifications and applicable Laws,
including cGMP; |
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(iii) |
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it shall obtain and maintain all necessary permits, registrations and licences
required for it to perform its obligations to Supplier under this Agreement and shall
comply with all applicable Laws in carrying out its obligations under this Agreement; |
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(iv) |
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Purchaser shall carry and keep in good force during the Term of this Agreement
and for a period of [Redacted: Term] thereafter, insurance coverage, including product
liability insurance, in such form and amount as a reasonable party in similar
circumstances would carry and keep to |
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fulfill its obligations hereunder (in an amount no less than [Redacted: Amount].
Purchaser shall submit a certificate of such insurance (which shall include such
information) to Supplier for its approval within [Redacted: Term] of the date of
signature of this Agreement. If such certificate is not furnished within [Redacted:
Term], Supplier shall notify Purchaser in writing and give Purchaser [Redacted:
Term] to cure such breach. If Purchaser fails to provide the certificate during such
[Redacted: Term] cure period, Supplier may, at its option, immediately terminate
this Agreement or any amendment thereof; |
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(v) |
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[Redacted: Representation]; |
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(vi) |
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[Redacted: Representation]; |
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(vii) |
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Purchaser is a corporation duly organized, validly existing and in good
standing under the laws of the Province of Québec; |
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(viii) |
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Purchaser has the power and authority to conduct its business as currently being
conducted and as contemplated herein; |
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(ix) |
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Purchaser has the power and authority to make, deliver and perform its
obligations under this Agreement and has taken all necessary action to authorize the
execution, delivery and performance of this Agreement; |
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(x) |
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the execution, delivery and performance of this Agreement by Purchaser will not
violate any agreement or instrument to which Purchaser is a party. |
8.3 Undertakings Relating to Representations and Warranties
Purchaser and Supplier agree to promptly notify each other in the event any of the representations
made to the other hereunder is inaccurate.
ARTICLE IX INTELLECTUAL PROPERTY
9.1 Ownership.
(a) Purchaser Rights. Supplier acknowledges that Purchaser is the sole owner of Purchaser
Intellectual Property and of all data and information relating to the Products, including the
Specifications and any other information
relating thereto delivered by Purchaser to Supplier under this Agreement, except to the extent such
information is in the public domain, without breach of Suppliers confidentiality obligations or
owned by a Third Party.
(b) Supplier Rights. Purchaser acknowledges that Supplier is the sole owner of the Supplier
Intellectual Property.
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(c) Product Developments. All Intellectual Property relating to a Product conceived, reduced to
practice, authored or otherwise generated or developed in the course of activities under this
Agreement, either by or on behalf of Supplier, except if it has general applicability to the
manufacture of pharmaceutical products other than the Products, shall
be Product Developments.
Purchaser shall own all right, title and interest in and to all Product Developments, whether made,
conceived, reduced to practice, authored or otherwise generated or developed solely by Supplier
personnel, or jointly by Supplier and Purchaser personnel, and all rights to Intellectual Property
arising therefrom. Supplier will, and hereby does, assign to Purchaser all of its rights, title and
interest in and to Product Developments and rights to Intellectual Property arising therefrom.
Supplier will provide reasonable assistance to Purchaser, at Purchasers expense, in obtaining and
enforcing Purchasers ownership of the Product Developments including as applicable the assignment
to Purchaser of the right, title and interest of its employees or independent contractors in and to
such Product Developments.
(d) Patents. As soon as practicable after reduction to practice by Supplier of any Product
Development, Supplier shall inform Purchaser in writing of such Product Development. Upon
Purchasers reasonable request and at Purchasers expense, Supplier shall take such reasonable
actions as Purchaser deems necessary or appropriate to assist Purchaser in obtaining patent or
other proprietary protection in Purchasers name with respect to all Product Developments.
(e) License. Under the terms and subject to the conditions of this Agreement, Purchaser hereby
grants Supplier a non-exclusive, royalty-free license to use the Purchaser Intellectual Property
and the Product Developments for the sole purpose of performing its obligations hereunder in
Canada. Unless otherwise agreed to in writing by Purchaser, Supplier shall have no right to make or
manufacture Product for the benefit of a Third Party and to supply, distribute or sell the Products
to a Third Party or use any Purchaser Intellectual Property for any other purpose. Supplier shall
have no right to grant sub-licenses to any Person, except if agreed to otherwise in writing between
the Parties.
9.2 Reproduction of and Right to Use Trademarks.
Solely in connection with Suppliers performance of its obligations under this Agreement, Purchaser
hereby grants Supplier the non-exclusive right in Canada to reproduce and print on the Products
and/or Product packaging such trademarks, trade dress, brand names, and/or trade names that
Purchaser may designate in writing from time to time, strictly in accordance with trademark usage
and packaging guidelines set forth in the Specifications or otherwise provided by Purchaser in
writing. Samples of all such uses of Purchasers trademarks, trade dress, brand names and/or trade
names on the Products or Product packaging shall be submitted to Purchaser for its written approval
prior to production. The permission granted to Supplier herein is restricted to usage of such
trademarks, trade dress, brand names and/or trade names on or in connection with the Manufacturing
of the Products supplied under this Agreement, and the performance of any additional services
requested by Purchaser pursuant to the terms of this
- 26 -
Agreement, and such permission extends only for the Term of this Agreement or such shorter period
as may be designated or required by Purchaser.
9.3 Suppliers Ownership of Other Property.
Except as set forth in Schedule G attached hereto, it is agreed that Supplier is the sole owner
of any and all machinery and equipment used by Supplier in connection with the Manufacturing of the
Products in accordance with this Agreement.
9.4 Infringement by a Third Party.
(a) Notice. In the event that either Party becomes aware of actual or threatened infringement by a
Third Party of Intellectual Property related to the Manufacture, sale, supply or distribution of
any Product, that Party shall promptly so notify the other in writing. Purchaser shall have the
right, but not the obligation, to bring at its own expense an infringement action or file any other
appropriate action or claim related to infringement of such Intellectual Property against any Third
Party. Supplier shall have the option to join in at its sole costs and expenses (but not to
control) such action if Supplier has been damaged by the actions of such Third Party.
(b) Settlement. Each Party shall cooperate and provide reasonable assistance in any action as
described above. [Redacted: Settlement Conditions]
(c) Damages. Purchaser shall retain any damages or other monetary awards that it recovers pursuant
to any action under this Section 9.4.
9.5 Right to not Manufacture.
Supplier shall not be required to Manufacture or supply any Product to which:
[Redacted: Conditions].
ARTICLE
X INDEMNITIES
10.1 Indemnity of Supplier.
Subject to the limitations provided for in Section 10.4 hereof, and except to the extent that
Supplier is obligated to indemnify Purchaser under Section 10.2 hereof, Purchaser shall defend,
indemnify and hold harmless Supplier, its Affiliates, and its and their respective officers,
directors, employees, agents and representatives harmless from and against any and all Losses
suffered, incurred or sustained by any of them or to which any of them becomes subject at any time
by reason of any Proceeding to the extent arising out of or resulting from:
(a) the use, Manufacture, processing, testing, packaging, labelling or storage of or any other
dealing with any or all of the Products, but only to the extent that such liability does not arise
as a result of the negligence or wilful misconduct of Supplier and its agents
- 27 -
in performing its obligations under this Agreement, a breach of any material term of this Agreement
by Supplier and its agents, including, without limitation, Suppliers representations and
warranties or failure by Supplier and its agents to perform a covenant under this Agreement;
(b) subject to Section 5.3 hereof, any recall or market withdrawals of any Product Manufactured by
Supplier;
(c) any claim that the Manufacturing of a Product under this Agreement or its sale or supply to
Purchaser infringes a Third Partys Intellectual Property, except where such claim arises out of or
results from the use of Suppliers Intellectual Property;
(d) the breach by Purchaser of any of the material terms of this Agreement including, without
limitation, Purchaser representations and warranties provided for in Section 8.2 hereof; or
(e) the negligence or wilful misconduct of Purchaser, its officers, directors, employees and agents
in performing its obligations under this Agreement.
10.2 Indemnity of Purchaser.
Subject to the limitations provided for in Section 10.4 hereof, and except to the extent that
Purchaser is obligated to indemnify Supplier under Section 10.1 hereof, Supplier shall defend,
indemnify and hold harmless Purchaser, its Affiliates, and the officers, directors, employees,
agents and representatives harmless from and against any and all
Losses suffered, incurred or sustained by any of them or to which any of them becomes subject at
any time by reason of any Proceeding to the extent arising out of or resulting from:
(a) the negligence or wilful misconduct of Supplier, its officers, directors, employees and agents,
in performing its obligations under this Agreement;
(b) a breach by Supplier of any of the material terms of this Agreement including, without
limitation, the Supplier representations and warranties provided for in Section 8.1 hereof;
(c) any recall or market withdrawals of Products Manufactured by Supplier related to the quality of
the Product for Commercial Sale in the Territory and caused by Supplier as provided for in Section
5.3 hereof;
(d) any claim that the Manufacturing of a Product under this Agreement or its sale or supply to
Purchaser infringes a Third Partys Intellectual Property, except where such claim arises out of or
results from the use of Purchasers Intellectual Property.
10.3 Indemnity Proceedings.
(a) Notice of Claim. If a claim by a Third Party is made against an Indemnitee, and if the
Indemnitee intends to seek indemnity with respect thereto under this Agreement, the
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Indemnitee shall promptly (and in any case within [Redacted: Term] of such claim being made) notify
the Indemnitor of such claim with reasonable particulars. The Indemnitor shall have [Redacted:
Term] after receipt of such notice to undertake, conduct and control, through counsel of its own
choosing (reasonably acceptable to Indemnitee) and at its own expense, the settlement or defense
thereof, and the Indemnitee shall reasonably cooperate with the Indemnitor in connection therewith,
except that with respect to settlements entered into by the Indemnitor: [Redacted: Settlement
Conditions]
(b) Conduct of Proceedings. If the Indemnitor undertakes, conducts and controls the settlement or
defense of such claim, (i) the Indemnitor shall permit the Indemnitee to participate in such
settlement or defense through counsel chosen by the Indemnitee, provided that the fees and expenses
of such counsel shall be borne by the Indemnitee; and (ii) the Indemnitor shall promptly reimburse
the Indemnitee for the full amount of any loss resulting from any claim and all related expenses
(other than the fees and expenses of counsel as aforesaid) incurred by the Indemnitee. The
Indemnitee shall not pay or settle any claim so long as the Indemnitor is reasonably contesting any
such claim in good faith on a timely basis. Notwithstanding the two immediately preceding
sentences, [Redacted: Settlement Conditions].
(c) Intellectual Property Claim. Notwithstanding Section 10.3(a) and (b), any claim by a Third
Party for violation, misappropriation or infringement of Intellectual Property for which a Party
has the right to seek indemnification hereunder against the other Party shall be conducted and
controlled by the Party whose Intellectual Property is being violated, infringed or claimed to be
invalid or unenforceable. The Indemnitor shall have the exclusive right to select counsel for such
Proceedings or action and the Indemnitor may consult with the Indemnitee and take into
consideration Indemnitees view and comments to the extent reasonable in defending against any such
action or Proceeding, on all material aspects of the defense. Either Party shall have the right to
join the Proceeding or action defended by the Indemnitor and to be represented by counsel of its
choice at its own cost and expense. Except as expressly set forth above, the Indemnitor shall pay
all costs and expenses of the Indemnitee associated with such Proceedings or action other than the
expenses of the Indemnitee if the Indemnitee elects to join the Proceedings or action as set forth
above. [Redacted: Settlement Conditions].
(d) Indemnitee Rights. With respect to Third Party claims, if the Indemnitor does not notify the
Indemnitee within [Redacted: Term] after the receipt of the Indemnitees notice of a claim of
indemnity hereunder that it elects to undertake the defense thereof, the Indemnitee shall have the
right, but not the obligation, to contest, settle or compromise the claim in the exercise of its
reasonable judgement using counsel of its choice at the expense of the Indemnitor.
(e) Employee Assistance. In the event of any claim by a Third Party against an Indemnitee, the
defense of which is being undertaken and controlled by the Indemnitor, the Indemnitee will use all
reasonable efforts to make available to the Indemnitor those employees whose assistance, testimony
or presence is necessary to assist the Indemnitor in evaluating and in defending any such claim;
provided that the Indemnitor shall be
- 29 -
responsible for the expense associated with any employees made available by the Indemnitee to the
Indemnitor hereunder, which expense shall be equal to an amount to be mutually agreed upon per
person per hour or per day or each day or portion thereof that such employees are assisting, and
which shall not exceed the actual cost to the Indemnitee associated with such employees.
10.4 Limitation of Liability.
(a) Indirect Damages. Notwithstanding the provisions of this Agreement which might otherwise be to
the contrary, neither Party shall be liable to the other, or have any obligation to indemnify any
Indemnitee, as the case may be, for Losses which were not foreseen or foreseeable (including loss
of profits, loss of revenue and expected savings or loss of information) and the Parties hereby
expressly agree that in no event shall either Party be liable for any indirect, incidental,
special, consequential, exemplary or punitive damages or Losses.
(b) Aggregate Liability. Each Partys total aggregate liability for damages sustained by the other
Party as a result of a direct claim made by the other Party under this Agreement shall, except in
cases of an intentional or gross fault, be no greater than
[Redacted: Amount]. Notwithstanding the
foregoing, Purchasers and Suppliers total aggregate liability shall in no event be limited in the
event of any Losses resulting from
[Redacted: Events]
ARTICLE XI TERM AND TERMINATION
11.1
Term of Agreement.
(a) Initial Term. This Agreement is effective from the date of its execution and shall continue in
effect until the later of (i) [Redacted: Date] and (ii) the date on which US patent No. 5,861,379
will expire (Initial Term) unless earlier terminated or extended in accordance with the terms of
the Agreement.
(b)
Renewal Term. This Agreement will be automatically renewed for successive periods of [Redacted:
Term] each (Renewal Terms) following the expiration of the Initial term, unless otherwise
indicated by either Party to the other with a prior [Redacted: Term] written notice.
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11.2 Termination of Agreement.
(a) Termination for Breach. Any non-defaulting Party may terminate this Agreement with written
notice to the other Party, if the other Party defaults in a material respect in the performance or
observance of any of its obligations under this Agreement and such default continues, unremedied,
for a period of [Redacted: Term] following written notice of such default to the defaulting Party.
Such cure period shall be increased to [Redacted: Term] if the default is a failure to comply with
Applicable Laws, including cGMP.
(b) Bankruptcy, etc. Either Party may terminate this Agreement upon notice to the other Party, if
the other Party makes an assignment for the benefit of its creditors, is adjudged bankrupt, becomes
insolvent, ceases or threatens to cease to carry on business, files or consents to the filing of a
petition in bankruptcy, seeks to take advantage of any legislation relating to insolvency,
arrangement or relief of debtors, winds-up or liquidates, or if any receiver, trustee, liquidator
or similar official is appointed of such other Party or any of its property.
(c) Termination for Convenience. Either Party may terminate this Agreement without penalty, for any
reason upon giving a [Redacted: Term] prior written notice to the other Party of such termination.
(d) Termination under Section 9.5(a) and 9.5(b). Supplier may terminate this Agreement, without
penalty, by written notice to Purchaser if an act under Section 9.5(a) occurs and [Redacted:
Termination Conditions].
Either Party may terminate this Agreement without penalty by giving written notice to the other
Party if an act under Section 9.5(b) occurs [Redacted: Termination Conditions].
(e) Termination under Section 3.8(b) or 7.1 (d). Either Party may terminate this Agreement, without
penalty, by written notice to the other Party within the delay prescribed in the cGMP or applicable
Law to comply with a change, if the costs to comply with cGMP or applicable Law exceed the
threshold set forth in Section 3.8(b) hereof. Purchaser shall have the right to terminate this
Agreement by written notice to Supplier if the FDA or HPFBI requires Purchaser to stop selling the
Products in the Territory.
(f) Product not Approved. This Agreement will terminate in the event the Product is not approved
for Commercial Sale in the Territory by the FDA by [Redacted: Term].
(g) Effect of Termination. Upon termination or expiration of this Agreement for any reason:
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(i) |
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Purchaser shall [Redacted: Purchasers Obligations]; |
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(ii) |
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Purchaser will have access to any Manufacturing Records and Batch retention
samples relating to the Manufacturing of the Products under this |
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Agreement for the period during which the Manufacturing Records and Batch retention
sample must be kept by Supplier in accordance with this Agreement or the Quality
Agreement; |
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(iii) |
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Supplier shall provide to Purchaser the originals of all Specifications;
provided, however, that a copy of such document may be retained by Supplier for
archival purposes, as means of determining any continuing obligation or
confidentiality, but for no other purpose; |
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(iv) |
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Purchaser shall, within [Redacted: Term] of the date of termination of this
Agreement, pay to Supplier any outstanding payments to be made pursuant to this
Agreement, including without limitation, any and all payment due pursuant to this
Section 11.2(g) or Section 3.2 hereof; |
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(v) |
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the license granted to Supplier under Section 9.1(e) hereof shall be terminated; and |
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(vi) |
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Any termination of this Agreement in accordance with this Section 11.2(a), (b)
or (d) shall not prevent the non-defaulting Party to seek any other remedy or take any
other action or recourse against the defaulting Party in order to be indemnified as a
consequence thereto in accordance with Article X of this Agreement, unless expressly
indicated otherwise herein. |
ARTICLE XII MISCELLANEOUS
12.1 Relationship of the Parties.
The relationship between Supplier and Purchaser created pursuant to this Agreement is intended to
be and shall be solely that of independent contractors. Neither Party, nor its employees, agents or
representatives shall under any circumstances be considered employees, agents, partners, joint
venturers or representatives of the other Party. Neither Party, nor its employees, agents or
representative shall act or attempt to act, or represent themselves, directly or by implication, as
an employee, agent, joint venturer, partner or representative of the other Party or in any manner
assume or create, or attempt to assume or create, any obligation or liability of any kind, express
or implied, on
behalf of or in the name of the other Party. No person other than Supplier or Purchaser may rely on
or enforce any provision of this Agreement.
12.2 Force Majeure.
(a) Defined. In this Agreement, Force Majeure means an event or occurrence beyond the reasonable
control of a Party which by the exercise of reasonable diligence could not be overcome, including,
but not limited to, [Redacted: Definition of Force Majeure].
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(b) Non-Default. A Party shall be deemed not to be in default with respect to non-performance
of any of its obligations under this Agreement, if and so long as such non-performance is due in
whole or in some material way to an event of Force Majeure and that Party has used commercially
reasonable efforts to remove the event of Force Majeure and to perform its obligations under the
Agreement. If an event of Force Majeure occurs, the Party affected shall promptly notify the other
Party of the occurrence of the event, its extent and probable duration.
(c) Cessation of Force Majeure. Subject to Section 12.2(b) hereof, if Supplier is unable to supply
Purchaser with its requirements of Products by reason of Force Majeure, Force Majeure shall excuse
Suppliers performance until the Force Majeure has ceased and for a reasonable period of time
thereafter, to allow Supplier to restore itself to the position it was in with respect to the
Manufacturing of Products immediately prior to the Force Majeure. Supplier acknowledges that
Purchaser shall have the right to have Batches of Product forecasted in the Firm Zones of Ongoing
Forecasts Manufactured by Third Parties for the duration of the existence of Suppliers Force
Majeure. The Batches of Product Manufactured by the Third Parties shall [Redacted: Calculation of
Batches] hereof. Within [Redacted: Term] of notification by Supplier that it is able to resume the
necessary supply of the Products to Purchaser, Purchaser shall resume obtaining its requirements of
Products from Supplier pursuant to the terms of this Agreement. Supplier shall suffer no penalty or
incur any liability for its inability to perform hereunder by reason of Force Majeure. For greater
certainty, the Purchaser shall not have to comply with the Preferred Basis and Annual Minimum
Purchase during Force Majeure up until receipt of Suppliers notice that it is able to resume
Manufacturing of the Product pursuant to this Section 12.2(c) [Redacted: Obligations of Supplier]
for such given Calendar Year.
(d) Termination. If a Party fails to perform any of its obligations under this Agreement by reason
of Force Majeure and such non-performance continues for a period of [Redacted: Term] from the first
occurrence of the event of Force Majeure, the other Party may, [Redacted: Termination Conditions] ,
terminate this Agreement by providing written notice to that effect to the non-performing Party. In
the event of such termination, both Parties respective rights and obligations under this Agreement
shall terminate except for any amounts previously due and owing by one Party to the other and
except for any other obligations which this Agreement expressly provides shall survive termination.
12.3 Further Assurances.
Each Party will at any time and from time to time, upon the request of the other Party, execute and
deliver such further documents and do such further acts and things as the other Party may
reasonably request to evidence, carry out and give full effect to the terms, conditions, intent and
meaning of this Agreement.
12.4 Confidentiality.
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This Agreement is subject to the CDA which is incorporated herein by reference and attached hereto
as Schedule D; provided, however, that the Parties agree that (i) the provisions of the CDA shall
apply to all information and data provided by either Party or their agent(s) in confidence or as
confidential and (ii) the definition of Purpose therein shall be extended to include the
performance of each of Supplier and Purchasers obligations under this Agreement.
12.5 Notices.
Unless otherwise mentioned herein, any notice or other communication made under this Agreement
(other than routine business communication) shall be in writing and shall be properly given: (i)
when delivered if sent by personal delivery; (ii) when transmitted if sent by facsimile with
confirmation of transmission; (iii) the next day if sent by a recognized overnight courier; or (iv)
three days after being posted if sent by registered mail return receipt requested, addressed:
(a) if to Supplier, to it at: 16751 Trans Canada Highway
Kirkland,
Québec, Canada H9H 4J4
Attn: Chief Operating Officer
[Redacted: Facsimile Number]
with a copy to: DRAXIS Specialty Pharmaceuticals Inc.
16751 Trans Canada Highway
Kirkland, Québec, Canada H9H 4J4
Attn: Legal Department
[Redacted: Facsimile Number]
(b) if to Purchaser, to it at: 2310 Alfred-Nobel Blvd.
Montreal,
Québec, Canada H4S 2B4
Attn.: Vice President, Pharmaceutical Development
[Redacted: Facsimile Number]
A Party may change its address for notice by notifying the other Party at any time in accordance
with the provisions of this Agreement.
12.6 Entire Agreement.
This Agreement, and any and all schedules attached thereto, supersedes any prior agreements between
the Parties as to the subject matter of the Agreement, whether oral or in writing, and contains the
entire understanding between the Parties as to the subject matter of the Agreement. For greater
clarity, this Agreement does not supersede agreements currently outstanding that relate to the non
Commercial Sale of the Product.
12.7 Waiver.
No delay or failure on the part of a Party in exercising any rights under this Agreement shall
affect any of such Partys rights.
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12.8 Amendment.
This Agreement may not be modified or amended except by further written statement signed by both
Parties.
12.9 Severability.
Any provision of this Agreement that is held to be inoperative, unenforceable or invalid in any
jurisdiction shall be inoperative, unenforceable or invalid in that jurisdiction without affecting
any other provision hereof in that jurisdiction or the operation, enforceability or validity of
that provision in any other jurisdiction, and to this end the provisions hereof are declared to be
severable.
12.10 Enurement.
This Agreement is binding on and enures to the benefit of each Party and its successors and
permitted assigns.
12.11 Assignment.
Neither Party shall assign or otherwise transfer any rights under or interest in this Agreement
without the other Partys prior written consent, which consent shall not be unreasonably withheld,
delayed or conditioned. Notwithstanding the foregoing, each Party shall have the right to assign
the Agreement to any of its Affiliates without the prior written consent of the other Party;
provided that the assignor shall remain solidarily liable for the obligations of its Affiliate.
Purchaser shall have the right to assign this Agreement to [Redacted: Name]. and upon such
assignment, Purchaser shall be relieved from its obligations hereunder provided however that (i)
Purchaser shall not be relieved of its obligations existing or arising prior to the date of the
assignment or the Effective Date of this Agreement, whichever occurs last, and (ii) [Redacted:
Name] has agreed in writing to assume and to be liable
for any and all obligations and liabilities of Purchaser under this Agreement as of the date of the
assignment or the Effective Date of this Agreement, whichever occurs last.
12.12 Counterparts.
This Agreement may be executed in counterparts and by facsimile transmission, each of which shall
be deemed to be an original and which together shall constitute one and the same agreement.
12.13 Contra Proferentum.
This Agreement is the result of mutual negotiations between the Parties, and each Party agrees that
no part of this Agreement shall be interpreted against the other Party on the grounds that
particular language was drafted by such Party.
12.14 Subcontracting.
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Supplier may be permitted to subcontract in whole or in part its obligations under this Agreement
upon the consent of Purchaser, such consent not be to unreasonably withheld or delayed.
12.15 Governing Law.
This Agreement shall be governed by and construed in accordance with the laws of the Province of
Québec and the laws of Canada applicable therein. Any disputes arising between the Parties relating
to this Agreement shall be subject to the exclusive jurisdiction and venue of the provincial and
federal courts located in the Province of Québec, and the Parties hereby waive any objection which
they may have now or hereafter to the laying of venue of any proceedings in said courts and to any
claim that such proceedings have been brought in an inconvenient forum, and further irrevocably
agree that a judgment or order in any such proceedings shall be conclusive and binding upon each of
them and may be enforced in the courts of any other jurisdiction.
12.16 Non-Solicitation.
Neither Party shall solicit (either directly or indirectly) for employment or employ any of each
others personnel during the Term of this Agreement, except if such employment is the result of a
general solicitation of personnel by such Party by public advertisement of employment opportunities
or otherwise. In the event either Party desires to solicit for employment or employ one of the
other Partys personnel, then such Party must obtain the other Partys prior written approval of
such solicitation or employment.
12.17 Survival.
The following provisions shall survive the expiration or termination of this Agreement: Sections
5.2, 5.3, 6.6, 8.1(a)(v), 8.2(a)(iv), 9.1, Article 10, 11.2(g), 12.4, 12.5, 12.15 and
12.17 for the period of time indicated in said Sections, if any.
12.18 English Language.
The Parties have expressly requested that this Agreement and all ancillary documents be drafted in
English. Les parties ont exigé que cette entente ainsi que tous les documents y afférent soient
rédigés en anglais.
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date written above, by their
authorized officers, who by signing confirm their authority and intention to bind the Party they
represent.
DRAXIS PHARMA GENERAL PARTNERSHIP,
By way of its managing partner,
DRAXIS SPECIALTY PHARMACEUTICALS INC.
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Per: |
(Signed) Marcelo Morales
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Marcelo Morales |
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Chief Operating Officer |
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THERATECHNOLOGIES INC.
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Per: |
(Signed) Pierre Perazzelli
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Pierre Perazzelli |
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Vice President, Pharmaceutical Development |
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Per: |
(Signed) Luc Tanguay
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Luc Tanguay |
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Senior Executive Vice President and Chief Financial Officer |
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Manufacture and Supply Agreement Redacted final
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Schedule A
SPECIFICATIONS
[Redacted: Description of Specifications]
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Schedule B
QUALITY AGREEMENT
[Redacted]
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Schedule C
PRICES
[Redacted: Prices]
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Schedule D
CONFIDENTIAL DISCLOSURE AGREEMENT
[Redacted]
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Schedule E
PROPOSALS
[Redacted]
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Schedule F
DESIGNATED SUPPLIERS
[Redacted: Names of Suppliers]
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Schedule G
OWNERSHIP OF MACHINERY AND EQUIPMENT BY PURCHASER
[Redacted: Description of Machinery]
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Schedule H
FORM OF CERTIFICATE OF MANUFACTURE
[Redacted: Certificate]
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Schedule I
QUARANTINE SHIPMENT AUTHORIZATION
[Redacted: Authorization]
- 1 -
ex-99.92
Exhibit 99.92
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KPMG LLP
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Telephone
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(514) 840-2100 |
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Chartered Accountants
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Fax
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(514) 840-2187 |
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600 de Maisonneuve Blvd. West
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Internet
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www.kpmg.ca |
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Suite 1500 |
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Tour KPMG |
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Montréal (Québec) H3A 0A3 |
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Consent of Independent Auditors
The Board of Directors
Theratechnologies Inc.
We consent to the use in this registration statement on Form 40-F of Theratechnologies Inc. (the
Company) of our reports dated:
i) |
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February 8, 2011 with respect to the consolidated statements of financial position of the
Company as at November 30, 2010 and 2009 and December 1, 2008, and the consolidated statements of
comprehensive income, changes in equity and cash flows for the years ended November 30, 2010 and
2009; |
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ii) |
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January 22, 2010 (except for note 15 A which is as of February 10, 2010) with respect to the
consolidated balance sheets of the Company as at November 30, 2009 and 2008 and the consolidated
statements of earnings, comprehensive loss, shareholders equity and cash flows for the years then
ended |
each of which is contained in this registration statement on Form 40-F of the Company.
/s/ KPMG LLP
Chartered Accountants
Montréal, Canada
June 13, 2011
KPMG LLP
is a Canadian limited liability partnership and a member firm of the
KPMG
network of
independent member firms affiliated with KPMG International
Cooperative
(KPMG International), a Swiss entity.
KPMG Canada provides services to KPMG LLP.