UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of July 2014
Commission File Number 001-35203
THERATECHNOLOGIES INC.
(Translation of registrants name into English)
2310 Alfred-Nobel Boulevard
Montréal, Québec, Canada
H4S 2B4
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Yes ¨ No x
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Yes ¨ No x
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrants home country), or under the rules of the home country exchange on which the registrants securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrants security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ¨ No x
If Yes is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-______________.
THERATECHNOLOGIES INC.
Exhibit |
Description | |
99.1 | Interim Consolidated Financial Statements for the six-month periods ended May 31, 2014 and May 31, 2013 | |
99.2 | Managements Discussions and Analysis for the three-month and six-month periods ended May 31, 2014 | |
99.3 | Press Release Dated July 9, 2014 | |
99.4 | Canadian Form 52-109F2 Certification of Interim Filings CEO | |
99.5 | Canadian Form 52-109F2 Certification of Interim Filings CFO |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
THERATECHNOLOGIES INC. | ||
By: | /s/ Luc Tanguay | |
Name: Luc Tanguay | ||
Title: President and Chief Executive Officer |
Date: July 9, 2014
Exhibit 99.1
Theratechnologies Inc.
Interim Consolidated Financial Statements
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars)
THERATECHNOLOGIES INC.
Interim Consolidated Statements of Financial Position
(Unaudited)
(in thousands of Canadian dollars)
Note | As at May 31, 2014 |
As at November 30, 2013 |
||||||||||
$ | $ | |||||||||||
Assets |
||||||||||||
Current assets |
||||||||||||
Cash |
310 | 967 | ||||||||||
Bonds |
40 | 99 | ||||||||||
Trade and other receivables |
148 | 489 | ||||||||||
Tax credits and grants receivable |
7 | 4,170 | | |||||||||
Inventories |
8 | 10,134 | 10,995 | |||||||||
Prepaid expenses |
904 | 404 | ||||||||||
Derivative financial assets |
145 | 106 | ||||||||||
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15,851 | 13,060 | |||||||||||
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Non-current assets |
||||||||||||
Bonds |
5,202 | 11,287 | ||||||||||
Property and equipment |
253 | 281 | ||||||||||
Intangible assets |
9 | 15,919 | 216 | |||||||||
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|
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21,374 | 11,784 | |||||||||||
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Total assets |
37,225 | 24,844 | ||||||||||
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Liabilities |
||||||||||||
Current liabilities |
||||||||||||
Accounts payable and accrued liabilities |
5,914 | 3,371 | ||||||||||
Current portion of long-term obligation |
10 | 2,472 | | |||||||||
Deferred revenue |
6 | 1,279 | ||||||||||
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8,392 | 4,650 | |||||||||||
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Non-current liabilities |
||||||||||||
Deferred revenue |
| 1,492 | ||||||||||
Long-term obligation |
10 | 12,767 | | |||||||||
Other liabilities |
158 | 174 | ||||||||||
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12,925 | 1,666 | |||||||||||
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Total liabilities |
21,317 | 6,316 | ||||||||||
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Equity |
||||||||||||
Share capital |
280,872 | 280,872 | ||||||||||
Contributed surplus |
8,272 | 8,232 | ||||||||||
Deficit |
(273,368 | ) | (270,841 | ) | ||||||||
Accumulated other comprehensive income |
132 | 265 | ||||||||||
|
|
|
|
|||||||||
15,908 | 18,528 | |||||||||||
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|
|
|||||||||
Total liabilities and equity |
37,225 | 24,844 | ||||||||||
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|
|||||||||
Contingent liability |
12 | |||||||||||
Commitments |
13 | |||||||||||
Subsequent event |
17 |
The accompanying notes are an integral part of these interim consolidated financial statements.
1
THERATECHNOLOGIES INC.
Interim Consolidated Statements of Comprehensive Income (Loss)
(Unaudited)
(in thousands of Canadian dollars, except per share amounts)
For the three-month periods ended May 31, |
For the six-month periods ended May 31, |
|||||||||||||||||||
Note | 2014 | 2013 | 2014 | 2013 | ||||||||||||||||
$ | $ | $ | $ | |||||||||||||||||
Revenue |
||||||||||||||||||||
Sale of goods |
| 996 | 675 | 1,447 | ||||||||||||||||
Research services Up-front payments and initial technology access fees |
4 | 2,450 | 463 | 2,770 | 927 | |||||||||||||||
Royalties and licence fees |
(57 | ) | 872 | 620 | 1,756 | |||||||||||||||
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2,393 | 2,331 | 4,065 | 4,130 | |||||||||||||||||
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Operating expenses |
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Cost of sales |
||||||||||||||||||||
Cost of goods sold |
| 864 | 600 | 1,262 | ||||||||||||||||
Unallocated production costs |
14 | 201 | 1,039 | 471 | ||||||||||||||||
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14 | 1,065 | 1,639 | 1,733 | |||||||||||||||||
Research and development expenses, net of tax credits of nil (2013 $28) for the three-month period and nil (2013 $56) for the six-month period |
2,121 | 1,791 | 3,417 | 3,246 | ||||||||||||||||
Selling and market development expenses |
5 | 2,148 | 69 | 3,527 | 131 | |||||||||||||||
General and administrative expenses |
1,370 | 906 | 2,340 | 1,873 | ||||||||||||||||
Restructuring costs |
| | | (3,093 | ) | |||||||||||||||
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5,653 | 3,831 | 10,923 | 3,890 | |||||||||||||||||
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Profit (loss) from operating activities |
(3,260 | ) | (1,500 | ) | (6,858 | ) | 240 | |||||||||||||
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Finance income |
6 | 123 | 166 | 228 | 326 | |||||||||||||||
Finance costs |
6 | 46 | (31 | ) | 13 | (71 | ) | |||||||||||||
Federal investment tax credits |
7 | 4,110 | | 4,110 | | |||||||||||||||
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4,279 | 135 | 4,351 | 255 | |||||||||||||||||
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Profit (loss) before income taxes |
1,019 | (1,365 | ) | (2,507 | ) | 495 | ||||||||||||||
Income tax expense |
(12 | ) | (17 | ) | (20 | ) | (17 | ) | ||||||||||||
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Net profit (loss) for the period |
1,007 | (1,382 | ) | (2,527 | ) | 478 | ||||||||||||||
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Other comprehensive income (loss), net of tax |
||||||||||||||||||||
Items that may be reclassified subsequently to profit or loss: |
||||||||||||||||||||
Net change in fair value of available-for-sale financial assets, net of tax |
(18 | ) | (67 | ) | (43 | ) | (39 | ) | ||||||||||||
Net change in fair value of available-for-sale financial assets transferred to net profit (loss), net of tax |
(65 | ) | (49 | ) | (90 | ) | (70 | ) | ||||||||||||
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(83 | ) | (116 | ) | (133 | ) | (109 | ) | |||||||||||||
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Total comprehensive income (loss) for the period |
924 | (1,498 | ) | (2,660 | ) | 369 | ||||||||||||||
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Basic and diluted earnings (loss) per share |
11b | ) | 0.02 | (0.02 | ) | (0.04 | ) | 0.01 | ||||||||||||
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|
The accompanying notes are an integral part of these interim consolidated financial statements.
2
THERATECHNOLOGIES INC.
Interim Consolidated Statements of Changes in Equity
(Unaudited)
For the six-month periods ended May 31, 2014 and 2013
(in thousands of Canadian dollars)
2014 | ||||||||||||||||||||||||||||
Share capital | Unrealized gains (losses) on available- for-sale financial assets* |
|||||||||||||||||||||||||||
Note | Number of shares |
Amount | Contributed surplus |
Deficit | Total | |||||||||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||||||||||
Balance as at November 30, 2013 |
61,010,603 | 280,872 | 8,232 | (270,841 | ) | 265 | 18,528 | |||||||||||||||||||||
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Total comprehensive income for the period |
||||||||||||||||||||||||||||
Net loss for the period |
(2,527 | ) | | (2,527 | ) | |||||||||||||||||||||||
Other comprehensive income (loss) |
||||||||||||||||||||||||||||
Net change in fair value of available-for-sale financial assets, net of tax |
| (43 | ) | (43 | ) | |||||||||||||||||||||||
Net change in fair value of available-for-sale financial assets transferred to net loss, net of tax |
| (90 | ) | (90 | ) | |||||||||||||||||||||||
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Total comprehensive loss for the period |
(2,527 | ) | (133 | ) | (2,660 | ) | ||||||||||||||||||||||
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Transactions with owners, recorded directly in equity |
||||||||||||||||||||||||||||
Share-based compensation for stock option plan |
11a | ) | | | 40 | | | 40 | ||||||||||||||||||||
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Total contributions by owners |
| | 40 | | | 40 | ||||||||||||||||||||||
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Balance as at May 31, 2014 |
61,010,603 | 280,872 | 8,272 | (273,368 | ) | 132 | 15,908 | |||||||||||||||||||||
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* | Accumulated other comprehensive income |
The accompanying notes are an integral part of these interim consolidated financial statements.
3
THERATECHNOLOGIES INC.
Interim Consolidated Statement of Changes in Equity, Continued
(Unaudited)
For the six-month periods ended May 31, 2014 and 2013
(in thousands of Canadian dollars)
2013 | ||||||||||||||||||||||||||||
Share capital | Unrealized gains (losses) on available- for-sale financial assets* |
|||||||||||||||||||||||||||
Note | Number of shares |
Amount | Contributed surplus |
Deficit | Total | |||||||||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||||||||||
Balance as at November 30, 2012 |
61,010,603 | 280,872 | 8,158 | (266,786 | ) | 426 | 22,670 | |||||||||||||||||||||
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Total comprehensive income for the period |
||||||||||||||||||||||||||||
Net profit for the period |
478 | | 478 | |||||||||||||||||||||||||
Other comprehensive income (loss) |
||||||||||||||||||||||||||||
Net change in fair value of available-for-sale financial assets, net of tax |
| (39 | ) | (39 | ) | |||||||||||||||||||||||
Net change in fair value of available-for-sale financial assets transferred to net profit, net of tax |
| (70 | ) | (70 | ) | |||||||||||||||||||||||
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Total comprehensive income for the period |
478 | (109 | ) | 369 | ||||||||||||||||||||||||
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Transactions with owners, recorded directly in equity |
||||||||||||||||||||||||||||
Share-based compensation for stock option plan |
11a | ) | | | 42 | | | 42 | ||||||||||||||||||||
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Total contributions by owners |
| | 42 | | | 42 | ||||||||||||||||||||||
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Balance as at May 31, 2013 |
61,010,603 | 280,872 | 8,200 | (266,308 | ) | 317 | 23,081 | |||||||||||||||||||||
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* | Accumulated other comprehensive income |
The accompanying notes are an integral part of these interim consolidated financial statements.
4
THERATECHNOLOGIES INC.
Interim Consolidated Statements of Cash Flows
(Unaudited)
(in thousands of Canadian dollars)
For the three-month periods ended May 31, |
For the six-month periods ended May 31, |
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Note | 2014 | 2013 | 2014 | 2013 | ||||||||||||||||
$ | $ | $ | $ | |||||||||||||||||
Cash flows from |
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Operating activities |
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Net profit (loss) for the period |
1,007 | (1,382 | ) | (2,527 | ) | 478 | ||||||||||||||
Adjustments for |
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Depreciation of property and equipment |
14 | 25 | 28 | 67 | ||||||||||||||||
Amortization of intangible assets |
9 | 144 | | 144 | | |||||||||||||||
Gain on disposal of property and equipment |
| (60 | ) | | (60 | ) | ||||||||||||||
Change in deferred revenue |
(2,454 | ) | (466 | ) | (2,765 | ) | (922 | ) | ||||||||||||
Share-based compensation for stock option plan |
11a | ) | 21 | 29 | 40 | 42 | ||||||||||||||
Income tax |
12 | 17 | 20 | 17 | ||||||||||||||||
Writedown of inventories |
8 | | | 936 | 192 | |||||||||||||||
Lease inducements and amortization |
(8 | ) | (7 | ) | (16 | ) | (26 | ) | ||||||||||||
Change in fair value of derivative financial assets |
(2 | ) | 54 | (58 | ) | 9 | ||||||||||||||
Change in fair value of liability related to deferred stock unit plan |
1 | (53 | ) | 62 | 3 | |||||||||||||||
Change in fair value of derivative financial liabilities |
6 | | 13 | | 15 | |||||||||||||||
Interest income |
(58 | ) | (117 | ) | (138 | ) | (256 | ) | ||||||||||||
Interest received |
74 | 180 | 202 | 439 | ||||||||||||||||
Accretion expense |
6 | 170 | | 170 | | |||||||||||||||
Unrealized foreign currency gain on long-term obligation |
(166 | ) | | (166 | ) | | ||||||||||||||
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(1,245 | ) | (1,767 | ) | (4,068 | ) | (2 | ) | |||||||||||||
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Changes in operating assets and liabilities |
||||||||||||||||||||
Trade and other receivables |
145 | (835 | ) | 337 | (513 | ) | ||||||||||||||
Tax credits and grants receivable |
(4,170 | ) | (28 | ) | (4,170 | ) | (56 | ) | ||||||||||||
Inventories |
(131 | ) | 579 | (75 | ) | (164 | ) | |||||||||||||
Prepaid expenses |
(462 | ) | (313 | ) | (500 | ) | (92 | ) | ||||||||||||
Accounts payable and accrued liabilities |
2,389 | 398 | 2,697 | (523 | ) | |||||||||||||||
Provisions |
| (2,105 | ) | | (5,605 | ) | ||||||||||||||
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(2,229 | ) | (2,304 | ) | (1,711 | ) | (6,953 | ) | |||||||||||||
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Cash flows used in operating activities |
(3,474 | ) | (4,071 | ) | (5,779 | ) | (6,955 | ) | ||||||||||||
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Investing activities |
||||||||||||||||||||
Acquisition of intangible assets |
(487 | ) | | (828 | ) | | ||||||||||||||
Proceeds from sale of property and equipment |
| 60 | | 60 | ||||||||||||||||
Proceeds from sale of bonds |
4,034 | 4,335 | 5,927 | 5,836 | ||||||||||||||||
Prepayment of derivative financial assets |
| | | (50 | ) | |||||||||||||||
Proceeds from disposal of derivate financial assets |
| | 23 | | ||||||||||||||||
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Cash flows from investing activities |
3,547 | 4,395 | 5,122 | 5,846 | ||||||||||||||||
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Net change in cash for the period |
73 | 324 | (657 | ) | (1,109 | ) | ||||||||||||||
Cash Beginning of period |
237 | 79 | 967 | 1,512 | ||||||||||||||||
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Cash End of period |
310 | 403 | 310 | 403 | ||||||||||||||||
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|
See note 14 for other information.
The accompanying notes are an integral part of these interim consolidated financial statements.
5
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
1 | The reporting entity and its future operations |
Theratechnologies Inc. is a specialty pharmaceutical company addressing unmet medical needs in metabolic disorders to promote healthy ageing and improved quality of life.
The interim 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 (Quebec) and is domiciled in Quebec, Canada. The Company is located at 2310 Alfred-Nobel Boulevard, Montréal, Quebec H4S 2B4.
The Companys ability to generate revenue is currently solely based on the commercialization of EGRIFTATM in the United States.
On December 13, 2013, the Company announced that it had reached an agreement with EMD Serono, Inc. (EMD Serono Termination Agreement) to regain all rights under the EMD Serono Agreement, including commercialization rights for EGRIFTATM in the United States. The closing of the transaction occurred on May 1, 2014. Operations of the Company have significantly changed upon the completion of the EMD Serono transaction which may impact the risk profile of its cash flows, and the contractual obligation with respect to the early termination fee (note 10 long-term obligation) will increase the Companys liquidity risk and may require additional funding.
During the last fiscal year, the Company experienced manufacturing difficulties at its third-party manufacturer, which led to shortages of EGRIFTATM and negatively impacted sales and operating results. Thereafter, the Company resumed manufacturing. On February 14, 2014, the manufacturing difficulties resurfaced. The Company ceased manufacturing again and there is no longer any inventory available. As a result of the manufacturing difficulties, the Company undertook to carry out work to evaluate its current manufacturing process. A plan has been developed based upon temporarily reverting to the initial presentation of EGRIFTATM (1 mg vial), which was problem free during the first two years of marketing the product. In June 2014, one batch of EGRIFTATM in the 1 mg presentation has been produced, which is currently undergoing routine testing. While it is supplying market demand with the 1 mg presentation, the Company will continue to improve its 2 mg production cycle. Once it has confidence that the cycle is robust, the approval of the FDA to bring the 2 mg presentation back to market will be sought. The Company currently has sufficient funding to offset the interruption it is experiencing in its revenue stream. If, however, the Company encounters significant delays in re-establishing the supply chain, it may require additional funds in the next 12 months in order to meet its obligations and sustain operations.
These circumstances could result in a material uncertainty that could cast significant doubt about the Companys ability to continue as a going concern.
6
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements, Continued
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
The consolidated financial statements have been prepared on a going concern basis in accordance with IFRS. The going concern basis of presentation assumes that the Company will continue its operations for the foreseeable future and be able to realize its assets and discharge its liabilities and commitments in the normal course of business. If the going concern assumption were not appropriate for these financial statements, adjustments to the carrying value of assets and liabilities, reported expenses and consolidated statement of financial position classifications would be necessary. Such adjustments could be material.
2 | Basis of preparation |
Accounting framework
These unaudited interim consolidated financial statements (interim financial statements), including comparative information, have been prepared using accounting policies consistent with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB) and in accordance with International Accounting Standard (IAS) 34, Interim Financial Reporting.
Certain information, in particular the accompanying notes normally included in the annual financial statements prepared in accordance with IFRS, has 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 consolidated financial statements for the year ended November 30, 2013 and the notes thereto. These interim financial statements have not been reviewed by the Companys auditors.
These interim financial statements were authorized for issue by the Companys Audit Committee on July 8, 2014.
Summary of accounting policies
Except as described below, the accounting policies applied in these interim consolidated financial statements are the same as those applied in the Companys consolidated financial statements as at and for the year ended November 30, 2013.
Intangible assets
Commercialization rights
Commercialization rights acquired by the Company have finite useful lives and are measured at cost less accumulated amortization and any accumulated impairment losses. They are amortized at fixed rates based on their estimated useful life of 111 months on the straight-line basis.
The amortization method and useful life of intangible assets are reviewed every year and adjusted as required.
7
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements, Continued
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
Financial liabilities
The Company has classified its long-term obligation as other financial liabilities. Financial liabilities are initially recognized on the date on which they originate at fair value less any directly attributable transaction costs. Subsequent to initial recognition, these liabilities are measured at amortized cost using the effective interest method.
Basis of measurement
The Companys interim financial statements have been prepared on a going concern and historical cost basis, except for available-for-sale financial assets, derivative financial assets, liabilities related to the deferred stock unit plan and derivative financial liabilities, which are measured at fair value.
Use of estimates and judgments
The preparation of the Companys interim 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 assumptions and estimation uncertainties that have the most significant effect on the amounts recognized in the interim financial statements are disclosed in note 2 to the annual consolidated financial statements as at November 30, 2013 except:
There are assumptions and estimations uncertainties with respect to the determination of the useful life and the determination of the fair value of the long-term obligation (note 10).
Functional and presentation currency
These interim 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.
8
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements, Continued
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
3 | Changes in accounting policies |
IFRS 10, Consolidated Financial Statements
In May 2011, the IASB issued IFRS 10, Consolidated Financial Statements, which replaces SIC-12, Consolidation: Special Purpose Entities, and parts of IAS 27, Consolidated and Separate Financial Statements. IFRS 10 builds on existing principles by identifying the concept of control as the determining factor in whether an entity should be included within the consolidated statements of an entity. The standard provides additional guidance to assist in the determination of control where this is difficult to assess. IFRS 10 became effective December 1, 2013. The adoption of this standard had no impact on the Companys interim financial statements.
IFRS 13, Fair Value Measurement
In May 2011, the IASB issued IFRS 13, Fair Value Measurement. IFRS 13 improves consistency and reduces complexity by providing a precise definition of fair value and a single source of fair value measurement and disclosure requirements for use across IFRS. IFRS 13 became effective December 1, 2013. The adoption of this standard had no impact on the Companys interim financial statements.
Amendments to IAS 19, Employee Benefits
In June 2011, the IASB published an amended version of IAS 19, Employee Benefits. The amendments impact termination benefits, which would now be recognized at the earlier of when the entity recognizes costs for a restructuring within the scope of IAS 37, Provisions, Contingent Liabilities and Contingent Assets, and when the entity can no longer withdraw the offer of the termination benefits. The adoption of this standard had no impact on the Companys interim financial statements.
4 | Revenue and deferred revenue |
Actelion Pharmaceuticals Canada Inc.
In April 2014, the Company announced that the distribution and licence agreement with Actelion Pharmaceutical Canada Inc. had been terminated by mutual agreement. Consequently, the Company regained all rights under the supply, distribution and licensing agreement entered into in February 2012.
EMD Serono, Inc.
On December 13, 2013, the Company entered into a termination and transfer agreement with EMD Serono, Inc. (EMD Serono Termination Agreement) in order to regain all of the commercialization rights to EGRIFTATM in the United States. The transaction closed on May 1, 2014. The commercialization rights acquired were accounted for as intangible assets.
9
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements, Continued
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
As a consequence of the EMD Serono Termination Agreement, the Company will no longer be obligated to develop a new formulation of EGRIFTATM and the related remaining balance in the Companys deferred revenue account has been included in revenue on the closing date.
5 | Selling and market development expenses |
For the three-month periods ended May 31, |
||||||||||||
Note | 2014 | 2013 | ||||||||||
$ | $ | |||||||||||
Selling and market development expenses |
2,004 | 69 | ||||||||||
Amortization of intangible assets |
9 | 144 | | |||||||||
|
|
|
|
|||||||||
2,148 | 69 | |||||||||||
|
|
|
|
For the
six-month periods ended May 31, |
||||||||||||
Note | 2014 | 2013 | ||||||||||
$ | $ | |||||||||||
Selling and market development expenses |
3,383 | 131 | ||||||||||
Amortization of intangible assets |
9 | 144 | | |||||||||
|
|
|
|
|||||||||
3,527 | 131 | |||||||||||
|
|
|
|
10
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements, Continued
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
6 | Finance income and finance costs |
Recognized in net profit (loss):
For the
three-month periods ended May 31, |
||||||||
2014 | 2013 | |||||||
$ | $ | |||||||
Interest income |
58 | 117 | ||||||
Net gain on disposal of available-for-sale financial assets |
65 | 49 | ||||||
|
|
|
|
|||||
Finance income |
123 | 166 | ||||||
|
|
|
|
|||||
Accretion expense (note 10) |
(170 | ) | | |||||
Bank charges |
| (7 | ) | |||||
Net foreign currency gain (loss) |
50 | (24 | ) | |||||
Unrealized foreign currency gain on long-term obligation |
166 | | ||||||
Loss on financial instruments carried at fair value |
| | ||||||
|
|
|
|
|||||
Finance costs |
46 | (31 | ) | |||||
|
|
|
|
|||||
Net finance income recognized in net profit (loss) |
169 | 135 | ||||||
|
|
|
|
For the
six-month periods ended May 31, |
||||||||
2014 | 2013 | |||||||
$ | $ | |||||||
Interest income |
138 | 256 | ||||||
Net gain on disposal of available-for-sale financial assets |
90 | 70 | ||||||
|
|
|
|
|||||
Finance income |
228 | 326 | ||||||
|
|
|
|
|||||
Accretion expense (note 10) |
(170 | ) | | |||||
Bank charges |
(3 | ) | (22 | ) | ||||
Net foreign currency gain (loss) |
30 | (31 | ) | |||||
Unrealized foreign currency gain on long-term obligation |
166 | | ||||||
Loss on financial instruments carried at fair value |
(10 | ) | (18 | ) | ||||
|
|
|
|
|||||
Finance costs |
13 | (71 | ) | |||||
|
|
|
|
|||||
Net finance income recognized in net profit (loss) |
241 | 255 | ||||||
|
|
|
|
11
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements, Continued
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
7 | Federal investment tax credits |
The Company settled a dispute with the Canada Revenue Agency in respect of an investment tax credit refund claim related to its 1994 and 1995 taxation years, resulting in a refund of $4,110 ($1,650 of investment tax credit refund and $2,520 in interest less associated fees). This refund was received on July 3, 2014.
The $1,650 of investment tax credit reduces the unused and unrecorded federal tax credits listed in note 11 to the November 30, 2013 consolidated financial statements.
8 | Inventories |
As at May 31, 2014 |
As at November 30, 2013 |
|||||||
$ | $ | |||||||
Raw materials |
9,476 | 9,523 | ||||||
Work in progress |
| 205 | ||||||
Finished goods |
658 | 1,267 | ||||||
|
|
|
|
|||||
10,134 | 10,995 | |||||||
|
|
|
|
During the six-month period ended May 31, 2014, the Company recorded an inventory provision of $936 on work in progress (2013 $192), to write down their value to their estimated net realizable value. The net inventory provision of $936 was recorded in cost of sales as unallocated production costs (2013 $192).
The writedowns in 2014 and 2013 were due to a loss incurred during conversion of raw materials to finished goods.
12
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements, Continued
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
9 | Intangible assets |
Commercialization rights |
||||
$ | ||||
Cost |
||||
Balance as at November 30, 2013 |
216 | |||
Additions |
15,847 | |||
|
|
|||
Balance as at May 31, 2014 |
16,063 | |||
|
|
|||
Accumulated amortization |
||||
Balance as at November 30, 2013 |
| |||
Amortization |
144 | |||
|
|
|||
Balance as at May 31, 2014 |
144 | |||
|
|
Cost includes the commercialization rights to EGRIFTATM in the United States regained under the terms of the EMD Serono Termination Agreement for an amount of $15,235 (see note 10) and related acquisition costs of $828.
The amortization expense is included in selling and market development expenses.
10 | Long-term obligation |
2014 | ||||
$ | ||||
Early Termination Fee |
15,239 | |||
Current portion |
2,472 | |||
|
|
|||
Non-current portion as at May 31, 2014 |
12,767 | |||
|
|
Under the terms of the EMD Serono Termination Agreement, the Company agreed to pay an early termination fee of US$20,000 (the Early Termination Fee) (CDN$21,684) evenly over a five-year period starting on the first anniversary of the closing date.
The obligation is initially recognized at fair value, and is considered Level 3 (see note 16) in the fair value hierarchy for financial instruments. The valuation model considered the present value of expected payments, discounted using a risk-adjusted discount rate. The significant unobservable input used is the risk-adjusted discount rate of 13.5%. Effective interest rate of 13.5% is calculated annually and accounted for in accretion of the obligation value.
13
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements, Continued
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
In order to secure the payment of the Early Termination Fee, the Company agreed to grant EMD Serono a security interest on its present and future, corporeal and incorporeal, movable property related to EGRIFTATM until such time as the amount of US$20,000 (CDN$21,684) has been reimbursed in full to EMD Serono. Thereafter, the Company and EMD Serono agreed to reduce the security interest to all present and future, corporeal and incorporeal, movable property related to EGRIFTATM in the United States only to secure the payment of the Royalties.
In addition, the EMD Serono Termination Agreement provides that in the event there occurs a change of control of the Company before November 1, 2015, EMD Serono has the option to accelerate the full payment of the Early Termination Fee and to seek the payment of an amount intended to equal the net present value of the maximum future Royalties. If such change of control occurs after November 1, 2015, EMD Serono has the option to accelerate the payment of all unpaid Early Termination Fee.
Long-term obligation is payable as follows:
Capital | Accrued interest |
Total | ||||||||||
$ | $ | $ | ||||||||||
Less than one year |
2,302 | 2,035 | 4,337 | |||||||||
Between one and five years |
12,767 | 4,580 | 17,347 | |||||||||
|
|
|
|
|
|
|||||||
15,069 | 6,615 | 21,684 | ||||||||||
|
|
|
|
|
|
11 | Share capital |
a) | Stock option plan |
The Company has established a stock option plan under which it may grant 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 of up to five years. As at May 31, 2014, 1,477,472 options were available to be granted by the Company (as at May 31, 2013 1,431,636).
All options are to be settled by the physical delivery of the shares.
14
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements, Continued
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
Changes in the number of options outstanding were as follows:
Number of options |
Weighted average exercise price per option |
|||||||
$ | ||||||||
Options as at November 30, 2012 |
1,426,298 | 4.34 | ||||||
Expired |
(15,000 | ) | 5.40 | |||||
Granted |
880,000 | 0.37 | ||||||
Forfeited |
(415,461 | ) | 5.11 | |||||
|
|
|
|
|||||
Options as at November 30, 2013 |
1,875,837 | 2.30 | ||||||
Granted |
125,000 | 0.50 | ||||||
Forfeited |
(138,168 | ) | 3.18 | |||||
|
|
|
|
|||||
Options as at May 31, 2014 |
1,862,669 | 2.12 | ||||||
|
|
|
|
During the six-month period ended May 31, 2014, $40 (2013 $42) was recorded as share-based compensation expense for the stock option plan. The fair value of options granted was estimated at the grant date using the Black-Scholes model and the following weighted average assumptions:
For the six-month periods ended May 31, |
||||||||
2014 | 2013 | |||||||
Risk-free interest rate |
1.97% | 1.88% | ||||||
Expected volatility |
82.22% | 81.00% | ||||||
Average option life |
7.5 years | 8 years | ||||||
Expected dividends |
Nil | Nil | ||||||
Grant-date share price |
$0.39 | $0.37 | ||||||
Option exercise price |
$0.39 | $0.37 |
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 taking into consideration 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.
15
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements, Continued
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
The following table summarizes the weighted average fair value of stock options granted during the periods ended May 31:
For the three-month periods ended May 31, |
||||||||||||||||
2014 | 2013 | |||||||||||||||
Number of options |
Weighted average grant-date fair value |
Number of options |
Weighted average grant-date fair value |
|||||||||||||
$ | $ | |||||||||||||||
Options granted |
| | 50,000 | 0.22 | ||||||||||||
|
|
|
|
|
|
|
|
For the six-month periods ended May 31, |
||||||||||||||||
2014 | 2013 | |||||||||||||||
Number of options |
Weighted average grant-date fair value |
Number of options |
Weighted average grant-date fair value |
|||||||||||||
$ | $ | |||||||||||||||
Options granted |
125,000 | 0.36 | 880,000 | 0.24 | ||||||||||||
|
|
|
|
|
|
|
|
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.
b) | Earnings (loss) per share |
For the six-month period ended May 31, 2014, the calculation of basic earnings (loss) per share was based on the net profit (loss) attributable to common shareholders of the Company of $(2,527) (2013 $478), and a weighted average number of common shares outstanding of 61,010,603 (2013 61,010,603), calculated as follows:
For the three-month periods ended May 31, |
||||||||
2014 | 2013 | |||||||
Issued common shares as at March 1 |
61,010,603 | 61,010,603 | ||||||
|
|
|
|
|||||
Weighted average number of common shares |
61,010,603 | 61,010,603 | ||||||
|
|
|
|
16
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements, Continued
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
For the six-month periods ended May 31, |
||||||||
2014 | 2013 | |||||||
Issued common shares as at December 1 |
61,010,603 | 61,010,603 | ||||||
|
|
|
|
|||||
Weighted average number of common shares |
61,010,603 | 61,010,603 | ||||||
|
|
|
|
The calculation of diluted earnings per share was based on a weighted average number of common shares calculated as follows:
For the three-month periods ended May 31, |
||||||||
2014 | 2013 | |||||||
Weighted average number of common shares |
61,010,603 | 61,010,603 | ||||||
Effect of potential dilutive share options |
22,228 | | ||||||
|
|
|
|
|||||
Weighted average number of diluted common shares |
61,032,831 | 61,010,603 | ||||||
|
|
|
|
For the six-month periods ended May 31, |
||||||||
2014 | 2013 | |||||||
Weighted average number of common shares |
61,010,603 | 61,010,603 | ||||||
|
|
|
|
|||||
Weighted average number of diluted common shares |
61,010,603 | 61,010,603 | ||||||
|
|
|
|
As at May 31, 2014, 1,812,669 options that may potentially dilute earnings per share in the future were not considered in the computation, since the exercise price of these options was higher than the average market price.
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.
17
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements, Continued
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
12 | Contingent liability |
A motion to authorize the institution of a class action was originally filed in July 2010 in the Superior Court of Québec, District of Montreal, entitled 121851 Canada Inc. v. Theratechnologies Inc. et al., Number 500-06-000515-102. The complaint alleged that the Company, a director and a former executive officer violated the secondary market liability provisions of the Securities Act (Québec) by failing to disclose a material change relating to the administration of EGRIFTATM. The plaintiff sought damages on behalf of a class of persons who were shareholders at May 21, 2010 and who sold their common shares on May 25 or 26, 2010. On February 24, 2012, the Superior Court of Québec authorized 121851 Canada Inc. to institute a class action against the Company, a director and a former executive officer. On March 20, 2012, the Company filed a motion seeking permission to appeal this judgement with the Court of Appeal of Québec, District of Montreal, Number 500-09-022519-128, and the hearing took place on January 24, 2013. The Companys motion was dismissed by the Court on July 17, 2013. An application for leave to appeal the decision issued by the Court of Appeal was filed in November 2013 with the Supreme Court of Canada. Such application was approved by the Supreme Court of Canada on February 20, 2014 and the hearing has been tentatively scheduled for December 1, 2014.
In addition, 121851 Canada Inc. filed another motion in the Superior Court of Québec, district of Montreal, in May 2013, to institute a class action against the Company, a director and a former executive officer. The second motion is based on the same facts and seeks the same conclusion as the first motion except that damages are sought under the Civil Code of Québec instead of the Securities Act (Québec). The parties have agreed to stay this motion until a final decision is issued under the first motion.
The Company intends to contest these class actions and consider them to be without merit. 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.
13 | Commitments |
a) | Credit facilities |
In the second quarter of 2014, the Company terminated its $1,800 revolving credit facility.
b) | Royalties |
Under the terms of the EMD Serono Termination Agreement, the Company agreed to pay EMD Serono an increasing royalty (the Royalties) based on annual net sales. The Royalties will be paid until a cumulative aggregate amount is reached or until January 1, 2024, the first of these events to occur.
c) | Post-approval commitments |
The Company is responsible for all of the costs of the long-term observational safety study evaluating the safety of long-term administration of EGRIFTATM. The total costs of the study are estimated to average $2,600 per year, over a fifteen-year period. From the beginning of the study until May 31, 2014, $2,366 has been spent on this study. The Company is also responsible for the Phase 4 clinical trial to assess whether EGRIFTATM increases the incidence or progression of diabetic retinopathy in diabetic HIV-infected patients with lipodystrophy and excess abdominal fat. The trial is estimated to cost approximately $20,000. Expenditures to date amount to $6,363.
18
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements, Continued
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
14 | Other information |
The Company entered into the following transactions which had no impact on the cash flows:
May 31, 2014 |
November 30, 2013 |
|||||||
$ | $ | |||||||
Additions to intangible assets included in accounts payable and accrued liabilities and long-term obligation |
15,235 | 216 | ||||||
Reimbursement of prepayment of derivative financial assets included in trade and other receivables |
| (4 | ) |
15 | 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.
a) | Credit risk |
Credit risk is the risk of a 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.
b) | Liquidity risk |
Liquidity risk is the risk that the Company will not be able to meet its financial obligations as they become due. 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.
19
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements, Continued
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
The Company has adopted an investment policy in respect of the safety and preservation of its capital designed 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 May 31, 2014 and November 30, 2013:
May 31, 2014 | ||||||||||||||||||||
Carrying amount |
Contractual amount |
Less than 1 year |
From 1 to 5 years |
More than 5 years |
||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Accounts payable and accrued liabilities |
5,914 | 5,914 | 5,914 | | | |||||||||||||||
Long-term obligation |
15,239 | 21,684 | 4,337 | 17,347 | | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
21,153 | 27,598 | 10,251 | 17,347 | | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
November 30, 2013 | ||||||||||||||||||||
Carrying amount |
Contractual amount |
Less than 1 year |
From 1 to 5 years |
More than 5 years |
||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Accounts payable and accrued liabilities |
3,371 | 3,371 | 3,371 | | | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
3,371 | 3,371 | 3,371 | | | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
c) | Currency risk |
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 long term debt, sale of goods and expenses incurred in US dollars.
From time to time, the Company enters into forward foreign exchange contracts. No forward foreign exchange contract was in circulation on May 31, 2014 or November 30, 2013.
20
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements, Continued
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
Exchange rate fluctuations for foreign currency transactions can cause cash flows as well as amounts recorded in the consolidated statements of comprehensive income (loss) 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 (loss) income. 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 in the original currencies exposed to currency risk at the following dates:
May 31, 2014 |
||||
US$ | ||||
Cash |
158 | |||
Accounts payable and accrued liabilities |
(3,457 | ) | ||
Long-term obligation |
(14,055 | ) | ||
|
|
|||
Total exposure |
(17,354 | ) | ||
|
|
|||
November 30, 2013 |
||||
US$ | ||||
Cash |
858 | |||
Trade and other receivables |
408 | |||
Accounts payable and accrued liabilities |
(1,356 | ) | ||
|
|
|||
Total exposure |
(90 | ) | ||
|
|
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 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 until close to maturity. The unrealized gains or losses on bonds are recorded in accumulated other comprehensive income.
Cash bears interest at a variable rate. Trade and other receivables, accounts payable and accrued liabilities and long term debt bear no interest.
21
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements, Continued
(Unaudited)
May 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
16 | 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 measured at fair value
In establishing fair value, the Company uses a fair value hierarchy based on levels as defined below:
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. |
Level 3: | Defined as inputs that are based on little or no observable market data, therefore requiring entities to develop their own assumptions. |
Other financial assets and liabilities
The Company has determined that the carrying values of its short-term financial assets and financial liabilities, including cash, trade and other receivables and accounts payable and accrued liabilities, approximate their fair value because of the relatively short period to maturity of the instruments.
Bonds and derivative financial assets and liabilities 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, if any, are not taken into account in determining fair value.
17 | Subsequent event |
In June 2014, a loss of $92 of materials was incurred related to manufacturing issues.
22
Exhibit 99.2
MANAGEMENTS DISCUSSION AND ANALYSIS
FOR THE THREE-MONTH AND SIX-MONTH PERIODS ENDED MAY 31, 2014
The following Managements Discussion and Analysis, or MD&A, provides Managements point of view on the financial position and results of operations of Theratechnologies Inc., on a consolidated basis, for the three- and six-month periods ended May 31, 2014 as compared to the three- and six-month periods ended May 31, 2013. This MD&A is dated July 8, 2014, was approved by our Audit Committee, and should be read in conjunction with our unaudited interim consolidated financial statements and the notes thereto as at May 31, 2014, as well as the MD&A and audited consolidated financial statements including the notes thereto as at November 30, 2013. The interim consolidated financial statements for the three- and six-month periods ended May 31, 2014 have not been reviewed by our auditors.
The financial information contained in this MD&A and in our unaudited interim consolidated financial statements and audited consolidated financial statements has been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. All monetary amounts set forth in this MD&A 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.
Unless otherwise indicated or unless the context requires otherwise, all references in this MD&A to Theratechnologies, the Company, the Corporation, we, our, us or similar terms refer to Theratechnologies Inc. and its subsidiaries on a consolidated basis. 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. Tesamorelin refers to the use of tesamorelin for the potential treatment of other diseases. EGRIFTA® is our registered trademark in the United States and it is used in that country to commercialize tesamorelin for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
This MD&A contains information that we believe may affect our prospective financial condition, cash flows and results of operations. Readers are cautioned to consult the section, Forward-Looking Information, below.
Additional information about the Company can be obtained on SEDAR at www.sedar.com or on EDGAR at www.sec.gov.
Business Overview
We are a specialty pharmaceutical company addressing unmet medical needs in metabolic disorders to promote healthy ageing and improved quality of life.
Our first product, EGRIFTA (tesamorelin for injection), was approved by the United States Food and Drug Administration, or 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. From January 10, 2011 until April 30, 2014, EGRIFTA was marketed in the United States by EMD Serono, Inc., or EMD Serono, pursuant to a collaboration and licensing agreement executed in October 2008, and subsequently amended in April 2012, or EMD Serono Agreement. On December 13, 2013, we entered into a termination and transfer agreement with EMD Serono, or EMD Serono Termination Agreement, in order to regain all of the commercialization rights to EGRIFTA in the United States. The transaction closed on May 1, 2014.
The regaining of the US commercialization rights to EGRIFTA is having a significant impact on the nature of our business and, as a consequence, on our financial reporting after the May 1, 2014 closing date. Our revenues now include the full proceeds of sales of EGRIFTA to wholesalers and our expenses encompass all of the marketing and distribution expenses previously incurred by EMD Serono. We also have new financial obligations in the form of debt and royalties payable to EMD Serono.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
We are moving forward in the US market under a specialty pharmaceutical business model that is solely focused on our own product. All US activities are aimed directly at elevating the importance of treating excess abdominal fat in HIV-infected patients with lipodystrophy, for patients, health-care providers and third-party payors. Our goal is to increase the patient base, which will ultimately lead to higher revenues and cash flow. We also plan to leverage our US commercial experience to enhance our worldwide partnership initiatives, helping us to drive performance and become more proactive and responsive to partners needs.
On June 9, 2014, we announced that the United States Patent and Trademark Office, or USPTO, has issued a patent term extension certificate for tesamorelin. Pursuant to this certificate, the USPTO has extended the term of US patent No. 5,861,379 (tesamorelin composition of matter patent) by five years until May 2020.
Technical issues observed during the production of EGRIFTA in its 2 mg presentation caused us to suspend manufacturing on February 14, 2014 and there is currently no inventory in the distribution network. In order to replenish inventory and resume shipping as soon as possible, we have temporarily reverted to the initial presentation of EGRIFTA (1 mg vial), which was problem free during the first two years of marketing the product. Regulatory clearance for this change has been obtained from the FDA. We have produced a batch of EGRIFTA in the 1 mg presentation, which is currently undergoing routine testing and should be available for distribution to patients between mid-August and mid-September 2014.
On April 30, 2014, we announced that we received a notice of compliance (regulatory approval) for EGRIFTA from Health Canada. We also announced that as of the same date, we entered into a termination agreement with Actelion Pharmaceuticals Canada Inc. (our former commercial partner for the Canadian market), pursuant to which we regained all of the rights to EGRIFTA in Canada. As a result, we are now preparing a Supplemental New Drug Submission, or SNDS, seeking approval for EGRIFTA in its 1 mg presentation. In the meantime we are laying plans for reimbursement programs, applying for permits and developing a marketing strategy for the Canadian market. Our marketing plan will incorporate key learnings from our experience in the United States.
In order to expand the commercial distribution of EGRIFTA globally, we have also granted exclusive commercialization rights to an affiliate of sanofi, or sanofi, for Latin America, Africa and the Middle East. Currently, the largest potential markets in sanofis territory are Brazil and Mexico and sanofi is focusing its efforts on marketing authorization applications in these two countries. In June 2014, sanofi informed us that the Brazilian regulatory authority has issued a Good Manufacturing Practices, or GMP, certificate for our third-party manufacturer of EGRIFTA. Receipt of the GMP certificate has allowed the marketing authorization application in Brazil to proceed.
We have exclusive commercialization rights for EGRIFTATM in the rest of the world. We believe that most of the potential lies in Europe where our strategy is to seek commercial partners who can help us pursue alternative approaches including filing only in certain European countries and dispensing EGRIFTA by way of named patient programs.
In June 2014, we settled a dispute with the Canada Revenue Agency in respect of an investment tax credit refund claim related to our 1994 and 1995 taxation years, resulting in a refund of $4,110,000 which was recorded in the second quarter. This refund was received on July 3, 2014.
We currently have sufficient funding to manage the interruption we are experiencing in our revenue stream. If, however, we encounter significant delays in re-distributing EGRIFTATM, we may require additional funds in the next 12 months in order to meet our obligations and sustain operations. See Financial Position below.
2
Revenues
Prior to the closing of the EMD Serono Termination Agreement on May 1, 2014, our revenues were mainly composed of sales of EGRIFTA to EMD Serono for re-sale, royalties received from EMD Serono on U.S. sales to customers, and research services, which included milestone payments and the amortization of the initial payment received upon the closing of the EMD Serono Agreement. From May 1, 2014, on, our revenues are primarily sales of EGRIFTA to customers. Consolidated revenue for the three- and six-month periods ended May 31, 2014 were $2,393,000 and $4,065,000 compared to $2,331,000 and $4,130,000 in the comparable periods of fiscal 2013.
2014 | 2013 | 2014 | 2013 | |||||||||||||
(in thousands of Canadian dollars) |
(3 months) | (6 months) | ||||||||||||||
Sale of goods |
| 996 | 675 | 1,447 | ||||||||||||
Amortization of upfront payment |
2,450 | 463 | 2,770 | 927 | ||||||||||||
Royalties |
(57 | ) | 872 | 620 | 1,756 | |||||||||||
Revenue |
2,393 | 2,331 | 4,065 | 4,130 |
Revenue generated from the sale of goods in the three- and six-month periods ended May 31, 2014 was nil and $675,000 compared to $996,000 and $1,447,000 in the comparable periods of fiscal 2013. Shipments to EMD Serono in the first quarter of 2014 represented all of the goods that were available in inventory and, with manufacturing suspended, there were no goods available for sale in the second quarter.
With the closing of the EMD Serono Termination Agreement on May 1, 2014, we are no longer amortizing the initial payment of $27,097,000 received upon the closing of the EMD Serono Agreement. Consequently, all of the $2,450,000 unamortized balance of the initial payment was recognized as revenue in the second quarter of 2014.
The lower sale of goods described above had a direct impact on royalties, which are almost entirely derived from the sales of EGRIFTA by EMD Serono. The lower royalties necessitated the adjustment of previous management estimates and resulted in the reported negative royalty revenue of $(57,000) in the three-month period ended May 31, 2014 and downward adjusted royalty revenue of $620,000 in the six-month period ended May 31, 2014, compared to $872,000 and $1,756,000 in the comparable periods of fiscal 2013.
Cost of Sales
The cost of sales in the three- and six-month periods ended May 31, 2014 was $14,000 and $1,639,000 compared to $1,065,000 and $1,733,000 in the comparable periods of fiscal 2013. The cost of sales is made up of cost of goods sold and unallocated production costs. The cost of goods sold component in 2014 amounted to nil in the three-month period and $600,000 in the six-month period compared to $864,000 and $1,262,000 in the comparable periods of fiscal 2013. Unallocated production costs were $14,000 and $1,039,000 in the three- and six-month periods ended May 31, 2014 compared to $201,000 and $471,000 in the comparable periods of fiscal 2013. The higher unallocated production costs in the six-month period ended May 31, 2014 are due largely to inventory write downs related to the manufacturing issues in the first quarter.
3
R&D Expenses
R&D expenses, net of tax credits, in the three- and six-month periods ended May 31, 2014 were $2,121,000 and $3,417,000 compared to $1,791,000 and $3,246,000 in the comparable periods of fiscal 2013. R&D expenses are largely made up of expenses for the two Phase 4 clinical trials currently being conducted. Expenses related to the diabetic retinopathy study were $1,186,000 and $1,856,000 for the three and six-month periods ended May 31, 2014, compared to $856,000 and $1,619,000 in the comparable periods of fiscal 2013. Expenses for the long-term safety study were $232,000 and $432,000 for the three and six-month periods ended May 31, 2014, compared to $210,000 and $342,000 in the comparable periods of fiscal 2013.
Selling and Market Development Expenses
Selling and market development expenses amounted to $2,148,000 and $3,527,000 for the three- and six-month periods ended May 31, 2014, compared to $69,000 and $131,000 in the comparable periods of fiscal 2013. The significant increase in expenses in fiscal 2014 is principally due to organization building and marketing initiatives tied to our reacquired commercialization rights for EGRIFTA in the United States market. In future periods, selling and market development expenses are expected to continue to be higher than in the past as we assume full responsibility for EGRIFTA marketing in the United States. In addition, following the closing of the EMD Serono Termination Agreement on May 1, 2014, selling and market development expenses now include the amortization of the $16,063,000 intangible asset value established for the EGRIFTA commercialization rights. This amortization expense amounted to $144,000 in the three-month period ended May 31, 2014.
General and Administrative Expenses
General and administrative expenses amounted to $1,370,000 and $2,340,000 in the three- and six-month periods ended May 31, 2014, compared to $906,000 and $1,873,000 in the comparable periods of fiscal 2013. The increase in expenses in 2014 is largely temporary in nature and is principally due to professional fees.
Restructuring Costs
There were no restructuring costs in the three- and six-month periods ended May 31, 2014. In the first three months of fiscal 2013, we recovered previously expensed restructuring costs in the amount of $3,093,000. The recovery came as a result of a lease amendment agreement entered into in April 2013, which eliminated the remaining $3,133,000 of an onerous lease provision established in conjunction with restructuring initiatives in 2012.
Net Financial Income
Finance income for the three- and six-month periods ended May 31, 2014 was $123,000 and $228,000 compared to $166,000 and $326,000 in the comparable periods of fiscal 2013. Interest revenue has trended lower due to a gradual decline in the portfolio size as investments are liquidated to fund operations.
Finance costs for the three-month period ended May 31, 2014 were $46,000 which included $170,000 of accretion on the $15,239,000 debt owed to EMD Serono for the early termination of the EMD Serono Agreement, offset by a foreign exchange gain of $216,000. For the six-month period ended May 31, 2014, finance costs were $13,000, which was principally the $170,000 of debt accretion, offset by a foreign exchange gain of $196,000. Finance costs were $31,000 and $71,000 in the comparable three- and six-month periods of fiscal 2013.
Federal Investment Tax Credits
The Company settled a dispute with the Canada Revenue Agency in respect of an investment tax credit refund claim related to its 1994 and 1995 taxation years, resulting in a refund of $4,110,000 ($1,650,000 of investment tax credit refund and $2,520,000 in interest less associated fees). There were no items of this nature in the comparable periods of fiscal 2013.
4
The $1,650,000 of investment tax credit reduces the unused and unrecorded federal tax credits listed in note 11 of our November 30, 2013 consolidated financial statements.
Net Profit/Loss
Taking into account the revenue and expense variations described above, the net profit for the three-month period ended May 31, 2014 was $1,007,000, compared to a net loss of $1,382,000 in the comparable period of fiscal 2013. For the six-month period ended May 31, 2014, the net loss was $2,527,000, compared to a net profit of $478,000 in the comparable period of fiscal 2013. On a per share basis, the net profit was $0.02 in the three-month period May 31, 2014 compared to net loss of $(0.02) in the comparable period of fiscal 2013. In the six-month period ended May 31, 2014, the net loss was $(0.04) compared to a net profit of $0.01 in the comparable period of fiscal 2013.
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.
2014 | 2013 | 2012 | ||||||||||||||||||||||||||||||
(In thousands of dollars, except per share amounts) |
Q2 | Q1 | Q4 | Q3 | Q2 | Q1 | Q4 | Q3 | ||||||||||||||||||||||||
Sale of goods |
| $ | 675 | $ | 311 | $ | 786 | $ | 996 | $ | 451 | $ | 1,375 | $ | 1,725 | |||||||||||||||||
Upfront and milestone payments |
$ | 2,450 | $ | 320 | $ | 320 | $ | 463 | $ | 463 | $ | 464 | $ | 868 | $ | 1,070 | ||||||||||||||||
Royalties and license fees |
$ | (57 | ) | $ | 677 | $ | 615 | $ | 928 | $ | 872 | $ | 884 | $ | 1,656 | $ | 1,027 | |||||||||||||||
Revenue |
$ | 2,393 | $ | 1,672 | $ | 1,246 | $ | 2,177 | $ | 2,331 | $ | 1,799 | $ | 3,899 | $ | 3,822 | ||||||||||||||||
Net profit (loss) |
$ | 1,007 | $ | (3,534 | ) | $ | (2,598 | ) | $ | (1,935 | ) | $ | (1,382 | ) | $ | 1,860 | $ | (4,341 | ) | $ | (698 | ) | ||||||||||
Basic and diluted profit (loss) per share |
$ | 0.02 | $ | (0.06 | ) | $ | (0.04 | ) | $ | (0.03 | ) | $ | (0.02 | ) | $ | 0.03 | $ | (0.07 | ) | $ | (0.01 | ) |
Revenue from the sale of goods in the second quarter of 2014 was nil due to a lack of inventory following the suspension of EGRIFTA manufacturing on February 14, 2014.
Revenue generated from sale of goods declined in fiscal 2013, reflecting lower shipments to EMD Serono and a lower selling price. The lower level of shipments was largely due to reductions in EMD Seronos inventory as well as to a supply shortage, which occurred in the fourth quarter as a result of the manufacturing problems encountered earlier in the year. The lower selling price in 2013 was the result of the introduction of the new single-vial presentation of EGRIFTA in October 2012.
With the closing of the EMD Serono Termination Agreement on May 1, 2014, the initial payment of $27,097,000, received upon the closing of the EMD Serono Agreement, is no longer being amortized. Consequently, all of the $2,450,000 unamortized balance of the initial payment was recognized as revenue in the second quarter of 2014.
The lower sale of goods in the first two quarters of 2014 had a direct impact on royalties, which are almost entirely derived from the sales of EGRIFTA by EMD Serono. The lower royalties necessitated the adjustment of previous management estimates and resulted in the reported negative royalty revenue of $(57,000) in the second quarter of 2014 and a downward adjustment in reported royalty revenue from $677,000 to $620,000 in the first quarter of 2014.
5
The royalties and license fees reported for the fourth quarter of fiscal 2012 are for the 5-month period from July 1, 2012 to November 30, 2012 as they include royalties actually received in the three months ended September 30, 2012 as well as an amount of $699,000 based on managements estimate of the royalties earned on EGRIFTA sales in October and November 2012.
The net profit reported in the second quarter of 2014, includes $4,110,000 received in settlement of a dispute over an investment tax credit refund claim related to our 1994 and 1995 taxation years.
The net loss reported in the fourth quarter of fiscal 2012 includes restructuring costs of $4,526,000.
The net profit in the first quarter of 2013 resulted from the elimination of an onerous lease provision in the amount of $3,093,000, which was no longer required following the signing of an amended lease agreement with our landlord.
Financial Position
Cash flows used in operating activities for the three- and six-month periods ended May 31, 2014 were $3,474,000 and $5,779,000 compared to $4,071,000 and $6,955,000 in the comparable periods of fiscal 2013. As at May 31, 2014, liquidities, which include cash and bonds, amounted to $5,552,000 and tax credits and grants receivable amounted to $4,170,000 for a total of $9,722,000 compared to $12,353,000 at November 30, 2013.
On December 13, 2013, the Company announced that it had reached an agreement with EMD Serono to regain all rights under the EMD Serono Agreement, including commercialization rights for EGRIFTATM in the United States. The closing of the transaction occurred on May 1, 2014. Operations of the Company have significantly changed upon the completion of the EMD Serono transaction which may impact the risk profile of its cash flows, and the contractual obligation with respect to the early termination fee (note 10 long term debt) will increase the Companys liquidity risk and may require additional funding.
During the last fiscal year, the Company experienced manufacturing difficulties at its third-party manufacturer, which led to shortages of EGRIFTATM and negatively impacted sales and operating results. Thereafter, the Company resumed manufacturing. On February 14, 2014, the manufacturing difficulties resurfaced. The Company ceased manufacturing again and there is no longer any inventory of EGRIFTATM available. As a result of the manufacturing difficulties, the Company undertook to carry out work to evaluate its current manufacturing process. A plan has been developed based upon temporarily reverting to the initial presentation of EGRIFTATM (1 mg vial), which was problem free during the first two years of marketing the product. In June 2014, one batch of EGRIFTATM in the 1 mg presentation was produced, which is currently undergoing routine testing. While it is supplying market demand with the 1 mg presentation, the Company will continue to improve its 2 mg production cycle. Once it has confidence that the cycle is robust, the approval of the FDA to bring the 2 mg presentation back to market will be sought. The Company currently has sufficient funding to offset the interruption it is experiencing in its revenue stream. If, however, the Company encounters significant delays in re-establishing the supply chain, it may require additional funds in the next 12 months in order to meet its obligations and sustain operations.
These circumstances could result in a material uncertainty that could cast significant doubt about the Companys ability to continue as a going concern.
6
Contractual Obligations
Under the terms of the EMD Serono Termination Agreement, the Company agreed to pay EMD Serono an increasing royalty, or Royalties, based on annual net sales. The Royalties will be paid until a cumulative aggregate amount is reached or until January 1, 2014, the first of these events to occur.
Also under the terms of the EMD Serono Termination Agreement, the Company agreed to pay an early termination fee of US$20,000,000 ($21,684,000), or Early Termination Fee, evenly over a five-year period starting on the first anniversary of the closing date.
The obligation is initially recognized at fair value, calculated using the present value of expected payments, discounted using a risk-adjusted discount rate of 13.5%. Effective interest rate of 13.5% is calculated annually and accounted for in accretion of the obligation value.
In order to secure the payment of the Early Termination Fee, the Company agreed to grant EMD Serono a security interest on its present and future corporeal and incorporeal movable property related to EGRIFTATM until such time as the Early Termination Fee has been reimbursed in full to EMD Serono. Thereafter, the Company and EMD Serono agreed to reduce the security interest to all present and future, corporeal and incorporeal movable property related to EGRIFTATM in the United States only to secure the payment of the Royalties.
In addition, the EMD Serono Termination Agreement provides that in the event there occurs a change of control of the Company before November 1, 2015, EMD Serono has the option to accelerate the full payment of the Early Termination Fee and to seek the payment of an amount intended to equal the net present value of the maximum future Royalties. If such change of control occurs after November 1, 2015, EMD Serono has the option to accelerate the payment of all unpaid Early Termination Fee.
Long-term obligation is payable as follows:
Capital $ |
Accrued Interest $ |
Total $ |
||||||||||
Less than one year |
2,302,000 | 2,035,000 | 4,337,000 | |||||||||
Between one and five years |
12,767,000 | 4,580,000 | 17,347,000 | |||||||||
15,069,000 | 6,615,000 | 21,684,000 |
The Company is responsible for all of the costs of the long-term observational safety study evaluating the safety of long-term administration of EGRIFTA. The total costs of the study are estimated to average $2,600,000 per year, over a fifteen-year period. From the beginning of the study until May 31, 2014, $2,366,000 has been spent on this study. The Company is also responsible for the Phase 4 clinical trial to assess whether EGRIFTA increases the incidence or progression of diabetic retinopathy in diabetic HIV-infected patients with lipodystrophy and excess abdominal fat. The trial is estimated to cost $20,000,000. Expenditures to date amount to $6,363,000.
In the second quarter of 2014, the Company terminated its $1,800,000 revolving credit facility.
7
Financial Risk Management
Credit risk
Credit risk is the risk of a 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.
Liquidity risk
Liquidity risk is the risk that the Company will not be able to meet its financial obligations as they become due. 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 designed 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 May 31, 2014 and November 30, 2013:
May 31, 2014 | ||||||||||||||||||||
Carrying $ |
Contractual $ |
Less than $ |
From 1 to $ |
More than $ |
||||||||||||||||
Accounts payable and accrued liabilities |
5,914,000 | 5,914,000 | 5,914,000 | | | |||||||||||||||
Long-term obligation |
15,239,000 | 21,684,000 | 4,337,000 | 17,347,000 | | |||||||||||||||
21,153,000 | 27,598,000 | 10,251,000 | 17,347,000 | | ||||||||||||||||
November 30, 2013 | ||||||||||||||||||||
Carrying $ |
Contractual $ |
Less than $ |
From 1 to $ |
More than $ |
||||||||||||||||
Accounts payable and accrued liabilities |
3,371,000 | 3,371,000 | 3,371,000 | | | |||||||||||||||
3,371,000 | 3,371,000 | 3,371,000 | | |
Currency risk
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 long term debt, sale of goods, and expenses incurred in US dollars.
8
From time to time, the Company enters into forward foreign exchange contracts. No forward foreign exchange contract was outstanding as of May 31, 2014 and November 30, 2013.
Exchange rate fluctuations for foreign currency transactions can cause cash flows as well as amounts recorded in the consolidated statements of comprehensive income (loss) 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 (loss). 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 in the original currencies exposed to currency risk at the following dates:
May 31, 2014 | ||||
US$ | ||||
Cash |
158,000 | |||
Accounts payable and accrued liabilities |
(3,457,000 | ) | ||
Long-term obligation |
(14,055,000 | ) | ||
Total exposure |
(17,354,000 | ) | ||
November 30, 2013 | ||||
US$ | ||||
Cash |
858,000 | |||
Trade and other receivables |
408,000 | |||
Accounts payable and accrued liabilities |
(1,356,000 | ) | ||
Total exposure |
(90,000 | ) |
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 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 until close to maturity. The unrealized gains or losses on bonds are recorded in accumulated other comprehensive income.
Cash bears interest at a variable rate. Trade and other receivables, accounts payable and accrued liabilities and long-term obligation bear no interest.
9
Recent Changes in Accounting Standards
IFRS 10, Consolidated Financial Statements
In May 2011, the IASB issued IFRS 10, Consolidated Financial Statements, which replaces SIC-12, Consolidation: Special Purpose Entities, and parts of IAS 27, Consolidated and Separate Financial Statements. IFRS 10 builds on existing principles by identifying the concept of control as the determining factor in whether an entity should be included within the consolidated statements of an entity. The standard provides additional guidance to assist in the determination of control where this is difficult to assess. IFRS 10 became effective December 1, 2013. The adoption of this standard had no impact on the Companys consolidated interim financial statements.
IFRS 13, Fair Value Measurement
In May 2011, the IASB issued IFRS 13, Fair Value Measurement. IFRS 13 improves consistency and reduces complexity by providing a precise definition of fair value and a single source of fair value measurement and disclosure requirements for use across IFRS. IFRS 13 became effective December 1, 2013. The adoption of this standard had no impact on the Companys consolidated interim financial statements.
Amendments to IAS 19, Employee Benefits
In June 2011, the IASB published an amended version of IAS 19. The amendments impact termination benefits, which would now be recognized at the earlier of when the entity recognizes the costs for a restructuring within the scope of IAS 37, Provisions, Contingent Liabilities and Contingent Assets, and when the entity can no longer withdraw the offer of the termination benefits. The adoption of this standard had no impact on the Companys consolidated interim financial statements.
Subsequent Event
In June 2014, a loss of $92,000 of materials was incurred related to manufacturing issues.
Outstanding Share Data
On July 7, 2014, the number of common shares issued and outstanding was 61,010,603 while outstanding options granted under our stock option plan were 1,862,669.
Internal Control
No change has occurred in our internal control over financial reporting during the period beginning on March 1, 2014 and ending on May 31, 2014.
Economic and Industry Factors
Economic and industry factors were substantially unchanged from those reported in our 2013 MD&A.
Forward-Looking Information
This MD&A contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our managements belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as may, will, should, could, would, outlook, believe, plan, envisage, anticipate, expect and estimate, or the negatives of these terms, or variations of them. The forward-looking statements contained in this MD&A include, but are not limited to, statements regarding: the timing to resume the distribution of EGRIFTATM in the United States, our capacity to increase the patient base of EGRIFTATM in the United States and to generate higher revenues and cash flow therefrom, our capacity to improve the 2 mg production cycle and the capacity of our commercial partner outside of the United States to obtain approval and commercialize EGRIFTATM in Brazil and Mexico.
10
Forward-looking statements are based upon a number of assumptions and include, but are not limited to, the following: the manufactured lot of EGRIFTATM will pass routine testing, no delay will be encountered in connection with the packaging or shipping of the new lot of EGRIFTATM recently manufactured, we will be able to increase our patient base in the United States demand for EGRIFTATM will increase over time in the United States despite the drug shortage, EGRIFTATM will be accepted by the marketplace in territories outside of the United States and will be on the list of reimbursed drugs by third-party payors in these territories, the relationships with our commercial partners and third-party suppliers will be conflict-free and no unexpected events resulting in unplanned material expenses will occur.
Forward-looking statements are subject to a variety of risks and uncertainties, many of which are beyond our control that could cause our actual results to differ materially from those that are disclosed in or implied by the forward-looking statements contained in this MD&A. These risks and uncertainties include, but are not limited to, the following: the risk that the manufactured lot of EGRIFTATM fails routine testing and becomes unavailable for distribution, the risk that we are unable to find commercial partners in Europe, the risk that we incur various delays in resuming the distribution of EGRIFTATM in the United States and that such delays require that we seek financing through the issuance of equity, debt-securities or the sale of assets in order to continue our operations, the risk that we are unable to grow the patient base for EGRIFTATM in the United States and that our commercial operations do not generate high revenues, the risk that EGRIFTATM is not approved in Brazil and Mexico, the risk that conflicts occur with our third-party suppliers jeopardizing the manufacture and/or commercialization of EGRIFTATM, the risk that EGRIFTATM is withdrawn from the market as a result of defects or recalls if and when it becomes available, the risk that, even if approved in territories outside of the United States, EGRIFTATM is not accepted in these marketplaces or is not on the list of reimbursed drugs by third-party payors and the risk that unexpected events occur resulting in unplanned material expenses.
We refer potential investors to the Risk Factors section of our Annual Report on Form 20-F dated February 27, 2014 available at www.sedar.com, www.sec.gov and www.theratech.com for additional risks regarding the Company and its operation. 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 statements reflect current expectations regarding future events and speak only as of the date of this MD&A and represent our expectations as of that date.
We undertake no obligation to update or revise the information contained in this MD&A, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.
11
Exhibit 99.3
|
Theratechnologies Announces Financial Results for Second Quarter of 2014
Montreal, Canada July 9, 2014 Theratechnologies Inc. (Theratechnologies) (TSX: TH) today announced its financial results for the second quarter ended May 31, 2014.
Second quarter 2014 financial highlights
| Revenues of $2,393,000 |
| Cash payment of $4,100,000 by Revenue Canada received on July 3, 2014 |
| Selling and market development expenses of $2,148,000 mainly associated with marketing initiatives being undertaken in the United States |
| Net profit of $1,007,000 |
| $9,722,000 in liquidities available at quarter-end including bonds, tax credits and grants receivable |
The second quarter marked two important milestones for Theratechnologies, said Luc Tanguay, President and CEO. Most notably, we have now regained all rights to EGRIFTA in the U.S. and are well advanced with our plans to reap the associated benefits. We expect to begin distributing our drug to U.S. patients between mid-August and mid-September. The second achievement was in Canada, where we received regulatory approval for EGRIFTA and simultaneously regained the rights to the Canadian market, Mr. Tanguay noted.
Update on production
Technical issues observed during the production of EGRIFTA in its 2 mg presentation caused us to suspend manufacturing on February 14, 2014 and there is currently no inventory in the distribution network. In order to replenish inventory and resume shipping as soon as possible, we have temporarily reverted to the initial presentation of EGRIFTA (1 mg vial), which was problem free during the first two years of marketing the product. Regulatory clearance for this change has been obtained from the U.S. Food and Drug Administration. We have now produced one batch of EGRIFTA in the 1 mg presentation, which is currently undergoing routine testing and should be available for distribution to patients between mid-August and mid-September 2014.
Second Quarter Financial Results
The financial results presented in this press release are taken from the Companys Managements Discussion and Analysis, or MD&A, and unaudited consolidated financial statements for the period ended May 31, 2014, which have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. The MD&A for the second quarter ended May 31, 2014, and the unaudited consolidated financial statements can be found at www.theratech.com, www.sedar.com and www.sec.gov. Unless specified otherwise, all amounts in this press release are in Canadian dollars and all capitalized terms have the meaning ascribed thereto in our MD&A. As used herein, EGRIFTATM refers to tesamorelin for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. EGRIFTATM is our trademark.
Prior to the closing of the EMD Serono Termination Agreement on May 1, 2014, our revenues were mainly composed of sales of EGRIFTA to EMD Serono for re-sale, royalties received from EMD Serono on U.S. sales to customers, and research services, which included milestone payments and the amortization of the initial payment received upon the closing of the EMD Serono Agreement. From May 1, 2014, on, our revenues are primarily sales of EGRIFTA to customers. Consolidated revenue for the three- and six-month periods ended May 31, 2014 were $2,393,000 and $4,065,000 compared to $2,331,000 and $4,130,000 in the comparable periods of fiscal 2013.
Revenue generated from the sale of goods in the three- and six-month periods ended May 31, 2014 was nil and $675,000 compared to $996,000 and $1,447,000 in the comparable periods of fiscal 2013. Shipments to EMD Serono in the first quarter of 2014 represented all of the goods that were available in inventory and, with manufacturing suspended, there were no goods available for sale in the second quarter.
The lower sale of goods described above had a direct impact on royalties, which are almost entirely derived from the sales of EGRIFTA by EMD Serono. The lower royalties necessitated the adjustment of previous management estimates and resulted in the reported negative royalty revenue of $(57,000) in the three-month period ended May 31, 2014 and downward adjusted royalty revenue of $620,000 in the six-month period ended May 31, 2014, compared to $872,000 and $1,756,000 in the comparable periods of fiscal 2013.
With the closing of the EMD Serono Termination Agreement on May 1, 2014, we are no longer amortizing the initial payment of $27,097,000 received upon the closing of the EMD Serono Agreement. Consequently, all of the $2,450,000 unamortized balance of the initial payment was recognized as revenue in the second quarter of 2014.
The cost of sales in the three- and six-month periods ended May 31, 2014 was $14,000 and $1,639,000 compared to $1,065,000 and $1,733,000 in the comparable periods of fiscal 2013. The cost of sales is made up of cost of goods sold and unallocated production costs. The cost of goods sold component in 2014 amounted to nil in the three-month period and $600,000 in the six-month period compared to $864,000 and $1,262,000 in the comparable periods of fiscal 2013. Unallocated production costs were $14,000 and $1,039,000 in the three- and six-month periods ended May 31, 2014 compared to $201,000 and $471,000 in the comparable periods of fiscal 2013. The higher unallocated production costs in the six-month period ended May 31, 2014 are due largely to inventory write downs related to the manufacturing issues in the first quarter.
Research and development, or R&D, net of tax credits, in the three- and six-month periods ended May 31, 2014 were $2,121,000 and $3,417,000 compared to $1,791,000 and $3,246,000 in the comparable periods of fiscal 2013. R&D expenses are largely made up of expenses for the two Phase 4 clinical trials currently being conducted. Expenses related to the diabetic retinopathy study were $1,186,000 and $1,856,000 for the three and six-month periods ended May 31, 2014, compared to $856,000 and $1,619,000 in the comparable periods of fiscal 2013. Expenses for the long-term safety study were $232,000 and $432,000 for the three and six-month periods ended May 31, 2014, compared to $210,000 and $342,000 in the comparable periods of fiscal 2013.
2
Selling and market development expenses amounted to $2,148,000 and $3,527,000 for the three- and six-month periods ended May 31, 2014, compared to $69,000 and $131,000 in the comparable periods of fiscal 2013. The significant increase in expenses in fiscal 2014 is principally due to organization building and marketing initiatives tied to our reacquired commercialization rights for EGRIFTA in the United States market. In future periods, selling and market development expenses are expected to continue to be higher than in the past as we assume full responsibility for EGRIFTA marketing in the United States. In addition, following the closing of the EMD Serono Termination Agreement on May 1, 2014, selling and market development expenses now include the amortization of the $16,063,000 intangible asset value established for the EGRIFTA commercialization rights. This amortization expense amounted to $144,000 in the three-month period ended May 31, 2014.
General and administrative expenses amounted to $1,370,000 and $2,340,000 in the three- and six-month periods ended May 31, 2014, compared to $906,000 and $1,873,000 in the comparable periods of fiscal 2013. The increase in expenses in 2014 is largely temporary in nature and is principally due to professional fees.
There were no restructuring costs in the three- and six-month periods ended May 31, 2014. In the first three months of fiscal 2013, we recovered previously expensed restructuring costs in the amount of $3,093,000. The recovery came as a result of a lease amendment agreement entered into in April 2013, which eliminated the remaining $3,133,000 of an onerous lease provision established in conjunction with restructuring initiatives in 2012.
Finance income for the three- and six-month periods ended May 31, 2014 was $123,000 and $228,000 compared to $166,000 and $326,000 in the comparable periods of fiscal 2013. Interest revenue has trended lower due to a gradual decline in the portfolio size as investments are liquidated to fund operations.
Finance costs for the three-month period ended May 31, 2014 were $46,000 which included $170,000 of accretion on the $15,239,000 debt owed to EMD Serono for the early termination of the EMD Serono Agreement, offset by a foreign exchange gain of $216,000. For the six-month period ended May 31, 2014, finance costs were $13,000, which was principally the $170,000 of debt accretion, offset by a foreign exchange gain of $196,000. Finance costs were $31,000 and $71,000 in the comparable three- and six-month periods of fiscal 2013.
The Company settled a dispute with the Canada Revenue Agency in respect of an investment tax credit refund claim related to its 1994 and 1995 taxation years, resulting in a refund of $4,110,000 ($1,650,000 of investment tax credit refund and $2,520,000 in interest less associated fees). There were no items of this nature in the comparable periods of fiscal 2013.
3
Taking into account the revenue and expense variations described above, the net profit for the three-month period ended May 31, 2014 was $1,007,000, compared to a net loss of $1,382,000 in the comparable period of fiscal 2013. For the six-month period ended May 31, 2014, the net loss was $2,527,000, compared to a net profit of $478,000 in the comparable period of fiscal 2013. On a per share basis, the net profit was $0.02 in the three-month period May 31, 2014 compared to net loss of $(0.02) in the comparable period of fiscal 2013. In the six-month period ended May 31, 2014, the net loss was $(0.04) compared to a net profit of $0.01 in the comparable period of fiscal 2013.
Cash flows used in operating activities for the three- and six-month periods ended May 31, 2014 were $3,474,000 and $5,779,000 compared to $4,071,000 and $6,955,000 in the comparable periods of fiscal 2013.
As at May 31, 2014, liquidities, which include cash and bonds, amounted to $5,552,000 and tax credits and grants receivable amounted to $4,170,000 for a total of $9,722,000 compared to $12,353,000 at November 30, 2013.
On December 13, 2013, the Company announced that it entered into the EMD Serono Termination Agreement to regain all rights under the EMD Serono Agreement, including commercialization rights for EGRIFTATM in the United States. The closing of the transaction occurred on May 1, 2014. Operations of the Company have significantly changed upon the completion of the EMD Serono transaction which may impact the risk profile of its cash flows, and the contractual obligation with respect to the early termination fee (note 10 long-term obligation, of the Company`s interim consolidated financial statements) will increase the Companys liquidity risk and may require additional funding.
During the last fiscal year, the Company experienced manufacturing difficulties at its third-party manufacturer, which led to shortages of EGRIFTATM and negatively impacted sales and operating results. Thereafter, the Company resumed manufacturing. On February 14, 2014, the manufacturing difficulties resurfaced. The Company ceased manufacturing again and there is no longer any inventory of EGRIFTATM available. As a result of the manufacturing difficulties, the Company undertook to carry out work to evaluate its current manufacturing process. A plan has been developed based upon temporarily reverting to the initial presentation of EGRIFTATM (1 mg vial), which was problem free during the first two years of marketing the product. In June 2014, one batch of EGRIFTATM in the 1 mg presentation was produced, which is currently undergoing routine testing. While it is supplying market demand with the 1 mg presentation, the Company will continue to improve its 2 mg production cycle. Once it has confidence that the cycle is robust, the approval of the FDA to bring the 2 mg presentation back to market will be sought. The Company currently has sufficient funding to offset the interruption it is experiencing in its revenue stream. If, however, the Company encounters significant delays in re-establishing the supply chain, it may require additional funds in the next 12 months in order to meet its obligations and sustain operations.
These circumstances could result in a material uncertainty that could cast significant doubt about the Companys ability to continue as a going concern.
4
Subsequent Event
In June 2014, a loss of $92,000 of materials was incurred related to manufacturing issues.
Conference Call Details
A conference call will be held today at 8:30 a.m. (ET) to discuss the results. The call will be hosted by Luc Tanguay, President and Chief Executive Officer. The conference call will be open to questions from financial analysts. Media and other interested individuals are invited to participate in the call on a listen-only basis.
The conference call can be accessed by dialling 1-877-223-4471 (North America) or 1-647-788-4922 (International). The conference call will also be accessible via webcast at http://www.gowebcasting.com/5634. Audio replay of the conference call will be available until July 16, 2014, by dialling 1-416-621-4642 (North America) or 1-800-585-8367 (International) and by entering the playback code 65670188.
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical company addressing unmet medical needs in metabolic disorders to promote healthy ageing and improved quality of life. Further information about Theratechnologies is available on the Companys website at www.theratech.com, on SEDAR at www.sedar.com and on the SECs website at www.sec.gov.
Forward-Looking Information
This Press Release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our managements belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as may, will, should, could, would, outlook, believe, plan, envisage, anticipate, expect and estimate, or the negatives of these terms, or variations of them. The forward-looking statements contained in this Press Release include, but are not limited to, statements regarding: the timing to resume the distribution of EGRIFTATM in the United States, our capacity to improve the 2 mg production cycle and our capacity to offset the interruption of our revenue stream.
Forward-looking statements are based upon a number of assumptions and include, but are not limited to, the following: the manufactured lot of EGRIFTATM will pass routine testing and distribution of EGRIFTATM in the United States will resume as planned, no delay will be encountered in connection with the packaging or shipping of the new lot of EGRIFTATM recently manufactured, we will be able to increase our patient base in the United States, demand for EGRIFTATM will increase over time in the United States despite the drug shortage, and no unexpected events resulting in unplanned material expenses will occur.
5
Forward-looking statements are subject to a variety of risks and uncertainties, many of which are beyond our control that could cause our actual results to differ materially from those that are disclosed in or implied by the forward-looking statements contained in this Press Release. These risks and uncertainties include, but are not limited to, the following: the risk that the manufactured lot of EGRIFTATM fails routine testing and becomes unavailable for distribution, the risk that we incur various delays in resuming the distribution of EGRIFTATM in the United States and that such delays require that we seek financing through the issuance of equity, debt-securities or the sale of assets in order to continue our operations, the risk that conflicts occur with our third-party suppliers jeopardizing the manufacture and/or commercialization of EGRIFTATM, the risk that EGRIFTATM is withdrawn from the market as a result of defects or recalls if and when it becomes available and the risk that unexpected events occur resulting in unplanned material expenses.
We refer potential investors to the Risk Factors section of our Annual Report on Form 20-F dated February 27, 2014 available at www.sedar.com, www.sec.gov and www.theratech.com for additional risks regarding the Company and its operation. 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 statements reflect current expectations regarding future events and speak only as of the date of this Press Release and represent our expectations as of that date.
We undertake no obligation to update or revise the information contained in this Press Release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.
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Contact:
Denis Boucher
Phone: 514-913-1957
6
Exhibit 99.4
FORM 52-109F2
CERTIFICATION OF INTERIM FILINGS
FULL CERTIFICATE
I, Luc Tanguay, President and Chief Executive Officer of Theratechnologies Inc., certify the following:
1. | Review: I have reviewed the interim financial report and interim MD&A, (together, the interim filings) of Theratechnologies Inc. (the issuer) for the interim period ended May 31, 2014. |
2. | No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings. |
3. | Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings. |
4. | Responsibility: The issuers other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in Regulation 52-109 respecting Certification of Disclosure in Issuers Annual and Interim Filings (c. V-1.1, r. 27), for the issuer. |
5. | Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuers other certifying officers(s) and I have, as at the end of the period covered by the interim filings |
(a) | designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that |
(i) | material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and |
(ii) | information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and |
(b) | designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuers GAAP. |
5.1 | Control framework: The control framework the issuers other certifying officer(s) and I used to design the issuers ICFR is the Internal Control over Financial Reporting Guidance for Smaller Public Companies (COSO). |
5.2 | N/A |
5.3 | N/A |
6. | Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuers ICFR that occurred during the period beginning on March 1, 2014 and ended on May 31, 2014 that has materially affected, or is reasonably likely to materially affect, the issuers ICFR. |
Date: July 9, 2014
/s/ Luc Tanguay |
Luc Tanguay |
President and Chief Executive Officer |
Exhibit 99.5
FORM 52-109F2
CERTIFICATION OF INTERIM FILINGS
FULL CERTIFICATE
I, Marie-Noël Colussi, Vice President, Finance of Theratechnologies Inc. and performing similar functions to a chief financial officer and providing this certification in my capacity as chief financial officer, certify the following:
1. | Review: I have reviewed the interim financial report and interim MD&A, (together, the interim filings) of Theratechnologies Inc. (the issuer) for the interim period ended May 31, 2014. |
2. | No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings. |
3. | Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings. |
4. | Responsibility: The issuers other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in Regulation 52-109 respecting Certification of Disclosure in Issuers Annual and Interim Filings (c. V-1.1, r. 27), for the issuer. |
5. | Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuers other certifying officers(s) and I have, as at the end of the period covered by the interim filings |
(a) | designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that |
(i) | material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and |
(ii) | information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and |
(b) | designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuers GAAP. |
5.1 | Control framework: The control framework the issuers other certifying officer(s) and I used to design the issuers ICFR is the Internal Control over Financial Reporting Guidance for Smaller Public Companies (COSO). |
5.2 | N/A |
5.3 | N/A |
6. | Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuers ICFR that occurred during the period beginning on March 1, 2014 and ended on May 31, 2014 that has materially affected, or is reasonably likely to materially affect, the issuers ICFR. |
Date: July 9, 2014
/s/ Marie-Noël Colussi |
Marie-Noël Colussi |
Vice President, Finance, providing this certification in capacity as chief financial officer |