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 October 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 nine-month periods ended August 31, 2014 and August 31, 2013 | |
99.2 | Managements Discussions and Analysis for the three-month and nine-month periods ended August 31, 2014 | |
99.3 | Press Release Dated October 8, 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/ Jocelyn Lafond | |
Name: Jocelyn Lafond Title: Vice President, Legal Affairs, and Corporate Secretary |
Date: October 8, 2014
Exhibit 99.1
Theratechnologies Inc.
Interim Consolidated Financial Statements
(Unaudited)
August 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 August 31, 2014 |
As at November 30, 2013 |
||||||||||
$ | $ | |||||||||||
Assets |
||||||||||||
Current assets |
||||||||||||
Cash |
2,523 | 967 | ||||||||||
Bonds |
35 | 99 | ||||||||||
Trade and other receivables |
76 | 489 | ||||||||||
Inventories |
8 | 10,479 | 10,995 | |||||||||
Prepaid expenses |
743 | 404 | ||||||||||
Derivative financial assets |
182 | 106 | ||||||||||
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|
|
|
|||||||||
14,038 | 13,060 | |||||||||||
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|
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Non-current assets |
||||||||||||
Bonds |
3,070 | 11,287 | ||||||||||
Property and equipment |
239 | 281 | ||||||||||
Intangible assets |
9 | 15,487 | 216 | |||||||||
|
|
|
|
|||||||||
18,796 | 11,784 | |||||||||||
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|
|||||||||
Total assets |
32,834 | 24,844 | ||||||||||
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|
|||||||||
Liabilities |
||||||||||||
Current liabilities |
||||||||||||
Accounts payable and accrued liabilities |
5,533 | 3,371 | ||||||||||
Current portion of long-term obligation |
10 | 2,989 | | |||||||||
Deferred revenue |
3 | 1,279 | ||||||||||
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|
|||||||||
8,525 | 4,650 | |||||||||||
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|
|||||||||
Non-current liabilities |
||||||||||||
Deferred revenue |
| 1,492 | ||||||||||
Long-term obligation |
10 | 12,803 | | |||||||||
Other liabilities |
20 | 174 | ||||||||||
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12,823 | 1,666 | |||||||||||
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|
|||||||||
Total liabilities |
21,348 | 6,316 | ||||||||||
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|
|
|||||||||
Equity |
||||||||||||
Share capital |
280,872 | 280,872 | ||||||||||
Contributed surplus |
8,293 | 8,232 | ||||||||||
Deficit |
(277,762 | ) | (270,841 | ) | ||||||||
Accumulated other comprehensive income |
83 | 265 | ||||||||||
|
|
|
|
|||||||||
11,486 | 18,528 | |||||||||||
|
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|
|
|||||||||
Total liabilities and equity |
32,834 | 24,844 | ||||||||||
|
|
|
|
|||||||||
Contingent liability |
12 | |||||||||||
Commitments |
13 |
The accompanying notes are an integral part of these interim consolidated financial statements.
1
Theratechnologies Inc.
Interim Consolidated Statements of Comprehensive Loss
(Unaudited)
(in thousands of Canadian dollars, except per share amounts)
For the three-month periods ended August 31, |
For the nine-month periods ended August 31, |
|||||||||||||||||||
Note | 2014 | 2013 | 2014 | 2013 | ||||||||||||||||
$ | $ | $ | $ | |||||||||||||||||
Revenue |
||||||||||||||||||||
Sale of goods |
| 786 | 675 | 2,233 | ||||||||||||||||
Research services Up-front payments and initial technology access fees |
4 | | 463 | 2,770 | 1,390 | |||||||||||||||
Royalties and licence fees |
4 | 928 | 624 | 2,684 | ||||||||||||||||
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4 | 2,177 | 4,069 | 6,307 | |||||||||||||||||
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Operating expenses |
||||||||||||||||||||
Cost of sales |
||||||||||||||||||||
Cost of goods sold |
| 678 | 600 | 1,940 | ||||||||||||||||
Unallocated production costs |
212 | 145 | 1,251 | 616 | ||||||||||||||||
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212 | 823 | 1,851 | 2,556 | |||||||||||||||||
Research and development expenses, net of tax credits of nil (2013 $91) for the three-month period and nil (2013 $147) for the nine-month period |
1,036 | 2,578 | 4,453 | 5,824 | ||||||||||||||||
Selling and market development expenses |
5 | 1,720 | 59 | 5,247 | 190 | |||||||||||||||
General and administrative expenses |
914 | 741 | 3,254 | 2,614 | ||||||||||||||||
Restructuring costs |
| | | (3,093 | ) | |||||||||||||||
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3,882 | 4,201 | 14,805 | 8,091 | |||||||||||||||||
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Loss from operating activities |
(3,878 | ) | (2,024 | ) | (10,736 | ) | (1,784 | ) | ||||||||||||
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Finance income |
6 | 66 | 107 | 294 | 433 | |||||||||||||||
Finance costs |
6 | (574 | ) | (8 | ) | (561 | ) | (79 | ) | |||||||||||
Federal investment tax credits |
7 | | | 4,110 | | |||||||||||||||
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(508 | ) | 99 | 3,843 | 354 | ||||||||||||||||
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Loss before income taxes |
(4,386 | ) | (1,925 | ) | (6,893 | ) | (1,430 | ) | ||||||||||||
Income tax expense |
(8 | ) | (10 | ) | (28 | ) | (27 | ) | ||||||||||||
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Loss for the period |
(4,394 | ) | (1,935 | ) | (6,921 | ) | (1,457 | ) | ||||||||||||
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Other comprehensive 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 |
(27 | ) | (58 | ) | (70 | ) | (97 | ) | ||||||||||||
Net change in fair value of available-for-sale financial assets transferred to net profit (loss), net of tax |
(22 | ) | (6 | ) | (112 | ) | (76 | ) | ||||||||||||
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(49 | ) | (64 | ) | (182 | ) | (173 | ) | |||||||||||||
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Total comprehensive loss for the period |
(4,443 | ) | (1,999 | ) | (7,103 | ) | (1,630 | ) | ||||||||||||
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Basic and diluted loss per share |
11b | ) | (0.07 | ) | (0.03 | ) | (0.11 | ) | (0.02 | ) | ||||||||||
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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 nine-month periods ended August 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 loss for the period |
||||||||||||||||||||||||||||
Net loss for the period |
(6,921 | ) | | (6,921 | ) | |||||||||||||||||||||||
Other comprehensive loss |
||||||||||||||||||||||||||||
Net change in fair value of available-for-sale financial assets, net of tax |
| (70 | ) | (70 | ) | |||||||||||||||||||||||
Net change in fair value of available-for-sale financial assets transferred to net loss, net of tax |
| (112 | ) | (112 | ) | |||||||||||||||||||||||
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Total comprehensive loss for the period |
(6,921 | ) | (182 | ) | (7,103 | ) | ||||||||||||||||||||||
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Transactions with owners, recorded directly in equity |
||||||||||||||||||||||||||||
Share-based compensation for stock option plan |
11a | ) | | | 61 | | | 61 | ||||||||||||||||||||
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Total contributions by owners |
| | 61 | | | 61 | ||||||||||||||||||||||
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|
|||||||||||||||||
Balance as at August 31, 2014 |
61,010,603 | 280,872 | 8,293 | (277,762 | ) | 83 | 11,486 | |||||||||||||||||||||
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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 nine-month periods ended August 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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|
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Total comprehensive loss for the period |
||||||||||||||||||||||||||||
Net loss for the period |
(1,457 | ) | | (1,457 | ) | |||||||||||||||||||||||
Other comprehensive loss |
||||||||||||||||||||||||||||
Net change in fair value of available-for-sale financial assets, net of tax |
| (97 | ) | (97 | ) | |||||||||||||||||||||||
Net change in fair value of available-for-sale financial assets transferred to net profit, net of tax |
| (76 | ) | (76 | ) | |||||||||||||||||||||||
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Total comprehensive loss for the period |
(1,457 | ) | (173 | ) | (1,630 | ) | ||||||||||||||||||||||
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Transactions with owners, recorded directly in equity |
||||||||||||||||||||||||||||
Share-based compensation for stock option plan |
11a | ) | | | 68 | | | 68 | ||||||||||||||||||||
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Total contributions by owners |
| | 68 | | | 68 | ||||||||||||||||||||||
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Balance as at August 31, 2013 |
61,010,603 | 280,872 | 8,226 | (268,243 | ) | 253 | 21,108 | |||||||||||||||||||||
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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 August 31, |
For the nine-month periods ended August 31, |
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Note | 2014 | 2013 | 2014 | 2013 | ||||||||||||||||
$ | $ | $ | $ | |||||||||||||||||
Cash flows from |
||||||||||||||||||||
Operating activities |
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Loss for the period |
(4,394 | ) | (1,935 | ) | (6,921 | ) | (1,457 | ) | ||||||||||||
Adjustments for |
||||||||||||||||||||
Depreciation of property and equipment |
14 | 26 | 42 | 93 | ||||||||||||||||
Amortization of intangible assets |
9 | 432 | | 576 | | |||||||||||||||
Gain on disposal of property and equipment |
| | | (60 | ) | |||||||||||||||
Change in deferred revenue |
(3 | ) | (466 | ) | (2,768 | ) | (1,388 | ) | ||||||||||||
Share-based compensation for stock option plan |
11a | ) | 21 | 26 | 61 | 68 | ||||||||||||||
Income tax |
8 | 10 | 28 | 27 | ||||||||||||||||
Writedown of inventories |
8 | 51 | 184 | 987 | 376 | |||||||||||||||
Lease inducements and amortization |
(138 | ) | (8 | ) | (154 | ) | (34 | ) | ||||||||||||
Change in fair value of derivative financial assets |
(37 | ) | (2 | ) | (95 | ) | 7 | |||||||||||||
Change in fair value of liability related to deferred stock unit plan |
37 | 2 | 99 | 5 | ||||||||||||||||
Change in fair value of derivative financial liabilities |
| (15 | ) | | | |||||||||||||||
Interest income |
(44 | ) | (101 | ) | (182 | ) | (357 | ) | ||||||||||||
Interest received |
67 | 157 | 269 | 596 | ||||||||||||||||
Accretion expense |
6 | 508 | | 678 | | |||||||||||||||
Unrealized foreign currency gain on long-term obligation |
6 | 45 | | (121 | ) | | ||||||||||||||
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(3,433 | ) | (2,122 | ) | (7,501 | ) | (2,124 | ) | |||||||||||||
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Changes in operating assets and liabilities |
||||||||||||||||||||
Trade and other receivables |
72 | 955 | 409 | 442 | ||||||||||||||||
Tax credits and grants receivable |
4,170 | 471 | | 415 | ||||||||||||||||
Inventories |
(396 | ) | 1,223 | (471 | ) | 1,059 | ||||||||||||||
Prepaid expenses |
161 | 191 | (339 | ) | 99 | |||||||||||||||
Accounts payable and accrued liabilities |
(418 | ) | (100 | ) | 2,279 | (623 | ) | |||||||||||||
Provisions |
| (3 | ) | | (5,608 | ) | ||||||||||||||
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3,589 | 2,737 | 1,878 | (4,216 | ) | ||||||||||||||||
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Cash flows from (used in) operating activities |
156 | 615 | (5,623 | ) | (6,340 | ) | ||||||||||||||
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Investing activities |
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Acquisition of intangible assets |
| | (828 | ) | | |||||||||||||||
Proceeds from sale of property and equipment |
| | | 60 | ||||||||||||||||
Proceeds from sale of bonds |
2,057 | 606 | 7,984 | 6,442 | ||||||||||||||||
Prepayment of derivative financial assets |
| | | (50 | ) | |||||||||||||||
Proceeds from disposal of derivate financial assets |
| | 23 | | ||||||||||||||||
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Cash flows from investing activities |
2,057 | 606 | 7,179 | 6,452 | ||||||||||||||||
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Net change in cash for the period |
2,213 | 1,221 | 1,556 | 112 | ||||||||||||||||
Cash Beginning of period |
310 | 403 | 967 | 1,512 | ||||||||||||||||
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Cash End of period |
2,523 | 1,624 | 2,523 | 1,624 | ||||||||||||||||
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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)
August 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, at that time, there was no inventory of finished goods available. A plan was developed based on temporarily reverting to the initial presentation of EGRIFTATM (1 mg vial), which was supplied without any commercial delays during the first two years of marketing the product. In early September 2014, shipments of EGRIFTATM resumed using the 1 mg presentation. The Company currently has funding to meet its financial obligations while it re-establishes its revenue stream.
If, however, it encounters significant setbacks in relation to projected sales levels and/or manufacturing and supply issues, the Company will require additional funds in the next 12 months in order to meet its obligations and sustain operations. As of the date of these interim consolidated financial statements, there is no new funding agreement in place. These circumstances could result in a material uncertainty that casts substantial doubt about the Companys ability to continue as a going concern.
6
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
August 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
The interim 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 interim consolidated 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 consolidated 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 consolidated financial statements have not been reviewed by the Companys auditors.
These interim consolidated financial statements were authorized for issue by the Companys Audit Committee on October 7, 2014.
Summary of accounting policies
Except as described below, the accounting policies applied in these interim 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
(Unaudited)
August 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 consolidated 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 consolidated financial statements in conformity with IFRS requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.
Information about critical judgments in applying accounting policies and assumptions and estimation uncertainties that have the most significant effect on the amounts recognized in the interim consolidated financial statements are disclosed in note 2 to the annual consolidated financial statements as at November 30, 2013 except:
There are assumptions and estimation uncertainties with respect to the determination of the useful life and the determination of the fair value of the intangible assets (note 9) and the determination of fair value of the long-term obligation (note 10).
Functional and presentation currency
These interim consolidated financial statements are presented in Canadian dollars, which is the Companys functional currency. All financial information presented in Canadian dollars has been rounded to the nearest thousand.
8
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
August 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
3 | Recent changes in accounting standards |
New standards issued but not yet adopted
IFRS 9, Financial instruments
On July 24, 2014, the IASB issued the final version of IFRS 9, bringing together the classification and measurement, impairment and hedge accounting phases of the IASBs project to replace IAS 39. The final version of IFRS 9 supersedes all previous versions of IFRS 9 and is effective for periods beginning on or after January 1, 2018; however an entity may elect to apply earlier versions of IFRS 9 if the entitys relevant date of initial application is before February 1, 2015.
IFRS 15, Revenue from Contracts with Customers
In May 2014, the IASB issued IFRS 15 which establishes principles for reporting the nature, amount, timing and uncertainty of revenue and cash flows arising from an entitys contracts with customers. It provides a single model in order to depict the transfer of promised goods or services to customers.
IFRS 15 supersedes the following standards: IAS 11, Construction Contracts, IAS 18, Revenue, IFRIC 13, Customer Loyalty Programmes, IFRIC 15, Agreements for the Construction of Real Estate, IFRIC 18, Transfers of Assets from Customers, and SIC-31, Revenue Barter Transactions Involving Advertising Services.
The core principle of IFRS 15 is that an entity recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services.
IFRS 15 also includes a cohesive set of disclosure requirements that would result in an entity providing comprehensive information about the nature, amount, timing and uncertainty of revenue and cash flows arising from the entitys contracts with customers.
This standard is effective for annual periods beginning on or after January 1, 2017 with earlier adoption permitted, the Company has not yet assessed the impact of the adoption of this standard on its consolidated financial statements.
9
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
August 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
Standards adopted
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 consolidated 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 consolidated 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 consolidated 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.
10
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
August 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 August 31, |
||||||||||||
Note | 2014 | 2013 | ||||||||||
$ | $ | |||||||||||
Selling and market development expenses |
1,288 | 59 | ||||||||||
Amortization of intangible assets |
9 | 432 | | |||||||||
|
|
|
|
|||||||||
1,720 | 59 | |||||||||||
|
|
|
|
For the nine-month periods ended August 31, |
||||||||||||
Note | 2014 | 2013 | ||||||||||
$ | $ | |||||||||||
Selling and market development expenses |
4,671 | 190 | ||||||||||
Amortization of intangible assets |
9 | 576 | | |||||||||
|
|
|
|
|||||||||
5,247 | 190 | |||||||||||
|
|
|
|
11
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
August 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
6 | Finance income and finance costs |
Recognized in net loss:
For the three-month periods ended August 31, |
||||||||
2014 | 2013 | |||||||
$ | $ | |||||||
Interest income |
44 | 101 | ||||||
Net gain on disposal of available-for-sale financial assets |
22 | 6 | ||||||
|
|
|
|
|||||
Finance income |
66 | 107 | ||||||
|
|
|
|
|||||
Accretion expense (note 10) |
(508 | ) | | |||||
Bank charges |
(1 | ) | (3 | ) | ||||
Net foreign currency loss |
(20 | ) | (5 | ) | ||||
Unrealized foreign currency loss on long-term obligation |
(45 | ) | | |||||
|
|
|
|
|||||
Finance costs |
(574 | ) | (8 | ) | ||||
|
|
|
|
|||||
Net finance (loss) income recognized in net loss |
(508 | ) | 99 | |||||
|
|
|
|
For the nine-month periods ended August 31, |
||||||||
2014 | 2013 | |||||||
$ | $ | |||||||
Interest income |
182 | 357 | ||||||
Net gain on disposal of available-for-sale financial assets |
112 | 76 | ||||||
|
|
|
|
|||||
Finance income |
294 | 433 | ||||||
|
|
|
|
|||||
Accretion expense (note 10) |
(678 | ) | | |||||
Bank charges |
(4 | ) | (25 | ) | ||||
Net foreign currency gain (loss) |
10 | (36 | ) | |||||
Unrealized foreign currency gain on long-term obligation |
121 | | ||||||
Loss on financial instruments carried at fair value |
(10 | ) | (18 | ) | ||||
|
|
|
|
|||||
Finance costs |
(561 | ) | (79 | ) | ||||
|
|
|
|
|||||
Net finance (loss) income recognized in net loss |
(267 | ) | 354 | |||||
|
|
|
|
12
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
August 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 August 31, 2014 |
As at November 30, 2013 |
|||||||
$ | $ | |||||||
Raw materials |
9,226 | 9,523 | ||||||
Work in progress |
185 | 205 | ||||||
Finished goods |
1,068 | 1,267 | ||||||
|
|
|
|
|||||
10,479 | 10,995 | |||||||
|
|
|
|
During the nine-month period ended August 31, 2014, the Company recorded an inventory provision of $122 on raw materials (2013 nil) and of $865 on work in progress (2013 $376), to write down their value to their estimated net realizable value. The net inventory provision of $987 was recorded in cost of sales as unallocated production costs (2013 $376).
The writedowns in 2014 and 2013 were due to losses incurred during conversion of raw materials to finished goods and losses associated with changing over from the 2 mg vial to the 1 mg vial of EGRIFTATM.
13
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
August 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 August 31, 2014 |
16,063 | |||
|
|
|||
Accumulated amortization |
||||
Balance as at November 30, 2013 |
| |||
Amortization |
576 | |||
|
|
|||
Balance as at August 31, 2014 |
576 | |||
|
|
|||
Carrying amounts |
||||
November 30, 2013 |
216 | |||
August 31, 2014 |
15,487 |
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 (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 |
15,792 | |||
Current portion |
(2,989 | ) | ||
|
|
|||
Non-current portion as at August 31, 2014 |
12,803 | |||
|
|
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) evenly over a five-year period starting on the first anniversary of the closing date.
14
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
August 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
The obligation is initially recognized at fair value, and is considered Level 3 (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.
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 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 |
2,309 | 2,040 | 4,349 | |||||||||
Between one and five years |
12,803 | 4,594 | 17,397 | |||||||||
|
|
|
|
|
|
|||||||
15,112 | 6,634 | 21,746 | ||||||||||
|
|
|
|
|
|
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 August 31, 2014, 1,477,472 options were available to be granted by the Company (as at August 31, 2013 1,441,636).
All options are to be settled by the physical delivery of the shares.
15
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
August 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 August 31, 2014 |
1,862,669 | 2.12 | ||||||
|
|
|
|
During the nine-month period ended August 31, 2014, $61 (2013 $68) 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
nine-month periods ended August 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.
16
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
August 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 nine-month period ended August 31, 2014. No options were granted during the three-month period ended August 31, 2014:
For the nine-month periods ended August 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) | Loss per share |
For the three- and nine-month periods ended August 31, 2014, basic loss per share was calculated using 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 August 31, |
||||||||
2014 | 2013 | |||||||
Issued common shares as at June 1 |
61,010,603 | 61,010,603 | ||||||
|
|
|
|
|||||
Weighted average number of common shares |
61,010,603 | 61,010,603 | ||||||
|
|
|
|
For the nine-month periods ended August 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 | ||||||
|
|
|
|
17
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
August 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
As at August 31, 2014, 1,862,669 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.
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 considers 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.
18
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
August 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
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 August 31, 2014, $2,642 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 $6,713.
d) | Leases |
During the third quarter, the Company received a notice of lease termination from its landlord. Consequently, in accordance with the terms of its amended lease agreement, the Company will be relocating in the first quarter of fiscal 2015. While potential new locations have been identified, a new lease has yet to be signed.
As at August 31, 2014, the minimum payments required under the terms of the non-cancellable lease are as follows:
$ | ||||
Less than one year |
34 | |||
|
|
19
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
August 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:
August 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.
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.
20
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
August 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
The following are amounts due on the contractual maturities of financial liabilities as at August 31, 2014 and November 30, 2013:
August 31, 2014 | ||||||||||||||||||||
Carrying amount |
Contractual amount |
Less than 1 year |
From 1 to 5 years |
More than 5 years |
||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Accounts payable and accrued liabilities |
5,533 | 5,533 | 5,533 | | | |||||||||||||||
Long-term obligation |
15,792 | 21,746 | 4,349 | 17,397 | | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
21,325 | 27,279 | 9,882 | 17,397 | | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
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 obligation, 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 outstanding on August 31, 2014 or 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 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. 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.
21
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
August 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
The following table presents the significant items in the original currencies exposed to currency risk at the following dates:
August 31, 2014 |
||||
US$ | ||||
Cash |
130 | |||
Accounts payable and accrued liabilities |
(3,402 | ) | ||
Long-term obligation |
(14,524 | ) | ||
|
|
|||
Total exposure |
(17,796 | ) | ||
|
|
|||
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 obligation bear no interest.
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.
22
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements
(Unaudited)
August 31, 2014 and 2013
(in thousands of Canadian dollars, except per share amounts)
Financial assets and financial 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 financial 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 historical 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.
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Exhibit 99.2
MANAGEMENTS DISCUSSION AND ANALYSIS
FOR THE THREE-MONTH AND NINE-MONTH PERIODS ENDED AUGUST 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 nine-month periods ended August 31, 2014 as compared to the three- and nine-month periods ended August 31, 2013. This MD&A is dated October 7, 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 August 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 nine-month periods ended August 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. On December 13, 2013, we entered into an agreement with EMD Serono, or EMD Serono Termination Agreement, in order to regain the commercialization rights to EGRIFTA in the United States. The transaction closed on May 1, 2014.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
The EMD Serono Termination Agreement paved the way for a fundamental shift in our business plan. 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 flows. 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.
The regaining of the US commercialization rights to EGRIFTA is also having a significant impact on our financial reporting in the periods following 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 related marketing and distribution expenses, which were previously incurred by EMD Serono. We also have new financial obligations in the form of debt and royalties payable to EMD Serono.
Technical issues and other disruptive events at our third-party manufacturer caused us to suspend manufacturing of EGRIFTA in its 2mg presentation on February 14, 2014 and, at that time, there was no inventory of finished goods available. In order to replenish inventory and resume shipping as soon as possible, we reverted to the initial presentation of EGRIFTA (1mg vial), which was supplied to us without any commercial delays during the first two years of marketing the product. Shipping resumed in early September 2014. Several batches of EGRIFTA are currently in process with our third-party manufacturer and we expect to have sufficient quantities available to both meet market demand and steadily rebuild inventory in the months ahead.
On April 30, 2014, we announced that we received a notice of compliance (regulatory approval) for EGRIFTA in the 2mg presentation 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. We have filed a Supplemental New Drug Submission seeking approval to commercialize EGRIFTA in its 1mg presentation in Canada and we are awaiting a response from Health Canada. In the meantime we are preparing for the Canadian market launch.
There were no material developments in the third quarter with respect to the European market and those markets served by sanofi, our commercial partner in Latin America, Africa and the Middle East, except in Israel where the Minister of Health cancelled the approval for registration of EGRIFTATM after a review of the data on file and after considering that the registration process was halted in Europe. sanofi advised us that it is assessing the opportunity to appeal the decision.
With the resumption of EGRIFTA shipments in September 2014, we expect our revenue stream to grow sufficiently to allow us to meet our financial obligations. If, however, we encounter significant setbacks in relation to projected sales levels and/or manufacturing and supply issues we will require additional funds in the next 12 months in order to meet our obligations and sustain operations. See Financial Position below.
Revenues
Prior to the closing of the EMD Serono Termination Agreement, 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 from EMD Serono. From May 1, 2014, on, our revenues are essentially sales of EGRIFTA, which were nil from May 1 to August 31, 2014 due to the supply shortage we experienced. Sales of EGRIFTA resumed in mid-September and, as of the date of this MD&A, demand for the product is building in a satisfactory manner and in accordance with our forecasts.
2
Consolidated revenue for the three- and nine-month periods ended August 31, 2014 was $4,000 and $4,069,000 compared to $2,177,000 and $6,307,000 in the comparable periods of fiscal 2013.
2014 | 2013 | 2014 | 2013 | |||||||||||||
(in thousands of Canadian dollars) |
(3 months) | (9 months) | ||||||||||||||
Sale of goods |
| 786 | 675 | 2,223 | ||||||||||||
Amortization of upfront payment |
| 463 | 2,770 | 1,390 | ||||||||||||
Royalties |
4 | 928 | 624 | 2,684 | ||||||||||||
Revenue |
4 | 2,177 | 4,069 | 6,307 |
Revenue generated from the sale of goods in the three- and nine-month periods ended August 31, 2014 was nil and $675,000 compared to $786,000 and $2,233,000 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 shipments in the second and third quarters.
Amortization of upfront payment in the three- and nine-month periods ended August 31, 2014 was nil and $2,770,000 compared to $463,000 and $1,390,000 in the comparable periods of fiscal 2013. With the closing of the EMD Serono Termination Agreement on May 1, 2014, all of the unamortized balance of the initial payment was recognized as revenue in the second quarter of 2014.
Royalties in the three- and nine-month periods ended August 31, 2014 were $4,000 and $624,000 compared to $928,000 and $2,684,000 in the comparable periods of fiscal 2013. Prior to May 1, 2014, royalties from EMD Serono were adversely affected by the previously described EGRIFTA supply shortage. With the closing of the EMD Serono Termination Agreement on May 1, 2014, EMD Serono is no longer selling EGRIFTA and is therefore no longer obligated to pay royalties to the Company.
Cost of Sales
The cost of sales in the three- and nine-month periods ended August 31, 2014 was $212,000 and $1,851,000 compared to $823,000 and $2,556,000 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 nine-month period compared to $678,000 and $1,940,000 in the comparable periods of fiscal 2013. Unallocated production costs were $212,000 and $1,251,000 in the three- and nine-month periods ended August 31, 2014 compared to $145,000 and $616,000 in the comparable periods of fiscal 2013. The higher unallocated production costs in the three-month period ended August 31, 2014 were principally fixed costs and costs associated with changing over from the 2mg to the 1mg presentation of EGRIFTA. In the nine months ended August 31, 2014 unallocated production costs included fixed costs, changeover costs and inventory write downs.
R&D Expenses
R&D expenses, net of tax credits, in the three- and nine-month periods ended August 31, 2014 were $1,036,000 and $4,453,000 compared to $2,578,000 and $5,824,000 in the comparable periods of fiscal 2013. R&D expenses in 2013 included approximately $1,500,000 of costs related to our efforts to improve the lyophilization cycle used in the manufacture of EGRIFTA. R&D expenses in 2014 are largely made up of expenses for the two Phase 4 clinical trials currently being
3
conducted as well as staffing and regulatory expenses. Expenses related to the diabetic retinopathy study were $350,000 and $2,206,000 for the three and nine-month periods ended August 31, 2014, compared to $493,000 and $2,112,000 in the comparable periods of fiscal 2013. Expenses for the long-term safety study were $276,000 and $708,000 for the three and nine-month periods ended August 31, 2014, compared to $179,000 and $521,000 in the comparable periods of fiscal 2013.
Selling and Market Development Expenses
Selling and market development expenses amounted to $1,720,000 and $5,247,000 for the three- and nine-month periods ended August 31, 2014, compared to $59,000 and $190,000 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 and Canada. 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 intangible asset value established for the EGRIFTA commercialization rights. This amortization expense amounted to $432,000 and $576,000 in the three- and nine-month periods ended August 31, 2014.
General and Administrative Expenses
General and administrative expenses amounted to $914,000 and $3,254,000 in the three- and nine-month periods ended August 31, 2014, compared to $741,000 and $2,614,000 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 nine-month periods ended August 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 nine-month periods ended August 31, 2014 was $66,000 and $294,000 compared to $107,000 and $433,000 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 August 31, 2014 were $574,000 which included $508,000 of accretion on the $15,792,000 debt owed to EMD Serono under the terms of the EMD Serono Termination Agreement, as well as a foreign exchange loss of $45,000. For the nine-month period ended August 31, 2014, finance costs were $561,000, which was principally $678,000 of debt accretion, offset by a foreign exchange gain of $121,000. Finance costs were $8,000 and $79,000 in the comparable three- and nine-month periods of fiscal 2013.
Federal Investment Tax Credits
In the second quarter of fiscal 2014, 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). This refund was received on July 3, 2014.
.
4
Net Loss
Taking into account the revenue and expense variations described above, the net loss for the three-month period ended August 31, 2014 was $4,394,000, compared to a net loss of $1,935,000 in the comparable period of fiscal 2013. For the nine-month period ended August 31, 2014, the net loss was $6,921,000, compared to a net loss of $1,457,000 in the comparable period of fiscal 2013. On a per share basis, the net loss was $(0.07) in the three-month period August 31, 2014 compared to net loss of $(0.03) in the comparable period of fiscal 2013. In the nine-month period ended August 31, 2014, the net loss was $(0.11) per share compared to a net loss of $(0.02) per share 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) |
Q3 | Q2 | Q1 | Q4 | Q3 | Q2 | Q1 | Q4 | ||||||||||||||||||||||||
Sale of goods |
| | $ | 675 | $ | 311 | $ | 786 | $ | 996 | $ | 451 | $ | 1,375 | ||||||||||||||||||
Upfront and milestone payments |
| $ | 2,450 | $ | 320 | $ | 320 | $ | 463 | $ | 463 | $ | 464 | $ | 868 | |||||||||||||||||
Royalties and license fees |
$ | 4 | $ | (57 | ) | $ | 677 | $ | 615 | $ | 928 | $ | 872 | $ | 884 | $ | 1,656 | |||||||||||||||
Revenue |
$ | 4 | $ | 2,393 | $ | 1,672 | $ | 1,246 | $ | 2,177 | $ | 2,331 | $ | 1,799 | $ | 3,899 | ||||||||||||||||
Net profit (loss) |
$ | (4,394 | ) | $ | 1,007 | $ | (3,534 | ) | $ | (2,598 | ) | $ | (1,935 | ) | $ | (1,382 | ) | $ | 1,860 | $ | (4,341 | ) | ||||||||||
Basic and diluted profit (loss) per share |
$ | (0.07 | ) | $ | 0.02 | $ | (0.06 | ) | $ | (0.04 | ) | $ | (0.03 | ) | $ | (0.02 | ) | $ | 0.03 | $ | (0.07 | ) |
Revenue from the sale of goods in the second and third quarters 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, all of the $2,450,000 unamortized balance of the initial payment was recognized as revenue in the second quarter of 2014.
The lack of shipments in the second and third 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.
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, takes into account $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 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.
The net loss reported in the fourth quarter of fiscal 2012 includes restructuring costs of $4,526,000.
Financial Position
Cash flows generated from operating activities for the three-month period ended August 31, 2014 amounted to $156,000 (including the $4,170,000 tax credits reimbursement) compared to $615,000 in the comparable period of 2013. In the nine months ended August 31, 2014, cash flows uses in operating activities were $5,623,000 compared to $6,340,000 in the comparable period of 2013. As at August 31, 2014, liquidities, which include cash and bonds, amounted to $5,628,000 compared to $12,353,000 at November 30, 2013.
The closing of the transaction with EMD Serono on May 1, 2014, significantly changed the operations of the Company, which may impact the risk profile of its cash flows, and the contractual obligation with respect to the early termination fee (note 10long 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, at that time, there was no inventory of finished goods available. A plan was developed based upon temporarily reverting to the initial presentation of EGRIFTATM (1mg vial), which was supplied without any commercial delays during the first two years of marketing the product. In early September 2014, shipping of EGRIFTATM resumed using the 1 mg presentation. The Company currently has funding to meet its financial obligations while it re-establishes its revenue stream.
If, however, it encounters significant setbacks in relation to projected sales levels, and/or manufacturing and supply issues, the Company will require additional funds in the next 12 months in order to meet its obligations and sustain operations. As of the date of this MD&A, there is no new funding agreement in place. These circumstances could result in a material uncertainty that casts substantial doubt about the Companys ability to continue as a going concern.
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, 2024, 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, or Early Termination Fee, evenly over a five-year period starting on the first anniversary of the closing date.
6
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 |
2,309,000 | 2,040,000 | 4,349,000 | |||||||||
Between one and five years |
12,803,000 | 4,594,000 | 17,397,000 | |||||||||
15,112,000 | 6,634,000 | 21,746,000 |
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 August 31, 2014, $2,642,000 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 $6,713,000.
During the third quarter, the Company received a notice of lease termination from its landlord. Consequently, in accordance with the terms of its amended lease agreement, the Company will be relocating in the first quarter of fiscal 2015. While potential new locations have been identified, a new lease has yet to be signed.
As at August 31, 2014, the minimum payments required under the terms of the non-cancellable lease are as follows:
$ | ||||
Less than one year |
34,000 |
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 August 31, 2014 and November 30, 2013:
August 31, 2014 | ||||||||||||||||||||
Carrying amount |
Contractual amount |
Less than 1 year |
From 1 to 5 years |
More than 5 years |
||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Accounts payable and accrued liabilities |
5,533,000 | 5,533,000 | 5,533,000 | | | |||||||||||||||
Long-term obligation |
15,792,000 | 21,746,000 | 4,349,000 | 17,397,000 | | |||||||||||||||
21,325,000 | 27,279,000 | 9,882,000 | 17,397,000 | | ||||||||||||||||
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 |
3,371,000 | 3,371,000 | 3,371,000 | | | |||||||||||||||
3,371,000 | 3,371,000 | 3,371,000 | | |
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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 outstanding as of August 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:
August 31, 2014 | ||||
US$ | ||||
Cash |
130,000 | |||
Accounts payable and accrued liabilities |
(3,402,000 | ) | ||
Long-term obligation |
(14,524,000 | ) | ||
|
|
|||
Total exposure |
(17,796,000 | ) | ||
|
|
|||
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.
9
Cash bears interest at a variable rate. Trade and other receivables, accounts payable and accrued liabilities and long-term obligation bear no interest.
Recent Changes in Accounting Standards
New Standards Issued but not yet Adopted
IFRS 9, Financial Instruments
On July 24, 2014, the IASB issued the final version of IFRS 9, bringing together the classification and measurement, impairment and hedge accounting phases of the IASBs project to replace IAS 39. The final version of IFRS 9 supersedes all previous versions of IFRS 9 and is effective for periods beginning on or after January 1, 2018, however an entity may elect to apply earlier versions of IFRS 9 if the entitys relevant date of initial application is before February 1, 2015.
IFRS 15, Revenue from Contracts with Customers
In May 2014, the IASB issued IFRS 15 which establishes principles for reporting the nature, amount, timing and uncertainty of revenue and cash flows arising from an entitys contracts with customers. It provides a single model in order to depict the transfer of promised goods or services to customers.
IFRS 15 supersedes the following standards: IAS 11, Construction Contracts, IAS 18, Revenue, IFRIC 13, Customer Loyalty Programmes, IFRIC 15, Agreements for the Construction of Real Estate, IFRIC 18, Transfers of Assets from Customers, and SIC-31, Revenue Barter Transactions Involving Advertising Service.
The core principle of IFRS 15 is that an entity recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services.
IFRS 15 also includes a cohesive set of disclosure requirements that would result in an entity providing comprehensive information about the nature, amount, timing and uncertainty of revenue and cash flows arising from the entitys contracts with customers.
This standard is effective for annual periods beginning on or after January 1, 2017 with earlier adoption permitted. The Company has not yet assessed the impact of the adoption of this standard on its consolidated financial statements.
Standards Adopted
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.
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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.
Outstanding Share Data
On October 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 June 1, 2014 and ending on August 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 our capacity to increase the patient base of EGRIFTATM in the United States and to generate higher revenues and cash flow therefrom and our expectations regarding the quantity of EGRIFTATM available to meet market demand and rebuild our inventory.
Forward-looking statements are based upon a number of assumptions and include, but are not limited to, the following: the manufacturing of lots of EGRIFTATM will meet the product specifications and pass routine testing, no delay will be encountered in connection with the planned manufacturing schedule, the packaging and shipping of new lots of EGRIFTATM, we will be able to increase our patient base in the United States through our educational efforts vis-à-vis physicians, patient demand for EGRIFTATM will increase over time in the United States despite the past drug shortage and 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 problems occur in the manufacturing of lots of EGRIFTATM, the risk that new lots of EGRIFTATM fail routine testing and become unavailable for distribution resulting in a potential drug shortage, 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 and require that we seek financing through the issuance
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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, 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.
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Exhibit 99.3
Theratechnologies Announces Financial Results for Third Quarter of 2014
Montreal, Canada October 8, 2014 Theratechnologies Inc. (Theratechnologies) (TSX: TH) today announced its financial results for the third quarter ended August 31, 2014.
Third quarter 2014 financial highlights
| Company ended product shortage which affected revenues in the third quarter |
| Selling and market development expenses of $1,720,000 mainly associated with marketing initiatives being undertaken in the United States |
| Net loss of $4,394,000 |
| $5,628,000 in liquidities available at quarter-end including bonds |
The end of the third quarter coincided with the end of the product shortage which had been affecting us since February. Shipping of new vials of the 1mg presentation to the U.S. occurred in September and marks an important moment in our company. In the fourth quarter, we will record our first direct sales of EGRIFTA since regaining rights in the U.S. After only a few days back on the market, demand is building in a satisfactory manner and in accordance with our forecasts, said Luc Tanguay, President and CEO, Theratechnologies Inc.
Third 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 August 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 third quarter ended August 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 on May 1, 2014 of the EMD Serono Termination Agreement, 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 from EMD Serono. From May 1, 2014, on, our revenues are essentially sales of EGRIFTA, which were nil from May 1 to August 31, 2014 due to the supply shortage we experienced. Sales of EGRIFTA resumed in mid-September and, as of the date of this press release, demand for the product is building in a satisfactory manner and in accordance with our forecasts. Consolidated revenue for the three- and nine-month periods ended August 31, 2014 was $4,000 and $4,069,000 compared to $2,177,000 and $6,307,000 in the comparable periods of fiscal 2013.
Revenue generated from the sale of goods in the three- and nine-month periods ended August 31, 2014 was nil and $675,000 compared to $786,000 and $2,233,000 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 shipments in the second and third quarters.
Amortization of upfront payment in the three- and nine-month periods ended August 31, 2014 was nil and $2,770,000 compared to $463,000 and $1,390,000 in the comparable periods of fiscal 2013. With the closing of the EMD Serono Termination Agreement on May 1, 2014, all of the unamortized balance of the initial payment was recognized as revenue in the second quarter of 2014.
Royalties in the three- and nine-month periods ended August 31, 2014 were $4,000 and $624,000 compared to $928,000 and $2,684,000 in the comparable periods of fiscal 2013. Prior to May 1, 2014, royalties from EMD Serono were adversely affected by the previously described EGRIFTA supply shortage. With the closing of the EMD Serono Termination Agreement, EMD Serono is no longer selling EGRIFTA and is therefore no longer obligated to pay royalties to the Company.
The cost of sales in the three- and nine-month periods ended August 31, 2014 was $212,000 and $1,851,000 compared to $823,000 and $2,556,000 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 nine-month period compared to $678,000 and $1,940,000 in the comparable periods of fiscal 2013. Unallocated production costs were $212,000 and $1,251,000 in the three- and nine-month periods ended August 31, 2014 compared to $145,000 and $616,000 in the comparable periods of fiscal 2013. The higher unallocated production costs in the three-month period ended August 31, 2014 were principally fixed costs and costs associated with changing over from the 2mg to the 1mg presentation of EGRIFTA. In the nine months ended August 31, 2014 unallocated production costs included fixed costs, changeover costs and inventory write downs.
Research & development, or R&D, expenses, net of tax credits, in the three- and nine-month periods ended August 31, 2014 were $1,036,000 and $4,453,000 compared to $2,578,000 and $5,824,000 in the comparable periods of fiscal 2013. R&D expenses in 2013 included approximately $1,500,000 of costs related to our efforts to improve the lyophilization cycle used in the manufacture of EGRIFTA. R&D expenses in 2014 are largely made up of expenses for the two Phase 4 clinical trials currently being conducted as well as staffing and regulatory expenses. Expenses related to the diabetic retinopathy study were $350,000 and $2,206,000 for the three and nine-month periods ended August 31, 2014, compared to $493,000 and $2,112,000 in the comparable periods of fiscal 2013. Expenses for the long-term safety study were $276,000 and $708,000 for the three and nine-month periods ended August 31, 2014, compared to $179,000 and $521,000 in the comparable periods of fiscal 2013.
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Selling and market development expenses amounted to $1,720,000 and $5,247,000 for the three- and nine-month periods ended August 31, 2014, compared to $59,000 and $190,000 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 and Canada. 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 intangible asset value established for the EGRIFTA commercialization rights. This amortization expense amounted to $432,000 and $576,000 in the three- and nine-month periods ended August 31, 2014.
General and administrative expenses amounted to $914,000 and $3,254,000 in the three- and nine-month periods ended August 31, 2014, compared to $741,000 and $2,614,000 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 nine-month periods ended August 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 nine-month periods ended August 31, 2014 was $66,000 and $294,000 compared to $107,000 and $433,000 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 August 31, 2014 were $574,000 which included $508,000 of accretion on the $15,792,000 debt owed to EMD Serono under the terms of the EMD Serono Termination Agreement, as well as a foreign exchange loss of $45,000. For the nine-month period ended August 31, 2014, finance costs were $561,000, which was principally $678,000 of debt accretion, offset by a foreign exchange gain of $121,000. Finance costs were $8,000 and $79,000 in the comparable three- and nine-month periods of fiscal 2013.
In the second quarter of fiscal 2014, 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 fiscal 2013. This refund was received on July 3, 2014.
Taking into account the revenue and expense variations described above, the net loss for the three-month period ended August 31, 2014 was $4,394,000, compared to a net loss of $1,935,000 in the comparable period of fiscal 2013. For the nine-month period ended August 31, 2014, the net loss was $6,921,000, compared to a net loss of $1,457,000 in the comparable period of fiscal 2013. On a per share basis, the net loss was $(0.07) in the three-month period August 31, 2014 compared to net loss of $(0.03) in the comparable period of fiscal 2013. In the nine-month period ended August 31, 2014, the net loss was $(0.11) per share compared to a net loss of $(0.02) per share in the comparable period of fiscal 2013.
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Cash flows generated from operating activities for the three-month period ended August 31, 2014 amounted to $156,000 (including the $4,170,000 tax credits reimbursement) compared to $615,000 in the comparable period of 2013. In the nine months ended August 31, 2014, cash flows uses in operating activities were $5,623,000 compared to $6,340,000 in the comparable period of 2013.
As at August 31, 2014, liquidities, which include cash and bonds, amounted to $5,628,000 compared to $12,353,000 at November 30, 2013.
The closing of the transaction with EMD Serono on May 1, 2014, significantly changed the operations of the Company, which may impact the risk profile of its cash flows, and the contractual obligation with respect to the early termination fee (note 10long 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, at that time, there was no inventory of finished goods available. A plan was developed based upon temporarily reverting to the initial presentation of EGRIFTATM (1mg vial), which was supplied without any commercial delays during the first two years of marketing the product. In early September 2014, shipping of EGRIFTATM resumed using the 1 mg presentation. The Company currently has funding to meet its financial obligations while it re-establishes its revenue stream.
If, however, it encounters significant setbacks in relation to projected sales levels, and/or manufacturing and supply issues, the Company will require additional funds in the next 12 months in order to meet its obligations and sustain operations. As of the date of this press release, there is no new funding agreement in place. These circumstances could result in a material uncertainty that casts substantial doubt about the Companys ability to continue as a going concern.
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/5899. Audio replay of the conference call will be available two hours after the calls completion until October 15, 2014, by dialling 1-800-585-8367 (North America) or 1-416-621-4642 (International) and by entering the playback code 9571968.
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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 future sales of EGRIFTATM in the United States and the Companys growth based thereon.
Forward-looking statements are based upon a number of assumptions and include, but are not limited to, the following: the manufacturing of lots of EGRIFTATM will meet the product specifications and pass routine testing, no delay will be encountered in connection with the planned manufacturing schedule as well as with the packaging and shipping of new lots of EGRIFTATM, we will be able to increase our patient base in the United States through our educational efforts vis-à-vis physicians, patient demand for EGRIFTATM will increase over time in the United States despite the past drug shortage and 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 press release. These risks and uncertainties include, but are not limited to, the following: the risk that problems occur in the manufacturing of lots of EGRIFTATM, the risk that new lots of EGRIFTATM fail routine testing and become unavailable for distribution resulting in a potential drug shortage, 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 and 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 and the risk that unexpected events occur resulting in unplanned material expenses.
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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
514-913-1957
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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 August 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 June 1, 2014 and ended on August 31, 2014 that has materially affected, or is reasonably likely to materially affect, the issuers ICFR. |
Date: October 8, 2014
/s/ Luc Tanguay |
Luc Tanguay President and Chief Executive Officer |
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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 August 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 June 1, 2014 and ended on August 31, 2014 that has materially affected, or is reasonably likely to materially affect, the issuers ICFR. |
Date: October 8, 2014
/s/ Marie-Noël Colussi |
Marie-Noël Colussi Vice President, Finance, providing this certification in capacity as chief financial officer |
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