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 April 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 ¨ 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 three-month periods ended February 28, 2014 and February 28, 2013 | |
99.2 | Managements Discussions and Analysis for the three-month period ended February 28, 2014 | |
99.3 | Press Release Dated April 14, 2014 | |
99.4 | Canadian Form 52-109F2 Certification of Interim FilingsCEO | |
99.5 | Canadian Form 52-109F2 Certification of Interim FilingsCFO |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
THERATECHNOLOGIES INC. | ||
By: | /s/ Luc Tanguay | |
Name: Luc Tanguay | ||
Title: President and Chief Executive Officer |
Date: April 14, 2014
Exhibit 99.1
Theratechnologies Inc.
Interim Consolidated Financial Statements
(Unaudited)
February 28, 2014
(in thousands of Canadian dollars)
Theratechnologies Inc.
Interim Consolidated Statements of Financial Position
(Unaudited)
(in thousands of Canadian dollars)
Note | As at February 28, 2014 |
As at November 30, 2013 |
||||||||||
$ | $ | |||||||||||
Assets |
||||||||||||
Current assets |
||||||||||||
Cash |
237 | 967 | ||||||||||
Bonds |
54 | 99 | ||||||||||
Trade and other receivables |
293 | 489 | ||||||||||
Inventories |
4 | 10,003 | 10,995 | |||||||||
Prepaid expenses |
442 | 404 | ||||||||||
Derivative financial assets |
143 | 106 | ||||||||||
|
|
|
|
|||||||||
11,172 | 13,060 | |||||||||||
|
|
|
|
|||||||||
Non-current assets |
||||||||||||
Bonds |
9,333 | 11,287 | ||||||||||
Property and equipment |
267 | 281 | ||||||||||
Other assets |
420 | 216 | ||||||||||
|
|
|
|
|||||||||
10,020 | 11,784 | |||||||||||
|
|
|
|
|||||||||
Total assets |
21,192 | 24,844 | ||||||||||
|
|
|
|
|||||||||
Liabilities |
||||||||||||
Current liabilities |
||||||||||||
Accounts payable and accrued liabilities |
3,603 | 3,371 | ||||||||||
Current portion of deferred revenue |
1,288 | 1,279 | ||||||||||
|
|
|
|
|||||||||
4,891 | 4,650 | |||||||||||
|
|
|
|
|||||||||
Non-current liabilities |
||||||||||||
Other liabilities |
166 | 174 | ||||||||||
Deferred revenue |
1,172 | 1,492 | ||||||||||
|
|
|
|
|||||||||
1,338 | 1,666 | |||||||||||
|
|
|
|
|||||||||
Total liabilities |
6,229 | 6,316 | ||||||||||
|
|
|
|
|||||||||
Equity |
||||||||||||
Share capital |
280,872 | 280,872 | ||||||||||
Contributed surplus |
8,251 | 8,232 | ||||||||||
Deficit |
(274,375 | ) | (270,841 | ) | ||||||||
Accumulated other comprehensive income |
215 | 265 | ||||||||||
|
|
|
|
|||||||||
14,963 | 18,528 | |||||||||||
|
|
|
|
|||||||||
Total liabilities and equity |
21,192 | 24,844 | ||||||||||
|
|
|
|
The accompanying notes are an integral part of these interim consolidated financial statements.
Theratechnologies Inc.
Interim Consolidated Statements of Comprehensive (Loss) Income
(Unaudited)
(in thousands of Canadian dollars, except per share amounts)
For the three-month periods ended |
||||||||||||
Note | February 28, 2014 |
February 28, 2013 |
||||||||||
$ | $ | |||||||||||
Revenue |
||||||||||||
Sale of goods |
675 | 451 | ||||||||||
Research services Up-front payments and initial technology access fees |
320 | 464 | ||||||||||
Royalties and licence fees |
677 | 884 | ||||||||||
|
|
|
|
|||||||||
1,672 | 1,799 | |||||||||||
|
|
|
|
|||||||||
Operating expenses |
||||||||||||
Cost of sales |
||||||||||||
Cost of goods sold |
600 | 398 | ||||||||||
Unallocated production costs |
1,025 | 270 | ||||||||||
|
|
|
|
|||||||||
1,625 | 668 | |||||||||||
Research and development expenses, net of tax credits of nil (2013 $28) |
1,296 | 1,455 | ||||||||||
Selling and market development expenses |
1,379 | 62 | ||||||||||
General and administrative expenses |
970 | 967 | ||||||||||
Restructuring costs |
| (3,093 | ) | |||||||||
|
|
|
|
|||||||||
5,270 | 59 | |||||||||||
|
|
|
|
|||||||||
(Loss) profit from operating activities |
(3,598 | ) | 1,740 | |||||||||
|
|
|
|
|||||||||
Finance income |
105 | 160 | ||||||||||
Finance costs |
(33 | ) | (40 | ) | ||||||||
|
|
|
|
|||||||||
72 | 120 | |||||||||||
|
|
|
|
|||||||||
(Loss) profit before income taxes |
(3,526 | ) | 1,860 | |||||||||
Income tax expense |
6 | (8 | ) | | ||||||||
|
|
|
|
|||||||||
Net (loss) profit for the period |
(3,534 | ) | 1,860 | |||||||||
|
|
|
|
|||||||||
Other comprehensive (loss) income, net of tax |
||||||||||||
Items that may be reclassified to loss in the future: |
||||||||||||
Net change in fair value of available-for-sale financial assets, net of tax |
(25 | ) | 28 | |||||||||
Net change in fair value of available-for-sale financial assets transferred to net profit (loss), net of tax |
(25 | ) | (21 | ) | ||||||||
|
|
|
|
|||||||||
(50 | ) | 7 | ||||||||||
|
|
|
|
|||||||||
Total comprehensive (loss) income for the period |
(3,584 | ) | 1,867 | |||||||||
|
|
|
|
|||||||||
Basic and diluted (loss) earnings per share |
5(b) | (0.06 | ) | 0.03 | ||||||||
|
|
|
|
The accompanying notes are an integral part of these interim consolidated financial statements.
Theratechnologies Inc.
Interim Consolidated Statements of Changes in Equity
(Unaudited)
(in thousands of Canadian dollars)
For the three-month period
ended February 28, 2013 |
||||||||||||||||||||||||||||
Share capital | Contributed surplus |
Deficit | Unrealized gains (losses) on available- for-sale financial assets* |
Total | ||||||||||||||||||||||||
Note | Number of shares |
Amount | ||||||||||||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||||||||||
Balance as at November 30, 2012 |
61,010,603 | 280,872 | 8,158 | (266,786 | ) | 426 | 22,670 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Total comprehensive income for the period |
||||||||||||||||||||||||||||
Net profit for the period |
1,860 | | 1,860 | |||||||||||||||||||||||||
Other comprehensive income (loss) |
||||||||||||||||||||||||||||
Net change in fair value of available-for-sale financial assets, net of tax |
| 28 | 28 | |||||||||||||||||||||||||
Net change in fair value of available-for-sale financial assets transferred to net profit, net of tax |
| (21 | ) | (21 | ) | |||||||||||||||||||||||
|
|
|
|
|
|
|||||||||||||||||||||||
Total comprehensive income for the period |
1,860 | 7 | 1,867 | |||||||||||||||||||||||||
|
|
|
|
|
|
|||||||||||||||||||||||
Transactions with owners, recorded directly in equity |
||||||||||||||||||||||||||||
Share-based compensation plan |
||||||||||||||||||||||||||||
Share-based compensation for stock option plan |
5(a) | | | 13 | | | 13 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Total contributions by owners |
| | 13 | | | 13 | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance as at February 28, 2013 |
61,010,603 | 280,872 | 8,171 | (264,926 | ) | 433 | 24,550 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
* | Accumulated other comprehensive income |
The accompanying notes are an integral part of these interim consolidated financial statements.
Theratechnologies Inc.
Interim Consolidated Statement of Changes in Equity (continued)
(Unaudited)
(in thousands of Canadian dollars)
For the three-month period ended February 28, 2014 | ||||||||||||||||||||||||||||
Note |
Share capital | Contributed |
Deficit |
Unrealized for-sale |
Total |
|||||||||||||||||||||||
Number of shares |
Amount | |||||||||||||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||||||||||
Balance as at November 30, 2013 |
61,010,603 | 280,872 | 8,232 | (270,841 | ) | 265 | 18,528 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Total comprehensive loss for the period |
||||||||||||||||||||||||||||
Net loss for the period |
(3,534 | ) | | (3,534 | ) | |||||||||||||||||||||||
Other comprehensive loss |
||||||||||||||||||||||||||||
Net change in fair value of available-for-sale financial assets, net of tax |
| (25 | ) | (25 | ) | |||||||||||||||||||||||
Net change in fair value of available-for-sale financial assets transferred to net profit, net of tax |
| (25 | ) | (25 | ) | |||||||||||||||||||||||
|
|
|
|
|
|
|||||||||||||||||||||||
Total comprehensive loss for the period |
(3,534 | ) | (50 | ) | (3,584 | ) | ||||||||||||||||||||||
|
|
|
|
|
|
|||||||||||||||||||||||
Transactions with owners, recorded directly in equity |
||||||||||||||||||||||||||||
Share-based compensation plan |
||||||||||||||||||||||||||||
Share-based compensation for stock option plan |
5(a) | | | 19 | | | 19 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Total contributions by owners |
| | 19 | | | 19 | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance as at February 28, 2014 |
61,010,603 | 280,872 | 8,251 | (274,375 | ) | 215 | 14,963 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
* | Accumulated other comprehensive income |
The accompanying notes are an integral part of these interim consolidated financial statements.
Theratechnologies Inc.
Interim Consolidated Statements of Cash Flows
(Unaudited)
(in thousands of Canadian dollars)
For the three-month periods ended |
||||||||||||
Note | February 28, 2014 |
February 28, 2013 |
||||||||||
$ | $ | |||||||||||
Cash flows from |
||||||||||||
Operating activities |
||||||||||||
Net (loss) profit for the period |
(3,534 | ) | 1,860 | |||||||||
Adjustments for |
||||||||||||
Depreciation of property and equipment |
14 | 42 | ||||||||||
Change in deferred revenue |
(311 | ) | (456 | ) | ||||||||
Share-based compensation for stock option plan |
5(a) | 19 | 13 | |||||||||
Income tax expense |
6 | 8 | | |||||||||
Writedown of inventories |
4 | 936 | 192 | |||||||||
Lease inducements and amortization |
(8 | ) | (19 | ) | ||||||||
Change in fair value of derivative financial assets |
(56 | ) | (45 | ) | ||||||||
Change in fair value of liability related to deferred stock unit plan |
61 | 56 | ||||||||||
Change in fair value of derivative financial liabilities |
| 2 | ||||||||||
Interest income |
(80 | ) | (132 | ) | ||||||||
Interest received |
128 | 252 | ||||||||||
|
|
|
|
|||||||||
(2,823 | ) | 1,765 | ||||||||||
|
|
|
|
|||||||||
Changes in operating assets and liabilities |
||||||||||||
Trade and other receivables |
192 | 322 | ||||||||||
Tax credits and grants receivable |
| (28 | ) | |||||||||
Inventories |
56 | (743 | ) | |||||||||
Prepaid expenses |
(38 | ) | 221 | |||||||||
Accounts payable and accrued liabilities |
308 | (921 | ) | |||||||||
Provisions |
| (3,500 | ) | |||||||||
|
|
|
|
|||||||||
518 | (4,649 | ) | ||||||||||
|
|
|
|
|||||||||
Cash flows used in operating activities |
(2,305 | ) | (2,884 | ) | ||||||||
|
|
|
|
|||||||||
Investing activities |
||||||||||||
Proceeds from sale of bonds |
1,893 | 1,501 | ||||||||||
Payment of other assets |
(341 | ) | | |||||||||
Prepayment of derivative financial assets |
| (50 | ) | |||||||||
Proceeds from disposal of derivate financial assets |
23 | | ||||||||||
|
|
|
|
|||||||||
Cash flows from investing activities |
1,575 | 1,451 | ||||||||||
|
|
|
|
|||||||||
Net change in cash for the period |
(730 | ) | (1,433 | ) | ||||||||
Cash Beginning of period |
967 | 1,512 | ||||||||||
|
|
|
|
|||||||||
Cash End of period |
237 | 79 | ||||||||||
|
|
|
|
See note 7 for other information.
The accompanying notes are an integral part of these interim consolidated financial statements.
Theratechnologies Inc.
Notes to Interim Consolidated Financial Statements
(Unaudited)
February 28, 2014
(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 an 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. The Companys revenues are mainly derived from sales of EGRIFTATM to EMD Serono, Inc. (EMD Serono) for re-sale, royalties received from EMD Serono on US sales of EGRIFTATM to customers, milestone payments from the collaboration and licensing agreement entered into with EMD Serono (the EMD Serono Agreement) and the amortization of the initial payment received upon the closing of the EMD Serono Agreement.
On December 13, 2013, the Company announced that it had reached an agreement with EMD Serono to regain all rights under the EMD Serono Agreement, including commercialization rights for EGRIFTATM in the United States. Under the terms of the termination and transfer agreement entered into with EMD Serono (the EMD 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. The Company also 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. The closing of the transaction is expected to occur on May 1, 2014. In order to secure the payment of the termination fee, the Company will be granting EMD Serono a security interest on the Companys present and future worldwide corporeal and incorporeal movable property related to tesamorelin (see note 27 Subsequent events to the November 30, 2013 consolidated financial statements). Future operations of the Company will significantly change 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 will increase the Companys liquidity risk and may require additional funding.
1
Theratechnologies Inc.
Notes to Interim Consolidated Financial Statements
(Unaudited)
February 28, 2014
(in thousands of Canadian dollars, except per share amounts)
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 and the Company ceased manufacturing again. As of the date of the financial statements, there is no longer any inventory at EMD Seronos principal distribution center. As a result of the manufacturing difficulties, the Company undertook to carry out work to evaluate its current manufacturing process. The Company is working with EMD Serono, the third-party manufacturer, regulatory consultants and the FDA in order to resolve the supply shortage as soon as possible. A plan has been developed that is based upon temporarily reverting to the initial presentation of EGRIFTATM (1 mg vial), which was problem free during the first two years of marketing the product. The target is to resume production of the 1 mg presentation towards the end of the second quarter of 2014. While it is supplying market demand with the 1 mg presentation, the Company will continue to improve its 2 mg production cycle. Once it has confidence that the cycle is robust, the approval of the FDA to bring the 2 mg presentation back to market will be sought. The Company currently has sufficient funding to offset the interruption it is experiencing in his revenue stream. If, however, the Company encounters significant delays in re-establishing the supply chain, it may require additional funds in the next 12 months in order to meet its obligations and sustain operations.
These circumstances could result in a material uncertainty that could cast significant doubt about the Companys ability to continue as a going concern.
The consolidated financial statements have been prepared on a going concern basis in accordance with IFRS. The going concern basis of presentation assumes that the Company will continue its operations for the foreseeable future and be able to realize its assets and discharge its liabilities and commitments in the normal course of business. If the going concern assumption were not appropriate for these financial statements, adjustments to the carrying value of assets and liabilities, in particular impairing of property and equipment, 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.
2
Theratechnologies Inc.
Notes to Interim Consolidated Financial Statements
(Unaudited)
February 28, 2014
(in thousands of Canadian dollars, except per share amounts)
Certain information, in particular the accompanying notes normally included in the annual consolidated financial statements prepared in accordance with IFRS, has been omitted or condensed. These interim financial statements do not include all disclosures required under IFRS and, accordingly, should be read in conjunction with the annual consolidated financial statements for the year ended November 30, 2013 and the notes thereto. These interim financial statements have not been reviewed by the Companys auditors.
Summary of accounting policies
The preparation of financial data is based on accounting principles and practices consistent with those used in the preparation of the annual consolidated financial statements as at November 30, 2013.
Other new or amended accounting standards had no impact on the Companys accounting methods.
Basis of measurement
The Companys interim financial statements have been prepared on a going concern and historical cost basis, except for available-for-sale financial assets, derivative financial assets, liabilities related to the deferred stock unit plan and derivative financial liabilities, which are measured at fair value.
Use of estimates and judgments
The preparation of the Companys interim financial statements in conformity with IFRS requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the interim financial statements and the reported amounts of revenues and expenses during the reporting period.
Information about critical judgments in applying accounting policies and assumptions and estimation uncertainties that have the most significant effect on the amounts recognized in the interim financial statements are disclosed in note 2 of the annual consolidated financial statements as at November 30, 2013.
Functional and presentation currency
These interim financial statements are presented in Canadian dollars, which is the Companys functional currency. All financial information presented in Canadian dollars has been rounded to the nearest thousand.
3
Theratechnologies Inc.
Notes to Interim Consolidated Financial Statements
(Unaudited)
February 28, 2014
(in thousands of Canadian dollars, except per share amounts)
3 | Changes in accounting policies |
IFRS 10, Consolidated Financial Statements
In May 2011, the IASB issued IFRS 10, Consolidated Financial Statements, which replaces SIC-12, Consolidation: Special Purpose Entities, and parts of IAS 27, Consolidated and Separate Financial Statements. IFRS 10 builds on existing principles by identifying the concept of control as the determining factor in whether an entity should be included within the consolidated statements of an entity. The standard provides additional guidance to assist in the determination of control where this is difficult to assess. IFRS 10 became effective December 1, 2013. The adoption of this standard had no impact on the Companys 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 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 consolidated financial statements.
4 | Inventories |
As at February 28, 2014 |
As at November 30, 2013 |
|||||||
$ | $ | |||||||
Raw materials |
9,345 | 9,523 | ||||||
Work in progress |
| 205 | ||||||
Finished goods |
658 | 1,267 | ||||||
|
|
|
|
|||||
10,003 | 10,995 | |||||||
|
|
|
|
4
Theratechnologies Inc.
Notes to Interim Consolidated Financial Statements
(Unaudited)
February 28, 2014
(in thousands of Canadian dollars, except per share amounts)
During the three-month period ended February 28, 2014, the Company recorded an inventory provision of $936 on work in progress (2013 $192), to write down their value to their estimated net realizable value. The net inventory provision of $936 was recorded in cost of sales (2013 $192).
The writedowns in 2014 and 2013 were due to a loss of raw materials incurred during their conversion to finished goods.
5 | 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 February 28, 2014, 1,462,472 options were available to be granted by the Company (February 28, 2013 1,317,343).
All options are to be settled by the physical delivery of the shares.
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 | ||||||
Granted |
880,000 | 0.37 | ||||||
Expired |
(15,000 | ) | 5.40 | |||||
Forfeited |
(415,461 | ) | 5.11 | |||||
|
|
|
|
|||||
Options as at November 30, 2013 |
1,875,837 | 2.30 | ||||||
Granted |
125,000 | 0.50 | ||||||
Forfeited |
(123,168 | ) | 3.12 | |||||
|
|
|
|
|||||
Options as at February 28, 2014 |
1,877,669 | 2.13 | ||||||
|
|
|
|
5
Theratechnologies Inc.
Notes to Interim Consolidated Financial Statements
(Unaudited)
February 28, 2014
(in thousands of Canadian dollars, except per share amounts)
During the three-month period ended February 28, 2014, $19 (2013 $13) 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:
As at February 28, 2014 |
As at November 30, 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.
The following table summarizes the weighted average fair value of stock options granted during the three-month periods ended:
February 28, 2014 |
February 28, 2013 | |||||
Number of options |
Weighted average grant-date fair value |
Number of options |
Weighted average grant-date fair value | |||
$ | $ | |||||
125,000 |
0.36 |
830,000 |
0.29 |
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.
6
Theratechnologies Inc.
Notes to Interim Consolidated Financial Statements
(Unaudited)
February 28, 2014
(in thousands of Canadian dollars, except per share amounts)
b) | (Loss) earnings per share |
For the three-month period ended February 28, 2014, the calculation of basic (loss) earnings per share was based on the net (loss) profit attributable to common shareholders of the Company of $(3,534) (February 28, 2013 $1,860), and a weighted average number of common shares outstanding of 61,010,603 (February 28, 2013 61,010,603), calculated as follows:
For the three-month periods ended |
||||||||
February 28, 2014 |
February 28, 2013 |
|||||||
$ | $ | |||||||
Issued common shares as at December 1 |
61,010,603 | 61,010,603 | ||||||
Effect of share options exercised |
| | ||||||
|
|
|
|
|||||
Weighted average number of common shares |
61,010,603 | 61,010,603 | ||||||
|
|
|
|
As at February 28, 2014, 1,877,669 options were excluded from the diluted weighted average number of common shares calculation as their effect would have been anti-dilutive. All options outstanding as at February 28, 2014 could potentially dilute basic loss per share in the future.
6 | Income tax expense |
For the three-month periods ended |
||||||||
February 28, 2014 |
February 28, 2013 |
|||||||
$ | $ | |||||||
Deferred tax expense |
||||||||
Origination and reversal of temporary differences |
(948 | ) | 502 | |||||
Change in unrecognized deductible temporary differences |
948 | (502 | ) | |||||
Other |
(8 | ) | | |||||
|
|
|
|
|||||
(8 | ) | | ||||||
|
|
|
|
7
Theratechnologies Inc.
Notes to Interim Consolidated Financial Statements
(Unaudited)
February 28, 2014
(in thousands of Canadian dollars, except per share amounts)
7 | Other information |
The Company entered into the following transactions which had no impact on the cash flows:
February 28, 2014 |
November 30, 2013 |
|||||||
$ | $ | |||||||
Additions to other assets included in accounts payable and accrued liabilities |
79 | 216 | ||||||
Reimbursement of prepayment of derivative financial assets included in trade and other receivables |
| (4 | ) |
8
Exhibit 99.2
MANAGEMENTS DISCUSSION AND ANALYSIS
FOR THE THREE-MONTH PERIOD ENDED FEBRUARY 28, 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-month period ended February 28, 2014 as compared to the three-month period ended February 28, 2013. This MD&A is dated April 14, 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 February 28, 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-month period ended February 28, 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.
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. EGRIFTA is currently marketed in the United States by EMD Serono, Inc., or EMD Serono, pursuant to a collaboration and licensing agreement executed in October 2008, as amended in April 2012, or the EMD Serono Agreement. EMD Serono launched EGRIFTA on January 10, 2011.
In order to expand the commercial distribution of EGRIFTA, we have also granted exclusive commercialization rights to an affiliate of sanofi, or sanofi, for Latin America, Africa and the Middle East. Currently, the largest potential markets in sanofis territory are Brazil and Mexico and sanofi is focusing its efforts on marketing authorization applications in these two countries.
Our commercial partner in Canada is Actelion Pharmaceuticals Canada Inc., or Actelion. In the first quarter of 2014, Health Canadas Therapeutic Products Directorate, or TPD, resumed its review of our New Drug submission, or NDS. The process is ongoing and we are waiting for a decision on the NDS in the near future.
Theratechnologies Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
We have exclusive commercialization rights for EGRIFTATM for Europe, Russia, South Korea, Taiwan, Thailand and certain central Asian countries. Our current strategy for Europe is to seek commercial partners who can help us pursue alternative approaches including filing only in certain European countries and dispensing EGRIFTA by way of named patient programs.
On December 13, 2013, we entered into a termination and transfer agreement with EMD Serono, or EMD Serono Termination Agreement, to regain all rights under the EMD Serono Agreement. The closing of this transaction is expected to occur on May 1, 2014, or Closing Date. Regaining the US commercialization rights to EGRIFTA will have a significant impact on the nature of our business and, as a consequence, on our financial reporting after the Closing Date. Our revenues will represent the full proceeds of sales of EGRIFTA to wholesalers and our expenses will expand to encompass all of the marketing and distribution expenses previously incurred by EMD Serono. We will have new financial obligations in the form of debt and royalties payable to EMD Serono.
The EMD Serono Termination Agreement gives us the opportunity to move forward in the US market with a specialty pharmaceutical business model that is solely focused on our own product. All US activities will be aimed directly at elevating the importance of treating excess abdominal fat in HIV-infected patients with lipodystrophy, an indication unique to EGRIFTA, for patients, health care providers and third-party payors. Our goal is to increase the patient base, which will ultimately lead to higher revenues and cash flow. We also plan to leverage our US commercial experience to enhance our worldwide partnership initiatives, helping us to drive performance and become more proactive and responsive to partners needs.
In order to execute our commercial plans for the United States market, we retained the services of inVentiv Health to establish and manage our sales and marketing operations. The services to be provided by inVentiv Health include sales force, marketing support, patient communications, regulatory compliance, reimbursement and market access. These activities, which got under way in the first quarter of 2014, have since been scaled back in light of the manufacturing issues observed during the production of new batches of EGRIFTA, which caused us to suspend manufacturing.
As of the date of this MD&A, there is no longer any inventory at EMD Seronos principal distribution center. We are working with EMD Serono, our third-party manufacturer, regulatory consultants and the FDA in order to resolve the supply shortage as soon as possible. We now have a plan that is based upon temporarily reverting to the initial presentation of EGRIFTA (1 mg vial), which was problem free during the first two years of marketing the product. While we are supplying market demand with the 1 mg presentation, we will continue to improve our 2 mg production cycle. Once we have confidence that the cycle is robust, we will seek the approval of the FDA to bring the 2 mg presentation back to market. The target is to resume production of the 1 mg presentation towards the end of our second quarter and we currently have sufficient funding to offset the interruption we are experiencing in our revenue stream. If, however, we encounter significant delays in re-establishing the supply chain, we may require additional funds in the next 12 months in order to meet our obligations and sustain operations. See Financial Position below.
Resolving the EGRIFTA manufacturing problems and ensuring that we have a reliable source of supply are immediate priorities for the Company.
Revenues
Our revenues are mainly sales of EGRIFTA to EMD Serono for re-sale, royalties received from EMD Serono on U.S. sales to customers, and research services, which include milestone payments and the amortization of the initial payment received upon the closing of the agreement with EMD Serono. Consolidated revenue for the three months ended February 28, 2014 amounted to $1,672,000 compared to $1,799,000 in the comparable period of fiscal 2013.
2
(in Canadian dollars) |
2014 | 2013 | ||||||
|
|
|||||||
Sale of goods |
$ | 675,000 | $ | 451,000 | ||||
Upfront and milestone payments |
$ | 320,000 | $ | 464,000 | ||||
Royalties and license fees |
$ | 677,000 | $ | 884,000 | ||||
|
|
|||||||
Revenue |
$ | 1,672,000 | $ | 1,799,000 |
Revenue generated from sale of goods amounted to $675,000 in the three-month period ended February 28, 2014 compared to $451,000 in the comparable period of Fiscal 2013. Shipments in the first quarter of 2014 represented all of the goods that were available for sale. The lower level of shipments in the first quarter of 2013 was attributable to the procurement policies of EMD Serono.
Royalties, which are almost entirely derived from the sales of EGRIFTA, were $677,000 in three-month period ended February 28, 2014 compared to $884,000 in the comparable period of fiscal 2013. The supply shortages in the first quarter of fiscal 2014 adversely affected EMD Serono sales, resulting in lower royalty revenue.
Revenue also includes the amortization of the initial payment of $27,097,000 received upon the closing of the EMD Serono Agreement. For the three-month period ended February 28, 2014, $320,000 was recognized as revenue related to the initial payment, compared to $464,000 in the comparable period in fiscal 2013. The amortization amounts are adjusted periodically to allow sufficient time for the development work required under the EMD Serono Agreement that has yet to be completed. At February 28, 2014, the remaining deferred revenue related to this transaction recorded on the consolidated statement of financial position amounted to $2,451,000.
Cost of Sales
For the three month period ended February 28, 2014, the cost of sales was $1,625,000 compared to $668,000 in the comparable period 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 $600,000 compared to $398,000 in the prior-year period, reflecting higher sale of goods in the first quarter of fiscal 2014 as described above. Unallocated production costs were $1,025,000 in 2014 compared to $270,000 in the prior-year period, due largely to inventory write downs related to manufacturing issues
R&D Expenses
R&D expenses, net of tax credits, amounted to $1,296,000 in the three-month period ended February 28, 2014 compared to $1,455,000 in the comparable period of fiscal 2013. R&D expenses include our share of expenses for the two Phase 4 clinical trials currently being conducted by EMD Serono. We are responsible for all of the costs associated with the diabetic retinopathy study, which amounted to $670,000 in 2014 compared to $763,000 in the prior-year period. Our fifty percent share of the long-term safety study was $200,000 in three-month period ended February 28, 2014 compared to $132,000 in the comparable period of fiscal 2013.
Selling and Market Development Expenses
Selling and market development expenses amounted to $1,379,000 for the three-month period ended February 28, 2014, compared to $62,000 in the comparable period of fiscal 2013. The increased expenses were related to the previously described marketing initiatives being undertaken with inVentiv Health for the United States market.
3
General and Administrative Expenses
General and administrative expenses amounted to $970,000 in the three-month period ended February 28, 2014, virtually unchanged from $967,000 in the comparable period of fiscal 2013.
Restructuring Costs
There were no restructuring costs in the three-month period ended February 28, 2014. In the comparable period 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-month period ended February 28, 2014 was $105,000 compared to $160,000 in the comparable period 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 February 28, 2014 were $33,000 compared to $40,000 in the comparable period of fiscal 2013.
Net Loss
Taking into account the revenue and expense variations described above, we recorded a net loss of $3,534,000 or $0.06 per share in the three months ended February 28, 2014 compared to a net profit of $1,860,000 or $0.03 per share in the comparable period of fiscal 2013.
Financial Position
Cash flows used in operating activities for the three-month period ended February 28, 2014 amounted to $2,305,000 compared to $2,884,000 in the comparable period of 2013. As at February 28, 2014, liquidities, which include cash, bonds, and tax credits and grants receivable, amounted to $9,624,000 compared to $12,353,000 at November 30, 2013.
On December 13, 2013, the Company announced that it had reached an agreement with EMD Serono to regain all rights under the EMD Serono Agreement, including commercialization rights for EGRIFTA in the United States. Under the terms of the termination and transfer agreement entered into with EMD Serono (the EMD Termination Agreement), the Company agreed to pay an early termination fee of US$20,000,000 (the Early Termination Fee) evenly over a five-year period starting on the first anniversary of the closing date. The Company also 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. The closing of the transaction is expected to occur on May 1, 2014. In order to secure the payment of the termination fee, the Company will be granting EMD Serono a security interest on the Companys present and future worldwide corporeal and incorporeal movable property related to tesamorelin (see note 27 Subsequent events to the November 30, 2013 consolidated financial statements). Future operations of the Company will significantly change 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 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 EGRIFTA and negatively impacted sales and operating results. Thereafter, the Company resumed manufacturing. On February 14, 2014, the manufacturing difficulties resurfaced and the Company ceased manufacturing again. As of the date of this MD&A, there is no longer any inventory at EMD Seronos principal distribution center. As a result of the manufacturing difficulties, the Company undertook to carry out work to evaluate its current manufacturing process. The Company is working with EMD Serono, the third-party manufacturer, regulatory consultants and the FDA in order to resolve the supply shortage as soon as
4
possible. A plan has been developed that is based upon temporarily reverting to the initial presentation of EGRIFTA (1 mg vial), which was problem free during the first two years of marketing the product. The target is to resume production of the 1 mg presentation towards the end of the Companys second quarter of 2014. While it is supplying market demand with the 1 mg presentation, the Company will continue to improve its 2 mg production cycle. Once it has confidence that the cycle is robust, the approval of the FDA to bring the 2 mg presentation back to market will be sought. The Company currently has sufficient funding to offset the interruption it is experiencing in its revenue stream. If, however, the Company encounters significant delays in re-establishing the supply chain, it may require additional funds in the next 12 months in order to meet its obligations and sustain operations.
These circumstances could result in a material uncertainty that could cast significant doubt about the Companys ability to continue as a going concern.
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) |
Q1 | Q4 | Q3 | Q2 | Q1 | Q4 | Q3 | Q2 | ||||||||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||
Sale of goods |
675 | $ | 311 | $ | 786 | $ | 996 | $ | 451 | $ | 1,375 | $ | 1,725 | $ | 856 | |||||||||||||||||
Upfront and milestone payments |
320 | $ | 320 | $ | 463 | $ | 463 | $ | 464 | $ | 868 | $ | 1,070 | $ | 1,069 | |||||||||||||||||
Royalties and license fees |
677 | $ | 615 | $ | 928 | $ | 872 | $ | 884 | $ | 1,656 | $ | 1,027 | $ | 731 | |||||||||||||||||
|
|
|||||||||||||||||||||||||||||||
Revenue |
1,672 | $ | 1,246 | $ | 2,177 | $ | 2,331 | $ | 1,799 | $ | 3,899 | $ | 3,822 | $ | 2,656 | |||||||||||||||||
Net (loss) profit |
$ | (3,534 | ) | $ | (2,598 | ) | $ | (1,935 | ) | $ | (1,382 | ) | $ | 1,860 | $ | (4,341 | ) | $ | (698 | ) | $ | (1,417 | ) | |||||||||
Basic and diluted (loss) profit per share |
$ | (0.06 | ) | $ | (0.04 | ) | $ | (0.03 | ) | $ | (0.02 | ) | $ | 0.03 | $ | (0.07 | ) | $ | (0.01 | ) | $ | (0.02 | ) |
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 the 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. While the EGRIFTA selling price is now lower than in previous years, our markup in percentage terms remains unchanged.
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 losses reported in the first and fourth quarters of Fiscal 2012 include restructuring costs of $6,176,000 and $4,526,000 respectively.
5
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.
Recent Changes in Accounting Standards
IFRS 10, Consolidated Financial Statements
In May 2011, the IASB issued IFRS 10, Consolidated Financial Statements, which replaces SIC-12, Consolidation: Special Purpose Entities, and parts of IAS 27, Consolidated and Separate Financial Statements. IFRS 10 builds on existing principles by identifying the concept of control as the determining factor in whether an entity should be included within the consolidated statements of an entity. The standard provides additional guidance to assist in the determination of control where this is difficult to assess. IFRS 10 became effective December 1, 2013. The adoption of this standard had no impact on the Companys consolidated financial statements.
IFRS 13, Fair Value Measurement
In May 2011, the IASB issued IFRS 13, Fair Value Measurement. IFRS 13 improves consistency and reduces complexity by providing a precise definition of fair value and a single source of fair value measurement and disclosure requirements for use across IFRS. IFRS 13 became effective December 1, 2013. The adoption of this standard had no impact on the Companys consolidated 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 financial statements.
Outstanding Share Data
On April 13, 2014, the number of common shares issued and outstanding was 61,010,603 while outstanding options granted under our stock option plan were 1,877,669.
Internal Control
No change has occurred in our internal control over financial reporting during the period beginning on December 1, 2013 and ending on February 28, 2014.
Contractual Obligations
There were no material changes in contractual obligations during the three-month period ended February 28, 2014, other than in the ordinary course of business.
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 strategy to seek commercial partners in Europe which could lead to filing of marketing authorization applications in certain European countries or dispensing EGRIFTA by way of named patient programs, the timing to close the transaction with EMD Serono based on the EMD Serono Termination Agreement, our capacity to increase the patient base of EGRIFTA in the United States and to generate higher revenues and cash flow therefrom, the timing to resume the manufacture of EGRIFTA with the 1 mg presentation, our capacity to improve the 2 mg production cycle and the capacity of our commercial partners outside of the United States to commercialize EGRIFTA in their respective territories.
Forward-looking statements are based upon a number of assumptions and include, but are not limited to, the following: the closing of the transaction with EMD Serono will occur on May 1 , 2014, we will resume production of EGRIFTA towards the end of our second quarter 2014, no manufacturing problems will be encountered with the 1 mg presentation of EGRIFTA, we will be able to increase our patient base in the United States following the closing of the transaction with EMD Serono, demand for EGRIFTA will increase over time in the United States despite the recent drug shortage, EGRIFTA will be accepted by the marketplace in territories outside of the United States and will be on the list of reimbursed drugs by third-party payors in these territories, the relationships with our commercial partners and third-party suppliers will be conflict-free and no unexpected events resulting in unplanned material expenses will occur.
Forward-looking statements are subject to a variety of risks and uncertainties, many of which are beyond our control that could cause our actual results to differ materially from those that are disclosed in or implied by the forward-looking statements contained in this MD&A. These risks and uncertainties include, but are not limited to, the following: the risk that we are unable to find commercial partners in Europe, the risk that the closing of the transaction with EMD Serono is delayed or cancelled, the risk that we incur delays in resuming the manufacture of EGRIFTA and that such delays require that we seek financing through the issuance of equity, debt-securities or the sale of assets in order to continue our operations, the risk that the 1 mg presentation of EGRIFTA has defects, the risk that we are unable to grow the patient base for EGRIFTA in the United States and that our commercial operations do not generate high revenues, the risk that EGRIFTA is not approved in all or some of the territories where our commercial partners have filed and intend to file marketing authorization applications, including Canada, Mexico and Brazil, the risk that conflicts occur with our third-party suppliers jeopardizing the manufacture and/or commercialization of EGRIFTA, the risk that EGRIFTA is withdrawn from the market as a result of defects or recalls if and when it becomes available, the risk that our intellectual property is not adequately protected, the risk that, even if approved in territories outside of the United States, EGRIFTA 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. 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.
6
Exhibit 99.3
|
|
Theratechnologies Announces Financial Results for First Quarter of 2014
Montreal, Canada April 14, 2014 Theratechnologies Inc. (Theratechnologies) (TSX: TH) today announced its financial results for the first quarter ended February 28, 2014.
First quarter 2014 financial highlights
| Revenues of $1,672,000 |
| Royalties of $677,000 |
| Selling and market development expenses of $1,379,000 mainly associated with marketing initiatives being undertaken in the United States |
| Net loss of $3,534,000 |
| $9,624,000 in liquidities available at quarter-end |
From a financial perspective, the first quarter results were very satisfactory and in accordance with our plan, said Luc Tanguay, President and Chief Executive Officer of Theratechnologies. However, recent manufacturing difficulties have presented us with a significant technical challenge.
We now have succeeded in developing a plan, which targets the resumption of manufacturing by the end of our second quarter, Mr. Tanguay continued. In the meantime, preparations to assume the marketing of EGRIFTATM in the United States are proceeding well and we are looking forward to this exciting new phase in our development, he said.
Update on production
As of the date of this press release, there is no longer any inventory at EMD Seronos principal distribution center. We are working with EMD Serono, our third-party manufacturer, regulatory consultants and the FDA in order to resolve the supply shortage as soon as possible. We now have a plan that is based upon temporarily reverting to the initial presentation of EGRIFTA (1 mg vial), which was problem free during the first two years of marketing the product. While we are supplying market demand with the 1 mg presentation, we will continue to improve our 2 mg production cycle. Once we have confidence that the cycle is robust, we will seek the approval of the FDA to bring the 2 mg presentation back to market. The target is to resume production of the 1 mg presentation towards the end of our second quarter.
First 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 February 28, 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 first quarter ended February 28, 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. As used herein, EGRIFTATM refers to tesamorelin for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. EGRIFTATM is our trademark.
Our revenues are mainly sales of EGRIFTA to EMD Serono for re-sale, royalties received from EMD Serono on U.S. sales to customers, and research services, which include milestone payments and the amortization of the initial payment received upon the closing of the agreement with EMD Serono. Consolidated revenue for the three months ended February 28, 2014 amounted to $1,672,000 compared to $1,799,000 in the comparable period of fiscal 2013.
Revenue generated from sale of goods amounted to $675,000 in the three-month period ended February 28, 2014 compared to $451,000 in the comparable period of Fiscal 2013. Shipments in the first quarter of 2014 represented all of the goods that were available for sale. The lower level of shipments in the first quarter of 2013 was attributable to the procurement policies of EMD Serono.
Royalties, which are almost entirely derived from the sales of EGRIFTA, were $677,000 in three-month period ended February 28, 2014 compared to $884,000 in the comparable period of fiscal 2013. The supply shortages in the first quarter of fiscal 2014 adversely affected EMD Serono sales, resulting in lower royalty revenue.
Revenue also includes the amortization of the initial payment of $27,097,000 received upon the closing of the EMD Serono Agreement. For the three-month period ended February 28, 2014, $320,000 was recognized as revenue related to the initial payment, compared to $464,000 in the comparable period in fiscal 2013. The amortization amounts are adjusted periodically to allow sufficient time for the development work required under the EMD Serono Agreement that has yet to be completed. At February 28, 2014, the remaining deferred revenue related to this transaction recorded on the consolidated statement of financial position amounted to $2,451,000.
For the three month period ended February 28, 2014, the cost of sales was $1,625,000 compared to $668,000 in the comparable period 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 $600,000 compared to $398,000 in the prior-year period, reflecting higher sale of goods in the first quarter of fiscal 2014 as described above. Unallocated production costs were $1,025,000 in 2014 compared to $270,000 in the prior-year period, due largely to inventory write downs related to manufacturing issues.
Research and development, or R&D, net of tax credits, amounted to $1,296,000 in the three-month period ended February 28, 2014 compared to $1,455,000 in the comparable period of fiscal 2013. R&D expenses include our share of expenses for the two Phase 4 clinical trials currently being conducted by EMD Serono. We are responsible for all of the costs associated with the diabetic retinopathy study, which amounted to $670,000 in 2014 compared to $763,000 in the prior-year period. Our fifty percent share of the long-term safety study was $200,000 in three-month period ended February 28, 2014 compared to $132,000 in the comparable period of fiscal 2013.
Selling and market development expenses amounted to $1,379,000 for the three-month period ended February 28, 2014, compared to $62,000 in the comparable period of fiscal 2013. The increased expenses were related to the previously described marketing initiatives being undertaken with inVentiv Health for the United States market.
2
General and administrative expenses amounted to $970,000 in the three-month period ended February 28, 2014, virtually unchanged from $967,000 in the comparable period of fiscal 2013.
There were no restructuring costs in the three-month period ended February 28, 2014. In the comparable period 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-month period ended February 28, 2014 was $105,000 compared to $160,000 in the comparable period 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 February 28, 2014 were $33,000 compared to $40,000 in the comparable period of fiscal 2013.
Taking into account the revenue and expense variations described above, we recorded a net loss of $3,534,000 or $0.06 per share in the three months ended February 28, 2014 compared to a net profit of $1,860,000 or $0.03 per share in the comparable period of fiscal 2013.
Cash flows used in operating activities for the three-month period ended February 28, 2014 amounted to $2,305,000 compared to $2,884,000 in the comparable period of 2013. As at February 28, 2014, liquidities, which include cash, bonds, and tax credits and grants receivable, amounted to $9,624,000 compared to $12,353,000 at November 30, 2013.
On December 13, 2013, the Company announced that it had reached an agreement with EMD Serono to regain all rights under the collaboration and licensing agreement with EMD Serono, including commercialization rights for EGRIFTA in the United States. Under the terms of the termination and transfer agreement entered into with EMD Serono (the EMD Termination Agreement), the Company agreed to pay an early termination fee of US$20,000,000 (the Early Termination Fee) evenly over a five-year period starting on the first anniversary of the closing date. The Company also 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. The closing of the transaction is expected to occur on May 1, 2014. In order to secure the payment of the termination fee, the Company will be granting EMD Serono a security interest on the Companys present and future worldwide corporeal and incorporeal movable property related to tesamorelin (see note 27 Subsequent events to the November 30, 2013 consolidated financial statements). Future operations of the Company will significantly change 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 will increase the Companys liquidity risk and may require additional funding.
3
During the last fiscal year, the Company experienced manufacturing difficulties at its third-party manufacturer, which led to shortages of EGRIFTA and negatively impacted sales and operating results. Thereafter, the Company resumed manufacturing. On February 14, 2014, the manufacturing difficulties resurfaced and the Company ceased manufacturing again. As of the date of this press release, there is no longer any inventory at EMD Seronos principal distribution center. As a result of the manufacturing difficulties, the Company undertook to carry out work to evaluate its current manufacturing process. The Company is working with EMD Serono, the third-party manufacturer, regulatory consultants and the FDA in order to resolve the supply shortage as soon as possible. A plan has been developed that is based upon temporarily reverting to the initial presentation of EGRIFTA (1 mg vial), which was problem free during the first two years of marketing the product. The target is to resume production of the 1 mg presentation towards the end of the Companys second quarter of 2014. While it is supplying market demand with the 1 mg presentation, the Company will continue to improve its 2 mg production cycle. Once it has confidence that the cycle is robust, the approval of the FDA to bring the 2 mg presentation back to market will be sought. The Company currently has sufficient funding to offset the interruption it is experiencing in its revenue stream. If, however, the Company encounters significant delays in re-establishing the supply chain, it may require additional funds in the next 12 months in order to meet its obligations and sustain operations.
These circumstances could result in a material uncertainty that could cast significant doubt about the Companys ability to continue as a going concern.
Conference Call Details
A conference call will be held today at 5:00 p.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 www.theratech.com. Audio replay of the conference call will be available until April 21, 2014, by dialling 1-800-585-8367 (North America) or 1-416-621-4642 (International) and by entering the playback code 22640338.
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical company addressing unmet medical needs in metabolic disorders to promote healthy ageing and improved quality of life. Further information about Theratechnologies is available on the Companys website at www.theratech.com, on SEDAR at www.sedar.com and on the SECs website at www.sec.gov.
Forward-Looking Information
This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our managements belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as may, will, should, could, would, outlook, believe, plan, envisage, anticipate, expect and estimate, or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to, statements regarding: the timing to close the transaction with EMD Serono based on the EMD Termination Agreement, the timing to resume the manufacture of EGRIFTA with the 1 mg presentation, our capacity to improve the 2 mg production cycle and the capacity of our commercial partners outside of the United States to commercialize EGRIFTA in their respective territories.
Forward-looking statements are based upon a number of assumptions and include, but are not limited to, the following: the closing of the transaction with EMD Serono will occur on May 1, 2014, we will resume production of EGRIFTA towards the end of our second quarter 2014, no manufacturing problems will be encountered with the 1 mg presentation of EGRIFTA, demand for EGRIFTA will increase over time in the United States despite the recent drug shortage, EGRIFTA will be accepted by the marketplace in territories outside of the United States and will be on the list of reimbursed drugs by third-party payors in these territories, the relationships with our commercial partners and third-party suppliers will be conflict-free and no unexpected events resulting in unplanned material expenses will occur.
Forward-looking statements are subject to a variety of risks and uncertainties, many of which are beyond our control that could
cause our actual results to differ materially from those that are disclosed in or implied by the forward-looking statements contained in this press release. These risks and uncertainties include, but are not limited to, the following: the risk that
the closing of the transaction with EMD Serono is delayed or cancelled, the risk that we incur delays in resuming the manufacture of EGRIFTA and that such delays require that we seek financing through the issuance of equity, debt-securities or the sale of assets in order to continue our operations, the
risk that the 1 mg presentation of EGRIFTA has defects, the risk that demand for EGRIFTA has decreased as a result of the current drug shortage and that we are unable to overcome this difficulty if and
when EGRIFTA becomes available, the
risk that EGRIFTA is not approved in all or some of the territories where our commercial partners have filed and intend to file
marketing authorization applications, including Canada, Mexico and Brazil, the risk that conflicts occur with our third-party suppliers jeopardizing the manufacture and/or commercialization of EGRIFTA, the risk that EGRIFTA is withdrawn from the market as a
result of defects or recalls if and when it becomes available, the risk that, even if approved in territories outside of the United States, EGRIFTA 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. 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.
Contact:
Denis Boucher
NATIONAL Public Relations
Phone: 514-843-2393
4
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 February 28, 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 December 1, 2013 and ended on February 28, 2014 that has materially affected, or is reasonably likely to materially affect, the issuers ICFR. |
Date: April 14, 2014
/s/ Luc Tanguay |
Luc Tanguay |
President and Chief Executive Officer |
Exhibit 99.5
FORM 52-109F2
CERTIFICATION OF INTERIM FILINGS
FULL CERTIFICATE
I, Marie-Noël Colussi, Vice President, Finance of Theratechnologies Inc. and performing similar functions to a chief financial officer and providing this certification in my capacity as chief financial officer, certify the following:
1. | Review: I have reviewed the interim financial report and interim MD&A, (together, the interim filings) of Theratechnologies Inc. (the issuer) for the interim period ended February 28, 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 December 1, 2013 and ended on February 28, 2014 that has materially affected, or is reasonably likely to materially affect, the issuers ICFR. |
Date: April 14, 2014
/s/ Marie-Noël Colussi |
Marie-Noël Colussi |
Vice President, Finance, providing this certification in capacity as chief financial officer |