Exhibit 99.14
Consolidated Financial Statements of
(Unaudited)
(Unaudited)
THERATECHNOLOGIES INC.
Nine-month periods ended August 31, 2010 and 2009
THERATECHNOLOGIES INC.
Consolidated Financial Statements
(Unaudited)
Consolidated Financial Statements
(Unaudited)
Periods ended August 31, 2010 and 2009
Financial Statements | ||||
Consolidated Balance Sheets | 1 | |||
Consolidated Statements of Operations | 2 | |||
Consolidated Statements of Comprehensive Loss | 3 | |||
Consolidated Statements of Shareholders’ Equity | 4-5 | |||
Consolidated Statements of Cash Flows | 6 | |||
Notes to Consolidated Financial Statements | 7 |
THERATECHNOLOGIES INC.
Consolidated Balance Sheets
(Unaudited)
Consolidated Balance Sheets
(Unaudited)
August 31, 2010 and November 30, 2009
(in thousands of dollars)
(in thousands of dollars)
August 31, | November 30, | |||||||
2010 | 2009 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash | $ | 2,370 | $ | 1,519 | ||||
Bonds | 1,694 | 10,036 | ||||||
Accounts receivable | 131 | 375 | ||||||
Tax credits receivable | 514 | 1,666 | ||||||
Inventories | 4,585 | 2,225 | ||||||
Research supplies | 283 | 287 | ||||||
Prepaid expenses | 680 | 302 | ||||||
10,257 | 16,410 | |||||||
Bonds | 39,355 | 51,807 | ||||||
Property and equipment | 1,106 | 1,229 | ||||||
Other assets | 41 | 41 | ||||||
$ | 50,759 | $ | 69,487 | |||||
Liabilities and Shareholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued liabilities | $ | 3,823 | $ | 5,901 | ||||
Current portion of deferred revenues (note 7) | 6,849 | 6,847 | ||||||
10,672 | 12,748 | |||||||
Deferred revenues (note 7) | 8,557 | 13,691 | ||||||
Deferred lease inducements | 167 | — | ||||||
Shareholders’ equity: | ||||||||
Capital stock (note 3) | 279,389 | 279,169 | ||||||
Contributed surplus | 7,356 | 6,484 | ||||||
Accumulated other comprehensive income | 872 | 1,282 | ||||||
Deficit | (256,254 | ) | (243,887 | ) | ||||
(255,382 | ) | (242,605 | ) | |||||
Total shareholders’ equity | 31,363 | 43,048 | ||||||
Contingency (note 4) | ||||||||
$ | 50,759 | $ | 69,487 | |||||
See accompanying notes to unaudited consolidated financial statements.
1
THERATECHNOLOGIES INC.
Consolidated Statement of Operations
(Unaudited)
Consolidated Statement of Operations
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
(in thousands of dollars, except per share amounts)
August 31, | August 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
(3 months) | (9 months) | |||||||||||||||
Revenues: | ||||||||||||||||
Royalties, technologies and other (note 7) | $ | 1,717 | $ | 12,601 | $ | 5,151 | $ | 15,750 | ||||||||
Interest | 435 | 547 | 1,522 | 1,724 | ||||||||||||
2,152 | 13,148 | 6,673 | 17,474 | |||||||||||||
Operating costs and expenses: | ||||||||||||||||
Research and development | 2,930 | 5,681 | 11,298 | 17,692 | ||||||||||||
Tax credits | (448 | ) | (294 | ) | (783 | ) | (1,384 | ) | ||||||||
2,482 | 5,387 | 10,515 | 16,308 | |||||||||||||
General and administrative | 2,225 | 1,337 | 6,083 | 5,515 | ||||||||||||
Cost of Sales | 120 | — | 120 | — | ||||||||||||
Selling and market development | 521 | 495 | 1,901 | 1,516 | ||||||||||||
Patents | 81 | 105 | 421 | 226 | ||||||||||||
Fees associated with collaboration and licensing agreement (note 7) | — | — | — | 4,269 | ||||||||||||
5,429 | 7,324 | 19,040 | 27,834 | |||||||||||||
(Net loss) net earnings | $ | (3,277 | ) | $ | 5,824 | $ | (12,367 | ) | $ | (10,360 | ) | |||||
Basic and diluted (loss) earnings per share (note 3 (d)) | $ | (0.05 | ) | $ | 0.10 | $ | (0.20 | ) | $ | (0.17 | ) | |||||
See accompanying notes to unaudited consolidated financial statements.
2
THERATECHNOLOGIES INC.
Consolidated Statements of Comprehensive Loss
(Unaudited)
Consolidated Statements of Comprehensive Loss
(Unaudited)
Periods ended August 31, 2010 and 2009
(In thousands of dollars)
(In thousands of dollars)
August 31, | August 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
(3 months) | (9 months) | |||||||||||||||
(Net loss) net earnings | $ | (3,277 | ) | $ | 5,824 | $ | (12,367 | ) | $ | (10,360 | ) | |||||
Unrealized gains (losses) on available-for-sale financial assets | 586 | 342 | (151 | ) | 1,327 | |||||||||||
Reclassification adjustment for gains and losses on available-for-sale financial assets | (65 | ) | (48 | ) | (259 | ) | (118 | ) | ||||||||
Comprehensive (loss) earnings | $ | (2,756 | ) | $ | 6,118 | $ | (12,777 | ) | $ | (9,151 | ) | |||||
See accompanying notes to unaudited consolidated financial statements.
3
THERATECHNOLOGIES INC.
Consolidated Statements of Shareholders’ Equity
(Unaudited)
Consolidated Statements of Shareholders’ Equity
(Unaudited)
Nine-month period ended August 31, 2010
(In thousands of dollars)
(In thousands of dollars)
Accumulated | ||||||||||||||||||||||||
other | ||||||||||||||||||||||||
compre- | ||||||||||||||||||||||||
Capital stock | Contributed | hensive | ||||||||||||||||||||||
Number | Dollars | surplus | income | Deficit | Total | |||||||||||||||||||
Balance, November 30, 2009 | 60,429,393 | $ | 279,169 | $ | 6,484 | $ | 1,282 | $ | (243,887 | ) | $ | 43,048 | ||||||||||||
Issuance of share capital (note 3) | 2,880 | 15 | — | — | — | 15 | ||||||||||||||||||
Exercise of stock options: | ||||||||||||||||||||||||
Cash proceeds | 77,493 | 128 | — | — | — | 128 | ||||||||||||||||||
Ascribed value | — | 77 | (77 | ) | — | — | — | |||||||||||||||||
Stock-based compensation | — | — | 949 | — | — | 949 | ||||||||||||||||||
Net loss | — | — | — | — | (12,367 | ) | (12,367 | ) | ||||||||||||||||
Unrealized gains on available-for- sale financial assets | — | — | — | (410 | ) | — | (410 | ) | ||||||||||||||||
Balance, August 31, 2010 | 60,509,766 | $ | 279,389 | $ | 7,356 | $ | 872 | $ | (256,254 | ) | $ | 31,363 | ||||||||||||
See accompanying notes to unaudited consolidated financial statements.
4
THERATECHNOLOGIES INC.
Consolidated Statements of Shareholders’ Equity, Continued
(Unaudited)
Consolidated Statements of Shareholders’ Equity, Continued
(Unaudited)
Nine-month period ended August 31, 2009
(In thousands of dollars)
(In thousands of dollars)
Accumulated | ||||||||||||||||||||||||
other | ||||||||||||||||||||||||
compre- | ||||||||||||||||||||||||
Capital stock | Contributed | hensive | ||||||||||||||||||||||
Number | Dollars | surplus | income | Deficit | Total | |||||||||||||||||||
Balance, November 30, 2008 | 58,215,090 | $ | 269,219 | $ | 5,585 | $ | 372 | $ | (228,230 | ) | $ | 46,946 | ||||||||||||
Issuance of share capital (note 2 (a)) | — | — | — | — | (599 | ) | (599 | ) | ||||||||||||||||
Share issue costs (notes 3 and 7) | 2,182,387 | 9,861 | — | — | — | 9,861 | ||||||||||||||||||
Stock-based compensation | — | — | 705 | — | — | 705 | ||||||||||||||||||
Net loss | — | — | — | — | (10,360 | ) | (10,360 | ) | ||||||||||||||||
Unrealized gains on available- for-sale financial assets | — | — | — | 1,209 | — | 1,209 | ||||||||||||||||||
Balance, August 31, 2009 | 60,397,477 | $ | 279,080 | $ | 6,290 | $ | 1,581 | $ | (239,189 | ) | $ | 47,762 | ||||||||||||
See accompanying notes to unaudited consolidated financial statements.
5
THERATECHNOLOGIES INC.
Consolidated Statements of Cash Flows
(Unaudited)
Consolidated Statements of Cash Flows
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars)
(in thousands of dollars)
August 31, | August 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
(3 months) | (9 months) | |||||||||||||||
Cash flows from operating activities: | ||||||||||||||||
Net loss | $ | (3,277 | ) | $ | 5,824 | $ | (12,367 | ) | $ | (10,360 | ) | |||||
Adjustments for: | ||||||||||||||||
Amortization of property and equipment | 92 | 157 | 374 | 441 | ||||||||||||
Lease inducements and amortization | 125 | — | 167 | — | ||||||||||||
Stock-based compensation | 431 | 205 | 949 | 705 | ||||||||||||
(2,629 | ) | 6,186 | (10,877 | ) | (9,214 | ) | ||||||||||
Changes in operating assets and liabilities: | ||||||||||||||||
Interest receivable on bonds | 317 | 74 | 696 | (728 | ) | |||||||||||
Accounts receivable | 45 | 56 | 244 | 415 | ||||||||||||
Tax credits receivable | 1,488 | (293 | ) | 1,152 | (1,383 | ) | ||||||||||
Inventories | (89 | ) | — | (2,360 | ) | (1,594 | ) | |||||||||
Research supplies | (12 | ) | 1,797 | 4 | 2,023 | |||||||||||
Prepaid expenses | (17 | ) | (200 | ) | (378 | ) | (326 | ) | ||||||||
Accounts payable and accrued liabilities | (3,216 | ) | (922 | ) | (1,950 | ) | (2,590 | ) | ||||||||
Deferred revenues | (1,714 | ) | (1,715 | ) | (5,132 | ) | 22,252 | |||||||||
(3,198 | ) | (1,203 | ) | (7,724 | ) | 18,069 | ||||||||||
(5,827 | ) | 4,983 | (18,601 | ) | 8,855 | |||||||||||
Cash flows from financing activities: | ||||||||||||||||
Share issuance | 37 | — | 143 | 9,861 | ||||||||||||
Share issue costs | — | — | — | (8 | ) | |||||||||||
37 | — | 143 | 9,853 | |||||||||||||
Cash flows from investing activities: | ||||||||||||||||
Additions to property and equipment | (43 | ) | (55 | ) | (379 | ) | (290 | ) | ||||||||
Acquisition of bonds | — | — | — | (19,631 | ) | |||||||||||
Disposal of bonds | 4,706 | 3,963 | 19,688 | 13,805 | ||||||||||||
4,663 | 3,908 | 19,309 | (6,116 | ) | ||||||||||||
Net (decrease) increase in cash | (1,127 | ) | 8,891 | 851 | 12,592 | |||||||||||
Cash, beginning of period | 3,497 | 3,834 | 1,519 | 133 | ||||||||||||
Cash, end of period | $ | 2,370 | $ | 12,725 | $ | 2,370 | $ | 12,725 | ||||||||
See note 5 (a) for supplemental cash flow information.
See accompanying notes to unaudited consolidated financial statements.
6
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements
(Unaudited)
Notes to Consolidated Financial Statements
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
(in thousands of dollars, except per share amounts)
1. | Basis of presentation: |
The financial statements included in this report are unaudited and reflect normal and recurring adjustments which are, in the opinion of the Company, considered necessary for a fair presentation of its results. These financial statements have been prepared in conformity with Canadian generally accepted accounting principles (“GAAP”). The same accounting policies as described in the Company’s latest annual report have been used. However, these financial statements do not include all disclosures required under GAAP and, accordingly, should be read in connection with the financial statements and the notes thereto included in the Company’s latest annual report. These interim financial statements have not been reviewed by the auditors. |
2. | New accounting policies: |
(a) | Adoption of new accounting standards: |
Goodwill and intangible assets | |||
Effective with the commencement of its 2009 fiscal year, the Company adopted the Canadian Institute of Chartered Accountants (“CICA”) Handbook Section 3064, Goodwill and Intangible Assets, which will replace Section 3062, Goodwill and Other Intangible Assets, and Section 3450, Research and Development Costs. The standard provides guidance on the recognition of intangible assets in accordance with the definition of an asset and the criteria for asset recognition, whether these assets are separately acquired or internally developed. The impact of adopting this standard has been to increase the opening deficit and to reduce other assets as at December 1, 2008 by $599, which is the amount of patent costs related to periods prior to these dates. | |||
Lease inducements | |||
Lease inducements arising from leasehold improvements allowance and rent-free inducements received are deferred and amortized over the term of the lease on a straight-line basis. |
7
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
(in thousands of dollars, except per share amounts)
2. | New accounting policies (continued): |
(b) | Future accounting changes: | ||
International Financial Reporting Standards | |||
In February 2008, the Accounting Standards Board of Canada (“AcSB”) announced that accounting standards in Canada, as used by public companies, will converge with International Financial Reporting Standards (“IFRS”), for financial periods beginning on and after January 1, 2011 with the option to early adopt IFRS upon receipt of approval from the Canadian Securities regulatory authorities. | |||
The Company’s mandatory changeover from current Canadian GAAP to IFRS applies to the fiscal year beginning December 1, 2011. However, the Company plans to file an exemption with the Canadian securities regulatory authorities to early adopt IFRS beginning December 1, 2009, the change over date. The Company intends to file its November 30, 2010 financial statements under IFRS with December 1, 2008 being the proposed transition date. Should the exemption be granted, the comparative annual period for fiscal 2009 will be restated under IFRS as will all quarterly filings for 2009 and 2010. |
3. | Capital stock: |
During the second quarter of 2010, the Company received subscriptions in the amount of $15 ($7 for the same period in 2009) for the issue of 2,880 common shares (2,550 for the same period in 2009) in connection with its share purchase plan. |
(a) | Shareholder rights plan: | ||
On February 10, 2010, the Board of Directors of the Company adopted a shareholder rights plan (the “Plan”), effective as of such date. The Plan is designed to provide adequate time for the Board of Directors, and the shareholders, to assess an unsolicited takeover bid for the Company. In addition, the Plan provides the Board of Directors with sufficient time to explore and develop alternatives for maximizing shareholder value if a takeover bid is made, as well as provide shareholders with an equal opportunity to participate in a takeover bid and receive full and fair value for their common shares (the “Common Shares”). The Plan, if approved by the shareholders, will expire at the close of the Company’s annual meeting of shareholders in 2013. |
8
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
(in thousands of dollars, except per share amounts)
3. | Capital stock (continued): |
(a) | Shareholder rights plan (continued): | ||
The rights issued under the Plan will initially attach to and trade with the Common Shares and no separate certificates will be issued unless an event triggering these rights occurs. The rights will become exercisable only when a person, including any party related to it, acquires or attempts to acquire 20% or more of the outstanding Common Shares without complying with the “Permitted Bid” provisions of the Plan or without approval of the Board of Directors. Should such an acquisition occur or be announced, each right would, upon exercise, entitle a rights holder, other than the acquiring person and related persons, to purchase Common Shares at a 50% discount to the market price at the time. | |||
Under the Plan, a Permitted Bid is a bid made to all holders of the Common Shares and which is open for acceptance for no less than 60 days. If, at the end of the 60-day period, at least 50% of the outstanding Common Shares, other than those owned by the offeror and certain related parties, have been tendered, the offeror may take up and pay for the Common Shares but must extend the bid for a further 10 days to allow other shareholders to tender. | |||
(b) | Stock option plan: | ||
Changes in outstanding options granted under the Company’s stock option plan for the year ended November 30, 2009 and the nine-month period ended August 31, 2010 were as follows: |
Weighted | ||||||||
average | ||||||||
exercise price | ||||||||
Number | per share | |||||||
Options as at November 30, 2008 | 2,161,800 | $ | 6.52 | |||||
Granted | 680,500 | 1.83 | ||||||
Cancelled and expired | (176,500 | ) | 8.34 | |||||
Options as at November 30, 2009 | 2,665,800 | 5.20 | ||||||
Granted | 335,000 | 4.03 | ||||||
Cancelled and expired | (60,337 | ) | 6.32 | |||||
Exercised | (77,493 | ) | 1.65 | |||||
Options as at August 31, 2010 | 2,862,970 | $ | 5.14 | |||||
9
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
(in thousands of dollars, except per share amounts)
3. | Capital stock (continued): |
(c) | Stock-based compensation and other stock-based payments: | ||
The estimated fair value of the options granted was estimated at the date of grant using the Black-Scholes option pricing model with the following weighted average assumptions: |
2010 | 2009 | |||||||
Risk-free interest rate | 2.49 | % | 1.80 | % | ||||
Volatility | 81 | % | 79 | % | ||||
Average option life in years | 6 | 6 | ||||||
Dividend yield | Nil | Nil | ||||||
The risk-free interest rate is based on the implied yield on a Canadian Treasury zero-coupon issue with a remaining term equal to the expected term of the option. The volatility is based solely on historical volatility equal to the expected term of the option. The average life of the options is estimated considering the vesting period, the term of the option and the length of time that similar grants have remained outstanding in the past. Dividend yield was excluded from the calculation, since it is the present policy of the Company not to retain in cash in order to keep funds available to finance the Company’s growth. | |||
The following table summarizes the weighted average fair value of stock options granted during the periods ended August 31, 2010 and 2009: |
Weighted average | ||||||||
Number of | grant-date | |||||||
Periods ended August 31 (9 months) | options | fair value | ||||||
2010 | 335,000 | $ | 2.83 | |||||
2009 | 660,500 | 1.24 | ||||||
Weighted average | ||||||||
Number of | grant-date | |||||||
Periods ended August 31 (3 months) | options | fair value | ||||||
2010 | 70,000 | $ | 3.36 | |||||
2009 | — | — | ||||||
10
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
(in thousands of dollars, except per share amounts)
3. | Capital stock (continued): |
(d) | Diluted (loss) earnings per share: | ||
The following table presents a reconciliation between basic and diluted (loss) earnings per share: |
August 31, | August 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
(3 months) | (9 months) | |||||||||||||||
Basic (loss) earnings per share: | ||||||||||||||||
Basic weighted average number of common shares outstanding | 60,502,515 | 60,397,477 | 60,469,621 | 60,284,591 | ||||||||||||
Basic (loss) earnings per share | $ | (0.05 | ) | $ | 0.10 | $ | (0.20 | ) | $ | (0.17 | ) | |||||
Diluted (loss) earnings per share: | ||||||||||||||||
Basic weighted average number of common shares outstanding | 60,502,515 | 60,397,477 | 60,469,621 | 60,284,591 | ||||||||||||
Plus impact of stock options | — | 237,498 | — | — | ||||||||||||
Diluted weighted average number of common shares outstanding | 60,502,515 | 60,634,975 | 60,469,621 | 60,284,591 | ||||||||||||
Diluted (loss) earnings per share | $ | (0.05 | ) | $ | 0.10 | $ | (0.20 | ) | $ | (0.17 | ) | |||||
11
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
(in thousands of dollars, except per share amounts)
4. | Contingency: |
On July 26, 2010, the Company received a motion of authorization to institute a class action against the Company and certain of its executive officers (the “Motion”). This Motion was filed in the Superior Court of Quebec, district of Montreal. The applicant is seeking to initiate a class action suit to represent the class of persons who were shareholders at May 21, 2010 and who sold their common shares of the Company on May 25 or 26, 2010. This applicant alleges that the Company did not comply with its continuous disclosure obligations as a reporting issuer by failing to disclose a material change. The Company is of the view that the allegations contained in the Motion are frivolous and entirely without merit and intends to take all appropriate actions to vigorously defend its position. |
As of October 11, 2010, the Motion has not yet been heard by the Superior Court of Quebec. |
The Company subscribed insurances covering the responsibility of its administrators and officers in the exercise of their functions. |
5. | Supplemental information: |
(a) | The following transactions were conducted by the Company and did not impact cash flows: |
August 31, | November 30, | |||||||
2010 | 2009 | |||||||
Additions to property and equipment included in accounts payable and accrued liabilities | $ | 55 | $ | 183 | ||||
(b) | For the nine-month period ended August 31, 2010, the Company has reclassified in net loss $259 of realized gains on available-for-sale financial assets previously recorded in accumulated other comprehensive income ($118 in 2009). | ||
On August 31, 2010, the accumulated other comprehensive loss was composed of unrealized gains on available-for-sale financial assets of $872 (gains of $1,282 on November 30, 2009). |
12
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
(in thousands of dollars, except per share amounts)
5. | Supplemental information (continued): |
(c) | For the periods ended August 31, 2010 and 2009, the following items were included in the determination of the Company’s net loss: |
2010 | 2009 | |||||||
Amortization of property and equipment | $ | 374 | $ | 441 | ||||
Stock-based compensation | 949 | 705 | ||||||
6. | Financial instruments: |
(a) | Carrying value and fair value: | ||
The Company has determined that the carrying values of its short-term financial assets and liabilities, including cash, accounts receivable, as well as accounts payable and accrued liabilities, approximate their fair value because of the relatively short period to maturity of these instruments. | |||
Bonds and investments in public companies are stated at estimated fair value, determined by inputs that are directly observable. | |||
(b) | Interest income and expenses: | ||
Interest income consists of interest earned on cash and bonds. | |||
(c) | Loss on exchange: | ||
General and administrative expenses include a loss on foreign exchange of $144 ($580 in 2009) for the nine-month period ended August 31, 2010. |
7. | Collaboration and licensing agreement: |
On October 28, 2008, the Company entered into a collaboration and licensing agreement with EMD Serono, Inc. (“EMD Serono”), an affiliate of Merck KGaA, of Darmstadt, Germany, regarding the exclusive commercialization rights of tesamorelin in the United States for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy (the “Initial Product”). The Company retains all tesamorelin commercialization rights outside of the United States. |
13
THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Periods ended August 31, 2010 and 2009
(in thousands of dollars, except per share amounts)
(in thousands of dollars, except per share amounts)
7. | Collaboration and licensing agreement (continued): |
Under the terms of the agreement, the Company is responsible for the development of the Initial Product up to obtaining marketing approval in the United States. The Company is also responsible for product production and for the development of a new formulation of the initial product. EMD Serono is responsible for conducting product commercialization activities. |
At the closing of the agreement, on December 15, 2008, the Company received US$30,000 (CAD$36,951), which includes an initial payment of US$22,000 (CAD$27,097) and US$8,000 (CAD$9,854) as a subscription for common shares in the Company by Merck KGaA at a price of US$3.67 (CAD$4.52) per share. The Company may receive up to US$215,000, which amount includes the initial payment of US$22,000, the equity investment of US$8,000, as well as payments based on the achievement of certain development, regulatory and sales milestones. The Company will also be entitled to receive increasing royalties on annual net sales of tesamorelin in the United States, if applicable. |
The initial payment of $27,097 has been deferred and is being amortized over its estimated service period on a straight-line basis. This period may be modified in the future based on additional information that may be received by the Company. For the nine-month period ended August 31, 2010, an amount of $5,134 related to this transaction was recognized as revenue. At August 31, 2010, the deferred revenues related to this transaction amounted to $15,403. |
On August 12, 2009, the US Food and Drug Administration accepted the New Drug Application (“NDA”) made by the Company for tesamorelin. Under the terms of the Company’s Collaboration and Licensing Agreement with EMD Serono, the acceptance of the tesamorelin NDA resulted in a milestone payment of US$10,000 (CAD$10,884). This milestone payment has been recorded in the third quarter of 2009. |
The Company may conduct research and development for additional indications. Under the Collaboration and Licensing Agreement, EMD Serono will have the option to commercialize additional indications for tesamorelin in the United States. If it exercises this option, EMD Serono will pay half of the development costs related to such additional indications. In such cases, the Company will also have the right, subject to EMD Serono’s agreement, to participate in the promotion of the additional indications. |
14