Theratechnologies inc.
TSX : TH

Theratechnologies inc.

October 05, 2009 16:05 ET

Theratechnologies Announces Financial Results for the Third Quarter 2009

- Theratechnologies strengthens its balance sheet -

MONTREAL, QUEBEC--(Marketwire - Oct. 5, 2009) - Theratechnologies (TSX:TH) today announced its financial results for the third quarter ended August 31, 2009. This quarter was marked by the US Food and Drug Administration's ("FDA") acceptance to file the New Drug Application ("NDA") for tesamorelin as well as by the receipt of a $10 million milestone payment.

"With a liquidity position of $70 million at the end of this quarter, we plan to end the year with a higher level of liquidities than we started the year with," noted Mr. Luc Tanguay, Senior Executive Vice President and CFO of Theratechnologies. "This financial situation positions us well to execute our business plan without any need to access the capital markets," Mr. Tanguay concluded.

"The acceptance to file tesamorelin's NDA marked the beginning of the FDA's substantive review of our regulatory file. The successful achievement of this first regulatory step is very encouraging for the Company," stated Mr. Yves Rosconi, President and CEO of Theratechnologies. "With the US regulatory review process underway, we are now in a position to focus on Theratechnologies' growth opportunities which include the expansion into additional markets where patients are suffering from lipodystrophy," Mr. Rosconi concluded.


MANAGEMENT'S DISCUSSION AND ANALYSIS FOR THE THIRD QUARTER

Revenues

Royalties, technologies and other

Consolidated revenues for the three-month period ended August 31, 2009, amounted to $12,601,000 compared to $106,000 for the same period in 2008. Revenues of the third quarter 2009 include a milestone payment of $10,844,000 associated with the US Food and Drug Administration's ("FDA") acceptance to file the New Drug Application ("NDA") for tesamorelin submitted by the Company, on May 29, 2009. Under the terms of the collaboration and licensing agreement with EMD Serono, Inc. ("EMD Serono"), the acceptance to file tesamorelin's NDA was associated with a milestone payment of US $10 million. All milestone payments, including the aforementioned payment, are recorded when they are earned, as stated in the agreement upon the achievement of predetermined milestones.

For the nine-month period ended August 31, 2009, consolidated revenues were $15,750,000 compared to $116,000 for the same period in 2008. The increased revenues in 2009 are related to the payment received on December 15, 2008 upon the closing of the collaboration and license agreement with EMD Serono. This payment of US $30,000,000 (CAD $36,951,000) included an initial payment of US $22,000,000 (CAD $27,097,000) and a subscription for common shares by Merck KGaA at a price of US $3.67 (CAD $4.52) per share, resulting in gross proceeds of US $8,000,000 (CAD $9,854,000).

The initial payment of $27,097,000 has been deferred and is being amortized over its estimated service period on a straight-line basis. This period may be modified based on additional future information. For the nine-month period ended August 31, 2009, an amount of $4,849,000 related to this transaction was recognized as revenue. At May 31, 2009, the deferred revenues related to this transaction amounted to $22,248,000.

Interest

Interest revenues for the three-month period ended August 31, 2009, amounted to $547,000 compared to $604,000 for the same period in 2008. For the nine-month period ended August 31, 2009, interest revenues were $1,724,000 compared to $1,909,000 for the same period in 2008. This decrease in interest revenues is associated with a lower return on investments as well as a slight decrease in the average level of liquidity during the period.

R&D Activities

Research and Development (R&D) expenditures, before tax credits, totalled $5,681,000 for the third quarter of 2009, compared to $9,602,000 for the same period in 2008, representing a decrease of 40.8%. For the nine-month period ended August 31, 2009, R&D expenditures were $17,692,000, compared to $29,013,000 for the same period in 2008, representing a decrease of 39.0%. The decrease in R&D expenses is due to the conclusion of the Phase 3 clinical trials evaluating tesamorelin in HIV-associated lipodystrophy. The R&D expenses incurred in the third quarter of 2009 are related to the activities associated with the management of the FDA's questions, as a normal part of the review process, and the preparation for a larger-scale production of tesamorelin. The R&D expenses for the third quarter include a non-recurring charge of $1,395,000 associated with the devaluation of research material produced to obtain stability data and to validate the commercial production process, as requested by the FDA.

Other Expenses

For the third quarter of 2009, general and administrative expenses amounted to $1,337,000, compared to $1,392,000 for the same period in 2008. For the nine-month period ended August 31, 2009, general and administrative expenses amounted to $5,515,000 compared to $4,311,000 for the same period in 2008. The increased expenses for the nine-month period ended August 31, 2009 are principally due to an increase in the exchange loss as well as costs associated with revising the Company's business plan in the first quarter.

Selling and market development costs amounted to $495,000 for the third quarter of 2009, compared to $1,281,000 for the same period in 2008. For the nine-month period ended August 31, 2009, selling and market development expenses amounted to $1,516,000, compared to $2,687,000 for the same period in 2008. The decrease in selling and market development costs is due to the signing of an agreement with EMD Serono for the US commercialization of tesamorelin in HIV-associated lipodystrophy. Following the signing of this agreement, the sales and market development expenses are principally composed of business development expenses outside the United States and the costs of managing the agreement with EMD Serono.

Net Results

Taking account of the changes in revenues and expenses described above, the Company recorded a third-quarter net earnings of $5,824,000 ($0.10 earnings per share), compared to a net loss of $11,220,000 ($0.19 loss per share) for the same period in 2008. For the nine-month period ended August 31, 2009, the net loss was $10,360,000 ($0.17 loss per share), compared to a net loss of $33,466,000 ($0.59 loss per share) for the same period in 2008.

The third-quarter net earnings include revenues of $12,596,000 related to the agreement with EMD Serono. Excluding this item, the adjusted net loss (see Annex A) amounted to $6,772,000, a decrease of 39.6% compared to the same period in 2008.

For the nine-month period ended August 31, 2009, the net loss included revenue of $15,733,000 and a non-recurring charge of $4,269,000 related to the agreement with EMD Serono. Excluding these two items, the adjusted net loss (see Annex A) amounted to $21,824,000, a decrease of 34.8% compared to the same period in 2008.

Quarterly Financial Information

The selected financial information provided below is derived from the Company's unaudited quarterly financial statements for each of the last eight quarters. This information has been restated following the adoption of the Canadian Institute of Chartered Accountants ("CICA") Handbook Section 3064, Goodwill and Intangible Assets.



(in thousands of Canadian dollars, except per share amounts)
-----------------------------------------------------------
-----------------------------------------------------------
2009
-----------------------------------------------------------
Q3 Q2 Q1
-----------------------------------------------------------
Revenues $13,148 $2,317 $2,009
Net earnings
(net loss) $5,824 $(5,430) $(10,754)
Basic and diluted
benefit (loss)
per share $0.10 $(0.09) $(0.18)
-----------------------------------------------------------
-----------------------------------------------------------

2008 2007
-----------------------------------------------------------------------
Q4 Q3 Q2 Q1 Q4
-----------------------------------------------------------------------
Revenues $616 $710 $716 $599 $1,294
Net earnings
(net loss) $(15,145) $(11,220) $(11,382) $(10,864) $(10,300)
Basic and diluted
benefit (loss)
per share $(0.26) $(0.19) $(0.20) $(0.20) $(0.19)
-----------------------------------------------------------------------
-----------------------------------------------------------------------


As described above, the increased revenues in 2009 are related to the amortization of the initial payment received at the closing of the agreement with EMD Serono, including a milestone payment of $10,884,000 recorded in August 2009. The increase in the fourth quarter net loss in 2008 is due to an impairment loss related to intellectual property.

Financial Position

At August 31, 2009, liquidities, which include cash and bonds, amounted to $66,390,000, with tax credits receivable amounting to $3,167,000 for a total of $69,557,000.

For the three-month period ended August 31, 2009, the cash flow for operating activities, excluding changes in operating assets and liabilities, was $6,186,000, compared to a burn rate from operating activities of $10,750,000 for the same period in 2008. Excluding the revenue of $12,596,000 related to the agreement with EMD Serono, the adjusted burn rate from operating activities, excluding changes in operating assets and liabilities (see Annex A), was $6,410,000, a decrease of 40.4%, compared to the corresponding period in 2008.

For the nine-month period ending August 31, 2009, the burn rate from operating activities, excluding changes in operating assets and liabilities, was $9,214,000, compared to $32,033,000 for the same period in 2008. The decrease in the 2009 burn rate is mainly related to the payments received as part of the agreement with EMD Serono as well as the decline in R&D expenditures and in selling and market development costs. Excluding the revenue of $15,733,000 and the non-recurring charge of $4,269,000 related to the agreement with EMD Serono, the adjusted burn rate from operating activities, excluding changes in operating assets and liabilities (see Annex A), was $20,678,000, a decrease of 35.4%, compared to the corresponding period in 2008.

New Accounting Policies

Refer to Note 2 of the Company's unaudited Consolidated Financial Statements for the third quarter of 2009.

The impact of adopting Section 3064, Goodwill and Intangible Assets, of the CICA Handbook was to increase the opening deficit and to reduce other assets on December 1, 2007 and 2008 by $941,000 and $599,000 respectively. These amounts correspond to adjustments made to patent costs related to periods prior to these dates. Furthermore, following the adoption of this standard, patents and amortization of other assets presented on the consolidated statements of earnings were reduced by $47,000 for the nine-month period ended August 31, 2008.

Outstanding Share Data

On October 2, 2009, the number of shares issued and outstanding was 60,397,477, while outstanding options granted under the stock option plan were 2,680,466.

Contractual obligations

There were no material changes in contractual obligations during the first nine months of the year, other than in the ordinary course of business.

Economic and Industry Factors

Economic and industry factors were substantially unchanged from those reported in the Company's 2008 Annual Report.

About Theratechnologies

Theratechnologies (TSX:TH) is a Canadian biopharmaceutical company with core expertise in peptide-based therapeutics. Its most advanced compound, tesamorelin, is an analogue of the human growth hormone releasing factor.

In 2008, Theratechnologies completed its Phase 3 clinical program evaluating tesamorelin in treating excess abdominal fat in HIV patients with lipodystrophy. In addition, the Company signed a collaboration and licensing agreement with EMD Serono, Inc., for the commercialization of tesamorelin in the United States.

With a New Drug Application recently filed with the US authorities, Theratechnologies' growth strategy is firmly focused on the development of tesamorelin, in the United States and in other potential lipodystrophy markets, as well as through additional clinical programs for other medical conditions.

Additional information about Theratechnologies

Further information about Theratechnologies is available on the Company's website at www.theratech.com. Additional information, including the Annual Information Form and the Annual Report, is also available on SEDAR at www.sedar.com.

Forward-Looking Information

This press release and the management's discussion and analysis for the third quarter incorporated therein contain certain statements that are considered "forward-looking information" within the meaning of applicable securities legislation. This forward-looking information includes, the approval by the FDA of tesamorelin as a therapeutic product, the commercialization of tesamorelin and its success in the treatment of HIV-associated lipodystrophy in the US, the Company's success to penetrate markets outside of the US and that no unforeseen events occur that would result in the Company increasing its capital. Words such as "will", "may", "could", "should", "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or variations of these terms and similar expressions denote forward-looking information.

Forward-looking information is based upon a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond the Company's control, which could cause actual results to differ materially from those that are disclosed in or implied by such information. These risks and uncertainties include, in particular, the risk that the Company may not obtain all required approvals from the FDA and from other regulatory agencies to market its products, the risk that the Company's products may not be accepted by the market, delays or cost overruns that could result from the use of third-party suppliers and the risk that the Company may not conclude partnership agreements outside of the United States.

Although the forward-looking information is based upon what the Company believes are reasonable assumptions, certain assumptions used in these forward looking statements, and the Company's anticipated objectives, take into consideration that the FDA and other regulatory agencies will approve the US commercialization of tesamorelin for the treatment of HIV-associated lipodystrophy, that the Company will continue to have a good business relationship with its third party suppliers and that the Company will not face any unexpected events.

Consequently, all of the forward-looking information contained herein is qualified by the foregoing cautionary statements, and there can be no guarantee that the results or developments anticipated by the Company will be realized or, even if substantially realized, that they will have the expected consequences or effects on the Company, its business, its financial condition or its results of operation. Furthermore, the forward-looking information reflects current expectations regarding future events only as of the date of release of this press release.

Investors are referred to the Company's public filings available at www.sedar.com. In particular, further details and descriptions of these risks and other factors are disclosed in the "Risk and Uncertainties" section of the Company's Annual Information Form, dated February 24, 2009, for the year ended November 30, 2008. The Company does not undertake to update or amend such forward-looking information whether as a result of new information, future events or otherwise, except as may be required by applicable law.


ANNEX A

Non-GAAP measures

The Company uses measures that do not conform to generally accepted accounting principles ("GAAP") to assess its operating performance. Securities regulators require that companies caution readers that earnings and other measures adjusted to a basis other than GAAP do not have standardized meanings and are unlikely to be comparable to similar measures used by other companies. Accordingly, these measures should not be considered in isolation. The Company uses non-GAAP measures such as adjusted net loss and the adjusted burn rate from operating activities before changes in operating assets and liabilities, to measure its performance from one period to the next without including changes caused by certain items that could potentially distort the analysis of trends in its operating performance, and because such measures provide meaningful information on the Company's financial condition and operating results.

Definition and reconciliation of non-GAAP measures

In order to measure performance from one period to another, without accounting for changes related to revenues and fees associated with the collaboration and license agreement with EMD Serono, management uses adjusted net loss and adjusted burn rate before changes in operating assets and liabilities. These items are excluded because they affect the comparability of the financial results and could potentially distort the analysis of trends in the Company's operating performance. The exclusion of these items does not necessarily indicate that they are non-recurring.



(Thousands of dollars)

August 31st August 31st
(3 months) (9 months)
Adjusted net loss 2009 2008 2009 2008

Net earnings (net loss),
per the financial
statements $5,824 $(11,220) $(10,360) $(33,466)

Adjustments:

Revenues associated with a
collaboration and license
agreement (note 7 to the
consolidated financial
statements) (12,596) - (15,733) -
Fees associated with
collaboration and
license agreement - - 4,269 -
-----------------------------------------------
Adjusted net loss $(6,772) $(11,220) $(21,824) $(33,466)
-----------------------------------------------

August 31st August 31st
(3 months) (9 months)

Adjusted burn rate before
changes in operating
assets and liabilities 2009 2008 2009 2008
Cash flow (burn rate)
before changes in
operating assets and
liabilities, per the
financial statements $6,186 $(10,750) $(9,214) $(32,033)
----------------------------------------------

Adjustments:

Revenues associated with a
collaboration and license
agreement (note 7 to the
consolidated financial
statements) (12,596) - (15,733) -
Fees associated with
collaboration and
license agreement - - 4,269 -
Adjusted burn rate before
changes in operating
assets and liabilities $(6,410) $(10,750) $(20,678) $(32,033)



THERATECHNOLOGIES INC.
Consolidated Balance Sheets
(Unaudited)

August 31, 2009, with comparative figures as at November 30, 2008
(in thousands of dollars)

--------------------------------------------------------
--------------------------------------------------------
August 31, November 30,
2009 2008
--------------------------------------------------------
(Restated -
note 2 (a))

Assets

Current assets:
Cash $12,725 $133
Bonds 9,562 10,955
Accounts receivable 220 610
Tax credits receivable 3,167 1,784
Inventories 1,594 -
Research supplies 1,029 301
Prepaid expenses 723 397
--------------------------------------------------------
29,020 14,180

Bonds 44,103 35,249
Investments in public companies 343 41
Property and equipment 1,128 1,299
Other assets (note 3) - 2,776

--------------------------------------------------------
$74,594 $53,545
--------------------------------------------------------
--------------------------------------------------------

Liabilities and Shareholders' Equity

Current liabilities:
Accounts payable and accrued
liabilities $4,580 $7,198
Current portion of deferred
revenues (note 7) 6,850 -
--------------------------------------------------------
11,430 7,198

Deferred revenues (note 7) 15,402 -

Shareholders' equity:
Capital stock (note 4) 279,080 269,219
Contributed surplus 6,290 5,585

Accumulated other
comprehensive income 1,581 372
Deficit (239,189) (228,829)
--------------------------------------------------------
(237,608) (228,457)

--------------------------------------------------------
Total shareholders' equity 47,762 46,347

--------------------------------------------------------
$74,594 $53,545
--------------------------------------------------------
--------------------------------------------------------

See accompanying notes to unaudited consolidated financial statements.



THERATECHNOLOGIES INC.
Notes to Consolidated Statements of Earnings
(Unaudited)

Periods ended August 31, 2009 and 2008
(in thousands of dollars, except per share amounts)

--------------------------------------------------------------------
--------------------------------------------------------------------
August 31, August 31,
--------------------------------------------------------------------
2009 2008 2009 2008
--------------------------------------------------------------------
(Restated (Restated -
note 2 (a)) note 2 (a))
(3 months) (9 months)

Revenues:
Royalties,
technologies
and other $12,601 $106 $15,750 $116
Interest 547 604 1,724 1,909
13,148 710 17,474 2,025

Operating costs
and expenses:
Research and
development 5,681 9,602 17,692 29,013
Tax credits (294) (588) (1,384) (1,777)
--------------------------------------------------------------------
5,387 9,014 16,308 27,236

General and
administrative 1,337 1,312 5,515 4,311
Selling and market
development 495 1,281 1,516 2,687
Patents and
amortization of
other assets 105 180 226 512
Fees associated
with the strategic
review process - 143 - 745
Fees associated with
collaboration and
licensing agreement
(note 7) - - 4,269 -
--------------------------------------------------------------------
7,324 11,930 27,834 35,491

Net earnings
(net loss) $5,824 $(11,220) $(10,360) $(33,466)
--------------------------------------------------------------------
--------------------------------------------------------------------

Basic and diluted
earnings (loss) per
share (note 4 (C)) $0.10 $(0.19) $(0.17) $(0.59)
--------------------------------------------------------------------
--------------------------------------------------------------------

See accompanying notes to unaudited consolidated financial statements.



THERATECHNOLOGIES INC.
Consolidated Statements of Comprehensive Earnings
(Unaudited)

Periods ended August 31, 2009 and 2008
(in thousands of dollars)

--------------------------------------------------------------------
--------------------------------------------------------------------
August 31, August 31,
--------------------------------------------------------------------
2009 2008 2009 2008
--------------------------------------------------------------------
(Restated (Restated -
note 2 (a)) note 2 (a))
(3 months) (9 months)

Net earnings
(net loss) $5,824 $(11,220) $(10,360) $(33,466)

Unrealized gains on
available-for-sale
financial assets 342 20 1,327 62

Reclassification
adjustment for gain
and losses on
available-for-sale
financial assets (48) - (118) -

--------------------------------------------------------------------
Comprehensive
earnings (loss) $6,118 $(11,200) $(9,151) $(33,404)
--------------------------------------------------------------------
--------------------------------------------------------------------

See accompanying notes to unaudited consolidated financial statements.



THERATECHNOLOGIES INC.
Consolidated Statements of Shareholders' Equity
(Unaudited)

Nine-month period ended August 31, 2009
(in thousands of dollars)

Accumulated
other
Capital stock Contri- compre-
---------------- buted 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
4 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.



Nine-month period ended August 31, 2008
(in thousands of dollars)

Accumulated
other
compre-
Capital stock Contri- hensive
---------------- buted income
Number Dollars surplus (Loss) Deficit Total
------------------------------------------------------------------------

Balance,
November
30, 2007 54,531,133 $238,842 $4,807 $(333) $(177,339) $65,977

Change in
accounting
policies
(note 2 (a)) - - - - (941) (941)

Issuance of
share
capital 3,503,671 29,778 - - - 29,778

Share issue
costs - - - - (1,938) (1,938)

Exercise of
stock options:
Cash
proceeds 119,666 397 - - - 397
Ascribed value - 81 (81) - - -

Stock-based
compensation - - 678 - - 678

Net loss - - - - (33,466) (33,466)

Unrealized
gains on
available-
for-sale
financial
assets - - - 62 - 62

------------------------------------------------------------------------
Balance,
August 31,
2008 58,154,470 $269,098 $5,404 $(271) $(213,684) $60,547
------------------------------------------------------------------------
------------------------------------------------------------------------

See accompanying notes to unaudited consolidated financial statements.



THERATECHNOLOGIES INC.
Consolidated Statements of Cash Flows
(Unaudited)

Periods ended August 31, 2009 and 2008
(in thousands of dollars)

--------------------------------------------------------------------
--------------------------------------------------------------------
August 31, August 31,
--------------------------------------------------------------------
2009 2008 2009 2008
--------------------------------------------------------------------
(Restated (Restated -
note 2 (a)) note 2 (a))
(3 months) (9 months)

Cash flows from
operating activities:
Net earnings
(net loss) $5,824 $(11,220) $(10,360) $(33,466)
Adjustments for:
Amortization
of property
and equipment 157 156 441 465
Amortization of
other assets - 97 - 290
Stock-based
compensation 205 217 705 678
--------------------------------------------------------------------
6,186 (10,750) (9,214) (32,033)

Changes in
operating assets
and liabilities:
Interest
receivable
on bonds 74 105 (728) 186
Accounts receivable 56 (270) 415 (114)
Tax credits
receivable (293) 1,159 (1,383) (31)
Stocks - - (1,594) -
Research supplies 1,797 357 2,023 1,080
Prepaid expenses (200) 197 (326) (92)
Accounts payable
and accrued
liabilities (922) (306) (2,590) 2,441
Deferred revenues (1,715) - 22,252 -
--------------------------------------------------------------------
(1,203) 1,242 18,069 3,470

--------------------------------------------------------------------
4,983 (9,508) 8,855 (28,563)

Cash flows from
financing activities:
Share issuance - 111 9,861 30,175
Share issue costs - (204) (8) (1,907)
--------------------------------------------------------------------
- (93) 9,853 28,268

Cash flows from
investing activities:
Addition to property
and equipment (55) (34) (290) (270)
Acquisition of bonds - - (19,631) (13,172)
Disposal of bonds 3,963 11,268 13,805 20,774
--------------------------------------------------------------------
3,908 11,234 (6,116) 7,332

--------------------------------------------------------------------
Net change in cash 8,891 1,633 12,592 7,037

Cash, beginning
of period 3,834 7,982 133 2,578

--------------------------------------------------------------------
Cash, end of period $12,725 $9,615 $12,725 $9,615
--------------------------------------------------------------------
--------------------------------------------------------------------

See note 5 (a) for supplemental cash flow information.

See accompanying notes to unaudited consolidated financial statements.


THERATECHNOLOGIES INC.
Notes to Consolidated Financial Statements
(Unaudited)

Periods ended August 31, 2009 and 2008
(in thousands of dollars, except per share amounts)


1. Basis of presentation:

The financial statements included in this report are unaudited and reflect normal and recurring adjustments which are, in the opinion of the Company, considered necessary for a fair presentation of its results. These financial statements have been prepared in conformity with Canadian generally accepted accounting principles. The same accounting policies as described in the Company's latest annual report have been used, except as described in note 2 below. However, these financial statements do not include all disclosures required under generally accepted accounting principles and, accordingly, should be read in connection with the financial statements and the notes thereto included in the Company's latest annual report. These interim financial statements have not been reviewed by 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 has 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 as well as clarifying the application of the concept of matching revenues and expenses, whether these assets are separately acquired or internally developed. The impact of adopting this standard has been to increase the opening deficit and to reduce other assets at December 1st of 2007 and 2008 by $941 and $599, respectively, which is the amount of patent costs related to periods prior to these dates. Furthermore, following the adoption of this standard, patents and amortization of other assets presented on the consolidated statements of earnings were reduced by $47 for the nine-month period ended August 31, 2008.

Inventories

Effective with the commencement of its 2009 fiscal year, the Company adopted CICA Section 3031, Inventories, which replaces Section 3030 and harmonizes the Canadian standards related to inventories with International Financial Reporting Standards (IFRS). This Section provides changes to the measurement and more extensive guidance on the determination of cost, including allocation of overhead; narrows the permitted cost formulas; requires impairment testing; and expands the disclosure requirements to increase transparency. As the Company had no inventories on November 30, 2008, the adoption of this section had no impact on the Company's consolidated financial statements.

(b) Future accounting changes:

International Financial Reporting Standards

In February 2008, Canada's Accounting Standards Board of Canada ("AcSB") confirmed that Canadian GAAP, as used by publicly accountable enterprises, would be fully converged into IFRS, as issued by the International Accounting Standards Board ("IASB"). The changeover date is for interim and annual financial statements relating to fiscal years beginning on or after January 1, 2011. As a result, the Company will be required to report under IFRS for its 2012 interim and annual financial statements. The Company will convert to these new standards according to the timetable set within these new rules. The Company has not determined the impact of adopting the standards on its consolidated financial statements.

3. Other assets:



--------------------------------------------------------------
--------------------------------------------------------------
November 30,
2008
--------------------------------------------------------------
(Restated -
note 2 (a))

Accumulated Net book
Cost amortization value
--------------------------------------------------------------
Intellectual property $7,670 $7,670 $-
Research supplies 2,751 - 2,751
Other assets 25 - 25

--------------------------------------------------------------
$10,446 $7,670 $2,776
--------------------------------------------------------------
--------------------------------------------------------------


4. Capital stock:

Under the terms of the agreement with EMD Serono Inc., the Company issued 2,179,837 common shares for a cash consideration of $9,854 (see note 7).

During the second quarter of 2009, the Company received subscriptions in the amount of $7 for the issue of 2,550 common shares in connection with its share purchase plan.

(a) Share option plan:

Changes in outstanding options granted under the Company's stock option plan for the year ended November 30, 2008 and the nine-month period ended August 31, 2009 were as follows:



-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted
average
Number exercise price
-------------------------------------------------------------------------

Options as at November 30, 2007 (audited) 2,207,633 $6.32
Granted 111,000 7.98
Exercised (119,666) 3.32
Cancelled (37,167) 9.57

-------------------------------------------------------------------------
Options as at November 30, 2008 (audited) 2,161,800 6.52

Granted 660,500 1.80
Cancelled and expired (141,834) 7.89

-------------------------------------------------------------------------
Options as at August 31, 2009 2,680,466 $5.28
-------------------------------------------------------------------------
-------------------------------------------------------------------------


(b) Stock-based compensation and other stock-based payments:

The fair value of the options granted was estimated at the date of grant using the Black-Scholes option pricing model with the following weighted average assumptions:



---------------------------------------------------------
---------------------------------------------------------
2009 2008
---------------------------------------------------------

Risk-free interest rate 1.80% 3.41%
Volatility 79% 70%
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, and the term of the option and the length of time of similar grants have remained outstanding in the past. Dividend yield was excluded from the calculation, since it is the present policy of the Company to retain all earnings to finance operations and future growth.

The following table summarizes the weighted average fair value of stock options granted during the periods ended August 31, 2009 and 2008:


-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted average
Number of grant-date
options fair value
-------------------------------------------------------------------------

Periods ended August 31 (3 months)
2009 - $-
2008 - -
Periods ended August 31 (9 months)
2009 660,500 $1.24
2008 101,000 5.45

-------------------------------------------------------------------------
-------------------------------------------------------------------------


(C) Diluted (earnings) loss per share:

The following table presents a reconciliation between basic and diluted earnings (loss) per share:



--------------------------------------------------------------------
--------------------------------------------------------------------
August 31, August 31,
2009 2008 2009 2008
--------------------------------------------------------------------
(3 months) (9 months)

Basic earnings (loss)
per share:
Basic weighted
average number of
common shares
outstanding 60,397,477 58,145,358 60,284,591 57,167,178

--------------------------------------------------------------------
Basic earnings
(loss) per share $0.10 $(0.19) $(0.17) $(0.59)
--------------------------------------------------------------------
--------------------------------------------------------------------

Diluted earnings
(loss) per share:
Basic weighted
average number of
common shares
outstanding 60,397,477 58,145,358 60,284,591 57,167,178
Plus impact of
stock options 237,498 - - -

--------------------------------------------------------------------
Diluted weighted
average number
of common shares
outstanding 60,634,975 58,145,358 60,284,591 57,167,178
--------------------------------------------------------------------
--------------------------------------------------------------------

Diluted earnings
(loss) per share $0.10 $(0.19) $(0.17) $(0.59)
--------------------------------------------------------------------
--------------------------------------------------------------------


Furthermore, 1,380,833 options (2008 - 646,500) could have an effect on the calculation in the future, since their exercise prices were higher than the average market price during the reporting periods of 2009 and 2008.


5. Supplemental information:

(a) The following transactions were conducted by the Company and did not impact cash flows:



----------------------------------------------------------------------
----------------------------------------------------------------------
August 31, November 30,
2009 2008
----------------------------------------------------------------------
(Restated -
note 2 (a))

Additions to property and equipment
included in accounts payable and
accrued liabilities $28 $48

Share issue costs included in accounts
payable and accrued liabilities - 8

----------------------------------------------------------------------
----------------------------------------------------------------------


(b) For the nine-month period ended August 31, 2009, the Company has reclassified in net earnings $118 of realized gains on available-for-sale financial assets previously recorded in accumulated other comprehensive income (2008 - nil).

(C) For the periods ended August 31, 2009, the research and development expenses include a charge of $1,395 associated with the write-down of research supplies produced to obtain stability data and to validate the commercial production process, as requested by the US Food and Drug Administration ("FDA").

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 prices quoted on active markets.

(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 $580 (gain of $63 in 2008) for the nine-month period ended August 31, 2009.

7. Collaboration and licensing agreement:

On October 28, 2008, the Company entered into a collaboration and licensing agreement with EMD Serono, Inc., an affiliate of Merck KGaA, regarding the exclusive commercialization rights of tesamorelin in the United States for the treatment of excess abdominal fat in HIV patients with lipodystrophy (the "Initial Product"). Theratechnologies retains all tesamorelin commercialization rights outside of the US.

Under the terms of the agreement, the Company is responsible for the development of the Initial Product up to obtaining marketing approval in the United States. The Company is also responsible for product production and for the development of a new formulation of the initial product. EMD Serono is responsible for conducting product commercialization activities.

At the closing of the agreement, on December 15, 2008, the Company received US$30,000 (CAD$36,951) which includes an initial payment of US$22,000 (CAD$27,097) and US$8,000 (CAD$9,854) as a subscription for common shares in the Company by Merck KGaA at a price of US$3.67 (CAD$4.52) per share. The Company may receive up to US$215,000 (CAD$265,000), which amount includes the initial payment of US$22,000, the equity investment of US$8,000, as well as payments based on the achievement of certain development, regulatory and sales milestones. The Company will also be entitled to receive escalating royalties on annual net sales of tesamorelin in the US.

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, 2009, an amount of $4,849 related to this transaction was recognized as revenue. At August 31, 2009, the deferred revenues related to this transaction amounted to $22,248.

On August 12, 2009, the FDA accepted to file the New Drug Application ("NDA") made by the Company for its lead compound tesamorelin. Under the terms of the Company's collaboration and licensing agreement with EMD Serono, the acceptance to file tesamorelin NDA is associated with a payment of US$10,000 (CAN$10,884). This milestone payment has been recorded in the third quarter of 2009.

The Company may conduct research and development for additional indications. EMD Serono will have the option to commercialize additional indications for tesamorelin in the US. If it exercises this option, EMD Serono will pay half of the development costs related to such additional indications. In such cases, the Company will also have the right, subject to EMD Serono's agreement, to participate in the promotion of the additional indications.

8. Comparative figures:

Certain of the 2008 comparative figures have been reclassified to conform with the financial statement presentation adopted in 2009.

Contact Information

  • Theratechnologies Inc.
    Andrea Gilpin
    Vice President, IR & Communications
    514-336-7800, ext. 205
    communications@theratech.com
    or
    Theratechnologies Inc.
    Luc Tanguay
    Senior Executive Vice President and
    Chief Financial Officer
    514-336-7800, ext. 204
    ltanguay@theratech.com