EX-99.1 2 d330324dex991.htm EXHIBIT 99.1 Exhibit 99.1

Exhibit 99.1

Consolidated Financial Statements of

(Unaudited)

THERATECHNOLOGIES INC.

Three-month periods ended February 29, 2012 and February 28, 2011


THERATECHNOLOGIES INC.

Consolidated Financial Statements

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

 

Financial Statements

  

Consolidated Statements of Financial Position

     1   

Consolidated Statements of Comprehensive Income

     2   

Consolidated Statements of Changes in Equity

     3   

Consolidated Statements of Cash Flows

     5   

Notes to the Consolidated Financial Statements

     6   


THERATECHNOLOGIES INC.

Consolidated Statements of Financial Position

(Unaudited)

As at February 29, 2012 and November 30, 2011

(in thousands of Canadian dollars)

 

 

     Note      February 29,
2012
    November 30,
2011
 
            $     $  

Assets

       

Current assets:

       

Cash

        63        2,559   

Bonds

        3,590        752   

Trade and other receivables

     6         336        1,784   

Tax credits and grants receivable

        429        346   

Inventories

     7         13,572        10,332   

Prepaid expenses

        1,460        2,308   

Derivative financial assets

     9 (a)         651        347   
     

 

 

   

 

 

 

Total current assets

        20,101        18,428   
     

 

 

   

 

 

 

Non-current assets:

       

Bonds

        24,807        33,476   

Property and equipment

        833        969   
     

 

 

   

 

 

 

Total non-current assets

        25,640        34,445   
     

 

 

   

 

 

 

Total assets

        45,741        52,873   
     

 

 

   

 

 

 

Liabilities

       

Current liabilities:

       

Accounts payable and accrued liabilities

     8         4,614        7,129   

Provisions

     10 (b)         771        52   

Derivative financial liabilities

        —          16   

Current portion of deferred revenue

     4         4,287        4,279   
     

 

 

   

 

 

 

Total current liabilities

        9,672        11,476   
     

 

 

   

 

 

 

Non-current liabilities:

       

Provisions

     10 (b)         3,460        —     

Other liabilities

        320        775   

Deferred revenue

     4         3,209        4,279   
     

 

 

   

 

 

 

Total non-current liabilities

        6,989        5,054   
     

 

 

   

 

 

 

Total liabilities

        16,661        16,530   
     

 

 

   

 

 

 

Equity

       

Share capital

        280,788        280,488   

Contributed surplus

        8,202        8,242   

Deficit

        (260,330     (252,846

Accumulated other comprehensive income

        420        459   
     

 

 

   

 

 

 

Total equity

        29,080        36,343   
     

 

 

   

 

 

 

Contingent liability

     11        

Commitments

     12        

Subsequent events

     13        
     

 

 

   

 

 

 

Total liabilities and equity

        45,741        52,873   
     

 

 

   

 

 

 

See accompanying notes to unaudited consolidated financial statements.

 

1


THERATECHNOLOGIES INC.

Consolidated Statements of Comprehensive Income

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

     Note      February 29,
2012
    February 28,
2011
 
            $     $  

Revenue:

       

Sale of goods

     4         1,279        1,798   

Research services:

       

Upfront payments and initial technology access fees

     4         1,070        1,711   

Royalties and license fees

     4         841        9   
     

 

 

   

 

 

 

Total revenue

        3,190        3,518   
     

 

 

   

 

 

 

Cost of sales

     5         1,337        2,595   

Research and development expenses, net of tax credits of $83 (2011 - $153)

        1,313        2,993   

Selling and market development expenses

        261        477   

General and administrative expenses

        2,043        3,215   

Restructuring costs

     10 (b)         6,058          
     

 

 

   

 

 

 

Total operating expenses

        11,012        9,280   
     

 

 

   

 

 

 

Results from operating activities

        (7,822     (5,762

Finance income

        277        372   

Finance costs

        67        (577
     

 

 

   

 

 

 

Total net finance income (costs)

        344        (205
     

 

 

   

 

 

 

Net loss before income taxes

        (7,478     (5,967
     

 

 

   

 

 

 

Income tax (expense) recovery

        (6     35   
     

 

 

   

 

 

 

Net loss

        (7,484     (5,932
     

 

 

   

 

 

 

Other comprehensive income (loss), net of tax:

       

Net change in fair value of available-for-sale financial assets, net of tax

        7        (324

Net change in fair value of available-for-sale financial assets transferred to net loss, net of tax

        (46     (16
     

 

 

   

 

 

 
        (39     (340
     

 

 

   

 

 

 

Total comprehensive loss for the period

        (7,523     (6,272
     

 

 

   

 

 

 

Basic and diluted loss per share

     9 (c)         (0.12     (0.10
     

 

 

   

 

 

 

See accompanying notes to unaudited consolidated financial statements.

 

2


THERATECHNOLOGIES INC.

Consolidated Statements of Changes in Equity

(Unaudited)

Three-month period ended February 29, 2012

(in thousands of Canadian dollars)

 

     Note      Share capital      Contributed
surplus
    Unrealized
gains or
losses on
available-
for-sale
financial
assets(i)
    Deficit     Total  
        Number      Dollars           
                   $      $     $     $     $  

Balance as at November 30, 2011

        60,865,266         280,488         8,242        459        (252,846     36,343   
     

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss for the period:

                 

Net loss

        —          —          —         —          (7,484     (7,484

Other comprehensive loss:

                 

Net change in fair value of available-for-sale financial assets, net of tax

        —          —          —          7       —          7   

Net change in fair value of available-for-sale financial assets transferred to net loss, net of tax

        —          —          —          (46     —          (46
     

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss for the period

        —          —          —         (39     (7,484     (7,523
     

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Transactions with owners, recorded directly in equity:

                 

Share-based compensation plan:

                 

Share-based compensation for stock option plan

     9 (b)         —          —          71        —         —         71   

Exercise of stock options:

                 

Monetary consideration

     9 (b)         104,503         189         —          —          —          189   

Attributed value

     9 (b)         —          111         (111     —         —         —    
     

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total contributions by owners

        104,503         300         (40     —         —         260   
     

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Balance as at February 29, 2012

        60,969,769         280,788         8,202        420        (260,330     29,080   
     

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

 

(i) 

Accumulated other comprehensive income.

See accompanying notes to unaudited consolidated financial statements.

 

3


THERATECHNOLOGIES INC.

Consolidated Statements of Changes in Equity, Continued

(Unaudited)

Three-month period ended February 28, 2011

(in thousands of Canadian dollars)

 

     Share capital      Contributed
surplus
    Unrealized
gains  or
losses  on
available-
for-sale
financial
assets(i)
    Deficit     Total  
   Number      Dollars           
            $      $     $     $     $  

Balance as at November 30, 2010

     60,512,764         279,398         7,808        566        (235,116     52,656   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss for the period:

              

Net loss

     —          —          —         —         (5,932     (5,932

Other comprehensive loss:

              

Net change in fair value of available-for-sale financial assets, net of tax

     —          —          —         (324     —         (324

Net change in fair value of available-for-sale financial assets transferred to net loss, net of tax

     —          —          —         (16     —          (16
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss for the period

     —          —          —         (340     (5,932     (6,272
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Transactions with owners, recorded directly in equity:

              

Share-based compensation plan:

              

Share-based compensation for stock option plan

     —          —          427        —         —         427   

Exercise of stock options:

              

Monetary consideration

     3,000         5         —         —         —         5   

Attributed value

     —          4         (4     —         —         —    
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total contributions by owners

     3,000         9         423        —         —         432   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Balance as at February 28, 2011

     60,515,764         279,407         8,231        226        (241,048     46,816   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

 

(i) 

Accumulated other comprehensive income.

See accompanying notes to unaudited consolidated financial statements.

 

4


THERATECHNOLOGIES INC.

Consolidated Statements of Cash Flows

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars)

 

     Note    February 29,
2012
    February 28,
2011
 
          $     $  

Operating activities:

       

Net loss

        (7,484     (5,932

Adjustments for:

       

Depreciation of property and equipment

        88        67   

Write-down of property and equipment

        49        —     

Share-based compensation for stock option plan

   9 (b)      71        427   

Income tax expense (recovery)

        6        (35

Write-down of inventories

   7      8        375   

Lease inducements and amortization

        (455     126   

Change in fair value of derivative financial assets

   9 (a)      (57     116   

Change in fair value of liability related to the deferred stock unit plan

   9 (a)      54        (93

Change in fair value of derivative financial liabilities

        (16     —     
     

 

 

   

 

 

 

Operating activities before changes in operating assets and liabilities

        (7,736     (4,949

Change in accrued interest income on bonds

        222        (234

Change in trade and other receivables

        1,448        (1,232

Change in tax credits and grants receivable

        (83     (153

Change in inventories

        (3,248     (672

Change in prepaid expenses

        848        322   

Change in accounts payable and accrued liabilities

        (2,497     866   

Change in provisions

        4,179        —     

Change in deferred revenue

        (1,062     (1,712
     

 

 

   

 

 

 
       

 

(193

 

 

   

 

(2,815

 

 

     

 

 

   

 

 

 

Cash flows used in operating activities

        (7,929     (7,764

Financing activities:

       

Proceeds from exercise of stock options

        189        5   
     

 

 

   

 

 

 

Cash flows from financing activities

        189        5   

Investing activities:

       

Acquisition of property and equipment

        (73     (41

Proceeds from sale of bonds

        5,564        8,579   

Acquisition of bonds

        —          (26,059

Prepayment of derivative financial assets

        (247     (837
     

 

 

   

 

 

 

Cash flows from (used in) investing activities

 

       

 

5,244

 

  

 

   

 

(18,358

 

 

     

 

 

   

 

 

 

Net change in cash

        (2,496     (26,117

Cash as at December 1

 

       

 

2,559

 

  

 

   

 

26,649

 

  

 

     

 

 

   

 

 

 

Cash as at February 29 and February 28

        63        532   
     

 

 

   

 

 

 

See note 10 for supplemental information.

See accompanying notes to unaudited consolidated financial statements.

 

5


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

1. Reporting entity:

Theratechnologies Inc. is a specialty pharmaceutical company that discovers and develops innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor (“GRF”) peptides.

The 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 incorporated under Part 1A of the Québec Companies Act and is domiciled in Québec, Canada. The Company is located at 2310 boul. Alfred-Nobel, Montréal, Québec, H4S 2B4.

 

2. Basis of preparation:

 

  (a) Accounting framework:

These unaudited consolidated interim financial statements (“interim financial statements”), including comparative figures, have been prepared using accounting policies consistent with International Financial Reporting Standards (“IFRS”) as prescribed by the International Accounting Standards Board (“IASB”) and in accordance with International Accounting Standard (“IAS”) 34 - Interim Financial Reporting (“IAS 34”).

Certain information, in particular the accompanying notes normally included in the annual financial statements prepared in accordance with IFRS, has been omitted or condensed. These interim financial statements do not include all disclosures required under IFRS and, accordingly, should be read in conjunction with the annual financial statements for the year ended November 30, 2011 and the notes thereto.

 

  (b) 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 audited annual financial statements as at November 30, 2011.

Other new or amended accounting standards also had no impact on the Company’s accounting methods.

 

  (c) Basis of measurement:

The Company’s consolidated financial statements have been prepared on a going concern and historical cost basis, except for available-for-sale financial assets, derivative financial assets, liabilities related to the deferred stock unit plan and derivative financial liabilities, which are measured at fair value.

 

6


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

2. Basis of preparation (continued):

 

  (d) Use of estimates and judgements:

The preparation of the Company’s interim financial statements in conformity with IFRS requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.

Information about critical judgements in applying accounting policies and assumption and estimation uncertainties that have the most significant effect on the amounts recognized in the consolidated financial statements is noted below:

 

   

Revenue and deferred revenue:

Revenue recognition is subject to critical judgements, particularly in collaboration agreements that include multiple deliverables, as judgement is required in allocating revenue to each component, including upfront payments, milestone payments, research services, royalties and license fees and sale of goods.

 

   

Stock option plan:

There is estimation uncertainty with respect to selecting inputs to Black-Scholes model used to determine the fair value of the stock options.

 

   

Income taxes:

In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income. The generation of future taxable income is dependent on the successful commercialization of the Company’s products and technologies.

 

   

Contingent liability:

Management uses judgment in assessing the possibility of any outflow in settlement of contingent liabilities.

Other areas of judgement and uncertainty relate to the estimation of accruals for clinical trial expenses, the recoverability of inventories, the measurement of the amount and assessment of the recoverability of tax credits and grants receivable and capitalization of development expenditures.

 

7


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

2. Basis of preparation (continued):

 

  (d) Use of estimates and judgements (continued):

Reported amounts and note disclosure reflect the overall economic conditions that are most likely to occur and anticipated measures management intends to take. Actual results could differ from those estimates.

The above estimates and assumptions are reviewed regularly. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.

 

  (e) Functional and presentation currency:

These interim consolidated financial statements are presented in Canadian dollars, which is the Company’s functional currency. All financial information presented in Canadian dollars has been rounded to the nearest thousand.

 

3. Upcoming changes in accounting standards:

 

  (a) Amendments to existing standards:

Annual improvements to IFRS:

The IASB’s improvements to IFRS contain seven amendments that result in accounting changes for presentation, recognition or measurement purposes. The most significant features of the IASB’s annual improvements project published in May 2010 which are applicable for annual period beginning on or after January 1, 2011 with partial adoption permitted are included under the specific revisions to standards discussed below.

 

  (i) IFRS 7:

Amendment to IFRS 7, Financial Instruments: Disclosures:

Multiple clarifications related to the disclosure of financial instruments and in particular in regards to transfers of financial assets.

 

  (ii) IAS 1:

Amendment to IAS 1, Presentation of Financial Statements:

Entities may present the analysis of the components of other comprehensive income either in the statement of changes in equity or within the notes to the financial statements.

 

8


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

3. Upcoming changes in accounting standards (continued):

 

  (a) Amendments to existing standards (continued):

Annual improvements to IFRS (continued):

 

  (iii) IAS 24:

Amendment to IAS 24, Related Party Disclosures:

There are limited differences in the definition of what constitutes a related party; however, the amendment requires more detailed disclosures regarding commitments.

 

  (iv) IAS 34:

Amendment to IAS 34, Interim Financial Reporting:

The amendments place greater emphasis on the disclosure principles for interim financial reporting involving significant events and transactions, including changes to fair value measurements and the need to update relevant information from the most recent annual report.

The adoption of these amendments to existing standards had no impact on the consolidated financial statements.

 

  (b) New or revised standards and interpretations issued but not yet adopted:

In addition, the following new or revised standards and interpretations have been issued but are not yet applicable to the Company:

 

  (i) IFRS 9, Financial Instruments:

Effective for annual periods beginning on or after January 1, 2015, with earlier adoption permitted.

Applies to the classification and measurement of financial assets and liabilities. It is the first of three phases of a project to develop standards to replace IAS 39, Financial Instruments.

 

  (ii) IFRS 10, Consolidated Financial Statements:

Effective for annual periods beginning on or after January 1, 2013, with earlier adoption permitted.

Establishes principles for the presentation and preparation of consolidated financial statements when an entity controls one or more other entities. IFRS 10 replaces the consolidation requirements in SIC-12, Consolidation - Special Purpose Entities, and IAS 27, Consolidated and Separate Financial Statements.

 

9


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

3. Upcoming changes in accounting standards (continued):

 

  (b) New or revised standards and interpretations issued but not yet adopted (continued):

 

  (iii) IFRS 13, Fair Value Measurement:

Effective for annual periods beginning on or after January 1, 2013, with earlier adoption permitted.

Provides new guidance on fair value measurement and disclosure requirements.

The Company has not yet determined the impact of these amendments to existing standards on the consolidated financial statements.

 

4. Revenue and deferred revenue:

 

  (a) EMD Serono Inc.:

On October 28, 2008, the Company entered into a collaboration and licensing agreement with EMD Serono Inc. (“EMD Serono”), an affiliate of the Group 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”).

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, which was obtained on November 10, 2010. The Company is also responsible for product production and for developing 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 ($36,951), which included an initial payment of US$22,000 ($27,097) and US$8,000 ($9,854) as a subscription for common shares in the Company by Merck KGaA at a price of US$3.67 ($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.

Royalties on sales are paid quarterly in arrears based on the calendar quarter and, in each year, the royalty rate increases once a pre-agreed level of sales is reached. For the three-month period ended February 29, 2012, an amount of $836 (2011 –$4) was recognized as royalty revenue in relation to the sales period from October 1, 2011 to December 31, 2011.

 

10


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

4. Revenue and deferred revenue (continued):

 

  (a) EMD Serono Inc. (continued):

For the three-month period ended February 29, 2012, an amount of $1,279 (2011 – $1,798) was recognized as sale of goods to EMD Serono.

The initial payment of $27,097 has been deferred and is being amortized on a straight-line basis over the estimated period for developing a new formulation of the Initial Product. This period may be modified in the future based on additional information that may be received by the Company. In April 2011, further development work has caused the Company to extend the services period to year-end 2013 rather than year-end 2012. For the three-month period ended February 29, 2012, an amount of $1,070 (2011 – $1,711) was recognized as revenue. As at February 29, 2012, the deferred revenue related to this transaction amounted to $7,488 (November 30, 2011 – $8,558).

The Company may conduct research and development activities 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 an agreement with EMD Serono, to participate in promoting these additional indications.

 

  (b) Sanofi-aventis:

On December 6, 2010, the Company announced the signing of a distribution and licensing agreement with Sanofi-aventis (“Sanofi”), covering the commercial rights for EGRIFTATM in Latin America, Africa, and the Middle East for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.

Under the terms of the agreement, the Company will sell EGRIFTATM to Sanofi at a transfer price equal to the higher of a percentage of Sanofi’s net selling price and a predetermined floor price. The Company has retained all future development rights to EGRIFTATM and will be responsible for conducting research and development for any additional clinical programs. Sanofi will be responsible for conducting all regulatory activities for EGRIFTATM in the aforementioned territories, including applications for approval in the different countries for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The Company also granted Sanofi an option to commercialize tesamorelin for other indications in the territories mentioned above. If such option is not exercised, or is declined, by Sanofi, the Company may commercialize tesamorelin for such indications on its own or with a third party.

No revenue was recognized for the three-month period ended February 29, 2012 under this agreement.

 

11


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

4. Revenue and deferred revenue (continued):

 

  (c) Ferrer Internacional S.A.:

On February 3, 2011, the Company entered into a distribution and licensing agreement with Ferrer Internacional S.A. (“Ferrer”) covering the commercial rights for EGRIFTATM for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in Europe, Russia, South Korea, Taiwan, Thailand and certain central Asian countries.

Under the terms of the agreement, the Company will sell EGRIFTATM to Ferrer at a transfer price equal to the higher of a significant percentage of the Ferrer’s net selling price and a predetermined floor price. The Company has retained all development rights to EGRIFTATM for other indications and will be responsible for conducting research and development for any additional programs. Ferrer will be responsible for conducting all regulatory and commercialization activities in connection with EGRIFTATM for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in the territories mentioned above. The Company will be responsible for the manufacture and supply of EGRIFTATM to Ferrer. The Company has the option to co-promote EGRIFTATM for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy in the territories. Ferrer has the option to enter into a co-development and commercialization agreement using tesamorelin relating to any such new indications. The terms and conditions of such a co-development and commercialization agreement will be negotiated based on any additional program chosen for development.

No revenue was recognized for the three-month period ended February 29, 2012 under this agreement.

 

  (d) Actelion Pharmaceuticals Canada Inc.:

On February 20, 2012, the Company entered into a supply, distribution and licensing agreement (the “Agreement”) with Actelion Pharmaceuticals Canada Inc. (“Actelion”) for the commercialization rights to tesamorelin in Canada for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.

 

12


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

4. Revenue and deferred revenue (continued):

 

  (d) Actelion Pharmaceuticals Canada Inc. (continued):

Under terms of the Agreement, the Company will sell tesamorelin to Actelion at a transfer price equal to the higher of a percentage of Actelion’s net selling price and a predetermined floor price. Actelion will be responsible for conducting all regulatory and commercialization activities for tesamorelin for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy in Canada subject to the Agreement. The Company will be responsible for the manufacture and supply of tesamorelin to Actelion. The Company has retained all development rights to tesamorelin for other indications and will be responsible for conducting development activities for any additional potential indications. The Company also granted Actelion an option to commercialize tesamorelin for other indications in Canada. If such option is not exercised, or is declined, by Actelion, the Company may commercialize tesamorelin for such indications on its own or with a third party.

No revenue was recognized for the three-month period ended February 29, 2012 under the Agreement.

 

5. Cost of sales:

 

     Note      February 29,
2012
     February 28,
2011
 
            $      $  

Cost of goods sold

        1,203         1,798   

Other costs

        84         164   

Write-down of inventories

     7         8         375   

Production development costs

        42         258   
     

 

 

    

 

 

 
        1,337         2,595   
     

 

 

    

 

 

 

 

13


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

6. Trade and other receivables:

 

     February 29,
2012
     November 30,
2011
 
     $      $  

Trade receivables

     4         1,364   

Sales tax receivable

     112         227   

Loans granted to employees under the share purchase plan

     7         10   

Other receivables

     213         183   
  

 

 

    

 

 

 
     336         1,784   
  

 

 

    

 

 

 

 

7. Inventories:

 

     February 29,
2012
     November 30,
2011
 
     $      $  

Raw materials

     9,633         5,751   

Work in progress

     1,241         1,096   

Finished goods

     2,698         3,485   
  

 

 

    

 

 

 
     13,572         10,332   
  

 

 

    

 

 

 

During the three-month period ended February 29, 2012, the Company recorded an inventory provision of $8 over raw materials (2011 – $109), nil over work in progress (2011 – $132) and nil over finished goods (2011 – $134) to write down their value to their estimated net realizable value. The net inventory provision of $8 (2011 – $375) was recorded in cost of sales.

The write-down of 2011 was due to pricing related to raw materials that were originally purchased under research and development conditions and not under the Company’s current long-term procurement agreements.

 

14


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

8. Accounts payable and accrued liabilities:

 

     Note     February 29,
2012
     November 30,
2011
 
           $      $  

Trade payables

       2,004         3,429   

Accrued liabilities and other payables

       1,140         1,314   

Salaries and benefits due to related parties

       392         724   

Employee salaries and benefits payable

       444         1,332   

Liability related to the deferred stock unit plan

     (a)      634         330   
    

 

 

    

 

 

 
       4,614         7,129   
    

 

 

    

 

 

 

 

9. Share capital:

 

  (a) Deferred stock unit plan:

On December 10, 2010, the Board of Directors adopted a deferred stock unit plan (the “DSU Plan”) for the benefit of its directors and officers (the “Beneficiaries”). The goal of the DSU Plan is to increase the Company’s ability to attract and retain high-quality individuals to act as directors or officers and better align their interests with those of the shareholders of the Company in the creation of long-term value. Under the terms of the DSU Plan, Beneficiaries who are directors are entitled to elect to receive all or part of their annual retainer to act as directors and Chair of the Board in DSU. Beneficiaries who act as officers are entitled to elect to receive all or part of their annual bonus, if any, in DSU. The value of a DSU (the “DSU Value”) is equal to the average closing price of the common shares on The Toronto Stock Exchange on the date on which a Beneficiary determines that he desires to receive or redeem DSU and during the four (4) previous trading days. Beneficiaries who act as directors must elect to receive DSU before December 23 of a calendar year for the ensuing calendar year, whereas Beneficiaries who act as officers must make that election within 48 hours after having been notified of their annual bonus. For the purposes of granting DSU, the DSU Value for directors is determined as at December 31 of a calendar year and the DSU Value for officers is determined on the second business day after they have been notified of their annual bonus.

 

15


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

9. Share capital (continued):

 

  (a) Deferred stock unit plan (continued):

DSU may only be redeemed when a Beneficiary ceases to act as a director or an officer of the Company. Except that under the terms of the employment agreement of the president and chief executive officer of the Company, he may require that his DSU be redeemed after three (3) years from the date the DSU were granted. Upon redemption, the Company must provide a Beneficiary with an amount in cash equal to the DSU Value on the Redemption Date. Beneficiaries may not sell, transfer or otherwise assign their DSU or any rights associated therewith other than by will or in accordance with legislation regarding the vesting and partition of successions.

The DSU are totally vested at the grant date. In the case of the DSU granted to officers for annual bonuses, a DSU liability is recorded at the grant date in place of the liability for the bonuses payments. In the case of the directors, the expense related to DSU and their liabilities are recognized at the grant date. During the three-month period ended February 29, 2012, $250 (2011 – $494) was recorded as an expense and is included in general and administrative expenses. At the beginning of the year, amounts due to officers totalling nil (2011 – $300) were settled with the issuance of DSU. The liability related to the DSU is adjusted periodically to reflect any change in market value of common shares. During the three-month period ended February 29, 2012, a loss of $54 (2011 – gain of $93) was recognized due to the change in the fair value of DSU. This loss is included in gain (loss) on financial instruments carried at fair value. As at February 29, 2012, the Company has a total of 248,697 DSU outstanding (November 30, 2011 – 143,655) and a liability related to the DSU of $634 (November 30, 2011 – $330).

 

16


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

9. Share capital (continued):

 

  (a) Deferred stock unit plan (continued):

To protect against fluctuations in the value of the DSU, the Company entered into two cash settled forward stock contracts in the first quarter of 2011 ($580 for the first and $257 for the second; these amounts correspond to 146,875 common shares of the Company at a price of $5.69 and $5.72, respectively). The contracts initially expired in December 2011. On December 2, 2011, the two cash settled forward stock contracts have been amended to expire in November 2012. They were not designated as hedging instruments for accounting purposes. The Company entered into another cash settled forward contract in December 2011. The Company paid $247 as advance payment on the contract. This amount corresponds to 101,822 common shares of the Company at a price of $2.42. Changes in fair value of these contracts are, therefore, included in gain (loss) on financial instruments carried at fair value in the period in which they occur. In connection with these forward stock contracts, the Company invested $1,084 in term deposits, as advance payments, with the same counterparty, such term deposits maturing at the same time as the cash settled forward stock contracts. During the three-month period ended February 29, 2012, a gain of $57 (2011 - loss of $116) related to the change in the fair value of derivative financial assets was recognized. As at February 29, 2012, the fair value of cash settled forward stock contracts was $651 (November 30, 2011 – $347) and is recorded in derivative financial assets.

 

  (b) Stock option plan:

The Company has established a stock option plan under which it can grant to 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 29, 2012, 1,292,846 options could still be granted by the Company (788,172 as at February 28, 2011).

All options are to be settled by physical delivery of shares.

 

17


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

9. Share capital (continued):

 

  (b) Stock option plan (continued):

Changes in outstanding options granted under the Company’s stock option plan for the year ended November 30, 2011 and the three-month period ended February 29, 2012 were as follows:

 

     Options     Weighted
average

exercise  price
per option
 
           $  

Options at November 30, 2010

     2,849,138        5.12   

Granted

     250,000        5.65   

Expired

     (309,000     11.17   

Forfeited

     (116,003     4.46   

Exercised

     (344,665     1.94   
  

 

 

   

 

 

 

Options at November 30, 2011

     2,329,470        4.87   

Expired

     (20,000     10.95   

Forfeited

     (116,838     6.39   

Exercised

     (104,503     1.81   
  

 

 

   

 

 

 

Options at February 29, 2012

     2,088,129        4.88   
  

 

 

   

 

 

 

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

 

     February 29,
2012
     February 28,
2011
 

Risk-free interest rate

     —           2.72

Expected volatility

     —           74.46

Average option life in years

     —           7.5   

Expected dividends

     —           nil   

Grant-date share price

     —         $ 5.65   

Option exercise price

     —         $ 5.65   

 

18


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

9. Share capital (continued):

 

  (b) Stock option plan (continued):

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 considering the vesting period at the grant date, the life of the option and the average length of time of 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 in all earnings to finance operations and future growth.

The following table summarizes the measurement date weighted average fair value of stock options granted during the periods ended February 29, 2012 and February 28, 2011:

 

     Number of
options
     Weighted
average
grant date
fair value
 
            $  

2012

     —           —     

2011

     250,000         4.08   

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 Company’s 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.

 

19


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

9. Share capital (continued):

 

  (c) Earnings per share:

The calculation of basic earnings per share for the period of three months ended February 29, 2012 was based on the net loss attributable to common shareholders of the Company of $7,484 (2011 – $5,932), and a weighted average number of common shares outstanding of 60,914,265 (2011 – 60,514,420). The weighted average number of common shares is calculated as follows:

 

     February 29,
2012
     February 28,
2011
 

Issued common shares at December 1

     60,865,266         60,512,764   

Effect of share options exercised

     48,999         1,656   
  

 

 

    

 

 

 

Weighted average number of common shares

     60,914,265         60,514,420   
  

 

 

    

 

 

 

At February 29, 2012, 2,088,129 options (2011 – 3,038,971) were excluded from the diluted weighted average number of common shares calculation as their effect would have been anti-dilutive. All options outstanding at February 29, 2012 could potentially dilute basic earnings per share in the future.

 

10. Supplemental information:

 

  (a) Cash flow information:

The Company entered into the following transactions which had no impact on the cash flows:

 

     February 29,
2012
     February 28,
2011
 
     $      $  

Additions to property and equipment included in accounts payable and accrued liabilities

     —           43   
  

 

 

    

 

 

 

In addition, interest received totaled $453 (2011 – $122).

 

20


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

10. Supplemental information (continued):

 

  (b) Restructuring costs:

On December 7, 2011, the Company announced that it was discontinuing its clinical program evaluating tesamorelin in muscle wasting associated with COPD, resulting in the lay-off of 34 employees. Consequently, the Company now occupies approximately fifty percent of its leased premises, giving rise to an onerous lease provision. Restructuring costs recorded in the first quarter ended February 29, 2012 were as follows:

 

     $  

Restructuring costs:

  

Lease:

  

Onerous lease provision

     4,055   

Write-off of the related deferred lease inducements

     (481
  

 

 

 
     3,574   

Other restructuring costs:

  

Employee termination benefits

     1,163   

Termination of the COPD clinical program

     1,036   

Professional fees and other

     285   
  

 

 

 
     2,484   
  

 

 

 
     6,058   
  

 

 

 

Provisions related to the restructuring in the consolidated statements of financial position:

 

     Onerous lease
provision
    Other
costs
    Total  
     $     $     $  

Balance at November 30, 2011

     —          52        52   

Provisions made during the period

     4,055        2,484        6,539   

Payments

     (128     (2,239     (2,367

Accretion expense

     7        —          7   
  

 

 

   

 

 

   

 

 

 

Balance at February 29, 2012

     3,934        297        4,231   

Less current portion

     (474     (297     (771
  

 

 

   

 

 

   

 

 

 

Non-current portion

     3,460        —         3,460   
  

 

 

   

 

 

   

 

 

 

 

21


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

10. Supplemental information (continued):

 

  (b) Restructuring costs (continued):

The onerous lease provision includes a provision for the future lease costs of the vacant portion of the premises, net of estimated of sublease rentals that could reasonably be obtained. The provision is being accreted to its face value through a charge to finance costs in the consolidated statements of comprehensive income. The provision is based on management’s best estimates of sublease rates that have yet to be negotiated, the timing of a sublease transaction, discount rates and other factors.

 

11. Contingent liability:

On July 26, 2010, the Company received a motion of authorization to institute a class action lawsuit against the Company, a director and a former executive officer (the “Motion”). The Motion was filed in the Superior Court of Québec, district of Montréal (the “Court”). 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. The applicant alleges that the Company did not comply with its continuous disclosure obligations as a reporting issuer by failing to disclose certain alleged adverse effects relating to the administration of EGRIFTATM.

The Motion was authorized by the Court on February 24, 2012. Despite the granting of such motion, the Company is of the view that the allegations against it are entirely without merit and will take all appropriate actions to vigorously defend its position. The Company is seeking leave to appeal the decision authorizing the Motion and the hearing regarding leave to appeal is scheduled to occur on June 5, 2012.

The Company has subscribed to insurance covering its potential liability and the potential liability of its directors and officers in the performance of their duties for the Company subject to a $200 deductible.

 

22


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

12. Commitments:

This disclosure is to update the note 24 of the Audited annual financial statements of 2011.

 

  (a) Post-approval commitments:

In connection with its approval of EGRIFTATM, the United States Food and Drug Administration, or FDA, has required the following three post-approval commitments:

 

  -

a single vial formulation of EGRIFTATM (the development of a new presentation of the same formulation);

 

  -

a long-term observational safety study using EGRIFTATM; and

 

  -

a Phase 4 clinical trial using EGRIFTATM.

The Company has developed a new presentation of EGRIFTATM which complies with the first of the FDA’s post-approval requirements. It is required to be available by November 2013.

The long-term observational safety study is to evaluate the safety of long-term administration of EGRIFTATM and the protocol for this study, which has been submitted to the FDA by EMD Serono, has yet to be finalized.

The Phase 4 clinical trial is to assess whether EGRIFTATM has an impact on diabetic retinopathy in diabetic HIV-infected patients with lipodystrophy and excess abdominal fat. EMD Serono is responsible for executing the trial and is to be reimbursed by the Company for the direct costs involved. The FDA-approved protocol for the trial calls for patients to inject themselves daily with either EGRIFTATM or placebo over a three-year treatment period. While the Company is committed to supporting the trial, management believes that the protocol conditions will be difficult to meet. The Company estimates that, if completed, the trial could cost approximately $20,000 over a four- to five-year period.

 

  (b) Long-term procurement agreements:

As at February 29, 2012, the Company had entered into long-term procurement agreements with third-party suppliers in connection with the commercialization of EGRIFTATM. As at February 29, 2012, the Company had outstanding purchase orders under these agreements amounting to $3,246 for the manufacture of EGRIFTATM for delivery in the fiscal years 2012 and 2013.

 

23


THERATECHNOLOGIES INC.

Notes to the Consolidated Financial Statements, Continued

(Unaudited)

Three-month periods ended February 29, 2012 and February 28, 2011

(in thousands of Canadian dollars, except per share amounts)

 

 

13. Subsequent events:

Stock option plan

Between March 1, 2012 and April 10, 2012, 40,834 options were exercised at a weighted average exercise price of $1.31 per share for a cash consideration of $53.

 

24