6-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

under the Securities Exchange Act of 1934

October 13, 2021

Commission File Number 001-35203

 

 

THERATECHNOLOGIES INC.

(Translation of registrant’s name into English)

 

 

2015 Peel Street, Suite 1100

Montréal, Québec, Canada

H3A 1T8

(Address of principal executive offices)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

Form 20-F  ☐            Form 40-F  ☒

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

Yes  ☐            No  ☒

Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

Yes  ☐            No  ☒

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes  ☐            No  ☒

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-______________.

 

 

 


THERATECHNOLOGIES INC.

 

Exhibit

  

Description

99.1    Consolidated Interim Financial Statements for the Three-Month and Nine-Month Periods Ended August 31, 2021 and August 31, 2020
99.2    Management’s Discussion and Analysis for the Three-Month and Nine-Month Periods Ended August 31, 2021
99.3    Certification of Interim Filings of the President and Chief Executive Officer
99.4    Certification of Interim Filings of the Senior Vice President and Chief Financial Officer


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

THERATECHNOLOGIES INC.
By:  

/s/ Paul Lévesque

Name: Paul Lévesque
Title:   President and Chief Executive Officer

Date: October 13, 2021

EX-99.1
Table of Contents

Exhibit 99.1

Interim Consolidated Financial Statements

(in thousands of United States dollars)

THERATECHNOLOGIES INC.

Three- and nine-month periods ended

August 31, 2021 and 2020

(Unaudited)


Table of Contents

THERATECHNOLOGIES INC.

Table of Contents

(Unaudited)

 

 

(in thousands of United States dollars)

 

     Page  
Interim Consolidated Statements of Financial Position      1  
Interim Consolidated Statements of Comprehensive Loss      2  
Interim Consolidated Statements of Changes in Equity      3  
Interim Consolidated Statements of Cash Flows      4  
Notes to Interim Consolidated Financial Statements      5 -18  


Table of Contents

THERATECHNOLOGIES INC.

Interim Consolidated Statements of Financial Position

(Unaudited)

As at August 31, 2021 and November 30, 2020

 

(in thousands of United States dollars)

 

     Note     

August 31,
2021

$

    

November 30,
2020

$

 

Assets

        

Current assets

        

Cash

        32,446        12,737  

Bonds and money market funds

        19,138        8,031  

Trade and other receivables

        13,107        12,430  

Tax credits and grants receivable

        406        755  

Inventories

        27,293        25,145  

Prepaid expenses and deposits

        4,568        5,189  

Derivative financial assets

        809        520  

 

 

Total current assets

        97,767        64,807  

 

 

Non-current assets

        

Property and equipment

        782        865  

Right-of-use assets

        2,268        2,618  

Intangible assets

        22,183        24,529  

Other assets

        3,661        7,323  

Deferred financing costs

     9(c)        341        -  

 

 

Total non-current assets

        29,235        35,335  

 

 

Total assets

        127,002        100,142  

 

 

Liabilities

        

Current liabilities

        

Accounts payable and accrued liabilities

        35,300        34,815  

Provisions

     5        3,274        1,947  

Other obligations

     6        4,965        4,666  

Current portion of lease liabilities

     8        462        425  

Income taxes payable

        41        16  

Deferred revenue

        28        50  

 

 

Total current liabilities

        44,070        41,919  

 

 

Non-current liabilities

        

Convertible unsecured senior notes

     7        53,752        52,403  

Lease liabilities

     8        2,233        2,555  

Other liabilities

     9(e)        75        41  

 

 

Total non-current liabilities

        56,060        54,999  

 

 

Total liabilities

        100,130        96,918  

 

 

Equity

        

Share capital and warrants

     9        335,716        287,312  

Equity component of convertible unsecured senior notes

        4,457        4,457  

Contributed surplus

        12,457        12,065  

Deficit

        (325,347)        (300,129)  

Accumulated other comprehensive loss

        (411)        (481)  

 

 

Total equity

        26,872        3,224  

 

 

Total liabilities and equity

        127,002        100,142  

 

 

 

The accompanying notes are an integral part of these interim consolidated financial statements.    (1)


Table of Contents

THERATECHNOLOGIES INC.

Interim Consolidated Statements of Comprehensive Loss

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

 

(in thousands of United States dollars, except per share amounts)

 

           For the three-month
periods ended August 31,
     For the nine-month
periods ended August 31,
 
     Note    

2021

$

    

2020

$

    

2021

$

    

2020

$

 

Revenue

     3       17,852        14,049        51,069        46,930  

 

 

Operating expenses

             

Cost of sales

             

Cost of goods sold

       4,283        4,611        13,187        15,780  

Other production-related costs

       -          280        -          811  

Amortization of other assets

       1,221        1,220        3,662        3,661  

Research and development expenses

(net of tax credits of $92 and $209

(2020 – $196 and $196)) for the

three and nine-month periods

       8,296        4,183        19,596        11,224  

Selling expenses

       7,657        7,025        20,716        20,327  

General and administrative expenses

       3,633        2,699        11,079        8,975  

 

 

Total operating expenses

       25,090        20,018        68,240        60,778  

 

 

Loss from operating activities

       (7,238)        (5,969)        (17,171)        (13,848)  

 

 

Finance income

     4       64        528        143        749  

Finance costs

     4       (2,318)        (1,327)        (4,752)        (4,019)  

 

 
       (2,254)        (799)        (4,609)        (3,270)  

 

 

Loss before income taxes

       (9,492)        (6,768)        (21,780)        (17,118)  

 

 

Income taxes

       (18)        -          (44)        -    

 

 

Net loss

       (9,510)        (6,768)        (21,824)        (17,118)  

 

 

Other comprehensive income (loss)

             

Items that may be reclassified to net profit

(loss) in the future:

             

Net change in fair value of financial

assets at fair value through

other comprehensive income

(FVOCI)

       (35)        (11)        (96)        8  

Exchange differences on translation

of foreign operations

       433        (451)        166        (495)  

 

 
       398        (462)        70        (487)  

 

 

Total comprehensive loss

       (9,112)        (7,230)        (21,754)        (17,605)  

 

 

Basic and diluted loss per share

     9 (f)      (0.10)        (0.09)        (0.24)        (0.22)  

 

 

 

The accompanying notes are an integral part of these interim consolidated financial statements.    (2)


Table of Contents

THERATECHNOLOGIES INC.

Interim Consolidated Statements of Changes in Equity

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

 

(in thousands of United States dollars)

 

           For the nine-month period ended August 31, 2021  
     Note     Share capital
and warrants
                                    
           Number
of shares
     Amount      Equity
component
of convertible
notes
     Contributed
surplus
     Deficit      Accumulated
other
comprehensive
loss
     Total  
                  $      $      $      $      $      $  

Balance as at November 30, 2020

       77,013,411        287,312        4,457        12,065        (300,129)        (481)        3,224  

 

 

Total comprehensive loss

                      

Net loss

       -        -        -        -        (21,824)        -        (21,824)  

Other comprehensive income:

                      

Net change in fair value of FVOCI financial assets

       -        -        -        -        -        (96)        (96)  

Exchange differences on translation of foreign operations

       -        -        -        -        -        166        166  

 

 

Total comprehensive loss

       -        -        -        -        (21,824)        70        (21,754)  

 

 

Transactions with owners, recorded directly in equity

                      

Public issue of common shares and warrants

     9 (a)      16,727,900        46,002        -        -        -        -        46,002  

Share issue costs

       -        -        -        -        (3,394)        -        (3,394)  

Exercise of warrants

       221,900        706        -        -        -        -        706  

Share issue – Oncology

     9 (b)      481,928        668        -        (668)        -        -        -  

Share-based compensation plan:

                      

Share-based compensation for stock option plan

     9 (d)      -        -        -        1,493        -        -        1,493  

Exercise of stock options:

                      

Monetary consideration

     9 (d)      665,000        595        -        -        -        -        595  

Attributed value

       -        433        -        (433)        -        -        -  

 

 

Total contributions by owners

       18,096,728        48,404        -        392        (3,394)        -        45,402  

 

 

Balance as at August 31, 2021

       95,110,139        335,716        4,457        12,457        (325,347)        (411)        26,872  

 

 
           For the nine-month period ended August 31, 2020  
           Share capital and warrants                                     
           Number
of shares
     Amount      Equity
component
of convertible
notes
     Contributed
surplus
     Deficit      Accumulated
other
comprehensive
loss
     Total  
                  $      $      $      $      $      $  

Balance as at November 30, 2019

       76,953,411        287,035        4,457        10,783        (277,462)        21        24,834  

 

 

Total comprehensive loss

                      

Net loss

       -        -        -        -        (17,118)        -        (17,118)  

Other comprehensive income:

                      

Net change in fair value of FVOCI financial assets

       -        -        -        -        -        8        8  

Exchange differences on translation of foreign operations

       -        -        -        -        -        (495)        (495)  

 

 

Total comprehensive loss

       -        -        -        -        (17,118)        (487)        (17,605)  

 

 

Transactions with owners, recorded directly in equity

                      

Share based compensation plan:

                      

Share based compensation for stock option plan

       -        -        -        1,152        -        -        1,152  

Exercise of stock options:

                      

Monetary consideration

       60,000        145        -        -        -        -        145  

Attributed value

       -        132        -        (132)        -        -        -  

 

 

Total contributions by owners

       60,000        277        -        1,020        -        -        1,297  

 

 

Balance as at August 31, 2020

       77,013,411        287,312        4,457        11,803        (294,580)        (466)        8,526  

 

 

 

 

The accompanying notes are an integral part of these interim consolidated financial statements.    (3)


Table of Contents

THERATECHNOLOGIES INC.

Interim Consolidated Statement of Cash Flows

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

(in thousands of United States dollars)

 

            For the three-month periods ended August 31,      For the nine-month periods ended August 31,  
     Note     

2021

$

    

2020

$

    

2021

$

    

2020

$

 

Cash flows from (used in)

              

Operating activities

              

Net loss

        (9,510)        (6,768)        (21,824)        (17,118)  

Adjustments for:

              

Depreciation of property and equipment

        61        62        174        183  

Amortization of intangible assets and other assets

        2,016        2,016        6,047        5,816  

Amortization of right-of-use assets

        112        111        338        329  

Share-based compensation for stock option plan and stock appreciation rights

        401        349        1,527        1,168  

Write-down of inventories

        -        282        -        676  

Change in fair value of derivative financial assets

        (48)        (141)        (272)        108  

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

        50        140        273        (100)  

Interest on convertible unsecured senior notes

        847        838        2,482        2,482  

Interest income

        (64)        (32)        (143)        (278)  

Foreign exchange

        969        (586)        335        (550)  

Accretion expense

        612        485        1,801        1,508  

 

 
        (4,554)        (3,244)        (9,262)        (5,776)  

 

 

Change in operating assets and liabilities

              

Trade and other receivables

        (2,800)        3,967        (700)        1,896  

Tax credits and grants receivable

        50        (193)        367        (193)  

Inventories

        1,157        (984)        (2,178)        (5,152)  

Prepaid expenses and deposits

        948        773        618        1,442  

Accounts payable and accrued liabilities

        2,843        579        827        228  

Provisions

        (717)        (642)        1,327        (72)  

Deferred revenue

        -        21        (22)        (21)  

Income tax payable

        19        -        25        -  

Deferred financing costs

        (79)        -        (79)        -  

 

 
        1,421        3,521        185        (1,872)  

 

 

Cash flows from (used in) operating activities

        (3,133)        277        (9,077)        (7,648)  

 

 

Financing activities

              

Repayment of long-term obligation

        -        (3,500)        -        (3,500)  

Proceeds from exercise of stock options

        354        -        595        145  

Proceeds from exercise of warrants

        78        -        706        -  

Proceeds from issue of common shares and warrants

        -        -        46,002        -  

Share issue costs

        (36)        -        (3,394)        -  

Interest paid on convertible unsecured senior notes

        (1,653)        (1,653)        (3,306)        (3,306)  

Payments of lease liabilities

        (159)        (141)        (477)        (417)  

 

 

Cash flows from (used in) financing activities

        (1,416)        (5,294)        40,126        (7,078)  

 

 

Investing activities

              

Proceeds from sale of bonds and money market funds

        -        701        640        2,959  

Acquisition of bonds and money market funds

        (1,180)        (5)        (11,614)        (56)  

Interest received

        47        57        (273)        355  

Proceeds from sale of derivative financial assets

        -        -        -        (17)  

Acquisition of intangible assets

        -        -        (39)        -  

Acquisition of property and equipment

        (48)        (7)        (94)        (20)  

 

 

Cash flows from (used in) investing activities

        (1,181)        746        (11,380)        3,221  

 

 

Net change in cash

        (5,730)        (4,271)        19,669        (11,505)  

Cash, beginning of period

        38,235        21,440        12,737        28,661  

Effect of foreign exchange on cash

        (59)        73        40        86  

 

 

Cash, end of period

        32,446        17,242        32,446        17,242  

 

 

Supplemental cash flow disclosures

     10              

 

The accompanying notes are an integral part of these interim consolidated financial statements.    (4)


Table of Contents

THERATECHNOLOGIES INC.

Notes to Interim Consolidated Financial Statements

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

 

(in thousands of United States dollars)

 

Theratechnologies Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.

The interim consolidated financial statements include the accounts of Theratechnologies Inc. and its wholly-owned subsidiaries (together referred to as the Company and individually as the subsidiaries of the Company).

Theratechnologies Inc. is governed by the Business Corporations Act (Québec) and is domiciled in Québec, Canada. The

Company’s head office is located at 2015 Peel Street, Suite 1100, Montréal, Québec, H3A 1T8.

 

1

Basis of preparation

 

  a)

Accounting framework

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

Certain information, in particular the accompanying notes normally included in the annual consolidated financial statements prepared in accordance with IFRS, has been omitted or condensed. These interim financial statements do not include all disclosures required under IFRS and, accordingly, should be read in conjunction with the annual consolidated financial statements for the year ended November 30, 2020 and the notes thereto.

These interim consolidated financial statements have been authorized for issue by the Company’s Audit Committee on October 12, 2021.

 

  b)

Basis of measurement

The Company’s interim consolidated financial statements have been prepared on going concern and historical cost bases, except for bonds and money market funds, derivative financial assets, liabilities related to cash-settled share-based arrangements and derivative financial liabilities, which are measured at fair value. Effective December 1, 2019, lease liabilities are measured at the present value of lease payments not paid at commencement date. Equity-classified shared-based payment arrangements are measured at fair value at grant date pursuant to IFRS 2, Share-based Payment.

The methods used to measure fair value are discussed further in Note 12.

 

(5)


Table of Contents

THERATECHNOLOGIES INC.

Notes to Interim Consolidated Financial Statements

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

 

(in thousands of United States dollars)

 

  c)

Use of estimates and judgments

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 interim financial statements, and the reported amounts of revenues and expenses during the reporting periods.

Information about critical judgments in applying accounting policies and assumptions and estimation uncertainties that have the most significant effect on the amounts recognized in the interim financial statements are disclosed in Note 1 of the annual consolidated financial statements as at November 30, 2020.

 

  d)

Functional and presentation currency

The Company’s functional currency is the United States dollar (USD).

All financial information presented in USD has been rounded to the nearest thousand.

 

2

Significant accounting policies

The significant accounting policies as disclosed in the Company’s annual consolidated financial statements for the year ended November 30, 2020 have been applied consistently in the preparation of these interim financial statements, except as described below.

Deferred Financing Costs

Deferred financing costs consists of fees charged by underwriters, attorneys, accountants, and other fees directly attributable to future issuances of shares. Provided these costs are determined to be recoverable, these costs are deferred and charged subsequently against the gross proceeds of the related equity transaction on a proportionate basis when it occurs. If at such time, the Company deems that these costs are no longer recoverable, they will be expensed as a component of finance expenses.

 

(6)


Table of Contents

THERATECHNOLOGIES INC.

Notes to Interim Consolidated Financial Statements

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

 

(in thousands of United States dollars)

 

3

Revenue

Net sales by product were as follows:

 

     

For the three-month

periods ended August 31,

 
    

2021

$

 

 

    

2020

$

 

 

EGRIFTA® and EGRIFTA SVTM

     11,224        6,864  

Trogarzo®

     6,628        7,185  
       17,852        14,049  

 

      For the nine-month
periods ended August 31,
 
    

2021

$

 

 

    

2020

$

 

 

EGRIFTA® and EGRIFTA SVTM

     30,256        24,648  

Trogarzo®

     20,813        22,282  
       51,069        46,930  

Net sales by geography were as follows:

 

     

For the three-month

periods ended August 31,

 
    

2021

$

 

 

    

2020

$

 

 

United States

     17,109        14,049  

Europe

     743        -  
       17,852        14,049  

 

(7)


Table of Contents

THERATECHNOLOGIES INC.

Notes to Interim Consolidated Financial Statements

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

 

(in thousands of United States dollars)

 

     

For the nine-month

periods ended August 31,

 
    

2021

$

 

 

    

2020

$

 

 

Canada

     287        231  

United States

     48,578        46,699  

Europe

     2,204        -  
       51,069        46,930  

 

4

Finance income and finance costs

 

      Note     

For the three-month

periods ended August 31,

 
       

2021

$

 

 

   

2020

$

 

 

Net foreign currency gain

        -       496  

Interest income

              64       32  

Finance income

              64       528  

Accretion expense

     6, 7, 8        (612     (485

Interest on convertible unsecured senior notes

        (847     (838

Bank charges

        (6     (5

Net foreign currency loss

        (851     -  

Loss on financial instruments carried at fair value

              (2     1  

Finance costs

              (2,318     (1,327

Net finance costs recognized in net profit or loss

              (2,254     (799

 

(8)


Table of Contents

THERATECHNOLOGIES INC.

Notes to Interim Consolidated Financial Statements

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

 

(in thousands of United States dollars)

 

      Note      For the nine-month
periods ended August 31,
 
           

2021

$

   

2020

$

 

Net foreign currency gain

        -       471  

Interest income

        143       278  
       

Finance income

              143       749  

Accretion expense

     6, 7, 8        (1,801     (1,508

Interest on convertible unsecured senior notes

        (2,482     (2,482

Bank charges

        (19     (21

Net foreign currency loss

        (449     -  

Loss on financial instruments carried at fair value

              (1     (8

Finance costs

              (4,752     (4,019

Net finance costs recognized in net profit or loss

              (4,609     (3,270

 

5

Provisions

 

     

Chargebacks
and rebates

$

   

Returns

$

   

Other

$

   

Total

$

 

Balance as at November 30, 2019

     2,182       247       55       2,484  

Provisions made

     10,314       948       2,973       14,235  

Provisions used

     (10,818     (935     (3,019     (14,772

Balance as at November 30, 2020

     1,678       260       9       1,947  

Provisions made

     7,274       641       -       7,915  

Provisions used

     (6,120     (459     (9     (6,588

Balance as at August 31, 2021

     2,832       442       -       3,274  

 

(9)


Table of Contents

THERATECHNOLOGIES INC.

Notes to Interim Consolidated Financial Statements

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

 

(in thousands of United States dollars)

 

6

Other obligations

The movement in the other obligations is as follows:

 

     

Commercialization
rights – Trogarzo®
North American  Territory

$

   

Commercialization
rights – Trogarzo®
European Territory

$

    

Total

$

 

Balance as at November 30, 2019

     3,417       4,570        7,987  

Payment

     (3,500     -        (3,500

Accretion expense

     83       96        179  

Balance as at November 30, 2020

     -       4,666        4,666  

Accretion expense

     -       299        299  

Balance as at August 31, 2021, all current

     -       4,965        4,965  

On October 1st, 2021, the payment for the commercialization Rights-Trogarzo European Territory was made by the Company.

 

7

Convertible unsecured senior notes

The movement in the carrying value of the convertible unsecured senior notes is as follows:

 

      $  

Convertible unsecured senior notes as at November 30, 2019

     50,741  

Accretion expense

     1,662  

Convertible unsecured senior notes as at November 30, 2020

     52,403  

Accretion expense

     1,349  

Convertible unsecured senior notes as at August 31, 2021

     53,752  

 

(10)


Table of Contents

THERATECHNOLOGIES INC.

Notes to Interim Consolidated Financial Statements

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

 

(in thousands of United States dollars)

 

8

Lease liabilities

 

      Carrying value
$
 

Balance as at December 1, 2019

     3,192  

Accretion expense

     215  

Lease payments

     (568

Effect of change in exchange rates

     141  

Balance as at November 30, 2020

     2,980  

Accretion expense

     153  

Lease payments

     (477

Effect of change in exchange rates

     39  

Balance as at August 31, 2021

     2,695  

Current portion

     (462

Non-current portion

     2,233  

 

9

Share capital and warrants

  a) Public offering

On January 19, 2021, the Company completed a public offering for the sale and issuance of 16,727,900 units at a price of $2.75 per unit for a gross cash consideration of $46,002, including the full exercise of the over-allotment option.

Each unit comprises one common share of the Company and one-half of one common share purchase warrant of the Company (each whole warrant, a Warrant) and is classified in Share Capital and Warrants within equity. As at August 31, 2021, 221,900 Warrants were exercised and there were 8,142,050 Warrants outstanding. Each Warrant entitles the holder thereof to purchase one common share at an exercise price of $3.18 at any time until January 19, 2024.

 

(11)


Table of Contents

THERATECHNOLOGIES INC.

Notes to Interim Consolidated Financial Statements

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

 

(in thousands of United States dollars)

 

  b)

Milestone oncology

In March 2021, the Company issued 481,928 common shares under the terms of the acquisition agreement entered into with all of the shareholders of Katana Biopharma Inc. (Katana) for Katana’s in-licensed oncology platform. The purchase price for the oncology platform provided for share-based consideration to be issued upon attainment of two milestones. The first milestone consisted in initiating a Phase 1 clinical trial evaluating TH1902 for the treatment of Sortilin positive solid tumors. This milestone was achieved in March 2021. The estimated fair value of the share-based consideration of $668 initially recorded in contributed surplus on the date of the acquisition was reclassified to share capital in the second quarter.

 

  c)

ATM program

Under the terms of a sales agreement dated July 23, 2021, the Company may issue and sell from time to time its common shares, having an aggregate offering price of up to US $50,000, through or to the Agent, as agent or principal, in the United States. Sales of the common shares will be made in transactions that are deemed to be “at-the-market distributions” (ATM). No common shares will be sold on the TSX or on other trading markets in Canada as “at-the-market distributions”. Subject to the terms and conditions of the sales agreement, the Agent will use its commercially reasonable efforts to sell the common shares from time to time, based upon the Company’s instructions. The Common Shares would be issued at market prices prevailing at the time of the sale and, as a result, prices may vary between purchasers and during the period of distribution. The Agent will be entitled to compensation at a fixed commission rate of three percent (3.0%) of the gross sales price per common share sold. The Company has no obligation to sell any of the common shares. Either the Company or the Agent may terminate the sales agreement in their sole discretion at any time by giving written notice. As at August 31, 2021, no common shares were issued. Total costs of $341 incurred in connection with the ATM program were recorded as deferred financing costs in the Interim Consolidated Statements of Financial Position.

 

  d)

Stock option plan

The Company has established a stock option plan (Plan) under which it can grant its directors, officers, employees, researchers and consultants non-transferable options for the purchase of common shares. The exercise date of an option may not be later than 10 years after the grant date. A maximum number of 7,700,000 options can be granted under the Plan. Generally, the options vest at the grant date or over a period of up to three years. As at August 31, 2021, 3,924,250 options could still be granted by the Company (2020 – 2,292,697) under the Plan.

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

 

(12)


Table of Contents

THERATECHNOLOGIES INC.

Notes to Interim Consolidated Financial Statements

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

 

(in thousands of United States dollars)

 

Changes in the number of options outstanding during the past two years were as follows:

 

      Weighted average exercise price per option  
      Number of
options
    CAD      USD  

Options exercisable in CA$

       

Options as at November 30, 2019 – CA$

     2,415,784       3.93        2.96  

Granted – CA$

     1,077,721       3.06        2.25  

Forfeited – CA$

     (130,146     5.08        3.63  

Exercised (share price: CA$3.77 (US$2.68))

     (60,000     3.38        2.40  

Options outstanding as at August 31, 2020 – CA$

     3,303,359       3.61        2.62  

Options as at November 30, 2020 – CA$

     3,203,693       3.59        2.76  

Granted – CA$

     1,057,831       3.94        3.10  

Forfeited – CA$

     (113,461     4.11        3.27  

Exercised (share price: CA$4.18 (US$3.36))

     (665,000     1.11        0.89  

Options outstanding as at August 31, 2021 – CA$

     3,483,063       4.15        3.29  

Options exercisable as at August 31, 2021 – CA$

     1,899,924       4.51        3.58  

Options exercisable in US$

       

Options as at November 30, 2020 – US$

     12,500       -        2.35  

Granted – US$

     102,608       -        3.18  

Options outstanding as at August 31, 2021 – US$

     115,108       -        3.09  

Options exercisable as at August 31, 2021 – US$

     -       -        -  

During the nine-month period ended August 31, 2021, $1,493 (2020 – $1,152) was recorded as share-based compensation expense for the Plan. The fair value of options granted during the period was estimated at the grant date using the Black-Scholes model and the following weighted average assumptions:

 

      2021      2020  

Options exercisable in CA$

     

Risk-free interest rate

     1.35%        0.95%  

Expected volatility

     70%        70%  

Average option life in years

     8.5 years        8.5 years  

Grant-date share price

   $ 3.13 (CA$3.94)      $ 2.34 (CA$3.06)  

Option exercise price

   $ 3.13 (CA$3.94)      $ 2.34 (CA$3.06)  

 

(13)


Table of Contents

THERATECHNOLOGIES INC.

Notes to Interim Consolidated Financial Statements

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

 

(in thousands of United States dollars)

 

      2021  

Options exercisable in US$

 

  

Risk-free interest rate

     1.22%  

Expected volatility

     64%  

Average option life in years

     8.5 years  

Grant-date share price

     $2.83  

Option exercise price

     $2.83  

The risk-free interest rate is based on the implied yield on a Canadian government or U.S. zero-coupon issue, with a remaining term equal to the expected term of the option. The volatility is based on weighted average historical volatility adjusted for a period equal to the expected life. The life of the options is estimated taking into consideration the vesting period at the grant date, the life of the option and the average length of time similar grants have remained outstanding in the past. The dividend yield was excluded from the calculation, since it is the present policy of the Company to retain all earnings to finance operations and future growth.

The following table summarizes the measurement date weighted average fair value of stock options granted during the following periods:

 

      Number
of options
     Weighted
average grant
date fair value
 

Options exercisable in CA$

     

For the three-month period ended August 31, 2021

     38,500        $2.26 (CAD$2.85)  

For the nine-month period ended August 31, 2021

     1,057,831        $2.16 (CAD$2.72)  

For the three and nine-month periods ended August 31, 2020

     1,077,721        $1.60 (CAD$2.08)  

 

      Number
of options
     Weighted
average grant
date fair value
 

Options exercisable in US$

     

For the three-month period ended August 31, 2021

     21,515        2.34  

For the nine-month period ended August 31, 2021

     102,608        1.98  

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 differ 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.

 

(14)


Table of Contents

THERATECHNOLOGIES INC.

Notes to Interim Consolidated Financial Statements

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

 

(in thousands of United States dollars)

 

  e)

Stock appreciation rights (SARs)

On October 4, 2018, the Company’s Board of Directors approved a SARs plan for its consultants that entitles the grantee to a cash payment based on the increase in the stock price of the Company’s common shares from the grant date to the settlement date. The exercise date of an SAR may not be later than 10 years after the grant date. Generally, the SARs vest over a period of three years.

During the nine-month period ended August 31, 2021, $35 (2020 – $16) was recorded as share-based compensation expense for the SARs plan. Since these awards will be cash-settled, the fair value of SARs granted is estimated at each reporting period using the Black-Scholes model and the following weighted average assumptions.

 

      Measurement
date as at
August 31, 2021
 

Risk-free interest rate

     1.22%  

Expected volatility

     64%  

Average option life in years

     7.5 years  

Period-end share price

     $3.61 (CAD$4.55)  

SAR exercise price

     $4.45 (CAD$5.62)  

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 SAR. The volatility is based on weighted average historical volatility adjusted for a period equal to the expected life. The life of the SARs is estimated taking into consideration the vesting period at the grant date, the life of the SARs and the average length of time similar grants have remained outstanding in the past. The dividend yield was excluded from the calculation, since it is the present policy of the Company to retain all earnings to finance operations and future growth.

The following table summarizes the measurement date weighted average fair value of SARs granted during the period ended:

 

For the three-month period ended August 31  
     Number
of SARs
     Weighted
average grant
date fair value
 
     

2021

     75,000        $1.98 (CAD$2.50)  

At August 31, 2021, 115,000 SARs were outstanding. The liability related to the SARs of $75 (November 30, 2020: $41) is included in Other liabilities in the Consolidated Statement of Financial Position.

 

(15)


Table of Contents

THERATECHNOLOGIES INC.

Notes to Interim Consolidated Financial Statements

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

 

(in thousands of United States dollars)

 

  f)

Loss per share

For the three and nine-month periods August 31, 2021 and 2020, the weighted average number of common shares outstanding was calculated as follows:

 

      For the three-month periods
ended August 31,
 
     2021      2020  

Issued common shares as at June 1

     94,820,639        77,013,411  

Effect of share options exercised

     116,141        -  

Effect of broker warrants exercised

     14,984        -  
     

Weighted average number of common shares, basic and diluted

     94,951,764        77,013,411  

 

      
For the nine-month periods
ended August 31,

 
     2021      2020  

Issued common shares as at December 1

     77,013,411        76,953,411  

Effect of share options exercised

     277,683        31,018  

Effect of public issue of common shares

     14,021,350        -  

Effect of broker warrants exercised

     118,403        -  
     

Weighted average number of common shares, basic and diluted

     91,430,847        76,984,429  

For the nine-month period ended August 31, 2021, 3,598,171 (2020 – 3,303,359) share options, 8,142,050 Warrants and 3,872,053 common shares potentially issuable from the conversion of the $57,500 aggregate principal amount of notes, that may potentially dilute loss per share in the future, were excluded from the weighted average number of diluted common shares calculation as their effect would have been anti-dilutive.

 

10

Supplemental cash flow disclosures

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

 

     

August 31,
2021

$

    

August 31,
2020

$

 

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

     9        6  

Deferred financing costs included in accounts payable and accrued liabilities

     262        -  

Initial recognition of right-of-use assets and lease liabilities

     -        3,192  

Reclassification of other liabilities to right-of use-assets

     -        238  

 

(16)


Table of Contents

THERATECHNOLOGIES INC.

Notes to Interim Consolidated Financial Statements

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

 

(in thousands of United States dollars)

 

11

Financial instruments

The nature and extent of the Company’s exposure to risks arising from financial instruments are consistent with the disclosure in the annual consolidated financial statements as at November 30, 2020.

 

12

Determination of fair values

Certain of the Company’s accounting policies and disclosures require the determination of fair value, for both financial and non-financial assets and liabilities. Fair values have been determined for measurement and/or disclosure purposes based on the following methods. When applicable, further information about the assumptions made in determining fair values is disclosed in the notes specific to that asset or liability.

Financial assets and financial liabilities measured at fair value

In establishing fair value, the Company uses a fair value hierarchy based on levels as defined below:

Level 1: Defined as observable inputs such as quoted prices in active markets.

Level 2: Defined as inputs other than quoted prices in active markets that are either directly or indirectly observable.

Level 3: Defined as inputs that are based on little or no observable market data, therefore requiring entities to develop their own assumptions.

Other financial assets and financial liabilities

The Company has determined that the carrying values of its short-term financial assets and financial liabilities, including cash, trade and other receivables and accounts payable and accrued liabilities, approximate their fair value because of their relatively short period to maturity.

Bonds and money market funds and derivative financial assets and liabilities are stated at fair value, determined by inputs that are primarily based on broker quotes at the reporting date (Level 2).

The fair value of the convertible unsecured senior notes, including the equity portion, as at August 31, 2021, was approximately $52,325 (Level 1) based on market quotes.

Share-based payment transactions

The fair value of the employee stock options are measured based on the Black-Scholes valuation model. Measurement inputs include share price on measurement date, exercise price of the instrument, expected volatility (based on weighted average historical volatility adjusted for a period equal to the expected life, weighted average expected life of the instruments (based on historical experience and general option holder behaviour), expected dividends, and the risk-free

 

(17)


Table of Contents

THERATECHNOLOGIES INC.

Notes to Interim Consolidated Financial Statements

(Unaudited)

For the three- and nine-month periods ended August 31, 2021 and 2020

 

 

(in thousands of United States dollars)

 

interest rate (based on government bonds). Service and non-market performance conditions attached to the transactions, if any, are not taken into account in determining fair value.

The deferred stock units liability is recognized at fair value and considered Level 2 in the fair value hierarchy for financial instruments. The fair value is determined using the quoted price of the common shares of the Company.

 

13

Operating segments

The Company has a single operating segment. Over 95% (2020 – 97%) of the Company’s revenues are generated from one customer, RxCrossroads, which is domiciled in the United States.

 

      For the nine-month periods
ended August 31,
 
      

2021

$

 

 

    

2020

$

 

 

RxCrossroads

     48,477        45,512  

Others

     2,592        1,418  
     
      51,069      46,930  

 

All of the Company’s non-current assets are located in Canada and Ireland. Of the Company’s non-current assets of $29,235, $28,051 as at August 31, 2021 are located in Canada and $1,184 are located in Ireland (November 30, 2020: $35,335, of which $34,006 were in Canada and $1,329 were in Ireland).

 

(18)

EX-99.2

Exhibit 99.2

 

LOGO

MANAGEMENT’S DISCUSSION AND ANALYSIS

FOR THE THREE- AND NINE-MONTH PERIODS ENDED AUGUST 31, 2021

The following Management’s Discussion and Analysis (MD&A) provides Management’s point of view on the financial position and results of operations of Theratechnologies Inc., on a consolidated basis, for the three- and nine-month periods ended August 31, 2021 compared to the three- and nine-month periods ended August 31, 2020. Unless otherwise indicated or unless the context requires otherwise, all references in this MD&A to “Theratechnologies”, the “Company”, the “Corporation”, “we”, “our”, “us” or similar terms refer to Theratechnologies Inc. and its subsidiaries on a consolidated basis. This MD&A is dated October 11, 2021, was approved by our Audit Committee on October 12, 2021 and should be read in conjunction with our unaudited interim consolidated financial statements and the notes thereto as at August 31, 2021 (Interim Financial Statements), as well as the MD&A and audited annual consolidated financial statements, including the notes thereto, as at November 30, 2020.

Except as otherwise indicated, the financial information contained in this MD&A and in our Interim Financial Statements has been prepared using accounting policies consistent with International Financial Reporting Standards (IFRS), as issued by the International Accounting Standards Board (IASB), and in accordance with International Accounting Standard (IAS) 34, Interim Financial Reporting.

The Company’s functional and presentation currency is the United States dollar (USD). All monetary amounts set forth in this MD&A and the Interim Financial Statements are expressed in USD, unless otherwise noted.

In this MD&A, the use of EGRIFTA® and EGRIFTA SV® (tesamorelin for injection) refers to tesamorelin for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy and the use of Trogarzo® (ibalizumab-uiyk) injection refers to ibalizumab for the treatment of multidrug resistant HIV-1 infected patients. The use of tesamorelin refers to the use of our tesamorelin compound for the potential treatment of nonalcoholic steatohepatitis (NASH) in the general population and in people living with HIV.

Forward-Looking Information

This MD&A contains forward-looking statements and forward-looking information (collectively, Forward-Looking Statements), within the meaning of applicable securities laws, that are based on our management’s beliefs and assumptions and on information currently available to our management. You can identify Forward-Looking Statements by terms such as “may”, “will”, “should”, “could”, “promising”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this MD&A include, but are not limited to, statements regarding the conduct of our clinical trials with TH1902 and tesamorelin, the results expected to be obtained from the conduct of these clinical trials, the timelines associated with the filing of a supplemental Biologic License Application (sBLA) with the U.S. Food and Drug Administration (FDA) and with the beginning of the screening of patients for the intramuscular (IM) study using Trogarzo®, the potential approval by regulatory agencies of tesamorelin for the treatment of NASH, the development of a multi-dose pen injector using the F8 formulation, the potential benefits to be derived from the addition of a partner for our Phase 3 clinical trial evaluating

 

     

Theratechnologies Inc.

2015 Peel, 11th Floor

Montreal, Québec H3A 1T8

     


tesamorelin for the treatment of NASH, and the growth of our revenues from sales of EGRIFTA SV® and Trogarzo®.

Although the Forward-Looking Statements contained in this MD&A are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements. Certain assumptions made in preparing the Forward-Looking Statements include that: the current COVID-19 pandemic will have limited adverse effect on the Company’s operations and its business plan; sales of EGRIFTA SV® and Trogarzo® in the United States will increase over time; the Company’s commercial practices in the U.S. and the countries of the European Union (EU) will not be found to be in violation of applicable laws; the long-term use of EGRIFTA SV® and Trogarzo® will not change their respective current safety profile; no recall or market withdrawal of EGRIFTA SV® and Trogarzo® will occur; no laws, regulation, order, decree or judgment will be passed or issued by a governmental body negatively affecting the marketing, promotion or sale of EGRIFTA SV® and Trogarzo® in countries where such products are commercialized; continuous supply of EGRIFTA SV® and Trogarzo® will be available; the Company’s relations with third-party suppliers ofEGRIFTA SV® and Trogarzo® will be conflict-free and such third-party suppliers will have the capacity to manufacture and supply EGRIFTA SV® and Trogarzo® to meet market demand on a timely basis; no biosimilar version of EGRIFTA SV® will be approved by the FDA; the Company’s intellectual property will prevent companies from commercializing biosimilar versions of EGRIFTA SV® in the U.S.; Trogarzo® will be reimbursed in key European countries; the FDA will approve the F8 formulation and the multi-dose pen injector; the Company will succeed in pursuing the conduct of its Phase 1 clinical trial using TH1902; the Company will be able to secure additional resources to initiate its Phase 3 clinical trial evaluating tesamorelin for the treatment of NASH; research and development activities using peptides derived from its oncology platform will yield positive results allowing for the development of new drugs for the treatment of cancer; the Company’s European infrastructure is adequate to commercialize Trogarzo® in the EU; and the Company’s business plan will not be substantially modified.

Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond Theratechnologies’ control that could cause actual results to differ materially from those that are disclosed in or implied by such Forward-Looking Statements. These risks and uncertainties include, but are not limited to, those related to or arising from: the adverse impact of the COVID-19 pandemic on (a) the Company’s sales efforts and sales initiatives, (b) the capacity of the Company’s suppliers to meet their obligations vis-à-vis the Company, (c) the Company’s research and development activities, (d) the health of the Company’s employees and its capacity to rely on its resources, as well as (e) global trade; the Company’s ability and capacity to grow the sales of EGRIFTA SV® and Trogarzo® successfully in the United States and Trogarzo® in Europe; the Company’s capacity to meet supply and demand for its products; the market acceptance of EGRIFTA SV® and Trogarzo® in the U.S. and of Trogarzo® in Europe; the continuation of the Company’s collaborations and other significant agreements with its existing commercial partners and third-party suppliers and its ability to establish and maintain additional collaboration agreements; the Company’s success in continuing to seek and maintain reimbursements for EGRIFTA SV® and Trogarzo® by third-party payors in the U.S.; the success and pricing of other competing drugs or therapies that are or may become available in the marketplace; the Company’s ability to protect and maintain its intellectual property rights in EGRIFTA SV® and tesamorelin; the Company’s success in

 

      2

Theratechnologies Inc.

2015 Peel Street, 11th Floor

Montreal, Québec H3A 1T8

     


obtaining reimbursement for Trogarzo® in key European countries, together with the level of reimbursement, if at all; the Company’s ability and capacity to commercialize Trogarzo® in key countries in the EU; the Company’s ability to obtain the approval by the FDA of the F8 formulation and the multi-dose pen injector; the Company’s ability to secure additional resources to initiate its Phase 3 clinical trial evaluating tesamorelin for the treatment of NASH; the Company’s ability to successfully conduct its Phase 3 clinical trial using tesamorelin for the treatment of NASH and its Phase 1 clinical trial using TH1902 in various types of cancer; the Company’s ability to find a partner on terms satisfactory to the Company; the Company’s capacity to acquire or in-license new products and/or compounds; the discovery of a cure for HIV; the Company’s expectations regarding its financial performance, including revenues, expenses, gross margins, profitability, liquidity, capital expenditures and income taxes; and the Company’s estimates regarding its capital requirements.

In addition to the risks inherent to the conduct of clinical trials, there exist risks that the FDA will not approve tesamorelin for the treatment of NASH without the Company having substantial evidence and data from the conduct of Phase 2 clinical trials evaluating tesamorelin for the treatment of NASH in the general population and solely relying on data emanating from the conduct of one Phase 3 clinical trial. There is also risk that the FDA may require additional clinical trials to be conducted in order to obtain approval. Moreover, there exist risks that the EMA will not approve tesamorelin for the treatment of NASH because the trial design that the Company intends to pursue does not include the primary endpoint required under the current EMA guidelines.

We refer current and potential investors to the “Risk Factors” section of our Annual Information Form dated February 24, 2021 available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov as an exhibit to our report on Form 40-F dated February 25, 2021 under Theratechnologies’ public filings for additional risks related to the Company. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on Forward-Looking Statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this MD&A and represent our expectations as of that date.

We undertake no obligation to update or revise the information contained in this MD&A, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.

BUSINESS OVERVIEW

Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. We have a promising pipeline of investigational medicines in oncology and NASH and two approved medicines (EGRIFTA SV® and Trogarzo®) for people living with HIV. The Company has a sales and marketing infrastructure to commercialize its products in the U.S. and Europe. We continue to assess the market for potential product acquisitions or in-licensing transactions that would be complementary to our business and further drive future sustainable growth and value creation.

RECENT AND NOTABLE UPDATES

Pipeline Updates

 

      3

Theratechnologies Inc.

2015 Peel Street, 11th Floor

Montreal, Québec H3A 1T8

     


   

TH1902 Study Update: The Company’s Phase 1 study evaluating its novel investigational proprietary peptide-drug conjugate (PDC) TH1902 for the treatment of sortilin-positive cancers is progressing as planned. To date, the study has dosed several patients with tumors for which no known effective therapies exist, with some receiving more docetaxel, when conjugated to TH1902, than the indicated dose of docetaxel alone (80-100mg/m2). Patients that have received up to 300mg/m2 of TH1902 (the equivalent of 130mg/m2 of docetaxel), or approximately 1.5 times the indicated dose of docetaxel, have not experienced any grade 2 adverse events. The last patient dosed received 420mg/m2 of TH1902, or approximately 2 times the indicated dose of docetaxel, and experienced a grade 4 adverse event (neutropenia). The Company is awaiting all safety information to assess the next dosing level and to pursue the study as per the protocol. Part A of the Phase 1 trial is ongoing until the maximum tolerated dose (MTD) is identified. Theratechnologies’ expects to provide another update on the Phase 1/Part A study when it has reached MTD of TH1902.

 

   

Phase 3 Development of Tesamorelin for NASH: The Company continues to evaluate its opportunities to most effectively execute its Phase 3 development program evaluating tesamorelin for the treatment of NASH, including seeking a potential partner. Theratechnologies previously announced that an external U.S.-based biopharma advisory firm was retained to assist in identifying a potential partnership for this program. On September 13, 2021, Theratechnologies hosted a virtual NASH event featuring key opinion leaders (KOLs) in hepatology and NASH, which was well-attended.

 

   

Lifecycle Management for Treatment of HIV: Based on an internal data assessment, the TMB-302 study evaluating an intravenous (IV) Push mode of administration of Trogarzo® for the treatment of HIV-1 infection achieved consistent and statistically significant results demonstrating that there was no difference in pharmacokinetics (PK) between IV Push and IV Infusion. This more convenient IV Push mode of administration may offer patients a rapid infusion time and requires only two quick infusions per month potentially increasing patient compliance and thereby allowing patients to benefit from long-acting protection against HIV-1 when Trogarzo® is administered with other antiretrovirals. Based on these results, an sBLA is expected to be filed with the FDA in the fourth quarter of 2021. Theratechnologies and TaiMed Biologics Inc. (TaiMed) are also evaluating an intramuscular (IM) method of administration for Trogarzo® within the TMB-302 study. Patient screening for the IM study is planned for the fourth quarter of Fiscal 2021.

 

   

TH1902 Preclinical Data Published in Peer-Reviewed Journal, Cancer Science: Preclinical research of TH1902 for the treatment of sortilin-positive triple negative breast cancer (TNBC) was published in the peer-reviewed journal Cancer Science, confirming the in vivo efficacy and safety of TH1902 against TNBC through a SORT1 receptor-mediated mechanism. This research also further supports sortilin as a potential targetable biomarker for hard-to-treat cancers.

 

   

New Preclinical Findings for TH1902 for Potential Treatment of Metastatic Cancers: In June 2021, the Company announced new preclinical in vivo findings

 

      4

Theratechnologies Inc.

2015 Peel Street, 11th Floor

Montreal, Québec H3A 1T8

     


 

on the anti-metastatic effect and tolerability of TH1902. If confirmed in humans, the Company believes TH1902 could be used in the treatment of metastasis.

Commercial Updates

 

   

Trogarzo® Pricing Agreement in Italy: Theratechnologies and the Italian Medicines Agency, AIFA, have reached a pricing and reimbursement agreement for Trogarzo®. The Company expects Trogarzo to be commercially available to all eligible patients in Italy before the end of 2021.

 

   

Trogarzo® PROMISE Study: The Company is initiating a post-authorization study in the EU evaluating the real-world long-term efficacy and safety of Trogarzo® in combination with other antiretrovirals. The study, named Prospective and Retrospective, Observational Multicenter Ibalizumab Study of Efficacy (PROMISE), is expected to enroll patients in the EU in the fourth quarter of 2021. A similar study which is intended to collect real-world clinical data of Trogarzo® in the U.S. (PROMISE-US), is expected to begin in the U.S. in the first quarter of 2022. 

Corporate Updates

 

   

Appointment of Mace Rothenberg, M.D. as Oncology Advisor: Theratechnologies recently appointed Mace Rothenberg, M.D. as a scientific advisor for the Company’s SORT1+ Technology oncology platform. Dr. Rothenberg brings more than 30 years of experience across government, academia and the biopharmaceutical industry, most recently serving as Chief Medical Officer (CMO) at Pfizer before his retirement earlier this year. During his time at Pfizer as CMO, the company initiated, completed and obtained emergency use authorization for its COVID-19 vaccine and obtained regulatory approval for 11 new cancer medicines. Dr. Rothenberg is a Fellow of the American College of Physicians and the American Society of Clinical Oncology.

 

   

New At-The-Market Facility Established: On July 23, 2021, the Company announced that it established an at-the-market (ATM) equity program allowing Theratechnologies to issue and sell up to US $50 million of common shares from treasury to the public at the Company’s sole discretion and at the prevailing market price.

 

   

New Board Member Appointed: In June 2021, the Company appointed Mr. Frank Holler as an independent member to its Board of Directors. Mr. Holler is a recognized biotechnology industry leader with expertise in capital markets.

OUR MEDICINES

The Company has two approved medicines for people living with HIV, namely Trogarzo® in the U.S., EU, and United Kingdom (UK), and EGRIFTA SV® in the U.S. EGRIFTA® is commercially available in Canada, but sales of EGRIFTA® in Canada are not material to our business.

 

      5

Theratechnologies Inc.

2015 Peel Street, 11th Floor

Montreal, Québec H3A 1T8

     


EGRIFTA SV® is a new formulation of EGRIFTA® that was approved by the FDA for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy and launched in the United States in November 2019. Unlike EGRIFTA®, EGRIFTA SV® can be kept at room temperature, comes in a single vial and has a higher concentration resulting in a smaller volume of administration.

Trogarzo® was the first HIV treatment approved with a new mechanism of action in more than 10 years. It is the first in a new class of antiretrovirals (ARV) and is a long-acting ARV therapy that can lead to an undetectable viral load in heavily treatment-experienced adult HIV-infected patients when used in combination with other ARVs. The treatment is infused once every two weeks.

Trogarzo® was approved by the FDA in March 2018 for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant (MDR) HIV-1 infection failing their current antiretroviral regimen. Trogarzo® was also approved by the EMA in September 2019 for the treatment of adults infected with MDR HIV-1 for whom it is otherwise not possible to construct a suppressive antiviral regimen. Trogarzo® is currently commercially available in Germany and in the fourth quarter of 2021, the Company secured a pricing agreement for Trogarzo® in Italy. A number of patients are also being treated with Trogarzo® in other European countries through early access programs. Trogarzo® will be launched on a country-by-country basis across Europe as it gains reimbursement in each individual country. In addition, the Company has received regulatory approval in Israel for Trogarzo® and is working to secure pricing and reimbursement.

In March 2016, we obtained the rights to commercialize Trogarzo® in the U.S. and Canada pursuant to a distribution and licensing agreement with TaiMed. In March 2017, the agreement was amended to include the commercial rights to Trogarzo® in the EU and in other countries such as Israel, Norway, Russia and Switzerland (TaiMed Agreement).

The Company’s commercial strategy for the 2021 fiscal year is to generate revenue growth through increased sales of its medicines in the U.S. while working on securing an appropriate price and widespread reimbursement for Trogarzo® in key European countries and pursue the launch of Trogarzo® in those key European countries.

OUR PIPELINE

Theratechnologies has established a promising pipeline of investigational medicines in areas of high unmet need, including oncology, NASH and HIV.

SORT1+ Technology

The Company is currently developing a platform of new proprietary peptides for cancer drug development targeting SORT1 receptors called SORT1+ TechnologyTM. SORT1 is a receptor that plays a significant role in protein internalization, sorting and trafficking. It is highly expressed in cancer cells compared to healthy tissue making it an attractive target for cancer drug development. Expression has been demonstrated in, but not limited to, ovarian, triple-negative breast, endometrial, skin, small cell and non-small cell lung, colorectal and pancreatic cancers. Expression of SORT1 is associated with aggressive disease, poor prognosis and decreased survival. It is estimated that the SORT1 receptor is expressed in 40% to 90% of cases of endometrial, ovarian, colorectal, triple-negative breast and pancreatic cancers.

 

      6

Theratechnologies Inc.

2015 Peel Street, 11th Floor

Montreal, Québec H3A 1T8

     


The Company’s innovative PDCs generated through our SORT1+ Technology demonstrate distinct pharmacodynamic and pharmacokinetic properties that differentiate them from traditional chemotherapy. In contrast to traditional chemotherapy, our proprietary PDCs are designed to enable selective delivery of certain anti-cancer drugs within the tumor microenvironment, and more importantly, directly inside SORT1 cancer cells. Commercially available anticancer drugs, like docetaxel, doxorubicin or tyrosine kinase inhibitors are conjugated to our PDC to specifically target SORT1 receptors. This could potentially improve the efficacy and safety of those agents.

In preclinical data, the Company’s lead investigational PDC, TH1902, derived from our SORT1+ Technology, has shown to improve anti-tumor activity and reduce neutropenia and systemic toxicity compared to traditional chemotherapy. Additionally, in preclinical models, TH1902 has shown to bypass the multidrug resistance protein 1 (MDR1; also known as P-glycoprotein) and inhibit the formation of vasculogenic mimicry - two key resistance mechanisms of chemotherapy treatment. TH1902 combines our proprietary peptide to the cytotoxic drug docetaxel.

In December 2020, we filed an IND application with the FDA for the Phase 1 first-in-human clinical trial evaluating TH1902 for the treatment of various cancers. The FDA granted fast track designation to TH1902 as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. In March 2021, a Phase 1 clinical trial was initiated evaluating TH1902 for the treatment of cancers where the sortilin receptor is expressed. The Phase 1 clinical trial design includes a Part A dose escalation study to evaluate the safety, pharmacokinetics, MTD and preliminary anti-tumor activity of TH1902 administered once every three weeks in patients with advanced solid tumors refractory to available anti-cancer therapies. Once the MTD is determined, the Company expects a total of 40 additional patients will be enrolled in a Part B study to evaluate the potential anti-tumor activity of TH1902 in patients with endometrial, ovarian, colorectal, triple-negative breast and pancreatic cancers.

See “Recent and Notable Updates – TH1902 Study Update” above for a description of the status of the Phase 1 study.

The Company has retained the services of a global, large-scale CRO to assist with the conduct of its Phase 1 clinical trial. The detailed study protocol is available at ClinicalTrials.gov under the identifier number: NCT04706962.

The Company is also evaluating TH1904 in preclinical research, its second PDC derived from its SORT1+ Technology. TH1904 is conjugated to the cytotoxic drug doxorubicin.

The SORT1+ Technology was acquired in February 2019 as part of the acquisition of Katana Biopharma Inc., (Katana). Through the acquisition, Theratechnologies obtained the worldwide rights to this platform based on an exclusive royalty-bearing license entered into between Katana and Transfer Plus L.P. The Canadian Cancer Society and the Government of Quebec, through the Consortium Québécois sur la découverte du médicament (CQDM), will contribute a total of 1.4 million dollars towards some of the research currently being conducted for the development of our targeted oncology platform.

Tesamorelin

 

      7

Theratechnologies Inc.

2015 Peel Street, 11th Floor

Montreal, Québec H3A 1T8

     


In fiscal year 2020, the Company completed the evaluation and development of the F8 formulation, which based on internal studies, is bioequivalent to the original commercialized formulation of tesamorelin (F1 formulation). The F8 formulation has a number of advantages over the current formulation of EGRIFTA SV®. Specifically, it is twice as concentrated resulting in a smaller volume of administration and is intended to be presented in a multi-dose vial that can be reconstituted once per week. Similar to the current formulation of EGRIFTA SV®, the F8 formulation is stable at room temperature, even once reconstituted.

The F8 formulation is patent protected in the U.S. until 2033 and until 2034 in major European countries.

The Company is currently working on the development of a multi-dose pen injector to be used in conjunction with the F8 formulation and we intend to seek marketing approval of the pen. We plan to file an sBLA for the F8 formulation in early 2022 for the treatment of lipodystrophy in people living with HIV. An sBLA filing of the multi-dose pen injector is expected to be filed later in 2022.

In November 2020, the Company filed an IND with the FDA for the Phase 3 clinical trial evaluating tesamorelin for the treatment of NASH and received a “Study May Proceed” letter for the Phase 3 clinical trial from the FDA in December 2020. The IND filing followed our announcement made in September 2020 regarding our intent to develop tesamorelin for the treatment of NASH in the general population.    

On July 15, 2021, the Company announced that it had completed discussions with the FDA and the EMA regarding the Phase 3 clinical trial in NASH.

The finalized Phase 3 trial design is planned for a multicenter, randomized, double-blind, placebo-controlled two-part study designed to evaluate the safety and efficacy of tesamorelin in liver-biopsy confirmed patients with NAS score of at least 4 and stage 2 or 3 fibrosis. Part 1 of the study will include a total of approximately 1,100 patients (1:1, tesamorelin:placebo), including approximately 75 to 100 people living with HIV. A second liver biopsy will be performed after the first approximately 1,100 participants have completed 18 months of treatment. This should form the basis for filing an sBLA with the FDA.

The clinical trial will also include a futility analysis that would be conducted after the first approximately 400 patients have completed 18 months of treatment and have received a second liver biopsy. The futility analysis will provide a perfunctory review indicating if an early treatment effect with tesamorelin has been observed and will determine if the study should proceed as planned.

Following a potential sBLA approval, Part 2 of the trial will continue to enroll an additional approximately 1,800 patients (3:1, tesamorelin:placebo) to continue to measure clinical outcomes over a period of five years. A total of approximately 2,900 patients are expected to be enrolled.

Based on regulatory discussions, the final Phase 3 clinical trial design will result in higher costs than what the Company had previously estimated. As a result of the total cost of the Phase 3 clinical trial, the Company is evaluating its options to best execute its late-

 

      8

Theratechnologies Inc.

2015 Peel Street, 11th Floor

Montreal, Québec H3A 1T8

     


stage development program, including seeking a potential partner. An external U.S.-based biopharma advisory firm was retained to assist in identifying a potential partner.

Ibalizumab for HIV

Based on an internal data assessment, the TMB-302 study evaluating an intravenous (IV) Push mode of administration of Trogarzo® for the treatment of HIV-1 infection achieved consistent and statistically significant results demonstrating that there was no difference in pharmacokinetics (PK) between IV Push and IV Infusion. This more convenient IV Push mode of administration may offer patients a rapid infusion time and requires only two quick infusions per month potentially increasing patient compliance thereby allowing patients to benefit from long-acting protection against HIV-1 when Trogarzo® is administered with other ARVs. Based on these results, an sBLA is expected to be filed with the FDA in the fourth quarter of 2021. The study was conducted and funded by the Company’s partner, TaiMed.

Theratechnologies and TaiMed are also evaluating an intramuscular (IM) method of administration for Trogarzo® within the TMB-302 study. A protocol amendment was approved by the FDA and patient screening is planned for the fourth quarter of 2021. The study will be conducted and funded by Theratechnologies with support from TaiMed. Under the terms of the TaiMed Agreement, we are entitled to commercialize the new methods of administration of Trogarzo® if, and when, approved.

In connection with the September 2019 approval of Trogarzo® in Europe, the Company is initiating a post-authorization efficacy study (Registry) in the EU to evaluate the real-world long-term efficacy and safety of Trogarzo® in combination with other ARVs, at the EMA’s request. The study, named Prospective and Retrospective, Observational Multicenter Ibalizumab Study of Efficacy (PROMISE), is expected to have sites activated in the EU in the fourth quarter of 2021. A similar study, which is intended to collect real-world clinical data of Trogarzo® in the U.S. (PROMISE-US), is expected to begin in the first quarter of 2022.

2021 BUSINESS STRATEGY AND OBJECTIVES

Our 2021 Business Strategies and Objectives are as follows:

   

Continue to grow our revenues in the United States from increased sales of EGRIFTA SV® and Trogarzo®;

 

   

Successfully obtain reimbursement for Trogarzo® in key European countries and launch Trogarzo® in some of these countries;

 

   

Initiate a Phase 3 clinical trial evaluating tesamorelin for the treatment of NASH by the end of the third quarter of calendar year 2021; (new trial initiation timeframe to be determined following securing additional resources or potential partnership agreement)

 

   

Initiate a Phase 1 clinical trial evaluating TH1902 for the treatment of various cancer types in the second quarter of calendar year 2021 (achieved in Q1’21 ahead of target);

 

   

Seek and pursue potential product acquisitions, in-licensing transactions or other opportunities complementary to our business; and,

 

   

Manage our financial position to ensure we can successfully execute on our business strategy and objectives.

 

      9

Theratechnologies Inc.

2015 Peel Street, 11th Floor

Montreal, Québec H3A 1T8

     


Third-Quarter Fiscal 2021 Financial Results

Revenue

Consolidated revenue for the three and nine-month periods ended August 31, 2021 was $17,852,000 and $51,069,000 compared to $14,049,000 and $46,930,000 for the same periods ended August 31, 2020.

Revenue for the third quarter of 2021 were up 27% compared to the third quarter of 2020. Most of that growth was attributable to strong EGRIFTA SV® revenues, which increased 64% over the same quarter last year. The strong third-quarter performance for EGRIFTA SV® was related to higher unit sales and a higher selling price and were also supported by stronger new prescriptions, a sign of a return to pre-COVID-19 levels. Sales of Trogarzo® were down 7.8% compared to the third quarter of last year. Lower unit sales were somewhat offset by a higher selling price and were the result of lower patient access to hospitals and clinics because of COVID-19, as well as the impact of a new competitor.

Cost of Sales

For the three- and nine-month periods ended August 31, 2021, cost of sales was $5,504,000 and $16,849,000 compared to $6,111,000 and $20,252,000 for the same periods ended August 31, 2020. Cost of goods sold was $4,283,000 and $13,187,000 in the three and nine-month periods of 2021 compared to $4,611,000 and $15,780,000 for the same periods in the previous year. The decrease in cost of goods sold was mainly due to lower cost of EGRIFTA SV® and lower unit sales of Trogarzo®, as well as a lower average cost for Trogarzo®. Cost of sales also included the amortization of the other asset of $1,221,000 and $3,662,000 for the three and nine-month periods ended August 31, 2021. In addition, cost of sales for the three- and nine-month periods ended August 31, 2020, include write-downs of $280,000 and $811,000 to recognize inventories at net realizable value, which included write-downs of $422,000 during the nine-month period ended August 31, 2020 on excess stock of EGRIFTA® mainly due to the Company’s decision to switch patients to and only actively commercialize EGRIFTA SV® in the U.S. No such amounts were recorded for the three- and nine-month periods ended August 31, 2021.

R&D Expenses

R&D expenses for the three- and nine-month periods ended August 31, 2021 amounted to $8,296,000 and $19,596,000 compared to $4,183,000 and $11,224,000 in the comparable periods of Fiscal 2020.

The increase was largely due to the development of our oncology platform, the preparation of our Phase 3 trial for tesamorelin in the treatment of NASH, the F8 formulation and the multi-dose pen injector, as well as regulatory expenses and increased medical education initiatives in Europe in preparation for the Trogarzo® launch.

Selling Expenses

Selling expenses increased to $7,669,000 and $20,728,000 for the three- and nine-month periods ended August 31, 2021 compared to $7,025,000 and $20,327,000 for the same periods last year.

The increase was mainly associated with increased activities in Europe in preparation for the Trogarzo® launch.

 

      10

Theratechnologies Inc.

2015 Peel Street, 11th Floor

Montreal, Québec H3A 1T8

     


General and Administrative Expenses

General and administrative expenses in the three- and nine-month periods ended August 31, 2021 amounted to $3,633,000 and $11,079,000 compared to $2,699,000 and $8,975,000 reported in the comparable periods of Fiscal 2020.

The increase in general and administrative expenses was mainly associated with an overall increase in business activities, senior hires to support our sales activities in the U.S., and increased activity in Europe.

Net Finance Costs

Net finance costs for the three- and nine-month periods ended August 31, 2021 were $(2,254,000) and $(4,609,000) compared to $(799,000) and $(3,270,000) in the comparable periods of Fiscal 2020.

The change in finance income and finance costs in 2021 versus the comparable periods in 2020 was mostly due to foreign currency variations. We recorded a net foreign currency loss of $851,000 in the three-month period ended August 31, 2021, versus a net foreign currency gain of $496,000 in the same period in 2020. For the nine-month period ended August 31, 2021, we recorded a net foreign currency loss of $449,000 versus a net foreign currency gain of $471,000 in the same period in 2020.

Finance costs also included accretion expense, which was $612,000 for the third quarter of 2021 and $1,801,000 for the nine-month period ended August 31, 2021 compared to $485,000 and $1,508,000 for the same periods last year.

Adjusted EBITDA

For the reasons noted above, Adjusted EBITDA, which is a non-GAAP measure, for the three- and nine- month periods ended August 31, 2021 was $(4,648,000) and $(9,085,000) compared to $(3,149,000) and $(5,676,000) in the comparable periods of Fiscal 2020. See “Non-IFRS Financial Measures” below.

Net loss

Taking into account the revenue and expense variations described above, we recorded a net loss of $9,510,000 or $(0.10) per share in the third quarter of Fiscal 2021 and a net loss of $21,824,000 or $(0.24) per share for the nine-month period ended August 31, 2021 compared to a net loss of $6,768,000 or $(0.09) per share in the three-month period ended August 31, 2020 and a net loss of $17,118,000 or $(0.22) per share compared to the nine-month period ended August 31, 2020.

Financial Position

For the three- and nine-month periods ended August 31, 2021, cash flow generated/(used) in operating activities was $(3,133,000) and $(9,077,000) compared to $277,000 and $(7,648,000) for the same periods last year.

In the third quarter of Fiscal 2021, changes in operating assets and liabilities had a positive impact on cash flow of $1,421,000. These changes were mainly due to an increase in accounts payables and accrued liabilities of $2,843,000, a decrease in inventories of

 

      11

Theratechnologies Inc.

2015 Peel Street, 11th Floor

Montreal, Québec H3A 1T8

     


$1,157,000, which were offset by an increase in trade and other receivables of $2,800,000.

In the first nine months of Fiscal 2021, changes in operating assets and liabilities positively affected cash flow by $185,000 and negatively impacted cash flow by $1,872,000 in the comparable period of fiscal 2020.

As of August 31, 2021, cash, bonds and money market funds amounted to $51,584,000. Based on management’s estimate and current level of operations, the current liquidity position is sufficient to finance the Company’s operations for at least the next 12 months.

 

      12

Theratechnologies Inc.

2015 Peel Street, 11th Floor

Montreal, Québec H3A 1T8

     


    Quarterly Financial Information

The following table is a summary of our unaudited consolidated operating results for the last eight quarters.

    (in thousands of dollars, except per share amounts)

 

      2021      2020      20191      
      Q3      Q2      Q1        Q4      Q3      Q2      Q1        Q4    

 Revenue

     17,852        17,787        15,430          19,123        14,049        17,162        15,719          16,400    

 Operating expenses

                                  

Cost of sales

                                            

Cost of goods sold

     4,283        4,714        4,190          5,190        4,611        5,769        5,400          5,754    

Other production-related costs

     -        -        -          240        280        391        140          14    

Amortization of other asset

     1,221        1,220        1,221          1,220        1,220        1,220        1,221          1,221    

R&D

     8,296        6,417        4,883          6,795        4,183        3,622        3,419          3,877    

Selling

     7,657        6,901        6,158          6,532        7,025        6,941        6,361          7,673    

General and administrative

     3,633        3,884        3,562          3,255        2,699        3,706        2,570          3,258    

 Total operating expenses

     25,090        23,316        20,014          23,232        20,018        21,649        19,111          21,797    

Net finance costs

     (2,254)        (1,023)        (1,332)          (1,424)        (799)        (1,319)        (1,152)          (1,058)    

Income taxes

     (18)        (20)        (6)          (16)        -        -        -          -    

 Net loss

     (9,510)        (6,392)        (5,922)          (5,549)        (6,768)        (5,806)        (4,544)          (6,455)    

 Basic and diluted loss per share

     (0.10)        (0.07)        (0.07)          (0.07)        (0.09)        (0.08)        (0.06)          (0.08)    

 

  1

The Company adopted IFRS 16 – Leases, using the modified retrospective approach, effective for Fiscal 2020, beginning on December 1, 2019. Accordingly, comparative figures for Fiscal 2019 have not been restated and continue to be reported under IAS 17–. See note 1 in the Audited Financial Statements for the year ended November 30, 2020.

 

      13

Theratechnologies Inc.

2015 Peel Street, 11th Floor

Montreal, Québec H3A 1T8

     


Factors Affecting the Variability of Quarterly Results

There are quarter-over-quarter variations in net sales revenue, principally due to changes in distributor inventory levels with some additional impact from time to time related to average net selling price, which is affected by changes in the mix of private payors versus government drug reimbursement plans.

Subsequent Event

Stock options

Between September 1, 2021 and October 11, 2021, no options were exercised.

Recent Changes in Accounting Standards

There were no changes in accounting standards during Q3 Fiscal 2021.

Outstanding Share Data

As of October 11, 2021, the Company had 95,121,639 common shares issued and outstanding, 8,130,550 warrants outstanding, and 3,598,171 outstanding options. We also had $57,500,000 aggregate principal amount of 5.75% convertible unsecured senior notes due June 30, 2023 issued and outstanding as a result of the Offering. These notes are convertible into common shares at the option of the holder at a conversion price of $14.85, representing a conversion rate of approximately 67.3401 common share per $1,000 principal amount of notes. The conversion of all of the outstanding notes would result in the issuance of 3,872,055 common shares.

Contractual Obligations

There was no material change in contractual obligations during the three-month period ended August 31, 2021.

Economic and Industry Factors

The WHO declared a global pandemic on March 11, 2020. Authorities around the world implemented confinement measures designed to curb the spread of the COVID-19. Those measures have severely limited face-to-face access to healthcare providers. The industry as a whole has had to adapt to this new reality and uncertainty remains.

Internal Control

There was no change in the Company’s internal control over financial reporting, or ICFR, that occurred during the three-month period ending August 31, 2021 that has materially affected, or is reasonably likely to materially affect, the Company’s ICFR.

Non-IFRS Financial Measures

Reconciliation of net profit or loss to adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA)

Adjusted EBITDA is a non-IFRS financial measure. A reconciliation of the Adjusted EBITDA to net loss is presented in the table below. We use adjusted financial measures to assess our operating performance. Securities regulations require that companies caution readers that earnings and other measures adjusted to a basis other than IFRS do not have standardized meanings and are unlikely to be comparable to similar measures used by other companies. Accordingly, they should not be considered in isolation. We use

 

      14

Theratechnologies Inc.

2015 Peel Street, 11th Floor

Montreal, Québec H3A 1T8

     


Adjusted EBITDA to measure operating performance from one period to the next without the variation caused by certain adjustments that could potentially distort the analysis of trends in our business, and because we believe it provides meaningful information on our financial condition and operating results.

We obtain our Adjusted EBITDA measurement by adding to net profit or loss, finance income and costs, depreciation and amortization, and income taxes. We also exclude the effects of certain non-monetary transactions recorded, such as share-based compensation and write-downs (or related reversals) of inventories, for our Adjusted EBITDA calculation. We believe it is useful to exclude these items as they are either non-cash expenses, items that cannot be influenced by management in the short term, or items that do not impact core operating performance. Excluding these items does not imply they are necessarily nonrecurring. Share-based compensation costs are a component of employee remuneration and can vary significantly with changes in the market price of the Company’s shares. In addition, other items that do not impact core operating performance of the Company may vary significantly from one period to another. As such, Adjusted EBITDA provides improved continuity with respect to the comparison of our operating results over a period of time. Our method for calculating Adjusted EBITDA may differ from that used by other companies.

 

      15

Theratechnologies Inc.

2015 Peel Street, 11th Floor

Montreal, Québec H3A 1T8

     


Adjusted EBITDA

(In thousands of U.S. dollars)

 

                                                                                                   
    

Three-month periods

ended August 31,

 

      

Nine-month periods

ended August 31,

 

 

 

   2021        2020        2021      2020  

Net loss

     (9,510)          (6,768)          (21,824)        (17,118)  

Add (deduct):

               

Depreciation and amortization

     2,189          2,189          6,559        6,328  

Net finance costs

     2,254          799          4,609        3,270  

Share-based compensation

     401          349          1,527        1,168  

Write-down of inventories

     -          282          -        676  

Income taxes

     18          -          44        -  

Adjusted EBITDA

     (4,648)          (3,149)          (9,085)        (5,676)  

 

      16

Theratechnologies Inc.

2015 Peel Street, 11th Floor

Montreal, Québec H3A 1T8

     
EX-99.3

Exhibit 99.3

FORM 52-109F2

CERTIFICATION OF INTERIM FILINGS

FULL CERTIFICATE

I, Paul Lévesque, President and Chief Executive Officer of Theratechnologies Inc., certify the following:

 

1.

Review: I have reviewed the interim financial statements and interim MD&A, (together, the “interim filings”) of Theratechnologies Inc. (the “issuer”) for the interim period ended August 31, 2021.

 

2.

No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings.

 

3.

Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial statements together with the other financial information included in the interim filings fairly present in all material respects the financial condition, results of operations and cash flows of the issuer, as of the date of and for the periods presented in the interim filings.

 

4.

Responsibility: The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (“DC&P”) and internal control over financial reporting (“ICFR”), as those terms are defined in Regulation 52-109 respecting Certification of Disclosure in Issuers’ Annual and Interim Filings, for the issuer.

 

5.

Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officers(s) and I have, as at the end of the period covered by the interim filings

 

  (a)

designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that

 

  (i)

material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and

 

  (ii)

information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and

 

  (b)

designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP.

 

5.1

Control framework: The control framework the issuer’s other certifying officer(s) and I used to design the issuer’s ICFR is the Internal Control over Financial Reporting – Guidance for Smaller Public Companies (COSO).

 

5.2

N/A

 

5.3

N/A


6.

Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer’s ICFR that occurred during the period beginning on June 1, 2021 and ended on August 31, 2021 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.

 

Date: October 13, 2021

(Signed) Paul Lévesque

 

 

Paul Lévesque
President and Chief Executive Officer

 

- 2 -

EX-99.4

Exhibit 99.4

FORM 52-109F2

CERTIFICATION OF INTERIM FILINGS

FULL CERTIFICATE

I, Philippe Dubuc, Senior Vice President and Chief Financial Officer of Theratechnologies Inc., certify the following:

 

1.

Review: I have reviewed the interim financial statements and interim MD&A, (together, the “interim filings”) of Theratechnologies Inc. (the “issuer”) for the interim period ended August 31, 2021.

 

2.

No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings.

 

3.

Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial statements together with the other financial information included in the interim filings fairly present in all material respects the financial condition, results of operations and cash flows of the issuer, as of the date of and for the periods presented in the interim filings.

 

4.

Responsibility: The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (“DC&P”) and internal control over financial reporting (“ICFR”), as those terms are defined in Regulation 52-109 respecting Certification of Disclosure in Issuers’ Annual and Interim Filings, for the issuer.

 

5.

Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officers(s) and I have, as at the end of the period covered by the interim filings

 

  (a)

designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that

 

  (i)

material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and

 

  (ii)

information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and

 

  (b)

designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP.

 

5.1

Control framework: The control framework the issuer’s other certifying officer(s) and I used to design the issuer’s ICFR is the Internal Control over Financial Reporting – Guidance for Smaller Public Companies (COSO).

 

5.2

N/A

 

5.3

N/A


6.

Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer’s ICFR that occurred during the period beginning on June 1, 2021 and ended on August 31, 2021 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.

Date: October 13, 2021

 

(Signed) Philippe Dubuc

 

Philippe Dubuc
Senior Vice President and Chief Financial Officer

 

- 2 -