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
April 10, 2024
Commission File Number 001-35203
THERATECHNOLOGIES INC.
(Translation of registrants 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 registrants home country), or under the rules of the home country exchange on which the registrants securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrants security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ☐ No ☒
If Yes is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-______________.
THERATECHNOLOGIES INC.
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/ Philippe Dubuc | |
Name: |
Philippe Dubuc | |
Title: Senior Vice President and Chief Financial Officer |
Date: April 10, 2024
Exhibit 99.1
Interim Consolidated Financial Statements
(In thousands of United States dollars)
THERATECHNOLOGIES INC.
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
THERATECHNOLOGIES INC.
Table of Contents
(In thousands of United States dollars)
(Unaudited)
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 - 21 |
THERATECHNOLOGIES INC.
Interim Consolidated Statements of Financial Position
(In thousands of United States dollars)
As at February 29, 2024 and November 30, 2023
(Unaudited)
Note | February 29, 2024 |
November 30, 2023 |
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Assets |
||||||||||||
Current assets |
||||||||||||
Cash |
$ | 32,240 | $ | 34,097 | ||||||||
Bonds and money market funds |
6,213 | 6,290 | ||||||||||
Trade and other receivables |
9,996 | 13,023 | ||||||||||
Tax credits and grants receivable |
499 | 524 | ||||||||||
Income taxes receivable |
| 4 | ||||||||||
Deferred tax assets |
| 29 | ||||||||||
Inventories |
5 | 6,303 | 6,066 | |||||||||
Prepaid expenses and deposits |
2,587 | 3,154 | ||||||||||
Derivative financial assets |
103 | 110 | ||||||||||
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Total current assets |
57,941 | 63,297 | ||||||||||
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Non-current assets |
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Property and equipment |
1,133 | 1,206 | ||||||||||
Right-of-use assets |
686 | 770 | ||||||||||
Intangible assets |
12,136 | 12,496 | ||||||||||
Deferred tax assets |
29 | | ||||||||||
Deferred financing costs |
165 | | ||||||||||
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Total non-current assets |
14,149 | 14,472 | ||||||||||
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Total assets |
$ | 72,090 | $ | 77,769 | ||||||||
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Liabilities |
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Current liabilities |
||||||||||||
Accounts payable and accrued liabilities |
$ | 29,929 | $ | 28,471 | ||||||||
Provisions |
6 | 6,195 | 9,603 | |||||||||
Current portion of Loan Facility |
7 | 12,354 | 7,286 | |||||||||
Current portion of lease liabilities |
8 | 431 | 421 | |||||||||
Marathon Warrants |
9(b) | 1,262 | 1,475 | |||||||||
Income taxes payable |
106 | | ||||||||||
Deferred revenue |
38 | 38 | ||||||||||
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Total current liabilities |
50,315 | 47,294 | ||||||||||
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Non-current liabilities |
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Loan Facility |
7 | 45,895 | 50,688 | |||||||||
Lease liabilities |
8 | 460 | 573 | |||||||||
Other liabilities |
22 | 84 | ||||||||||
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Total non-current liabilities |
46,377 | 51,345 | ||||||||||
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Total liabilities |
96,692 | 98,639 | ||||||||||
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Equity |
||||||||||||
Share capital and warrants |
9 | 363,927 | 363,927 | |||||||||
Contributed surplus |
23,867 | 23,178 | ||||||||||
Deficit |
(413,140 | ) | (408,659 | ) | ||||||||
Accumulated other comprehensive income |
744 | 684 | ||||||||||
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Total equity |
(24,602 | ) | (20,870 | ) | ||||||||
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Total liabilities and equity |
$ | 72,090 | $ | 77,769 | ||||||||
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The accompanying notes are an integral part of these interim consolidated financial statements.
1
THERATECHNOLOGIES INC.
Interim Consolidated Statements of Comprehensive Loss
(In thousands of United States dollars, except per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
Note | 2024 | 2023 | ||||||||||
Revenue |
3 | $ | 16,247 | $ | 19,908 | |||||||
Operating expenses |
||||||||||||
Cost of goods sold |
5,284 | 4,693 | ||||||||||
Research and development expenses, net of tax credits of $32 (2023 $72) |
3,752 | 9,356 | ||||||||||
Selling expenses |
5,701 | 6,814 | ||||||||||
General and administrative expenses |
3,756 | 4,452 | ||||||||||
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Total operating expenses |
18,493 | 25,315 | ||||||||||
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Loss from operating activities |
(2,246 | ) | (5,407 | ) | ||||||||
Finance income |
4 | 629 | 348 | |||||||||
Finance costs |
4 | (2,754 | ) | (5,288 | ) | |||||||
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(2,125 | ) | (4,940 | ) | |||||||||
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Loss before income taxes |
(4,371 | ) | (10,347 | ) | ||||||||
Income tax expense |
(110 | ) | (96 | ) | ||||||||
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Net loss for the period |
(4,481 | ) | (10,443 | ) | ||||||||
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Other comprehensive income (loss), net of tax |
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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) financial assets |
60 | 77 | ||||||||||
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60 | 77 | |||||||||||
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Total comprehensive loss for the period |
$ | (4,421 | ) | $ | (10,366 | ) | ||||||
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Basic and diluted loss per share |
9(d) | (0.10 | ) | (0.43 | ) | |||||||
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The accompanying notes are an integral part of these interim consolidated financial statements.
2
THERATECHNOLOGIES INC.
Interim Consolidated Statements of Changes in Equity
(In thousands of United States dollars, except for share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
For the three-month period ended February 28, 2023 |
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Note | Share capital and Public Offering Warrants |
Equity component of convertible notes |
Accumulated other comprehensive income |
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Number of shares(1) |
Amount | Contributed surplus |
Deficit | Total | ||||||||||||||||||||||||||||
Balance as at November 30, 2022 |
24,201,582 | 338,751 | 2,132 | 18,810 | (382,649 | ) | 385 | (22,571 | ) | |||||||||||||||||||||||
Total comprehensive loss for the period |
| | | (10,443 | ) | | (10,443 | ) | ||||||||||||||||||||||||
Net loss for the period |
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Other comprehensive income (loss): |
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Net change in fair value of FVOCI financial assets, net of tax |
| | | | | 77 | 77 | |||||||||||||||||||||||||
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Total comprehensive loss for the period |
| | | (10,443 | ) | 77 | (10,366 | ) | ||||||||||||||||||||||||
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Transactions with owners, recorded directly in equity |
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Share-based compensation for stock option plan |
| | | 626 | | | 626 | |||||||||||||||||||||||||
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Total contributions by owners |
| | | 626 | | | 626 | |||||||||||||||||||||||||
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Balance as at February 28, 2023 |
24,201,582 | $ | 338,751 | $ | 2,132 | $ | 19,436 | $ | (393,092 | ) | $ | 462 | $ | (32,311 | ) | |||||||||||||||||
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For the three-month period ended February 29, 2024 |
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Note | Share capital and Public Offering Warrants |
Equity component of convertible notes |
Accumulated other comprehensive income |
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Number of shares(1) |
Amount | Contributed surplus |
Deficit | Total | ||||||||||||||||||||||||||||
Balance as at November 30, 2023 |
45,980,019 | 363,927 | | 23,178 | (408,659 | ) | 684 | (20,870 | ) | |||||||||||||||||||||||
Total comprehensive loss for the period |
| | | | (4,481 | ) | | (4,481 | ) | |||||||||||||||||||||||
Net loss for the period |
||||||||||||||||||||||||||||||||
Other comprehensive income (loss): |
||||||||||||||||||||||||||||||||
Net change in fair value of FVOCI financial assets, net of tax |
| | | | | 60 | 60 | |||||||||||||||||||||||||
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Total comprehensive loss for the period |
| | | (4,481 | ) | 60 | (4,421 | ) | ||||||||||||||||||||||||
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Transactions with owners, recorded directly in equity |
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Share-based compensation for stock option plan |
9(c) | | | | 689 | | | 689 | ||||||||||||||||||||||||
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Total contributions by owners |
| | | 689 | | | 689 | |||||||||||||||||||||||||
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Balance as at February 29, 2024 |
45,980,019 | $ | 363,927 | $ | $ | 23,867 | $ | (413,140 | ) | $ | 744 | $ | (24,602 | ) | ||||||||||||||||||
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1 | See Note 1 for share consolidation. |
The accompanying notes are an integral part of these interim consolidated financial statements.
3
THERATECHNOLOGIES INC.
Interim Consolidated Statements of Cash Flows
(In thousands of United States dollars)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
Note | 2024 | 2023 | ||||||||||
Cash flows from (used in) |
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Operating |
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Net loss for the period |
$ | (4,481 | ) | $ | (10,443 | ) | ||||||
Adjustments for |
||||||||||||
Depreciation of property and equipment |
73 | 98 | ||||||||||
Amortization of intangible and other assets |
360 | 739 | ||||||||||
Amortization of right-of-use assets |
84 | 102 | ||||||||||
Share-based compensation for stock option plan and stock appreciation rights |
627 | 576 | ||||||||||
Gain on lease termination |
| (121 | ) | |||||||||
Change in fair value of derivative financial assets |
7 | 331 | ||||||||||
Change in fair value of liability related to deferred stock unit plan |
(3 | ) | (155 | ) | ||||||||
Interest on convertible unsecured senior notes and term loan |
4 | 2,274 | 1,784 | |||||||||
Interest paid on convertible unsecured senior notes and term loan |
(2,325 | ) | (2,188 | ) | ||||||||
Interest income |
(420 | ) | (227 | ) | ||||||||
Interest received |
430 | 240 | ||||||||||
Income tax expense |
110 | 96 | ||||||||||
Foreign exchange |
(26 | ) | 285 | |||||||||
Loss on Loan Facility modifications |
| 2,650 | ||||||||||
Accretion expense and amortization of deferred financing costs |
4 | 374 | 533 | |||||||||
Change in fair value of Marathon Warrants |
(213 | ) | | |||||||||
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(3,129 | ) | (5,700 | ) | |||||||||
Change in operating assets and liabilities |
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Trade and other receivables |
3,027 | 2,085 | ||||||||||
Tax credits and grants receivable |
24 | (72 | ) | |||||||||
Inventories |
(237 | ) | 4,578 | |||||||||
Prepaid expenses and deposits |
567 | 1,644 | ||||||||||
Accounts payable and accrued liabilities |
1,422 | (6,545 | ) | |||||||||
Provisions |
(3,382 | ) | 671 | |||||||||
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1,421 | 2,361 | |||||||||||
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(1,708 | ) | (3,339 | ) | |||||||||
Financing activities |
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Share issue costs |
(153 | ) | (37 | ) | ||||||||
Payments of lease liabilities |
8 | (122 | ) | (125 | ) | |||||||
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(275 | ) | (162 | ) | |||||||||
Investing activities |
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Proceeds from sale of bonds and money market funds |
134 | | ||||||||||
Acquisition of derivative financial assets |
| (104 | ) | |||||||||
Acquisition of property and equipment |
| (222 | ) | |||||||||
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134 | (326 | ) | ||||||||||
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Net change in cash during the period |
(1,849 | ) | (3,827 | ) | ||||||||
Cash, beginning of period |
34,097 | 23,856 | ||||||||||
Effect of foreign exchange on cash |
(8 | ) | (6 | ) | ||||||||
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Cash, end of period |
$ | 32,240 | $ | 20,023 | ||||||||
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Refer to Note 10 for supplemental cash flow disclosures.
The accompanying notes are an integral part of these interim consolidated financial statements.
4
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
Theratechnologies Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.
The consolidated financial statements (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).
The Company has one material wholly-owned subsidiary:
| Theratechnologies U.S., Inc., a company governed by the Delaware General Corporation Law (Delaware). Theratechnologies U.S., Inc. provides the services of personnel to Theratechnologies Inc. for its activities in the United States. |
Theratechnologies Inc. is governed by the Business Corporations Act (Québec) and is domiciled in Québec, Canada. The Company is located at 2015 Peel Street, Suite 1100, Montréal, Québec, H3A 1T8, Canada.
1. | Basis of preparation |
(a) | Share consolidation |
On July 19, 2023, the Board of Directors approved a consolidation of the issued and outstanding common shares (the Common Shares) on the basis of one for four (1-for-4) common shares (the Consolidation) effective July 31, 2023. All references in these Financial Statements to the number of common shares, Public Offering Warrants (as defined in Note 8(a)), Marathon Warrants (as defined in Note 8(b)), Options (as defined in Note 8(c)), weighted average number of common shares, basic and diluted loss per share and the exercise prices of the Public Offering Warrants, Marathon Warrants and Options have been retrospectively adjusted and restated to reflect the effect of the Consolidation for all periods presented.
(b) | Accounting framework |
These unaudited interim consolidated financial statements (interim financial statements), including comparative information, have been prepared in accordance with International Accounting Standard (IAS) 34, Interim Financial Reporting of International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB).
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, 2023 and the notes thereto.
These interim financial statements have been authorized for issue by the Companys Audit Committee on April 9, 2024.
(c) | Going concern uncertainty |
As part of the preparation of these Interim Financial Statements, management is responsible for identifying any event or situation that may cast doubt on the Companys ability to continue as a going concern. Substantial doubt regarding the Companys ability to continue as a going concern exists if events or conditions, considered collectively, indicate that the Company may be unable to honor its obligations as they fall due during a period of at least, but not limited to, 12 months from February 29, 2024. If the Company concludes that events or conditions cast substantial doubt on its ability to continue as a going concern, it must assess whether the plans developed to mitigate these events or conditions will remove any possible substantial doubt.
5
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
1. | Basis of preparation (continued) |
(c) | Going concern uncertainty (continued) |
For the three-month ended February 29, 2024, the Company incurred a net loss of $4,481 (2023-$10,443) and had positive cash flows from operating activities of $1,421 (2023- $2,361). As at February 29, 2024, cash amounted to $32,240 and bonds and money market funds amounted to $6,213.
The Companys Loan Facility contains various covenants, including minimum liquidity covenants whereby the Company needs to maintain significant cash, cash equivalent and eligible short-term investments balances in specified accounts, which restricts the management of the Companys liquidity (refer to Note 6). A breach of the liquidity covenant (a Liquidity Breach) provides the lender with the ability to demand immediate repayment of the Loan Facility and makes available to the lender the collateralized assets, which include substantially all cash, bonds and money market funds which are subject to control agreements, and may trigger an increase of 300 basis points of the interest rate on the outstanding loan balance. During fiscal 2023, the Company incurred a Liquidity Breach and entered into several amendments to the Marathon Credit Agreement to amend certain of the terms and conditions therein (see note 6).
As at February 29, 2024, the material covenants of the Marathon Credit Agreement, as amended, include: (i) minimum liquidity requirements to be between $15,000 and $20,000, based on the Marathon adjusted EBITDA (as defined in the Marathon Credit Agreement, the Marathon Adjusted EBITDA) targets over the most recently ended four fiscal quarters; and (ii) quarterly minimum Marathon Adjusted EBITDA targets. There is no assurance that the lender will agree to amend or to waive any future potential covenant breaches, if any. The Company does not meet the condition precedents to drawdown additional amounts under the Marathon Credit Agreement and does not currently have other committed sources of financing available to it.
The Companys ability to continue as a going concern for a period of at least, but not limited to, 12 months from February 29, 2024, involves significant judgement and is dependent on the adherence to the conditions of the Marathon Credit Agreement or to obtain the support of the lender (including possible waivers and amendments, if necessary), increase its revenues and the management of its expenses (including the reorganization mainly focused on its R&D activities in order to meet or exceed the Marathon Adjusted EBITDA target and generate sufficient positive operating cash flows. Some elements of managements plans are outside of managements control and the outcome cannot be predicted at this time. Should managements plans not materialize, the Company may be in default under the Marathon Credit Agreement, be forced to reduce or delay expenditures and capital additions and seek additional alternative financing, or sell or liquidate its assets. As a result, there is material uncertainty related to events or conditions that cast substantial doubt about the Companys ability to continue as a going concern.
These Interim Financial Statements have been prepared assuming the Company will continue as a going concern, which assumes the Company will continue its operations in the foreseeable future and will be able to realize its assets and discharge its liabilities and commitments in the normal course of business. These Interim Financial Statements do not include any adjustments to the carrying values and classification of assets and liabilities and reported expenses that might result from the outcome of this uncertainty and that may be necessary if the going concern basis was not appropriate for these Interim Financial Statements. If the Company was unable to continue as a going concern, material impairment of the carrying values of the Companys assets, including intangible assets, could be required.
6
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
1. | Basis of preparation (continued) |
(d) | Basis of measurement |
The Companys interim 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 warrant liabilities, which are measured at fair value. 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.
(e) | Use of estimates and judgments |
The preparation of the Companys interim financial statements in conformity with IFRS requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the interim financial statements, and the reported amounts of revenues and expenses during the reporting 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, 2023.
(f) | Functional and presentation currency |
The Companys 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 Companys annual consolidated financial statements for the year ended November 30, 2023 have been applied consistently in the preparation of these interim financial statements.
Changes in accounting policies
Standards issued but not yet effective.
A number of new standards are effective for annual periods beginning after December 1, 2023 and earlier application is permitted; however, the Company has not early adopted the new or amended standards in preparing these consolidated interim financial statements. Refer to Note 1 of the annual consolidated financial statements as at November 30, 2023 for a description of those standards.
7
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
3. | Revenue |
Net sales by product were as follows:
2024 | 2023 | |||||||
EGRIFTA SV® |
$ | 9,586 | $ | 12,711 | ||||
Trogarzo® |
6,661 | 7,197 | ||||||
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$ | 16,247 | $ | 19,908 | |||||
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Net sales by geography were as follows:
2024 | 2023 | |||||||
United States |
$ | 16,169 | $ | 19,645 | ||||
Europe |
78 | 263 | ||||||
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$ | 16,247 | $ | 19,908 | |||||
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4. | Finance income and finance costs |
Note | 2024 | 2023 | ||||||||||
Gain on financial instruments carried at fair value |
$ | 209 | $ | | ||||||||
Gain on lease termination |
| 121 | ||||||||||
Interest income |
420 | 227 | ||||||||||
|
|
|
|
|||||||||
Finance income |
629 | 348 | ||||||||||
Accretion expense and amortization of deferred financing costs |
7 and 8 | (374 | ) | (533 | ) | |||||||
Interest on convertible unsecured senior notes and term loan |
(2,274 | ) | (1,784 | ) | ||||||||
Bank charges |
(6 | ) | (20 | ) | ||||||||
Loss on financial instruments carried at fair value |
| (176 | ) | |||||||||
Net foreign currency loss |
(2 | ) | (125 | ) | ||||||||
Other |
(98 | ) | | |||||||||
Loss on Laon Facility modifications |
| (2,650 | ) | |||||||||
|
|
|
|
|||||||||
Finance costs |
(2,754 | ) | (5,288 | ) | ||||||||
|
|
|
|
|||||||||
Net finance costs recognized in net profit or loss |
$ | (2,125 | ) | $ | (4,940 | ) | ||||||
|
|
|
|
8
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
5. | Inventories |
In the first quarter of 2024, an inventory provision of $837 (2023 nil) was recognized pending marketing approval of the F8 formulation of tesamorelin and recorded in cost of goods sold.
6. | Provisions |
Chargebacks and rebates |
Returns | Restructuring | Total | |||||||||||||
Balance as at November 30, 2022 |
$ | 6,032 | $ | 1,485 | $ | | $ | 7,517 | ||||||||
Provisions made |
15,407 | 1,086 | 1,963 | 18,456 | ||||||||||||
Provisions used |
(14,506 | ) | (309 | ) | (1,721 | ) | (16,536 | ) | ||||||||
Effect of change in exchange rate |
168 | | (2 | ) | 166 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance as at November 30, 2023 |
$ | 7,101 | $ | 2,262 | $ | 240 | $ | 9,603 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Provisions made |
3,629 | 430 | 18 | 4,077 | ||||||||||||
Provisions used |
(6,717 | ) | (535 | ) | (207 | ) | (7,459 | ) | ||||||||
Effect of change in exchange rate |
(26 | ) | | | (26 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance as at February 29, 2024 |
$ | 3,987 | $ | 2,157 | $ | 51 | 6,195 | |||||||||
|
|
|
|
|
|
|
|
7. | Loan Facility |
On July 20, 2022, the Company entered into a credit agreement with certain funds and accounts for which Marathon Asset Management, L.P. acts as investment manager (collectively, Marathon) providing for up to $100,000 (the Loan Facility or Marathon Credit Agreement) in loan. The disbursement of the loan was to be made available to the Company over time in four various tranches with each bearing specific conditions to be met by the Company.
On July 27, 2022, a principal amount of $40,000 (Tranche 1 Loan) was funded while on June 21, 2023, a second $20,000 (Tranche 2 Loan) was funded as a result of the lender removing during the first quarter of 2023 the condition related to the submission to the FDA of the results from the human factor study the Company was then conducting. The Company does not meet the conditions precedents to draw down the additional tranches of capital of $15,000 and $25,000, respectively.
9
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
7. | Loan Facility (continued) |
On July 3, 2023, the Company incurred a Liquidity Breach resulting in the lender having the ability to demand immediate repayment of the debt and in making available to the lender the collateralized assets, which include substantially all cash, bonds and money market funds which are subject to control agreements. On July 10, 2023, the Company and the lender amended the terms of the Marathon Credit Agreement to reduce the minimum liquidity covenant for the period of July 10 to July 28, 2023 as follows:
| From $20,000 to $14,000 between July 10, 2023 up to and including July 21, 2023; and |
| From $14,000 to $16,000 between July 22, 2023 up to and including July 28, 2023. |
On July 28, 2023, the Company and the lender entered into an additional amendment to the terms of the Marathon Credit Agreement to provide, amongst other things, for the minimum liquidity covenant to be $15,000 from July 29, 2023, up to and including October 31, 2023. After such date, the minimum liquidity covenant was set at $20,000; provided, however, that if the F8 formulation of tesamorelin was not approved by the United States Food and Drug Administration by March 31, 2024, the minimum liquidity covenant was set at $30,000. On September 21, 2023, the Company obtained a waiver from the lender relating to the Liquidity Breach for the period between July 3, 2023 up to end and including July 9, 2023. On October 13, 2023, the Company and the lender entered into an additional amendment to the Marathon Credit Agreement (the Fifth Amendment) providing for, amongst other things, the following amendments:
| revising the minimum liquidity requirements for all times following October 31, 2023 to be between $15,000 and $20,000, based on thresholds for Marathon Adjusted EBITDA over the most recently ended four fiscal quarters; |
| revising the minimum revenue requirements to be based on Marathon Adjusted EBITDA-based targets instead of quarterly revenue-based targets, beginning with the quarter ending November 30, 2023; |
| deleting the prohibition against the Company having a going concern explanatory paragraph in the opinion of the independent registered public accounting firm of the Company that accompanies to the Companys annual report. |
In consideration of the Fifth Amendment, the Company agreed to (i) pay an amount equal to $540 amortized value ($600), or 100 basis points calculated on the outstanding principal amount of the funded debt as of October 13, 2023 ($60,000), which amount was added to the outstanding principal amount of the funded debt as payment in kind; and (ii) reset the exercise price of the Marathon Warrants, which are now exercisable into 1,250,000 common shares at $2.30 per common share, down from the previous $5.80 per common share.
The salient conditions of the amounts drawn under the Loan Facility are as follows:
| The Loan Facility has an initial term of five years, provides for an interest-only period of 24 months, and bears interest at the Secured Overnight Financing Rate (SOFR) plus 9.5%. The Tranche 1 Loan and Tranche 2 Loan are repayable in equal monthly installments on an amortization schedule of 36 months starting in July 2024. The Company is entitled to prepay the outstanding Loan Facility at any time subject to certain prepayment premium amount: for Tranche 1 Loan until July 27, 2024, an amount equal to the make whole amount, and after this date, a maximum amount of 3% of the principal amount being prepaid. For Tranche 2 Loan, until June 21, 2025, an amount equal to the make whole amount , and after this date, a maximum amount of 3% of the principal amount being prepaid; |
10
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
7. | Loan Facility (continued) |
| The Loan Facility provides Marathon Adjusted EBITDA-based targets and minimum liquidity requirements (both as defined in the Marathon Credit Agreement) for all times to be between $15,000 and $20,000 based on thresholds for Marathon Adjusted EBITDA over the most recently ended four financial quarters; |
| The Loan Facility requires the lenders consent to incur additional debt and to make acquisitions, dispositions, in-licensing and out-licensing of products or assets. A breach of the terms and conditions of the Marathon Credit Agreement will create an event of default resulting in an increase of 300 basis points on the outstanding loan and provide the lender with the ability to demand immediate repayment of the debt; |
| The lender has a first ranking security interest on all of the Companys assets, subject to certain credit card arrangements restrictions. |
11
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
The movement in the carrying value of the Loan Facility is as follows:
Proceeds from Loan Facility on July 27, 2022 |
$ | 40,000 | ||
Transaction costs |
(2,285 | ) | ||
Accretion expense |
179 | |||
|
|
|||
Term loan as at November 30, 2022 |
$ | 37,894 | ||
Proceeds from Tranche 2 Loan on June 21, 2023 |
20,000 | |||
Costs related to issuance of Tranche 2 Loan |
(1,182 | ) | ||
Costs related to Marathon Warrants |
(78 | ) | ||
Consideration for the Fifth Amendment |
540 | |||
Accretion expense |
800 | |||
|
|
|||
Term loan as at November 30, 2023 |
$ | 57,974 | ||
Accretion expense |
275 | |||
|
|
|||
Term loan as at February 29, 2024 |
$ | 58,249 | ||
Current portion |
(12,354 | ) | ||
Non-current portion |
45,895 | |||
|
|
8. | Lease liabilities |
Carrying value |
||||
Balance as at November 30, 2022 |
$ | 1,922 | ||
Accretion expense |
101 | |||
Lease payments |
(452 | ) | ||
Effect of change in exchange rates |
17 | |||
Termination |
(920 | ) | ||
New lease |
326 | |||
|
|
|||
Balance as at November 30, 2023 |
$ | 994 | ||
Accretion expense |
19 | |||
Lease payments |
(122 | ) | ||
|
|
|||
Balance as at February 29, 2024 |
891 | |||
Current portion |
(431 | ) | ||
|
|
|||
Non-current portion |
$ | 460 | ||
|
|
12
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
9. | Share capital and warrants |
(a) | Public offering Warrants |
On January 19, 2021, the Company completed a public offering for the sale and issuance of units. Each unit was comprised of one common share of the Company and one half of one common share purchase warrant of the Company (each whole warrant, a Public Offering Warrant) and is classified in Share Capital and Public Offering Warrants within equity. During the first quarter ended February 29, 2024, no Public Offering Warrants were exercised (November 30, 2023 nil).
The 8,130,550 Public Offering Warrants expired on January 19, 2024.
On October 31, 2023, the Company completed a public offering for the sale and issuance of 12,500,000 common shares at a price of $1.00 per common share for gross proceeds of $12,500. On November 14, 2023, the Company issued 160,000 common shares at a price of $1.00 per common share for gross proceeds of $160 in relation to the partial exercise of the over-allotment option. The Company has also completed a concurrent private placement (the Concurrent Private Placement) with Investissement Québec of 9,118,184 common shares and 3,381,816 fully-funded, non-voting subscription receipts, exchangeable at all times into common shares on a one-for-one basis in, in each case, at $1.00 for gross proceeds of $12,500. The subscription receipts were issued to limit the share ownership of the investor to not more than 19.9% of the issued and outstanding common shares and the subscription receipts are exchangeable at any time, provided ownership limitations are respected. The Company has also entered into an investor rights agreement pursuant to which Investissement Québec will be entitled to nominate one director to the Companys board of directors for as long as it holds 50% of the Common Shares purchased pursuant to the Concurrent Private Placement. The cost of the offering amounted to $2,053.
13
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
9. | Share capital and warrants (continued) |
(b) | Marathon Warrants |
On February 27, 2023, the Company issued to Marathon an aggregate of 5,000,000 common share purchase warrants (the Marathon Warrants) exercisable into 1,250,000 common shares, at an exercise price of $5.80, post Consolidation. The Marathon Warrants are exercisable for a period of seven years. The Marathon Warrants are not traded on any stock exchange, are transferable only to affiliates of Marathon or to other potential lenders under the terms of the Loan Facility and their affiliates and may be exercised on a cashless basis. Accordingly, the Marathon Warrants are derivative financial liabilities measured at fair value through profit or loss.
The Marathon Warrants were issued as consideration for various amendments made to the Marathon Credit Agreement, including:
| An amendment to remove a condition precedent to the disbursement of the Tranche 2 Loan requiring the Company to have filed with the FDA the results of a human factor study before June 30, 2023; and |
| An amendment to allow for the inclusion of a going concern explanatory paragraph in the annual report of the independent registered public accounting firm for the fiscal year ended November 30, 2022. |
In consideration of the Fifth Amendment, the Company has agreed to reset the exercise price of the 5,000,000 Marathon Warrants, which are now exercisable into 1,250,000 common shares at $2.30 per common share. (Refer to Note 7).
The fair value of the Marathon Warrants was treated as a cash outflow in testing whether the debt modification was a substantial modification and it was concluded that the modification was not substantial. At the issuance, $2,650 were recorded as loss on debt modification using the Black-Sholes model and the assumptions set forth in the table below. An amount of $350 was recorded reflecting the increase of fair value of Marathon Warrants for the repricing upon entering into the Fifth Amendment. The derivative financial liability relating to the Marathon Warrants is recorded as a liability on the consolidated statement of financial position and resulted in a gain on fair value remeasurement of $213 for the quarter ended February 29, 2024.
Measurement date as at February 29, 2024 |
Issuance date measurement |
|||||||
Risk-free interest rate |
4.25 | % | 3.92 | % | ||||
Expected volatility |
89.86 | % | 61.985 | % | ||||
Average option life in years |
6 years | 7 years | ||||||
Share price |
$ | 1.45 | 3.80 | |||||
Warrant exercise price |
$ | 2.30 | 5.80 | |||||
|
|
|
|
14
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
9. | Share capital and warrants (continued) |
(b) | Marathon Warrants (continued) |
The risk-free interest rate is based on the implied yield on a Canadian government zero-coupon issue, with a remaining term equal to the term of the Marathon warrant life. The volatility is based on weighted average historical volatility adjusted for changes expected due to publicly available information. The life of the Marathon warrant is based upon the contractual term. 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.
(c) | Stock option plan |
The Company has established a stock option plan (the Option Plan) under which it can grant its directors, officers, employees, researchers and consultants non-transferable options (the Option) for the purchase of common shares. The exercise date of an Option may not be later than 10 years after the grant date. On March 28, 2023, the Companys Board of Directors amended the Option Plan to provide, among other things, that the maximum number of common shares that may be issued under the Option Plan (together with any other security-based compensation arrangements) shall not exceed 17% of the issued and outstanding common shares, on a non-diluted basis. The Option Plan has a reloading or evergreen feature, so that when Options are exercised, the number of common shares issuable under the Option Plan will be replenished and such exercised Options will be available to be regranted in the future. Shareholders ratified this amendment on May 9, 2023. Generally, the Options vest on the grant date or over a period of up to three years.
As at February 29, 2024, 5,764,622 Options could still be granted by the Company (2023 137,347) under the Option Plan.
All options are to be settled by the physical delivery of common shares.
Changes in the number of options outstanding during the past two years were as follows:
15
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
9. | Share capital and warrants (continued) |
(c) | Stock option plan (continued) |
Weighted average |
||||||||||||
Number of options |
CAD | USD | ||||||||||
Options outstanding in CA$ |
||||||||||||
Options as at November 30, 2022 CA$ |
1,180,052 | $ | 15.92 | $ | 11.84 | |||||||
Granted CA$ |
792,193 | 5.16 | 3.80 | |||||||||
|
|
|
|
|
|
|||||||
Options outstanding as at February 28, 2023 CA$ |
1,972,245 | $ | 11.60 | $ | 8.48 | |||||||
|
|
|
|
|
|
|||||||
Options as at November 30, 2023 CA$ |
1,774,559 | 11.51 | 8.48 | |||||||||
Forfeited and expired CA$ |
(708 | ) | 15.41 | 11.41 | ||||||||
|
|
|
|
|
|
|||||||
Options outstanding as at February 29, 2024 CA$ |
1,773,851 | 11.51 | 8.48 | |||||||||
|
|
|
|
|
|
|||||||
Options exercisable as at February 29, 2024 CA$ |
1,199,279 | 13.35 | 9.83 | |||||||||
|
|
|
|
|
|
|||||||
Options exercisable as at February 28, 2023 CA$ |
806,050 | $ | 15.80 | $ | 11.56 | |||||||
|
|
|
|
|
|
16
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
9. | Share capital and warrants (continued) |
(c) | Stock option plan (continued) |
Options outstanding in US$ |
||||||||
Options as at November 30, 2022 US$ |
106,643 | 10.00 | ||||||
Granted US$ |
203,935 | 3.80 | ||||||
|
|
|
|
|||||
Options outstanding as at February 28, 2023 US$ |
310,578 | 5.92 | ||||||
|
|
|
|
|||||
Options as at November 30, 2023 US$ |
279,369 | 6.02 | ||||||
Forfeited and expired US$ |
(1,250 | ) | 3.80 | |||||
|
|
|
|
|||||
Options outstanding as at February 29, 2024 US$ |
278,119 | 6.84 | ||||||
|
|
|
|
|||||
Options exercisable as at February 29, 2024 US$ |
123,191 | 8.03 | ||||||
|
|
|
|
|||||
Options exercisable as at February 28, 2023 US$ |
37,014 | 9.52 | ||||||
|
|
|
|
During the three-month period ended February 29, 2024, $689 (2023 $626) was recorded as share-based compensation expense for the Plan. No options were granted during the first quarter ended February 29, 2024. The fair value of options granted during the 2023 period was estimated at the grant date using the Black-Scholes model and the following weighted average assumptions:
2023 | ||||
Options granted in CA$ |
||||
Risk-free interest rate |
3.33 | % | ||
Expected volatility |
64.3 | % | ||
Average option life in years |
9.5 years | |||
Grant-date share price |
$ | 3.80 (CA$5.16) | ||
Option exercise price |
$ | 3.80 (CA$5.16) |
17
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
9. | Share capital and warrants (continued) |
(c) | Stock option plan (continued) |
2023 | ||||
Options granted in US$ |
||||
Risk-free interest rate |
3.92 | % | ||
Expected volatility |
62 | % | ||
Average option life in years |
9.5 years | |||
Grant-date share price |
$ | 3.80 | ||
Option exercise price |
$ | 3.80 | ||
|
|
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 period ended:
For the three-month periods ended |
||||||||
Number of options |
Weighted average grant date fair value |
|||||||
Options granted in CA$ |
||||||||
February 28, 2023 |
792,193 | $ | 2.76 (CA$3.76) | |||||
|
|
|
|
18
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
9. | Share capital and warrants (continued) |
(c) | Stock option plan (continued) |
For the three-month periods ended |
||||||||
Number of options |
Weighted average grant date fair value |
|||||||
Options granted in US$ |
||||||||
February 28, 2023 |
203,935 | $ | 2.72 | |||||
|
|
|
|
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 Companys stock option awards. This model also requires certain subjective assumptions, including future stock price volatility and average option life, which greatly affect the calculated values.
(d) | Loss per share |
The calculation of basic loss per share was based on the net loss attributable to common shareholders of the Company of $4,481 (2023 $10,443) and a weighted average number of common shares outstanding calculated as follows:
February 29, 2024 |
February 28, 2023 |
|||||||
Issued common shares as at December 1 |
45,980,019 | 24,201,582 | ||||||
Effect of subscription receipts issue |
3,381,816 | | ||||||
|
|
|
|
|||||
Weighted average number of common shares, basic and diluted |
49,361,835 | 24,201,582 | ||||||
|
|
|
|
For the three-month period ended February 29, 2024 2,051,970 (2023 2,282,823) Options and 5,000,000 Marathon Warrants were excluded from the weighted average number of diluted common shares calculation as their effect would have been anti-dilutive. The Public Offering Warrants and the convertible unsecured senior notes were also excluded from the weighted average number of diluted common share calculation for the periods they were outstanding.
19
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
10. Supplemental cash flow disclosures
The Company entered into the following transactions which had no impact on its cash flows:
February 29, 2024 |
February 28, 2023 |
|||||||
Additions to property and equipment included in accounts payable and accrued liabilities |
$ | | $ | 74 | ||||
Deferred financing costs included in accounts payable and accrued liabilities |
165 | 196 | ||||||
|
|
|
|
11. | Financial instruments |
The nature and extent of the Companys exposure to risks arising from financial instruments are consistent with the disclosure in the annual consolidated financial statements as at November 30, 2023, considering the update below.
12. | Determination of fair values |
Certain of the Companys 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 Company has determined that the carrying value of its Loan Facility approximates its fair value because the terms were modified near the end of the 2023 fiscal year-end.
20
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 29, 2024 and February 28, 2023
(Unaudited)
12. | Determination of fair values (continued) |
Share-based payment transactions
The fair value of the Share Options is 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 changes expected due to publicly available information), weighted average expected life of the instruments (based on historical experience and general option holder behaviour), expected dividends, and the risk-free 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 fair value of the DSUs is determined using the quoted price of the common shares of the Company and considered Level 2 in the fair value hierarchy.
Marathon Warrants
The Marathon Warrants are recognized at fair value and considered Level 3 in the fair value hierarchy.
13. | Operating segments |
The Company has a single operating segment. Over 99% of the Companys revenues are generated from one customer, RxCrossroads, which is domiciled in the United States.
2024 | 2023 | |||||||
RxCrossroads |
$ | 16,169 | $ | 16,645 | ||||
Others |
78 | 263 | ||||||
|
|
|
|
|||||
$ | 16,247 | $ | 19,908 | |||||
|
|
|
|
As at February 29, 2024, the Companys non-current assets of $14,149 are located in Canada ($13,809), the United States ($56) and Ireland ($284).
14. | Subsequent event |
On March 22, 2024, the Company announced that it will phase down its preclinical oncology research activities. The Company will continue to prioritize its ongoing Phase 1 clinical trial of sudocetaxel zendusortide (TH1902), a novel peptide-drug conjugate (PDC), in patients with advanced ovarian cancer. The phasing down of research activities is aligned with the Companys focus on its commercial business and will further optimize its organizational cost structure. These changes are expected to result in a restructuring charge of approximately $600 related to severance and other expenses and approximately $800 in accelerated depreciation on equipment. The Company anticipates all charges to be fully taken during 2024.
21
Exhibit 99.2
MANAGEMENTS DISCUSSION AND ANALYSIS
FOR THE THREE MONTHS ENDED FEBRUARY 29, 2024
The following Managements Discussion and Analysis (MD&A) provides Managements point of view on the financial position and results of operations of Theratechnologies Inc., on a consolidated basis, for the three-month period ended February 29, 2024, compared to the three-month period ended February 28, 2023. 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 April 8, 2024, was approved by our Audit Committee on April 9, 2024, and should be read in conjunction with our unaudited interim consolidated financial statements and the notes thereto as at February 29, 2024 (Interim Financial Statements), as well as the MD&A and audited annual consolidated financial statements, including the notes thereto, as at November 30, 2023.
Except as otherwise indicated, the financial information contained in this MD&A and in our Interim Financial Statements has been prepared in accordance with International Accounting Standard (IAS) 34, Interim Financial Reporting of International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB).
The Companys 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. EGRIFTA® and EGRIFTA SV® are registered trademarks of Theratechnologies and Trogarzo® is a registered trademark of TaiMed Biologics Inc. (TaiMed) under exclusive license to us for use in the United States of America and Canada.
FORWARD-LOOKING INFORMATION
This MD&A contains forward-looking statements and forward-looking information within the meaning of applicable securities laws that are based on our managements belief and assumptions and on information currently available to our management, collectively, forward-looking statements. In some cases, you can identify forward-looking statements by terms such as may, will, should, could, would, expect, plan, anticipate, believe, estimate, project, predict, intend, potential, continue and similar expressions intended to identify forward-looking statements. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results,
Theratechnologies Inc.
2015 Peel, 11th Floor
Montreal, Quebec H3A 1T8
levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements include, but are not limited to, statements about: our revenue guidance and Adjusted EBITDA guidance for Fiscal 2024; our expectations regarding the commercialization of EGRIFTA SV® and Trogarzo®; our ability and capacity to grow the sales of EGRIFTA SV® and Trogarzo® successfully in the United States and to meet our financial guidance; our capacity to meet supply and demand for our products; the market acceptance of EGRIFTA SV® and Trogarzo® in the United States; the continuation of our collaborations and other significant agreements with our existing commercial partners and third-party suppliers and our ability to establish and maintain additional collaboration agreements; our success in continuing to seek and in maintaining reimbursement for EGRIFTA SV® and Trogarzo® by third-party payors in the United States; the pricing and reimbursement conditions of other competing drugs or therapies that are or may become available; our ability to protect and maintain our intellectual property rights in tesamorelin; our capacity to meet the undertakings, covenants and obligations contained in the Marathon Credit Agreement (as defined below) and not be in default thereunder; our expectation regarding the refiling of a dossier for the F8 formulation of tesamorelin by the end of the first half of calendar year 2024; our capacity to find a partner to conduct a Phase 2b/3 clinical trial using tesamorelin for the treatment of NASH in the general population; our capacity to enroll patients for the conduct of our Phase 1 clinical trial in ovarian cancer using sudocetaxel zendusortide; our capacity to find a partner to pursue the development of TH1902 and our SORT1+ TechnologyTM platform; our capacity to control expenses to achieve a positive adjusted EBITDA to meet our guidance for Fiscal 2024; our expectations regarding our financial performance, including revenues, expenses, gross margins, profitability, liquidity, capital expenditures and income taxes; and our estimates regarding our capital requirements.
Such statements reflect our current views with respect to future events and are subject to certain risks, uncertainties and assumptions which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed in or implied by the forward-looking statements. Certain assumptions made in preparing the forward-looking statements include that: sales of EGRIFTA SV® and Trogarzo® in the United States will increase over time; our expenses will remain under control; our commercial practices in the United States 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 the United States; continuous supply of EGRIFTA SV® and Trogarzo® will be available to meet market demand on a timely basis; our relations with third-party suppliers of EGRIFTA SV® and Trogarzo® will be conflict-free; the level of product returns and the value of chargebacks and rebates will not exceed our estimates in relation thereto; no biosimilar version of tesamorelin will be approved by the FDA; no vaccine or cure will be found for the prevention or eradication of HIV; we will not default under the terms and conditions of the Marathon Credit Agreement, including meeting the minimum liquidity and Marathon Adjusted EBITDA (as defined below) target covenants therein; the interest rate on the amount borrowed under the Marathon Credit Agreement will not materially vary upwards; the Corporation will continue as a going concern; we will be able to enroll patients to complete the conduct of our Phase 1 clinical trial in ovarian cancer using sudocetaxel zendusortide; we will find a partner to
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
conduct a Phase 2b/3 clinical trial studying tesamorelin for the treatment of NASH in the general population; we will be able to answer satisfactorily the questions raised by the FDA in their CRL (as defined below) and to resubmit a dossier seeking the approval of the F8 formulation of tesamorelin we will find a partner to pursue the development of TH1902 and our SORT1+ TechnologyTM platform; the timelines set forth herein will not be materially adversely impacted by unforeseen events that could arise subsequent to the date of this MD&A; our business plan will not be substantially modified; and no international event, such as a pandemic or worldwide war, will occur and adversely affect global trade.
Forward-looking information 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 information. These risks and uncertainties include, but are not limited to, those related to or arising from: the Companys ability and capacity to grow the sales of EGRIFTA SV® and Trogarzo® successfully in the United States; the Companys capacity to meet supply and demand for its products; the market acceptance of EGRIFTA SV® and Trogarzo® in the United States; the continuation of the Companys 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 Companys success in continuing to seek and maintain reimbursements for EGRIFTA SV® and Trogarzo® by third-party payors in the United States; the success and pricing of other competing drugs or therapies that are or may become available in the marketplace; events that could disrupt the Companys ability to successfully meet the timelines set forth herein; the discovery of a cure for HIV; the Companys failure to meet the terms and conditions set forth in the Marathon Credit Agreement resulting in an event of default and entitling the lender to increase the interest rate by 300 basis points over the current rate and foreclosing on all of our assets; our inability to satisfactorily answer the questions raised by the FDA in the CRL leading to our decision to no longer pursue the approval of the F8 formulation of tesamorelin; the inability of the Company to enter into a partnership agreement with a third party for its NASH program or for its oncology program; the occurrence of events changing the Companys expectations regarding its financial performance, including revenues, expenses, gross margins, profitability, liquidity, capital expenditures and income taxes; and its capital requirements.
We refer current and potential investors to the Risk Factors section of our Form 20-F dated February 21, 2024, available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov, under Theratechnologies public filings. 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.
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
NON-IFRS AND NON-US GAAP MEASURE
The information presented in this MD&A includes a measure that is not determined in accordance with IFRS or U.S. generally accepted accounting principles (U.S. GAAP), being the term Adjusted EBITDA. Adjusted EBITDA is used by the Corporation as an indicator of financial performance and is obtained by adding to net profit or loss, finance income and costs, depreciation and amortization, income taxes, share-based compensation from stock options, certain restructuring costs and certain write-downs (or related reversals) of inventories. Adjusted EBITDA excludes the effects of items that primarily reflect the impact of long-term investment and financing decisions rather than the results of day-to-day operations. The Corporation believes that this measure can be a useful indicator of its operational performance from one period to another. The Corporation uses this non-IFRS measure to make financial, strategic and operating decisions. Adjusted EBITDA is not a standardized financial measure under the financial reporting framework used to prepare the financial statements of the Corporation to which the measure relates and might not be comparable to similar financial measures disclosed by other issuers. A quantitative reconciliation of Adjusted EBITDA is presented under the heading Reconciliation of Adjusted EBITDA in this MD&A.
The calculation of the Adjusted EBITDA in this MD&A is different from the calculation of the adjusted EBITDA (the Marathon Adjusted EBITDA) under the credit agreement entered into with affiliates of Marathon in July 2022, as amended from time to time, (the Marathon Credit Agreement) for the purpose of complying with the covenants therein.
BUSINESS OVERVIEW
We are a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.
Our business strategy is to grow revenues and to achieve a positive Adjusted EBITDA from the sale of our existing and potential future assets in North America and to develop a portfolio of complementary products, compatible with our expertise in drug development and our commercialization know-how.
OUR MEDICINES
We currently have two approved products: EGRIFTA SV® and Trogarzo® in the United States.
EGRIFTA SV® (tesamorelin for injection) is a new formulation of EGRIFTA® which was originally approved by the FDA in November 2010 and was launched in the United States in January 2011. EGRIFTA SV® was approved by the FDA in November 2018, was launched in 2019, and has now replaced EGRIFTA® in such country. 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. EGRIFTA SV® is currently the only approved therapy in the United States and is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. We have been commercializing this product in the United States since May 1st, 2014.
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
Trogarzo® (ibalizumab-uiyk) injection was approved by the FDA in March 2018 and, in combination with other antiretroviral(s) (ARV), is indicated for the treatment of human immunodeficient virus type 1(HIV-1) infection in heavily treatment-experienced adults with multidrug resistant (MDR) HIV-1 infection failing their current antiretroviral regimen. Trogarzo® was made commercially available in the United States in April 2018 and was the first HIV treatment approved with a new mechanism of action in more than 10 years. The treatment is administered every two weeks. It is a long-acting ARV therapy that can lead to an undetectable viral load in combination with other ARVs.
Trogarzo® was also approved by the European Medicines Agency (EMA) in September 2019 and is no longer under licence to us in Europe further to our decision to terminate and return to TaiMed our commercialization rights to this product in April 2022. The EMA has since withdrawn the marketing approval of Trogarzo® in Europe.
On October 3, 2022, the FDA approved a 30-second Intravenous (IV) Push method of administration for Trogarzo®. In December 2023, the FDA approved the Companys Labelling Prior Approval Supplement to include a 2000-mg intravenous (IV) Push loading dose for Trogarzo®. IV Push is a method by which the undiluted medication is pushed by syringe for faster administration into the bodys circulation and is designed to make Trogarzo® administration easier and more convenient for people with HIV and their health care providers.
OUR PIPELINE
Theratechnologies has established a promising pipeline of investigational medicines in areas of high unmet need, including innovative medicines in oncology and NASH. The Companys research & development activities also works on extending the lifecycle of its approved medicines, EGRIFTA SV® and Trogarzo® in HIV.
Lifecycle Management of Tesamorelin in Lipodystrophy
F8 Formulation
On September 25, 2023, the Corporation announced the filing of a sBLA with the FDA seeking the approval of a new formulation of tesamorelin for use in lipodystrophy (the F8 Formulation). On January 23, 2024, the Company received a complete response letter (CRL) from the FDA. The questions outlined in the CRL are largely related to chemistry, manufacturing and controls concerning the microbiology, assays, impurities and stability for both the lyophilized product and the final reconstituted drug product. In addition, the FDA requested further information to understand the potential impact of the proposed formulation on immunogenicity risk. The Company held a type A meeting with the FDA several weeks ago to further discuss the contents of the CRL and received important feedback on the file. Theratechnologies is now awaiting the FDAs minutes of the meeting and remains on track to resubmit the file and receive a decision from the FDA before the end of calendar year 2024.
The F8 Formulation is eight times more concentrated than EGRIFTA® and two times more concentrated than the current F4 formulation sold under the trade name EGRIFTA SV®. The Company plans to withdraw EGRIFTA SV® from the market if and when the F8 Formulation is approved by the FDA. The F8 Formulation can be kept at room temperature, comes in a single vial and has a higher concentration resulting in a smaller volume of administration than EGRIFTA SV®. The F8 Formulation has the distinct advantage of requiring a single reconstitution per seven days of daily therapy.
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
Once approved, the F8 Formulation could be used in our proposed Phase 2b/3 clinical trial studying tesamorelin for the treatment of NASH in the general population.
Lifecycle Management of Trogarzo® in MDR HIV-1
Intramuscular Method of Administration of Ibalizumab
On October 13, 2023, the Company announced results from a study evaluating the intramuscular (IM) method of administration of Trogarzo®. The TMB-302 study, conducted in partnership with TaiMed, enrolled 21 subjects (7 HIV-positive and 14 HIV-negative) to assess the pharmacokinetics, efficacy, and safety of IM administration of Trogarzo® as compared to IV infusion. Mean Trogarzo® trough concentrations were greater than 15 µg/mL, suggesting that IM injection was sufficient at maintaining the drug trough concentration above the therapeutic level of 0.3 µg/mL. The mean trough concentrations were comparable between IV infusion and IM injection in HIV-positive subjects. However, the primary endpoint measuring a 90% confidence interval of the ratio of IM injection to IV infusion (0.69, 1.08) did not meet the equivalence limits (0.8, 1.25). Viral suppression, a key secondary clinical endpoint, was maintained in all HIV-positive subjects throughout the IM phase and the overall study.
Each study subject received IM maintenance doses for eight weeks of treatment and a total of 152 IM injections were administered, which were well tolerated. One subject reported injection-site pruritus (itching) at a single time point, and no subjects reported injection-site pain when Trogarzo® was administered intramuscularly.
On January 2, 2024, we announced the filing of a sBLA with the FDA seeking the approval of the IM method of administration. On February 27, 2024, the Company received a Refusal to File Letter for the Trogarzo® IM method of administration sBLA from the FDA. The Refuse to File Letter indicates that it would require the conduct of a new study to pursue the registration of the IM method of administration, and we have decided to deprioritize this project for the foreseeable future.
Sudocetaxel Zendusortide
Phase 1 Clinical Trial
After pausing the Phase 1 clinical trial in December 2022, we announced, on June 2, 2023, the FDAs agreement to our amended Phase 1 clinical trial protocol for sudocetaxel zendusortide following the submission of such amended protocol. The amended protocol is designed to improve the therapeutic window of sudocetaxel zendusortide and extend its duration of therapy. The amended protocol includes a change in the frequency of administration to weekly dosing and a narrowing of the patient population to focus on those with high-grade serous ovarian cancer, including high-grade peritoneal or fallopian tube cancer, or high-grade endometrioid cancera population in which preliminary efficacy has been observed thus far. Patient selection has also been refined to focus on those who are less heavily pretreated, with no more than one taxane failure and a maximum of eight prior cancer treatment regimens.
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
The amended study is a modified 6+6 design with two different dosing regimens that are within the efficacious range for sudocetaxel zendusortide: 1.75 mg/kg on days 1, 8, and 15 of a 28-day cycle (similar to 210 mg/m2 every 3 weeks) and 2.5 mg/kg on the same schedule (similar to 300 mg/m2 every 3 weeks). A minimum of six patients will be enrolled at the 1.75 mg/kg dose followed by an observational period of three months to assess DLT. If deemed safe (0 or 1 DLT), the trial will enroll an additional six patients at the 2.5 mg/kg dose. Following a second three-month observational period, four more patients will be enrolled at the higher dose, for a total of 16 patients in Part 3 of the trial. The amended protocol also includes an option for a basket expansion stage that would comprise patients with selected, difficult-to-treat tumor types in which sudocetaxel zendusortide has shown activity.
On February 15, 2024, the Company announced the completion of enrollment of the first six participants in Part 3 of its Phase 1 clinical trial of sudocetaxel zendusortide in patients with advanced ovarian cancer, and on March 21, 2024, we announced that we were moving to the next dose level in Part 3 of its Phase 1 clinical trial of sudocetaxel zendusortide in patients with advanced ovarian cancer. The studys Medical Review Committee (MRC) has deemed the dose level in the first cohort of patients safe and has approved initiation of the next cohort with an increased dose, in accordance with the updated dose optimization protocol. Study centers are now actively recruiting patients for the second cohort, with one patient already enrolled and treated with the higher dose.
Consistent with the Companys objective of generating a positive Adjusted EBITDA on a quarterly basis, any new investments in sudocetaxel zendusortide will be stage-gated. Theratechnologies is currently reaching out to pharmaceutical companies to partner the development of sudocetaxel zendusortide once the Phase 1 clinical trial will have been completed.
For the fiscal year ended November 30, 2024 (Fiscal 2024), the Company has budgeted $4,800,000 to be allotted to the Phase 1 clinical trial and to other research and development activities related to its SORT1+Technology platform. Of this amount, $2,500,000 will be allocated to the Phase 1 clinical trial, $1,695,000 to laboratory work and employee salaries, and the remainder ($605,000) will be allocated to pharmaceutical development and other external expenses. In the first quarter ended February 29, 2024, the Company spent $389,000 on the Phase 1 clinical trial, $334,000 on laboratory work and employee salaries, and $113,000 on pharmaceutical development and other external expenses.
On March 22, 2024, the Company announced that it will phase down its preclinical oncology research activities. The Company will continue to prioritize its ongoing Phase 1 clinical trial of sudocetaxel zendusortide, in patients with advanced ovarian cancer. The phasing down of research activities is aligned with the Companys focus on its commercial business and will further optimize its organizational cost structure, pursuant to the goal of generating positive Adjusted EBITDA. These changes are expected to result in a restructuring charge of approximately $600,000 in charges related to severance and other expenses and approximately $800,000 in accelerated depreciation on equipment. The Company anticipates all charges to be fully taken during 2024.
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
Tesamorelin for NASH in the General Population
On September 10, 2020, we announced our intent to study tesamorelin for the potential treatment of NASH in the general population using the F8 Formulation. In November 2020, we filed an Investigational New Drug Application (IND) with the FDA for a Phase 3 clinical trial evaluating tesamorelin for the treatment of NASH and we received a Study May Proceed letter for such Phase 3 clinical trial from the FDA in December 2020. The letter contained a recommendation that the Corporation requests a meeting to discuss the questions and comments contained in such letter to address certain aspects of the proposed trial design to ensure alignment with the agencys expectations with NASH trials. The Corporation followed up on the FDAs recommendation and requested a meeting with the agency.
In July 2021, after completion of our discussions with both the FDA and the EMA, we announced that the final Phase 3 clinical trial design would result in higher costs than what we had expected and, as a result, we were assessing our options to best execute this program, including seeking a potential partner.
Currently, we are not planning on initiating this trial, unless we can find additional resources, including a partner. We continue to pursue potential NASH partners in the marketplace. We continue to maintain that the further development of tesamorelin allows the Corporation to keep its positioning as one of the few options for drug developers to immediately partner with a company in order to launch a Phase 2b/3 NASH clinical trial.
Recent Highlights:
Sudocetaxel Zendusortide (TH1902) and SORT1+ Technology
On February 15, 2024, the Company announced the completion of enrollment of the first six participants in Part 3 of its Phase 1 clinical trial of sudocetaxel zendusortide in patients with advanced ovarian cancer, and on March 21, 2024, we announced that we were moving to the next dose level in Part 3 of its Phase 1 clinical trial of sudocetaxel zendusortide in patients with advanced ovarian cancer. The studys Medical Review Committee (MRC) has deemed the dose level in the first cohort of patients safe and has approved initiation of the next cohort with an increased dose, in accordance with the updated dose optimization protocol. Study centers are now actively recruiting patients for the second cohort, with one patient already enrolled and treated with the higher dose.
On March 22, 2024, the Company announced that it will phase down its preclinical oncology research activities. The Company will continue to prioritize its ongoing Phase 1 clinical trial of sudocetaxel zendusortide, in patients with advanced ovarian cancer. The phasing down of research activities is aligned with the Companys focus on its commercial business and will further optimize its organizational cost structure, pursuant to the goal of generating positive Adjusted EBITDA. These changes are expected to result in a restructuring charge of approximately $600,000 in cash charges related to severance and other expenses and approximately $800,000 in non-cash charges. The Company anticipates all charges to be fully taken during 2024.
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
Appointment of new members to the Board of Directors
On March 21, 2024, the Company announced the appointment of Jordan Zwick, Chief Business Officer at Mirador Therapeutics Inc., to its Board of Directors and as a member of the Companys Audit Committee.
On April 5, 2024, the Company announced the appointment of Elina Tea, CFA, Chief Financial Officer at GLS North America, to its Board of Directors, as the designated candidate to Investissement Québec (IQ) pursuant to the investor rights agreement entered into between Theratechnologies and IQ in October, 2023. Ms. Tea has also been appointed to the Companys Audit Committee.
With the appointments of Jordan Zwick and Elina Tea, the Companys Audit Committee will now comprise four independent members including Gerald Lacoste and Frank Holler as Chair.
American Association for Cancer Research (AACR)
On March 28, 2024, Theratechnologies announced that two posters would be presented at the American Association for Cancer Research (AACR) Annual Meeting 2024, demonstrating the potential of its SORT1+ Technology platform including novel camptothecin-peptide conjugates and its lead investigational peptide drug conjugate (PDC) candidate, sudocetaxel zendusortide (TH1902), as anticancer treatments.
These preclinical presentations reinforce existing data for sudocetaxel zendusortide to activate anti-PD-L1 immunotherapy tumor cell killing in SORT+1 cancers and provide the first evidence for novel camptothecin-peptide conjugates in the treatment of SORT1+ colorectal cancers.
January 2021 Offering Use of Proceeds
The following table shows the estimated use of proceeds of the unit offering completed in January 2021, compared with the actual use of proceeds as at February 29, 2024:
In millions |
Estimated Use of Proceeds |
Actual Use of Proceeds |
Variance | |||||||||
Nash Phase 3 clinical trial |
$ | 30.5 | $ | 2.8 | $ | (27.7 | ) | |||||
Oncology R&D |
$ | 7.0 | $ | 10.5 | $ | 3.5 | ||||||
Commercial and marketing activities |
$ | 3.5 | | $ | (3.5 | ) | ||||||
Other |
$ | 1.5 | $ | 13.8 | $ | 12.3 | ||||||
Net Proceeds |
$ | 42.5 | $ | 27.1 | $ | (15.4 | ) |
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
As at February 29, 2024, approximately $2,828,000 had been used in connection with the NASH Phase 3 clinical trial. The amount spent on this program to date allowed the Corporation to advance the negotiation of the trial design for the conduct of a Phase 2b/3 clinical trial. We are unable to assess the amounts required to finalize the Phase 2b/3 clinical trial with the FDA since we have voluntarily decided not to respond to the last questions received in February 2022 in order to address these with any potential partner we may find to optimize the design, if deemed relevant. The Corporation expects that the recruitment and dosing of the first 350 patients would cost approximately $50,000,000. Subject to the quality of the data obtained from the treatment of the first 350 patients, the Corporation estimates that an amount in excess of $100,000,000 will be necessary to complete the Phase 2b/3 and Phase 3 clinical trial. As previously stated, we will seek a partner before initiating any additional spending on the NASH program.
As at February 29, 2024, approximately $10,490,000 had been used in connection with research and development activities in oncology. For Fiscal 2024, the Company has budgeted $4,800,000 to be allotted to the Phase 1 clinical trial evaluating sudocetaxel zendusortide and for other research and development activities related to its SORT1+Technology platform. Of this amount, $2,500,000 will be allocated to the Phase 1 clinical trial, $1,695,000 to laboratory work and employee salaries, and the remainder ($605,000) will be allocated to pharmaceutical development and other external expenses.
In the first quarter ended February 29, 2024, the Company spent $389,000 on the Phase 1 clinical trial, $334,000 on laboratory work and employee salaries, and $113,000 on pharmaceutical development and other external expenses.
Finally, the Corporation has not implemented new initiatives in terms of commercial and marketing activities, such that the funds earmarked for such use were added to its working capital. The variance between the amount reserved and the amount used as at February 29, 2024, represents funds held in cash pending their planned allocation as costs are incurred.
October 2023 Offering Use of Proceeds
The following table shows the estimated use of proceeds of the unit offering completed in October 2023, compared with the actual use of proceeds as at February 29, 2024:
In millions |
Estimated Use of Proceeds |
Actual Use of Proceeds |
Variance | |||||||||
Funding of working capital |
$ | 19.1 | | $ | (19.1 | ) | ||||||
General and administrative expenses |
$ | 2.0 | | $ | (2.0 | ) | ||||||
Commercialization expenses |
$ | 2.0 | | $ | (2.0 | ) | ||||||
Net Proceeds |
$ | 23.1 | | $ | (23.1 | ) |
As at February 29, 2024, the Company has not used any of the proceeds from the October 2023 Offering.
2024 Revenue and Adjusted EBITDA Guidance
Our anticipated FY2024 revenue guidance range is confirmed between $87 million and $90 million, or growth of the commercial portfolio in the range of 6.4% and 10.0%, as compared to the 2023 fiscal year results. We anticipate Adjusted EBITDA, a non-IFRS measure, to be between $13 and $15 million for fiscal 2024.
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
First-Quarter 2024 Revenues
(in thousands of U.S. dollars)
Three Months Ended | Change | |||||||||||
February 29, 2024 |
February 28, 2023 |
|||||||||||
EGRIFTA SV® net sales |
9,586 | 12,711 | (24.6 | %) | ||||||||
Trogarzo® net sales |
6,661 | 7,197 | (7.4 | %) | ||||||||
Revenue |
16,247 | 19,908 | (18.4 | %) |
First Quarter Fiscal 2024 Financial Results
Revenue
Consolidated revenue for the three months ended February 29, 2024, amounted to $16,247,000 compared to $19,908,000 for the same period last year, representing a decrease of 18.4%.
For the first quarter of Fiscal 2024, sales of EGRIFTA SV® reached $9,586,000 compared to $12,711,000 in the first quarter of the prior year, representing a decrease of 24.6%. Lower sales of EGRIFTA SV® were mostly the result of lower unit sales due to unusual loading of inventories which occurred in the first quarter of 2023 (mostly in December 2022 and January 2023). EGRIFTA SV® sales in the first quarter of our fiscal year are usually weaker than in the fourth quarter because of usual end-of-year loading by pharmacies in anticipation of annual price increases, as well as changes in insurance coverage by patients and co-pay resets that occur in the beginning of the year. EGRIFTA SV® sales were also impacted by larger government rebates and returns in the first quarter of fiscal 2024.
In the first quarter of Fiscal 2024, Trogarzo® sales amounted to $6,661,000 compared to $7,197,000 for the same quarter of 2023, representing a decrease of 7.4%. Trogarzo® unit sales in the first quarter of 2024 were down mostly as a result of the inventory loading at specialty pharmacies that occurred in the first quarter of 2023.
Cost of Sales
For the three-month period ended February 29, 2024, cost of sales was $5,284,000 compared to $4,693,000 in the comparable period of Fiscal 2023. In 2024, cost of sales was affected by a $837,000 provision related to the manufacturing of a batch of F8 formulation of tesamorelin, as the F8 Formulation was not yet approved by the FDA for commercialization. Excluding the provision taken in 2024, cost of goods sold was relatively stable for Trogarzo, but was affected for EGRIFTA SV® by slightly higher production related costs.
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
R&D Expenses
R&D expenses in the three-month period ended February 29, 2024 amounted to $3,752,000 compared to $9,356,000 in the comparable period of Fiscal 2023, a decrease of 60%. The decrease during the first quarter of Fiscal 2024 was largely due to lower spending on life-cycle management projects as well as lower activity in our oncology program. R&D expenses in 2023 also included expenses related to the production of the validation batches of BWFI ($536,000) and expenses related to the production of clinical batches of TH1902 ($838,000). No such expenses were recorded in 2024.
Selling Expenses
Selling expenses in the three-month period ended February 29, 2024, amounted to $5,701,000 compared to $6,814,000 in the comparable period of Fiscal 2023 or a 16.3% decrease. Lower selling expenses are related to the management of expenses in alignment with our goal of reaching and maintaining positive adjusted EBITDA on a yearly basis.
General and Administrative Expenses
General and administrative expenses in the first quarter of Fiscal 2024 amounted to $3,756,000, compared to $4,452,000 reported in the same period of Fiscal 2023, representing a decrease of 15.6%. The decrease is a result of lower overall spending across the Company, which results in the lower level of administrative support required.
Net Finance Costs
Net finance costs for the three-month period ended February 29, 2024, were $2,125,000 compared to $4,940,000 in the same period last year. The decrease in net finance cost is mostly due to the loss on debt modification, in 2023, of $2,650,000 related to the issuance of the Marathon Warrants issued in connection to the amendments to the Credit Agreement. Interest expense was $2,274,000, higher than $1,784,000 in 2023, mostly related to the higher interest rate and higher outstanding balance on the Marathon Credit Facility.
Adjusted EBITDA
Adjusted EBITDA was $(247,000) for the first quarter of fiscal 2024 compared to $(3,892,000) for the same period of 2023. The improvement is mainly due to the realignment of expenses with our focus on our commercial operations, and our goal of being adjusted EBITDA positive on a yearly basis. Adjusted EBITDA in the first quarter of 2023 was negatively affected by certain production costs, namely an expense related to the production of the validation batches of BWFI of $536,000, and $838,000 in expenses related to production batches of TH1902. See Non-IFRS and Non-US-GAAP Measure above and see Reconciliation of Adjusted EBITDA below for a reconciliation to Net Loss for the relevant periods.
Net loss
Taking into account the revenue and expense variations described above, we recorded a net loss of $4,481,000, or $0.10 per share, in the first quarter of Fiscal 2024, a marked improvement from the loss of $10,443,000, or $0.43 per share, recorded in the first quarter of Fiscal 2023.
12
Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
Financial Position, Liquidity and Capital Resources
Going Concern Uncertainty
As part of the preparation of these Interim Financial Statements, management is responsible for identifying any event or situation that may cast doubt on the Companys ability to continue as a going concern. Substantial doubt regarding the Companys ability to continue as a going concern exists if events or conditions, considered collectively, indicate that the Company may be unable to honor its obligations as they fall due during a period of at least, but not limited to, 12 months from February 29, 2024. If the Company concludes that events or conditions cast substantial doubt on its ability to continue as a going concern, it must assess whether the plans developed to mitigate these events or conditions will remove any possible substantial doubt.
For the three-month ended February 29, 2024, the Company incurred a net loss of $4,481,000 (2023-$10,443,000) and had positive cash flows from operating activities of $1,421,000 (2023- $2,361,000). As at February 29, 2024, cash amounted to $32,240,000 and bonds and money market funds amounted to $6,213,000.
The Companys Loan Facility contains various covenants, including minimum liquidity covenants whereby the Company needs to maintain significant cash, cash equivalent and eligible short-term investments balances in specified accounts, which restricts the management of the Companys liquidity (refer to Note 6 of the Interim Financial Statements). A breach of the liquidity covenant (a Liquidity Breach) provides the lender with the ability to demand immediate repayment of the Loan Facility and makes available to the lender the collateralized assets, which include substantially all cash, bonds and money market funds which are subject to control agreements, and may trigger an increase of 300 basis points of the interest rate on the outstanding loan balance. During Fiscal 2023, the Company incurred a Liquidity Breach and entered into several amendments to the Marathon Credit Agreement to amend certain of the terms and conditions therein (see note 6 of the Interim Financial Statements).
As at February 29, 2024, the material covenants of the Marathon Credit Agreement, as amended, include: (i) minimum liquidity requirements to be between $15,000,000 and $20,000,000, based on the Marathon adjusted EBITDA (as defined in the Marathon Credit Agreement, the Marathon Adjusted EBITDA) targets over the most recently ended four fiscal quarters; and, (ii) quarterly minimum Marathon Adjusted EBITDA targets There is no assurance that the lender will agree to amend or to waive any future potential covenant breaches, if any. The Company does not meet the condition precedents to drawdown additional amounts under the Marathon Credit Agreement and does not currently have other committed sources of financing available to it.
The Companys ability to continue as a going concern for a period of at least, but not limited to, 12 months from February 29, 2024, involves significant judgement and is dependent on the adherence to the conditions of the Marathon Credit Agreement or to obtain the support of the lender (including possible waivers and amendments, if necessary), increase its revenues and the management of its expenses (including the reorganization mainly focused on its R&D activities) in order to meet or exceed the Marathon Adjusted EBITDA target and generate sufficient positive operating cash flows. Some elements of managements plans are outside of managements control and the outcome cannot be predicted at this time. Should managements plans not materialize, the Company may be in default under the Marathon Credit Agreement, be forced to reduce or delay expenditures and capital additions and seek additional alternative financing, or sell or liquidate its assets. As a result, there is material uncertainty related to events or conditions that cast substantial doubt about the Companys ability to continue as a going concern.
13
Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
The Interim Financial Statements have been prepared assuming the Company will continue as a going concern, which assumes the Company will continue its operations in the foreseeable future and will be able to realize its assets and discharge its liabilities and commitments in the normal course of business. The Interim Financial Statements do not include any adjustments to the carrying values and classification of assets and liabilities and reported expenses that might result from the outcome of this uncertainty and that may be necessary if the going concern basis was not appropriate for the Interim Financial Statements. If the Company was unable to continue as a going concern, material impairment of the carrying values of the Companys assets, including intangible assets, could be required.
Analysis of cash flows
We ended the first quarter of fiscal 2024 with $38,453,000 in cash, bonds and money market funds. Available cash is invested in highly liquid fixed income instruments including governmental and municipal bonds, and money market funds.
For the three-month period ended February 29, 2024, cash used in operating activities before changes in operating assets and liabilities improved to $3,129,000, compared to $5,700,000 in the comparable period of Fiscal 2023.
In the first quarter of fiscal 2024, changes in operating assets and liabilities had a positive impact on cash flow of $1,421,000 (2023-positive impact of $2,361,000). These changes included a positive impact from lower accounts receivable ($3,027,000), lower prepaid expenses and deposits ($567,000), and higher accounts payable ($1,422,000). These positive impacts were offset by an increase in provisions ($3,382,000).
During the first quarter of 2024, cash provided by investing activities amounted to $134,000, and financing activities used $275,000 in cash.
14
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 Companys last 8 fiscal quarters.
(in thousands of dollars, except per share amounts)
2024 | 2023 | 2022 | ||||||||||||||||||||||||||||||
Q1 | Q4 | Q3 | Q2 | Q1 | Q4 | Q3 | Q2 | |||||||||||||||||||||||||
Revenue |
16,247 | 23,452 | 20,855 | 17,549 | 19,908 | 21,421 | 20,811 | 19,268 | ||||||||||||||||||||||||
Operating expenses |
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Cost of sales |
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Cost of goods sold |
5,284 | 5,066 | 4,967 | 4,909 | 4,693 | 5,909 | 5,292 | 7,759 | ||||||||||||||||||||||||
Amortization of other asset |
| | | | | | | 1,220 | ||||||||||||||||||||||||
R&D |
3,752 | 5,229 | 5,396 | 10,389 | 9,356 | 9,455 | 8,425 | 11,056 | ||||||||||||||||||||||||
Selling |
5,701 | 6,748 | 6,728 | 6,479 | 6,814 | 7,809 | 8,404 | 15,371 | ||||||||||||||||||||||||
General and administrative |
3,756 | 3,739 | 3,710 | 3,716 | 4,452 | 3,956 | 4,209 | 4,823 | ||||||||||||||||||||||||
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Total operating expenses |
18,493 | 20,857 | 20,801 | 25,493 | 25,315 | 27,129 | 26,330 | 40,229 | ||||||||||||||||||||||||
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Net finance costs |
(2,125 | ) | (5,005 | ) | (674 | ) | (1,943 | ) | (4,940 | ) | (2,078 | ) | (1,879 | ) | (1,644 | ) | ||||||||||||||||
Income taxes |
(110 | ) | (73 | ) | (126 | ) | (126 | ) | (96 | ) | (143 | ) | (151 | ) | (122 | ) | ||||||||||||||||
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Net loss |
(4,481 | ) | (2,755 | ) | (746 | ) | (10,013 | ) | (10,443 | ) | (7,929 | ) | (7,549 | ) | (22,727 | ) | ||||||||||||||||
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Basic and diluted loss per share |
(0.10 | ) | (0.08 | ) | (0.03 | ) | (0.40 | ) | (0.43 | ) | (0.36 | ) | (0.32 | ) | (0.96 | ) | ||||||||||||||||
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Factors Affecting the Variability of Financial 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. We have also taken steps to reduce spending in R&D, which had an impact starting in the third quarter of 2023 and should continue in 2024 as we reduce spending related to our oncology program in the latter part of the year.
15
Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
Recent Changes in Accounting Standards
Standards issued but not yet effective
Refer to Note 2 of the Interim Financial Statements for changes in accounting policies, new standards adopted and standards issued but not yet effective.
Outstanding Securities Data
As at April 8, 2024, the number of common shares issued and outstanding was 45,980,019. We also had 5,000,000 Marathon Warrants issued and outstanding, exercisable into 1,250,000 common shares, 2,051,970 options granted under our stock option plan and 3,381,816 Exchangeable Subscription Receipts.
Contractual Obligations
There was no material change in contractual obligations during the three-month period ended February 29, 2024
Internal Control
There was no change in the Companys internal control over financial reporting, or (ICFR), that occurred during the period beginning on December 1, 2023, and ending on February 29, 2024 that has materially affected, or is reasonably likely to materially affect, the Companys ICFR.
Subsequent Event
On March 22, 2024, the Company announced that it will phase down its preclinical oncology research activities. The Company will continue to prioritize its ongoing Phase 1 clinical trial of sudocetaxel zendusortide (TH1902), a novel peptide-drug conjugate (PDC), in patients with advanced ovarian cancer. The phasing down of research activities is aligned with the Companys focus on its commercial business and will further optimize its organizational cost structure. These changes are expected to result in a restructuring charge of approximately $600,000 related to severance and other expenses and approximately $800,000 in accelerated depreciation on equipment. The Company anticipates all charges to be fully taken during 2024.
16
Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
Reconciliation of Adjusted EBITDA
(In thousands of U.S. dollars)
Three-month periods ended February |
Years ended November 30 |
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29, 2024 | 28, 2023 | 2023 | 2022 | |||||||||||||
Net loss |
(4,481 | ) | (10,443 | ) | (23,957 | ) | (47,237 | ) | ||||||||
Add : |
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Depreciation and amortization1 |
517 | 939 | 3,315 | 12,471 | ||||||||||||
Net Finance costs2 |
2,125 | 4,940 | 12,909 | 6,886 | ||||||||||||
Income taxes |
110 | 96 | 421 | 443 | ||||||||||||
Restructuring costs |
18 | | 2,215 | 3,872 | ||||||||||||
Inventory provision |
837 | | 220 | 1,477 | ||||||||||||
Share-based compensation |
627 | 576 | 1,963 | | ||||||||||||
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Adjusted EBITDA |
(247 | ) | (3,892 | ) | (2,914 | ) | (22,088 | ) | ||||||||
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1 | Includes depreciation of property and equipment, amortization of intangible, other assets and right-of-use assets. |
2 | Includes all finance income and finance costs consisting of: Foreign exchange, interest income, accretion expense and amortization of deferred financing costs, interest expense, bank charges, gain or loss on financial instruments carried at fair value and loss on debt modification. |
17
Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
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 February 29, 2024. |
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 issuers other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in Regulation 52-109 respecting Certification of Disclosure in Issuers Annual and Interim Filings, for the issuer. |
5. | Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuers other certifying officers(s) and I have, as at the end of the period covered by the interim filings |
(a) | designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that: |
(i) | material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and |
(ii) | information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and |
(b) | designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuers GAAP. |
5.1 | Control framework: The control framework the issuers other certifying officer(s) and I used to design the issuers ICFR is the Internal Control Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). |
5.2 | N/A |
5.3 | N/A |
6. | Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuers ICFR that occurred during the period beginning on December 1, 2023, and ended on February 29, 2024, that has materially affected, or is reasonably likely to materially affect, the issuers ICFR. |
Date: April 10, 2024
/s/ Paul Lévesque |
Paul Lévesque |
President and Chief Executive Officer |
- 2 -
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 February 29, 2024. |
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 issuers other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in Regulation 52-109 respecting Certification of Disclosure in Issuers Annual and Interim Filings, for the issuer. |
5. | Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuers other certifying officers(s) and I have, as at the end of the period covered by the interim filings |
(a) | designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that: |
(i) | material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and |
(ii) | information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and |
(b) | designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuers GAAP. |
5.1 | Control framework: The control framework the issuers other certifying officer(s) and I used to design the issuers ICFR is the Internal Control Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). |
5.2 | N/A |
5.3 | N/A |
6. | Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuers ICFR that occurred during the period beginning on December 1, 2023, and ended on February 29, 2024, that has materially affected, or is reasonably likely to materially affect, the issuers ICFR. |
Date: April 10, 2024
/s/ Philippe Dubuc |
Philippe Dubuc |
Senior Vice President and Chief Financial Officer |
- 2 -