Registration statement pursuant to Section 12 of the Securities Exchange Act of 1934 |
Annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 |
Québec, |
2834 |
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(Province or other jurisdiction | (Primary | (I.R.S. Employer | ||
of incorporation or | Standard |
Identification Number) | ||
organization) | Industrial | |||
Classification | ||||
Code Number | ||||
(if applicable) |
Title Of Each Class | Trading Symbol |
Name Of Exchange On Which Registered | ||
Auditor Location: |
Auditor Firm ID: |
• | our expectations regarding the commercialization of EGRIFTA SV ® and Trogarzo® , despite new market entrants; |
• | our ability and capacity to grow the sales of EGRIFTA SV ® and Trogarzo® successfully in the United States; |
• | our capacity to meet supply and demand for our products; |
• | the market acceptance of EGRIFTA SV ® and Trogarzo® |
• | 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; |
• | the filing of a supplemental biologic application (“sBLA”) for an intramuscular method of administration of Trogarzo ® ; |
• | the approval of an intramuscular method of administration of Trogarzo ® by the United States Food and Drug Administration (“FDA”); |
• | the filing of a sBLA with the FDA for a new formulation of tesamorelin (“F8 Formulation”); |
• | the approval of the F8 Formulation by the FDA; |
• | our ability to successfully complete the human factors validation study (“HFS”) and to resubmit a CBE supplement with the FDA for EGRIFTA SV ® |
• | our capacity to meet the undertakings, covenants and obligations contained in the credit agreement entered into with Marathon’s affiliates and not be in default thereof; |
• | 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; |
• | the filing of an amendment to our protocol to resume the conduct of our Phase 1 clinical trial using TH1902 in various types of cancer; |
• | our capacity to find a partner to pursue the development of TH1902 once the Phase 1 clinical trial has resumed; |
• | our capacity to pursue the development of other peptide-drug conjugates (“PDC”) in the field of oncology; |
• | our capacity to acquire, in-license, or copromote new products; |
• | our expectations regarding our financial performance, including revenues, expenses, gross margins, profitability, liquidity, capital expenditures and income taxes; |
• | our estimates regarding our capital requirements; and |
• | our ability to meet the timelines set forth herein. |
• | 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® |
• | 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; |
• | our intellectual property will prevent companies from commercializing biosimilar versions of tesamorelin in the United States; |
• | we will file a sBLA for the F8 Formulation in the 2023 fiscal year; |
• | the FDA will approve the F8 Formulation; |
• | no vaccine or cure will be found for the prevention or eradication of HIV; |
• | the HFS will be successfully completed and we will resubmit a CBE supplement with the FDA for EGRIFTA SV ® |
• | the FDA will approve the CBE supplement; |
• | we will not default under the terms and conditions of the credit agreement entered into with Marathon’s affiliates, including meeting the minimum liquidity and revenue target covenants therein; |
• | we will meet all of the conditions set forth under the credit agreement entered into with Marathon’s affiliates to draw down the $20 million second tranche; |
• | the interest rate on the amount borrowed from Marathon’s affiliates under the credit agreement will not materially vary upwards; |
• | the Corporation will continue as a going concern; |
• | we will find a partner to conduct a Phase 2b/3 clinical trial studying tesamorelin for the treatment of NASH in the general population; |
• | the FDA will approve the amendments to our protocol allowing us to resume the conduct of our Phase 1 clinical trial using TH1902 in various types of cancer; |
• | our Phase 1 clinical trial studying TH1902 in various types of cancer will demonstrate positive efficacy and safety results; |
• | we will find a partner to pursue the development of TH1902 once the Phase 1 clinical trial has resumed; |
• | our research and development activities will yield positive results; |
• | the data obtained from our market research on the potential market for EGRIFTA SV ® ® in the United States are accurate; |
• | the timelines set forth herein will not be materially adversely impacted by unforeseen events that could arise subsequent to the date of this Annual Report; |
• | 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. |
Fees |
Fiscal Year Ended November 30, 2022 (CAD) |
Fiscal Year Ended November 30, 2021 (CAD) |
||||||
Audit Fees (1) |
$750,615 | $639,382 | ||||||
Audit-Related Fees (2) |
$53,865 | $48,943 | ||||||
Tax Fees (3) |
$115,293 | $170,027 | ||||||
All Other Fees |
-- | -- | ||||||
Total: |
$919,773 |
$858,352 |
(1) Refers to the aggregate fees billed by our external auditors for audit services, including interim reviews and work performed in connection with securities filings. (2) Refers to the aggregate fees billed for professional services rendered by our external auditors for translation. (3) Refers to the aggregate fees billed for professional services rendered by our external auditors for tax compliance, transfer pricing, tax advice and tax planning. |
Less than 1 |
More than |
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Contractual Obligations |
Total |
Year |
1 to 3 Years |
3 to 5 Years |
5 years |
|||||||||||||||
Convertible unsecured senior notes, including interest |
29,081,000 |
29,081,000 |
— |
— |
— |
|||||||||||||||
Lease Liabilities |
2,196,000 |
595,000 |
1,145,000 |
405,000 |
51,000 |
|||||||||||||||
Term loan, including interest (1) |
57,667,000 |
5,649,000 |
28,421,000 |
23,597,000 |
— |
|||||||||||||||
Purchase Obligations (2) |
3,822,000 |
3,822,000 |
— |
— |
— |
|||||||||||||||
Total |
$ |
92,766,000 |
$ |
39,147,000 |
$ |
29,566,000 |
$ |
24,002,000 |
$ |
51,000 |
||||||||||
(1) | Based on SOFR forward rates. The maturities above reflect the fact that the term loan has been amended in the subsequent event period and, as such, the contractual maturities are used. |
(2) | The Corporation has long-term procurement agreements with third party suppliers in connection with the commercialization of EGRIFTA SV ® and Trogarzo® . As at November 30, 2022, the Corporation had outstanding purchase orders and minimum payments under these agreements amounting to $1,644,000 for the manufacture of Trogarzo® , EGRIFTA SV ® and for various services. The Corporation also had research commitments and outstanding clinical material purchase orders amounting to $1,310,000 in connection with its oncology platform and $868,000 in connection with the F8 Formulation and a multi-dose pen injector developed for the F8 Formulation. |
THERATECHNOLOGIES INC. | ||||
By: |
/s/ Paul Lévesque | |||
Name: |
Paul Lévesque | |||
Title: |
President and Chief Executive Officer | |||
Date: February 28, 2023 |
Exhibit |
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99.1 | Annual Information Form dated February 27, 2023 for the year ended November 30, 2022 | |
99.2 | ||
99.3 | ||
99.4 | Certificate of CEO dated February 28, 2023 pursuant to Rule 13a-14(a) of the Exchange Act | |
99.5 | Certificate of CFO dated February 28, 2023 pursuant to Rule 13a-14(a) of the Exchange Act | |
99.6 | Certificate of CEO dated February 28, 2023 pursuant to 18 U.S.C. Section 1350, adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
99.7 | Certificate of CFO dated February 28, 2023 pursuant to 18 U.S.C. Section 1350, adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
99.8 | Consent of KPMG LLP | |
101.INS | XBRL Instance | |
101.SCH | XBRL Taxonomy Extension Schema | |
101.CAL | XBRL Taxonomy Extension Calculation Linkbase | |
101.DEF | XBRL Taxonomy Extension Definition Linkbase | |
101.LAB | XBRL Taxonomy Extension Label Linkbase | |
101.PRE | XBRL Taxonomy Extension Presentation Linkbase |