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 14, 2021
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.
Exhibit | Description | |
99.1 | Consolidated Interim Financial Statements for the Three-Month Periods Ended February 28, 2021 and February 29, 2020 | |
99.2 | Managements Discussion and Analysis for the Three-Month Period Ended February 28, 2021 | |
99.3 | Certification of Interim Filings of the President and Chief Executive Officer | |
99.4 | Certification of Interim Filings of the Senior Vice President and Chief Financial Officer |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
THERATECHNOLOGIES INC. |
By: /s/ Philippe Dubuc |
Name: Philippe Dubuc |
Title: Senior Vice President and Chief Financial Officer |
Date: April 14, 2021
Exhibit 99.1
Interim Consolidated Financial Statements
(In thousands of United States dollars)
THERATECHNOLOGIES INC.
Three-month periods ended February 28, 2021 and February 29, 2020
(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 - 18 |
THERATECHNOLOGIES INC.
Interim Consolidated Statements of Financial Position
(In thousands of United States dollars)
As at February 28, 2021 and November 30, 2020
(Unaudited)
Note | February 28, 2021 |
November 30, 2020 |
||||||||||
Assets |
||||||||||||
Current assets |
||||||||||||
Cash |
$ | 49,116 | $ | 12,737 | ||||||||
Bonds and money market funds |
7,600 | 8,031 | ||||||||||
Trade and other receivables |
10,791 | 12,430 | ||||||||||
Tax credits and grants receivable |
445 | 755 | ||||||||||
Inventories |
27,344 | 25,145 | ||||||||||
Prepaid expenses and deposits |
5,841 | 5,189 | ||||||||||
Derivative financial assets |
722 | 520 | ||||||||||
Total current assets |
101,859 | 64,807 | ||||||||||
Non-current assets |
||||||||||||
Property and equipment |
825 | 865 | ||||||||||
Right-of-use assets |
2,521 | 2,618 | ||||||||||
Intangible assets |
23,773 | 24,529 | ||||||||||
Other asset |
6,102 | 7,323 | ||||||||||
Total non-current assets |
33,221 | 35,335 | ||||||||||
Total assets |
$ | 135,080 | $ | 100,142 | ||||||||
Liabilities |
||||||||||||
Current liabilities |
||||||||||||
Accounts payable and accrued liabilities |
$ | 30,603 | $ | 34,815 | ||||||||
Provisions |
5 | 3,417 | 1,947 | |||||||||
Other obligations |
6 | 4,763 | 4,666 | |||||||||
Current portion of lease liabilities |
8 | 445 | 425 | |||||||||
Income taxes payable |
22 | 16 | ||||||||||
Deferred revenue |
50 | 50 | ||||||||||
Total current liabilities |
39,300 | 41,919 | ||||||||||
Non-current liabilities |
||||||||||||
Convertible unsecured senior notes |
7 | 52,834 | 52,403 | |||||||||
Lease liabilities |
8 | 2,482 | 2,555 | |||||||||
Other liabilities |
62 | 41 | ||||||||||
Total non-current liabilities |
55,378 | 54,999 | ||||||||||
Total liabilities |
94,678 | 96,918 | ||||||||||
Equity |
||||||||||||
Share capital and warrants |
333,369 | 287,312 | ||||||||||
Equity component of convertible unsecured senior notes |
4,457 | 4,457 | ||||||||||
Contributed surplus |
12,597 | 12,065 | ||||||||||
Deficit |
(309,436 | ) | (300,129 | ) | ||||||||
Accumulated other comprehensive loss |
(585 | ) | (481 | ) | ||||||||
Total equity |
40,402 | 3,224 | ||||||||||
Subsequent events |
14 | |||||||||||
Total liabilities and equity |
$ | 135,080 | $ | 100,142 |
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 28, 2021 and February 29, 2020
(Unaudited)
Note | 2021 | 2020 | ||||||||||
Revenue |
3 | $ 15,430 | $ 15,719 | |||||||||
Operating expenses |
||||||||||||
Cost of sales |
||||||||||||
Cost of goods sold |
4,190 | 5,400 | ||||||||||
Other production-related costs |
- | 140 | ||||||||||
Amortization of other asset |
1,221 | 1,221 | ||||||||||
Research and development expenses (net of tax credit of $25 (2020 nil)) |
4,883 | 3,419 | ||||||||||
Selling expenses |
6,158 | 6,361 | ||||||||||
General and administrative expenses |
3,562 | 2,570 | ||||||||||
Total operating expenses |
20,014 | 19,111 | ||||||||||
Loss from operating activities |
(4,584 | ) | (3,392 | ) | ||||||||
Finance income |
4 | 25 | 166 | |||||||||
Finance costs |
4 | (1,357 | ) | (1,318 | ) | |||||||
(1,332 | ) | (1,152 | ) | |||||||||
Loss before taxes |
(5,916 | ) | (4,544 | ) | ||||||||
Income taxes |
(6 | ) | - | |||||||||
Net loss for the period |
(5,922 | ) | (4,544 | ) | ||||||||
Other comprehensive income (loss), net of tax |
||||||||||||
Items that may be reclassified to net profit (loss) in the future: |
||||||||||||
Net change in fair value of FVOCI financial assets, net of tax |
(2 | ) | 10 | |||||||||
Exchange difference on translation of foreign operations |
(102 | ) | (2 | ) | ||||||||
(104 | ) | 8 | ||||||||||
Total comprehensive loss for the period |
$ (6,026) | $ (4,536) | ||||||||||
Basic and diluted loss per share |
9 | (d) | (0.07 | ) | (0.06 | ) |
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 per share amounts)
Three-month periods ended February 28, 2021 and February 29, 2020
(Unaudited)
For the three-month period ended February 28, 2021 | ||||||||||||||||||||||||||||||||
Note | Share capital and warrants | Equity component of convertible notes |
Deficit | Accumulated other comprehensive loss |
Total | |||||||||||||||||||||||||||
Number of shares |
Amount | Contributed surplus |
||||||||||||||||||||||||||||||
Balance as at November 30, 2020 |
77,013,411 | $ | 287,312 | $ | 4,457 | $ | 12,065 | $ | (300,129 | ) | $ | (481 | ) | $ | 3,224 | |||||||||||||||||
Total comprehensive loss for the period |
||||||||||||||||||||||||||||||||
Net loss for the period |
- | - | - | - | (5,922 | ) | - | (5,922 | ) | |||||||||||||||||||||||
Other comprehensive income: |
||||||||||||||||||||||||||||||||
Net change in fair value of FVOCI financial assets, net of tax |
- | - | - | - | - | (2 | ) | (2 | ) | |||||||||||||||||||||||
Exchange differences on translation of foreign operation |
- | - | - | - | - | (102 | ) | (102 | ) | |||||||||||||||||||||||
Total comprehensive loss for the period |
- | - | - | - | (5,922 | ) | (104 | ) | (6,026 | ) | ||||||||||||||||||||||
Transactions with owners, recorded directly in equity |
||||||||||||||||||||||||||||||||
Public issue of common shares and warrants |
9 | (a) | 16,727,900 | 46,002 | - | - | - | - | 46,002 | |||||||||||||||||||||||
Share issue costs |
- | - | - | - | (3,385 | ) | - | (3,385 | ) | |||||||||||||||||||||||
Share-based compensation plan: |
||||||||||||||||||||||||||||||||
Share-based compensation for stock option plan |
9 | (b) | - | - | - | 557 | - | - | 557 | |||||||||||||||||||||||
Exercise of stock options: |
||||||||||||||||||||||||||||||||
Monetary consideration |
9 | (b) | 100,000 | 30 | - | - | - | - | 30 | |||||||||||||||||||||||
Attributed value |
- | 25 | - | (25 | ) | - | - | - | ||||||||||||||||||||||||
Total contributions by owners |
16,827,900 | 46,057 | - | 532 | (3,385 | ) | - | 43,204 | ||||||||||||||||||||||||
Balance as at February 28, 2021 |
93,841,311 | $ | 333,369 | $ | 4,457 | $ | 12,597 | $ | (309,436 | ) | $ | (585 | ) | $ | 40,402 | |||||||||||||||||
For the three-month period ended February 29, 2020 | ||||||||||||||||||||||||||||||||
Note | Share capital | Equity component of convertible notes |
Contributed surplus |
Deficit | Accumulated other comprehensive income (loss) |
Total | ||||||||||||||||||||||||||
Number of shares |
Amount | |||||||||||||||||||||||||||||||
Balance as at November 30, 2019 |
76,953,411 | $ | 287,035 | $ | 4,457 | $ | 10,783 | $ | (277,462 | ) | $ | 21 | $ | 24,834 | ||||||||||||||||||
Total comprehensive loss for the period |
||||||||||||||||||||||||||||||||
Net loss for the period |
- | - | - | - | (4,544 | ) | - | (4,544 | ) | |||||||||||||||||||||||
Other comprehensive income: |
||||||||||||||||||||||||||||||||
Net change in fair value of FVOCI financial assets, net of tax |
- | - | - | - | - | 10 | 10 | |||||||||||||||||||||||||
Exchange differences on translation of foreign operation |
- | - | - | - | - | (2 | ) | (2 | ) | |||||||||||||||||||||||
Total comprehensive loss for the period |
- | - | - | - | (4,544 | ) | 8 | (4,536 | ) | |||||||||||||||||||||||
Transactions with owners, recorded directly in equity |
||||||||||||||||||||||||||||||||
Share-based compensation plan: |
||||||||||||||||||||||||||||||||
Share-based compensation for stock option plan |
9 | (b) | - | - | - | 364 | - | - | 364 | |||||||||||||||||||||||
Total contributions by owners |
- | - | - | 364 | - | - | 364 | |||||||||||||||||||||||||
Balance as at February 29, 2020 |
76,953,411 | $ | 287,035 | $ | 4,457 | $ | 11,147 | $ | (282,006 | ) | $ | 29 | $ | 20,662 |
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 28, 2021 and February 29, 2020
(Unaudited)
Note | 2021 | 2020 | ||||||||||
Cash flows from (used in) |
||||||||||||
Operating |
||||||||||||
Net loss for the period |
$ | (5,922 | ) | $ | (4,544 | ) | ||||||
Adjustments for |
||||||||||||
Depreciation of property and equipment |
56 | 60 | ||||||||||
Amortization of intangible and other assets |
2,016 | 1,861 | ||||||||||
Amortization of right-of-use assets |
113 | 109 | ||||||||||
Share-based compensation for stock option plan and stock appreciation rights |
578 | 365 | ||||||||||
Write-down of inventories |
- | 3 | ||||||||||
Change in fair value of derivative financial assets |
(190 | ) | 147 | |||||||||
Change in fair value of liability related to deferred stock unit plan |
188 | (145 | ) | |||||||||
Interest on convertible unsecured senior notes |
4 | 802 | 802 | |||||||||
Interest income |
(25 | ) | (166 | ) | ||||||||
Foreign exchange |
(93 | ) | 13 | |||||||||
Accretion expense |
4 | 581 | 502 | |||||||||
(1,896 | ) | (993 | ) | |||||||||
Change in operating assets and liabilities |
||||||||||||
Trade and other receivables |
1,649 | 230 | ||||||||||
Tax credits and grants receivable |
325 | - | ||||||||||
Inventories |
(2,148 | ) | 256 | |||||||||
Prepaid expenses and deposits |
(650 | ) | 700 | |||||||||
Accounts payable and accrued liabilities |
(3,984 | ) | (5,391 | ) | ||||||||
Income taxes payable |
6 | - | ||||||||||
Provisions |
1,470 | 406 | ||||||||||
Deferred revenue |
- | (33 | ) | |||||||||
(3,332 | ) | (3,832 | ) | |||||||||
(5,228 | ) | (4,825 | ) | |||||||||
Financing |
||||||||||||
Proceeds from issue of common shares and warrants |
9 | (a) | 46,002 | - | ||||||||
Share issue costs |
(3,053 | ) | - | |||||||||
Proceeds from exercise of stock options |
30 | - | ||||||||||
Payments of lease liabilities |
(158 | ) | (141 | ) | ||||||||
Interest paid on convertible unsecured senior notes |
(1,653 | ) | (1,653 | ) | ||||||||
41,168 | (1,794 | ) | ||||||||||
Investing |
||||||||||||
Acquisition of bonds and money market funds |
(2 | ) | (30 | ) | ||||||||
Proceeds from sale of bonds and money market funds |
437 | 1,399 | ||||||||||
Interest received |
32 | 191 | ||||||||||
Acquisition of property and equipment |
(27 | ) | (3 | ) | ||||||||
440 | 1,557 | |||||||||||
Net change in cash during the period |
36,380 | (5,062 | ) | |||||||||
Cash, beginning of period |
12,737 | 28,661 | ||||||||||
Effect of foreign exchange on cash |
(1 | ) | 1 | |||||||||
Cash, end of period |
$ | 49,116 | $ | 23,600 |
See 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
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 28, 2021 and February 29, 2020
(Unaudited)
Theratechnologies Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.
The interim consolidated financial statements include the accounts of Theratechnologies Inc. and its wholly owned subsidiaries (together referred to as the Company and individually as the subsidiaries of the Company).
Theratechnologies Inc. is governed by the Business Corporations Act (Québec) and is domiciled in Québec, Canada. The Company is located at 2015 Peel Street, Suite 1100, Montréal, Québec, H3A 1T8.
1. | Basis of preparation |
(a) | Accounting framework |
These unaudited interim consolidated financial statements (interim financial statements), including comparative information, have been prepared using accounting policies consistent with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB) and in accordance with International Accounting Standard (IAS) 34, Interim Financial Reporting.
Certain information, in particular the accompanying notes normally included in the annual consolidated financial statements prepared in accordance with IFRS, has been omitted or condensed. These interim financial statements do not include all disclosures required under IFRS and, accordingly, should be read in conjunction with the annual consolidated financial statements for the year ended November 30, 2020 and the notes thereto.
These interim financial statements have been authorized for issue by the Companys Audit Committee on April 13, 2021.
(b) | 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 derivative financial liabilities, which are measured at fair value. Effective December 1, 2019, lease liabilities are measured at the present value of lease payments not paid at commencement date. Equity-classified shared-based payment arrangements are measured at fair value at grant date pursuant to IFRS 2, Share-based Payment.
The methods used to measure fair value are discussed further in Note 12.
5
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 28, 2021 and February 29, 2020
(Unaudited)
1. | Basis of preparation (continued) |
(c) | 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, 2020.
(d) | 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, 2020 have been applied consistently in the preparation of these interim financial statements.
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 28, 2021 and February 29, 2020
(Unaudited)
3. | Revenue |
Net sales by product were as follows:
2021 | 2020 | |||||||
EGRIFTA® net sales |
$ | 8,688 | $ | 8,515 | ||||
Trogarzo® net sales |
6,742 | 7,204 | ||||||
$ | 15,430 | $ | 15,719 |
Net sales by geography were as follows:
2021 | 2020 | |||||||
Canada |
$ | 139 | $ | 109 | ||||
United States |
14,576 | 15,610 | ||||||
Europe |
715 | - | ||||||
$ | 15,430 | $ | 15,719 |
4. | Finance income and finance costs |
Note | 2021 | 2020 | ||||||||||
Interest income |
$ | 25 | $ | 166 | ||||||||
Finance income |
25 | 166 | ||||||||||
Accretion expense |
6, 7, 8 | (581 | ) | (502 | ) | |||||||
Interest on convertible unsecured senior notes |
(802 | ) | (802 | ) | ||||||||
Net foreign currency gain (loss) |
24 | (12 | ) | |||||||||
Gain (loss) on financial instruments carried at fair value |
2 | (2 | ) | |||||||||
Finance costs |
(1,357 | ) | (1,318 | ) | ||||||||
Net finance costs recognized in net profit or loss |
$ | (1,332 | ) | $ | (1,152 | ) |
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 28, 2021 and February 29, 2020
(Unaudited)
5. | Provisions |
Chargebacks and rebates |
Returns | Other | Total | |||||||||||||
Balance as at November 30, 2019 |
$ | 2,182 | $ | 247 | $ | 55 | $ | 2,484 | ||||||||
Provisions made |
10,314 | 948 | 2,973 | 14,235 | ||||||||||||
Provisions used |
(10,818 | ) | (935 | ) | (3,019 | ) | (14,772 | ) | ||||||||
Balance as at November 30, 2020 |
$ | 1,678 | $ | 260 | $ | 9 | $ | 1,947 | ||||||||
Provisions made |
2,169 | 229 | 780 | 3,178 | ||||||||||||
Provisions used |
(1,344 | ) | (195 | ) | (169 | ) | (1,708 | ) | ||||||||
Balance as at February 28, 2021 |
$ | 2,503 | $ | 294 | $ | 620 | $ | 3,417 |
6. | Other obligations |
The movement in the other obligations is as follows:
Commercialization rights Trogarzo® North American Territory |
Commercialization rights Trogarzo® European Territory |
Total | ||||||||||
Balance as at November 30, 2019 |
3,417 | 4,570 | 7,987 | |||||||||
Payment |
(3,500 | ) | - | (3,500 | ) | |||||||
Accretion expense |
83 | 96 | 179 | |||||||||
Balance as at November 30, 2020 |
- | 4,666 | 4,666 | |||||||||
Accretion expense |
- | 97 | 97 | |||||||||
Balance as at February 28, 2021, all current |
$ | - | $ | 4,763 | $ | 4,763 |
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 28, 2021 and February 29, 2020
(Unaudited)
7. | Convertible unsecured senior notes |
The movement in the carrying value of the convertible unsecured senior notes is as follows:
Convertible unsecured senior notes as at November 30, 2019 |
$ | 50,741 | ||
Accretion expense |
1,662 | |||
Convertible unsecured senior notes as at November 30, 2020 |
$ | 52,403 | ||
Accretion expense |
431 | |||
Convertible unsecured senior notes as at February 28, 2021 |
$ | 52,834 |
8. | Lease liabilities |
Carrying value |
||||
Balance as at December 1, 2019 |
$ | 3,192 | ||
Accretion expense |
215 | |||
Lease payments |
(568 | ) | ||
Effect of change in exchange rates |
141 | |||
Balance as at November 30, 2020 |
2,980 | |||
Accretion expense |
53 | |||
Lease payments |
(158 | ) | ||
Effect of change in exchange rates |
52 | |||
Balance as at February 28, 2021 |
2,927 | |||
Current portion |
(445 | ) | ||
Non-current portion |
$ | 2,482 |
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 28, 2021 and February 29, 2020
(Unaudited)
9. | Share capital and warrants |
(a) | Public offering |
On January 19, 2021, the Company completed a public offering for the sale and issuance of 16,727,900 units at a price of $2.75 per unit for a gross cash consideration of $46,002, including the full exercise of the over-allotment option.
Each Unit is comprised of one common share of the Company and one-half of one common share purchase warrant of the Company (each whole warrant, a Warrant). As at February 28, 2021, no Warrants were exercised and there were 8,363,950 Warrants outstanding. Each Warrant entitles the holder thereof to purchase one common share at an exercise price of US$3.18 at any time until January 19, 2024.
(b) | Stock option plan |
The Company has established a stock option plan (the Plan) under which it can grant its directors, officers, employees, researchers and consultants non-transferable options for the purchase of common shares. The exercise date of an option may not be later than 10 years after the grant date. A maximum number of 7,700,000 options can be granted under the Plan. Generally, the options vest at the grant date or over a period of up to three years. As at February 28, 2021, 3,679,302 options could still be granted by the Company (2020 1,060,717) under the Plan.
All options are to be settled by the physical delivery of common shares.
10
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 28, 2021 and February 29, 2020
(Unaudited)
9. | Share capital (continued) |
(b) | Stock option plan (continued) |
Changes in the number of options outstanding during the past two years were as follows:
Weighted average exercise price per option |
||||||||||||
Number of options |
CAD | USD | ||||||||||
Options exercisable in CA$ |
||||||||||||
Options as at November 30, 2019 CA$ |
2,415,784 | $ | 3.93 | $ | 2.96 | |||||||
Granted CA$ |
577,800 | 3.22 | 2.42 | |||||||||
Forfeited CA$ |
(5,666 | ) | 8.85 | 6.74 | ||||||||
Options outstanding as at February 29, 2020 CA$ |
2,987,918 | 3.78 | 2.81 | |||||||||
Options as at November 30, 2020 CA$ |
3,203,693 | 3.59 | 2.76 | |||||||||
Granted CA$ |
1,019,331 | 3.93 | 3.09 | |||||||||
Forfeited CA$ |
(10,000 | ) | 3.22 | 2.52 | ||||||||
Exercised (share price: CA$3.29 (US$2.59)) |
(100,000 | ) | 0.38 | 0.30 | ||||||||
Options outstanding as at February 28, 2021 CA$ |
4,113,024 | $ | 3.75 | $ | 2.95 | |||||||
Options exercisable as at February 28, 2021 CA$ |
2,410,129 | $ | 3.66 | $ | 2.88 | |||||||
Options exercisable in US$ |
||||||||||||
Options as at November 30, 2020 US$ |
12,500 | 2.35 | ||||||||||
Granted US$ |
81,093 | 3.10 | ||||||||||
Options outstanding as at February 28, 2021 US$ |
93,593 | 3.00 | ||||||||||
Options exercisable as at February 28, 2021 US$ |
- | - |
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 28, 2021 and February 29, 2020
(Unaudited)
9. | Share capital (continued) |
(b) | Stock option plan (continued) |
During the three-month period ended February 28, 2021, $557 (2020 $364) was recorded as share-based compensation expense for the Plan. The fair value of options granted during the period was estimated at the grant date using the Black-Scholes model and the following weighted average assumptions:
2021 | 2020 | |||||||
Options exercisable in CA$ |
||||||||
Risk-free interest rate |
1.36% | 1.22% | ||||||
Expected volatility |
71% | 77% | ||||||
Average option life in years |
8.5 years | 8.5 years | ||||||
Grant-date share price |
$ | 3.10 (CA$3.93 | ) | $ | 2.42 (CA$3.22 | ) | ||
Option exercise price |
$ | 3.10 (CA$3.93 | ) | $ | 2.42 (CA$3.22 | ) |
2021 | ||||
Options exercisable in US$ |
||||
Risk-free interest rate |
1.40% | |||
Expected volatility |
73% | |||
Average option life in years |
8.5 years | |||
Grant-date share price |
$3.10 | |||
Option exercise price |
$3.10 |
The risk-free interest rate is based on the implied yield on a Canadian government or U.S. zero-coupon issue, with a remaining term equal to the expected term of the option. The volatility is based on weighted average historical volatility adjusted for a period equal to the expected life. The life of the options is estimated taking into consideration the vesting period at the grant date, the life of the option and the average length of time similar grants have remained outstanding in the past. The dividend yield was excluded from the calculation, since it is the present policy of the Company to retain all earnings to finance operations and future growth.
12
THERATECHNOLOGIES INC.
Notes to Interim Consolidated Financial Statements (continued)
(In thousands of United States dollars except for share and per share amounts)
Three-month periods ended February 28, 2021 and February 29, 2020
(Unaudited)
9. | Share capital (continued) |
(b) | Stock option plan (continued) |
The following table summarizes the measurement date weighted average fair value of stock options granted during the period ended:
For the three-month periods ended | ||||||||
Number of options |
Weighted average grant date fair value |
|||||||
Options exercisable in CA$ |
||||||||
February 28, 2021 |
1,019,331 | $ | 2.14 (CA$2.72 | ) | ||||
February 29, 2020 |
577,800 | $ | 1.74 (CA$2.34 | ) | ||||
For the three-month periods ended | ||||||||
Number of options |
Weighted average grant date fair value |
|||||||
Options exercisable in US$ |
||||||||
February 28, 2021 |
81,093 | $ | $2.19 |
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 four highly subjective assumptions, including future stock price volatility and average option life, which greatly affect the calculated values.
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 28, 2021 and February 29, 2020
(Unaudited)
9. | Share capital (continued) |
(c) | Stock appreciation rights (SARs) |
On October 4, 2018, the Companys Board of Directors approved a SARs plan for its consultants that entitles the grantee to a cash payment based on the increase in the stock price of the Companys common shares from the grant date to the settlement date. The exercise date of an SAR may not be later than 10 years after the grant date. Generally, the SARs vest over a period of three years.
During the three-month period ended February 28, 2021, $21 (2020 $1) was recorded as share-based compensation expense for the SARs plan. Since these awards will be cash-settled, the fair value of SARs granted is estimated at each reporting period using the Black-Scholes model and the following weighted average assumptions. No SARs were granted during the three-month period ended February 28, 2021.
Measurement date as at February 28, 2021 |
||||
Risk-free interest rate |
1.36% | |||
Expected volatility |
63% | |||
Average option life in years |
6 years | |||
Period-end share price |
$3.22 (CA$4.09 | ) | ||
SAR exercise price |
$3.22 (CA$4.09 | ) |
The risk-free interest rate is based on the implied yield on a Canadian government zero-coupon issue, with a remaining term equal to the expected term of the SAR. The volatility is based on weighted average historical volatility adjusted for a period equal to the expected life. The life of the SARs is estimated taking into consideration the vesting period at the grant date, the life of the SARs and the average length of time similar grants have remained outstanding in the past. The dividend yield was excluded from the calculation, since it is the present policy of the Company to retain all earnings to finance operations and future growth.
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 28, 2021 and February 29, 2020
(Unaudited)
9. | Share capital (continued) |
(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 $5,922 (2020 $4,544) and a weighted average number of common shares outstanding of 84,692,788 (2020 76,953,411), calculated as follows:
February 28, 2021 |
February 29, 2020 |
|||||||
Issued common shares as at December 1 |
77,013,411 | 76,953,411 | ||||||
Effect of share options exercised |
58,889 | - | ||||||
Effect of public issue of common shares |
7,620,488 | - | ||||||
Weighted average number of common shares, basic and diluted |
84,692,788 | 76,953,411 |
For the three-month period ended February 28, 2021, 4,206,617 (2020 2,987,918) share options, 8,363,950 Warrants and 3,872,053 common shares potentially issuable from the conversion of the $57,500 aggregate principal amount of notes, that may potentially dilute loss per share in the future, were excluded from the weighted average number of diluted common shares calculation as their effect would have been anti-dilutive.
10. | Supplemental cash flow disclosures |
The Company entered into the following transactions which had no impact on its cash flows:
February 28, 2021 |
February 29, 2020 |
|||||||
Additions to property and equipment included in accounts payable and accrued liabilities |
$ | 1 | $ | - | ||||
Additions to intangible assets included in accounts payable and accrued liabilities |
39 | - | ||||||
Share issue costs included in accounts payable and accrued liabilities |
332 | - | ||||||
Initial recognition of right-of-use assets and lease liabilities |
- | 3,192 | ||||||
Reclassification of other liabilities to right-of-use assets |
- | 238 |
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 28, 2021 and February 29, 2020
(Unaudited)
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, 2020.
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 fair value of the convertible unsecured senior notes, including the equity portion, as at February 28, 2021, was approximately $51,175 (Level 1) based on market quotes.
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 28, 2021 and February 29, 2020
(Unaudited)
12. | Determination of fair values (continued) |
Share-based payment transactions
The fair value of the employee stock options are measured based on the Black-Scholes valuation model. Measurement inputs include share price on measurement date, exercise price of the instrument, expected volatility (based on weighted average historical volatility adjusted a period equal to the expected life, weighted average expected life of the instruments (based on historical experience and general option holder behaviour), expected dividends, and the risk-free interest rate (based on government bonds). Service and non-market performance conditions attached to the transactions, if any, are not taken into account in determining fair value.
The deferred stock units liability is recognized at fair value and considered Level 2 in the fair value hierarchy for financial instruments. The fair value is determined using the quoted price of the common shares of the Company.
13. | Operating segments |
The Company has a single operating segment. Over 90% of the Companys revenues are generated from one customer, RxCrossroads, which is domiciled in the United States.
2021 | 2020 | |||||||||
|
RxCrossroads | $ | 14,517 | $ | 15,136 | |||||
Others | 913 | 583 | ||||||||
$ | 15,430 | $ | 15,719 |
All of the Companys non-current assets are located in Canada and Ireland, as is the Companys head office. Of the Companys non-current assets of $33,221, $31,924 as at February 28, 2021 are located in Canada and $1,297 are located in Ireland.
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 28, 2021 and February 29, 2020
(Unaudited)
14. | Subsequent events |
Warrants
Since the end of the first quarter ended February 28, 2021, 177,850 Warrants, issued in January 2021 (Note 9(a)), were exercised and 177,850 common shares were issued for a cash consideration of $566.
Stock options
Between March 1, 2021 and April 12, 2021, 100,000 options were exercised and 100,000 common shares were issued for a cash consideration of $30.
Milestone oncology
In March 2021, the Company issued 481,928 common shares under the terms of the acquisition agreement entered into with all of the shareholders of Katana Biopharma Inc. (Katana) for Katanas in-licensed oncology platform. The purchase price for the oncology platform provided for share-based consideration to be issued upon attainment of two milestones. The first milestone consisted in initiating a Phase 1 clinical trial evaluating TH1902 for the treatment of sortilin positive solid tumors. This milestone was achieved in March 2021. The estimated fair value of the share-based consideration of $614, initially recorded in contributed surplus on the date of the acquisition, will be reclassified to share capital in the second quarter.
18
Exhibit 99.2
MANAGEMENTS DISCUSSION AND ANALYSIS
FOR THE THREE-MONTH PERIOD ENDED FEBRUARY 28, 2021
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 28, 2021 compared to the three-month period ended February 29, 2020. Unless otherwise indicated or unless the context requires otherwise, all references in this MD&A to Theratechnologies, the Company, the Corporation, we, our, us or similar terms refer to Theratechnologies Inc. and its subsidiaries on a consolidated basis. This MD&A is dated April 12, 2021, was approved by our Audit Committee on April 13, 2021 and should be read in conjunction with our unaudited interim consolidated financial statements and the notes thereto as at February 28, 2021 (Interim Financial Statements), as well as the MD&A and audited annual consolidated financial statements, including the notes thereto, as at November 30, 2020.
Except as otherwise indicated, the financial information contained in this MD&A and in our Interim Financial Statements has been prepared using accounting policies consistent with International Financial Reporting Standards (IFRS), as issued by the International Accounting Standards Board, or IASB, and in accordance with International Accounting Standard (IAS) 34, Interim Financial Reporting.
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. The use of tesamorelin refers to the use of our tesamorelin compound for the potential treatment of nonalcoholic steatohepatitis (NASH) in the general population and in people living with HIV.
Forward-Looking Information
This MD&A contains forward-looking statements and forward-looking information (collectively, Forward-Looking Statements), within the meaning of applicable securities laws, that are based on our managements beliefs and assumptions and on information currently available to our management. You can identify Forward-Looking Statements by terms such as may, will, should, could, would, outlook, believe, plan, envisage, anticipate, expect and estimate, or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this MD&A include, but are not limited to, statements regarding the conduct of our clinical trials with TH1902 and tesamorelin, the timelines associated to those clinical trials and the filing of an sBLA with the FDA, the development of a multi-dose pen injector using the F8 formulation, the growth of our revenues and the value generated from our commercial and research and development activities.
Although the Forward-Looking Statements contained in this MD&A are based upon what the Company believes are reasonable assumptions in light of the information currently
Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements. Certain assumptions made in preparing the Forward-Looking Statements include that: the current COVID-19 pandemic will have limited adverse effect on the Companys operations and its business plan; sales of EGRIFTA SV® and Trogarzo® in the United States will increase over time; the Companys commercial practices in the United States and the countries of the European Union will not be found to be in violation of applicable laws; the long-term use of EGRIFTA SV® and Trogarzo® will not change their respective current safety profile; no recall or market withdrawal of EGRIFTA SV® and Trogarzo® will occur; no laws, regulation, order, decree or judgment will be passed or issued by a governmental body negatively affecting the marketing, promotion or sale of EGRIFTA SV® and Trogarzo® in countries where such products are commercialized; continuous supply of EGRIFTA SV® and Trogarzo® will be available; the Companys relations with third-party suppliers of EGRIFTA SV® and Trogarzo® will be conflict-free and such third-party suppliers will have the capacity to manufacture and supply EGRIFTA SV® and Trogarzo® to meet market demand on a timely basis; no biosimilar version of EGRIFTA SV® will be approved by the FDA; the Companys intellectual property will prevent companies from commercializing biosimilar versions of EGRIFTA SV® in the United States; Trogarzo® will be reimbursed in key European countries; the FDA will approve the F8 formulation and the multi-dose pen injector; the FDA and the European regulatory agencies will approve a common design for the Phase 3 clinical trial studying tesamorelin for the treatment of NASH in the general population; the Company will succeed in conducting such Phase 3 clinical trial and its Phase 1 clinical trial using TH1902 in various types of cancer; the Companys research and development activities using peptides derived from its oncology platform will yield positive results allowing for the development of new drugs for the treatment of cancer; the Companys European infrastructure is adequate to commercialize Trogarzo® in Germany and in other European countries; and the Companys business plan will not be substantially modified.
Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond Theratechnologies control that could cause actual results to differ materially from those that are disclosed in or implied by such Forward-Looking Statements. These risks and uncertainties include, but are not limited to, those related to or arising from: the adverse impact of the COVID-19 pandemic on (a) the Companys sales efforts and sales initiatives, (b) the capacity of the Companys suppliers to meet their obligations vis-à-vis the Company, (c) the Companys research and development activities, (d) the health of the Companys employees and its capacity to rely on its resources, as well as (e) global trade; the Companys ability and capacity to grow the sales of EGRIFTA SV® and Trogarzo® successfully in the United States and Trogarzo® in Europe; the Companys capacity to meet supply and demand for its products; the market acceptance of EGRIFTA SV® and Trogarzo® in the United States and of Trogarzo® in Europe; 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; the Companys ability to protect and maintain its intellectual property rights in EGRIFTA SV® and tesamorelin; the Companys success in obtaining reimbursement for Trogarzo® in key European countries, together with the level of reimbursement, if at all; the Companys ability and capacity to commercialize Trogarzo® in Germany and to launch Trogarzo® in other key
2
Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
countries of the European Union; the Companys ability to obtain the approval by the FDA of the F8 formulation and the multi-dose pen injector; the Companys ability to obtain an agreement with the FDA for its Phase 3 clinical trial design studying tesamorelin in the NASH general population; the Companys ability to successfully conduct its Phase 3 clinical trial using tesamorelin for the treatment of NASH in the general population and its Phase 1 clinical trial using TH1902 in various types of cancer; the Companys capacity to acquire or in-license new products and/or compounds; the discovery of a cure for HIV; the Companys expectations regarding its financial performance, including revenues, expenses, gross margins, profitability, liquidity, capital expenditures and income taxes; and the Companys estimates regarding its capital requirements.
We refer current and potential investors to the Risk Factors section of our Annual Information Form dated February 24, 2021 available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov as an exhibit to our report on Form 40-F dated February 25, 2021 under Theratechnologies public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on Forward-Looking Statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this MD&A and represent our expectations as of that date.
We undertake no obligation to update or revise the information contained in this MD&A, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.
BUSINESS OVERVIEW
Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. We have a promising pipeline of investigational medicines in NASH and oncology and two approved medicines (EGRIFTA SV® and Trogarzo®) for people living with HIV. The Company has a sales and marketing infrastructure to commercialize its products in the United States and Europe. We continue to assess the market for potential product acquisitions or in-licensing transactions that would be complementary to our business and further drive future sustainable growth and value creation.
RECENT HIGHLIGHTS AND PROGRAM UPDATES
● | Additional data for TH1902 at AACR support broad applicability: On April 10, 2021, new positive in vivo preclinical data on TH1902 were presented in two posters at the American Association for Cancer Research (AACR). These data demonstrated sustained tumor regression, better anti-tumor activity and tolerability with TH1902 compared to docetaxel alone in all cancer types studied, namely melanoma, pancreatic, ovarian, endometrial, colorectal and triple-negative breast cancers. The anti-tumor effect of TH1902 also persisted longer post-treatment than with docetaxel alone. Furthermore, these data showed that in all cancers studied, neutropenia was absent after six consecutive treatments with TH1902 at an equivalent dose of the maximum tolerated dose (MTD) of docetaxel, whereas a single treatment of docetaxel strongly reduced neutrophil counts. These new data further support the development of TH1902 for the potential treatment in various cancers as well as highlight its broad applicability in potentially treating all sortilin-expressing solid tumors that are refractory to standard therapy. |
3
Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
● | Strategic additions to commercial organization: On March 29, 2021, we announced the addition of two new senior leaders to support the Companys commercial and pipeline operations. John Leasure joined the Company as Global Commercial Officer and Peter Kowal joined as Vice President, HIV-U.S. Commercial Operations. John and Peter bring to Theratechnologies sales and marketing expertise in HIV, endocrinology and oncology. |
● | Phase 1 trial of TH1902 for the treatment of cancer initiated: In March 2021, the Company initiated a Phase 1 clinical trial evaluating TH1902, its lead investigational peptide-drug conjugate (PDC), for the treatment of sortilin positive (SORT1+) solid tumors. The Company received fast track designation from the U.S. Food and Drug Administration (FDA) for TH1902 in February 2021. |
● | Planned Phase 3 trial of tesamorelin for the treatment of NASH: The initiation of a Phase 3 clinical trial evaluating tesamorelin for the treatment of NASH is on track to begin in the third quarter of calendar year 2021. Per the FDAs recommendation, the Company has confirmed a date to meet with the agency and discuss the proposed trial design and protocol. The Company received a Study May Proceed letter for the Phase 3 trial from the FDA in January 2021 and we have retained the services of a global, large-scale CRO with experience in implementing large and late-stage clinical trials to assist with the execution of the trial. |
● | Intellectual property position strengthened in NASH: On March 16, 2021, the U.S. Patent and Trademark Office (USPTO) issued a new U.S. Patent, No. 10,946,073, covering among other things, a method for preventing or delaying the onset of liver fibrosis or reducing liver fibrosis or its progression in a subject suffering from nonalcoholic fatty liver disease (NAFLD) or NASH, wherein said subject has a hepatic fat fraction of at least about 10%, through the administration of an effective amount of tesamorelin. This patent is scheduled to expire in 2040 and adds to the Companys strong intellectual property position in NASH. Theratechnologies has an exclusive license with Massachusetts General Hospital (MGH) to this patent. Combined with previously announced patents, the Company is well-positioned in the development and potential commercialization of tesamorelin for the treatment of NASH and other liver diseases. |
● | Lifecycle management of tesamorelin for the treatment of HIV: The Company has developed a new formulation of tesamorelin known as the F8 formulation. The F8 formulation has a number of significant improvements over our current F4 formulation, which is currently commercialized as EGIRFTA SV® for the treatment of HIV-associated lipodystrophy. The F8 formulation is twice as concentrated as the F4 formulation resulting in a smaller volume of administration and is intended to be presented in a multi-dose vial that can be reconstituted once per week. A multi-dose pen injector is also being developed for the administration of the F8 formulation. The Company plans to file an sBLA for the F8 formulation and multi-dose pen injector in early 2022 for the treatment of HIV-associated lipodystrophy and plans to use the F8 formulation for its planned Phase 3 clinical trial in NASH. |
● | Lifecycle management of ibalizumab for the treatment of HIV: Enrollment is complete in a study evaluating an intravenous (IV) push administration of Trogarzo® |
4
Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. The study is expected to be completed in the third quarter of 2021. The IV study is being conducted and funded by the Companys partner, TaiMed Biologics, Inc. (TaiMed). Theratechnologies and TaiMed are also planning to evaluate an intramuscular (IM) method of administration for Trogarzo® and the study will be conducted and funded by Theratechnologies. |
OUR MEDICINES
The Company has two approved medicines for people living with HIV, namely Trogarzo® in the United States, European Union (EU), and United Kingdom, and EGRIFTA SV® in the United States. EGRIFTA® is commercially available in Canada, but sales of EGRIFTA® in Canada are not material to our business.
EGRIFTA SV® is a new formulation of EGRIFTA® that was approved by the FDA for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy and launched in the United States in November 2019. Unlike EGRIFTA®, EGRIFTA SV® can be kept at room temperature, comes in a single vial and has a higher concentration resulting in a smaller volume of administration.
Trogarzo® was the first HIV treatment approved with a new mechanism of action in more than 10 years. It is the first in a new class of antiretrovirals (ARV) and is a long-acting ARV therapy that can lead to an undetectable viral load in heavily treatment-experienced adult HIV-infected patients when used in combination with other ARVs. The treatment is infused once every two weeks.
Trogarzo® was approved by the FDA in March 2018 for the treatment of human immunodeficiency 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 also approved by the European Medicines Agency (EMA) in September 2019 for the treatment of adults infected with MDR HIV-1 for whom it is otherwise not possible to construct a suppressive antiviral regimen. Trogarzo® is currently commercially available in Germany and the Company expects to launch Trogarzo® in key additional European countries later in 2021 and in 2022. A number of patients are also being treated with Trogarzo® in some European countries through early access programs. Trogarzo® will be launched on a country-by-country basis across Europe as it gains public reimbursement in each such country. In addition, the Company has filed a marketing authorization application (MAA) in Israel for Trogarzo®.
In March 2016, we obtained the rights to commercialize Trogarzo® in the United States and Canada pursuant to a distribution and licensing agreement with TaiMed. In March 2017, the agreement was amended to include the commercial rights to Trogarzo® in the EU and in other countries such as Israel, Norway, Russia and Switzerland (TaiMed Agreement).
The Companys commercial strategy for the 2021 fiscal year is to generate revenue growth through increased sales of its medicines in the United States while working on securing an appropriate price and widespread reimbursement for Trogarzo® in key European countries and launch Trogarzo® in those key European countries.
5
Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
Impact of the COVID-19 Pandemic
Throughout the global COVID-19 pandemic, face-to-face interactions in clinics, hospitals, AIDS services organizations and other offices were reduced, and patient treatment initiations were delayed due to restrictions implemented to stop the spread of COVID-19. In order to adapt to the pandemic environment, we transitioned to offering virtual interactions to continue to provide education and support for people in need of our medications, people living with HIV, case managers, healthcare providers and their staff, on how to manage HIV during the COVID-19 pandemic. In the fourth quarter of 2020, we announced a change to our U.S. sales infrastructure and a reallocation of resources to adapt to this new business environment and increase our presence in the healthcare community. During the first quarter of 2021, we continued to see some negative impact on our HIV revenues from the COVID-19 pandemic as many U.S. states maintained pandemic-related restrictions. In the EU, sales of Trogarzo® and the review of regulatory dossiers continued to be adversely impacted by COVID-19 due to strict lockdown measures imposed in many European countries. We have and continue to impose measures to address and mitigate the impact of the COVID-19 pandemic on our employees and customers and to continue to progress our research and development programs. To date, preparations for our upcoming Phase 3 clinical trial of tesamorelin for the treatment of NASH have not been materially adversely impacted by the COVID-19 pandemic.
OUR PIPELINE
Theratechnologies has established a promising pipeline of investigational medicines in areas of high unmet need, including NASH, oncology and HIV.
Tesamorelin
In fiscal year 2020, the Company completed the evaluation and development of the F8 formulation, which based on internal studies, is bioequivalent to the original commercialized formulation of tesamorelin (F1 formulation). The F8 formulation has a number of advantages over the current formulation of EGRIFTA SV®. Specifically, it is twice as concentrated resulting in a smaller volume of administration and is intended to be presented in a multi-dose vial that can be reconstituted once per week. Similar to the current formulation of EGRIFTA SV®, the F8 formulation is stable at room temperature, even once reconstituted.
The F8 formulation is patent protected in the United States until 2033 and until 2034 in major European countries. The USPTO issued U.S. Patent 10,799,562 to MGH relating to the treatment of hepatic disease using growth hormone related hormone (GHRH) or analogues thereof which is scheduled to expire in 2040. This patent application claims, among other things, a method for the treatment of NAFLD or NASH in a patient via the administration of tesamorelin. Furthermore, on March 16, 2021, the USPTO issued U.S. Patent, No. 10,946,073, among other things, a method for preventing or delaying the onset of liver fibrosis or reducing liver fibrosis or its progression in a subject suffering from NAFLD or NASH. We have an exclusive worldwide license with MGH for these patents and continue to seek opportunities for additional patent registrations for the use of tesamorelin to further strengthen our intellectual property position.
The Company is currently working on the development of a multi-dose pen injector to be used in conjunction with the F8 formulation and we intend to seek marketing approval of the pen in the same sBLA as that for the F8 formulation. We plan to file an sBLA for the
6
Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
F8 formulation and multi-dose pen injector in early 2022 for the treatment of lipodystrophy in people living with HIV.
In November 2020, the Company filed an IND with the FDA for the Phase 3 clinical trial evaluating tesamorelin for the treatment of NASH and received a Study May Proceed letter for the Phase 3 trial from the FDA in December 2020. The IND filing followed our announcement made in September 2020 regarding our intent to develop tesamorelin for the treatment of NASH in the general population.
The proposed Phase 3 clinical trial design will enroll participants with liver-biopsy confirmed NASH and stage 2 or 3 fibrosis. Participants will be randomized 1:1 to receive 2 mg of tesamorelin or placebo. A second liver biopsy will be performed after 18 months of treatment for the first 900 participants, approximately. These data will form the basis for filing an sBLA with the FDA to seek accelerated approval. The primary endpoint used to seek accelerated approval will be the percentage of participants achieving NASH resolution and no worsening of fibrosis compared to placebo. Participants will remain in the Phase 3 trial for a total of 60 months. Subject to additional discussions with regulatory agencies, approximately 2,000 participants in total are expected to be enrolled, including a cohort of approximately 75 to 100 participants with HIV.
Theratechnologies intends to use the F8 formulation for the Phase 3 clinical trial in NASH. The Phase 3 trial in NASH will compare the F8 formulation to a placebo.
Per the FDAs recommendation, the Company has confirmed a date to meet with the agency and discuss the proposed trial design and protocol. Concurrently, we are assessing our strategy regarding a filing with the EMA to initiate a Phase 3 clinical trial in the EU. Our goal is to initiate the Phase 3 clinical trial by the end of the third quarter of calendar year 2021. The timing of the trial initiation and the final number of patients enrolled are dependent upon any adjustments to the protocol and trial design as recommended by the FDA and EMA. The Company has retained the services of a global, large-scale CRO with experience in implementing large and late-stage clinical trials to assist with the execution of its Phase 3 clinical trial in NASH.
In March 2021, new data demonstrating the positive effect of tesamorelin in the circulation of immune activation markers associated with liver inflammation was presented at The Endocrine Societys Annual Meeting, ENDO 2021. These data concluded that treatment with tesamorelin for 12 months decreased circulating markers of T-cell and monocyte/macrophage activity. A corresponding downregulation of immune pathways in the liver was also observed. These conclusions suggest that treatment with tesamorelin may contribute to better regulated immune activation in a population with metabolic dysregulation and systemic inflammation. The data comes from a sub-analysis of a double-blind, randomized, 12-month investigator-initiated trial studying the effect of tesamorelin on liver fat in 61 people infected with HIV with NAFLD, which was conducted by Dr. Steven Grinspoon, Professor of Medicine, Harvard Medical School, Chief of the Metabolism Unit at MGH. Dr. Grinspoons findings were published in The Lancet HIV in October 2019.
SORT1+ Technology
The Company is currently developing a platform of new proprietary peptides for cancer drug development targeting the SORT1 receptor. SORT1 is expressed in ovarian, triple-
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
negative breast, skin, lung, colorectal and pancreatic cancers, among others. SORT1 plays a significant role in protein internalization, sorting and trafficking, and therefore, is an attractive target for anticancer drug development. Our innovative PDCs generated through our SORT1+ Technology features distinct pharmacodynamic and pharmacokinetic properties that differentiate them from traditional chemotherapy. In contrast to traditional chemotherapy, our proprietary PDCs are designed to enable selective delivery of certain anticancer drugs within the tumor microenvironment, and more importantly, directly inside SORT1+ cancer cells.
Our SORT1+ Technology was acquired in February 2019 as part of the acquisition of Katana Biopharma Inc., (Katana). Through the acquisition, Theratechnologies obtained the worldwide rights to this platform based on an exclusive royalty-bearing license entered into between Katana and Transfer Plus L.P.
Preclinical in vivo data has demonstrated that our SORT1+ Technology improved anti-tumor activity and reduced neutropenia and systemic toxicity. It also was shown in preclinical models to bypass the multidrug resistance protein 1 (MDR1); also known as P- glycoprotein, one of the mechanisms of chemotherapy drug resistance. In addition, our SORT1+ Technology has demonstrated activity in preclinical models against the formation of vasculogenic mimicry (VM) a mechanism also associated with cancer resistance. In vivo preclinical toxicity data have also demonstrated that TH1902 (docetaxel conjugate), could be administered at three times the MTD of docetaxel alone.
In December 2020, the Company filed an IND application with the FDA for the Phase 1 first-in-human clinical trial evaluating TH1902 for the treatment of various cancers. The proposed Phase 1 clinical trial design includes a dose escalation study to evaluate the safety, pharmacokinetics, MTD and preliminary anti-tumor activity of TH1902 administered once every three weeks in patients with advanced solid tumors refractory to available anti-cancer therapies. Once the MTD is determined, we expect a total of 40 additional patients will be enrolled to evaluate the potential anti-tumor activity of TH1902 in patients with endometrial, ovarian, colorectal, triple-negative breast and pancreatic cancers where it has been estimated that the sortilin receptor is expressed in 40% to 90% of cases.
In February 2021, we received fast track designation from the FDA for TH1902 as a single agent for the treatment of patients with SORT1+ recurrent advanced solid tumors that are refractory to standard therapy.
In March 2021, the Phase 1 trial was initiated. The Company has retained the services of a global, large-scale CRO to assist with the conduct of its Phase 1 clinical trial. The detailed study protocol is available at ClinicalTrials.gov under the identifier number: NCT04706962.
On April 10, 2021, new positive in vivo preclinical data on TH1902 were presented in two posters at the American Association for Cancer Research (AACR). These data demonstrated sustained tumor regression, better anti-tumor activity and tolerability with TH1902 compared to docetaxel alone in all cancer types studied, namely melanoma, pancreatic, ovarian, endometrial, colorectal and triple-negative breast cancers. The anti-tumor effect of TH1902 also persisted longer post-treatment than with docetaxel alone. In one poster, new data were presented on TH1902 in melanoma, which showed that
8
Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
TH1902 was associated with superior anti-tumor effect and sustained post-treatment effect compared to docetaxel alone. Other data highlights included better and sustained anti-tumor effect in pancreatic tumors and in triple-negative breast cancer. A treatment effect was also observed in colorectal cancer, which is encouraging as docetaxel is not recognized as standardized care for colorectal cancer due to the lack of response. The positive effect of TH1902 on tumor regression was also observed in these cancer types at an equimolar quarter dose compared to docetaxel alone. In a second poster, new data highlighted the sustained inhibition of ovarian and endometrial cancers with TH1902 at equimolar doses of docetaxel alone. Specifically, TH1902 showed improved anti-tumor activity in endometrial cancer at an equimolar quarter dose compared to docetaxel alone. Furthermore, these data showed that in all cancers studied, neutropenia was absent after six consecutive treatments with TH1902 at an equivalent dose of the maximum tolerated dose (MTD) of docetaxel, whereas a single treatment of docetaxel strongly reduced neutrophil counts.
In addition, further preclinical research activities are being conducted using TH1904, our second investigational PDC (doxorubicin conjugate). In vitro and in vivo experiments using TH1904 have demonstrated results similar to those obtained with TH1902 and support the development of additional investigational compounds using our SORT1+ Technology that may help in the fight against cancer.
Ibalizumab for HIV
A study evaluating an IV push administration of Trogarzo® is currently being conducted by TaiMed. Enrollment in this study is now complete and TaiMed expects to complete the trial in the third quarter of 2021. The study is evaluating the drug levels of Trogarzo using the IV push administration versus the approved IV infusion method of administration. The IV study is being conducted and funded by TaiMed. Theratechnologies and TaiMed are also planning to evaluate an IM method of administration for Trogarzo®. The study will be conducted and funded by Theratechnologies. Under the terms of the TaiMed Agreement, we are entitled to commercialize the new methods of administration of Trogarzo® if, and when, approved.
In connection with the September 2019 approval of Trogarzo® in Europe, the EMA has requested a post-authorization efficacy study (Registry) to be conducted to evaluate the long-term efficacy and durability of Trogarzo® in combination with other antiretrovirals. The enrollment of patients in this study is expected to begin in late 2021. The Company is also required to conduct a pediatric investigation plan (PIP) to evaluate Trogarzo® in children aged 6 to <18 years old. The PIP will be comprised of two studies with the first study expected to begin in the second half of 2021.
2021 BUSINESS STRATEGY AND OBJECTIVES
Our 2021 Business Strategies and Objectives are as follows:
● | Continue to grow our revenues in the United States from increased sales of EGRIFTA SV® and Trogarzo®; |
● | Successfully obtain reimbursement for Trogarzo® in key European countries and launch Trogarzo® in some of these countries; |
● | Initiate a Phase 3 clinical trial evaluating tesamorelin for the treatment of NASH by the end of the third quarter of calendar year 2021; |
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
● | Initiate a Phase 1 clinical trial evaluating TH1902 for the treatment of various cancer types in the second quarter of calendar year 2021 (achieved in Q121 ahead of target); |
● | Seek and pursue potential product acquisitions, in-licensing transactions or other opportunities complementary to our business; and, |
● | Manage our financial position to ensure we can successfully execute on our business strategy and objectives. |
First-Quarter Fiscal 2021 Financial Results
Revenue
Consolidated revenue for the three-month period ended February 28, 2021 was $15,430,000 compared to $15,719,000 for the same period ended February 29, 2020.
For the first quarter of fiscal 2021, net sales of EGRIFTA SV® reached $8,688,000 compared to $8,515,000 in the first quarter of the prior year, representing an increase of 2.0% over the first quarter of 2020, which included sales of both EGRIFTA SV® and EGRIFTA®.
In the first quarter of fiscal 2021, Trogarzo® net sales amounted to $6,742,000 compared to $7,204,000 for the same quarter of 2020, representing a decrease of 6.4%. Lower sales of Trogarzo® were a result of a decrease in unit sales, and higher rebates, which were offset by a higher selling price.
Cost of Sales
For the three months ended February 28, 2021, cost of sales was $5,411,000 compared to $6,761,000 for the same quarter in fiscal 2020, primarily due to the lower cost of goods sold. Cost of goods sold was $4,190,000 in the first quarter of 2021 compared to $5,400,000 for the same quarter the previous year. The decrease in cost of goods sold was mainly due to a combination of lower Trogarzo® sales, a lower cost for Trogarzo® and a lower cost of EGRIFTA SV® compared to EGRIFTA®. Cost of sales also included the amortization of the other asset of $1,221,000 in both Q1 2021 and Q1 2020.
R&D Expenses
R&D expenses amounted to $4,883,000 in the three-month period ended February 28, 2021 compared to $3,419,000 for the same period in 2020. The increase was largely due to higher spending in our oncology and NASH programs, increased spending in medical and patient education, as well as increased medical affairs spending in Europe.
Selling Expenses
Selling expenses amounted to $6,158,000 for the first quarter of 2021 compared to $6,361,000 for the same three-month period last year, reflecting a realignment of spending as a result of a lower headcount in our salesforce.
The amortization of the intangible asset value for the EGRIFTA® and Trogarzo® commercialization rights is also included in selling and market development expenses. As such, we recorded an expense of $795,000 for the first quarter of fiscal 2021 compared to $642,000 for the same quarter last year.
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
General and Administrative Expenses
General and administrative expenses amounted to $3,562,000 for the three months ended February 28, 2021 compared to $2,570,000 for the first quarter of 2020. The increase in general and administrative expenses was mainly associated with an overall increase in business activities and increased activity in Europe.
Finance Income
Finance income, consisting of interest income, amounted to $25,000 during the first quarter of 2021 compared to $166,000 in the first quarter of last year. Lower finance income was due in large part to a decreased liquidity position and a decrease in interest rates.
Finance Costs
Finance costs for the three months ended February 28, 2021 were $1,357,000 compared to $1,318,000 for the comparable period of 2020. Finance costs in the first quarter of 2021 and 2020 included interest of $802,000 on the senior convertible notes issued in June 2018.
Finance costs also included accretion expense of $581,000, compared to $502,000 for the comparable period in 2020.
Adjusted EBITDA
Adjusted EBITDA was $(1,821,000) for the first quarter of 2021 compared to $(994,000) for the same period of 2020. See Non-IFRS Financial Measures below.
Net loss
Taking into account the revenue and expense variations described above, we recorded a net loss of $5,922,000 or $0.07 per share in the first three months of fiscal 2021 compared to a net loss of $4,544,000 or $0.06 per share for the same period last year.
Financial Position
We ended the first quarter of fiscal 2021 with $56,716,000 in cash, bonds and money market funds.
During the first quarter of fiscal 2021, the Company completed a public offering for the sale and issuance of 16,727,900 units of the Company for a gross cash consideration of $46,002,000 including the full exercise of the over-allotment option. Share issue costs amounted to $3,385,000 resulting in net proceeds of $42,617,000.
Each unit is comprised of one common share of the Company and one-half of one common share purchase warrant of the Company (each whole warrant, a Warrant). Each Warrant entitles the holder to purchase one common share of the Company at an exercise price of $3.18 until January 19, 2024.
Our current cash, bond and money market funds will be sufficient to fund the Companys operations for the foreseeable future.
For the three-month period ended February 28, 2021, operating activities used $5,228,000 compared to $4,825,000 in the comparable period of fiscal 2020, primarily due
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
to the increased loss in 2021, partially offset by a smaller negative impact of changes in operating assets and liabilities.
In the first quarter of fiscal 2021, changes in operating assets and liabilities had a negative impact on cash flow of $3,332,000 (2020-negative impact of $3,832,000). These changes included a negative impact from accounts payables and accrued liabilities and inventories, and were offset by a decrease in trade and other receivables and an increase in provisions.
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
Quarterly Financial Information
The following table is a summary of our unaudited consolidated operating results for the last eight quarters.
(in thousands of dollars, except per share amounts)
2021 | 2020 | 20191 | ||||||||||||||||||||||||||||||
Q1 | Q4 | Q3 | Q2 | Q1 | Q4 | Q3 | Q2 | |||||||||||||||||||||||||
Revenue |
15,430 | 19,123 | 14,049 | 17,162 | 15,719 | 16,400 | 16,111 | 15,609 | ||||||||||||||||||||||||
Operating expenses |
||||||||||||||||||||||||||||||||
Cost of sales |
||||||||||||||||||||||||||||||||
Cost of goods sold |
4,190 | 5,190 | 4,611 | 5,769 | 5,400 | 5,754 | 5,215 | 5,346 | ||||||||||||||||||||||||
Other production-related costs |
- | 240 | 280 | 391 | 140 | 14 | 1 | 18 | ||||||||||||||||||||||||
Amortization of other asset |
1,221 | 1,220 | 1,220 | 1,220 | 1,221 | 1,221 | 1,221 | 1,221 | ||||||||||||||||||||||||
R&D |
4,883 | 6,795 | 4,183 | 3,622 | 3,419 | 3,877 | 2,152 | 2,285 | ||||||||||||||||||||||||
Selling |
6,158 | 6,532 | 7,025 | 6,941 | 6,361 | 7,673 | 6,389 | 6,972 | ||||||||||||||||||||||||
General and administrative |
3,562 | 3,255 | 2,699 | 3,706 | 2,570 | 3,258 | 1,772 | 1,784 | ||||||||||||||||||||||||
Total operating expenses |
20,014 | 23,232 | 20,018 | 21,649 | 19,111 | 21,797 | 16,750 | 17,626 | ||||||||||||||||||||||||
Finance income |
25 | 21 | 32 | 80 | 166 | 217 | 253 | 292 | ||||||||||||||||||||||||
Finance costs |
(1,357) | (1,445) | (831) | (1,399) | (1,318) | (1,275) | (1,253) | (1,449) | ||||||||||||||||||||||||
Income taxes |
(6) | (16) | - | - | - | - | - | - | ||||||||||||||||||||||||
Net loss |
(5,922) | (5,549) | (6,768) | (5,806) | (4,544) | (6,455) | (1,639) | (3,174) | ||||||||||||||||||||||||
Basic and diluted loss per share |
(0.07) | (0.07) | (0.09) | (0.08) | (0.06) | (0.08) | (0.02) | (0.04) |
1 | The Company adopted IFRS 16 Leases, using the modified retrospective approach, effective for Fiscal 2020, beginning on December 1, 2019. Accordingly, comparative figures for Fiscal 2019 have not been restated and continue to be reported under IAS 17. See note 1 in the Audited Financial Statements for the year ended November 30, 2020. |
13
Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
Factors Affecting the Variability of Quarterly Results
There are quarter-over-quarter variations in net sales revenue, principally due to changes in distributor inventory levels with some additional impact from time to time related to average net selling price, which is affected by changes in the mix of private payors versus government drug reimbursement plans.
Subsequent Events
Warrants
Since the end of the first quarter ended February 28, 2021, 177,850 Warrants, issued in January 2021 (see Financial Position), were exercised and 177,850 common shares were issued for a cash consideration of $566,000.
Stock options
Between March 1, 2021 and April 12, 2021, 100,000 options were exercised, and 100,000 common shares were issued for a cash consideration of $30,000.
Milestone oncology
In March 2021, the Company issued 481,928 common shares under the terms of the acquisition agreement entered into with all of the shareholders of Katana for Katanas in-licensed oncology platform. The purchase price for the oncology platform provided for share-based consideration to be issued upon attainment of two milestones. The first milestone consisted in initiating a Phase 1 clinical trial evaluating TH1902 for the treatment of sortilin positive solid tumors. This milestone was achieved in March 2021. The estimated fair value of the share-based consideration of $614,000, initially recorded in contributed surplus on the date of the acquisition, will be reclassified to share capital in the second quarter.
Recent Changes in Accounting Standards
There were no changes in accounting standards during the first quarter of fiscal 2021. .
Outstanding Share Data
As of April 12, 2021, the Company had 94,601,089 common shares issued and outstanding, 8,186,100 warrants outstanding, and 4,100,758 outstanding options. We also had $57,500,000 aggregate principal amount of 5.75% convertible unsecured senior notes due June 30, 2023 issued and outstanding as a result of the Offering. These notes are convertible into common shares at the option of the holder at a conversion price of $14.85, representing a conversion rate of approximately 67.3401 common share per $1,000 principal amount of notes. The conversion of all of the outstanding notes would result in the issuance of 3,872,055 common shares.
Contractual Obligations
There was no material change in contractual obligations during the three-month period ended February 28, 2021.
Economic and Industry Factors
The WHO declared a global pandemic on March 11, 2020. Authorities around the world implemented confinement measures designed to curb the spread of the COVID-19. Those measures have severely limited face-to-face access to healthcare providers. The industry as a whole has had to adapt to this new reality and uncertainty remains.
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
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, 2020 and ending on February 28, 2021 that has materially affected, or is reasonably likely to materially affect, the Companys ICFR.
Non-IFRS Financial Measures
Reconciliation of net profit or loss to adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA)
Adjusted EBITDA is a non-IFRS financial measure. A reconciliation of the Adjusted EBITDA to net loss is presented in the table below. We use adjusted financial measures to assess our operating performance. Securities regulations require that companies caution readers that earnings and other measures adjusted to a basis other than IFRS do not have standardized meanings and are unlikely to be comparable to similar measures used by other companies. Accordingly, they should not be considered in isolation. We use Adjusted EBITDA to measure operating performance from one period to the next without the variation caused by certain adjustments that could potentially distort the analysis of trends in our business, and because we believe it provides meaningful information on our financial condition and operating results.
We obtain our Adjusted EBITDA measurement by adding to net profit or loss, finance income and costs, depreciation and amortization, and income taxes. We also exclude the effects of certain non-monetary transactions recorded, such as share-based compensation and write-downs (or related reversals) of inventories, for our Adjusted EBITDA calculation. We believe it is useful to exclude these items as they are either non-cash expenses, items that cannot be influenced by management in the short term, or items that do not impact core operating performance. Excluding these items does not imply they are necessarily nonrecurring. Share-based compensation costs are a component of employee remuneration and can vary significantly with changes in the market price of the Companys shares. In addition, other items that do not impact core operating performance of the Company may vary significantly from one period to another. As such, Adjusted EBITDA provides improved continuity with respect to the comparison of our operating results over a period of time. Our method for calculating Adjusted EBITDA may differ from that used by other companies.
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Theratechnologies Inc.
2015 Peel Street, 11th Floor
Montreal, Québec H3A 1T8
Adjusted EBITDA
(In thousands of U.S. dollars)
Three-month periods
ended
|
||||||||
28, 2021
|
29, 2020
|
|||||||
Net loss |
(5,922 | ) | (4,544 | ) | ||||
Add (deduct): |
||||||||
Depreciation and amortization |
2,185 | 2,030 | ||||||
Finance costs |
1,357 | 1,318 | ||||||
Finance income |
(25 | ) | (166 | ) | ||||
Income taxes |
6 | - | ||||||
Share-based compensation |
578 | 365 | ||||||
Write-down of inventories |
- | 3 | ||||||
Adjusted EBITDA |
(1,821 | ) | (994 | ) |
16
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 28, 2021. |
2. | No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings. |
3. | Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial statements together with the other financial information included in the interim filings fairly present in all material respects the financial condition, results of operations and cash flows of the issuer, as of the date of and for the periods presented in the interim filings. |
4. | Responsibility: The 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 over Financial Reporting Guidance for Smaller Public Companies (COSO). |
5.2 | N/A |
5.3 | N/A |
6. | Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuers ICFR that occurred during the period beginning on December 1, 2020 and ended on February 28, 2021 that has materially affected, or is reasonably likely to materially affect, the issuers ICFR. |
Date: April 14, 2021
(Signed) Paul Lévesque
|
Paul Lévesque |
President and Chief Executive Officer |
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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 28, 2021. |
2. | No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings. |
3. | Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial statements together with the other financial information included in the interim filings fairly present in all material respects the financial condition, results of operations and cash flows of the issuer, as of the date of and for the periods presented in the interim filings. |
4. | Responsibility: The 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 over Financial Reporting Guidance for Smaller Public Companies (COSO). |
5.2 | N/A |
5.3 | N/A |
6. | Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuers ICFR that occurred during the period beginning on December 1, 2020 and ended on February 28, 2021 that has materially affected, or is reasonably likely to materially affect, the issuers ICFR. |
Date: April 14, 2021
(Signed) Philippe Dubuc
|
Philippe Dubuc |
Senior Vice President and Chief Financial Officer |
- 2 -