SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
April 27, 2022
Commission File Number 001-35203
(Translation of registrants name into English)
2015 Peel Street, Suite 1100
Montréal, Québec, Canada
(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 ☒
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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- .
|99.1||Material Change Report Dated April 27, 2022|
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.
|By:||/s/ Philippe Dubuc|
|Title:||Senior Vice President and Chief Financial Officer|
Date: April 27, 2022
MATERIAL CHANGE REPORT
ITEM 1 - NAME AND ADDRESS OF THE REPORTING ISSUER
THERATECHNOLOGIES INC. (Theratechnologies, we or the Company)
2015 Peel Street
Canada H3A 1T8
ITEM 2 - DATE OF MATERIAL CHANGE
April 27, 2022.
ITEM 3 - NEWS RELEASE
Theratechnologies issued a press release with respect to the material change described below on April 27, 2022 via Globe Newswire.
A copy of the press release is also available on SEDAR at www.sedar.com under the Corporations profile.
ITEM 4 - SUMMARY OF MATERIAL CHANGE
On April 27, 2022, Theratechnologies announced that it will focus its commercialization activities on the North American territory only and, as a result, will cease its Trogarzo® commercialization operations in Europe.
ITEM 5 - FULL DESCRIPTION OF MATERIAL CHANGE
5.1 Full description of material change
On April 27, 2022, Theratechnologies announced that it will focus its commercialization activities on the North American territory only and, as a result, will cease its Trogarzo® commercialization operations in Europe. The Company has sent a notice of termination to TaiMed Biologics Inc. (TaiMed) as per our contractual obligations and will return the European commercialization rights to Trogarzo® for TaiMed within the next 180 days. TaiMed is currently considering options for the continued commercial availability of Trogarzo in Europe.
This decision is expected to result in approximately US$1.5 to US$2.0 million in cash charges related to severance and other expenses associated with the termination of the agreement and approximately US$6.5 million in non-cash charges. The Company expects these charges to be fully taken during 2022. European net sales in the past twelve months represented less than 2% of the Companys overall revenues and the Company would like to reiterate that our revenue guidance remains unchanged for the current fiscal year.
This document contains forward-looking statements and forward-looking information, or, 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, promising, would, outlook, believe, plan, envisage, anticipate, expect and estimate, or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to, statements regarding our revenue guidance for the 2022 full fiscal year, the costs associated to the announced restructuring and sales of Egrifta SV® and Trogarzo® in the United States.
Although the forward-looking information contained in this press release is based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on this information since actual results may vary from the forward-looking information. 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; sales of EGRIFTA SV® and Trogarzo® in the United States will increase over time; the Companys 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 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; the assessment of the costs related to this restructuring will be accurate and no material unexpected expenses will be incurred as a result of such restructuring; and the Companys long-term business plan will not be substantially modified.
Forward-looking information assumptions are subject to a number of risks and uncertainties, many of which are beyond Theratechnologies control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These risks and uncertainties include, but are not limited to, those related to or arising from: the 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, as well as (d) global trade; the Companys ability and capacity to grow the sales of EGRIFTA SV® and Trogarzo® successfully in the United States; the Companys capacity to meet supply and demand for its products; the market acceptance of EGRIFTA SV® and Trogarzo® in the United States; the continuation of the Companys collaborations and other significant agreements with its existing commercial partners and third-party suppliers and its ability to establish and maintain additional collaboration agreements; the Companys success in continuing to seek and maintain reimbursements for EGRIFTA SV® and Trogarzo® by third-party payors in the United States; the success and pricing of other competing drugs or therapies that are or may become available in the marketplace; the Companys ability to protect and maintain its intellectual property rights in EGRIFTA SV® and tesamorelin; 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.
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We refer current and potential investors to the Risk Factors section of our Annual Information Form dated February 23, 2022 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 24, 2022 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 press release and represent our expectations as of that date.
We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.
5.2 Disclosure for restructuring transactions
ITEM 6 - RELIANCE ON SUBSECTION 7.1(2) OF NATIONAL INSTRUMENT 51-102
ITEM 7 - OMITTED INFORMATION
ITEM 8 - EXECUTIVE OFFICER
Inquiries in respect of the material change referred to herein may be made to:
Vice President, Legal Affairs
ITEM 9 - DATE OF REPORT
April 27, 2022.
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