Exhibit 99.1
MATERIAL CHANGE REPORT
Form 51-102F3
ITEM 1 - NAME AND ADDRESS OF COMPANY
THERATECHNOLOGIES INC. (Theratechnologies, we or the Company)
2015 Peel Street
11th Floor
Montréal, Québec
Canada H3A 1T8
ITEM 2 - DATE OF
MATERIAL CHANGE
January 24, 2024
ITEM 3 - NEWS RELEASE
A news release describing this material change was issued by the Company on January 24, 2024 via GLOBE
NEWSWIRE. A copy of the news release is available on the SEDAR+ website at www.sedarplus.ca and on the EDGAR
website at www.sec.gov/edgar as an attachment to a Form 6-K dated January 24, 2024.
ITEM 4 - SUMMARY OF MATERIAL CHANGE
On January 24, 2024, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response
Letter (CRL) in response to the Companys supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin. The Company will address the FDAs request and intends to pursue approval of this newer formulation of
tesamorelin.
ITEM 5 - FULL DESCRIPTION OF MATERIAL CHANGE
On January 24, 2024, the Company announced that the FDA has issued a CRL in response to the Companys sBLA for the
F8 formulation of tesamorelin. The Company will address the FDAs request and intends to pursue approval of this newer formulation of tesamorelin.
The questions outlined in the CRL are largely related to chemistry, manufacturing and controls concerning the microbiology,
assays, impurities and stability for both the lyophilized product and the final reconstituted drug product. In addition, the FDA requested further information to understand the potential impact of the proposed formulation on immunogenicity risk.
The Company will continue to commercialize EGRIFTA
SV®, which is the only approved treatment in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.
Forward-Looking Information
This document contains forward-looking statements and forward-looking information (collectively, the Forward-Looking
Statements) within the meaning of applicable securities laws, that are based on managements beliefs and assumptions and on information currently available to it. You can identify forward-looking statements by terms such as
may, will,