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manufacturing process of EGRIFTA SV®, but rather related to the manufacturing environment of the facility. The manufacturer is
finalizing its remediation measures and has confirmed to the Company that it plans to resume activities by mid-October. Based on these timelines, a batch of EGRIFTA SV® is currently scheduled to be manufactured on October 21, 2024.
In order to resume distribution of EGRIFTA SV®,
Theratechnologies was requested by the FDA to file a Prior Approval Supplement (“PAS”) describing the changes made by its manufacturer. The Company expects to file the PAS on or around the manufacturing date. A PAS is reviewed by the FDA
within four months of receipt.
The Company will update the market on any further material developments.
Forward-Looking Information
This material change report contains forward-looking statements and forward-looking information (collectively, the
“Forward-Looking Statements”) within the meaning of applicable securities laws, that are based on management’s beliefs and assumptions and on information currently available to it. 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 material change report include, but are not limited to, statements regarding: (i) the time period related to the availability of EGRIFTA SV® to patients;
(ii) the effectiveness of the measures to be implemented by the Company to manage the inventory level of EGRIFTA SV®; (iii) the dates on which the Company’s
manufacturer will resume its manufacturing activities and the manufacture of a new batch of EGRIFTA SV®; and (iv) the monetary impact on the Company’s revenue for the
fiscal year 2024.
Although the Forward-Looking Statements contained in this material change report are based upon what
the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements contained
in this material change report. Certain assumptions made in preparing the Forward-Looking Statements include that: (i) the FDA will be satisfied with the remediation measures implemented by the manufacturer in response to the observations
issued by the FDA and the manufacturer will resume its activities by mid-October and will manufacture a new batch of EGRIFTA SV® on
October 21, 2024; (ii) no delay in the implementation of the remaining remediation measures at the manufacturer’s site will occur; (iii) the information allowing the Company to file a PAS will be available to the Company prior to
October 21, 2024; (iv) the new batch of EGRIFTA SV® to be manufactured will meet the specifications for market release; (v) the FDA will approve the PAS as filed by the
Company; (vi) current market demand for EGRIFTA SV® will remain unaffected; and (vii) the financial impact assessment made by the Company about the potential revenue
shortfall from EGRIFTA SV® is accurate.
Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond the
Company’s 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: (i) the issuance of
additional observations by the FDA to the manufacturer following the finalization of their review of the remediation measures implemented at the manufacturer’s site; (ii) a delay by the manufacturer in