Theratechnologies Provides Update on EGRIFTA SV® Supply

Company Overview - Theratechnologies is a biopharmaceutical company focused on developing and commercializing innovative therapies for unmet medical needs [2] - The company is publicly traded on the TSX (TH) and NASDAQ (THTX) [2] Product Situation - EGRIFTA SV (tesamorelin for injection) is the only FDA-approved medicine of its kind for people with HIV [1] - A shortage of EGRIFTA SV will occur at the patient level in mid-January 2025 due to a voluntary shutdown of the contract manufacturing facility in 2024 [4] - Some pharmacies in the United States still have remaining inventory, but several have reported stockouts [4] Regulatory Process - Theratechnologies filed a Prior Approval Supplement (PAS) with the FDA on December 18, 2024 [5] - The company submitted questions regarding two recently manufactured batches of EGRIFTA SV waiting to be released [5] - FDA confirmed it will respond to the company's questions in writing by February 8, 2025 [5] Forward-Looking Statements - The company expects FDA to provide answers to its questions by February 8, 2025 [8] - Assumes current market demand for EGRIFTA SV will remain unaffected [8] - Believes the shortage will not adversely impact the company's financial conditions [8] - Anticipates being able to negotiate waivers of defaults with secured creditors if needed [8]