Theratechnologies announces risk of temporary supply disruption for EGRIFTA SV

Theratechnologies announced a risk of a temporary supply disruption for EGRIFTA SV in early 2025 caused by an unexpected voluntary shutdown of the Company’s contract manufacturer’s facility following an inspection by the FDA, as well as the FDA review timeline to resume distribution of the product. The Company will implement measures to carefully manage the inventory levels of EGRIFTA SV to meet patient demand until early January 2025, and estimates that these measures will result in a shortfall of approximately $1.6M in revenue from EGRIFTA SV for its FY24. Theratechnologies’ manufacturer of EGRIFTA SV recently implemented a three-month voluntary shutdown of its facility to address observations by the FDA Office of Compliance, following a plant inspection. In order to resume distribution of EGRIFTA SV, Theratechnologies was requested by the FDA to file a Prior Approval Supplement 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.