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Theratechnologies Announces a Risk of a Temporary Supply Disruption for EGRIFTA SV® in Early 2025
TheratechnologiesTheratechnologies(US:THTX) GlobeNewswire News Room·2024-09-17 21:00

Core Viewpoint - Theratechnologies Inc. announced a potential temporary supply disruption for EGRIFTA SV® due to a voluntary shutdown of its contract manufacturer's facility following an FDA inspection, which may impact revenue in fiscal year 2024 [1][4]. Group 1: Supply Disruption Details - The shutdown is expected to last three months and is not related to the manufacturing process of EGRIFTA SV®, but rather to the manufacturing environment [4]. - The manufacturer plans to resume activities by mid-October 2024, with a new batch of EGRIFTA SV® scheduled for production on October 21, 2024 [4][5]. Group 2: Financial Impact - The company estimates a revenue shortfall of approximately US$1.6 million from EGRIFTA SV® for fiscal year 2024 due to inventory management measures [2]. - Despite the anticipated revenue impact in Q4 2024, the company remains on track to deliver a strong Adjusted EBITDA for the current fiscal year [3]. Group 3: Regulatory Compliance - To resume distribution, the company is required to file a Prior Approval Supplement (PAS) with the FDA, which is expected to be submitted around the manufacturing date [5]. - The FDA will review the PAS within four months of receipt, and the company will provide updates on any material developments [5].