Theratechnologies Warns of Temporary Supply Disruption for EGRIFTA SV in Early 2025 Due to Third-Party Facility Shutdown

Supply Disruption:
Theratechnologies has announced a potential temporary supply disruption for EGRIFTA SV (tesamorelin for injection) in early 2025 due to an unexpected voluntary shutdown of its contract manufacturer’s facility following an FDA inspection.

Reason for Shutdown:
The shutdown is a result of observations made by the FDA’s Office of Compliance regarding the manufacturing environment, not the EGRIFTA SV manufacturing process itself.

Timeline:
The manufacturer plans to resume operations by mid-October, with the first new batch of EGRIFTA SV slated for production on October 21, 2024. However, the FDA review timeline for the Prior Approval Supplement (PAS) could delay the resumption of product distribution.

Impact on Revenue:
The company anticipates a revenue shortfall of approximately $1.6 million for its fiscal year 2024 due to the supply challenges.

Mitigation Efforts:
Theratechnologies plans to implement measures to manage EGRIFTA SV inventory levels through early January 2025 to minimize the impact on patients.

Confidence in Meeting Patient Needs:
Despite the disruption, the company is confident that it can meet patient needs in 2025.