MONTREAL – Theratechnologies (NASDAQ:) Inc. (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company with a market capitalization of $60.46 million, has resumed production of EGRIFTA SV® following a temporary closure of their contract manufacturer’s facility. The shutdown was a response to findings from a U.S. Food and Drug Administration (FDA) inspection. The company has announced that one batch of the drug has passed quality control and is pending FDA approval for market release, anticipated to be filed as a Prior Approval Supplement around mid-December 2024. According to InvestingPro analysis, the company maintains a “GOOD” overall financial health score despite operational challenges.
The manufacturing of two additional EGRIFTA SV® batches is in progress. Theratechnologies has taken steps to manage the existing inventory to meet patient needs until mid-January 2025. This strategic inventory management is part of their efforts to prevent a shortage for patients in 2025. The company’s strong gross profit margin of 77% and annual revenue of $84.32 million demonstrate its operational efficiency in the pharmaceutical sector.
EGRIFTA SV® is currently distributed exclusively in the United States. The company is working closely with the FDA and other stakeholders to ensure continuous supply and will inform the market of any significant updates.
Theratechnologies specializes in developing therapies for unmet medical needs. The company has cautioned investors not to rely too heavily on forward-looking statements, which are based on current assumptions and subject to risks and uncertainties that could cause actual results to differ. These risks include potential delays in filing the Prior Approval Supplement, FDA approval processes, and the possibility of decreased demand due to the risk of shortages.
The company’s latest developments are based on a press release statement and reflect its current expectations as of today. Theratechnologies has made no commitment to update the information going forward, except as required by law.
In other recent news, Theratechnologies Inc. has reported significant developments in its third-quarter earnings for 2024, along with progress in its HIV drug research. The biopharmaceutical company reported a net profit of $3 million and an 8% year-over-year revenue increase to $22.6 million. The company’s EBITDA also saw a substantial rise from $2.2 million in Q3 2023 to $7.2 million. Theratechnologies has adjusted its full-year…
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