Theratechnologies Inc (NASDAQ:THTX) stock fell 12.23% (As on April 9, 2:33:06 AM UTC-4, Source: Google Finance) after the company received US Food and Drug Administration approval of its Prior Approval Supplement to the supplemental biologics license application for Egrifta SV, or tesamorelin, used to reduce excess abdominal fat in adults with HIV and lipodystrophy. The approval removes the need for discretionary product release, allowing the company to resume normal distribution of Egrifta SV. The FDA also recently approved a new F8 formulation of tesamorelin, to be marketed as Egrifta WR, which will replace Egrifta SV in the US. Safety considerations include unestablished long-term cardiovascular effects, a weight-neutral profile, and no evidence of improved adherence to antiretroviral therapy

Moreover, on March 12, 2025, the Company announced that it presented data highlighting the limitations of using body mass index (BMI) alone in assessing cardiovascular (CV) risk in people with HIV (PWH). The study underscores the need to incorporate screening for excess visceral abdominal fat (EVAF) to better identify PWH at risk of CV disease.  On March 12, 2025, the Company announced that it presented data from a real-world, observational, registry study demonstrating the efficacy and safety of ibalizumab in reducing HIV RNA to undetectable levels in heavily treatment-experienced (HTE) patients with multidrug resistant HIV.

THTX in the first quarter of FY25 has swung to a first-quarter profit as revenue surged 17%. The company recorded a net profit of US$117,000, or nil per share, compared with a loss of US$4.5 million or US$0.10 per share, in the prior year period. Sales rose to US$19 million, boosted by a 45% jump in Egrifta SV sales. The increase was mostly due to higher unit sales and a higher selling price. Trogarzo sales fell 22% to US$5.2 million, due to an 18% drop in unit sales. Adjusted EBITDA was $2,321,000 for the first quarter of fiscal 2025 compared to $(247,000) for the same period of 2024.

As a result of the supply disruption of EGRIFTA SV during the first quarter of 2025 as a result in a one-time loss of 6 to 7 weeks of sales ($10 to $12 million), and taking into account the approval of EGRIFTA WR, the company estimates FY2025 revenue to be in the range of $80 million to $83 million while the company anticipate Adjusted EBITDA, a non-IFRS measure, to be between $10 and $12 million for the same period.