MONTREAL - Theratechnologies (NASDAQ:THTX) Inc. (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company, has revealed details from a study focusing on the treatment outcomes for heavily treatment-experienced individuals with HIV. The study, known as PROMISE-US, investigates the use of ibalizumab, a post-attachment inhibitor, in patients with lower CD4 cell counts and higher viral loads.
According to the study presented at IDWeek 2024, ibalizumab was chosen more frequently for patients with advanced HIV, demonstrating durability with most subjects remaining on therapy for over two years. The study aims to provide insights into long-term clinical outcomes and factors influencing virologic control in this patient group, which often struggles with multidrug resistance.
The PROMISE-US study is a phase 4, multicenter, observational registry evaluating the efficacy and safety of ibalizumab in combination with other antiretroviral therapies. As of November 2023, 114 participants were enrolled, with baseline characteristics such as race, ethnicity, sex, gender, and time since diagnosis being comparable across cohorts.
Initial findings indicate that patients on ibalizumab typically presented with higher viral loads and declining CD4 T cells. The study also explored the use of lenacapavir in combination with ibalizumab, noting that this subset of patients had the highest viral loads and lowest CD4 counts at baseline.
Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer at Theratechnologies, emphasized the company's commitment to understanding the long-term safety and efficacy of ibalizumab, especially for combination with long-term injectable therapies.
The information presented is based on a press release statement from Theratechnologies, aiming to shed light on treatment options for heavily treatment-experienced patients with multidrug-resistant HIV-1. The company continues to analyze data from the ongoing PROMISE-US study, with the objective of improving the management of HIV in patients facing limited treatment options due to resistance issues.
In other recent news, Theratechnologies Inc. reported notable gains in its third-quarter earnings for 2024, including a net profit of $3 million, an 8% year-over-year revenue increase to $22.6 million, and a significant EBITDA rise from $2.2 million in Q3 2023 to $7.2 million. The company has also adjusted its full-year revenue guidance to $83-$85 million and raised its EBITDA guidance to $17-$19 million. Despite a temporary supply constraint and a decrease in Trogarzo sales, the company saw a 27% year-over-year increase in EGRIFTA SV sales, contributing to its strong financial performance.
As part of recent developments, Theratechnologies plans to submit a prior authorization supplement for EGRIFTA SV and resubmit the F8 formulation of Tesamorelin. Furthermore, the company is focusing on identifying new product opportunities and partnerships and expects to recover Q4 2024 lost sales in early 2025. Despite anticipating a slower start to Q1 2025 sales due to inventory depletion, Theratechnologies expects sales recovery as inventory levels normalize and maintains confidence in its EBITDA sustainability.
InvestingPro Insights
As Theratechnologies Inc. (NASDAQ: THTX) continues its research into HIV treatments, investors should be aware of some key financial metrics and insights provided by InvestingPro.
Despite the promising developments in the PROMISE-US study, Theratechnologies faces some financial challenges. According to InvestingPro data, the company is not profitable over the last twelve months, with a negative P/E ratio of -80.3. This aligns with an InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year.
However, it's worth noting that Theratechnologies has shown some positive financial indicators. The company's revenue for the last twelve months as of Q3 2023 stood at $84.32 million, with a revenue growth of 5.75% over the same period. More impressively, the company's EBITDA growth was a substantial 191.71%, suggesting improved operational efficiency.
An InvestingPro Tip highlights that the stock price movements for THTX are quite volatile. This is reflected in the company's price performance, with a one-year price total return of -26.29% as of the data's reporting date.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights beyond those mentioned here. The platform provides a total of 11 tips for Theratechnologies, which could be valuable for those looking to make informed investment decisions in the biopharmaceutical sector.
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