Release Date: July 10, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Theratechnologies Inc (THTX, Financial) reported a positive net income for the first time in recent history.
- Revenue for the second quarter rebounded to $22 million, marking a 25% growth compared to the same quarter last year.
- Adjusted EBITDA for the quarter was $5.5 million, representing a solid 25% margin.
- EGRIFTA SV sales increased by 49% year-over-year, reaching $16.2 million.
- The company reaffirmed its full-year 2024 revenue guidance of $87 million to $90 million and adjusted EBITDA of $13 million to $15 million.
Negative Points
- Trogarzo net sales decreased by 13.4% year-over-year, primarily due to competitive pressures in the multidrug-resistant HIV treatment segment.
- R&D expenses decreased substantially, which may indicate reduced investment in future growth and innovation.
- The company is still addressing FDA questions regarding the F8 formulation of tesamorelin, delaying its potential approval.
- Net finance costs amounted to $2.2 million, including $2.3 million in interest on the Marathon loan facility.
- The oncology program's future spending will depend on partnerships, which introduces uncertainty in its development.
Q & A Highlights
Q: Do you have a rough idea of when we should see the final data readout for 1902?
A: Christian Marsolais, Senior Vice President and Chief Medical Officer: The protocol requires CT scans every second cycle to confirm responses, typically needing a minimum follow-up of about four months. We should have some signals by the fall.
Q: When do you approximately expect the FDA four-month review for the F8 formulation to begin?
A: Christian Marsolais, Senior Vice President and Chief Medical Officer: We are still working on addressing the FDA's questions related to microbiology, immunogenicity, and manufacturing. We will inform the market as soon as we are ready to submit the dossier.
Q: Can you provide any updates on your efforts to find potentially accretive assets to bolster your product portfolio?
A: Paul Levesque, President and Chief Executive Officer: We have been very active in discussions, particularly at JPMorgan and Bio conferences. We are looking for assets that complement our existing portfolio or create new opportunities. John Leasure, Global Commercial Officer, added that they are committed to finding the right assets without overpaying.
Q: What feedback did you receive from the ASCO presentation regarding your oncology program?
A: Christian Marsolais, Senior Vice President and Chief Medical Officer: The poster was well attended, and we received positive feedback. The data showed disease stabilization in 44% of patients, which is unusual for cytotoxic treatments in advanced patient populations. This has generated significant interest.
Q: Are you still on track to receive potential approval for the tesamorelin F8 sBLA this year?
A: Paul Levesque, President and Chief Executive Officer: Our goal is to get approval before the end of the current fiscal year. We are working hard to address the FDA's questions and plan to file when ready.
Q: Can you talk more about the targets and potential indications for your three additional PDCs?
A: Christian Marsolais, Senior Vice President and Chief Medical Officer: Our technology targets the SORT1 receptor. The new PDCs use payloads similar to those in ADC technology, such as exatecan. Preclinical data are promising, and we are also exploring combinations of PDCs for synergistic effects.
Q: What are your plans for the oncology program after the completion of the Phase 1 trial?
A: Philippe Dubuc, Chief Financial Officer: Any additional spending on oncology after the Phase 1 trial will be carried out through partnerships, so it will not affect our adjusted EBITDA in 2025 and beyond.
Q: How do you plan to leverage the new market dynamics for EGRIFTA SV?
A: Paul Levesque, President and Chief Executive Officer: EGRIFTA SV is the only FDA-approved medication to treat excess abdominal fats in people with HIV. We are actively leveraging the increased interest in weight loss treatments to benefit patients and shareholders.
Q: What are your financial expectations for the rest of the year?
A: Paul Levesque, President and Chief Executive Officer: We reaffirm our guidance for full-year 2024 revenues between $87 million and $90 million and an adjusted EBITDA in the range of $13 million to $15 million.
Q: How has the company's financial performance been in the second quarter?
A: Philippe Dubuc, Chief Financial Officer: We recorded net sales of $22 million, a 25% growth versus the same quarter last year. Adjusted EBITDA was $5.5 million, and we achieved a net profit of about $1 million for the quarter.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
