Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Chimerix Inc (CMRX, Financial) is nearing complete enrollment of its phase one dose escalation studies for ONC206, indicating progress in its pipeline.
- The phase three action study of dordaviprone is active in 15 countries, with the first interim data readout potentially less than a year away.
- The independent Data Monitoring Committee recommended the continuation of the action study without changes, highlighting the safety profile of dordaviprone.
- Chimerix Inc (CMRX) is preparing for potential commercialization of dordaviprone, forecasting a global market opportunity over $750 million.
- The company has a strong cash position with over $152 million in cash and cash equivalents, providing a cash runway into the fourth quarter of 2026.
Negative Points
- Chimerix Inc (CMRX) reported a net loss of $22.9 million for the third quarter of 2024, indicating ongoing financial challenges.
- Research and development expenses increased to $19.6 million, driven by spending on the action study, impacting overall financial performance.
- The cash burn rate experienced a modest increase this quarter, reflecting the costs associated with preparing for dordaviprone commercialization.
- There is uncertainty regarding the timing and receipt of milestone payments related to the Tembexa contract, affecting financial projections.
- The company faces risks and uncertainties related to regulatory approvals and market acceptance of its products, which could impact future growth.
Q & A Highlights
Q: Can you talk about how you're preparing the submission of the NDA for Australia and a potential launch by the end of 2025? Are you using these commercialization efforts to potentially scale the organization for a potential US launch too? Do you plan to leverage that NDA submission to dovetail into conversations with other regulatory agencies for an accelerated approval path as well?
A: Mike Andriole, President and CEO, explained that the NDA submission for Australia serves as a backbone for other markets, providing synergy and utility. The efficacy component will be based on phase two response rate data. Tom Riga, Chief Operating and Commercial Officer, added that they are preparing for market entry with a focus on payer engagement and infrastructure, while maintaining a conservative spending approach.
Q: EVS announced the execution of contract options for $67.4 million to acquire Tembexa for national preparedness efforts. How much of that total contract value would Chimerix be eligible to receive, and what would be the timing for receiving that milestone? Do you have any insight into how the monkeypox outbreak has affected the U.S. government's initiative to stockpile Tembexa for smallpox?
A: Mike Andriole noted that the monkeypox study could lead to potential royalties for Chimerix if international sales occur. Michelle LaSpaluto, CFO, stated that Chimerix is due approximately $2.7 million from the exercise, but it will be recorded once cash is received. The exercise extends to 2027.
Q: How is the company preparing for the potential commercialization of dordaviprone, and what are the expectations for market uptake?
A: Mike Andriole highlighted that they are preparing for potential commercialization within a year, with a strong foundation in place through expanded access programs in the US and Europe. They expect rapid uptake due to the lack of approved therapies for the patient population, forecasting a potential global market opportunity over $750 million.
Q: Can you provide an update on the progress of the ONC206 program and its next steps?
A: Mike Andriole reported that the phase one dose escalation study for ONC206 is nearing completion, with the compound being well-tolerated in adult and pediatric patients. The company plans to announce the next steps for the program in the coming months as they review clinical and preclinical data.
Q: What are the financial highlights from the third quarter of 2024?
A: Michelle LaSpaluto shared that Chimerix reported a net loss of $22.9 million, with R&D expenses increasing to $19.6 million due to the action study. G&A expenses decreased to $5.2 million. The company ended the quarter with over $152 million in cash, with a cash runway extending into the fourth quarter of 2026.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
