Release Date: May 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- BioCardia Inc reported positive results from three ongoing autologous and allogeneic cell therapy clinical trials, showing reduced mortality and major adverse cardiac events.
- The company highlighted an 86% relative risk reduction in heart death equivalents and a 24% relative risk reduction in non-fatal major adverse cardiac and cerebral vascular events in certain patients.
- BioCardia Inc is on track to submit final results for regulatory submission in Japan by the fourth quarter of 2024, with high expectations based on preliminary data.
- Medicare reimbursement approval for the confirmatory cardiac heart failure trial is expected to reduce study costs by more than $5 million, enhancing financial efficiency.
- The company has established multiple biotherapeutic clinical programs and partnerships, aiming to provide significant shareholder returns and achieve commercial approvals as early as 2025.
Negative Points
- Revenue for Q1 2024 was relatively low at $55,000, showing a slight decrease from $65,000 in the same period the previous year.
- The company continues to operate at a net loss, reporting a $2.3 million loss for Q1 2024, although this is an improvement from a $3.5 million loss in Q1 2023.
- BioCardia Inc is still in the process of completing trials and regulatory submissions, with critical data yet to be finalized and submitted.
- There are inherent risks involved with the development of new product technologies and obtaining regulatory approvals, which could impact future performance.
- The company's dependency on the success of clinical trials and regulatory approvals for future revenue and growth presents significant operational and financial risks.
Q & A Highlights
Q: Can you provide an update on the cardiac chronic myocardial ischemia program and whether additional patients will be added to the rolling cohort?
A: Peter Altman, President and CEO of BioCardia, explained that while one more patient has been consented but not yet treated, they have decided to stop enrolling additional patients. The company feels confident moving forward with the randomized phase based on the excellent trial results from the first enrolled patients.
Q: What are the ongoing discussions with Japan's PMDA regarding the CAR TMHF program?
A: Peter Altman mentioned that the PMDA is open to considering foreign data for approval and is particularly interested in the final data from the ongoing trial. BioCardia expects to complete the trial and submit the data by the end of the year, with further dialogues anticipated with PMDA.
Q: What are the potential developments with BioCardia's partners towards the end of Q2 and the end of 2024?
A: Peter Altman discussed the company's long-term involvement with its partners, emphasizing the transfer of experience and knowledge to ensure their success. He mentioned ongoing late-stage discussions with several groups who require delivery solutions, indicating that reaching final agreements takes time.
Q: Could you comment on the strategy for commercializing the CardioMEMS treatment in Japan if approval is received?
A: Peter Altman outlined a preference for partnering with a firm experienced in the Japanese market to distribute the treatment for both heart failure and chronic myocardial ischemia. However, he also mentioned the possibility of BioCardia establishing a profitable subsidiary in Japan if a suitable partner is not found.
Q: What are the implications of the positive results announced by Cell Proterra on their Phase 1/2b trial?
A: Peter Altman highlighted that while BioCardia is encouraged by Cell Proterra's results, the company prefers to let its partners lead their own clinical and regulatory strategies. He expressed optimism about the potential advancements towards conditional approval in Europe.
Q: What are the financial results for Q1 2024 compared to Q1 2023?
A: David McClung, CFO of BioCardia, reported that revenue was $55,000 for Q1 2024, slightly down from $65,000 in Q1 2023. However, expenses decreased significantly, leading to a reduced net loss of $2.3 million in Q1 2024 compared to $3.5 million in the previous year.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
