Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- HeartBeam Inc (BEAT, Financial) has developed a groundbreaking cable-free 12-lead ECG technology that can be used by patients anywhere, offering high-resolution data capture.
- The company is targeting large addressable markets worth over $100 billion annually in the US alone, with a strategy to disrupt traditional cardiac care.
- HeartBeam Inc (BEAT) has a strong pipeline of clinical evidence, with nine peer-reviewed publications and studies involving over 500 patients.
- The company has received industry recognition, including being named a 'Rising Star' at the Digital Health Hub Foundation Awards and winning a MedTech breakthrough award.
- HeartBeam Inc (BEAT) has a robust patent portfolio with 17 issued patents worldwide, supporting its innovative technology.
Negative Points
- The company is still awaiting foundational FDA clearance, which is crucial for its technology and future product submissions.
- HeartBeam Inc (BEAT) reported a net loss of nearly $5 million for the third quarter of 2024, highlighting ongoing financial challenges.
- The cash balance as of September 30, 2024, was $5.8 million, indicating limited financial runway without additional funding.
- The company does not anticipate significant revenue in 2025, suggesting a longer timeline to profitability.
- HeartBeam Inc (BEAT) faces uncertainties related to FDA submission timelines and outcomes, which could impact commercialization plans.
Q & A Highlights
Q: Can you provide more detail on the timing of the FDA clearance and what are the outstanding items?
A: Branislav Vajdic, President and Director, responded that while they cannot discuss the specifics of ongoing FDA discussions, the FDA is engaged and responsive. They remain confident in achieving FDA clearance in the near term and are preparing for an early access program post-clearance.
Q: Given your cash burn, what are your plans for raising capital?
A: Timothy Cruickshank, CFO, explained that they are managing cash burn closely, with a focus on maintaining and adding value-add investors. They plan to finance the company opportunistically while managing dilution, aligning cash requirements with upcoming milestones in advance of commercialization.
Q: Can you provide more context on the timing and reason for the change in CEO from Branislav to Rob?
A: Branislav Vajdic stated that the transition was long planned, with Rob Eno bringing a commercial background suitable for the company's current stage. Rob Eno added that Branislav will continue to lead technical efforts, ensuring the company benefits from his expertise.
Q: Can you provide an update on the timing and results of the valid ECG study?
A: Branislav Vajdic noted that the 198-patient valid ECG study has completed enrollment and data analysis. While results cannot be disclosed yet, they will form the basis of the upcoming second FDA submission. An 80-patient pilot study's results will be presented at the American Heart Association conference.
Q: If everything goes right with the FDA, what could 2025 revenues look like for HeartBeam?
A: Timothy Cruickshank mentioned that while they do not anticipate significant revenue in 2025, they are focused on refining their go-to-market strategy and pricing models through an early access program, which will inform their commercial launch strategy.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
