Heartbeam (BEAT) Q4 2024 earnings summary

Executive summary

• Achieved foundational FDA 510(k) clearance for a novel cable-free ECG system, with a second 510(k) submission for 12-lead synthesis software under review and pivotal study results to be presented in April 2025.

• Launched Early Access Program to refine workflows, validate messaging, and build a sales funnel ahead of commercialization.

• Completed pivotal clinical studies, with results accepted for presentation at major cardiology conferences (AHA, HRS).

• Closed a public offering raising $11.5 million to fund growth milestones, commercialization, and extend financial runway.

• Recognized with multiple industry awards for medical device innovation and technology advancement.

Financial highlights

• Net cash used in operating activities was $14.5 million for FY 2024, a 20% year-over-year increase, mainly due to R&D investments and clinical studies.

• R&D expenses rose to $11.1 million for 2024, up from $6.8 million in 2023, driven by pivotal study completion and FDA clearance efforts.

• G&A expenses were $8.8 million for 2024, with less than a 4% year-over-year increase.

• Net loss for FY 2024 was $19.4 million, compared to $14.6 million in FY 2023.

• Pro forma cash balance at year-end was $12.6 million, including proceeds from the public offering; cash and equivalents at year-end were $2.4 million.

Outlook and guidance

• Plans to initiate commercialization of 12-lead ECG synthesis software upon FDA clearance, with initial launch in two U.S. pilot markets and premium pricing.

• Early Access Program expected to refine workflow, validate messaging, and create a strong sales funnel.

• R&D and G&A spend in 2025 expected to align with 2024 baseline, with incremental spend tied to commercial readiness.

• Funding aligns with achieving FY 2025 milestones and potential inflection points.

• Plans to opportunistically finance further growth while minimizing dilution.