Heartbeam (BEAT) Q4 2025 earnings summary

Executive summary

• Achieved FDA 510(k) clearance for synthesized 12-lead ECG software in December 2025, enabling limited commercial launch targeting concierge, preventive cardiology, and direct pay healthcare segments, with ClearCardio as a key partner.

• Developed two form factors: a credit card-sized device and an extended-wear 12-lead ECG patch, leveraging proprietary 3D signal collection technology, with product demonstrations scheduled at major conferences.

• Initiated ALIGN-ACS and HEADSTART-ACS clinical studies in Europe and the U.S. to validate heart attack detection, aiming for future FDA indication expansion.

• Announced strategic AI collaboration with Mount Sinai to develop advanced ECG algorithms for disease prediction and management, enabling personalized cardiac insights at home.

• Appointed Bryan Humbarger as Chief Commercial Officer to lead commercial strategy.

Financial highlights

• Net loss for FY 2025 was $21.0M ($0.62 per share), with Q4 net loss of $5.3M; operating expenses totaled $21.1M, and R&D expenses rose to $13.5M.

• Net cash used in operating activities was $14.0M for FY 2025 and $2.9M for Q4, a 3% year-over-year and 30% quarterly decrease.

• Cash and equivalents totaled $4.4M at year-end 2025, up from $2.4M at year-end 2024.

• Raised $16.6M in financing activities during FY 2025, including equity sales and ATM offerings.

• Projected 2026 gross operating cash outflows of $17–$19M, including $3–$5M incremental investments for key milestones.

Outlook and guidance

• Commercial launch focuses on deep adoption in anchor concierge and preventive cardiology practices, with scaling and broader expansion planned for 2027.

• Cash flow breakeven anticipated at ~30,000 patients; break even possible within initial concierge segment.

• Ongoing clinical studies and regulatory engagement to support expanded indications and market entry, including heart attack detection and AI-driven disease management.

• Continued financial discipline and strategic funding to minimize shareholder dilution.

• Extended-wear ECG patch and AI-enabled disease assessment expected to drive future growth.