HeartBeam, Inc. (BEAT) Earnings

Management highlights

- Technology and Intellectual Property * HeartBeam owns 25 issued worldwide patents for its proprietary Tricore 3D signal reconstruction technology, which produces clinical-grade 12-lead EKGs across three form factors: the card (post-discharge home monitoring), the patch (in-hospital ER and post-procedure monitoring), and the remote unit (global remote patient access). * Two additional new patents have been granted: one for acoustic sensing to evaluate heart valve function, and one for fluid monitoring to detect fluid overload in congestive heart failure patients, expanding the platform's future capabilities. - Clinical and Regulatory Progress * The Align ACS pilot study for heart attack detection completed enrollment in under 4 months, and its data has been accepted for a full presentation at the October/November 2026 TCT conference. * The 500-patient Head Start ACS pilot study (supported by the Indonesian government) has surpassed 50% enrollment in under 3 months, and an article demonstrating HeartBeam's algorithm accuracy for heart attack detection is upcoming in JACC. * A 50-patient pilot trial for the patch form factor is enrolling ahead of schedule, and the full working prototype of the 12-lead EKG patch has been completed. * The pre-submission package for FDA approval of the heart attack detection indication was submitted the day of the call, starting the FDA's 75-day review period. - Commercial Launch Progress * Initial commercial launch of the card product is underway in four target US regions: New York, Dallas, South Florida, and Southern California, with first orders shipped and initial patients currently being onboarded. * The offering includes a differentiated 24/7 EKG reading service, which has received positive feedback from early adopter physicians and patients, who consistently praise the high quality of the 12-lead EKG output from the small form factor and ease of use. * Early commercial learnings have led to a streamlined integration strategy that embeds HeartBeam into new patient intake workflows at concierge practices, which is expected to accelerate adoption. - Cost Management and Financial Operations * The company implemented strict cost controls in Q2 2026, pausing non-core contractor projects, gaining efficiency through AI tools, and reducing overall operating expenditures. Executive and employee teams elected to take equity instead of cash for 2025 bonuses, reducing operating cash outflow by over $1 million.

Guidance

- Operating cash outflow: Full-year 2026 operating cash outflows are projected to come in below $14 million, with baseline Q4 2026 operating cash outflow expected to step down to below $2.5 million per quarter (potential upward variation from this baseline if pivotal trial spending begins before year-end, which management views as a positive outcome). - Cash runway: Following the $11.5 million April 2026 common stock capital raise and cost reductions, cash runway has been extended further into 2027 than previous guidance indicated. - Commercial revenue: Management expects order flow and commercial traction to accelerate meaningfully by the end of Q3 2026, with clearer visibility into 2027 growth available by the end of 2026. - Pivotal trial timeline: Management is cautiously optimistic that the pivotal trial for heart attack detection can begin before the end of 2026, following FDA review of the pre-submission. - Break-even: Management reaffirms that approximately 30,000 patients onboarded are needed to reach break-even/cash flow positivity, and this number is likely lower than previously stated given the reduced current cost profile.

Segment performance

HeartBeam is an early-stage commercial medical device company with only initial revenue generation from its concierge card product in Q2 2026. No formal product segment financials with absolute values or revenue contribution percentages were reported, as the company remains in the early launch phase and has not yet generated meaningful segment-level revenue.

Risks & headwinds

- The FDA may require a larger pivotal trial than management currently expects, which would increase spending and delay approval for the heart attack detection indication. * Commercial adoption in the concierge market may progress slower than currently expected, as the company is still in early days of workflow integration and customer onboarding. * Forward-looking statements around clinical trial timelines, commercial growth, and regulatory approval are inherently uncertain, and actual results could differ materially from current expectations due to the early-stage nature of the company's technology and commercial efforts.

Analyst Q&A

• Q: What is the data licensing strategy, which international markets are prioritized outside of the US, how large is the US concierge cardiology opportunity, and can manufacturing support 2027 ramp? /

  A: Management clarified the licensing reference was an overstatement, referring only to potential future licensing to integrated health networks that is still to be determined after trials. Currently the only international priority is the Indonesian government-supported trial, with all other focus on the US market. The US concierge market has ~1.9 million total patients, ~20% of which are at-risk cardiac patients, representing hundreds of thousands of potential target patients. Management confirmed existing manufacturing capacity is sufficient to support 2027 ramp-up.

• Q: What indication and regulatory pathway was proposed for the FDA pre-sub, when could the pivotal trial start, and how large will it be? /

  A: HeartBeam proposed the 510(k) regulatory pathway for the heart attack detection indication, based on identified predicate devices. Management cannot yet confirm trial size until FDA provides feedback after the 75-day review period, but does not expect an excessively large trial, and is cautiously optimistic the pivotal trial can start before the end of 2026.

• Q: How many covered lives are captured by the existing concierge agreements, and what key learnings have come from the pilot clinical studies and initial commercial onboarding? /

  A: Existing early agreements cover thousands of patients, with the four target geographies holding enough total patients to reach the ~30,000 patient break-even target. Pilot clinical studies delivered strong positive results (accepted for TCT presentation) and allowed the team to debug execution processes, preparing the team for a smooth pivotal trial start. Commercial onboarding learnings showed embedding HeartBeam directly into new patient intake workflows streamlines adoption and improves integration, which is now the core go-to-market strategy for concierge practices.