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HeartBeam(BEAT) - 2025 Q1 - Earnings Call Transcript
BEATHeartBeam(BEAT)2025-05-13 21:30

Financial Data and Key Metrics Changes - The company reported a net cash used in operating activities of 4.5millionforQ12025,with4.5 million for Q1 2025, with 3.6 million attributed to recurring baseline expenditures primarily for R&D and G&A aligned with milestones [34] - The company completed an 11.5millioncommonstockpublicofferingtostrategicallyfundoperationswhilemanagingdilution[39]BusinessLineDataandKeyMetricsChanges−TheHeartBeamsystemispositionedasthefirstpersonalcable−freeECGcapableofsynthesizinga12−leadECG,withsignificantadvancementsinregulatoryapprovalsandclinicalstudies[5][6]−TheVALIDECGstudymetitsclinicalendpoints,supportingtheFDAsubmissionforthe12−leadsynthesissoftware[41][70]MarketDataandKeyMetricsChanges−ThetargetmarketsegmentfortheHeartBeamsystemisestimatedtobea11.5 million common stock public offering to strategically fund operations while managing dilution [39] Business Line Data and Key Metrics Changes - The HeartBeam system is positioned as the first personal cable-free ECG capable of synthesizing a 12-lead ECG, with significant advancements in regulatory approvals and clinical studies [5][6] - The VALID ECG study met its clinical endpoints, supporting the FDA submission for the 12-lead synthesis software [41][70] Market Data and Key Metrics Changes - The target market segment for the HeartBeam system is estimated to be a 500 million serviceable market in the US, with strong demand from patients and physicians [28] - The coronary artery disease market is larger than the atrial fibrillation market, with 20 million patients in the US at elevated risk for heart attacks [29] Company Strategy and Development Direction - The company aims to secure FDA clearance for the 12-lead synthesis software and prepare for commercialization by the end of 2025 [42] - A strategic collaboration with AccuCardia is expected to enhance the commercial product offering by integrating ECG algorithms for rhythm classification [21][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing discussions with the FDA, indicating no disruptions or delays in the approval process [61][62] - The company is focused on building out infrastructure and customer support systems to ensure a successful product launch [25][32] Other Important Information - The company has achieved 20 issued patents worldwide, emphasizing the importance of intellectual property in its business strategy [26] - The early access program is providing valuable feedback on the product and its usability in real-world settings [25] Q&A Session Summary Question: Insights from the early access program - The company learned valuable insights from real patient interactions, including onboarding and training, which have helped refine the product [46][48] Question: Pricing strategy for commercialization - The anticipated pricing is expected to be between 50to50 to 100 per month, with potential tiered options for additional services [49][50] Question: Timing for building out infrastructure - The company plans to begin commercialization in Q4 2025, following FDA clearance, with initial efforts focused on two target markets [54][56] Question: Updates on FDA approval process - The company reported no disruptions from FDA staff attrition and remains on track for clearance by the end of the year [60][62] Question: Competitive position with AccuCardia partnership - The collaboration enhances the product offering by providing automated assessments for ECG readings, filling a critical gap in the workflow [64][66] Question: Manufacturing capabilities and tariff exposure - The company has secured a US-based contract manufacturer to mitigate tariff impacts and ensure quality control during initial production runs [72][74]