HeartBeam (NasdaqCM:BEAT) FY Conference Summary Company Overview - **Company**: HeartBeam - **Industry**: Medical Devices, specifically in cardiac monitoring technology - **Key Technology**: Development of a cable-free synthesized 12-lead ECG platform for at-home use, aimed at improving heart attack detection and reducing pre-hospital delays in care [2][4][31] Core Points and Arguments Company Background - **Founder**: Branislav Vajdic, co-inventor of flash memory at Intel, inspired to create HeartBeam after a personal family tragedy related to heart disease [2][3] - **Problem Addressed**: Heart attacks are the leading cause of death, with significant delays in patient response time before reaching hospitals [3][4] Product and Technology - **Device Functionality**: The HeartBeam device allows patients to perform a 12-lead ECG at home, providing real-time clinical-grade insights [4][6] - **FDA Clearances**: Received two FDA clearances, enabling the launch of the device and its associated algorithms [11][31] - **Market Potential**: Targeting an initial market of 5 million patients in the US, with potential expansion to over 50 million patients at risk of heart disease [10][11] Market Strategy - **Initial Target Market**: Focus on concierge and preventive cardiology practices, with a subscription model priced between $500-$1,000 per year per patient [12][14] - **Patient Engagement**: Plans to enhance patient retention through wellness AI algorithms and community features [39][40] - **Sales Strategy**: Aiming for a capital-efficient model without a large sales force, leveraging partnerships with practices to drive patient adoption [17][33] Financial Overview - **Recent Financial Performance**: Reported a net loss of $21 million for FY 2025, with a focus on maintaining capital efficiency [28][29] - **Projected Cash Outflows**: Expected operating cash outflows of $17-$19 million for 2026, with plans to achieve cash flow break-even at around 30,000 patients [30][31] Future Initiatives - **Heart Attack Detection**: Ongoing clinical studies to validate the device's effectiveness in detecting heart attacks, with plans for indication expansion [19][33] - **12-Lead Patch Development**: Working on a patch that converts symptoms into a 12-lead ECG, targeting the $2 billion ambulatory cardiac monitoring market [20][21] - **AI Integration**: Collaborating with Mount Sinai to develop AI algorithms for predictive screening and heart attack detection [24][25] Additional Important Insights - **Market Research Findings**: 80% of high-net-worth individuals expressed interest in purchasing the device, indicating strong demand [12] - **Competitive Landscape**: The device's 12-lead capability differentiates it from existing single-lead devices, potentially capturing a significant market share [42][44] - **Partnerships**: The collaboration with ClearCardio and Mount Sinai is seen as a strategic move to enhance product offerings and market reach [17][25] This summary encapsulates the key points from the HeartBeam FY Conference, highlighting the company's innovative approach to cardiac monitoring and its strategic plans for market entry and growth.

Financial Data and Key Metrics Changes - For the full year 2025, the net loss was $21 million or $0.62 per basic and diluted share, while the net loss for the fourth quarter was $5.3 million or $0.15 per share, aligning with expectations [26][27] - Net cash used in operating activities was less than $14 million for the full year and just $2.9 million for the fourth quarter, representing a 3% decrease year-over-year and a 30% decrease compared to the same quarter last year [27][28] - Cash and cash equivalents and restricted cash combined totaled $4.4 million at December 31, 2025 [28] Business Line Data and Key Metrics Changes - HeartBeam's initial product, the HeartBeam System, received FDA 510(k) clearance for arrhythmia assessment, marking a significant milestone for the company [5][6] - The company is focusing on a limited commercial launch targeting concierge and preventive cardiology practices, with a target price per patient of $500-$1,000 per year [10][11] - The HeartBeam 12-lead patch is expected to disrupt the ambulatory cardiac monitoring market, which is a $2 billion revenue market [7][18] Market Data and Key Metrics Changes - The company aims to capture a small portion of the 1.5 million Americans currently paying for concierge medicine, focusing on high-net-worth individuals who show a strong willingness to pay for advanced health technology [10][11] - The market research indicates that 86% of physicians would shift a portion of their patches to the 12-lead patch, implying a potential market shift [20][21] Company Strategy and Development Direction - HeartBeam is adopting a staged approach to commercialization, starting with a focused rollout in concierge cardiology and executive health [12][14] - The company plans to validate its model in a concentrated market before scaling to a broader patient base, including direct primary care practices and telehealth networks [11][12] - The strategic collaboration with Mount Sinai aims to combine expertise in clinically annotated ECG data with HeartBeam's signal collection technology [23][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's trajectory, highlighting the FDA clearance as a de-risking milestone and the potential for significant advancements in 2026 [29][30] - The company expects to achieve cash flow breakeven at approximately 30,000 patients, with a subscription model that has margins above 70% [13][28] Other Important Information - The HeartBeam 12-lead patch is designed to provide better diagnostic capabilities and integrate into existing workflows, leveraging existing reimbursement [19][22] - The company has completed the development of a working prototype of the 12-lead patch and is conducting clinical studies [24][25] Q&A Session Summary Question: Can you talk more about the timeline for the ALIGN pilot study and the patch initiatives? - Management indicated that the ALIGN-ACS pilot study is expected to enroll quickly due to its design and aims to complete by the end of Q3 2026, which will inform the pivotal study [35][36] Question: What does the account pipeline look like for the commercialization strategy? - The company is focusing on several anchor accounts in the first couple of quarters to validate its premium value proposition before scaling [38][40] Question: How should we think about R&D expenses trending in the upcoming quarters? - R&D expenses are expected to step up slightly in the first half of the year due to clinical trials and advanced developments, then return to current levels in the second half [46][48] Question: Are there plans for profit-sharing models as the company expands? - Management is open to exploring profit-sharing models as they expand but is currently focused on establishing a strong engagement with practices [81][84] Question: What are the thoughts on targeting telehealth providers? - The company sees significant opportunities in telehealth, emphasizing the unique capability of providing clinical-grade ECG technology directly to patients [88][90] Question: Can you provide background on the Mount Sinai relationship? - The relationship with Mount Sinai has been built over time through mutual respect and collaboration, leading to a deeper partnership focused on AI algorithms [94]

Heartbeam (NasdaqCM:BEAT) Q4 2025 Earnings call March 12, 2026 04:30 PM ET Company ParticipantsBryan Humbarger - CCORobert Eno - Founder and Executive ChairmanTimothy Cruickshank - CFONone - Company RepresentativeConference Call ParticipantsBill Sutherland - Equity Research AnalystKyle Bauser - Equity Research AnalystLeo Carpio - Equity Research AnalystNone - AnalystOperatorGreetings, and welcome to the HeartBeam Q4 2025 financial results conference call. At this time, all participants are in a listen-only ...

Financial Data and Key Metrics Changes - For the full year 2025, the net loss was $21 million or $0.62 per share, while the fourth quarter net loss was $5.3 million or $0.15 per share, aligning with expectations [28] - Net cash used in operating activities was less than $14 million for the full year and just $2.9 million for the fourth quarter, representing a 3% decrease year-over-year and a 30% decrease compared to the same quarter last year [28][29] - Cash and cash equivalents totaled $4.4 million at December 31, 2025, with access to capital markets remaining strong [29] Business Line Data and Key Metrics Changes - HeartBeam's core technology includes a portable cable-free ECG that synthesizes a 12-lead ECG, with FDA 510(k) clearance achieved for arrhythmia assessment [5][6] - The company is launching a second form factor, an on-demand 12-lead extended wear patch, which is expected to disrupt the $2 billion ambulatory cardiac monitoring market [8][20] - The initial commercial launch is focused on concierge and preventive cardiology practices, targeting a price per patient of $500-$1,000 per year [11][12] Market Data and Key Metrics Changes - The target market includes approximately 1.5 million Americans currently paying for concierge medicine, with a focus on high-net-worth individuals who show a strong willingness to adopt advanced health technology [11][12] - The company aims to capture a small portion of the concierge market initially, with plans to expand into larger patient segments, including direct primary care practices and telehealth networks [12][13] Company Strategy and Development Direction - HeartBeam's strategy involves a staged approach to commercialization, starting with a limited launch in concierge cardiology and executive health [13][16] - The company plans to validate its model in a concentrated market before scaling, with a focus on deep adoption within initial practices [12][16] - The collaboration with Mount Sinai aims to enhance AI capabilities and bring advanced algorithms to the HeartBeam device [25][98] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for the HeartBeam system, highlighting the strong interest from both patients and physicians [10][11] - The company anticipates significant advancements in 2026, with ongoing studies and product launches expected to drive growth [32][34] - The management emphasized maintaining financial discipline while advancing key milestones and developing the R&D pipeline [28][29] Other Important Information - The HeartBeam 12-lead patch is expected to provide better diagnostic capabilities and integrate into existing workflows, leveraging existing reimbursement [20][21] - The company has completed a working prototype of the patch and is conducting clinical studies to validate its effectiveness [23][26] Q&A Session Summary Question: Can you talk about the timeline for the ALIGN pilot study and the patch initiatives? - Management indicated that the ALIGN-ACS pilot study is expected to enroll quickly due to its design, with completion anticipated by the end of Q3 2026 [36][39] Question: What does the account pipeline look like for the commercialization strategy? - The focus is on a limited number of anchor accounts initially, with plans to validate the premium value proposition before scaling [41][43] Question: How should we think about R&D expenses trending in the upcoming quarters? - R&D expenses are expected to step up slightly in the first half of the year due to clinical trials, then return to baseline levels [49][51] Question: Can you provide details on the Mount Sinai relationship and potential for similar alliances? - The relationship with Mount Sinai was built on mutual respect and shared goals in advancing AI algorithms for ECG data, with openness to future partnerships [96][98]

Total Heart Intelligence… Wherever You Are FOURTH QUARTER 2025 FINANCIAL RESULTS CONFERENCE CALL MARCH 12, 2026 NASDAQ: BEAT Disclaimer The Company has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that it believes may affect its business, financial condition and results of operations. Also, these forward-looking statements represent the Company's estimates and assumptions only as of the date of this presentation. The Comp ...

Total Heart Intelligence… Wherever You Are ADVANCED CARDIAC INTELLIGENCE PLATFORM | 25 PATENTS | FDA CLEARED INVESTOR PRESENTATION March 12, 2026 Investor Presentation 2026 NASDAQ : BEAT Disclaimer This presentation contains forward-looking statements. All statements other than statements of historical fact contained in this presentation, including statements as to the Company's future results of operations and financial position, planned products and services, business strategy and plans and objectives of ...

Financial Data and Key Metrics Changes - The net loss for Q3 2025 was $5.3 million, or $0.15 per basic and diluted share, consistent with the prior quarter and in line with expectations [15][16] - Net cash used in operating activities was under $3.2 million, representing an 8% decrease quarter over quarter, building on a 23% decrease from the prior quarter [16] - Cash and cash equivalents at September 30, 2025, were $1.9 million, with a focus on maintaining a tight balance sheet [16][17] Business Line Data and Key Metrics Changes - The HeartBeam System is positioned as the first portable, cable-free ECG capable of synthesizing a 12-lead ECG, aimed at enhancing patient confidence in heart health [4][5] - The company has achieved significant milestones, including FDA 510(k) clearance for arrhythmia assessment and submission for 12-lead ECG synthesis software [10][11] Market Data and Key Metrics Changes - The initial commercial launch is anticipated to focus on prominent concierge and preventive cardiology practices in two U.S. regions, Southern California and South Florida, targeting approximately 75,000 patients [28][29] - Market research indicates strong interest from both physicians and patients, with a willingness to pay a premium for the HeartBeam System's functionality [9] Company Strategy and Development Direction - The company aims to create a new product category with the HeartBeam System, differentiating itself by combining an easy-to-use device with on-demand cardiologist support [13][14] - A controlled market entry strategy will be implemented, starting with a small number of practices to gather feedback before broader expansion [14] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about FDA interactions, categorizing them as productive, and anticipates clearance by year-end [22] - The company is focused on user experience and operational readiness ahead of commercialization, with plans to hire key commercial team members post-FDA clearance [11][17] Other Important Information - HeartBeam has been recognized as a global leader in portable cardiac diagnostics, ranking second worldwide in 12-lead ECG innovation [12][20] - The company has added three new patents, bringing the total to 24 issued patents worldwide [12][20] Q&A Session Summary Question: Can you discuss the FDA discussions and what factors need to be addressed for clearance? - Management described interactions with the FDA as productive and anticipates clearance before year-end [22] Question: What territories will be focused on for initial market launch? - The initial focus will be on prominent concierge and preventive cardiology practices in Southern California and South Florida [28][29] Question: How will pricing be structured for symptomatic versus asymptomatic readings? - A subscription model is planned, with details on pricing and the number of cardiology reads to be finalized [24] Question: How is inventory management and manufacturing capability being handled? - The company has a U.S.-based contract manufacturer and is confident in its manufacturing capabilities with off-the-shelf components [26] Question: What are the expectations for sales following commercialization? - Management indicated that while initial sales may be slow, significant growth is expected in the second half of 2026 [36] Question: Will the company work exclusively with HeartNexus for cardiology services? - While HeartNexus is a key partner, the company is open to expanding its network based on demand [39][40] Question: Are there plans for additional strategic partnerships to enhance production or operational capabilities? - The company is exploring various strategic partnerships to scale efficiently and enhance operational capabilities [42]

Company Overview & Strategy - HeartBeam aims to shift cardiac care from hospitals to home, similar to trends seen with glucose, blood pressure, and oxygen monitors[15, 16] - The company's synthesized 12-Lead ECG system, combined with on-demand cardiologist interpretation, is the foundation for a new cardiac care model[21] - HeartBeam is building an ecosystem around its core technology to deepen patient engagement and provide actionable insights for physicians[21, 23] - The company's near-term commercial strategy focuses on creating a new category, market entry through pilot programs, a focused commercial model, and patient retention[30] Regulatory & Clinical Milestones - HeartBeam received foundational FDA clearance for its system for arrhythmia assessment in December 2024[9, 13, 25] - FDA 510(k) clearance for the 12-Lead ECG Synthesis Software for arrhythmia assessment is anticipated in Q4 2025[13, 25, 34] - A pivotal clinical study (VALID-ECG) showed 93.4% overall diagnostic agreement for arrhythmia assessment[25] - New data presented at AHA Scientific Sessions in November 2025 supports HeartBeam's potential for early heart attack detection[27] Financial Performance (Q3 2025) - Total operating expenses were $5290 thousand[31] - Net loss was $5255 thousand, with an Earnings per Share (EPS) of $(0.15)[31] - Net cash used in operating activities was $3160 thousand, an 8% decrease quarter-over-quarter[31, 33] - Cash and cash equivalents and short-term investments totaled $1856 thousand as of September 30, 2025[31]

Product & Regulatory Milestones - HeartBeam System 在 2024 年 12 月获得了 FDA 的基础许可[21] - 12-lead ECG synthesis software application 已于 2025 年 1 月提交给 FDA，预计在 2025 年底获得批准[21] - 公司正在与 FDA 进行富有成效的讨论，以获得 12-lead ECG 合成软件的许可，并进一步讨论未来的许可和适应症，包括缺血适应症和 AccurKardia 自动算法[67] Financial Performance - 2025 财年第二季度运营活动中使用的净现金为 344 万美元[91] - 运营活动中使用的净现金环比减少 23%[91] - 经常性基线支出约为 310 万美元，低于历史基线 350 万美元[91] - 用于商业准备活动和制造能力的投资约为 30 万美元[91] - 截至 2025 年 6 月 30 日，现金和现金等价物总额为 5053000 美元[88] Market & Commercialization Strategy - 总体直接患者市场估计为每年 13 亿至 26 亿美元[76] - 公司正在执行商业准备计划，包括产品、基础设施和目标实践[66, 94] - 公司正在与目标礼宾实践会面，以建立溢价定价和订阅模式[79, 81] - 由于临近 FDA 批准，行业合作伙伴的兴趣显着增加[87, 94] Recognition - HeartBeam 因其在远程心脏诊断方面的创新而获得 2025 年医疗设备网络卓越计划奖[74] - HeartBeam 被评为 2025 年 Octane 高科技奖的决赛入围者[74]

Clinical and Regulatory Progress - The VALID-ECG pivotal study successfully met clinical endpoints for arrhythmia assessment[24, 31, 60] - The study results showed a 93.4% overall agreement between standard and synthesized 12-lead ECG in sinus rhythm and arrhythmia[34] - The company commenced initial FDA interactions on ischemia indication[24, 60] Commercial Readiness - The Early Access Program commenced in Q1 2025, providing key insights[47, 62] - The company signed a contract manufacturer for scaling[47, 62] - A strategic collaboration was signed with AccurKardia to enhance the commercial offering[28, 39, 62] Financial Results - Net cash used in operating activities was $4477 thousand for Q1 FY'25, an 8% increase quarter-over-quarter[55, 56] - The company completed an $11500 thousand common stock Public Offering in February 2025[56] - Total cash and cash equivalents and short-term investments were $8150 thousand as of March 31, 2025[55]