Earnings Call Transcript - BEAT Q3 2025

Operator, Operator

Greetings, and welcome to the HeartBeam Third Quarter 2025 Financial Results Conference Call. As a reminder, this conference call is being recorded. Before we begin the formal presentation, I want to remind everyone that statements made on the call and webcast may include predictions, estimates, and other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation. Please keep in mind that we're not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events. Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions. You should also review our most recent Form 10-K and Form 10-Q for a more complete discussion of these factors and other risks, particularly under the heading Risk Factors. A press release detailing these results crossed the wire this afternoon and is available in the Investor Relations section of our company's website, heartbeam.com. Your host today, Rob Eno, Chief Executive Officer, and Tim Cruickshank, Chief Financial Officer, will present results of operations for the third quarter ended September 30, 2025. And at this time, I would like to turn the call over to HeartBeam's Chief Executive Officer, Mr. Rob Eno. Please go ahead.

Robert Eno, CEO

Thank you, operator. The topics we'll cover in today's call are listed on the slide. We'll start with an overview of the HeartBeam system and the product vision. We'll touch on our recently achieved and upcoming milestones and highlight the upcoming commercial launch strategy, followed by financial results, and we'll end with a Q&A. Before we dive into updates since our last call in August, I wanted to remind everyone about our vision and our initial product, the HeartBeam System. HeartBeam is dedicated to developing groundbreaking ECG technology for patients to use at home to allow them to feel confident about their heart health. HeartBeam is developing the first-ever portable cable-free ECG that can synthesize a 12-Lead ECG. A unique IP-protected approach captures the heart's electrical signals in three dimensions or non-coplanar directions and synthesizes the signals into a 12-Lead ECG. The system is designed to be easy to carry and easy for patients to use at the time of symptom onset anywhere, anytime. The technology is supported by an on-demand cardiologist who can interpret the clinical-grade ECG and triage patients appropriately to ensure timely care. As a reminder, in December 2024, we received our foundational FDA 510(k) clearance. This was for the system as a whole for arrhythmia assessment, the credit card signal collection device, the patient application, a physician portal, and signal quality algorithms. This major milestone validated our unique approach. In January, we submitted our second FDA 510(k) application. This is for the software that synthesizes a 12-Lead ECG from our 3D signals for arrhythmia assessment. We're engaging in the final steps with the FDA related to our 510(k) submission and continue to anticipate clearance by the end of the year. This clearance will be a major inflection point for HeartBeam as these two clearances together will form the product with which we'll start our initial commercialization. We believe that the HeartBeam system can be part of one of the most important trends in medicine today, the movement of clinical-grade devices from the hospital and clinic to becoming a part of daily life at home. Connected clinical-grade technologies are changing the healthcare landscape by expanding access, reducing healthcare costs, and enabling personalized medicine. From continuous glucose monitors to home blood pressure cuffs, these technologies empower patients and provide physicians with insights that lead to identifying conditions earlier and monitoring trends over time. Heart disease is the leading cause of death worldwide and most cardiac events, whether arrhythmias or ischemia happen outside of the medical setting. Diagnosing these events is crucial and ECGs are the most common cardiac test, yet most at-home options have been limited to downgraded versions unable to provide a clinical-grade 12-Lead output. HeartBeam's credit card-sized system will change that by delivering a synthesized 12-Lead ECG into the patient's hands, starting with the arrhythmia assessment application. The ability to get clinical-grade insights when they need it, wherever they are, will enable patients to get more timely care. When a patient has symptoms and uses the HeartBeam system, they first open the smartphone application, which guides the patient through the process of taking a recording. Once the recording is complete, it's sent to the HeartBeam Cloud where it's processed and immediately sent to a cardiologist for review. Last month, we announced an agreement with HeartNexus, a group of U.S.-based board-certified cardiologists with coverage across the United States. When a patient has arrhythmia symptoms and takes a recording with the HeartBeam system, a HeartNexus cardiologist will send an ECG interpretation back to the patient. This agreement is a key part of the product and one of the final pieces needed for our commercial launch, which is anticipated to be early next year after our FDA clearance for the 12-Lead synthesis software for arrhythmia assessment, which we anticipate receiving before the end of the year. Next, I'd like to remind you about the larger ecosystem we're building around the HeartBeam system. This ecosystem dramatically increases the overall value of the system and will drive deeper adoption. As I mentioned, at the core of the ecosystem is the HeartBeam system itself, the first and only credit card-sized cable-free device that synthesizes a 12-Lead ECG. This is complemented by an on-demand U.S.-based board-certified cardiologist available to review ECG readings 24/7. Our market research confirms that this concept resonates strongly with both physicians and patients who have indicated a willingness to pay a premium for this functionality. Building around this foundation, we're creating an ecosystem to maximize the benefits of our technology and encourage stronger engagement among patients. Key components of our ecosystem include automated arrhythmia assessments for use during routine recordings, integration with wearables that trigger patients to take readings when their wearable produces inconclusive results or if worrisome underlying parameters are detected. Community features with tailored educational content and AI wellness features such as ECG-based cardiac age insights. We'll also be able to provide long-term trending of the HeartBeam synthesized 12-Lead ECGs, allowing the patient's physician to get longitudinal insights, including the trending of specific ECG parameters over time. Creating this ecosystem will add unique insights and actionable data for both patients and physicians that are unavailable elsewhere and add to the premium offering of HeartBeam. The team has done an exceptional job of achieving the milestones we said we're going to achieve over the past year. The highlights are listed here. Last December, we received our foundational FDA clearance for the HeartBeam system for arrhythmia assessment. In January, we submitted our second FDA 510(k) application for the 12-Lead ECG synthesis software for arrhythmia assessment. We successfully met the clinical endpoints in the VALID-ECG pivotal study, which is the basis for this 12-Lead synthesis submission. The study demonstrated a 93.4% overall diagnostic agreement between the HeartBeam synthesized 12-Lead ECG and a standard 12-Lead ECG in the assessment of arrhythmia. These results were presented at the Heart Rhythm Society meeting in April. We also started our early access program, or beta testing, which has provided us with valuable feedback, allowing us to enhance the onboarding, training, and overall user experience. And finally, as I mentioned, we signed the agreement with HeartNexus to service the cardiology reader service. We have a number of important milestones in the coming weeks and months. We continue to anticipate the FDA 510(k) clearance for the 12-Lead ECG synthesis software for arrhythmia assessment this quarter. In 2026, we expect to start enrollment on additional clinical trials on the clinical and cost-effectiveness benefits of HeartBeam. The focus of our clinical studies to date has been a comparison with standard 12-Lead ECGs. These planned post-market studies will be important for adoption and ultimately for payment and reimbursement. We're also preparing for commercialization. We anticipate hiring the Chief Commercial Officer and other key members of the commercial team upon FDA clearance. We also anticipate initial commercial agreements with concierge and preventive cardiology practices. While our focus remains squarely on working with the FDA toward the 12-Lead ECG synthesis clearance and preparing for commercial launch, we achieved several milestones that help us toward our longer-term goals. Important data were presented at two recent scientific meetings. First, at the HRX Live meeting in September, an abstract was presented on the capabilities of the HeartBeam AI algorithm in classifying arrhythmias. And earlier this week at the American Heart Association Scientific Sessions, data were presented on the promise of the HeartBeam 3D3-lead technology for the detection of coronary occlusions. These studies add to the growing body of clinical evidence. They demonstrate the progress and promise of our AI efforts, as well as the potential to apply the HeartBeam technology to heart attack detection. Intellectual property continues to be at the core of the company's efforts. With three newly issued patents, we now have 24 issued patents worldwide. In addition, HeartBeam was recognized as a global intellectual property and technology leader in portable cardiac diagnostics in a report from the IP firm PatentVest, with HeartBeam ranking #2 worldwide in the 12-Lead ECG innovation out of 243 companies analyzed. As we prepare for our initial launch, we've established clear strategic pillars. First, we're creating a new product category, and the overarching focus of our efforts will be establishing the HeartBeam system as the first personal cable-free synthesized 12-Lead ECG. We believe that the HeartBeam system is clearly differentiated from other offerings by combining an easy-to-use device that can produce a 12-Lead ECG with an on-demand cardiologist who can provide ECG assessment. Second, we're preparing a controlled market entry. We anticipate starting with a small number of prominent concierge and preventive cardiology practices, both independent practices and those associated with major healthcare systems. These practices will provide an opportunity to get early real-world feedback and will serve as reference accounts. Beyond that, our strategy is to focus initially on two U.S. geographic regions to prove the business model, followed by expansion of this model into additional regions. We plan to establish a small direct sales and marketing organization in the U.S. with sales reps and implementation specialists focused on a geographic region. We're exploring multiple options that will allow efficient expansion, including distribution partners and chains of concierge practices. A final key element of the strategy is demonstrating the value of the HeartBeam system to patients and practices, driving retention of our users over time. We'll focus on the patient experience and provider engagement to drive recurring use of the system as part of our strategy of developing a subscription model.

Timothy Cruickshank, CFO

Great. Thank you, Rob. I'll quickly go through some of the key financial data for the quarter ended September 30, 2025. We continue to be focused on our cash management as we maintain strong financial discipline aligned to achieving milestones. When we look at the quarter, net loss for the period was $5.3 million or $0.15 per basic and diluted share, consistent with the prior quarter and also in line with our expectations and analyst consensus. Of that net loss, I'll note a significant portion was related to noncash expenses such as stock-based compensation. So the result in net cash used in operating activities was under $3.2 million. That's an 8% decrease quarter-over-quarter, and it builds on the 23% decrease we had from the prior quarter. So we're pleased with our ability to balance competing priorities we have over the recent quarters by both maintaining a capital-efficient organization and also judiciously timing the key investments we need into the commercial readiness activities. So, you're seeing evidence of this as we continue to reduce our cash outflow. And we'll continue to take this approach as we derisk the business and while we're building the proof points we need prior to accelerating investments into commercial traction and scale. Cash and cash equivalents at September 30 were $1.9 million. Obviously, with a tight balance sheet, we're monitoring things closely, but we're confident in our approach of strategically funding the company consistent with how we've outlined it in the past. We've got optionality in place both in the vehicles and the sources of funding, and we have confidence in our ability to achieve near-term milestones, including the FDA clearance, which we believe will be a major inflection point for the company. We remain committed to minimizing dilution for our shareholders so that they're rewarded for their time and commitment to our company and our vision. Our Board, management team, and key insiders are more excited than ever about what lies ahead with commercialization on the near-term horizon. We believe very strongly in the value we're creating here at HeartBeam and getting this critical technology into the hands of clinicians and patients is going to be a really rewarding step for us here in the very near future. With that, Rob, I'll turn the call back over to you for closing summary.

Robert Eno, CEO

Thanks so much, Tim. So to summarize, this is an incredibly exciting time for HeartBeam. We continue to engage in positive and productive discussions with the FDA, and our anticipated timeline for the clearance by year-end remains intact. Combined with the foundational FDA clearance received in December 2024, this clearance will mark a pivotal milestone for the company to initiate our commercial launch. We've made significant progress with our commercial readiness plans in anticipation of the FDA clearance. Of note, we announced a partnership with HeartNexus to provide on-demand board-certified cardiologist reviews of synthesized 12-week ECGs for arrhythmia assessment. These two elements, an ECG that's capable of synthesizing a 12-week ECG and a cardiologist on call 24/7 able to provide ECG assessments to the patient, are the core of our system. While our focus is squarely on the interactions with the FDA and preparing for the commercial launch, we continue to prepare for the company's future. We added to the body of clinical evidence with two recent presentations at scientific meetings, one on AI and the other on heart attack detection. In addition, we added three newly issued patents, bringing the total to 24, and we're pleased to be recognized for our IP, ranking #2 worldwide in 12-Lead ECG innovation out of 243 companies analyzed. HeartBeam is at a very exciting inflection point, and we'll continue to work with our partners to strategically finance the company in a manner that adds to and creates shareholder value. We believe that HeartBeam's technology is poised to be a fundamental advance in cardiac care. Our team has worked incredibly hard on the development and validation of the technology, and we're excited to be nearing the next stage in the company's growth, introducing the groundbreaking technology of HeartBeam for patients to use at home to allow them to feel confident about their heart health. We thank you all for attending, and now I would like to open it up to Q&A. Operator?

Operator, Operator

And our first question for today will come from Kyle Bauser with ROTH Capital Partners.

Kyle Bauser, Analyst

Maybe we could start off on the discussions you've had with the FDA. Can you talk a little bit more about sort of what you're working on and responses and factors that you'll want to address ahead of a clearance?

Robert Eno, CEO

Yes. I can't really comment much more than that. I guess what I'd reiterate is that we continue to categorize our interactions with the FDA as productive. The normal process of FDA questions and us answering them, and we're continuing to anticipate the FDA clearance before the end of the year. But from the last clearance to this one, we haven't gone into more details of the characterization of the questions. I'll just leave it there.

Kyle Bauser, Analyst

Fair enough. Good to know the timeline is still on track before year-end. As you gear up for the commercial launch, you sort of talked about it a little bit, Rob. Are you still kind of focused on a couple of territories initially to gather feedback and intel ahead of a broader launch to say five to ten territories?

Robert Eno, CEO

That's exactly right. Yes. I think the nuance on that is the very first accounts, we believe, will be prominent accounts, some really exciting ones that we're talking to. Some of them are independent. Some of them are associated with major healthcare institutions. And in a sense, those can be reference accounts, those can be our pilot accounts. And then beyond that, we start to go deep into the two regions to start. And then exactly, as you say, we want to prove the model there to show everything around our sales model, that the expected coverage, we think. And as we get that, we can expand to a larger number of regions exactly.

Kyle Bauser, Analyst

Got it. Got it. And how should we be thinking about pricing regarding sort of symptomatic versus asymptomatic readings? I know you're able to charge a premium potentially for symptomatic readings and great to know about the recent partnership with HeartNexus, but just trying to understand how you're thinking through that. Now it's a little bit early.

Robert Eno, CEO

Yes, sure. No, yes, it is a little bit early, but what we've identified so far are a few things. We're planning on a subscription offering. The initial thought is that it will be upfront a one-year subscription and that one-year subscription gives you the device itself and access to a certain number of cardiology reads. And so we'll work on the details of that pricing level and how many reads. What we're building into the system, not exactly at the initial launch, but we're building in is the automated assessment, algorithmic assessment. So the vision that we're building toward there as that comes in, that requires an FDA clearance. As that comes in will be one pathway for routine recordings, which the patient will have an unlimited number of routine recordings because we want them to practice and to build up their data. And then when they're having symptoms, they go down this symptomatic pathway, and that is what uses one of their credits and activates the reader service.

Kyle Bauser, Analyst

That's helpful. Got it. And maybe one more. As you prepare for the commercial launch, how are you managing inventory levels? And how does your sort of manufacturing capabilities look at this point?

Robert Eno, CEO

Great. Tim, do you want to take that one?

Timothy Cruickshank, CFO

Thank you. We have a strong partnership with a U.S.-based contract manufacturer for our device commercialization. The exciting aspect of our latest round is that it utilizes entirely off-the-shelf components, requiring no custom parts. This means we have the necessary capabilities in place for product assembly. In the near term, our primary focus for the launch over the next year is not on the manufacturing process itself, as we have a clear path to sourcing parts without any lengthy lead times. We'll continue to monitor the situation, but since we are using standard components, we have multiple reliable sources for our parts. We're confident in our manufacturing capabilities, and our main concern is assessing demand and scaling production accordingly. Our primary focus will be on workflow and ensuring we get the onboarding process right, which we consider more critical than the manufacturing aspect.

Operator, Operator

Your next question will come from Bill Sutherland with the Benchmark Company.

William Sutherland, Analyst

Wanted to just maybe find out a little more color on the two initial market launches that you had planned. Maybe a sense of the available TAM that you're going to be looking at there? And just a couple of assumptions to help us think about the numbers that we might just begin to think about for next year and maybe the following year.

Robert Eno, CEO

Tim, would you take that?

Timothy Cruickshank, CFO

Yes, sure. No problem at all. Yes. So, the first two geographies, we've said before, most likely we have Southern California and South Florida, two really strong territories with a lot of great accounts and inbound demand there. The way we sort of look at it is the territory size, if you think about an average, the initial territories we're going after, 75,000 patients roughly in those that we would be targeting in those regions. You can do a really concentrated rollout in terms of the number of accounts that you really need to talk to, to start to get some good penetration there. And we plan on going to, as Rob indicated, individual practices and some of the institutions that have concierge practices associated with them to nail workflow, really make sure that the patient experience is right. But then within those territories, as we build that out, there are a number of concierge chains that we'll be able to look at to help accelerate adoption and growth. So, it's all about getting it right in the first couple of quarters, so keeping expectations modest in terms of what that means from a revenue and user perspective. But as we get to the second half of '26 is when we start to see some of the real penetration into those geographies and as we head to '27, when those concierge chains likely come on. Obviously, we'll be working to accelerate that faster, but I think that those three waves are how we're looking at it.

William Sutherland, Analyst

Okay. How do you target the marketing since it involves both the cardiologists and direct outreach to patients? I understand this is an out-of-pocket expense.

Robert Eno, CEO

Sure. Yes, I'll take that one. To start with, it's a prescription device that we are targeting at concierge and preventive cardiology practices. These practices already have patients and are comfortable discussing items that require out-of-pocket payment. The first step in our approach is to engage with these accounts, explain the product, and demonstrate how it can benefit their practice. We plan to assist the practices in reaching out to their patients, encouraging them to discuss the technology and consider adopting it. We will provide materials and support throughout this process, effectively collaborating with the practices. Over time, we also see opportunities to expand beyond existing patients at these concierge practices through referrals, allowing patients to refer others who might join the concierge practice or access the technology via other clinicians, as well as some direct-to-consumer marketing. We aim to be as efficient as possible, and initially working with concierge and preventive cardiology practices along with referrals seems to be the most effective strategy, but we will refine our approach as we progress with commercialization in these regions.

William Sutherland, Analyst

Great. And then I'm wondering, you are establishing this as a new category. But when you go into the practices, are they using something at this point that gets at some of the functionality of HeartBeam and that you'll have to take the position?

Robert Eno, CEO

Yes, the usage will vary. Some practices may not have anything similar, while others might be utilizing existing one-lead ECGs from different companies. We believe there isn’t a widely used solution that can synthesize the 12-lead ECG while also incorporating a reader service. It’s a blend; some practices may be introducing new technologies, while others may be promoting existing options to their patients. Our market research indicates that feedback has been very positive, with both patients and practices recognizing additional value in this offering and expressing enthusiasm about leveraging it.

Operator, Operator

We will now turn for any webcast questions.

Unknown Executive, Executive

Our first webcast question asks, you ended Q3 with $2 million in cash. What are your plans for additional funding?

Timothy Cruickshank, CFO

Sure, I'm happy to address that. While I can't provide specific details about our plans, I can share insights based on my prepared remarks. I noted the options we have regarding both vehicles and funding sources, and I want to emphasize our confidence in meeting the upcoming near-term milestones. We believe that the upcoming inflection point will allow us to strategically assess our balance sheet. We are focusing on two key priorities: minimizing dilution for our existing shareholders, which is very important to us, while also ensuring we have a strong balance sheet to seize future opportunities. I believe that by establishing a proper capital markets profile, we can unlock the stock's potential, reflecting the opportunities ahead. We are carefully managing these priorities and feel we are close to realizing both goals for the company. However, we will remain committed to the path to achieve this.

Unknown Executive, Executive

And one of the webcast questioner asks, if there are any contracts that are currently sitting on your front burner?

Robert Eno, CEO

Yes, I would say that we are having productive discussions with potential early users of the system, including some large and well-known practices. We've had very positive conversations there. After receiving FDA clearance and beginning commercialization, we look forward to making more announcements regarding this.

Unknown Executive, Executive

And do you have any expectations for the level of sales next year following the commencement of commercialization?

Timothy Cruickshank, CFO

I'm happy to address that. While I haven't provided specific guidance, I can share some insights. HeartBeam will be transitioning into a commercial entity in 2026. Our main focus will be on ensuring a positive experience for both physicians and patients, which may result in a slower start during the first quarter and first half of the year. However, as I mentioned earlier, we expect sales and user growth to pick up significantly in the latter half of the year. Given the strong demand we've received so far, we believe we can accelerate this process, but we are being realistic in our expectations as we enter the commercial phase for the first time. We've recently received new coverage, and the current research reports provide a solid framework for our early projections. As we gather more data and look to expand into new markets, we will seek opportunities to boost growth, particularly in light of the positive feedback we've received from concierge and preventative cardiology accounts. We are optimistic about the potential demand.

Unknown Executive, Executive

And once you obtain FDA clearance for arrhythmia detection, what is your planned pathway for pursuing an additional indication for myocardial infarction detection?

Robert Eno, CEO

Yes, that's a great question. We've discussed this before, but I'll reiterate. We have started initial discussions with the FDA and are planning to pursue this. We believe it involves the same product with an expanded indication. We have completed two proof-of-concept studies demonstrating the similarity between our device's output and that of a standard 12-Lead in patients with ischemic heart attacks. We intend to engage with the FDA to gain a better understanding of the regulatory process and the clinical trial requirements. Our expectation is that we will need to conduct a clinical study to demonstrate our system's performance compared to a 12-Lead in that patient population. We have some ideas on this and look forward to discussions with the FDA regarding their expectations and how to move forward with our plans.

Unknown Executive, Executive

Will you work exclusively with HeartNexus, or are you open to expanding your network to other telcardiology firms?

Robert Eno, CEO

Yes. First of all, we believe HeartNexus is a great partner and we are excited to collaborate with them. Our main strategy is to ensure that patients can use this product around the clock if they have symptoms. We also want to avoid placing the prescribing physician on call 24/7 unless they choose to be. We are receiving feedback from some accounts indicating they may prefer to manage this directly. Therefore, we are developing a version of the product that would allow certain accounts to conduct the readings themselves. Currently, we do not plan to work with any other companies beyond HeartNexus. We believe their scalability aligns well with our goals, but we are providing this option for accounts interested in handling that function on their own.

Timothy Cruickshank, CFO

I would just add that what's great about HeartNexus at our current stage of launch is their coverage across the U.S. For a company like ours, which is still learning about our usage rates, they can move quickly with us in these early days. They have an incredible team at HeartNexus, and they believe in this technology and want what's best. They are open to exploring various opportunities with us as we start to scale. Both of us are eager to expand as we continue to understand the demand.

Robert Eno, CEO

That's great context. They really are a great partner.

Unknown Executive, Executive

And regarding your commercial launch, are you looking or considering partnering with other companies as strategic partners to increase production or operational capabilities in any way?

Robert Eno, CEO

Yes, sorry, let me just, yes, absolutely. So, I'm just trying to make sure I can answer the question in the best way. We're definitely looking at all different types of strategic partners. We've talked a lot about that one of the areas we want to focus on is how do we scale most efficiently. And there's a couple of ways we believe we can scale efficiently, and that's with distribution partners or focusing on concierge and preventive cardiology chains. So, that from a sales and distribution perspective is one of the key things we're going to look into as we prove the concept and start to progress. We are open to and have had ongoing discussions with strategic partners in all kinds of different areas and are certainly open to exploring collaborations. We've talked about collaborations in the past on the AI algorithm side and the data side and even potential partners that could be co-development partners for some of the technologies that are in our pipeline.

Unknown Executive, Executive

Thank you. And that concludes our webcast questions.

Operator, Operator

I would like to turn the call back over to Mr. Eno for his closing remarks. Please go ahead.

Robert Eno, CEO

Great. Thank you, operator. I want to thank each one of you for joining the earnings conference call today. We look forward to continuing to update you on our ongoing progress and growth. If we were unable to answer any of your questions today, please reach out to our IR firm, MZ Group, who would be more than happy to assist. Thank you.

Operator, Operator

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.