HeartBeam, Inc. (BEAT) Earnings Call Transcript & Summary

Good afternoon, everyone, and thank you for taking the time. I know how busy all of your schedules are; we have a nice, concise presentation prepared for you, plus the agenda, which is visible to you. I'll walk through those items — the core technology, our highlights, heart attack detection, our first commercial launch, and the financials. If we could move to the following slide. Have we gotten to the next one — are we there yet? Yes, if you wouldn't mind, since I can't tell whether we've moved ahead to the following slide. Please just tell me, all right, that slide is showing. The thing that really fires everyone up at HeartBeam, as this slide makes clear, is that a heart attack strikes somebody every 40 seconds. The actual scope of that trauma can only be genuinely assessed through our TriCor signal capturing technology. So that we can get to as many of those patients as possible, we have built and trialed three distinct form factors, and each one takes its own unique approach. The card, as you are already aware, occupies the post-discharge space, where we believe a great many patients will take comfort in having a means of keeping tabs on their heart health. This patch works within the ER’s processes and the in-hospital tracking of cardiac patients who are at risk, sharply reducing how long it takes to capture a medical-grade 12-lead EKG and get that data available to read almost immediately. The HeartBeam remote unit meets the requirements for a device that patients can reach in distant locations. I’ll go over a bit more about this as the presentation continues. As you can see, the card appears at the far left, and this particular form factor is simply perfect for monitoring after discharge. So basically, when patients head home from the hospital and want reassurance, they need a way to check something, get a quick response through the 24-hour reading service, and receive guidance they can act on—they can figure out from that reading what the physician wants them to do. From my view, the on-demand patch is likely the most thrilling form factor; it's a device offering extended monitoring plus on-demand 12-lead capability, so it handles two things: 24-hour monitoring and, again, placing two fingers on those two electrodes—north and south, as shown in the picture—to obtain a medical-grade 12-lead EKG. This device is going to be aimed at ER departments as well as monitoring that happens in the hospital after a procedure. Take, for instance, someone admitted for an ablation, a person who arrived in the emergency room with a myocardial infarction, a patient recovering from cardiac surgery, or someone who has gotten stents. A lot of these individuals stay in the hospital a day or two before being transferred to a step-down unit. Imagine it this way: all that would be needed is a patch, and the nurse or physician could just tell the patient to put two fingers on those electrodes, and a true 12-lead EKG reading would be captured in near real-time. That fits the workflow and removes a great deal of time spent locating an EKG tech to come up from a floor, apply the sticky devices, and so on. In our view, this is truly disruptive to the whole space. You've heard us discuss the HeartBeam remote unit; that's a form factor which, once again, employs all of the same technology. This is the form factor we're presently using over in Indonesia, and we'll touch base on that, so we can give patients access almost anywhere they are, along with an understanding of what's happening with their heart health. Next slide, please. Okay. Yep, I have it. Turning to HeartBeam's foundational technology and platform: every medical device firm spends considerable effort building a protective barrier around its intellectual property. That is exactly what HeartBeam has done — we currently own 25 issued patents globally that cover our proprietary technology, the TriCor 3D signal reconstruction. In essence, we have the finest signal-capturing device available for interrogating an EKG signal. This presents us with huge opportunities to transform the way patients interact with their physicians and with their own personal cardiac health. As most of you are probably aware, this has been clinically validated. We have conducted many studies, which I will briefly mention. The FDA has given us clearance for arrhythmic assessment, and we're currently building the body of evidence that supports expanding into heart attack detection as well as future indications. In a minute I'll also give you an update on where that initiative stands. By now we've run hundreds and hundreds and hundreds of patients through our existing technology. We don't view it as a product. Naturally, we see what we're doing as a platform, since the technology is embedded into three different form factors; this opportunity tackles a fundamental gap in care by delivering clinical-grade 12-lead EKGs through multiple form factors. As far as we know, there's simply no other technology that does exactly what we're doing. We've put together this architecture—again, what we're relying on so our card can be utilized in the patch. Sorry, not the card itself; rather, so that our technology gets used inside the card, the patch, and after that within the HeartBeam remote. Moving to the next slide. When you review those key strategic priorities, the biggest one for us is heart attack detection. We are moving quickly on the initiatives related to the indication for heart attack detection. Regarding this particular initiative, our clinical validation work is running ahead of schedule. As this slide shows, a pre-submission is going to the FDA imminently. I’m glad to say that we did submit that pre-sub today, and we’re developing additional go-to-market and reimbursement plans as we collaborate with the FDA on obtaining clearance for heart attack detection; again, this will change how patients, physicians, and hospitals think about cardiac health. You’re also aware that our first commercial launch has begun; it is underway, and I believe you may recall that earlier in the year, we described this time as our learning phase and said that during the latter half of the year, we would begin gaining momentum in generating revenue. That is exactly what we are now doing. We're generating proof from actual deployments plus encouraging responses from doctors and patients — I'll say more about that shortly; that evidence is building a strong base for faster expansion. Concierge is an excellent vertical for us. Real demand exists there.

We have a large patient base—close to 2 million people enrolled in concierge services—and a significant portion of them are cardiac patients at elevated risk. Both the physicians and those patients want a solution that gives them confidence and lets them see their cardiac condition interpreted in real time. Now, about integrated network partnerships: as I noted a few weeks back, this is the effort where we approach large integrated networks, collaborate with them, and conduct pilots to learn how our technology could fit into their workflow. Two workflows draw particular interest. The first, clearly, is the emergency department, where people arrive experiencing chest pain—how might our technology be deployed in that environment? The second is the post-procedure setting, where patients stay in the hospital for observation—what's the best way to apply our technology there? As you know well, these integrated networks serve a huge number of patients. One we're in discussions with logs 50 million visits annually, and that figure doesn't include the emergency room. Emergency room visits number in the many millions, and interventional procedures exceed 100,000. From that single example alone, you can appreciate the potential of weaving HeartBeam into that workflow—removing steps, streamlining how they engage with the patient, and delivering real-time information. Next slide. I'll now update you on a few additional recent operational highlights. Next slide. As I said, the foremost thing we're pushing forward is heart attack detection. To us at HeartBeam—and I believe to the physicians and practitioners we talk with—this ranks among the most thrilling areas imaginable. A device you could wear or carry that delivers an actionable response when a patient has chest pain, determines whether it's a heart attack, and provides a reading in near real-time so that patient gets to the hospital—that transforms the equation dramatically. We know it's achievable, since we've conducted multiple clinical studies, which appear on this slide. We finished enrolling the ALIGN-ACS pilot study in under four months. When I say the technology is genuinely exciting, and that interest in it and uptake of it are genuinely exciting, this is the evidence. Any medical device company running a clinical trial is always striving to speed its completion—that's likely where the greatest focus goes once a trial is underway. We wrapped up in under four months. That shows you the enthusiasm is real. That's 134 patients who came into emergency rooms with chest pain, received a 12-lead EKG, and had that reading compared against the Heartbeam card. The results were outstanding. As a matter of fact, they met the requirements for acceptance at the TCT, taking place later this year in October and November, as a full presentation. Truly exciting data. With the HEADSTART-ACS pilot study, we have already gone past 50% enrollment in under three months. Once again, this shows how enthusiastic the physicians and nurses participating in this study are. It is a study of 500 patients. This is the one backed by the Indonesian government, assessing the accuracy, once more, of the Heartbeam ECG technology for detecting heart attacks in a real-world setting. Naturally, our hope is that this study will progress toward being incorporated into their workflow across their large hospitals and certain of their remote settings. That is simply an enormous market, with 280 million people in that market alone. In addition, we have an article forthcoming in JACC that further demonstrates that an algorithm combining the Heartbeam ECG device with patient risk factors and symptoms can accurately identify heart attack in patients. Again, an incredibly exciting study. As for the patch study, we started a pilot evaluating the patch in roughly 50 patients; it is also enrolling faster than expected at the same two hospitals where we conducted the ALIGN-ACS study; regarding the regulatory side, the results from all of these clinical studies are what we have been using in our talks with the FDA when discussing approval for the heart attack assessment indication. As I told you, the pre-sub has in fact been submitted as of today, and we are very excited about that; in this particular case, the FDA has 75 days after a pre-sub is submitted to respond to the company with additional information or not, and that starts the process that enables the company to proceed with a "pivotal trial." So we are very cautiously optimistic about what we have been able to achieve there. Next slide, please. Continuing with the Q2 2026 and some of the other highlights, we have obviously finished the working prototype for the 12-lead EKG patch; this is the first ambulatory patch device designed to help detect ischemia and complex arrhythmias. The patch market alone represents $2 billion in revenue. There is a video embedded into this particular slide, which unfortunately we cannot look at right now, but I would encourage anyone, later when you have time, to click on that video if you have not seen it and just watch it. It is only 50 seconds long. Picture how this patch would slot into the workflow inside the hospital as well as after discharge. But take the in-hospital setting: a nurse or a physician needs a reading on a patient being cared for in that facility, and all it takes is placing two fingers on those two electrodes — rather than tracking down an EKG tech, having them come up to the floor, obtaining a 12-lead EKG reading, and then waiting hours and hours and hours before actually seeing those results, as opposed to getting that information in real-time. Beyond that, I believe you may have spotted our press releases about the expansion of two new patents. Once again, these are two patents pointing toward the future direction we envision for our technology. One covers acoustic sensing, and the other covers fluid monitoring. Acoustic sensing, now, is a means of interrogating information that would give us insight into how the heart's valves are performing. And the fluid monitoring capability relies on impedance to establish whether a patient's fluid is rising; and as a lot of you probably know, among congestive heart failure patients, that is the big gotcha. A patient eats a bag of potato chips, becomes overloaded with fluid, calls 911, and gets rushed to the emergency room. But if at home they could figure out what the situation is, thanks to our reading service and their physician, chances are they could titrate their drugs right then and there. So those are two future aspects that are very exciting for our technology. Next slide; on commercial traction, and I'm going to work through this slide from the left to the right.

As you’re aware, we brought this product to market commercially. Now, a commercial launch of something like this may sound straightforward, but building in the full end-to-end 24-hour reader service, the onboarding workflow, and delivering customer success at that level is an enormous effort—and we’ve managed to accomplish it. That round-the-clock, 24/7 reader service is a major point of differentiation for what we offer, and it’s something both physicians and patients genuinely appreciate. So right now we’re working directly with practices on this rollout, planning workflow integration and implementation processes alongside those concierge practices we’ve already signed up. Moving to the right—as you know from Brian, and I should mention Brian would be on today’s call covering this slide, but he’s away on a college-visit road trip with his daughter—we already have multiple agreements in place that cover all 4 of the initial target markets we care most about. Those are listed there: New York, Dallas, South Florida, Southern California. The first orders have gone out, and the initial patients are being onboarded right now. And I can tell you we’re seeing genuine early traction in this area. As you can imagine, here’s how the process works in concierge practices: the doctors, the nurses, and a couple of select patients receive the device first. They observe how it functions. Are the readings accurate? Are they sharp? Is there any disruption to the workflow? Once they clear that stage—which is usually pretty brief, around two weeks—the next step is reviewing their patient pool and identifying which patients would benefit most from having the HeartBeam technology. That’s where we stand today. By the end of Q3, you’ll see what I’d describe as an increasing magnitude in order flow. Embedding HeartBeam into those workflows matters a great deal, and we’ve built a program that integrates HeartBeam into new patient intake at the concierge practices. This is one of the things concierge physicians are highly interested in: a patient arrives, and right at the outset, that patient can be connected with HeartBeam immediately—and we believe that will actually speed up adoption. Over in the far right-hand corner, we’ve chosen these practices strategically, and we’ll keep contracting with them. Brian has a strong and extensive list, and in a moment you’ll see a short testimonial from one of these practices about how they view our technology. Next slide, please. What have we learned over the first six months of the process we’re in now? The EKG quality. Not one physician who has seen or used the HeartBeam technology has failed to be absolutely impressed by the quality of the 12-lead EKG from a pocket-sized device. Honestly, I'd say they're genuinely blown away, since nothing quite like this has ever come their way. Everyone understands that 12-lead is the gold standard, so receiving that level of quality is genuinely striking. As a result, patients feel the same way, correct? Patients have said they're at ease getting the identical caliber of ECG they'd get at a clinic or hospital. Patient engagement, and how patients have been onboarded throughout this process, with them drawing comparisons between an EKG technician attaching every lead versus simply taking the card, holding it against the chest, placing 2 fingers on the electrodes, and obtaining a real-time 12-lead readout visible to them, to our 24-hour service, and to the physician — that has genuinely unlocked the opportunity in a simply massive way. Next slide, please; here's the physician perspective. Dr. Ram practices at the particularly large Generational Health in Beverly Hills. Previously, he served as chief of cardiology at Cedars-Sinai. He's a top-tier physician. I won't go through every point on the right-hand side. Once again, I'll direct you to what he said. "Having a 12-lead device in your pocket is amazing. This is the thing we've been waiting for." What he truly values about the technology is having a baseline with the HeartBeam, so whenever one of his patients experiences an event or a symptom and he receives a new reading, it gets compared against that baseline, which lets him genuinely grasp what's happening with his patients and respond suitably with some form of actionable event. That's simply essential for this type of service. Next slide, please. This is Jerry. Jerry — you could say Gene personally picked this individual. An 85-year-old patient, an Air Force veteran. He stands for the at-risk cardiac patients, roughly eight million of them across the U.S., a solid 2 million within concierge practices. This is someone who views the HeartBeam device as part of his quality of life. You can see what he said. "When I take a HeartBeam recording because something feels off, there's an instantaneous readout to my doctor. I don't need to wait hours or days." How much does that matter to this kind of patient? Then he continues in his own terms. It's a piece of cake to use, even for himself, who is not, shall we say, technology astute. But he goes on to say that every morning he checks his blood pressure, and every morning he gets an EKG reading, and that gives him comfort. And he represents just one of millions of patients whom our technology is going to impact. I'm going to stop there. I'm going to turn this over to Tim on the financials.

Thanks, Rich. Those are some solid updates. Now let's turn to the Q2 2026 financials, and we'll start with cash flow. Cash used in operations for the quarter came to $3.3 million in net terms. That represents a 7% reduction in operating cash outflow versus Q1 2026. It also marks a 3% decline from the comparable quarter a year earlier. Throughout the year — and especially during this latest quarter, Q2 2026 — we kept an intense focus on maintaining a disciplined cost structure. We're continuing that work as we absorb the learnings you saw on the commercial launch side and as we push forward on key initiatives such as heart attack detection and our other strategic efforts. During the past quarter we identified ways to boost efficiency and accomplish more while using fewer resources. A few illustrations: we worked to scale back and put on hold contractor projects that did not tie directly to our key initiatives. Wherever work was tangential rather than directly connected, we were able to shut certain projects down. We keep finding efficiencies throughout the company by leveraging AI tools. It's remarkable what the team accomplishes, spanning R&D, coding, and many other areas. Company executives and employees chose to take shares rather than cash when settling the 2025 bonus program. That trimmed our operating cash outflow by slightly more than $1 million, and it also speaks to how dedicated our team is and the enormous upside we all perceive in this opportunity — everyone wants to align with shareholders in every way they can. We wrapped up product development on our credit card-sized device, the HeartBeam System. We also finished developing the prototype 12-lead patch. Those represented major expenditures over the past several quarters, and now they're essentially done, which will keep helping to bring our cost profile down. All of this means our baseline Q4 2026 operating cash flow drops to roughly under $2.5 million per quarter. In Q3, we'll see some added noise tied to the leadership transition, plus a few final cash-related payments stemming from the contract changes we made. Once we reach Q4, you'll see it step down to that sub-$2.5 million level. It's truly impressive how the team has managed to accomplish as much as possible with the fewest resources. Two things to keep in mind regarding that sub-$2.5 million figure for Q4: the timing of when we begin the pivotal study for MI, and how quickly we enroll patients, could push us above that baseline spend — but that would be a wonderful problem to have. Based on what we're seeing with enrollment times across our two current MI studies and our collaborative work with the FDA, things are trending quite positively, and we expect to be spending into that trial before the year is out. Cash coming in from customers during the back half of the year will partly counterbalance that spending, as we begin to see the first effects of our commercial launch on both revenue and cash across the coming six months. There are a fair number of puts and takes on the baseline spend, but those are roughly the two main factors. Overall, we are trending toward finishing below $14 million in operating cash outflows for the full year of 2026. During our prior call, we mentioned the capital raise we closed in April of 2026 that bolstered our financial position, an $11.5 million common stock-only financing. As of June 30th, after accounting for the quarter's spend, cash equivalents and restricted cash came to $8.8 million. And now, given our lower cost structure, we have pushed our cash runway somewhat further into 2027 than we had previously suggested, and we will keep looking for ways to stretch it even more. Let us move quickly to the next slide; net loss for the quarter was $5 million. In Q2 2026, net loss, net loss EPS and net loss all matched our expectations directly. One thing worth flagging about net loss, and the reason for this slide, is the box at the bottom right: roughly $0.9 million of one-time items sit inside that $5 million net loss figure, both tied to the leadership transition we announced earlier. There is $600,000 of non-cash stock-based compensation stemming from vesting of awards and equity connected to the former CEO, plus $0.3 million tied to a severance accrual owed to the former CEO. Since those two items are one time in nature, that implies an underlying net loss for the quarter closer to $4.1 million. Absent the one-off items, that would represent a 12% decrease versus the prior quarter and a 17% decrease versus the same quarter a year earlier. Just to illustrate the early signs of how net loss is declining over the remainder of this half year, work already underway in the prior quarter, there will be plenty of evidence of that by the time we reach Q4; in summary, we keep gaining organizational efficiencies, doing more with less. In Q2 we concentrated on gathering learnings from the commercial launch and on finding ways to speed up key R&D and strategic initiatives, namely what Rich took you through regarding the heart attack detection program; these efforts had the coupled effect of extending our cash runway and very likely meaningfully shortening expected timelines tied to that heart attack detection program and indication expansion. Over the rest of this year we will keep making steady progress on these fronts, as well as with our initial commercial rollout; with that, Rich, I will turn it back to you.

Alright, thank you, Tim. Looking at the summary slide, I just want to briefly recap the points I covered. There's a truly enormous opportunity sitting right in front of us. HeartBeam stands right at the forefront, armed with technology that genuinely aligns with what physicians, networks, and patients alike are seeking. This is a validated technology backed by remarkably robust IP and a clinical evidence base that keeps expanding — something I've mentioned in connection with the trials and the published papers. I can't emphasize enough how significant the proprietary TriCor technology is. What I mean is, it lets us accomplish things and pull a patient's signal in ways that competitors simply are unable to match. The signal's richness is precisely what drives the difference in interpretation quality. It will also matter for upcoming improvements in how that signal-capturing technology gets used through AI and other approaches. When you look again at the card and the patch shown on the right, consider just how big an impact that will have for a great many at-risk cardiac patients; this technology accomplishes what other technologies today cannot do in a wireless format. Tim has already covered the capital-efficient strategy built around our core priorities. We'll remain committed to those core priorities. That's where our focus lies. Heart attack detection is hugely disruptive. We're quite confident in how our technology performs against a standard 12-lead EKG. Naturally, the clinical studies have demonstrated that, and the papers accepted so far have been of exceptionally high quality. And at this point we have the submission to the FDA, the pre-sub, and clearly we'll be in ongoing dialogue with them, but ultimately we'll be progressing toward approval via clinical trial, hopefully by year-end. On the initial commercial launch, I think I've already addressed that. Brian has described how we're rolling it out. Green shoots appear there, and we fully expect this to speed up now that we have a solid process and an intake strategy in place with these concierge services. I'm personally quite enthusiastic about working in the integrated network partnership arena. I believe there are so many hospitals and rural hospitals, but large networks too, where the patch and the card combined through the emergency room and post-procedures will genuinely transform workflow inside a hospital. It'll help the hospital in numerous ways regarding its own cost structure, but it'll also greatly help patients, because being able to obtain this information in near real-time is so essential for making decisions about a patient's health or whether further intervention is needed. So I'll pause there, and I believe we're going to open things up for some Q&A, and I'm happy to elaborate on any questions anyone might have.

Good afternoon, and thanks for taking my question. To start, a fairly comprehensive look at the company and its commercial position. Not long ago, in a press release, you brought up a strategic move toward, alongside your direct sales of medical devices, putting emphasis on licensing out the data generated by your synthesized 12-lead ECG. So perhaps you could give a bit more detail about which kinds of partners you're going after, which applications you expect to be most commercially appealing, and then how a successful licensing relationship would look? Thanks.

Yeah. Thanks for that question. I'd say licensing may have been somewhat of an overstatement, since it's built into essentially the concept and the initiative of collaborating with integrated systems to bring our technology into their workflow. That's what I meant when I referred to licensing. It's more a partnership than a pure licensing of the technology; we haven't done much work in the sense of a license in the strictest sense; what we're doing is partnering with those networks where the technology could be folded into their workflow. Now, that said, and still to be determined, what we're doing with the Ministry of Health in Indonesia could, in fact, amount to a licensing strategy, but that remains to be determined until we complete the trial and get into further discussions with them.

Okay, I understand. Great. And then maybe as well — I know you said part of that involved wanting to speed up adoption globally. Besides the trial that's happening in Indonesia, which other international markets are you putting first?

Well, frankly, at this moment the only thing we're putting first is the work with the Ministry of Health in Indonesia, since I believe that holds the key for us in terms of how that one form factor could fit into other settings outside of the U.S. We're going to use that to get to first base — understanding how that technology has been implemented in that particular, very, very large population of people — and then we'll move on from there. So we'll keep that one-

Got it. That's clear.

Where it stands. Yep. We'll keep working on that one. Apart from that, everything we're focused on is in the U.S.

Right, got it. So perhaps just one final question, going back to the U.S. and your initial commercial rollout to the concierge practices. Could you maybe talk about how large that opportunity is, and perhaps how many patients you've calculated fall under that umbrella of concierge or preventative cardiac care?

What does that runway look like? Where's the break even, maybe?

Yeah.

In the next, say, 12 months, what number of patients do you figure you could onboard? Thanks.

Sure, I can give you that — and Tim, feel free to jump in if I'm off base, since I don't have that figure right in front of me — but my understanding is that the concierge practices we're discussing have 1.9 million patients embedded in them. That's a big volume of patients. Naturally, not every one of them is what you'd call a "cardiac patient." But you can imagine that around 20% or so of those, or even more, are probably cardiac-oriented patients, somewhat like the Generational Health patient, Jerry. He's seeing increasingly more of that type of patient. So that alone is a really, really attractive market, correct? That's hundreds of thousands of patients who could actually get value from the HeartBeam technology. Now, what I think you're really getting at is how quickly we can roll it out. Well, we're figuring that out right now. The ones we're working with are relatively large concierge practices, and we're currently gathering the metrics on how many patients in each of those practices would be applicable for what we're doing. But broadly speaking, I think by the end of this year we'll have very good visibility into how rapidly 2027 can basically grow. Still, I can tell you that the green shoots we're seeing, along with the enthusiasm and excitement from those we're dealing with, look quite reasonable to me.

All right, fantastic. Then purely in terms of manufacturing, would you already have what's needed for the ramp all the way through 2027?

Yeah. That's correct. Okay, wonderful. Sounds good. Thanks a lot for answering every one of my questions. I'll get back in the queue.

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