iRhythm Holdings, Inc. (IRTC)
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44th Annual J.P. Morgan Healthcare Conference

Jan 12, 2026

Allen Gong
VP and Equity Research Analyst, JPMorgan Chase

Okay, thanks everyone for coming today. My name's Allen Gong here on the JP Morgan MedTech team. I'm really excited to have the management team of iRhythm here today this morning. We're going to start off with some prepared remarks from CEO Quentin Blackford, and then we're going to tag in Dan Wilson, CFO, for some Q&A after that. So Quentin, if you could start us off.

Quentin Blackford
CEO, iRhythm Technologies

Terrific. Can you guys hear me okay? Thanks for having us, Allen. We appreciate the opportunity to be here. We're excited to be here coming off of an incredible 2025 for iRhythm, and we're looking forward to an even more exciting 2026. As we look ahead, just a quick reminder, I will be using forward-looking statements during the course of this morning's presentation. I'd refer you to our company website, company filings, for any further information that you might be looking for there. When a signal changes everything, when we talk about signals in arrhythmias, we're not talking about just any one particular thing. Signals show up in a variety of different ways, and it's the complexity of that that creates the challenge for players in this space. For us, it also becomes the opportunity. We think about how these signals show up in practice on a daily basis.

Sometimes it's a story like Carissa, who finds herself dealing with severe health issues, only to have an EKG performed and told her that everything's perfectly fine. She's sent home, no issues. She finds herself back there less than a week later, again, another EKG performed, told that everything's fine, but this time she's sent home with a Zio, and we find over the duration of monitoring during those 14 days that she does, in fact, have a very dangerous arrhythmia that needs to be dealt with and treated, or we find a story like Julie, who has all the symptoms in the world that would indicate an arrhythmia is present, only to find out after monitoring for 14 days with Zio that there are, in fact, no arrhythmias present. We can rule out that we need to put her down that pathway.

Or somebody like Woody in the upper right-hand corner here, by all means, a very healthy individual, very active individual. He's in his 60s, outgoing, loves to golf, would never have suspected that there was an arrhythmia present, but his physician and his annual physical decided that he should wear a Zio, and we find out that he does, in fact, have arrhythmias underneath the surface that are lurking that need to be treated. Or more recently, in our efforts to move towards predictive capabilities, we're starting to take our 3 billion hours of heartbeat data, couple it with external medical records and data sets, and find in those medical records where patients likely have arrhythmias but have never been diagnosed before, and in this case, Louise, we find out that she does, in fact, have arrhythmias.

Somebody who would never have been monitored had we not identified through the proactive approach of looking through medical history files and finding those folks. The reality is an asymptomatic, reactive approach to monitoring for cardiac arrhythmias is not sufficient. It's why we have 27 million folks in the U.S. alone today who are undiagnosed with cardiac arrhythmias. We have to change that, and we are changing that. That's how iRhythm is changing the game. This is our 20th year as a company, our 20-year anniversary. We've had an incredible impact. We've been a terrific company in terms of addressing an unmet need in the marketplace. But the reality is the market is coming together with two forces converging at the same time. On the one hand, we've got demand that is growing tremendously. You've got an aging population.

You've got a silver tsunami of folks moving into the Medicare-aged population. We've got data that's telling us more and more every day that these arrhythmias are showing up in younger populations. You've got technology that's advancing with tremendous success, like PFA, that needs to be monitored both pre and post. You've got to move towards value-based care, population health. All of these things are lining up very well for the iRhythm story, and we meet the need in this very significant way. But at the same time, we have an access issue in this marketplace. There's not enough cardiologists and EPs to see the patients that need to be monitored. Nearly 50% of all counties in the U.S. alone have no cardiologists. That climbs to nearly 90% if you go into rural communities. We have to change the way we think about monitoring.

This is why moving to primary care is so important. It's a big effort on our part, and we're having tremendous success as we open up that channel. When you think about who iRhythm is today, we've got really three pillars that we focus on as we build out the platform of our capabilities. We've got a biosensor aspect to it, where we've got a wearable device. Patients today will wear that device for 14 days at a time. We'll record every single heartbeat. Most of our patients will wear it the duration of 14 days. On average, we get 13.8 days out of wear out of each patient's experience with us. We'll capture nearly 1.5 million heartbeats from that patient, and then we'll leverage the power of our AI.

We're on our second generation of an FDA-approved algorithm to comb through all of those heartbeats that we capture and identify with precision exactly what's going on. 99% of all of our physicians will agree with the findings that we put into the reports that we provide back to them. We've now got our third-generation algorithm in the hands of the FDA. We're excited by what that brings for us into the future and looking to get that into the market. And then we bring that all together in a digital capability, a digital workflow, a digital ecosystem, ZioSuite, which makes it very easy to prescribe for physicians, but also monitor the patients throughout, and then in the final report, prescribe, diagnose off of it, and store that in the EMR. It's a highly unique, differentiated capability.

More than 50% of all of our volume in the company today now flows through integrated accounts, and nearly 80 of our top 100 accounts are now fully integrated. A snapshot of who we are from a financial perspective and the market opportunity ahead. We'll deliver more than $740 million above the high end of our guidance for 2025 revenue. Notably, we'll also be profitable for the first time in the company's history and, importantly, free cash flow positive for the first time in our company's history in 2025, both meaningful milestones for us. Yet at the same time, we only have about 40% of the overall ACM market as we define it today, which in the U.S. is about 7 million tests being performed. In the international spaces that we're now in, just the countries we serve, there's about 3.2 million tests being performed.

We have less than 1% of that market opportunity. But we believe the market is very different than how we think about it today, particularly as you open up the ability to monitor for undiagnosed, unaware, the asymptomatic population. In the U.S. alone, we believe there's 27 million folks, the majority, which overlap with comorbid disease states, and I'll talk about this in a bit, that we need to go find, that we need to identify proactively, diagnose, and then get the proper treatment to avoid the downstream cost that these patients bring into the healthcare system. And then finally, we have a tremendous amount of research that stands behind our product. We've got more than 135 research manuscripts that have been published, nearly 40 of them independently peer-reviewed. We have no issue letting the data sort of stand behind our product.

We publish more data than any other player in this space. It's a competitive advantage for us. Here recently, the CAMELOT, the AVALON studies, the two of those have been meaningful as we sit down with payers, and we can show through head-to-head analysis that Zio is, in fact, better than the competitive players in this marketplace. Faster time to diagnosis, higher diagnostic yield, lower healthcare resource utilization. When we think about the market, today we serve a market of roughly 10 million tests being performed each and every year. That consists of 7 million tests in the U.S. and 3 million tests outside the states, just in the markets that we're serving. So there's six countries that make that up. However, we believe the future looks very different. So back to the market expansion, we think there's a near-term opportunity of roughly 30 million tests.

That's represented by 27 million undiagnosed folks that we believe exist in the U.S. alone and the 3 million tests in the international space in the markets that we serve. We think about the drivers of how we will continue to grow our business and where that growth comes from within the core market. Today, we've got about 72% market share in the long-term cardiac monitoring space. Think about that as patch-based monitoring beyond sort of three days. We target 14 days in everything that we do. That's the majority of our business. But we have 72% market share in that segment that's growing high teens. With that, we believe the majority of the undiagnosed population, the 27 million folks that are out there, ultimately will be monitored with a long-term patch. That is the ideal way to find these folks.

We know that 65% of all arrhythmias are found after 48 hours of monitoring. Short-duration monitoring simply just does not work. It does not meet the need. And you think about it, though, there's still nearly 2 million short-duration tests that are being performed in the U.S. marketplace every single year. That's a $500 million market opportunity for us to continue to go after. We will continue to take share in that space, and we're having great success with it today. Another really exciting opportunity for us is in the MCT space. So within this category, there's about 1 million MCT procedures being performed. Today, we've got about 15% market share within that category compared to the 72% market share in the long-term cardiac monitoring space. The reason for that, more than anything else, is first, we came into it as a follower.

We led with LTCM, and then we brought a product into the MCT space. That's what we call our Zio AT product. Frankly, that product is not as competitive as it needs to be. We know there are some gaps relative to the competitive offerings. We only monitor out to 14 days. Physicians are looking for a longer duration of monitoring, wanting to get out to north of 20 days. We're addressing those with the product that we have on file with the FDA as we speak, which I expect will be making its way into the market in 2027. We'll talk more about that in a slide or two. But for every 10 points of share that we can capture in this MCT category, it's roughly $80 million-$100 million of incremental opportunity to us on an annual basis.

Again, I don't think we get to 70% market share in MCT. The majority of our competitors, this is where they play most significantly, but I do think we can move that to 20%, 30%, 40% market share, which represents a significant growth opportunity for us and then finally, on the international side, just again to reiterate, we're in six countries. We have less than 1% market share in the countries that we now have entered into in a market that's serving up three million tests each and every year so tremendous opportunity to grow in that particular area. I talk about moving into the undiagnosed, asymptomatic space. I talk about the capacity constraints of the existing system, some of those structural challenges. The only way to address that is to continue to move up the care pathway into primary care.

We're having an incredible amount of success in doing that. We began this effort several years ago to open up the primary care segment. If you look at it, total claims across the entire marketplace, more than 20% of prescribing is now coming through primary care. The vast majority of that is being led by iRhythm. So for us, well over a 1/3 of our business comes through the primary care channel. It is, in fact, opening up. This is a great leading indicator of where things are going. Primary care is comfortable prescribing, comfortable diagnosing. If they aren't comfortable diagnosing, through the ZioSuite tool, we can bring virtual capabilities to the forefront that can help them get to a diagnosis, and it helps them understand where they're going to route their patient through their health networks in terms of where that care journey goes.

We're approaching primary care in two different ways. Sometimes we get asked, are you looking to build out a significant primary care commercial force? We are not. That is not how we're approaching this space. We've come at it in two ways. One is we leverage the relationship we have with our cardiologists and our EPs and the large independent health networks that we're already in. We're in the vast majority of these across the nation. These cardiologists, these EPs will bring primary care to the table, to educate them, to inform them of how easy it is to prescribe. In some cases, in these large networks, primary care will prescribe. The report will get published and produced into ZioSuite. The cardiologist, the EP will come into the digital tool. They'll read that report. They can diagnose electronically and then determine where that patient's going to move throughout their network.

It's becoming what we like to call a rule-in and a rule-out tool within these large networks. The other approach that we're taking is through large national accounts. We call them innovative channel partners. The majority of these are large national primary care partners that ultimately we contract with at the very top level, sort of a central point, and they push us down through their national networks. So from a sales rep perspective, we're able to cover the entire country quite well. This approach for us, as we've done the math, we think we can approach roughly 65% of all primary care physicians with this approach. As I think the momentum grows and the awareness around prescribing and primary care grows, I think word of mouth is going to continue to pull more and more folks into here.

When we think about how we're approaching these innovative channel partners, the majority of these programs that we're launching, and this has been a significant growth driver for us over the course of 25, most of these folks will target these comorbid disease states. So the overlap of arrhythmias within type 2 diabetes, within CKD, CAD, COPD, sleep, heart failure is enormous. And so when these innovative channel partners start with us and really target an unaware, undiagnosed population, usually it's in one of these disease states. And they'll start in one of these, and then they'll start to branch out into other particular areas. We know that arrhythmia folks within these disease states, when there's overlap, are incredibly more costly for the payers to manage. Hospitalization rates are incredibly higher. Length of stay in the hospital is incredibly higher. Visits to the ER are incredibly higher.

We know we can bend the curve from a cost perspective if we can find these arrhythmias before they result in a patient showing up in the emergency room. What's really fascinating with this approach is the accuracy at which we've been able to identify these patients in these large channel partner programs that likely have arrhythmias and then get a patch onto them and find out that they do, in fact, have an arrhythmia that the clinician would find relevant, that they would make some sort of decision from. We started to partner with a company. We made an investment in an AI firm by the name of Lucem this last year, combining our 3 billion hours of heartbeat data together with external medical records, history files, other indicators.

And what we've been able to do is produce algorithms that can very proactively go into a patient population with these partners, look across it from a digital perspective using the power of AI, and identify who we think, which patients we think in their population likely have arrhythmias, and then we get a patch on, proactively monitor. And what we're finding is more than 85% of the time we're accurate. That, in fact, where we think arrhythmia is present, there is an arrhythmia present. And again, these are folks who have never been diagnosed historically. It's a game changer. It's getting a lot of traction. We're actually starting to see this move beyond just the innovative channel partners into some of these health networks that we're partnering with, where they're wanting to launch the same sort of approach within their comorbid disease states in the populations that they're managing.

MCT, I talked about this. This is an incredibly exciting opportunity for us. Again, we've had great success here. Probably 15% market share in this category today compared to 72% market share in LTCM. But the reality is our current product just is not as competitive as we need it to be. The new product that we have on file with the FDA as we speak will move to a consistent common form factor as our long-term cardiac monitor. So it's going to bring with it a much better patient experience. It'll go out to 21 days versus the 14 days that we have today. What's interesting today is most MCT, competitive MCT products, when you look at the duration of monitoring they're getting, they're only getting around 14 days themselves.

And that's because you're changing patches or the physician will find what they were looking for earlier and won't patch third or fourth. With our product, you're going to get a full duration of 21 days. You're going to get a lot of data to analyze through that the AI work and we believe produce superior outcomes. Excited to get that through. Again, so with the FDA as we speak, expect that this will be a product that you'll see us bringing to the market in the 2027 timeframe. International, another big opportunity. We talk about being into the U.K. We've been there for a few years now. It's growing incredibly well. Japan, we just entered into that market, second largest market in the entire world, 1.6 million ACM tests being performed each and every year. We're about seven months into that effort. Tremendous progress so far.

In both of those countries, we're working through reimbursement as we speak. So we decided to go into those markets underneath the Holter rate code while we work directly with the government agencies there to get a more favorable rate established that we can work with into the future. In the EU countries here in the center, these four countries have very favorable reimbursement. And that's why we chose them out of the gate. Good progress in the early stages of launching into those markets as well. I talk about AI. I mean, at the end of the day, AI is what sets iRhythm apart. And what I find really fascinating and exciting about the future of our company is historically AI was really embedded in the product itself. It's how we really look through the heartbeat data that came off of the patch.

But we're starting to leverage the three billion hours of heartbeat data that we have connected with external data sets that can get us to the point where we're starting to become much more predictive in identifying where these arrhythmias exist, particularly in comorbid disease states, but also finding other health factors that are very interesting to our payers and our partners. Getting to the place where we can predict the onset of AFib. If we don't see it in the patch that you're wearing today, we can see through the markers you're likely to have it in the next six months, 12 months, 18 months. If you've never been diagnosed before, where we can predict that you likely do have it, need to be monitored. Opening up opportunities in sleep, hypertension, other adjacent markets.

These are all things that AI is opening the door for us and we're excited about into the future. Which brings me back to the platform. We're really investing in every one of the pillars of this platform. So when you think about it from a hardware perspective, excited by what we're moving forward with MCT alongside our long-term cardiac monitor. We're adding other sensing capabilities onto it as we speak. So we're bringing PPG onto the sensor. We'll shortly have SpO2 capabilities, hypertensive capabilities, heart rate variability, respiratory rate. All of these things open up new opportunities to diagnose other disease states as we move into the future.

And then on the AI side, I've talked about it a few times, just connecting our data sets with external data sets, leveraging the power of AI and the massive information that we do have. I think puts us in a really unique position to continue to advance there and then continue to drive integrations and workflow efficiency. It's so critical. If you're going to move into primary care, the workflow burden has to be incredibly light. And we're focused on how we can make that as little, as light as possible. We talk about EHR. We announced a collaboration with Epic a little over a year and a half ago. We know the power of integrations. When we get fully integrated with an account, we usually see volumes increase roughly 20%-25% post-integration. Epic is not the only system that we're working with.

We work across all EHR systems, but our goal is to be integrated with every one of our major customers. Again, I said it earlier, 80 of our top 100 accounts we're now integrated with. Nearly 52% of all of our volume is flowing through these integrated systems. Comprehensive evidence generation is another thing that sets us apart. Last year was probably, well, it was a record year for us in terms of evidence generation. We had nearly 28 publications that came out, continuing to articulate the difference between Zio and any of our competitors. We're publishing head-to-head data. We're showing through review of medical history files, whether that's with CMS and claims, commercial claims that we've far and away superior from a head-to-head perspective, diagnostic yield, time to diagnosis, healthcare resource utilization.

We're also showing in these comorbid disease states that if we can identify an arrhythmia earlier and prevent one of these patients who might have type 2 diabetes as an example from ever making their way to the. We're going to save that payer roughly $17,000 per patient. Or for every 1,000 patients we can find, it's roughly $15 million-$17 million of savings. That's getting a lot of attention from these payer partners and then sleep. We've talked about sleep for a little over probably two years now. We're now launching into sleep with dedicated pilots. We've got over 40 pilots that are now launched with accounts early, early in the effort here, but very pleased with the early indicators of the success that we believe we can have here. We know that over 20% of our current prescribing physicians of Zio are prescribing home sleep tests.

We believe, right through the integrations that we've built, a seamless workflow that we can make it very easy for these folks to ultimately look for sleep disease at the same time that they're looking for cardiac disease. Nearly 80% of all folks who have AFib have obstructive sleep apnea or sleep apnea. There's a tremendous amount of overlap. There's a real opportunity to win here. We're excited by what we're finding in the early stages here, and this will continue to grow over the course of the year. Just looking back on 2025 as I wrap up, obviously just a tremendous year for the company. We saw growth accelerate across every aspect of our business, the core business, innovative channel partners, MCT, international. Every one of those segments of the business grew quite nicely and accelerated from where they've been in the past.

Again, more than 50% of all volume now moving through integrated accounts. That's incredibly important to us. We think about FDA remediation. We don't talk a lot about it now because it's behind us. We spent a tremendous amount of time over the last 18 months really focused on addressing the questions of the FDA, making sure that we got a quality management system that is sufficient, if not above and beyond the expectations that they have with us. We've completed all remediation activities. We're now in the process of having a third party come in and audit ourselves, which we're more than happy to share with the FDA findings that come out of that, just demonstrating that we are holding ourselves to a different standard, and for the most part, those things are in our past.

And then I would just say from a financial perspective, a tremendous year from a profitability perspective. Again, first time in the company's history that we'll be profitable from an adjusted EBITDA perspective, first time that we will be free cash flow positive as well. Excited to see that and see that continue to grow into the future. So think about 2026. We put out expectations this morning, which more or less reinforced where we were at a little over a quarter ago. Again, we'll deliver in 2025 north of $740 million in revenue. We expect $870 million-$880 million in revenue in 2026. That's about 17%-18% growth off of where we expect to finish this year.

From a profitability perspective, we expect to be around 11.5%-12.5% adjusted EBITDA, which continues to be roughly 300-400 basis points of improvement, demonstrating the significant leverage opportunity that we have in the P&L as we continue to grow, but importantly, still make the investments that will open up the new market opportunities for us into the future. I'll wrap with this. I think iRhythm's in a terrific position. We're in a wonderful spot when you think about where the future of healthcare is going, aging population, value-based care, population health, younger generation wanting to more proactively manage their health. These are all things that accrue very well to where iRhythm is positioned. We've got several core markets that are expanding as we speak, 27 million folks undiagnosed. We've got several new adjacent markets like sleep, hypertension that really excite us.

Then we've got international opportunities as well, where we're very early, less than 1% market share. Of course, doing all of this while focused on the bottom line, making sure that we do it in a profitable way with a clear path to 15% adjusted EBITDA margins that we put out as we approach $1 billion in revenue. I think there's a potential for the company to get into the mid-20s. You'll see us talk about that once we get the historic goal of 15% achieved and set our sights on something new in the future. Thanks for your time. Allen, I'll turn it over to you. We can jump into Q&A.

Allen Gong
VP and Equity Research Analyst, JPMorgan Chase

Thanks, Quentin. I guess just to start off, you pre-announced the results today. I also provided initial 2026 guidance. So just looking at the $740+ million , there's obviously a lot of room up there. And we'll find out more about that in February, March, I imagine. But just for that record volume comment, can you help us break that down between Zio Monitor, between Zio AT, between innovative partnerships and other drivers? What drove that record volume quarter?

Quentin Blackford
CEO, iRhythm Technologies

Yeah, that volume continues to be strong, Allen, across really every aspect of the business. The core business is growing incredibly well. We had several large competitive conversions early in the year that continue to contribute very, very well and grow nicely. We continue to sign up more innovative channel partners in the fourth quarter, which quite honestly, I suspected, and it did slow a little bit from what we had seen in a prior couple of quarters.

But as you came into the holiday period, from the last time we spoke with you guys, we shared that we were at 18 innovative channel partners. That continued to grow, but that grew through the holiday period. Most folks aren't going to turn on those programs in the middle of holidays. They'll wait to the new year. But we did see continued progression within the channel partners, which was very nice to see. And I think AT, it continues to demonstrate there's a real opportunity in that market to capture share, whether that's new accounts that are coming on, prescribing both long-term cardiac monitoring, so Zio Monitor and Zio AT at the same time, or even legacy monitor accounts that are beginning to prescribe AT as well. There's a lot of great data out there that would articulate our AT product is as good as anything else out there.

We understand some of the customer feedback in terms of what they want to see enhanced in the product. We're committed to getting that to them with the new product that's with the FDA now. I don't know if there's anything else, Dan, you'd add. It was across the board, Allen. It was a strong quarter.

Allen Gong
VP and Equity Research Analyst, JPMorgan Chase

Looking at the guide that you provided today, I believe $870 million-$880 million, around 17%-18% growth. We'll have to see where that falls once you get the final numbers. You had previously talked to around 16%-18% growth. This comes in a little bit better than that. One of the drivers that I definitely want to touch on a bit more is on the pricing side, especially with physician fee schedule updates.

But just what gets you a little bit more bullish and what's keeping you conservative into the new year?

Quentin Blackford
CEO, iRhythm Technologies

You want to take it?

Dan Wilson
CFO, iRhythm Technologies

Yeah, sure. You did note price there. So when we originally kind of provided that preliminary 16%-18%, there was some CMS pricing benefit factored in. What ultimately landed was a bit better than that. That is contemplated in the 17%-18% that we gave today. And then from an absolute dollar standpoint, with 2025 preliminary results we provided this morning, obviously that absolute number going up as well. And similar to Q4, really good momentum across all of those different vectors. You've heard us talk about this many times as we set guidance. We want to put in what we have high confidence in, certainly our core business and the momentum maintaining there. AT continues to grow really, really nicely for us.

And innovative channel continues to open up in a meaningful way. There is some lumpiness to that part of the business. So we'll be thoughtful in terms of what we bake into guidance there. But all of that's factored into the numbers we gave this morning.

Allen Gong
VP and Equity Research Analyst, JPMorgan Chase

Got it. And then when we think about the innovative channel, right, you had mentioned that you'd reached 18 heading into the holiday period. I think you had added around six in the third quarter. It sounds like with the holiday period being a little bit more challenging to really start up these programs, how much, again, how much contribution are you expecting in 2026 from, let's say, the programs that have been ramping up, the newer programs that you added this year? And what are your assumptions around continuing to add programs in 2026, like new partnerships?

Quentin Blackford
CEO, iRhythm Technologies

Yeah, we'll definitely add more partners in 2026. That pipeline is incredibly strong. Feel very good about it. I think we've got good line of sight to what we expect to start in the first part of this year. The reality is through the holiday period, folks just aren't going to start up these programs. They're going to wait to the beginning of the new year. So we like what we see there. I think part of the challenge with each one of these innovative channel partners is everyone's a little bit different in terms of how they come out of the gate, how they start up. And with that approach, or sort of that being the fact that how they start up, our approach to it has been a little bit conservative to say, let's see how they come out of the gate. Let's see how they contribute.

And then we can start to roll those into our forward-looking guidance. So I think with the channel partners that we've got a good deal of history with, we feel very good about how to forecast those. We can forecast those nicely. They're going to continue to grow very nicely in 2026. We've rolled those expectations into our guidance. But it's the new folks coming on or folks that we have less duration of experience with that we're a bit more hesitant to bake into the formal guidance. And we'll let that play out. And we'll update expectations along the way. As Dan said, we're not going to get ahead of ourselves. I think we want to make sure we put a number out there we feel very good that we can deliver.

I feel good about that in terms of what we've put out there at this point in time. AT continues to perform quite well. But quite honestly, it's another year of competing in that market that we don't necessarily have the best product there. So we've ratcheted down some of the expectations around that. If we can continue to grow that as we have, great. There's going to be a terrific opportunity with it. But we're just trying to be thoughtful in terms of how we set these expectations. We're not going to get ahead of ourselves.

Allen Gong
VP and Equity Research Analyst, JPMorgan Chase

So you mentioned AT. And I guess with MCT submitted in third quarter of last year, I think 2027 is on the later end of when we would have hoped for a launch. So is that just we've seen a bit of the approval and submission of MCT has gone through some challenges?

So should we just think of that as conservatism around the timeline for the FDA getting back to you? Is there any reason why you expect that it might take a little bit longer to get that approval through? Or is it the launch process going to be a little bit more strenuous for you?

Quentin Blackford
CEO, iRhythm Technologies

Yeah, I think, look, we're in active dialogue with the FDA on MCT, encouraged by what we're seeing in the back and forth. There's clearly a lot of questions from the FDA around cybersecurity. No question at all. I think as we think about the long-term scalability of how to meet some of their questions and their expectations, we wrestle with, do we design or do we develop anything incrementally in the existing form factor or should we look at something different? A good example of that is take the gateway.

And I don't have it here, but we've got a gateway that's been with us for over a decade. As we move to a mobile gateway, would that give us more scalability if we did that from a development perspective? Are we talking about adding another month or two to the approval timeline? Those are the things we're considering as we go through it. We really want to make sure that we set this up for long-term scalability in the best way possible. And clearly, with the success of AT that we're having, I don't feel a rush to have to sort of make a poor decision long-term for the betterment of the near term, quite honestly. So looking through some of that. But the other challenge that we're running into, to be honest with you, is the success of AT has been beyond what we anticipated.

We're having to make inventory purchases to keep up with that demand, which now means you got to work through that before you can convert over to MCT, and so from my perspective, the best way to think about MCT is early part of 2027, and that's the way to set expectations at this point. I hear a lot of folks talk about 2026. I don't expect it to contribute in 2026. It's not in our numbers. I think 2027 is the right way to be thinking about that,

Allen Gong
VP and Equity Research Analyst, JPMorgan Chase

And I guess just talking about the MCT market more broadly, I think for the Zio Monitor, it's very well understood where the growth opportunities are at between symptomatic and now asymptomatic AF. MCT, there's a lot more potential conditions that you could be treating. You mentioned pre and post AF ablation, especially with PFA helping to accelerate that market.

Where else should we be looking for growth opportunities for Zio AT and eventually Zio MCT above and beyond just taking share in the market?

Quentin Blackford
CEO, iRhythm Technologies

I think one of the greatest opportunities is in the core legacy long-term cardiac monitor markets, the Zio Monitor space, where our customers have just shared with us, look, 14 days is not going to be sufficient for what we're looking for. We want to get beyond at least 20 days as a minimum. And this new product will do that. It'll get to 21 days. But those folks, they're not going to prescribe Zio AT. They've been clear. They want something with a longer duration. And so I think we'll meet that expectation with the new MCT product.

And so the ability to convert the opportunity with our Zio Monitor customers into them now prescribing our product for their MCT needs, I think, is a real opportunity. We're having great success on the competitive aspect, the new accounts coming in and converting from competitive MCT products into our Zio AT product. I think that we've done a great job. The teams have done a great job being able to articulate the value of Zio AT sort of compared to other competitive offerings and demonstrate that it's as good, if not better. And these new accounts are seeing that data. They're leaning into that data. They're experiencing it themselves. They're prescribing. It's the legacy accounts that we've had a harder time sort of flipping over. They're sort of stuck in that longer duration of monitoring.

So I think that's where the majority of the opportunity is going to come from. I think you get out beyond 21 days. I think even from a competitive perspective, it's going to be able to open up more doors than what we have today. There are some competitors or customers who are using competitive products who you knock on the door, and it's just not long enough in terms of duration. They don't want to take that call, right? So I do think it'll open up some additional opportunity for that competitive conversion. But 15% market share in that overall market compared to 70% in LTCM, I think there's an incredible opportunity there. I don't expect that we're going to deliver 70% market share in that MCT space. But again, if we can capture 10 points, it's $80 million-$100 million of revenue.

So if that 25% can get to, or sorry, 15% can get to 25% to 35%, 45%, it's going to be a significant driver for us.

Allen Gong
VP and Equity Research Analyst, JPMorgan Chase

You touched on the competitive landscape there. And I think this is kind of a two-part question, one for Zio Monitor, one for Zio AT. But when we first, quite a while ago now, when Zio XT was really starting to do quite well, we saw a flurry of patch competitors entering the market. A lot of them were then acquired by much larger competitors in the med tech space. And it's quite difficult to track how the strategy there has evolved. So just from a competitive landscape, your competitors are seeing you having great success with your innovative partnerships. Has there been a competitive response?

Is there a reason why your competitors couldn't go try to undercut you or get ahead of you and try to make these same kind of deals with these partners and with the benefit of scale and maybe some bundling or what have you and really compete on that front?

Quentin Blackford
CEO, iRhythm Technologies

Yeah. We hear some noise. I mean, we hear some noise at times of competitors talking about launching programs into innovative channel partners, comorbid disease states, the overlap. The challenge, and this is why I love the position that we have, is we led out of the gate as a company with a product that targeted sort of that 14-day monitoring, not the continuous feedback loop. It wasn't an MCT product, right? So it led with a lower cost, lower price profile that could be applied as easily in primary care as it could in cardiology and EP.

Whereas our competitors, they lead with MCT. And for them to step from MCT down into long-term cardiac monitoring, their cost profile of their product is incredibly prohibitive to do that, right? So you don't see a lot of folks do it. As a matter of fact, when we started to push primary care two years ago, I was met time after time after time by folks who said, that will never work. It'll never get prescribed in primary care. Your cost profile is never going to work. You can never make money down in that segment of the market. Look, we're prescribing more in primary care than we ever have before. We're more profitable than we ever have before. And I'll take that financial profile all day long.

We will drive hard into primary care because we have the right product feature cost profile to go there where our competitors do not. I think for so long, the reimbursement, quite honestly, was so much higher in MCT that everybody focused on MCT, and that's where they wanted to go. We took a very different approach. We went after long-term cardiac monitoring. We feel like that's better for the patient, and the patient gets better answers, faster answers, and it's better for the healthcare system from a cost perspective, for sure, so we don't see a lot of folks coming down here. We're trying to go as fast as we can, lock it up. That's why the integration aspect of what we do is so, so important. When we get integrated in and locked into an integrated system, the stickiness there is incredibly high.

I couldn't give you the name of a single account where we've got an EHR integration that's been completed that has walked away from doing business with iRhythm. Integrations are powerful. We've got to get them completed. I'd love to see 100% of the business. The reality is we won't ever get to 100%, but we make good progress there and excited about what we see.

Allen Gong
VP and Equity Research Analyst, JPMorgan Chase

With the time we have left, I do want to touch on the P&L, the profitability side of things. Feels like a lifetime ago, but you laid out long-term targets for 2027, getting to 15% EBITDA. I think we've definitely seen more focus and more improvement there over the last year or two. That's definitely been appreciated. And now you're set up to get to 11.5%-12.5% next year, I believe, or this year.

So that seems like a pretty good bridge to get to 15%. But what is getting you to that 11.5%-12.5% between gross margin? We saw that get to 70%+ . Hopefully, it had stayed there in fourth quarter. You've always talked about having room in G&A. So what is driving the expansion this year? And then what gets you that final 250-300 basis points next year before we start looking longer term?

Dan Wilson
CFO, iRhythm Technologies

Yeah, sure. So really pleased with the progress we're making. You noted it. 2025 was tremendous. First year of profitability in the company's history, as well as free cash flow positive. So really pleased with that. 2026 will be a continuation of that. Certainly opportunity within gross margin. You've heard us talk about investments into manufacturing automation. Our clinical operations team being really efficient and executing really, really well there. It starts with gross margin.

We'll continue to see expansion there. And then down the P&L, you noted G&A. That is our preferred kind of focus in terms of driving leverage. And importantly, I would say guidance that we've put out, as well as results historically, is a balanced plan where we are continuing to drive profitability, but importantly, continuing to invest in the opportunities we see in front of us. And you heard Quentin's remarks on all the different growth opportunities and growth levers that we see. And we want to make sure that we're investing into those opportunities while continuing to drive profitable expansion. And we like that setup.

Allen Gong
VP and Equity Research Analyst, JPMorgan Chase

Yeah, you kind of touched on the next question I had, which was you do have a lot of future growth opportunities, sleep apnea being one of the biggest ones. You've talked about 20% of those.

Patients are already kind of customers of yours, but then there's obviously the 80% that you aren't targeting yet. So when we talk about 15%, and I think you had mentioned getting to 20% beyond that, that contemplates continuing to invest in those opportunities. Revenue is upside, but the costs are kind of baked in there.

Quentin Blackford
CEO, iRhythm Technologies

That's right. I mean, it's how we run the business, quite honestly. We factor in the ability to invest in these opportunities without factoring in the revenue contribution to the full degree of it. That way, we've got the bandwidth to be able to invest. And as the revenue comes, it should be upside, which can fuel further investment out in the future. So costs are considered in that without the full revenue contribution coming through.

Allen Gong
VP and Equity Research Analyst, JPMorgan Chase

Okay, I think we have about a minute left. So Quentin, Dan, I'm going to turn it over to you for any closing remarks, any last thoughts you want investors to leave with today on the iRhythm story.

Quentin Blackford
CEO, iRhythm Technologies

Look, we couldn't be more excited about where the company's at. Obviously, 2025 was a terrific year. We saw momentum pick up across all aspects of the business. And the momentum on the profitability side was terrific as well. I think getting to free cash flow positivity was a big milestone for us. And hats off to the team for getting there. But I couldn't be more bullish on where the future is going. I think the market is so much bigger than what we've looked at historically. I think we're just in the front end of opening that up, and we'll have an opportunity to enjoy it. 2025 was a great year.

I think 2026 is going to be another wonderful year for the company. We appreciate the support and look forward to catching up with each of you guys over the course of the day, if not over the course of the year. So thank you.

Allen Gong
VP and Equity Research Analyst, JPMorgan Chase

Thank you.

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