Five, 9:20. Good morning. Welcome to day two of the Wolf Research Healthcare Conference. Pleased to be joined—I'm Mike Pollard, medical device analyst at Wolf Research. Pleased to be joined in this session by iRhythm. We have Chief Financial Officer Dan Wilson, and we have Head of Investor Relations Stephanie Zhadkevich. Dan and Stephanie, thanks for being here. Thanks for having us, Mike. Thank you. I had a great agenda, and we're going to get to it. I want to start first, though, with yesterday's dust-up. Some concerns or questions in the market about what some of the Medicare Administrative Contractors are looking at as it relates to coverage for ambulatory cardiac monitoring. I want to give you the space here, Dan, to just highlight for folks what's going on and kind of why we shouldn't be worked up about it. Sure. Yeah, happy to address it. There was a draft LCD written by three, MACs, Noridian, Palmetto, and CGS a couple of months ago. This is normal process as you think about reimbursement and coverage. There is a national coverage decision in place for ambulatory cardiac monitoring that does supersede any local coverage decisions. As technology changes in the market, other regulations, you think about the FDA and how they're regulating the space, you do often see MACs put in a local coverage decision. We saw that with Novitas a couple of years ago and went through a similar process, to be honest, where there was an initial proposed LCD, industry commented, provided their perspectives, and where that landed was in the right spot. Working through that process, this is proposed language. We did provide public comments to it, comment letter. We know other industry participants commented as well. We are confident the process will work out in the right way. We are confident that, or believe that, as written, there are some things in the language that MACs certainly did not intend for. That is the process of commenting, kind of educating on how these devices are delivered or services are delivered in the market. That is part of the process. In reading it yesterday, it does read as if it's written specifically for connected monitoring, MCT, mobile cardiac telemetry. Yet, in the setup, they identified all the different types of monitoring modalities. I guess my question on this is, is that where you're pushing back? It was an oversight to kind of paint all of the devices or services with a connected device brush. We do not believe that was their intention to apply kind of MCT guidelines to all modalities. Obviously, the clinical and economic evidence of long-term continuous monitoring is very clear. That is generally the frontline device for patients. It's very cost-effective, a third of the rates that you have for MCT. We do not believe that was their intention, and that was part of our comment. I'll also just add as observer, if they're trying to shift everything to an MCT modality, $800 a case, I'm rounding, and that's a million scripts a day. I'm rounding short-term, long-term Holter event monitoring collectively, 5 million scripts at $50-$250 a case. I'm rounding, I'm rounding. This would make no sense to me. I was writing to folks yesterday. The only immediate sense I can make of this is it makes no sense. I have to imagine when you first saw this, you were pretty surprised. Yes. This is a process that we've been through before and are confident that as we educate the MACs and our industry, other industry participants do as well, it lands in the right spot. We're working through that process. What's the timeline for kind of an I to be dotted T across? There's no set timeline in terms of when they potentially publish a final LCD here. We do know once they publish a final LCD, it's at least 45 days before it goes into effect. If you think about the MAC Novitas that had an LCD written two or three years ago, that was, call it a six-month process from proposed LCD to final LCD. Okay. All right. Let's go to the original framework. It's been a good year. It's been a good year. Your current 2025 revenue guidance is 8% higher by my math than the original guidance midpoint. XT monitor going well, AT going well, ICPs ramping from essentially nothing last year versus your original vision for this year. What has surprised you the most internally? Yeah, I think you hit on three big contributors there. That's, to me, one of the most encouraging things. We're seeing strength across multiple channels within our business. XT monitor, the core business, has certainly surprised in the positive. We've had a number of large accounts kind of launch full scale right from the start. That's because we are integrating with EHR. We are launching with primary care upstream prescribing from day one. They're launching with both monitor and AT. That also benefits AT. We've certainly always tried to serve these accounts in the past. I'd say it's been more of a launch with XT or monitor, then bring in AT, then EHR integration, and then work upstream to primary care. We were able to really kind of hit that full capacity from early days. There were multiple accounts that launched that way in 2025 and starting in late 2024. That has been certainly a nice contributor. AT has shown strength all year long, in fact, has accelerated growth even in Q3. Most Most recently, there was a competitor disruption that we took advantage of in Q4 last quarter. AT is performing incredibly well, even independent of that competitive disruption. I think that plays into what I just mentioned on the core side. When you are performing that way, generally, prescribers of MCT are also prescribing long-term continuous monitoring. That is the bigger segment of the market. Being positioned the way we are in that market naturally benefits us on the AT side. The innovative channel partner, this is something we have been excited about for some time. Believed it was a win, not if, and really starting to see that contribute in 2025. Really seeing kind of the product-market fit in that channel, the clinical evidence, the economic evidence, and motivated partners on the other end. Good color. We're going to get to the ICPs in a minute. I want to ask, 30,000 ft, your view on influence of these topics for just your category. It would be the rise of treating a technology cycle and treating AFib with things like pulse field ablation and just rising consumer awareness of AFib with wearables. Things we've talked about for a while. In diagnosing the upside this year, great execution, big bang launches, heard all that. How much would you attribute, if anything, to those two macro drivers, let's say, to just kind of this AF tide rise and your performance? Yeah, absolutely. They have been contributors to our performance. There are certainly market tailwinds there that we were ready and well-positioned to capture. The excitement in pulse fields is very clear. There is an energy level in electrophysiology that has not been there for some time. Obviously. Unintended. Yes, exactly. You have seen kind of PFA volumes continue to grow really nicely. Those patients need to be found upstream. There is a partnership between electrophysiology and cardiology and primary care to find these patients for PFA procedures. There is obviously post-ablation monitoring as well. Absolutely a tailwind to our business. Again, I think we are well-positioned to capitalize on that. Certainly from a wearables and just a general kind of consumer awareness around atrial fibrillation, absolutely a benefit and tailwind in the market. That has been there for a few years. Some years ago, it was debate, friend or enemy. I've concluded very much friend. Doctors are not at scale making definitive AF diagnoses off the watch. Correct. Yeah. All right. I have the CFO. We're going to do a few numbers. Fourth quarter, hate to zoom in, just accelerating growth throughout the year. Third quarter was 31%. The fourth quarter guidance implies 21% year- on- year at the midpoint. A deceleration. Your comp in the year ago, fourth quarter, is stiffer by about six percentage points m aybe that's one consideration. What else would you flag about this kind of outlook as to how you constructed it? We go from 31%- 21%. Looks like a lot of space. Yeah, I would say you hit the biggest piece there, which is the difficult comp in Q4 last year. That was when we really saw, I mentioned the competitive disruption that AT benefited. We also had an innovative channel partner in Q4 last year contribute in a big way within that quarter. I would really just point to that being a difficult comp. No change in kind of overall philosophy in terms of how we set guidance. We want to be thoughtful around what we factor in. The innovative channel part of our business is new and emerging. We mentioned having 18 partners. Each of those 18 partners operates in a different way. It makes it a little more difficult to kind of predict that part of our business. We want to be thoughtful around what we bake into guidance there. Hopefully, that plays through as upside, but do not have the same level of visibility there as we do in the core business. Want to be thoughtful, but would really just point to the difficult comp. Love the momentum in the business. Love our positioning and feel good about the business. Let's hit on the 2026 message or comment from the last call, and then we'll go to the innovative channel partner discussion. The blessing was Street's growth model in 2026. And this excludes any contribution from next-gen MCT in perhaps the back part of next year. So what I heard is you basically blessed high teens revenue growth, give or take, and that's before the product cycle. Is that correct? That is correct. That was what. You got it correctly. O kay. All right. Just not asking for guidance, but all of the kind of drivers in gear this year, new accounts, XT, AT, ICPs, anything preliminarily you would frame for next year as to something becomes a little more impactful than something else, or you'd think more of the same? I don't know if it's an exciting answer, but I think it's more of the same, to be honest. We haven't provided formal 2026 guidance, obviously, but we did kind of suggest on our Q3 call we were comfortable with where street numbers were at that time and started to give a little bit of visibility into how we're thinking about 2026. I could see core business continuing to perform and grow nicely for us in 2026. Have a number of new accounts that we've launched that will continue to grow. Still, 2 million short-term Holters and event monitors being prescribed every year that are out there as an opportunity to transition to long-term continuous monitoring. Feel really good about the core business continuing with that momentum. AT, again, we've seen accelerating growth and feel really good about continuing to drive our share in that market. You think about long-term continuous monitoring, we're over 70% share in that segment. Within MCT, we're closer to, call it, 15% or so. Still a big opportunity to continue to convert or gain share in that MCT segment. Believe we'll do that with AT, and certainly the MCT is the next leg of opportunity. Innovative channel, we'll believe that will continue to grow as overall portion of our business. Again, the predictability and the visibility into that segment is not quite the same as what we have on the core and the AT side, but feel really good about the momentum. Mentioned 18 partners now on our Q3 call and have a nice healthy pipeline there as well. Perfect transition, you set me up. I want to talk about the ICPs. You said it earlier, the view was when, not if. My first question is why now? Why is this unlocking in 2025? I think we have a team, kind of a dedicated team going after it, which we got organized a couple of years ago. We initially were kind of selling these programs into payers where we have found the product-market fit are these, what we call innovative channel partners. These are value-based care entities, ACOs, where they own both the risk of the patient like a payer would, but also have that touchpoint with the patient. They are either going into the home of these patients or seeing patients in clinics. They have kind of the patient, a captive patient there. They know the patient. They know the risk factors of the patient and can make the decisions because they own the risk of those patients to proactively monitor these patients. We've, as we do with all parts of our business, generating clinical evidence to support these programs. We've done quite a bit of that in 2025. Their incentive is find early, treat early, and that math works out for them. It does, yeah. Avoiding downstream costs is critical, right? Our pitch is essentially these patients are going to get diagnosed somewhere at some time. You kind of choose when and where. Do nothing, these patients are likely going to present and get diagnosed there, potentially in hospital. That's a $15,000-$17,000 event versus proactively monitoring in the patient's home for $250-$300. That economic argument makes a lot of sense. A lot of these partners too run pilots. They'll run a pilot of 100,000 patients. We lead with the data. We come back to them and say, these are the demographics of the patients you monitored. Here are all the different arrhythmias you found. They generally have a number in mind in terms of diagnostic yield that they're trying to exceed to know that they're going to have value in this program. That diagnostic yield has surpassed expectations. In fact, that's one of the most encouraging things about this segment of our business. Every partner that we've gotten to a pilot has continued on to a full commercial program because they've seen kind of the value proposition play through. What about heterogeneity? Are folks implementing this in the same way, all of these 18 partners, or is it a wide spectrum of strategies? It is a wide spectrum. You're figuring that out. There's some similarity, certainly. As that base grows, there's a little more similarities than not. Each partner kind of approaches it differently in terms of how they want to ramp and how they want to pace things, but also the patients that they want to target. Some patients use an M-STOPS criteria, if you remember the M-STOPS trial. Some partners have said, well, I have a heart failure problem in my population. I want to target those patients. They'll target that and then modify which patients they want to proactively monitor. Each partner is a bit different. On our side, we are trying to generate more and more data, particularly around other disease states, right? Diabetes, COPD, CKD, showing that these patients have undiagnosed arrhythmias that also need to be managed. Oftentimes, their symptoms are thought to be the comorbid condition that they're dealing with. Each partner is different, b ut again, the value proposition has been playing through nicely. About the topic of retesting. For someone that's in this high-risk pool, tested negative. Right. Are most of these deployments, next year, we'll write you another script and see o r what are you seeing on that front? Because I know this is part of before we're reluctant to overforecast. We're not yet super confident about the recurring opportunity here. How does that all look a year into it or so? We haven't seen that just yet, to be honest. We're still. You haven't seen the retesting? Correct. Yeah. Every partner that we're working with is still kind of working through their populations. Some of those conversations are starting to come into the conversation in terms of how they want to retest, whether it's every two years as an example. We believe there's still a long ways to go before that is a dynamic we have to consider. One thing to note, though, patients often switch from one of these groups to another. They would need to be retested if they move from one of these groups to another. There's patients aging in, right? This term, the silver tsunami, is now upon us. Over 4 million patients will be aging into Medicare age annually over the next five years, which is an acceleration of what we've seen in the past. Those patients will be coming into the population. Risk factors are changing too, right? A patient could be tested, comes back negative. Twelve months later, they can be diagnosed with something else that may warrant further testing. We did a partnership with Lusum Health that we announced a few months ago. It is around kind of developing this algorithm that's a tool that these groups can use to, say, put their patient population in there based on certain risk factors and immediately flag which patients are likely candidates for monitoring. That's a real-time algorithm that can update based on age and other risk factors that are dynamic. Last one on this, and then we'll move to next-gen MCT questions. You've probably seen our attempt to frame ICPs. You made a very precise or close enough disclosure from, I think, the first quarter, and then it's been we've had to guess. Our answer is this year, it's maybe 5% of your total revenue, $40 million-$45 million for the full year. If we make some assumptions about Q4, how did we do? A bit high. We said low single digits would put that just below that 5% mark. Okay. All right. That comment was specific to Q2 at the time. That's right. We did say it stepped up slightly in Q3, but still within that low single digit. We overmodeled slightly, but I got you. Good. All right. Let's shift to the next-gen MCT device and maybe just level set for the discussion. Just latest timeline communication. There's a submission in. We can all count a clock. I typically count six months for something like this, I think. March, April, potentially for a clearance. And then I think you've said second half of 2026 for a full commercial launch. Is that what? We did submit the 510(k) in September. You're right. Generally, 510(k)s are called six months start to finish. I think the government shutdown here is not going to do us any favors in terms of those timelines. We are being kind of cautious in terms of setting expectations for clearance and launch. We obviously talked about 2026 and probably best to consider MCT not contributing in 2026. We will leave that as upside if that plays through differently. The FDA is on a clock with 510(k)s. We should be hearing back from the FDA here soon on that first 60-day mark. We may get some visibility there in terms of overall timelines and can certainly update folks as we learn more. It also, sometimes the first response you get back from the FDA is pretty generic, and they're not really yet in the meat of their review. We have to see how it plays through. We're excited about the product, obviously. There will be some transition from AT to MCT that we want to be thoughtful around as well. We have inventory with AT, and actually have been building up the inventory given the strength that we've been seeing with AT. We want to be thoughtful around how we transition that. There was a period where we transitioned from XT to from Zio XT to Zio Monitor. That was over kind of, call it 12-18 months. We did things where we were continuing to serve the home enrollment part of our business with Zio XT while we were working through the inventory there. That's something that we may consider for AT to MCT as well. As we get into next year, as we get feedback from the FDA, we'll certainly start to give more visibility there. One of the questions on the product I guess get most frequently and maybe do not have the best answer, the 21 days. The CPT code, I believe the language is up to 30 days of monitoring. To this point, you have kind of served that with two ATs. The Zio MCT product will be a singular device for 21 days. Why design the 21 and not 30? Maybe just remind us on that. As you market this to physicians, how does the 21 days fit into their expectations for this concept? Yeah. One of the best-selling features of AT, and it will be of MCT as well, is that the patient puts it on, and they do not have to do anything else through that 14-day going to 21-day wear period. Everything is fully charged. The device goes on once and stays on, as well as the gateway that is the companion to it. It is a cellular connection for the device, for the patch, that does not need recharging either. That leads to higher patient compliance versus getting to 30 days. Competitive devices often require a patient to recharge things, swap out the adhesive multiple times. Anytime you introduce what we call patient friction, your compliance is going to go down. That will be a feature of MCT as well. We can deliver 21 days, not 14 days, which is the limit for AT. Yes, a physician can prescribe two ATs to get out to, call it 28 days. That comes through as two kind of separate services. It is two separate 14-day monitoring periods, two different end-of-wear reports. It is not stitched together. That is, call it single digit, 10% of overall volume is of AT volume where a prescriber wants 28 days. Vast majority, 90%+ of AT volume is for that 14-day period. Okay. This is AT is 15% of revenue. Is 10% of that 15% is the 28-day? Correct. Is that two revenue events for you? No. Okay. You're just one. Okay. Good. With Zio MCT, we'll get out to 21 days. Again, it'll be this same high patient compliance. For For the physicians that do want up to 30 days, they will also have the option to prescribe to Zio MCTs. Importantly, we will be stitching the report together to make it a 28-day report, not two separate reports. That'll be in. This is interesting. 90% of the AT scripts are actually 14-day. And relative to that, your own baseline, you're introducing 21. Correct. Okay. That was very helpful. Thank you. What about on the SG&A side? I think this is interesting. Same call point. AT's winning right now. I mean, as MCT, let's say we're in 2027 now. Is your expectation that your field force is really it's built to launch this, and there's not a ton of incremental required to do that? They are eager to launch it and are looking forward to launching it. Yeah, same call point, same commercial team that we have today, same operational infrastructure. It is all there ready to support MCT when we launch it. Incremental investments would probably be around more on the clinical data side, which we are doing to a degree with AT, but wanting to generate the evidence to show the superiority of Zio MCT relative to other devices, a lot like what we have done with Zio Monitor. In the last few minutes here, the tone around the FDA workflow has been quite constructive. Is there an event we expect or need to just wrap this up and formally kind of close the era? What is that event, and what would be a reasonable expectation to achieve it? Yeah. We talked about all the momentum in the business and the financial numbers that we've been putting up. We're really proud of the progress we've made on the FDA remediation side as well in 2025. That was our number one corporate priority going into the year and have been executing really well against that as well. Kudos to our internal teams for committing to that. We hit every timeline that we committed to with the FDA, have fully executed on the remediation plan that we outlined to the FDA back in August of last year. We did say we're going to go above and beyond that. We have an independent third-party audit firm coming in to essentially go above and beyond and do a full audit of our quality management system. That activity is taking place now, and that should wrap up in the coming months or so. We also committed to providing that to the FDA when that work wraps up. That would be an event to be on the lookout for. When the FDA decides, "Okay, you're all done, come in and do an inspection and remove the warning letter," that's on their timelines. We are focusing on what we can execute against and have been pleased with the progress we're making. Good. One minute left. OUS. What percent of revenue today? What's surprising to the upside? What's a challenge countrywise? Yeah. Low single digits and even lower than innovative channel. Importantly, though, we are seeding or making the investments to seed the markets that can potentially contribute in a bigger way going forward. The challenge is always reimbursement. Take Japan, for instance. We were in the second-largest ACM market in the world. We were really well positioned there to secure premium reimbursement, had a high medical needs designation specific to Zio, good physician support there, society support in the market, and ultimately got the existing Holter reimbursement rate. We are now executing a head-to-head study with Zio Monitor against in-market Japanese Holter monitors. That will take some time to run that study, and then we will resubmit and hopefully secure that premium reimbursement. The adoption and feedback and volumes have been scaling nicely there. It is just getting premium reimbursement, which is probably tricky. Supporting on the IDTF or equivalent side, are you supporting Japan from Japan, or is that from Malaysia? Currently from the U.S. There's opportunities potentially. You're Philippines. Philippines, yeah. Correct. MedTech is either Philippines or Malaysia, and I do get them twisted up. Good. We can leave it there. We're at time. Dan, Stephanie, thank you for the discussion. Thank you so much. Yep. Appreciate it.