iRhythm at Wells Fargo Conference: Strategic Growth in Focus

On Wednesday, 03 September 2025, iRhythm Technologies Inc. (NASDAQ:IRTC) presented at the Wells Fargo 20th Annual Healthcare Conference 2025, highlighting its strategic growth in the long-term continuous monitoring (LTCM) market. The conference call, led by CFO Dan Wilson, emphasized both the company’s strong market position and the challenges it faces in regulatory compliance and international expansion.

Key Takeaways

• iRhythm’s core LTCM business, particularly the ZioMonitor, has shown accelerated growth, driving revenue guidance increases.
• New account openings have significantly contributed to unit volume growth, accounting for over 50% of recent increases.
• The company is expanding into the mobile cardiac telemetry (MCT) market with the upcoming Zio MCT product.
• iRhythm is actively pursuing innovative channel partnerships, targeting a market of 27 million undiagnosed arrhythmias.
• Regulatory challenges include ongoing DOJ investigations and international reimbursement hurdles.

Financial Results

• Core LTCM Business (ZioMonitor):

- Experienced accelerated growth over the last three quarters.

- Contributed to two-thirds of the $30 million guidance raise in Q2.

• Zio AT:

- Maintained performance following competitive disruptions in Q4 of the previous year.

- Key factor in the revenue guidance increase after Q1.

• Overall Revenue Guidance:

- Raised after both Q1 and Q2 calls, projecting 22% to 23% growth.

• New vs. Same Store Growth:

- New store growth has driven over 50% of absolute volume growth recently.

- Same store growth also contributes to overall growth.

Operational Updates

• New Account Openings:

- Record numbers achieved each quarter of 2024.

- New accounts are responsible for over 50% of unit volume growth.

• EHR Integration:

- Enhances volume within existing accounts and opens Zio to all prescribers in the system.

• Primary Care Expansion:

- Aims to reach areas with limited cardiology access, expanding market potential.

• Innovative Channel Partnerships:

- Engaged with 40 entities, with 12 partnerships in place targeting 2 million potential users.

Future Outlook

• Market Opportunity:

- Transition from short-term Holters and event monitors to long-term monitoring is ongoing.

- Primary care expansion is key to reaching new patient demographics.

• Zio MCT:

- FDA submission is imminent, aiming to capture significant market share in the MCT segment.

• Innovative Channel Partnerships:

- Expected to become a significant part of revenue, targeting undiagnosed arrhythmias.

Q&A Highlights

• Zio MCT FDA Submission:

- Submission expected soon, with a typical 90-day review process anticipated.

• Market Share Expectations for Zio MCT:

- Aims for 20-30% share in the MCT segment within 1-2 years post-launch.

• DOJ Investigation:

- Over 400,000 documents produced; litigation ongoing regarding attorney-client privilege.

• International Expansion:

- Japan: Lacks premium pricing; requires data showing Zio’s superiority.

- UK: National reimbursement not secured; good adoption in the private market.

For a detailed understanding, readers are encouraged to refer to the full conference call transcript provided below.

Full transcript - Wells Fargo 20th Annual Healthcare Conference 2025:

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Good afternoon, everyone. I’m Nathan Traybeck, one of the medical device analysts at Wells Fargo. I’m pleased to have management from iRhythm with us. We have Dan Wilson, the CFO and Stephanie Zadkovich from IR. Thank you for joining us on the first day of

Dan Wilson, CFO, iRhythm: our conference. Thank you, Nathan. Great being here. Of course.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: So I thought we could just kick it off and with your LTCM business. So your core LTCM business, which is ZioMonitor, it has accelerated in each of the last three quarters and was the largest contributor to your revised guidance after the Q2 call. Can you talk about what has been driving this growth acceleration? How much of it is coming from your traditional kind of EP cardiologist accounts, PCPs and from the innovative channels?

Dan Wilson, CFO, iRhythm: Yes. Yes, great. Happy to start there. So as you noted, have seen kind of momentum building in our core business and seen a lot of exciting factors contributing to that momentum and the growth we’re seeing in that business. There’s a kind of a number of years of activity at work here and really starting to lead to the momentum that we’re seeing in the business.

And I’d point to a number of different things. Certainly, from a clinical evidence standpoint, that’s always been core to us as a business in demonstrating the superiority of long term continuous monitoring. Then more specifically, more recently with Avalon and Camelot, two large data sets that we’ve produced over the last, call it, eighteen months, really starting to separate Zio monitors, our long term continuous monitoring product versus competitors. And those two data sets were very clear in demonstrating the superiority of Zio, and that’s been a huge contributor to our growth and really powerful weapon that our commercial team is leveraging. Certainly, ZioMonitor, we’ve made that transition to the new hardware platform.

That is a fantastic device, getting very good feedback from patients and prescribers alike. That is certainly contributing. Everything we’re doing from an EHR integration standpoint is contributing. As you know, we’re pushing hard into primary care, and that’s been an effort really building over the last several years, and that momentum continues. So a number of factors all coming together, launching a number of really strong new accounts.

We mentioned last year, pretty much every quarter in 2024 was a record number of new accounts opened in that quarter. Those accounts generally take twelve months to ramp up or so and seeing that contribute in 2025 as

Nathan Traybeck, Medical Device Analyst, Wells Fargo: well. Okay. Logistics and new account openings. So you’ve had record new account openings, and it includes some recently launched IVNs. New accounts have been driving over 50% of your growth, your unit volume growth in recent quarters.

Can you talk about are these competitive conversions like these new accounts, they previously had another patch monitor? And how significant to this growth are accounts that adopted Zio when the BioTOL recall happened and are now adopting Zio Monitor because they use Zio AT?

Dan Wilson, CFO, iRhythm: Yes. Yes. So seeing a bit of both of that those dynamics. So we’ve mentioned, you know, large IDNs coming on board recently, what our commercial team terms big bang launches, and that these are accounts that are launching with Zio Monitor. They’re launching with Zio AT.

They’re launching with EHR integration, and they’re launching with primary care prescribing as well. So kind of what we would normally grow an account to over a multiyear period, we’re seeing accounts kind of adopt that from the start and really contribute and demonstrate meaningful volumes from the start. So seeing a lot of growth being contributed from that standpoint. AT certainly is performing well. We had a nice opening or opportunity in Q4 of last year, as you know, with a competitive disruption, seized that opportunity and have continued to win accounts even independent of that disruption.

So seeing a lot of good momentum with AT as well.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. And but so you kind of alluded to this, but the new accounts that have been adopted in Zio, I mean, how broad is the utilization within these accounts? And I guess, where is the opportunity for further growth within these Yes. New Good question. So generally, an

Dan Wilson, CFO, iRhythm: account starts with that clinical champion within cardiology or in electrophysiology if they’re a brand new account. Zio will come into the system in that way. Cardiologists will get experience with it. Sometimes it’s just being adopted by a single cardiologist or electrophysiologist, and then the growth opportunity is getting all prescribers within that department to prescribe Zio. Then there’s other growth plays that we execute on.

One is EHR integration. We know the data is very clear there. When we get an account, EHR integration or integrated the volume within that account, even if they’ve been in the account for years, there’s a step up in volume. And that’s because Zio is integrated into the workflows. It’s making it easier for prescribers to get their patients on Zio.

And it also opens up generally Zio to all prescribers in that system. So that’s an important growth contributor as well. And there’s other growth plays as well. So in the primary care, as I mentioned, generally cardiologists will adopt Zio, and then there’s an opportunity to go into other departments in that account. It can be primary care, it can be neurology sometimes, nephrology.

There’s many pockets of growth, and we’ve organized our sales team really to go after those growth plays, whether it be EHR integration or into primary care or other opportunities.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. Is there a way to quantify, I guess, the building blocks to your growth? Same store sales growth kind of within your existing accounts, how is growth trending? How much is are PCTs contributing to new growth? And then I guess just new accounts.

Is there a way to kind of like say onethree to onethree to onethree? Or any way you could kind of frame it? Yes.

Dan Wilson, CFO, iRhythm: We do give that stat each quarter in terms of absolute volume growth in that quarter, what the mix was coming from new store versus same store. And you mentioned a bit over 50% from new store over the last few quarters. Again, that points to all of the new accounts that we opened in 2024. Importantly, same store is contributing to growth as well, right? It is a contributor to growth.

Same store or new store, we define as accounts that have been opened up within the last twelve months. Same store have been opened for longer than twelve months. But some of those accounts in that base have been customers for years, and they’re still contributing to growth. So importantly, seeing growth from both new store and same store, and we expect that to continue.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. So if we think about their ability of just the long term continuous monitoring growth, is this a case where you kind of need where your recent record new account wins will drive sustained strong growth for the next few quarters, but future growth will still depend on driving new account adds. Is that really how we should think about it?

Dan Wilson, CFO, iRhythm: Yes. So one stat I’d like to point to, still 1,000,000 short term Holters being prescribed every year in The U. S. And over 500,000 event monitors. Those are two legacy technologies that we’ve been taking share from, and the market is very clearly moving into long term continuous monitoring, which is now the biggest modality in this in the market, we have over 70% share there.

So as the market shifts there, we’re in a great position to continue to win and grow share there. So still a big opportunity to shift the overall market from traditional Holter. I think there are also market expansion opportunities certainly as we’ve been moving into primary care. We know primary care is set up well to capture more patients otherwise would be seeing just in cardiology alone. I think there’s a stat over 50% of counties in The U.

S. Don’t have a cardiologist within their county. So it shows the importance of moving upstream into primary care. Generally, that’s where patients for ambulatory cardiac monitoring are initially presenting. And cardiologists and electrophysiologists want to see qualified patients, right?

They prefer that Zio be prescribed by primary care. And ultimately, the patients coming to cardiology or electrophysiology are patients that truly should be there. So we’ve seen the market fully adopt that push into primary care where we have our own strategies to help develop that. And I think there’s an opportunity to expand the overall market as we move more and more into primary care.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. If we think about just market share, if you have 70% long term continuous monitoring, as far as that’s a prescription volumes. But as far as like still accounts or facilities that don’t prescribe Zio, do you know like what your market share is in terms of the accounts that prescribe ambulatory to

Dan Wilson, CFO, iRhythm: be Yes. In don’t have the specific data, but I think it would be comparable to that 70% number of overall volume. There are absolutely still large recognizable institutions that are still leveraging or utilizing I won’t name them publicly. But there are certainly accounts out there that are opportunities for us.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. So let’s touch on your 25% guidance. I guess, what are some puts and takes to consider for your revenue guidance? Right now, you’re implying 22 to 23% growth. You’ve raised guidance on Q2 on the Q2 call by a significant amount, you said about two thirds of that $30,000,000 guidance raise came from the core long term continuous monitoring business.

I guess what gave you the confidence to raise guidance? And how should we think about where could there be upside to this guidance?

Dan Wilson, CFO, iRhythm: Yes. So you’re right. We attributed kind of two thirds of that raise to the core market, the remainder being both AT and Innovative Channel. Remember, we raised guidance after our Q1 call as well, primarily related to AT, as we saw that business sustain coming out of that competitive disruption in Q4. We saw that sustain into Q1, gave us confidence to raise guidance in Q1.

Bigger raise in Q2 and again, attributed that to the core market. I mentioned those large accounts that launched the volumes that we’re seeing from those groups. That was a big effort to get those accounts launched in the way that they launched, right? Mentioned the HR integration. That’s an investment on our side and on their side, developing all of the clinical workflows to ensure primary care is part of the prescriber base.

Those accounts are will sustain, and we’ll see those volumes continue to grow as well. And then again, all of the new accounts that we launched in 2024, they’re still ramping volumes within those groups as well. So we do try to be mindful in terms of how we set guidance and make sure we’re not getting ahead of ourselves factoring in what we have high confidence and then leaving things that are maybe a little less predictable as upside opportunities.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Is guidance does guidance assume a significant amount of kind of new account adds? Or is it more same store sales growth? How do you think about guidance when you put it together?

Dan Wilson, CFO, iRhythm: Yes. Remember, the way we define new store growth is accounts opened within the last twelve months. So a new store what we will define as new store growth in Q3 and Q4 are accounts that were been opened since Q3 or ’4. So we have good visibility into those accounts, certainly the same store accounts as well. So that’s all factored into how we set guidance.

Okay. I think we’ll just quickly move to ZOMCT. I guess, can you disclose if you already submitted it for approval? And should we expect a typical ninety day review process? Yes.

So we are putting the very final touches on the submission. Expect to have that go over to the FDA within the coming days. That isn’t something we’ll press release. It’s a submission. But certainly, we’ll look for opportunities to update investors once that is ultimately submitted.

In terms of timing, yes, the FDA is officially on the clock for ninety days. Overall, review cycles are longer than that, obviously. When they send over questions, that pauses the clock. Sometimes there’s additional data you need to gather and get back to them. We have yet to provide guidance in terms of timing expectations for clearance and ultimately commercial launch.

We’ll look to do that once we’re on the other side of submission and have a little better visibility.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. Just bigger picture, Zio MCT. So right now, your MCT share is around 10% to 12%, if I’m correct. How are you thinking broadly just at the rate of adoption that you could see once you launch the product? Where do you think what is your fair share in that market that you believe you could attain in the first year and maybe over a longer time horizon?

Dan Wilson, CFO, iRhythm: Yes. If you want to dream big, would point to the over 70% share that we have in long term continuous monitoring. We’ve demonstrated an ability to win that type of market share. And ultimately, we’ll look to drive as much share gain as we can in the MCT segment. We know Zio MCT is better product than Zio AT.

It will start to close these competitive gaps that we’ve pointed to with AT. And then we’re also launching from a position of strength with the momentum and the performance we’re seeing with AT today. So feel good about certainly continuing to grow our share within that MCT segment. We do believe there’s a segment in that market, call it, 30%, what’s referred to as buy and bill, where accounts are essentially buying kind of a capital equipment or buying the devices directly, licensing the software and then running a monitoring service on their own. That isn’t a business model that we offer today.

So that may put a cap in terms of where we can get our share within that segment unless we get that business model at some point in the future. But still tremendous opportunity to grow our share of that overall market.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: You obviously pioneered the long term continuous monitoring category. MCT, there are a lot of competitors there. So I don’t think that many people expect you to get 70% share over a long time horizon. But I guess if we think about is 20%, 30% share reasonable and cadaven once, two years after launch?

Dan Wilson, CFO, iRhythm: Yes. I’m glad you asked the follow on question because I don’t want to set expectations that we’re growing at 70% share of MCT. Yes, we’re low teens percent share today. We do believe that will continue to grow even with AT. And when we get MCT to market, expect that will continue to grow.

I think we’re in a we have a unique right to win. Certainly, it is a more competitive segment. You think about long term continuous monitoring and our share there. Long term continuous monitoring, as I mentioned, is the biggest segment of the overall market. That is generally what patients will start with, what accounts are using as the workhorse tool.

And then MCT is a little bit below that. So I think that puts us in a unique position to win. If accounts want a single vendor, we’re absolutely best in class on the long term continuous monitoring side. We’re going to be much more competitive with the DOMCT. I think that puts us in a unique position to win that business and continue to grow our share.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. You talked about how traditional MCT devices only provide 12.8 of analyzable results, while Zio MCT will be a twenty one day product. I guess help us to understand how broadly this is understood among physicians because I believe physicians generally expected a thirty day device for the MCOT category. And do you expect the launch of Zio MCT like do you expect there’s going be a significant education effort where you’ll need to convince physicians that you should move to a twenty one day device, you don’t need a thirty day device?

Dan Wilson, CFO, iRhythm: I think the hurdle comes down quite a bit from where we’re at today with a fourteen day device. And twenty one days certainly moves us in that right direction. I think there absolutely can be more education and probably clinical data as part of that to demonstrate, yes, if you’re prescribing up to thirty days of monitoring, that’s not what you’re getting. And the reason for that is a lot of the competitive devices to get to thirty days requires recharging of components of the device, swapping out an adhesive. Anytime you introduce what we call patient friction points, patient compliance is gonna come down.

And that’s why, you know, you see only 12.8 despite these being prescribed for thirty days. Patient takes off the device, puts it down, well, I’m feeling okay now, maybe I don’t need to put on that second device. And that introduces patient friction and reduces patient compliance. The advantage, which is an advantage of AT today as well, and certainly, ZU MCT is the patient will put it on and it’s a set it and forget it. They don’t have to do anything else, the rest of the monitoring period other than triggering the device when they’re feeling a symptom.

The device will pick up things on its own, but that’s really all that’s required. You don’t have to swap out the device. You don’t have to recharge anything. And that leads to better overall patient compliance and longer wear period. So I do believe there’s some education involved to make sure physicians understand that, and that’s part of the go to market strategy.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. If we could just touch on the innovative channels. So you disclosed a near term pipeline of 40 innovative channel entities that you are in active discussions with right now. Is there any way to think about the pace of signing these on? If we think about the 12 partnerships that you have today, it took about one point five years to bring them on.

I guess now that you have experience and a track record with these channels, should these 40 come on quicker, perhaps maybe by year end?

Dan Wilson, CFO, iRhythm: Yes. I would say the momentum is absolutely building. And you said a year and a half. You skipped past the four or five year effort to really build the market and develop the clinical evidence and really get that first partner established. So once we got that first partner and then the second partner or third partner, the momentum has certainly started to build.

And we have real world kind of data to show these partners as we’re selling these programs. So absolutely believe the momentum is building, and we’ve seen that selling cycle condense a bit in terms of that next incremental partner. It’s still a different selling cycle. These are 12 accounts versus thousands on the core business. So our experience and our history with this group is much less than what we see on the core business.

And for that reason, we’re not going to get ahead of ourselves. We want to make sure we’re being thoughtful in terms of forward expectations there. It’s a different selling cycle, one. And then as these partners come on, they generally will run a pilot first before launching into a full commercial program. The size and pace of the pilot is always different.

Which patients they want to target initially is different partner by partner. And then how they ramp into a full commercial program is a bit different partner by partner as well. So for that reason, we want to be thoughtful. We have a number of partners now that we have over a year’s experience with those types of partners. We have better history and better visibility into kind of where they’re headed, and something like that will start to bake into guidance.

Those 40, we’re going to leave the majority of that outside of guidance for the time being until we have a little more confidence around how those turn on. Okay.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: You disclosed the 12 accounts represent about 2,000,000 potential users. Can you confirm, are these patients who would, I guess, fall into the mSToPS criteria and would be willing to have a patch? Is that how you quantify that 2,000,000 number?

Dan Wilson, CFO, iRhythm: The so patients that adopt into the program or opt into the program, that would be another cut below that 2,000,000. So and we can talk about what we’re what we’re seeing there. But generally and and this is another factor why every partner is a bit unique. The patients they wanna target and the criteria that they’re using varies partner by partner. Sometimes it’s the mSToPS criteria.

Sometimes it’s, you know, I have I’m having a difficult time managing my heart failure patients in my population. That’s the group that I wanna start with. And so it it varies. We have seen kind of the overall patient population. The percentage of patients that are meeting the criteria that the partner is applying can range anywhere from thirty percent all the way up to seventy percent or eighty percent.

So it’s a pretty wide range there. And then of course, the prescribers need to be educated on the program, present that to patients and then patients ultimately opting in.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Are you kind of willing to disclose, I guess, the 40 that you’re in negotiations? And now how many lives that covers?

Dan Wilson, CFO, iRhythm: It’s difficult to get to that market data. We know you mentioned the 2,000,000 of the 12. Once we’re in really active dialogues with these partners, we kind of peel back the onion, understand the population within those groups, the demographics of the patient population and can put a finer estimate on it. You get deeper into the pipeline, that visibility isn’t quite there. Again, another reason why we want to be thoughtful in terms of how we kind of set expectations here.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: And these partnerships, they’re not I mean, some are significantly bigger than others. I think we previously estimated Signify would be 500,000 patients potentially, which is a quarter of the 2,000,000. I guess, is it fair to imply that the average size of the other 11 partnerships outside of Signify is significantly like it’s a pretty small number. And I guess how should we put that in the context of the available opportunity, the 40 that you’re working with now and then the 100 that were kind of are out there? Are there other partnerships that are the same size as Signify, bigger?

Any way to kind of frame sizes?

Dan Wilson, CFO, iRhythm: Yes. Yes. Signify is definitely one of the bigger partners out there in terms of scale and patients kind of under their umbrella. They’re not the biggest. If we look at the full pipeline, there’s other opportunities of similar scale and then a whole lot in the middle and below that.

So this is where our I think our opportunity is, is really pinpointing exactly from a high level top down perspective, we believe there’s 27,000,000 patients out there that are candidates for monitoring based on SToPS criteria and other things. Finding out exactly where those 20 7,000,000 patients are from a bottoms up build standpoint, that’s work that we’re doing now and informing kind of how we’re taking these programs to market. There are some obvious ones out there, Signify and others. We did talk about, maybe this helps from a sizing standpoint, innovative channel, we said was low single digits in terms of total percent of total volume in Q1 of this year. That stepped up slightly in Q2.

Signify by no means is the majority of that single digit percentage. They are a bigger partner for us, but there are others contributing to that as well.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. To your point just now, if we think about the universe of 100 potential partnerships that you could have, and you’re saying there are twenty seven million undiagnosed arrhythmias. I know you’re doing the work now, but is there a kind of a rough number? How many of the twenty seven million reside within those 100 accounts? Any way to kind of frame it?

That’s the challenge that

Dan Wilson, CFO, iRhythm: we have, and that’s the market landscaping effort that we’re doing, and we’ll certainly provide insights as we have it. We are we’ve in terms of how we’re going after this opportunity, we’ve carved out a team from our core sales team. There’s an independent team or a separate team that is focused on this channel. I think there’s further segmentation that we can do with even within that group to get very specific in terms of the type of partner profile that we’re selling into. But we’re early innings, learning as we go, and we’ll certainly provide those insights as we’re learning them.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: The one question I had just on Signify, I think on the last call, you talked about you added over 1,000 prescribers at Signify. Can you clarify, are these new physicians that never prescribed Zio before? And if so, what were they using? And is that 1,000 plus at the high end of what you would expect from any single partner?

Dan Wilson, CFO, iRhythm: It’s a big number, which is why we called it out. I think they have 11,000 prescribers overall and within that umbrella there. So 1,000 of 11,000, there’s still opportunity to continue to grow. I don’t believe they were using any ambulatory cardiac monitoring previously. So these are all new prescribers, which is part of the ramping effort, right?

We need to educate the prescribers on what ambulatory cardiac monitoring is and isn’t, which patients are candidates for it, how to get patients on Zio and everything else. So that is part of the effort. That isn’t true for every partner. Some partners have prescribers that have prescribed ambulatory cardiac monitoring previously, but at least with Signify that was Greenfield.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. If we just think about the twenty seven million undiagnosed arrhythmias in the context of six million to seven million ACM tests today, do you envision that, I guess, the innovative channel partnerships will ultimately become a material part of your revenue mix from the I think it’s 3% of your revenue today. Can it go to over 50%? Or is that more of a function of if you ever get USPSTF guidelines?

Dan Wilson, CFO, iRhythm: Yes. In the spirit of dreaming big, I think that is an opportunity and a possibility. How we get there, I think, is much less clear, certainly. I mentioned 1,000,000 point dollars short term holters still taking place every year in the market despite all the very clear evidence and everything we’ve been doing from a decade, so over the last decade. So health care never moves as quickly as you would like it to be.

We do believe we are on the right side of major market trends though in terms of moving upstream, being more proactive, being more preventative, moving care outside of the four walls of the hospital. So believe we’re absolutely in the right spot in terms of overall trends. In terms of how it moves year to year is a little less certain.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. In the last few minutes, I just want to touch on regulatory. Where do you stand with the quality of remediation today? And I guess what is left for you to do? And do you have any indication from your engagement with the FDA from when they could come back and do a reinspection?

Dan Wilson, CFO, iRhythm: Yes. Maybe with that last part of the question, they can come back at any time. We and maybe just rewind a little bit. So we laid out a twelve month remediation plan to the FDA back in August 2024, so a little more than a year ago. We’ve been executing against that plan.

We’ve been providing monthly updates to the FDA and met every one of our commitments and time lines that we laid out to the FDA there. Our most recent update to the FDA was we have completed those remediation activities that we committed to back in August 2024. We’ll wait for their feedback to see if they’re satisfied with those efforts or if there’s anything else that they want us to execute on. As a reminder, we also committed to going above and beyond what even the FDA asked for. And so we have an independent third party reviewer coming in to do essentially an audit of our quality management system.

That work is now kicking off. That will take us through the remainder of the year. We did commit to the FDA that we’ll provide findings from that audit as well. So that will be the next update to the FDA. We did have a meeting with the FDA just a couple of months ago, updated them on our progress.

Very good discussions, good tone, positive tone, felt collaborative. And we’re fully committed to working through the remediation and believe we’re making the right progress.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Did they give you kind of feedback in terms of whether or not the progress that you made is sufficient? Is that something that’s even discussed in those meetings? Because you kind of just answered, you said, we’ll see when they come back, if there’s anything else they could call out. It doesn’t seem like there’s an active discussion in terms of you’re on the right path and we feel comfortable coming back at any point. And I guess to that point is, do you feel like they would be compelled to come back to reinspect before approving the OMCT?

Dan Wilson, CFO, iRhythm: Don’t believe so. I believe those are separate and independent. And keep in mind, we have received three five ten clearances over the last twelve months, all while we were executing on this remediation plan. So certainly, a regulatory agency, they have the right to come in at any point, make any recommendations, you know, that they see at at any point. What we’re focused on what we control, which is, you know, continuing to kinda up level our quality management system.

We’re making very good progress there. We have this external firm coming in and believe we’re doing all the right things and certainly awaiting feedback from the FDA from that standpoint.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. Do you have any updates on the DOJ investigation? And I guess what could be some worst case outcomes from this investigation?

Dan Wilson, CFO, iRhythm: Yes. So still in the discovery phase. We produced over, I think, over 400,000 documents to the DOJ almost two years ago. There were documents that they were asking us to waive attorney client privilege on that is being litigated in court. We’ve appealed that decision.

We believe it’s important to maintain attorney client privilege on those documents. Still in the discovery phase, can’t speculate on potential outcomes, unfortunately.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. In the last two minutes, I just want to touch on OUS. So you did not secure premium pricing in Japan, which you expect that you would. While you have plans to do expanded studies to show Zio superiority and plan to appeal the reimbursement decision. In the meantime, you talk about the rate of adoption, how it’s trended?

And I guess, just remind us again of the market size in Japan and what the patch competition is like in that country?

Dan Wilson, CFO, iRhythm: Yes. So Japan, second biggest market globally for ambulatory cardiac monitoring, over 1,000,000 monitors per year there. Majority of that, if not all of that, is legacy traditional whole term monitoring. So big opportunity there to change the standard of care like we have in The U. S.

And bring in patch based long term continuous monitoring. You’re right, we didn’t get the premium reimbursement we were ultimately hoping for. Feedback was very clear. We need end market data showing Zio relative to end market halters. So that is the effort that we’re doing today.

And we’re now a few months into commercialization and seeing good adoption, good volumes, new accounts coming on board. Still very early, obviously, but still really like the long term possibility or opportunity within that market. Do want to get to that premium reimbursement, and that’s our near term focus.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. And the last few seconds, just The U. K. Has been pretty strong. I guess, is driving this?

Can you remind us that you have national reimbursement there today?

Dan Wilson, CFO, iRhythm: We do not yet. That’s been a bit frustrating. We felt like we’ve been on the goal line there for a few different times now, but haven’t broken through. Still pursuing that, and hopefully, we’ll get some good news there in the next twelve months or so. Meanwhile, we’re seeing very good healthy volume adoption within the private market primarily, which I think is good to seed the market.

And we had that AI award in The U. K. A few years ago where we had good initial adoption within some NHS sites. So good brand awareness of Zio. I think that market opportunity is there for us.

Similar to Japan, we’d like to see nationwide reimbursement before we can really open up that market in a bigger way.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Perfect. Well, Dan, Stephanie, thank you so much for joining us.

Dan Wilson, CFO, iRhythm: Appreciate it. Thank you very much. Bye.

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