Thanks for joining us at the B of A Healthcare Conference. I'm Stephanie Piazzola. I cover Medical Devices at B of A. Next up, we have iRhythm CFO, Dan Wilson. Thanks for joining us, and Stephanie from IR.
Thanks for having us.
Maybe we can get started with Q1 and the updated 2025 guidance. In Q1, you saw a strong beat of $5 million and raised the guidance by $15 million. Maybe we talk about some of the drivers of strength in the quarter and the confidence in them for the rest of the year driving that guidance raise.
Yeah, great. Q1 was a great quarter for us, second consecutive quarter where we grew over 20% year- over- year, which is a great benchmark for us and see a lot of momentum in the business, which played through in the quarter and then is reflected in the guide that we set out for the remainder of 2025. I would say, you know, no change to philosophy in terms of how we set guidance. We want to be thoughtful with the guidance that we put out there, high confidence guidance and things that are earlier in nature. I'm sure we'll talk about some of those that maybe we don't have quite the same level of confidence or line of sight to. We're going to leave those out and let those play through.
Primary driver of both the Q1 beat as well as the guidance range really was the strength of Zio AT, which grew tremendously in the quarter, again, second quarter in a row. That had a very good Q4, and we saw that continue into Q1 gives us confidence that's going to be sustainable and durable through 2025, which is reflected in that updated guidance.
Okay. And then when we think about the $15 million raise and maybe the cadence of the year, is there any seasonality to consider? You gave some color on the Q2 weighting being similar with historical seasonality. Is that also how we should think about Q3 and Q4?
Yeah, I think historical seasonality is a good way to think about 2025. Nothing unique there. Rough numbers, 22.5%, 25%, 25%, 27.5% in terms of full year revenue weighted across each of those four quarters. That's kind of the expectation for Q4 or for 2025. Nothing unique from a seasonality standpoint. Looking at year-over-year comps, obviously with the strength we saw in the second half of 2024, particularly Q4, that is a more difficult comp as we get to the back part of 2025. Otherwise, nothing necessarily unique to call out.
Following up on some of your comments in Zio AT and the good growth you've seen in the last two quarters and your confidence in that sustaining, maybe you can elaborate just a little bit on where that confidence is coming from and how much visibility you have into that volume sustaining and what that assumes from a competitive perspective as well.
Yeah. Yeah, so we did see a competitive disruption in the late Q3, Q4 timeframe. Last year, 2024, we took advantage of that opportunity and were able to pick up a number of new accounts through that disruption. Importantly, that competitor and the disruption they had resolved itself in Q4. They were back on the market aggressively in Q4 and into Q1. Despite that, we've been able to sustain a good amount of the business that we won during that disruption. I feel really good about that sustaining for the remainder of 2025. I would also say we're winning new accounts with AT, even independent of this competitive disruption. I think the team has a lot of confidence in the product. As we've been working through some of the regulatory matters, we have two 510(k)s that were cleared in the October timeframe last year.
I think that was a good milestone, and the team has really been leaning in on Zio AT. I feel really good about our ability to win new accounts and launch those new accounts with Zio AT and expect that to continue through 2025.
Maybe just to touch on the Zio monitoring side, you're already at 70% share. I guess how should we think about any incremental share capture potential or just volume growth for the Zio monitoring business?
Yeah, so it's seeing really good things with the core business there too with Zio Monitor, which is nearly 90% of overall revenue. Interestingly, when we had our analyst day back in 2022 and set long-range targets out five years to 2027, we assumed we would lose share in that market, right? Starting at 70%, figured it was the right way to approach that. We've actually seen the opposite of that. We've not only maintained share in that market, but have continued to take, call it a point or two over the last couple of years. I'd say our competitive positioning in that segment in particular has never been stronger. We launched Zio Monitor, our new generation hardware device about 18 months ago that has been really well received by the market.
It is a beautiful product, 72% lighter than Zio XT, the legacy device, and really a great patient experience. We've also done a really good job in terms of generating clinical evidence that differentiates Zio XT and Zio Monitor relative to competitive technologies out there. Camelot data that we released, I guess, a little more than a year ago and then more recently, similar set of data for commercial payers. Those are hundreds of thousands of patients in terms of the clinical data demonstrating the superiority of Zio Monitor. That's been a great tool for our sales team to drive continued penetration with Zio Monitor, and we feel really good about our competitive positioning.
Okay, great. Maybe just to touch on the gross margin guidance and tariffs, your guidance for this year is flat, which contemplates 50-75 basis points of negative impact from tariff. Maybe you could just elaborate on where you have the most exposure to tariffs and anything more on the assumptions, like when you start to see the impact and if that includes any mitigation actions that you could take.
To say the least, that has been a fluid situation. We set that guidance 50-75 basis points at the start of the year. At that time, the impact was really coming from imports from Mexico. Importantly, we do all of our manufacturing in the U.S., in California. We do source some components, some materials outside the U.S., which is where we're seeing that tariff impact. It shifted a little bit on our most recent call, seeing more of an impact from imports from China and Taiwan being the main drivers there. Obviously, the updates over the weekend probably changed those numbers a little bit. Feel good about that 50-75 basis points is kind of a worst case that does not assume any kind of offsetting strategies that we're looking to implement.
I think there is opportunity to execute on those and potentially reduce that exposure even in 2025, certainly going into 2026. We will likely update that estimate on our next earnings call. We are driving gross margin improvements underneath that. It has been offset a bit by the expected tariff exposure, but as we mitigate that or that shifts, I think we will potentially see gross margin expansion in 2025.
What are some of the mitigation actions you're looking at potentially taking?
Yeah, I think there's a number of different things. We're early in the strategy, so I don't want to get too far down the road there. Again, we're in a maybe potentially a bit of an easier position. We're doing the manufacturing in the U.S., so it's really just around where we source materials and if there's opportunities to evaluate different suppliers there.
Got it. Maybe digging into Zio AT a bit more and the primary care opportunity. Ending last year, you said you had 10% market share with Zio AT and that you expected to take one to two percentage points this year. I was curious, given the recent strength in Zio AT, do you have any updated thoughts on that one to two percentage points of share gain and maybe just remind us how you think about the market opportunity and how market share translates to revenue dollars?
Yep. Yeah. So with the strength we've seen with AT the last two quarters, I think we are outpacing that one to two points of market share growth. We'll update that once we have a better picture of kind of overall market growth, but we were absolutely outgrowing the market and taking share. To the earlier comments, expect that to maintain through 2025. We're just over 10% market share in that segment. If you think about long-term continuous monitoring where we play with our Zio Monitor product, we're 70% market share there. A real opportunity to close the gap there. There is a significant overlap with the two prescriber bases and a lot of benefit to prescribers and accounts to utilize the same vendor and same provider for both modalities. We feel really good about our ability to continue to grow our share there.
AT is performing well. We have a next-generation product, Zio MCT, that we're looking to submit with the FDA in Q3 this year. We believe that's another unlock of opportunity for us.
Just to follow up on that point, just how are things progressing with the FDA and your interactions on that filing?
Yep. Yeah. Continue to feel good about that Q3 filing date. Everything that we have control around, we continue to execute against and feel good about that Q3 timeline.
Maybe thinking about post-approval, how we should think about the potential ramp of adoption. Would you do a more limited market release first or could you start with a more broad launch? I guess just trying to get a sense of the potential contribution in 2026.
Yep. When we did a cutover from Zio XT to Zio Monitor, there was a period of time there where it was a kind of a phased launch, right, over the course of 12 months or so. I think there is an opportunity to move faster from AT to Zio MCT. It is on a hardware platform that has been utilized with Zio Monitor, so it has been tested on patients, obviously. I think there is opportunity to move faster there. Of course, we want to test the service, make sure we have the kinks worked out before going kind of full scale, but we will update guidance as we get a bit closer there. Our intention is to move to Zio MCT as quickly as we can.
Got it. Maybe thinking longer term about the share potential here, I think you said you could see share capture being at 30%-35%. Curious if any updated thoughts, I guess, similar to my other question, just given the recent strength, if you think that's still reasonable or if you could get there faster, which sounds like potentially yes, or if your overall outlook on that has increased.
Yep. I do think with the strength that we're seeing in AT, I think the benefit is when we get Zio MCT on the market, we are launching from a position of strength, which is only going to help things. Will we be satisfied with 30%-35%? No, we want to continue to drive greater than that, but we got to get to that milestone first. Yeah, feel good about it. We're focused on getting that submission into the FDA as kind of the next milestone and ultimately launching thereafter and excited about what we can do with it.
Okay, great. Maybe touching on the primary care opportunity, another growth driver you've talked about is the Epic partnership. I know it's still early in the rollout, but curious how that's going, how you've seen it contribute to volume growth so far, and maybe what you're seeing in terms of Epic accounts that were already Zio users versus getting new ones.
Yeah, absolutely. So very pleased with some of these early positive signals with this Epic integration. As you note, we are early in this rollout, right? Maybe as a reminder though, we have been doing EHR integrations for a number of years at this point. And to date, just over 40% of our registration volumes in the first quarter were from EHR integrated accounts, right? But the benefits of the Epic integration specifically is that we shrink the timeline to implementation by upwards of 60% or more and reduce the resources from the accounts IT side to actually implement, right? So all of that is working to enhance clinician workflows, make it easier from the ordering process perspective, and also easier for the physicians to review the report within their native instance of EHR.
Within these early pilot accounts, we have seen a bit of a volume uplift to date, right? We talked about versus pre-integration to post-integration, kind of the volume uplift is on average about 20% with some accounts showing kind of that 40% or more volume uplift, right? This is very early. Again, as you know, these are the pilot accounts, right? We do have a steady cadence of additional accounts, both existing accounts who have already been familiar with Zio, but also new accounts who will go through this EHR integration in 2025. Very pleased with those early signals.
I don't think you currently have much baked into guidance for this year.
Correct.
I guess just curious at what point you might start to consider adding that in, or is it more of next year?
Yeah, I think if we continue to execute and work through that pipeline and see a consistent kind of set of results in terms of that 20% uplift in volume, I think that at that point, there's an opportunity to bake it in. It's still early. It's only a handful of accounts to this point and want to see a bigger sample size before really baking in too much there.
Makes sense. And then on primary care adoption at IDNs, you've talked about a land and expand strategy there. At this stage, I guess what's the balance between the two and what you're seeing once an account is landed in terms of expansion in those accounts?
Yeah. Yeah, this land and expand strategy has been part of our strategy for a number of years. I think we've gotten more kind of organized around and structured in terms of really implementing that strategy within our commercial team. Have organized the team in a way that supports both of those aspects, have a team that's focused on landing new accounts and opening new accounts, and then have a team that immediately follows to drive some of these expansion plays within that account. That isn't always primary care. There are other opportunities for expansion. Getting an account to EHR integration is one play. More and more, expanding into primary care is a big part of the strategy and is really encouraging what we're seeing.
I believe it's better for patients, better for physicians, better for payers to bring Zio upstream earlier in the kind of the care pathway for patients. It feels like everyone is supporting that. Cardiologists and electrophysiologists, which are generally the clinical champion when an account is initially opened, are supporting this move up to primary care. They're helping drive the education and awareness of Zio upstream to the primary care physicians that are referring patients onto them. It feels like all incentives are aligned and really encouraged what we're seeing there. We did call out over a third of volume in Q1 2025 was through that primary care, through primary care prescribers. That has grown from, call it 20% or so in full year 2023. It's been a nice growth driver for us. I think it opens up a lot for us strategically.
Being in primary care, there's just a bigger opportunity to capture more patients through that channel.
On that one third that you mentioned in Q1, I guess, how do you see that trending through this year?
Yeah. We have not given forward guidance on that, but do expect that to continue to grow.
The other strategy you've talked about here is through the innovative channel partners. You announced you signed a new one in Q1. I guess can you talk about the type of contribution you're seeing so far from these partnerships? In general, I guess what's the process of getting these partnerships and how fast can they start contributing?
Yeah. Yep. This has been a really exciting part of what we're seeing in the business more recently. I will say this is a strategy that we have been working towards for a number of years in terms of asymptomatic monitoring and preventative care. It's been a big part of our strategy. We've been generating the clinical evidence, and I'd say we're really starting to see that traction kind of play through in the markets. Mentioned over a third of volume is through primary care. Think about innovative channel being a subsegment of that and call it low single digits as a percent of overall volume. I would say if you rewind 18-24 months ago, that was close to zero, if not zero. It has been starting to show up in our business. I do think we're just getting started here.
We did mention that one new account that we launched in Q1. There's a number of others in the pipeline and feel good about how that may ramp from here.
Maybe shifting to some questions on the P&L. Gross margin in Q1 came in ahead of your expectations. Maybe just talk about some of the puts and takes on the quarter.
Yeah. I would compliment our operations teams here, both on the manufacturing side as well as our clinical operations and just how efficiently they are operating and executing. We did launch phase one of our manufacturing automation last year. We have subsequent phases to come, phases two and three later this year and next year. That will be a nice source of margin for us. I would say it is just leveraging the infrastructure that we have built over the last decade, the IDTF infrastructure that we have in the U.S., more and more offshore capabilities. Leveraging that, operating efficiently, you are seeing that show up in gross margin.
I guess moving down to OpEx and the operating leverage you've talked about, I guess any expectations for OpEx this year that you've shared and on those operational excellence initiatives driving operating leverage, I guess talk a little bit about what some of those are and yeah.
Yeah. Yeah. We are focused more and more on profitable growth. We are still a growth company. We still see tremendous growth ahead of us. We want to be investing in that growth to capture those opportunities. At the same time, we want to continue to be more profitable. We are trying to find that right balance. I think we have been finding that right balance, kind of driving to that 400-500 basis points of profitability expansion year to year. That is reinvesting some of that revenue back into the business to go after some of these growth opportunities. I feel like we are finding the right balance. We did execute on some of these operational excellence initiatives you referred to last year. I would say there it was really being thoughtful around how the company operates. We have been a high-growth company for our entire lifespan.
Oftentimes companies just grow and try to keep up with that scale and maybe not operating in the most efficient way possible. We looked at that in terms of how we grew, what our structures look like, and found some opportunities to be more efficient there. I mentioned leveraging our global infrastructure. That is certainly a source of leverage for us, has been and will continue to be. I would say from an automation standpoint, an IT system standpoint, I think there is a lot of opportunity to be more efficient there and continuing to drive leverage into the future. I am sure we are going to talk about FDA remediation activities. There is incremental $15 million of spend going towards those activities. Ideally, we are wrapping those up by this year, and that will fall off and be a nice source of leverage for 2026.
Yeah. I guess I can ask now then just on the progress on the Form 483s and the warning letters, just how everything's tracking there.
Yep. Yep. Yeah. I feel really good about the progress we're making. We laid out a remediation plan, 12-month remediation plan with the FDA back in August. We continue to hit all of our commitments, all of our timelines that we outlined there. I feel good about continuing to execute on that plan. We will be going above and beyond that as we've been talking about publicly and really kind of a full overhaul of our quality management system. We're bringing an outside party in to essentially do an audit of our quality management system that'll take place really in the back half of this year, but feel really good about the progress we're making.
On your, I guess, longer-term margins, you have a long-term goal of 15% EBITDA margins at $1 billion in revenue. Can you get to mid-20% as you exceed that revenue? I guess how are you tracking towards that goal?
Yep. Yep. On pace to deliver that. Again, that is letting some leverage play through the P&L while also reinvesting back in the business, which we think is the right balance. That billion-dollar target at 15% margins really is just a point in time. We do expect to continue to be growing in that high teens, near 20% revenue standpoint. We believe that's the right margin profile for a business of that nature with the opportunities that we have in front of us.
Wanted to ask on maybe your R&D outlook because you've talked about a number of adjacent market opportunities and multisensing capabilities. Just curious about the outlook for investment needed to bring some of those opportunities to market and how we should think about that.
Yeah. Yeah. I think we feel good about our R&D spend as a percent of revenue and kind of maintaining that level. Again, we think that's the right level where we're investing in these growth opportunities. There's a lot there, right? The multisensing platform we want to continue to develop, obviously Zio MCT that's front and center for us that we're working towards getting on submission with the FDA in Q3, then moving on to that next generation platform. There's a lot we can do on the back end too in terms of AI tools, clinical workflow tools. Those are all investments that we're currently making. There's a nice healthy pipeline of things to continue to invest in. We'll look to make sure we're maintaining that right level of investment.
Maybe just to follow up on the revenue opportunity from the multisensing capability. You mentioned in the past that you can monitor for sleep disease for a few days and then for cardiac arrhythmias and increase the revenue opportunity without changing the cost. I guess anything more to share there on kind of what that model and opportunity looks like?
Yeah. Yeah. That's still an opportunity we believe in. That is an opportunity we're pursuing. I'd say the benefit of that platform is kind of twofold. One, we believe it's going to deepen kind of our competitive positioning or strengthen our competitive positioning in our core markets while also opening up opportunities in adjacent markets, sleep being probably the most obvious one and maybe nearest term one. We are working on those opportunities internally. Nothing to guide you all to just yet in terms of when that may contribute to revenue, but it is active programs inside the company.
Got it. On free cash flow, you anticipate being slightly negative this year and becoming positive next year. I guess any color on the cadence of this year and kind of the exit rate into next year and some of the assumptions needed to get to the positive expectation for next year?
Yeah. We were positive free cash flow actually in the back half of last year. We would expect a similar type of profile for this year. We are investing in all the things that I just mentioned, including some of the clinical workflow tools, the software tools that are used internally that are not necessarily in R&D, but are more capitalized investments. Those are active investments that we are making. We did say on our most recent call, just given potential supply chain disruptions, we are investing in building up inventory reserves as well. That comes with some incremental cash needs for this year. That is a one-time thing. That will be kind of a source of leverage going into next year.
It's an important milestone for the company getting to free cash flow positive, setting up 2025 to be slightly negative, and then expect to be free cash flow positive in 2026 and beyond.
Got it. Maybe just one on OUS and kind of the Japan update. You had expected $2 million in revenue on the full year guide, but that's come down a bit given the reimbursement update in Japan. I guess talk about your outlook here on the overall market opportunity given that reimbursement decision and maybe how we can think about this opportunity next year.
Yeah, absolutely. I think we're still excited about the Japanese market strategically. It's about 1.6 million ultra monitors performed per year, excuse me. It's definitely a strategically important country for us. We are moving forward with the commercialization in Japan. As you mentioned, it is at a reimbursement rate that was a bit disappointing for us. It's in line with the whole term monitor rates in country. We're excited to move forward. We are focused today when we move forward commercially on generating in-country clinical evidence. What we understand is kind of missing there is some head-to-head comparisons with some of the other patch-based monitoring technologies that are in the Japanese market today.
We are very confident that we can kind of show the value of Zio specifically as all of our additional, all of our other clinical evidence to date has already shown. We will submit that for future reimbursement cycles kind of starting with next year, certainly. Hopefully the MHLW will recognize that value. That is what we are doing to move forward there.
I guess on pricing overall, you mentioned it's a low single digit pricing headwind this year, which I think is unique to this year versus last year. I guess how do you think about pricing trending longer term?
Yeah. That low single digit pricing headwind has been fairly consistent the past several years and is something that we generally guide to. That again has been consistent. That is the right way to kind of frame expectations. Certainly, we'll look for opportunities to improve price where we can. We're also focused on growing volumes, and sometimes there's a trade-off there. That low single digit pricing headwind is a good way to think about it.
Okay. I think we are just about out of time. So we'll wrap it up there. Yeah. Thank you.
Thank you very much. Appreciate it.