iRhythm Holdings, Inc. (IRTC) Earnings Call Transcript & Summary

Welcome, everyone. I'm Robbie Marcus, the med tech analyst at JPMorgan, and I'm very happy to introduce our next company, which is iRhythm. And today is a first, its new CEO, Mike Coyle's first day at work, first day at the JPMorgan conference and first time presenting as the CEO. But before I hand it over to Mike, I just want to make a few housekeeping announcements. You can go ahead and get the slide deck from the JPMorgan conference website. You can go there to submit a question. I'll do my best to add -- to ask Mike all of the questions in the breakout afterwards, or feel free to e-mail me or chat me on Bloomberg. So with all that out of the way, Mike, why don't you go ahead, and we'll join you afterwards for Q&A.

Thank you very much, Robbie. And as Robbie just mentioned, this is my first day on the job. I couldn't think of a better place to start it than at the JPMorgan conference. But I will get some help during the Q&A session, just given a lot of details of the company that we're going to want to speak to. But first, let me say, I couldn't be more excited to join iRhythm in the leadership role for the company. This is a company that I have spent a lot of time watching over the years. Obviously, I've spent a lot of time in my career in cardiovascular and particularly in cardiac rhythm. And I've always viewed this space of basically the identification, detection of arrhythmias as one that was really ripe for a disruption. And as I've watched iRhythm over the years, they have really done a remarkable job in terms of being able to reinvent that segment. We're going to talk about it a little further into the deck, but they've created layers of differentiation in their capabilities that basically are really redefining the way the detection of arrhythmias and management of patients is being done. And despite the fact that they've had very strong growth here over time, the recent time period, I see us really just being at the beginning of the growth profile for this business. They're less than -- we're less than 40% penetrated into the core asymptomatic atrial fibrillation detection market or arrhythmia detection market, has significant opportunities to grow outside of the United States with international market development and really new indications for use for this technology that can take us into new areas such as asymptomatic atrial fibrillation. And really the core technology for their AI-enabled analysis of biometrics, I think, is applicable to things beyond the arrhythmia detection and management. So this is a company that I think has a very long-term growth profile associated with it that I'm going to be happy to lead and drive. And I really think they sit in a very unique place between tech and med tech, which I'm excited to become involved with. So with that, let's go to Slide #2. And I'll just remind you that some of the commentary in our presentation here today and in the Q&A afterwards will constitute forward-looking statements. I would direct investors to both our recently filed documents of 10-K and 10-Q to outline risk factors. And with that, we will jump into the body of the presentation. So let's start with Slide 3. And as I think many of you know, I have spent most of my career in the cardiovascular area, especially cardiac rhythm, and have really had an affinity for investments that can disrupt and invent new markets within this space, mostly on the therapeutic side of the business. But what attracted me to iRhythm is the fact that they are, right now, redefining the way arrhythmia management is done, reaching a diagnosis and patient management. And it's not about a single product or even 2 products. It's really about a set of core technologies that they bring together to provide a service for the very effective and efficient identification of arrhythmias that then can be treated to avoid very serious complications. And the system is really comprised of 3 really technology vectors. The first is single-use wearable patches or sensors. These technologies basically have form factors that allow them to be worn comfortably for 14- to 21-plus days for enabling the collection of large amounts of clinical data from the patient. They're able to store large amounts of high-fidelity electrograms and can store them on the device or can take them to the cloud directly with cellular connectivity. That core technology is then sent to the cloud or those core data sets, where the company has developed AI-enabled data and analytics that basically use deep neural networks and learning algorithms to be able to really, in a very high degree of sensitivity and specificity, identify the presence of arrhythmias from the raw data that they're sent. And they are able to do that with this technology in a way that is actually more efficient and effective than a board-certified cardiologist could do on their own. Those conclusions of that analysis that show what the arrhythmias are, are then put into a very user-friendly format, summary format that's delivered directly in clinically actionable reports to the customer. And what we've been able to do with that software development is to tie directly into the EHR systems to make them seamless to the use of the processes within the account, but also have enabled the physician to be able to see these data sets and their conclusions on multiple platforms, whether it's a desktop or mobile platform and even have developed patient-centric apps that allow direct communication with the patient. So it is the combination of these 3 technology vectors that really has disrupted the traditional Holter and MCT market and has been driving the significant growth that you've seen the company deliver. If we go to the next slide, Slide #4, the market that the company is addressing is really a very large one and one that's very poorly served by existing technologies, older technologies in the space. Cardiac arrhythmias are a huge burden in the marketplace or in the clinical space, not just here in the United States, but worldwide. The numbers I'm going to speak to are U.S. numbers since that's where the company is generally operated, but the opportunity is as large or larger outside the United States. And the arrhythmias we're talking about are not just atrial fibrillation, but other atrial tachycardias, things like the ventricular tachycardias, PVCs, premature ventricular contractions, as well as things such as AV block. And the -- these kinds of arrhythmias are highly prevalent. We'd estimate there are 11 million patients in the United States who experience these types of arrhythmias, and they're very demographically driven. So they are actually growing as the population ages. In fact, in atrial fibrillation alone, the prevalence of AF in a patient who reaches the age of 55 in the United States will have a lifetime expectancy for 40% of those patients developing AF. And when these patients actually manifest these rhythms, they wind up using a lot of expensive hospital services in the health care system. We would estimate 750,000 patients a year are hospitalized due to atrial fibrillation, either because of symptoms or because they've had a stroke or because they progressed into heart failure. And we'd estimate that over 130,000 patients a year actually die as a contributor to -- from AF, mostly from ischemic strokes as well as progression of heart failure. And these are some of the most expensive patients in the health care system. To give you an idea, if a patient has the presence of atrial fibrillation, whether they feel it or not, they're at a 5x higher risk of developing an ischemic stroke. And for many of those patients, the first time they'll ever know that they had an AF episode going on in their body is when they appear in the hospital for heart failure or because of a stroke, which is a shame because those patients have good technology options for therapy, such as oral anticoagulation, which would lower their risk for stroke by 80%. And so identifying these patients will help us avoid what is an extraordinarily expensive cost to the health care system with $34 billion a year just on stroke alone. So that's what the company is involved in developing their technology to do. If we go to Slide #5, you'll see that the market today is really focused on a segment of the population of those who actually experience symptoms. So these would be patients who either have palpitations or they have syncope or unexplained fainting, and then seek out diagnosis. And those patients represent about 5 million tests a year, where they're actually being investigated to see if they have an arrhythmia. And those arrhythmias are being detected across 3 core technologies. One is Holter monitoring, which is basically a 24- to 48-hour monitoring system that looks at multiple leads in a very inconvenient way on top of the patient and stores the data. The second most prevalent approach is through event monitors. This basically uses a single lead system where the patient can identify their symptoms by pushing a button and then those data are stored and returned and analyzed. And then probably the most sophisticated of these segments is the mobile cardiac telemetry segment, and this is where the actual data that is being collected from the patient is streaming via connected cellphone technology to continuous monitoring. These -- the technologies are dominated in terms of what's being used today in the Event and Holter segment. And frankly, these technologies are 25-plus-year-old approaches to doing a detection. What iRhythm has been involved in doing is really driving the reinvention of this market through its ZIO platform with 2 principal configurations. One, the ZIO XT, which basically stores data, which is then mailed back to us for very detailed analysis using AI technologies. And the other is the Zio AT product, which actually provides real-time monitoring from the patch technology. But to give you some idea, the overall market opportunity at a prevailing pricing for just the patients who are currently being tested for symptomatic AF is on the order of $1.8 billion. So a lot of running room for growth for the company, just penetrating the patients who currently are being serviced because of the better form factor for the ZIO technology. But there's a lot of differentiation as we go to the next slide, Slide 6, in the technology that's really important, I think, to understand. And I think Kevin King, who has been leading the company, has done a really nice job of outlining this concept of innovation stack. That is various different technology factors that come together to enable that full system to be provided. And it is the investment across these 5 areas that really has differentiated the ZIO platform from other technologies in the market. The first is the patient database itself. The company has been in existence for 9 years. And has collected over -- from 3 million patients, electrogram continuous strips, out to 750 million hours of data, which is a huge repository of raw data, but also data that has now been completely adjudicated for what rhythms exist within the data. And this is really important from an AI perspective because it gives us a rich data set on which to continuously improve the specificity and sensitivity of analysis. That analysis work is done by our proprietary data analysis software. These are AI techniques, deep neural networks, that are applied to the rhythms themselves and use this advanced learning to actually, in a very efficient way, identify quickly and efficiently where the rhythms exist for the patient. The third area of differentiation that is once these highly specific and sensitive data sets have been analyzed, they can be put into a very convenient form that can slide right into the workflow of the account. So be able to tie into the electronic health record of the hospital as well as provide the physician with adjudicated but sufficiently detailed data about the specific electrograms that gave rise to the diagnosis to get them comfortable that they are seeing the right diagnosis for the patient. Of course, the fourth area of focus is the patch itself. That form factor itself is differentiated in the marketplace because of its ability to be worn, which drives patient compliance over that 14- to 14-day-plus time period, but also has the opportunity to be able to store large amounts of data in a very high fidelity way that then can be transmitted for the AT version by cellphone networks to the cloud for analysis. And the other -- the fifth area that the company has really invested in for differentiation unique in the space has been the generation of clinical evidence on both the clinical effectiveness as well as cost effectiveness of the technology with over 40 peer-reviewed publications now available that are used to drive adoption of the technology. And the confidence that those publications have given us have now allowed us to be in a position where 95% of U.S. patients are actually on networks that will allow for in-network prescription of the product. So very significant areas of differentiation across these 5 technology areas that come together to provide the differentiation of the system. And these are all vectors of investment that the company continues to advance relative to competitors to build really a very strong strategic moat -- competitive moat in terms of separating itself from the other form factors. So all of this investment will be usable in new form factors as we iterate on the technology and so really become just a series of important technology builds to differentiate our product line. If you go to the next slide, you have been able to see the adoption rate of the technology here over the last several years has driven the strong revenue growth for the technology here in the United States. And as we've talked to customers, I think they summarized it best by saying the 2 things that they get from the ZIO system is: One, really clinically proven analysis that's very sensitive and specific; but then number two, it fits very efficiently and completely into their operational networks. And on that first point of clinically proven data, as I mentioned, we have 40 peer-reviewed publications that basically highlight the accuracy of these data and their cost effectiveness. There was a seminal publication. It was the Nature journal article which basically showed that the application of the deep neural network AI technologies that iRhythm has developed to the analysis of these software -- of these electrograms actually provided more sensitive and specific results than trained cardiologists. So a better outcome in terms of the ability to do it and obviously, more efficiently in terms of way it's delivered, which then gives our customers, especially the heads of clinical cardiology and heads of the electrophysiology labs, real confidence that they can put this into their referral network and actually get the right patients identified who need to come in for further therapeutic intervention and keep patients who don't need to be coming into the center from coming into the center. And this is really unique to the ZIO platform as we -- it's really been the only technology that's been able to be confirmed to actually be the equivalent of an implanted pacemaker in terms of its ability to look for AF burden. Other technologies simply have too many false negatives or too many false positives compared to the ZIO platform, both as a function of the form factor as well and more importantly, the AI data analysis. So this is what has really differentiated the technology in terms of its proven clinical benefit. But on the next slide, you'll see it's equally important that it fit seamlessly and operationally seamlessly into the operations of the customer. So the provider system tying into their electronic health records, but also to the physician and the patient to make it easy and conveniently actionable in terms of their ability to get confirmation of the presence of the rhythm. And the ZIO suite of digital information platform is really what enables this to occur. That data is -- after it's been adjudicated by the software systems is then presented to the physician in a very seamless way, whether it's through their desktop in the clinic or whether it's through their iPhone or portable phone. It allows for a very intuitive experience to be able to see what the conclusions of the data analysis are, but also to be able to look in detail at the specific strips of electrogram that show the overall presence of the rhythm. But then also, it's able to track how the patient is progressing through the system. Do they have the patch on? Has it been returned? In much the way you would do with a product coming from Amazon. And then obviously, the other opportunities to then interact with the patient themselves on compliance to the technology, and that is enabled through patient apps that tie into this seamless network. And all of this allows for a much faster and more intuitive experience for the customer to be able to quickly get to the answer. Is there a rhythm that we need to treat? And if so, what is it? And so this has really been what has been driving the differentiation of the overall system, and it has now been able to be put into formats that allow it to be done in the clinic as well as at home. And as you can imagine, pre-March of last year, 90% of the applications of this technology were being done in the clinic. But as COVID hit, there was a significant move toward actually doing this completely remotely so that a patient could be prescribed the patch. It could be put on to the patient by themselves and then monitored and returned and analyzed. And only if the patient actually had a rhythm that needed to be treated, would they then be sent into the office. So a very significant advantage that was really uncovered by the challenges of the COVID system. If we then go on to Slide #10, I'll just update you on developments and reimbursement. This is an area of focus for the company in terms of continuing to provide convenient reimbursement for the technology. There were important developments at the end of last year, especially in the area of coverage where, for the first time this technology, the XT technology, was granted a Category I code, CPT code, which is really a permanent code now that basically moves on from the Category III code that had been in place. So this is an important development and is effective here January 1 of this year because it really validates the permanent role that long-term MCT monitor or cardiac monitoring has in the marketplace. And really, we think we'll have a very positive impact on adoption of this technology among users. It also has some very tangible benefits to us in terms of being able to now apply this technology in the Medicaid population. And it also gives us an ability now to basically bill for the home enrollment services, which are effectively an ASP increase for the technology. We are also shifting our attention now on to the area of payment and basically the ability to establish pricing. As of this year, the beginning of this year, we will continue to focus on MAC level pricing for this technology as has been done for multiple years. And obviously, now with the strength of the Category I code as well as the increasing body of evidence showing not only the safety but the effectiveness or cost effectiveness of the technology should allow us to continue to receive effective pricing, and we expect that to be established here in the first quarter of this year. And then longer term, we are going to be looking to establish national pricing for the technology. Obviously, the existence now of the Category I code gives us an opportunity to work with CMS on the establishment of national pricing where we'll be working with other companies who have an interest in basically taking the AI technologies that are applied to analysis and incorporating them into a very cost-effective delivery of service. So this is something that we will be meeting with a consortium of companies that have an interest in that space. One of the things that gives us a great deal of confidence that we will get good established pricing in this area is just the large amount of data that we talked about in those 40 peer-reviewed data sets that show the cost effectiveness of this technology. An important development that occurred here at the end of last year in the U.K. is also going to help us in this area. And that is the receipt of NICE certification for the XT technology. So if you go to the next slide, Slide 11. There were a number of important advancements that took place in the U.K. here in the -- at the end of last year, including the ZIO technology being awarded the Artificial Intelligence in Healthcare Award among a very small group of 530 applicants who actually applied for this differentiation. And as a result, NIH is going to be investing in a program among several of their hospital trusts to drive adoption of the technology and look for extended evidence of cost effectiveness. So we think this will have an important drive of adoption of the technology into the NHS system as it supports the application of AI that they have been looking to as a way of driving efficiency in their system. Also at the end of last year, the National Institute for Health and Care Excellence, NICE, who is probably considered the most sophisticated cost-effectiveness assessment organization in the world, approved the Zio XT as for a private -- a positive payment recommendation. And they basically are supporting this as a cost-effective option that will provide better outcomes for patients in a more cost-effective way for anyone requiring monitoring over 24 hours. So this is a really important development in terms of providing additional evidence as to the cost effectiveness of the XT technology. And we can use this not only to drive growth for the technology in the U.K., but then also to have that be a platform of data to actually drive into the rest of Europe and beyond for more international market expansion. So if we move to Slide #12, all I've talked about in terms of the available market to date has really been that symptomatic group of patients. But we see a large market expansion opportunity to move into asymptomatic patients with this approach. And patients who are at elevated risk for AF but don't have symptoms are at significant risk for bad outcomes in both the area of stroke and hospitalizations for progressive heart failure. And we would estimate that there are roughly 10 million-plus patients out there who using measurements such as CHA2DS2-VASc, can be identified as being an elevated risk for AF. And by actually doing detection of AF using the ZIO system in advance of them actually developing systems, we see an opportunity for them to receive treatment, whether it be drug treatment or ablation treatment, to actually head off the bad outcomes that will come to a patient at elevated risk for AF. And in fact, just the appropriate use of NOAC therapy or oral anti-coagulation therapy in this patient population would lower their stroke risk by 80%. And the data sets that we've used to be able to identify this were recently published or presented at the American Heart Association, if you go to Slide 13, which was a study called mSToPS, which was done with a population of patients from the Aetna system and sponsored by the Scripps Institute, where basically patients with elevated CHA2DS2-VASc scores and at elevated risk for AF were put in to match control groups, one of which we received active monitoring with the ZIO system; and the other match control, just basically their normal treatment. They were followed for 3 years, and the dose data were presented at AHA here at the end of last year. And what we found was over 50% more patients were identified as having atrial fibrillation, which meant more of them were then actively treated for the atrial fibrillation. And as we follow those patients for 3 years, we're able to see a 20% reduction, very significant heart outcomes, including death hospitalization, death stroke and myocardial infarction. But we also saw an improved safety profile for these patients as fewer of them were inappropriately put on to oral anticoagulation medications, so lowering that overall risk, bleed risk in the patients as well. So this is very promising data showing the benefit one can have with the proactive use of the ZIO technology in patients who are at elevated risk for atrial fibrillation. And we will see follow-on analyses from this data set coming here at midyear as we generate the cost-effectiveness data associated with that study. Just moving to Slide 14. This is not the only work we have going on clinically. In fact, there are multiple trials that are going on to improve the availability of data on both the safety and efficacy of the use of the product in the asymptomatic patient population. And we think these data will become increasingly compelling both to payer systems, to integrate payer provider systems as well as to those who were generate clinical guidelines to be able to have more active use of monitoring in these at-risk patient populations. And as recently as 2018, the U.S. preventive services task force said there was not yet sufficient evidence to support using these technologies. But as these more impressive data sets have now been available and become visible, we're now seeing movement among guidelines generators, such as the European Society of Cardiology, to actually now begin to specify asymptomatic patients for use of the technology. And we expect, as data sets continue to enroll or report and reinforce this messaging, we see a significant opportunity to continue to grow the business. So moving then to Slide #15. That opportunity for growth that we see from both continued penetration at the expense of Holters and cardiac telemetry or -- at event recorders, the opportunity to expand into the international markets as well as the growth opportunity that we have in front of us in terms of expanded indication, we think will allow us to continue the very strong growth that the company has had. And as you see on the left, even post COVID, where other companies have struggled to provide any growth, iRhythm has been able to show very strong growth profiles for its overall business. And in the process of generating that growth, we've also been able to show important margin expansion opportunities, both at the gross margin and at the operating margin line, which we expect should continue. But we'll be balancing that margin expansion opportunity that we have with the very significant opportunity to invest in new growth along each of the technology and market growth factors that I mentioned. Beyond simply the growth profile of the business, the company is in a very strong position from a capitalization perspective with over $300 million in cash on hand and only $35 million in debt. So beyond being able to invest from our income statement generation of cash, we also have the opportunity to tap into our balance sheet to take full advantage of the growth opportunities in front of us. So with that, going to Slide 16, I'll just summarize by saying I couldn't be more excited about joining the company. That's -- iRhythm has been a company that is in the process of completely redefining the way arrhythmia management is done or detection is done and diagnosed. The platform that we have for ZIO is scalable into continued growth into the patient populations that I mentioned. And the service is proven from the investments that we've made as a company on both clinical and economic evidence to support its adoption in current markets and in market expansion. And we believe the opportunity to move into new indications for use really provide a significant total available market expansion opportunity over the next several years. The company has a very strong management team. Kevin King and his team have done a tremendous job bringing the company to where it is today. And I couldn't be more excited about the next phase of growth for the organization that I have an opportunity to now lead. So with that, Robbie, I'll bring you back on. And I think I'm going to basically invite our Head of the IR and Strategy, Dan Wilson; as well as Doug Devine, our CFO, to join in for the questioning. So with that, let me turn it over to you, Robbie.

Yes. So I'm going to ask you all the hard questions. I'm going to give them the easy ones since it's your first day here. Mike, I want to pick up right where you left off. And I think Kevin did a great job leading the company from the IPO up until recently and the execution. The whole iRhythm has been phenomenal. I know today is your first day. But after over 10 years at Medtronic, where you led the CVG business, what was it that attracted you to iRhythm? I'm sure you saw every company, every product, every company wanting to go public and you chose iRhythm. So what was it that drew you here?

Well, as I mentioned, I've been in the cardiac rhythm space for the better part of 25 new years, and I've always identified this area of detection and monitoring as an area that was ripe for disruption. And clearly, over the last several years, iRhythm has done a tremendous job of creating multiple layers of technology that have addressed this unmet clinical need, completely disrupted the way Holter monitors as well as the event recorders operate. But what's really impressive to me is that despite the strong growth profile of the business to date, they're really at the very front end of being able to penetrate symptomatic atrial fibrillation, international market expansion as well as expanded indications for use. So I see the sort of redundant layers of differentiation of their platform and these innovation stacks, coupled with the untapped market opportunity, as just being something that was just too exciting to think about.

I've had several questions mailed in. So I'm just going to ask it upfront. How did you get comfortable with the potential reimbursement update, let's call it, coming up in the next quarter or so before you ended up taking the role?

Well, the most important thing to me was the question of is this service and is this technology cost effective? And I think what iRhythm has done and really the only one in the industry who has done, has really invested in the generation of clinical and economic evidence to be able to show that this is cost effective. And I think you saw that in the recommendations coming from ACC, from HRS in terms of their support for how this really efficiently drives the identification of arrhythmias for treatment and eliminates waste in the system. And one of the things that got me particularly comfortable with that conclusion here was in December, the conclusions from the U.K. that this technology receiving approval. From my perspective, really is -- the NICE organization is probably the most sophisticated cost-effectiveness organization that I've worked with. And the fact that they have validated that technology really says that it really is highly cost effective at its current price points. But -- and I'm very comfortable that just the model that we have today of being able to use local pricing is going to give us the time we need to be able to move toward national pricing over time. But from my perspective, what was at the heart of it was the fact that this is the application of AI to this kind of patient analysis is going to drive cost effectiveness in the system.

It's pretty amazing that within a 24-hour period, you had probably, on one hand, NICE, one of the most strict organizations in the world and cost-effectiveness going all out, laying out the red carpet for ZIO and its platform. And then on the other hand, you had CMS basically punt on giving an answer. So it's not how we usually expect it to play out. But it sounds like you feel good about the cost effectiveness and the value that ZIO brings.

And frankly, I've seen this before in terms of the need for evolving approaches to reimbursement, right? If you went back over a decade ago, into the hospital side of the business when new technologies were being brought out, we needed to develop the tech add-on payment methodology within CMS in order to get those paid for. And they ultimately came to the conclusion that, that was an important development of their thought process around reimbursement because of the benefits to patients. And I think we're going to find something similar occurs here.

So Mike, you're coming from Medtronic, CVG, probably one of -- and I'm sure you know the answer, one of, if not, the largest cardiovascular organizations around the world. It's global, known for having some of the best relationships with regulators and payers around the world. And iRhythm is mostly a U.S. company and has a great relationship with its MACs right now. But from your point of view, what can your historical experience bring to iRhythm, not just today, but where the company you hope it should be in 3, 5, 10 years from now?

Well, clearly, I think that was one of the appeals of the opportunity that it clearly is a U.S.-based company, which gives us the opportunity to grow outside the U.S., and we have a lot of experience with that. We also see the opportunity to basically take advantage of some of the clinical evidence and market development generation experiences that I've had on the Medtronic side and therapeutics. But I think we can apply some of those lessons learned here to move into some of these new patient populations. And then finally, we have done a lot of work at Medtronic in the area of cost-effectiveness analysis with payers. And I think that work performance, guarantee programs, the idea of actually partnering on risk sharing are things that we can consider here at iRhythm for driving adoption directly with payers and with integrated payer provider systems. So those are all things that I think the learnings from Medtronic can really be helpful.

So late last year and over late last summer, we saw the SCREEN AF and then the mSToPS data. And in my head, if mSToPS in the asymptomatic patient population showed a cost reduction and a reduction in hospitalization, it's a home run by itself. But it did that and actually showed that patients live longer by wearing a ZIO patch for a month in high-risk patients, which for a test that costs $300, $400 that saves people's lives and makes them live longer, that seems like the biggest no-brainer in terms of adoption. So 2 questions for you. One, how do you envision this opportunity over the long run? And two, when are we going to get a better sense of the look, feel, touch and strategy around the device you're bringing out with Verily later this year?

So let me take the first question, and then maybe I'll ask Dan to help us with the Verily discussion. But from my perspective, the -- this is going to be a building process of generating more and more clinical evidence, economic evidence in the larger patient populations that will create more pull for adoption among greater payer provider networks and among payers. And so as you point out, the mSToPS data were very compelling from a clinical perspective. By midyear, we should have the cost effectiveness overlay on top of those data. And of course, there are a number of additional clinical trials that we are executing in much larger patient data sets that should provide even more confidence in terms of the ability to actually have this cost effectively applied. So to me, it's about continuing to roll out that evidence, but then establish the connections into the payer systems and into the integrated provider networks as well as frankly, the development guidelines that encourage the use of this technology because, to your point, it is absolutely a very cost-effective way of saving the health care system significant dollars in avoiding some very bad complications associated with the precedence of atrial fibrillation. But we don't consider -- we consider that an opportunity with just the existing products that we have. The Verily opportunity is one to potentially even expand or accelerate that market. And let me ask Dan to kind of comment on our status with Verily.

And Dan, I'm just going to let you know, we've got 2 minutes left in the presentation. So give us the CliffsNotes version, not the full expanded answer.

Fair enough. So we're a little more than a year into that collaboration and remain really excited about where that's headed. As Mike mentioned, we believe that can potentially increase the value proposition that we bring to payers and integrated networks for silent AF. The timing remains on pace. And this year, we should see a clear device that we can begin early efforts in terms of building evidence, establishing the technology, generating physicians' confidence in that technology, and that will take some time. We have a high bar and want to make sure that it is as clinically superior as ZIO is. And so we do need to take the time to build that evidence when we do bring it to market. In the meantime, as Mike mentioned, we have ZIO and we'll be pushing forward aggressively within silent AF around our ZIO service today.

Great. So we'll look forward to that product reveal sometime later this year. But look, we're out of time. I want to congratulate you on almost making it through your first day at iRhythm and really appreciate all of you for joining us today.

Well, we have several more meetings to go, but I appreciate the invitation. It really is exciting to be here and to really to start with iRhythm, which I'm very excited about.

Great. We'll end it there. Thanks, everyone, for joining and listening in.

Yes. Thank you.