Quentin Blackford
Analyst · Canaccord
Good afternoon, everyone, and thank you for joining us for our third quarter earnings call. We are pleased with iRhythm's progress in the quarter, and our results reflect the positive growth trajectory of our business across multiple channels as well as the meaningful operating leverage we continue to generate as we scale the Zio platform. I'll begin with the key highlights from the quarter and provide updates on our strategic priorities before turning the call over to Dan for a more detailed review of our financial results and outlook. Third quarter revenue was $221.6 million, up nearly 15% year-over-year against our toughest comparison of the year as we lap more than 30% growth in the third quarter of 2025. Overall performance was consistent with our guidance with our core Zio Monitor business again outperforming our expectations. That monitor business continues to be driven by durable demand and sustained momentum across primary care, innovative channels and international markets. We continue to expand the cardiac diagnostics market, both within traditional cardiology settings and across these underpenetrated opportunities. The strong performance in the core monitor business was offset by Zio AT, where revenue was roughly flat compared to the prior year. I also want to briefly highlight the record operating leverage we delivered during the quarter, reflected in gross margin of 74.2% and adjusted EBITDA margin of 23.1%. These results demonstrate the strength and scalability of our operating model as we continue to grow the business, while investing in the strategic initiatives that we believe will support future growth. This balanced approach supports both our long-term profitability and growth ambitions. Now I'm going to spend some time talking about the strategy we continue to execute to evolve from a leader in ambulatory cardiac monitoring into a broader cardiac and vitals monitoring and intelligence platform. First, I will walk through the opportunities that VitalConnect brings and then provide an update on the Zio MCT program. As a reminder, we closed the VitalConnect acquisition on October 5, well ahead of our prior expectation of closing by year-end. This acquisition is an exciting milestone for iRhythm as it significantly expands our capabilities and market opportunity. It also immediately adds a complementary FDA-cleared mobile cardiac telemetry offering to our portfolio. VitalConnect's platform can be used to monitor multiple physiological parameters, including ECG, heart rate, respiratory rate and body temperature as well as fall detection and the ability to connect additional parameters such as blood pressure and pulse oximetry. This platform supports ambulatory, inpatient, remote patient monitoring and hospital-to-home care, expanding our relevance across the patient journey and creating new opportunities within hospitals and health systems. VitalConnect will serve as our immediate MCT growth platform, while also providing important multimodality capabilities. It supports MCT, cardiac event monitoring, extended monitoring and Holter use cases with up to 30 days of monitoring service, live look-in functionality and the flexibility to transition between monitoring pathways when clinically appropriate. These capabilities are particularly important because our planned next-generation Zio MCT as currently designed, would not address every customer requirement, including live look-in, 30-day reporting and multi-modality workflows. We estimate these use cases represent approximately 25% of the MCT market and believe they are likely to grow over time. VitalConnect provides us immediate access to these opportunities and together with our Zio platform, will position us to address essentially the full MCT market with complementary solutions. This expanded portfolio also creates opportunities to deepen existing health system relationships, reach new customers and accelerate our participation in the broader MCT category. Realizing the full potential of VitalConnect requires more than expanding our product portfolio. We are integrating the technology into our customer EHR systems, incorporating VitalConnect's VistaCenter data and live look-in functionality, and enabling multimodality workflows. These capabilities are essential to driving broader adoption, particularly among our existing large integrated health system customers. In parallel, we are preparing the business to scale across supply chain, clinical operations, customer support, technology, quality, and implementation capacity. The earlier-than-expected transaction close allows us to accelerate commercial training into the first 2 weeks of November, enabling our teams to begin engaging customers, while we continue building the integration and operating infrastructure required for broader adoption. Our focus is squarely on executing a disciplined integration, and our initial progress reinforces our confidence in the significant value and new growth opportunities this acquisition will unlock for iRhythm. Having taken a significant step in broadening our MCT portfolio, we want to provide an updated view today of our go-forward path in this business. I'll start by directly addressing our next-generation Zio MCT program. In short, we have not delivered the way we want to here, and we recognize that this time line has shifted multiple times. We share in the frustration this has caused, not only for patients eagerly awaiting this program, but for our investors as well. Our ongoing commitment to you are transparency and clarity. We've evaluated our MCT strategy in light of the newly combined portfolio and how we can grow our presence in the MCT market as soon as possible. With VitalConnect, we immediately have an additional FDA-cleared MCT offering, and integrating this technology will be our near term priority. As a result, we no longer plan to submit Zio MCT to the FDA later this year. The addition of VitalConnect's capabilities open up what we believe will be a significant immediate growth opportunity, and this decision will allow us to focus on unlocking that value for patients and shareholders, while being deliberate in our planning and preparation to, in turn, maximize the value of our planned next-generation Zio MCT, our integrated MCT portfolio, and your investment. That said, we've made tangible progress with Zio MCT that gives us greater visibility into the path ahead. We've begun producing and testing the actual Zio MCT system in the configuration we intend to submit to the FDA, and we are advancing the remaining verification, documentation, and regulatory work. We expect to submit our Zio MCT filing to the FDA in 2027. Zio MCT is an important part of our long-term portfolio, as it is designed to build upon the simplicity patients and physicians value in Zio AT by providing an extended wear period and enhanced detection algorithms. We believe that an MCT portfolio today of Zio AT and VitalConnect give us an immediate best-in-class mobile cardiac telemetry portfolio that will further improve with the future introduction of Zio MCT, which we expect will eventually replace Zio AT. Turning next to Zio AT, we remain confident in its clinical value and the complementary set of solutions it creates with VitalConnect. In August, we published results from the CAMELOT-ALERT study in the American Heart Journal, evaluating nearly 450,000 Medicare beneficiaries across Zio AT, competing MCT platforms, and ambulatory event monitors. The study found that Zio AT delivered significantly higher diagnostic yield than both comparison groups, reinforcing the importance of platform capabilities and clinical workflows in driving diagnostic performance. That said, Zio AT performance was below our expectations during the quarter, where revenue was flat compared to the prior year versus our expectations of growth generally in line with our overall business. Based on customer and commercial feedback, we believe this was in part driven by delayed purchasing decisions following the announcement of the VitalConnect acquisition as they considered the combined portfolio and the potential availability of VitalConnect through the iRhythm sales channel. We expect these dynamics to persist in the near term, and we will be training our commercial team over the next few months on engaging with customers to sell the full portfolio. This further reinforces the importance of moving quickly to integrate VitalConnect and establish a comprehensive MCT offering that addresses a broader range of customer needs. Our near term priorities for MCT are clear: successfully integrate the VitalConnect team and business into iRhythm, actively commercialize VitalConnect in the MCT market, thoughtfully expand into adjacent multi-vital opportunities, and continuing advancing Zio MCT through the regulatory process. We believe our VitalConnect and Zio AT portfolio provides a strong foundation to participate more broadly in the MCT market in the near term, with Zio MCT remaining an important addition to the portfolio over time. Turning to innovative channels and primary care, we continue to see encouraging momentum as we expand cardiac monitoring beyond traditional cardiology settings. What is becoming clearer is that the market opportunity ahead of us is not simply about taking market share. It is about expanding our serviceable market in a meaningful way. More specifically, there is a measurable care gap for patients at risk of arrhythmias that can be addressed through better patient identification, better clinical workflow, and better access. Our research and analysis continue to support that there are more than 27 million patients in a defined ambulatory cardiac monitoring-eligible universe, creating a significant white space of opportunity. To more effectively prioritize and align our commercial approach, we are defining the addressable patient population through identifiable patient and provider categories. Symptomatic outpatients represent the largest portion of our undiagnosed opportunity, with many of these patients first seen in primary care. The data is clear. Patients presenting with the exact same symptoms in cardiology and electrophysiology settings are much more likely today to receive a cardiac monitor than patients presenting in other care settings, such as traditional primary care. That insight is shaping how we execute in both primary care overall and also in our innovative channel strategy. Starting with innovative channels, which was our fastest-growing business during the quarter once again, our partners increasingly view Zio as a way to identify and engage appropriate patients earlier rather than waiting for these patients to reach a specialist after repeated symptoms or acute care events. Importantly, our partners can make these determinations with confidence, as our early pilots have demonstrated greater than 85% accuracy in identifying patients with clinically relevant arrhythmias before they enter the diagnostic process. Primary care more broadly is also an important part of our upstream strategy. Zio's rule-in and rule-out capability can help primary care clinicians begin their diagnostic process earlier, enabling cardiologists to focus on patients who need higher acuity care. We recently launched targeted initiatives through the PatientPoint network, coordinating arrhythmia education for patients, physicians, and office staff. The objective is straightforward: improve recognition of symptoms and risk factors, help patients seek evaluation sooner, and make the connection between primary care and cardiology more efficient. Key enablers of this strategy are continued EHR integration, as well as AI, which is core to our business and embedded in our platform today with an advanced FDA-cleared AI algorithm that differentiates our monitoring service. We are continuing to bring forward new innovation on this front as we progress towards operationalizing our third-generation algorithm, which we expect to generate more than $100 million in cumulative savings over the next 5 years. We are excited to put this new capability into production in the early part of next year. And as AI advances, we believe durable value will come from more than a stand-alone algorithm, which is why we are focused on the broader ecosystem around cardiac monitoring, not just the output of an individual device. We are encouraged by the opportunity to close the sizable identified care gap and by the early commercial signals. The next phase is to turn these programs into a repeatable playbook through provider education, patient activation, targeted primary care coverage, workflow and EHR enablement, and continued clinical and economic evidence generation. If we execute that well, iRhythm can do more than take share in the monitoring market as it exists today. We can help expand the number of patients who are appropriately diagnosed and treated for arrhythmia, with a platform that can advance the same opportunity in other adjacencies like sleep. We also continue to make progress in other strategic areas of focus. In sleep diagnostics, we continue to see a substantial underpenetrated opportunity with meaningful overlap in cardiac patient populations. Our strategy is to simplify today's fragmented home sleep testing process by leveraging our expertise in diagnostics and workflow integration. We have made meaningful progress in operational readiness, including IDTF capabilities, and are now advancing toward commercial readiness and scalability, while maintaining a disciplined approach to investment. We also submitted an application to the FDA for a pediatric indication for our Zio Monitor, representing another potential meaningful opportunity to meet care needs for these patients and expand our core monitoring market. If cleared by the FDA, this would represent iRhythm's first pediatric indication, and we are excited about the potential to serve this market segment. We are also excited about recent clinical developments. In October, we published results from our EXCALIBUR study in clinical cardiology, extending the evidence generated through CAMELOT and AVALON into the Medicare Advantage population. The results once again demonstrated strong diagnostic performance with Zio long-term cardiac monitoring, along with lower downstream healthcare utilization and cost across a large, diverse insured population. Taken together, EXCALIBUR, CAMELOT, and AVALON provide comparative evidence across more than 1 million patients, further strengthening the breadth of clinical and economic evidence supporting Zio long-term continuous monitoring. Finally, I'd like to provide a brief update on a few regulatory items. Starting with the DOJ, we continue to engage in ongoing dialogue with the agency, including a meeting yesterday on status and path forward as part of that process, and we remain focused on reaching an appropriate resolution. And with respect to the FDA warning letter, as previously noted, we have completed our remediation activities, updated the agency accordingly, and are expecting a follow-up inspection, although we don't yet know when that will occur. As we look ahead, I believe iRhythm is well positioned to execute our long-term strategy. Our core business continues to generate durable growth and meaningful operating leverage. We are expanding our reach across primary care and innovative channels, investing in new clinical applications, and strengthening our operating foundation. With VitalConnect, we have meaningfully expanded our addressable market, strengthened our immediate MCT offering, and created a platform to serve patients, providers across a broader continuum of care. Our priorities remain focusing on disciplined execution and delivering sustained volume-led growth and continued profitability and free cash flow generation. With that, I will turn the call over to Dan.