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iRhythm Holdings, Inc.
4/30/2026
Hello, everyone. Thank you for joining us and welcome to iRhythm Holdings Q1 2026 earnings conference call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. To withdraw your question, press star one again. I will now hand the call over to Lisa Pecora, Senior Vice President of Finance and Investor Relations for opening remarks.
Thank you, Operator, and thank you all for joining iRhythm's first quarter 2026 earnings call. With me today are Quinton Blackford, iRhythm's President and Chief Executive Officer, and Dan Wilson, our Chief Financial Officer. Before we begin, please note that management will make forward-looking statements within the meaning of federal securities laws under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include but are not limited to statements regarding our intentions, beliefs, and expectations about future events, strategy, competition, products, operating plans, and performance. Forward-looking statements on this call are based on current estimates and assumptions, involve risks and uncertainties, and actual results may differ materially. These statements are made as of today, April 30, 2026, and are time-sensitive. We undertake no obligation to update or revise them, except as required by law. Accordingly, you should not place undue reliance on these statements. For discussion of risks and uncertainties, please refer to our most recent annual report on Form 10-K, quarterly reports on Form 10-Q, and other filings with the SEC. Additionally, during the call, we will discuss certain financial measures that have not been prepared in accordance with GAAP. Unless otherwise noted, all references to financial measures on this call are presented on a non-GAAP basis. These non-GAAP measures should not be considered in isolation or as a substitute for or superior to GAAP results. Reconciliations to the most directly comparable GAAP measures can be found in our earnings release and the slides accompanying today's call. And with that, I'll turn the call over to Quinton.
Good afternoon, everyone, and thank you for joining us. I'm pleased to be here to discuss our first quarter 2026 performance and outlook for the balance of the year. I will begin with an overview of the quarter, our strategic progress, and our outlook for 2026 and beyond. Dan will then talk about our financial performance and guidance in more detail. We delivered a strong first quarter, exceeding expectations on both the top and bottom line. Revenue grew 26% year-over-year, driven by volume, and we continued to execute on our profitability improvement commitments as we expanded margins. Importantly, our performance was broad-based across ZioMonitor and ZioAT and across each of our key growth pillars, including cardiology, primary care, innovative channels, and international. Our results reflect both strong execution in the core business and continued progress against the strategic priorities we believe will support durable growth over time. At the center of that strategy is our effort to expand the long-term continuous monitoring market by redefining how arrhythmias are diagnosed once patients enter the diagnostic pathway. A growing body of clinical evidence, now spanning more than 140 publications, consistently shows that nearly two-thirds of arrhythmias are often detected only after 48 hours of monitoring, reinforcing the limitations of short-duration monitoring. Yet, nearly 2 million short-duration Holter and event monitors are still prescribed annually in the U.S., representing a significant opportunity to upgrade care. By continuing to shift clinical practice towards longer-duration monitoring, we believe iRhythm is not only gaining share, but actively growing the market by increasing diagnostic yield and improving patient outcomes. XeoMonitor remains the foundation of our platform, supported by consistent prescribing trends, broad clinical adoption, and continued growth across new channels and international markets. XeoAT also continued to advance this quarter, taking share with new account wins and expanding utilization within existing accounts. That progress came despite a challenging prior year comparison and reinforces our view of the MCT category as a durable and increasingly important contributor to the platform. One of the most important drivers of our long-term opportunity is our continued move upstream in the patient pathway. We estimate that more than 27 million people in the U.S. are at risk for arrhythmias, many of whom are first evaluated in primary care settings. As a result, primary care is becoming an increasingly important entry point for earlier detection and more proactive management. We continue to expand our reach and engagement within primary care, helping clinicians rule arrhythmias in or out while enabling cardiology to focus more efficiently on the highest acuity patients. This is not a shift away from cardiology. Rather, it expands the overall market and improves patient flow, diagnostic efficiency, and care coordination across settings. A key enabler of this strategy is workflow integration. Approximately 53% of our volume now flows through EHR-integrated accounts, and more than three-quarters of our top 100 customers are now integrated. This level of integration is particularly valuable in primary care, where once embedded, we partner closely with our customers to help them develop best-in-class clinical pathways rather than just a transactional tool. We continue to see traction across innovative care channels, with growth supported by a broad and expanding set of value-based primary care and population health partners. Activity remains consistent and repeatable, driven by both new account wins and expanding utilization within existing relationships. Importantly, as certain programs mature, we're seeing adoption broaden across both symptomatic and asymptomatic populations, reinforcing the relevance and durability of the Xeo platform as care delivery continues to shift upstream and toward value-based models. International remains another emerging source of opportunity. In the UK, we had our best quarter in company history, reflecting growing traction and validation of our model in a cost-constrained health system. In Japan, we recently received an update to the reimbursement framework that introduces a modest supplemental payment for longer-duration monitoring. While the economics remain early and are not a meaningful contributor today, we view this as a positive signal that reflects growing recognition of the long-term continuous monitoring and reinforces the pathway to more favorable reimbursement as we generate local, head-to-head clinical evidence. We are also making progress in adjacent markets. In sleep, our pilots continue to produce encouraging early feedback and reinforce the meaningful opportunity ahead in a U.S. market of nearly 40 million sleep apnea patients, of which there is significant overlap with arrhythmia populations. Sleep is another good example of why workflow integration matters. Sleep diagnostics today remain highly fragmented across primary care, cardiology, sleep specialist, sleep labs, home testing, interpretation, and follow-up, and often across disconnected systems. Our focus is not simply on introducing a new device or algorithm, but on building a streamlined end-to-end clinical workflow that simplifies how sleep diagnostics are ordered, interpreted, and acted upon. As we have done in cardiac monitoring, we believe workflow simplification can create meaningful value for both providers and the healthcare system, particularly as care continues to shift upstream. From a clinical perspective, recent evidence continues to support our position and reinforces the significant opportunity ahead of us. At ACC, we shared new, real-world evidence showing Zio's high diagnostic yield for clinically actionable arrhythmias across cardiometabolic risk populations, including increased risk in chronic kidney disease and rising atrial fibrillation detection with obesity. We also launched iRhythm Academy, which scales high-quality, on-demand education to help clinicians adopt best practices and new advances more efficiently. At HRS, we presented new data reinforcing the superiority of Xeo after AF ablation and in pregnancy. In addition, we published two peer-reviewed studies highlighting the clinical and utilization advantages of long-term continuous monitoring using Xeo. The data show that traditional short-term monitoring often misses actionable arrhythmias and that Xeo enables earlier diagnosis with fewer repeat tests across both Medicare and commercially insured patients. Taken together, these efforts reinforce three points. Xeo long-term monitoring improves diagnostic yield. It expands relevance across broader patient populations, and it can reduce inefficiency and downstream cost, all of which are critical as we continue to expand beyond traditional symptomatic populations and move further upstream into earlier detection with the potential to lower downstream costs for the healthcare system. Consistent with that clinical expansion, recent CMS policy developments continue to emphasize objective diagnosis, quality, and measurable outcomes over documentation-driven strategies. The final 2027 Medicare Advantage Rate Announcement reflects funding stability alongside continued tightening around risk adjustment and coding practices. This policy trajectory reinforces the importance of confirmatory diagnostics that drive accurate diagnosis and appropriate care, and positions zeal well as healthcare continues to shift towards value-based models. With our vision to scale beyond traditional arrhythmia monitoring, our ability to execute is supported by an integrated, AI-enabled platform. We now have more than 3 billion hours of curated ECG data, and we continue to build on that foundation by combining internal and external data sets, including claims and EHR data to improve detection, identify at-risk patients earlier, and enhance clinical workflows. As we continue to advance our AI predictive capabilities, we are now in our first health system deployment of predictive identification workflows integrated with iRhythm monitoring solutions, and we have an active pipeline for additional health systems to follow. Early pilots show more than 85% accuracy in pre-identifying patients with clinically relevant arrhythmias, reinforcing our conviction that iRhythm is positioned not just to detect disease, but also help predict risk earlier and ultimately prevent it. Our initial programs focus on high-risk populations, including patients with diabetes, CKD, CAD, COPD, sleep disorders, and heart failure, where arrhythmias are both common and costly. These initiatives are designed to improve efficiency, quality, and reduce cost of care delivery, and we look forward to real-world data being published later this year. More broadly, iRhythm's durability in an AI-driven environment is grounded in the fact that healthcare value is not created by algorithms alone. It is created by operating an end-to-end, AI-embedded, FDA-regulated, clinically integrated, and reimbursed service at scale. Our platform is deeply embedded across leading health systems and supported by deep workflow integration, broad reimbursement, extensive clinical evidence, and a proprietary ECG data set that continues to grow significantly. Coupled with the operational complexity of device programs, specialized clinical support, and high regulatory scrutiny, our platform will continue to compound in value over time, particularly as we expand beyond cardiovascular into a multi-specialty intelligence platform. I'm pleased to share that same foundation is helping drive progress as we expand our AI capabilities with our new next generation AI algorithm. Leveraging our large proprietary multi-billion-hour dataset, we believe this next-generation algorithm, which will be used across our entire platform of XeoMonitor, XeoAT, and our future XeoMCT, can reduce clinical technician review time by as much as half over time, which would improve efficiency, support future margin expansion, and further strengthen our competitive position as we increase the clinical value to our patients and physicians. We submitted the 510 for this next generation AI algorithm to the FDA last year alongside, albeit separate, from our ZOMCT 510 submission. Next, I'd like to provide an update on our regulatory progress. As you know, we remain subject to an FDA warning letter. As part of our remediation efforts, we committed to address all of the agency's concerns. We also elected to go beyond the specific actions requested by the FDA, which included conducting a comprehensive review of our entire quality management system to identify and implement further improvements, which we have now completed. Consistent with our commitments to the agency, we also engaged an independent third party to conduct a comprehensive review of our quality management system. That review was completed in the first quarter and did not identify any material observations. We believe this outcome reflects both the seriousness with which we have approached this work and the substantial progress we have made. While the timing of any action by the FDA remains with the agency, we believe the work completed to date positions us well as the agency continues its review. With respect to our Next Generation MCT program, we've made a lot of progress over the past few months and are happy to reaffirm our first half 2027 release timeline. As we noted on our last earnings call, we identified a clear path to our Next Generation MCT clearance, including the determination that it was in our best long-term interest to move to a new mobile gateway sooner, which would require some additional work and data to be submitted to the FDA. As we continue to work collaboratively with the FDA, they have clarified that rather than submit additional data on a rolling basis, the preferred path is to provide a complete package once all elements are finalized later this year. We had anticipated this might be one outcome for how we might update our submission, so it falls within our previously communicated clearance and launch timeframe. We believe this collaborative approach enabling us to stay on track with our approval and launch timelines while also advancing an enhanced next-generation AI algorithm for clearance at a potentially earlier time point is a clear sign that all of our hard work over the past few years to improve our relationship with the FDA has been paying off. Looking ahead, our priorities remain clear. To drive durable, volume-led growth across cardiology, primary care, and innovative channels, continue expanding margins through operating discipline, efficiency, and scale, advance our innovation roadmap, including next-generation MCT and predictive AI, build international and adjacent markets with discipline, and maintain high standards of operational excellence and compliance in a rapidly evolving healthcare environment. With that, I'll turn the call over to Dan.
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