5/1/2025

speaker
Cameron
Conference Call Moderator

Good afternoon. Thank you for attending the iRhythm Technologies, Inc. first quarter 2025 earnings conference call. My name is Cameron and I'll be your moderator for today. All lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end. If you would like to ask a question, please press star one on your telephone keypad. Due to the interest of time, we ask that you ask one question and to requeue for any follow-up questions. Again, due to the interest of time, we ask that you ask one question and to re-queue for any follow-up questions. I would now like to pass the conference over to your host, Stephanie Zadkiewicz, Director of Investor Relations. You may proceed.

speaker
Stephanie Zadkiewicz
Director of Investor Relations

Thank you all for participating in today's call. Earlier today, I will then release financial results for the first quarter ended March 31st, 2025. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical fact should be deemed to be forward-looking statements. These are based upon our current estimates and various assumptions and reflect management's intentions, beliefs, and expectations about future events, strategies, competition, products, operating plans, and performance. These statements involve risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For list and description of the risks and uncertainties associated with our business, please refer to the risk factors section of our most recent annual and quarterly reports on Form 10-K and Form 10-Q, respectively, filed with the Securities and Exchange Commission. Also during the call, we will discuss certain financial measures that have not been prepared in accordance with U.S. GAAP with respect to our non-GAAP and cash-based results, including adjusted EBITDA, adjusted operating expenses, and adjusted net loss. Unless otherwise noted, all references to financial metrics are presented on an presentation of this additional information should not be considered an isolation of, as a substitute for, or superior to results compared in accordance with GAAP. Please refer to the tables in our earnings release intended to you for reconciliation of these measures to their most directly comparable GAAP financial measures. Unless otherwise indicated, all references to financial measures in this call, other than revenue, refer to non-GAAP results. This conference call contains time-sensitive information and is accurate only as of live broadcast today, May 1st, 2025. IRISM disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. And with that, I'll turn the call over to Quinton Blackford, IRISM's President and CEO.

speaker
Quinton Blackford
President and CEO

Thank you, Stephanie. Good afternoon, and thank you all for joining us today. Dan Wilson, our Chief Financial Officer, is joining me on today's call. My remarks will cover our business performance during the first quarter of 2025, and our outlook for the remainder of the year. I will then turn the call over to Dan to provide a detailed review of our first quarter financial results and updated guidance for 2025. iRhythm has begun 2025 in an exceptionally strong position with near record revenue unit volume, despite what is typically a meaningful seasonal sequential decline, resulting in robust top line results of $158.7 million, representing more than 20% growth compared to the first quarter 2024. This growth was driven by continued market penetration in our core U.S. business, increasing appreciation of Xeo's value proposition and national value-based care accounts, continued expansion into the undiagnosed arrhythmia market segment, and strong demand in our international business. Following record new account onboarding achieved during 2024, we were very pleased to observe significant volume demand throughout the first quarter of 2025 for both XeoMonitor and XeoAT. Demand within our ZioMonitor product line originated from cardiologists, electrophysiologists, and primary care physicians, and we were encouraged to see another large national innovative health channel partner begin implementing the ZioMonitor for their population. Additionally, the strong ZOAT demand noted in the fourth quarter of last year continued throughout the first quarter, and we continued to welcome a substantial number of new accounts to the iRhythm family. Marking a momentous occasion in iRhythm's history, during the first quarter, we surpassed 10 million cumulative patient reports since the company's inception, underscoring our unwavering commitment to delivering superior patient care. In our long-term continuous monitoring service line, momentum remains robust as we continue our strategic expansion into upstream care pathways, deepening our presence in existing cardiology and electrophysiology accounts, and drive further ACM modality mix shift away from short-term and event monitoring. We estimate that there are approximately 27 million patients in the United States who either present to their primary care provider with cardiac palpitations or are at a high risk to have cardiac arrhythmias due to patient-specific risk factors but remain unaware that an arrhythmia may be present. Many of these patients have comorbid chronic diseases and frequently misattribute arrhythmia symptoms. By implementing Xeo long-term continuous monitoring earlier in the care pathway, we can reduce time to diagnosis eliminate unnecessary specialist referrals where capacity is limited, and facilitate timely patient care. Furthermore, recent scientific evidence demonstrates that these improvements lead to reductions in hospitalizations, enhanced clinical outcomes, and decreased healthcare system costs. At large integrated delivery networks, our upstream expansion into primary care has been facilitated by our land and expand strategy of creating awareness, education, and clinical champion engagement to drive earlier monitoring in the care journey and enabling better targeting of patients in need of further referral to specialists. By enabling more efficient workflow and an earlier accurate diagnosis, we have the potential to drive additional capacity for specialists like cardiologists and electrophysiologists to see better qualified patients, which in time also may result in additional monitoring. Fueling this focus to move more broadly across large integrated delivery networks is the advancement of our Epic Aura partnership, Which is in the very early innings and demonstrating success with our first health systems on the platform already realizing the expected it and operational efficiency gains and dozens more health systems, either in progress or planning to kick off and or integration this quarter. Furthermore, our progress with large value based innovative channel partners who understand the importance of upstream identification of clinically actual arrhythmias continues to advance successfully. The majority of these organizations focus on earlier detection within targeted at-risk populations, recognizing that earlier identification often results in lower downstream cost of care and contributes to improved patient outcomes. Based upon recent real-world retrospective claims analysis performed by our partner, Eversana, for every 1,000 patients with certain comorbid conditions who are diagnosed with an arrhythmia earlier in the care pathway, it may result in over $10 million in downstream cost avoidance by preventing events that could increase healthcare resource utilization, such as emergency department visits or hospitalizations. During the first quarter of 2025, we drove the strongest revenue contribution to date from these innovative channel partners originating from undiagnosed arrhythmia monitoring. Our pipeline of interest from these accounts remains robust, and we are uniquely positioned to capture this emerging market opportunity due to our leadership and long-term continuous monitoring, our scalability, Our industry leading AI that contributes to superior clinical reporting in our extensive repository of clinical evidence demonstrating improved outcomes. The execution of our multi pronged approach to move further up the care pathway and open the primary care channel by implementing our land and expand strategy. In partnering with value based innovative channel partners has resulted in tremendous progress. Coming out of the first quarter nearly one third of our long term continuous monitoring volumes now originate from primary care physician channels. where healthcare providers continue to recognize the value that iRhythm is uniquely positioned to deliver. In addition to the strong demand for long-term continuous monitoring, iRhythm's mobile cardiac telemetry service achieved its strongest quarter in our history, with our commercial teams driving continued ZOAT momentum in accounts acquired during the fourth quarter of last year, as well as another strong quarter of new account additions in Q1. ZOAT as a proportion of revenue volume reached its highest level to date, and the year-over-year revenue growth rate continue to significantly outpace our overall corporate average. The sustained momentum in ZOAT represents a good portion of our improved revenue outlook for 2025, and we continue to look forward to submitting our new ZOMCT with the FDA in the third quarter of this year. Beyond our core U.S. business, we continue to make steady progress in bringing the ZO service to potentially millions more patients globally. In Europe, our commercial team in the United Kingdom has achieved another quarter of record volume, while we continue to navigate reimbursement dynamics with the National Health Service. In Switzerland, Austria, the Netherlands and Spain, our commercial teams continue to make progress with a solid pipeline of account activations and increasing clinician appreciation for Xeo across an expanding hospital footprint. Additionally, we announced today our commercial launch in Japan as the first ambulatory cardiac monitoring solution to utilize a 14-day PMDA-cleared artificial intelligence in arrhythmia detection. As the demand for effective long-term monitoring grows, we believe the introduction of Xeo in Japan represents an opportunity to enhance patient care and support evolving clinical needs in cardiac monitoring, an impact also recognized by our esteemed partners at the Japanese Heart Rhythm Society. Our entry into the second largest ambulatory cardiac monitoring market globally follows a recent decision by the Japanese Ministry of Health, Labor, and Welfare to reimburse Xeo at the established Holter monitoring rate. While this initial reimbursement decision is not ideal, we understand the necessity of demonstrating superiority against existing market products, which are predominantly Holter-style monitors. With this launch, we intend to generate additional clinical evidence through real-world studies and local IRB-approved research to support future reimbursement applications that better reflect Zio long-term continuous monitoring's value proposition. We look forward to continuing our collaboration with clinicians and working alongside Senco Medical Instruments, our distribution partner, to expand access to advanced cardiac monitoring services. In support of these efforts, we have continued to expand our already substantial repository of clinical evidence demonstrating the benefits of Zio ambulatory cardiac monitoring for improved patient outcomes, enhanced clinician efficiency, and optimize healthcare resource utilization. At the American College of Cardiology conference in March, our scientific evidence teams presented two large real-world studies encompassing over one million patients, demonstrating that short-term, halter-duration monitoring frequently fails to detect actionable arrhythmias, and that patient-reported symptoms are unreliable predictors of arrhythmic events. Specifically, among patients with daily or more frequent symptoms who were diagnosed with actionable arrhythmias, nearly two-thirds remained undetected through the first 48 hours of monitoring, indicating that 24- to 48-hour monitoring, such as with Holter, would have failed to identify these conditions. In the U.S. market, approximately 1.5 million 24- to 48-hour monitors, or nearly $400 million of market value, continue to be prescribed annually, representing a significant opportunity to continue to improve patient care within the current ambulatory cardiac monitoring market. More recently, at the Heart Rhythm Society Conference this past week, data was presented from the Avalon study of more than 400,000 patients, showing that real-world claims within a commercially insured patient population demonstrated once again that Zeo long-term continuous monitoring resulted in the highest diagnostic yield, lowest retest rate, and lowest risk of cardiovascular events during a one-year follow-up period compared to alternative ambulatory cardiac monitoring modalities in competitor brands. These results confirmed our earlier Camelot study, but within a younger, healthier, and commercially insured population. Collectively, these studies have now examined both Medicare and commercially insured well-rolled claims of more than 700,000 patients and provide important evidence of the clinical superiority of 14-day cardiac monitoring with Zio and contribute to the growing body of evidence supporting guideline updates and improved market access. Fundamental to delivering these results has been our continued transformation toward becoming a best-in-class organization committed to quality, integrity, and operational excellence. This dedication was recognized through several recent third-party awards for Xeomonitor, including the 2025 Red Dot Award and a Bronze Edison Award in the Cardiovascular Health Diagnostics and Monitoring category. We also reaffirmed this commitment to excellence in our latest Corporate Sustainability Report, which details our progress across four key pillars of corporate impact. quality and sustainable technology innovation, access and health equity, workforce and inclusion, and environmental matters. An essential component of our commitment to excellence is our organizational focus on quality systems. Throughout the first quarter of 2025, regulatory and quality matters have remained our highest corporate priority, and we continue to make significant progress on our remaining remediation and compliance activities. These initiatives will remain our priority throughout the year, and we are progressing well against the timelines we have committed regarding the warning letter and 483 observations. We remain dedicated to exceeding the FDA's expectations and are on track to complete these additional compliance efforts by the end of 2025. As previously communicated, we will allocate all necessary resources to ensure best in class quality standards and are committed to addressing the FDA's warning letter and observations to their complete satisfaction. Finally, I want to address the topics of tariffs. iRhythm is well positioned to navigate this uncertainty. Our number one priority remains our patients and physicians, and we are fully committed to ensuring uninterrupted access to our critical products and services. Our teams have implemented robust mitigation strategies that address potential supply chain concerns and cost implications. Importantly, iRhythm's unique value proposition aligns perfectly with healthcare's current focus on upstream intervention. Our ability to identify cardiac issues earlier in the care pathway directly supports reduced downstream cost and improved outcomes. This positioning becomes even more valuable in an environment where healthcare systems are seeking cost-effective solutions that deliver meaningful clinical impact. We remain confident in our ability to execute our growth strategy while managing these external challenges. With that, I'll turn the call over to Dan to discuss our recent financial performance.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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