iRhythm (NasdaqGS:IRTC) 2025 Conference September 10, 2025 12:50 PM ET Company ParticipantsQuentin Blackford - CEOConference Call ParticipantsDavid Rescott - Senior AnalystDavid RescottCome on. Come on.Quentin BlackfordHe says you're on.David RescottCome on now. There we go. All right. Thanks, everyone, for joining us. I'm David Rescott, Senior Med Tech Analyst here at Baird. Excited to have Quentin Blackford, CEO of iRhythm, to join us for this fireside chat here. I wanted to start off asking a little bit ...

Question-and-Answer SessionPatrick WoodMorgan Stanley, Research Division I might just dive right in, in the core LTCM market. I think there was quite a lot of shock. I had one of my teammates opened the door to my office on the Q2 and with deep surprised at the number you guys printed given it's so far above where people expected it to be. But you flagged that 2/3 of that beat was really the core base business. For those who are less familiar in the audience, maybe you could like elaborate a little bit what ...

Question-and-Answer SessionPatrick WoodMorgan Stanley, Research Division I might just dive right in, in the core LTCM market. I think there was quite a lot of shock. I had one of my teammates opened the door to my office on the Q2 and with deep surprised at the number you guys printed given it's so far above where people expected it to be. But you flagged that 2/3 of that beat was really the core base business. For those who are less familiar in the audience, maybe you could like elaborate a little bit what ...

Summary of Key Points from the Conference Call Company Overview - The discussion revolves around iRhythm Technologies, a company specializing in cardiac monitoring solutions, particularly the Zio product line, which includes long-term cardiac monitoring (LTCM) and upcoming non-continuous monitoring (NCT) products. Core Business Performance - iRhythm reported a significant Q2 performance, exceeding expectations, with two-thirds of the revenue beat attributed to the core business [3][4] - The company experienced strong momentum in its innovative channel business and the Zio AT business line, indicating robust growth drivers [4][20] - The average prescribing volume per new account has increased, reflecting the company's ability to convert larger accounts effectively [5][6] Product and Market Insights - The Zio product is positioned as a superior alternative to competitors, offering faster diagnosis, higher diagnostic yield, and lower healthcare resource utilization costs [7][6] - The company is seeing a shift towards integrating primary care physicians into the prescribing process, enhancing the overall service delivery [9][10] - The Amalfi study demonstrated the effectiveness of home enrollment in diagnosing arrhythmias, with a higher detection rate compared to traditional methods [13][14] Future Growth and Expectations - iRhythm anticipates continued strong performance in the second half of the year, supported by the core business and new account conversions [20][21] - The company is optimistic about the upcoming NCT product, which is expected to enhance its market share in the cardiac monitoring space [22][26] - The potential market for NCT is significant, with estimates suggesting that every 10% market share could equate to $100 million in incremental revenue [32][33] Asymptomatic Monitoring and AI Integration - Asymptomatic monitoring is identified as a key growth driver, with a focus on targeting populations with undiagnosed arrhythmias [37][39] - iRhythm is developing proprietary AI to identify at-risk patients, aiming for high accuracy in diagnosing arrhythmias [39][41] - The company is exploring partnerships to enhance its diagnostic capabilities and provide comprehensive care solutions [71][72] International Market Opportunities - Japan is highlighted as a significant market opportunity, with iRhythm entering at a Holter rate code to establish a presence and gather head-to-head data against local competitors [59][60] - The company aims to demonstrate superior outcomes to secure better reimbursement rates in the future [60][62] Challenges and Strategic Approaches - The company faces challenges in changing entrenched practices in the market, particularly regarding the use of traditional Holter monitors [61][65] - iRhythm is focusing on education and integration with existing healthcare systems to facilitate adoption of its products [66][68] - The company is also considering partnerships with therapeutic providers to enhance patient care pathways [71][72] Conclusion - iRhythm Technologies is positioned for growth with its innovative cardiac monitoring solutions, strong market presence, and strategic focus on asymptomatic monitoring and AI integration. The company is optimistic about future product launches and market expansion, particularly in Japan.

iRhythm (IRTC) FY 2025 Conference September 03, 2025 12:45 PM ET Company ParticipantsNathan Treybeck - VP - Equity ResearchDaniel Wilson - CFONathan TreybeckGood afternoon, everyone. I'm Nathan Traybeck, one of the medical device analysts at Wells Fargo. I'm pleased to have management from iRhythm with us. We have Dan Wilson, the CFO and Stephanie Zadkovich from IR. Thank you for joining us on the first day of our conference.Daniel WilsonThank you, Nathan. Great being here.Nathan TreybeckOf course.So I thou ...

Financial Data and Key Metrics Changes - The company raised its revenue guidance for FY 2025, implying a growth rate of 22% to 23%, with two-thirds of this increase attributed to the core long-term continuous monitoring business [21][22][24] - The company reported that over 50% of its recent growth has come from new account openings, indicating strong momentum in its core business [5][14] Business Line Data and Key Metrics Changes - The core LTCM business, ZioMonitor, has accelerated growth over the last three quarters, driven by clinical evidence and new hardware platform feedback [2][3][4] - New accounts opened in 2024 are contributing significantly to growth, with a notable performance from the Zio AT product line [6][7][14] Market Data and Key Metrics Changes - The company holds over 70% market share in long-term continuous monitoring, with significant opportunities to capture more from traditional Holter and event monitors [17][20] - The company is expanding into primary care, targeting areas with limited cardiology access, which presents a substantial growth opportunity [18][19] Company Strategy and Development Direction - The company is focused on integrating EHR systems to enhance prescription ease and volume within existing accounts [10][12] - The strategy includes expanding into innovative channels, with 40 potential partnerships in active discussions, aiming to accelerate growth in this segment [39][40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining growth from new accounts and highlighted the importance of primary care in capturing more patients [21][24] - The company is committed to improving its quality management system and is actively engaging with the FDA regarding its remediation plan [58][60] Other Important Information - The company is preparing for the submission of Zio MCT for FDA approval, with expectations of a typical 90-day review process [26][27] - The company is also addressing reimbursement challenges in Japan and the UK, with ongoing efforts to secure national reimbursement [66][70] Q&A Session Summary Question: What factors contributed to the revenue guidance increase? - Management attributed two-thirds of the guidance increase to the core long-term continuous monitoring business, with strong account launches and EHR integration efforts [21][22][24] Question: How significant are new account additions to growth? - New accounts opened in the last twelve months have driven over 50% of growth, with same-store sales also contributing positively [14][15] Question: What is the market share outlook for Zio MCT? - Management indicated a potential for significant share growth in the MCT segment, although they do not expect to reach 70% market share as seen in long-term continuous monitoring [32][34] Question: What is the status of the FDA remediation plan? - The company has completed its remediation activities and is awaiting feedback from the FDA, maintaining a positive and collaborative relationship [60][62] Question: How is the innovative channel strategy progressing? - Management noted that momentum is building with 40 potential partnerships, but they are cautious about setting expectations until more visibility is gained [39][40]

Key Takeaways IRTC's AMALFI trial found Zio monitoring improved AF detection and shortened diagnosis time.The study enrolled 5,040 participants across 27 UK practices, fully remote and randomized.Zio users had 26% higher AF detection and faster access to anticoagulation treatment. iRhythm Technologies, Inc. (IRTC) recently published the results from the Oxford University-led Active Monitoring for AtriaL FIbrillation (AMALFI) randomized clinical trial. The study showed that home-based screening with the comp ...

Core Insights - iRhythm Technologies, Inc. announced positive results from the AMALFI clinical trial, indicating that home-based screening with the Zio long-term continuous monitoring (LTCM) service significantly improved atrial fibrillation (AFib) detection and reduced time to diagnosis [1][5][6] Study Design and Population - The AMALFI trial was a randomized controlled trial involving 5,040 participants aged 65 and older with moderate to high stroke risk, comparing home-based screening using the Zio XT LTCM device to usual care over a follow-up period of 2.5 years [2][5] - Participants were identified through an automated search of electronic health records in 27 primary care practices in the UK, and the study was conducted entirely remotely without physical sites [2][6] Key Findings - The intervention group showed a higher rate of new AFib diagnoses (6.8%) compared to the control group (5.4%), with a statistically significant difference (p=0.03) [3][4] - The median time to diagnosis for the intervention group was 103 days, significantly shorter than the 530 days for the control group [3][4] - Participants in the intervention group had a longer average exposure to oral anticoagulation (1.63 months) compared to the control group (1.14 months), indicating improved treatment initiation [3] Implications for Healthcare - The study supports the feasibility of primary care-initiated, home-based diagnostic monitoring, aligning with the NHS's focus on disease prevention and early detection [4][6] - The findings suggest that the Zio LTCM service can be effectively implemented at scale, enhancing the identification of undiagnosed arrhythmias and enabling timely therapeutic interventions [7][8] Technology and Methodology - The Zio LTCM service utilizes a wearable ECG patch that captures continuous data for up to 14 days, processed by a deep-learned algorithm to detect various arrhythmias [6][7] - The service has been available in the US since 2008 and was introduced in the UK in 2014, demonstrating a commitment to improving patient outcomes through innovative technology [6][14]

Core Viewpoint - Spruce Point Capital Management issued a report projecting a long-term downside risk of 40% to 70% for iRhythm Technologies' stock, highlighting regulatory, competitive, and management challenges that could undermine the company's market position [1]. Company Overview - iRhythm Technologies is a medical technology firm known for its Zio line of wearable cardiac monitors, with its first device, the Zio XT, launched in 2009. The Zio Monitor records heart activity for up to 14 days and has secured approximately 70% of the extended wear monitoring market [2]. - In 2019, iRhythm introduced the Zio AT, which features cellular transmission capabilities for near real-time alerts to doctors regarding potential cardiac events [2]. Regulatory and Competitive Challenges - The Zio product has faced regulatory scrutiny due to safety concerns, and despite its reliance on this core product, iRhythm has proposed new growth avenues, including targeting asymptomatic patients and expanding internationally. However, Spruce Point questions the viability of these opportunities due to limited physician enthusiasm and increased competition [3]. - A forensic review by Spruce Point, including a survey of 100 cardiologists, raised concerns about the safety and competitiveness of iRhythm's products, as well as issues related to profitability and management credibility [4]. Regulatory Findings and Management Actions - The FDA identified multiple device deficiencies in iRhythm's analysis that could endanger patients' lives, yet the company allegedly did not act on these findings for several years. During this period, insiders reportedly sold between $90 million to $160 million worth of stock [5]. - Spruce Point argues that investors have been overly optimistic about iRhythm's growth narrative, noting that the company's shares have increased by 141% in the past year, while risks related to regulation and management credibility remain unresolved [6]. Financial Performance - In the second quarter, iRhythm reported an adjusted loss of $0.32, which was better than the consensus loss of $0.48. Sales reached $186.7 million, exceeding the consensus of $173.94 million [7]. - The company raised its fiscal 2025 sales guidance from $690 million-$700 million to $720 million-$730 million, compared to the consensus of $695.74 million [7]. - iRhythm published results from the AVALON study, indicating that its Zio long-term monitoring service outperforms other methods in arrhythmia diagnosis, speed, cardiovascular outcomes, and overall costs, based on real-world data from 428,707 patients [7].

Core Insights - The AVALON study published in the American Journal of Managed Care reinforces the clinical superiority of iRhythm Technologies' Zio long-term continuous monitoring (LTCM) service among commercially insured patients, demonstrating its effectiveness compared to other ambulatory cardiac monitoring (ACM) modalities [1][2][3] Study Findings - AVALON is the largest real-world study of its kind, involving 428,707 commercially insured patients, and shows that the Zio LTCM service has the highest diagnostic yield, fastest time to diagnosis, and lowest total healthcare costs compared to other monitoring modalities [4][6][11] - The Zio LTCM service was associated with a 2.04 times higher likelihood of new arrhythmia diagnosis within 90 days compared to Holter monitors, and 1.69 times compared to ambulatory event monitors (AEM) [8][12] - The median time from end-of-wear to arrhythmia diagnosis for the Zio LTCM service was 9 days, significantly faster than Holter (12 days) and AEM (30 days) [12] - The Zio LTCM service demonstrated the lowest total medical and pharmacy costs at $10,476 per patient-year, compared to Holter ($11,042), AEM ($11,492), and non-iRhythm LTCM services ($11,293) [12] Clinical Implications - The findings indicate that the Zio LTCM service leads to lower healthcare resource utilization, including fewer emergency department visits and hospitalizations, and a lower likelihood of cardiovascular events [11][12] - The study confirms that the Zio LTCM service's advantages extend across diverse patient populations and payer segments, building on previous findings from the Medicare-focused CAMELOT study [6][13] Company Commitment - iRhythm Technologies emphasizes its commitment to delivering clinically meaningful innovations that drive value across the healthcare system, as highlighted by the results of the AVALON study [3][10][14]