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]

Financial Performance & Guidance - Second quarter 2025 revenue reached $186.7 million, a 26.1% increase compared to the second quarter of 2024[8] - The company updated its 2025 annual net revenue guidance to $720 - $730 million[45] - The adjusted EBITDA margin is expected to be 8.0% - 8.5% of revenue for 2025[45] Market Opportunity & Penetration - The potential market includes over 27 million patients in the United States who could benefit from ambulatory cardiac monitoring[11] - The company has achieved over 30% penetration in the core U S ambulatory cardiac monitoring market as of December 31, 2024[13] - The international market represents a $1+ billion total addressable market (TAM) with 5+ million tests in prioritized countries across EMEA and Asia Pacific[36] Expansion & Growth Strategies - The company is targeting over 5 million ambulatory cardiac monitoring (ACM) tests in prioritized countries across EMEA and Asia Pacific[17] - There are over 27 million potential patients presenting in primary care who may be symptomatic or at-risk for arrhythmias[17,24] - The company is addressing population health management through targeted monitoring for undiagnosed arrhythmias, leveraging AI[25,26] Technology & Innovation - The company has curated over 2.5 billion hours of ECG data since its inception through 2024[15] - The company's AI capabilities are used for prediction of atrial fibrillation and heart failure[39,40]

Summary of iRhythm (IRTC) 2025 Conference Call Company Overview - **Company**: iRhythm Technologies, Inc. (IRTC) - **Industry**: Medical Technology, specifically in cardiac monitoring Key Points Market Position and Growth - iRhythm has seen strong momentum in its business, with growth exceeding 20% as of Q1 2025, following a consistent acceleration throughout 2024 [5][6] - The core market consists of 6.5 million tests annually, with iRhythm holding a 30% market share overall and over 70% in the long-term continuous monitoring (LTCM) segment [5][6] - There remains a significant opportunity to shift from traditional Holter monitors to LTCM, as 1.5 million short-term Holter tests are still performed annually [6][9] Competitive Landscape - The company is positioned to capture more market share in LTCM, with ongoing efforts to educate primary care physicians on the benefits of long-term monitoring [10][11] - Clinical studies, such as Camelot and Avalon, have demonstrated the superiority of iRhythm's Zio technology, showing the highest diagnostic yield and best patient outcomes [15][16] - Recent market access wins have allowed patients to bypass short-term Holter monitors and go directly to LTCM, expanding the potential patient base [17] Product Development and Innovation - iRhythm is on track to submit its next-generation product, Zio MCT, to the FDA by Q3 2025, which is expected to enhance its competitive position in the MCT segment [24][25] - The Zio MCT will extend wear time from 14 days to 21 days, addressing clinician concerns about monitoring duration [20][22] - The company is also exploring adjacent markets, such as sleep monitoring and multi-vital sign monitoring, to broaden its product offerings [45][46] Primary Care Strategy - A significant portion of growth is expected from primary care, with one-third of volumes currently being prescribed from this segment, up from 21% in 2023 [29][30] - There are 15.5 million patients with cardiac palpitations in primary care annually, presenting a substantial opportunity for LTCM [31][33] - iRhythm is implementing a two-pronged strategy to penetrate primary care, focusing on EHR integration and partnerships with value-based care entities [34][37] Regulatory and Remediation Efforts - The company has prioritized FDA remediation efforts following observations made in 2022, with over 80% of the remediation plan completed as of Q3 2025 [58][59] - iRhythm is proactively engaging with the FDA to ensure compliance and improve its quality management system [62][63] - The remediation activities have slightly delayed the Zio MCT submission, but the company remains confident in meeting its timelines [64] Market Dynamics and Competitor Impact - Competitive disruptions in the market have allowed iRhythm to capture additional business, retaining approximately 85% of the new business won during this period [50][51] - The company acknowledges that while the PFA (pulmonary vein isolation) procedures are a tailwind, they are not the primary driver of overall growth [53][54] Additional Insights - iRhythm's focus on generating clinical evidence continues to be a cornerstone of its strategy, helping to differentiate its products in a competitive landscape [14][15] - The company is exploring external partnerships to accelerate the development of new monitoring parameters, while also relying on internal teams for innovation [47][48] This summary encapsulates the key insights and strategic directions discussed during the iRhythm conference call, highlighting the company's growth potential, competitive advantages, and ongoing efforts in product development and regulatory compliance.

Financial Data and Key Metrics Changes - The company reported revenue of $158.7 million for Q1 2025, representing a 20.3% year-over-year growth compared to Q1 2024 [8][24] - Adjusted net loss for Q1 2025 was $30.3 million, or $0.95 per share, an improvement from an adjusted net loss of $38.1 million, or $1.23 per share, in Q1 2024 [26] - Adjusted EBITDA margin improved to negative 1.7% in Q1 2025 from negative 9.2% in Q1 2024, reflecting a 750 basis points improvement [26] Business Line Data and Key Metrics Changes - The Zio AT product line showed strong demand, contributing significantly to revenue growth, with Zio AT volume reaching its highest level to date [13][14] - New store growth accounted for approximately 65% of year-over-year volume growth, with home enrollment for Zio Services in the U.S. at about 23% of volume in Q1 [24] - The mobile cardiac telemetry service achieved its strongest quarter in history, indicating robust demand for long-term continuous monitoring [13] Market Data and Key Metrics Changes - The company noted a significant opportunity in the undiagnosed arrhythmia market, estimating around 27 million patients in the U.S. who may have undiagnosed arrhythmias [10] - Internationally, the company reported record volume in the UK and continued progress in Switzerland, Austria, the Netherlands, and Spain [14][15] - The launch of Zio in Japan is expected to enhance patient care, despite initial reimbursement challenges [16][17] Company Strategy and Development Direction - The company is focused on expanding its presence in upstream care pathways and primary care channels, aiming to drive earlier monitoring and diagnosis [11][12] - The partnership with Epic Aura is expected to improve operational efficiencies and increase volume growth in integrated accounts [12][56] - The company is committed to addressing FDA compliance and quality standards, with ongoing remediation efforts as a top priority [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth strategy despite economic uncertainties, highlighting the compelling value proposition of its products [22][32] - The company raised its full-year 2025 revenue guidance to $690 million to $700 million, reflecting strong momentum and durable volume growth [27][28] - Management acknowledged the potential impact of tariffs on gross margin but remains focused on mitigating supply chain concerns [29] Other Important Information - The company surpassed 10 million cumulative patient reports, marking a significant milestone in its history [10] - The company is actively exploring opportunities for inventory buildup to ensure supply chain stability amid growing demand [30] - Recent studies presented at conferences demonstrated the clinical superiority of Zio's long-term continuous monitoring compared to traditional methods [18] Q&A Session Summary Question: Outlook and Confidence in Guidance - Management noted strong momentum in the business, particularly with Zio AT, contributing to the raised guidance for the year [38][40] Question: Japan Reimbursement Challenges - The company expects lower contributions from Japan due to reimbursement rates but is committed to generating clinical evidence for future applications [44][46] Question: Zio AT Market Strength - Management indicated that Zio AT's success is driven by customer satisfaction and word-of-mouth, with a strong pipeline of new accounts [50][81] Question: Epic Integration Impact - Early signs from Epic integration show a high 20% increase in prescribing patterns in integrated accounts, though no incremental benefit is baked into guidance yet [57][58] Question: Volume from Innovative Channels - Volume from innovative channels is still in low single digits but is growing, with significant potential for future expansion [60][62] Question: Multi-Parameter Sensor Opportunities - The company is focused on developing a multi-parameter sensing platform and is open to M&A opportunities that align strategically [66] Question: FDA Submission Timeline - Management expressed confidence in submitting the Zio MCT to the FDA in Q3 2025, with ongoing remediation efforts on track [69][71]

Core Insights - iRhythm Technologies, Inc. announced the results of the AVALON study, which is the largest real-world comparative evaluation of ambulatory cardiac monitoring (ACM) among commercially insured patients, demonstrating the clinical superiority of the Zio long-term continuous monitoring (LTCM) service [1][3][19] Study Findings - The AVALON study involved a cohort of 428,707 commercially insured patients, focusing on diagnostic yield, likelihood of repeat testing, and cardiovascular (CV) events [1][6][18] - Zio LTCM service showed the highest diagnostic yield at 26.5%, significantly outperforming other modalities such as non-iRhythm LTCM (18.4%), ambulatory event monitors (AEM) (17.0%), and Holter monitoring (14.7%) [10][19] - Zio LTCM service was 2.04 times more likely to result in a new arrhythmia diagnosis compared to Holter monitors and 1.69 times more likely compared to AEM [11][19] - The likelihood of retesting within 180 days was lowest for Zio LTCM, with all non-iRhythm LTCMs being 1.95 times more likely to require a retest [12][19] - Zio LTCM service was associated with the lowest adjusted odds of cardiovascular events within one year compared to other ACM modalities [13][19] Digital Engagement - The MyZio App, designed to enhance patient engagement and symptom logging, was associated with increased symptom reporting and improved symptom-rhythm correlation [4][21] - Among 164,563 patients, 18.4% used the MyZio App, which led to a 1.85-fold increase in rhythm-correlated diary entries compared to non-users [23][24] - The app users demonstrated greater engagement, with higher rates of episodes identified through both button presses and diary entries [23][24] Clinical Evidence Base - iRhythm has a comprehensive clinical evidence program with over 125 original research manuscripts and insights derived from more than 2 billion hours of curated heartbeat data [15][19] - The AVALON study builds on previous findings from the CAMELOT study, expanding the understanding of Zio LTCM's clinical impact across different patient demographics [3][8][19]