Financial Performance - Revenue increased by $26.7 million, or 20%, to $158.7 million for the three months ended March 31, 2025, compared to $131.9 million for the same period in 2024[159] - Gross profit rose by $21.7 million, or 25%, to $109.2 million for the three months ended March 31, 2025[159] - Adjusted EBITDA for the three months ended March 31, 2025, was a loss of $2.6 million, an improvement from a loss of $12.1 million in the same period of 2024[141] - Net loss decreased by $14.97 million, or 33%, to $30.7 million for the three months ended March 31, 2025, compared to a net loss of $45.7 million for the same period in 2024[159] Revenue Sources - The proportion of revenue from contracted third-party payors was 53% for the three months ended March 31, 2025, compared to 54% in the same period of 2024[137] Expenses - Research and development expenses increased by $4.5 million, or 27%, to $21.5 million for the three months ended March 31, 2025[159] - Selling, general and administrative expenses increased by $11.3 million, or 10%, to $120.0 million for the three months ended March 31, 2025, compared to $108.7 million in the same period of 2024[165] - Cost of revenue increased by $5.0 million, or 11%, to $49.5 million for the three months ended March 31, 2025, compared to $44.4 million for the same period in 2024[161] Cash Flow - Cash used in operating activities was $7.9 million for the three months ended March 31, 2025, a decrease of $44.1 million from $52.0 million used in the same period of 2024[176] - Cash used in investing activities was $38.1 million for the three months ended March 31, 2025, an increase of $78.1 million compared to cash provided by investing activities of $40.0 million in the prior year[177] - Cash provided by financing activities was $1.7 million for the three months ended March 31, 2025, a decrease of $502.9 million from $504.6 million in the same period of 2024[178] - As of March 31, 2025, the company had cash and cash equivalents of $375.3 million and marketable securities of $145.3 million[170] - The company reported cash, cash equivalents, and marketable securities of $520.6 million as of March 31, 2025, down from $535.6 million as of December 31, 2024[195] Agreements and Obligations - The company has achieved milestone payments totaling $11.0 million under the Development Agreement with Verily, with potential additional payments of $1.75 million[172] - The company entered into a Technology License Agreement with BioIntelliSense, Inc., which includes a $15.0 million upfront fee and $40.0 million in convertible promissory notes[173][174] - As of March 31, 2025, the company had approximately $67.7 million in open purchase orders and contractual obligations, with the majority due within one year[189] Interest and Debt - Interest income increased by $1.86 million, or 61%, to $4.92 million for the three months ended March 31, 2025[159] - A hypothetical 10% change in interest rates would have impacted interest income by $0.5 million for the three months ended March 31, 2025, compared to $0.3 million for the same period in 2024[196] - The company had $661.3 million in outstanding aggregate principal amount of fixed-rate debt related to its 2029 Notes, with an estimated fair value of $689.2 million as of March 31, 2025[197] - The 2029 Capped Calls are expected to reduce potential dilution to common stock upon conversion of the 2029 Notes[198] Risk Management - The company does not anticipate being exposed to material risks due to changes in interest rates[196] - As of March 31, 2025, there had not been a material change in foreign currency risk information disclosed in the previous annual report[199] - The company has not used any derivative financial instruments to manage interest rate risk exposure[196] - There were no material changes to the company's critical accounting estimates during the three months ended March 31, 2025[192] - The company evaluates its estimates and judgments based on historical experience and other reasonable factors[191] Operational Highlights - The company provided Zio Services to over eight million patients and collected over 2 billion hours of curated heartbeat data[135] - The utilization of home enrollment services for Zio patches has significantly increased, adapting to the needs of physicians and patients[144]

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]

Financial Data and Key Metrics Changes - iRhythm reported Q1 2025 revenue of $158.7 million, representing a 20.3% year-over-year growth compared to Q1 2024 [10][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 for Q1 2025 was negative $2.6 million, improving from negative $14.6 million in Q1 2024, reflecting a 750 basis point improvement in adjusted EBITDA margin [26][23] 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 [14] - New store growth, defined as accounts opened in the last twelve months, accounted for approximately 65% of year-over-year volume growth [24] - The mobile cardiac telemetry service achieved its strongest quarter in history, indicating robust demand for Zio AT [14] Market Data and Key Metrics Changes - iRhythm's international business showed strong demand, particularly in the UK, with record volume achieved [15] - The company launched its services in Japan, marking its entry into the second-largest ambulatory cardiac monitoring market globally [16] - Approximately 27 million patients in the U.S. are at high risk for cardiac arrhythmias but remain undiagnosed, representing a significant market opportunity [12] Company Strategy and Development Direction - iRhythm is focused on expanding its presence in upstream care pathways and primary care channels, aiming to drive earlier monitoring and diagnosis [12][14] - The company is leveraging partnerships with innovative health channel partners to enhance its market penetration and improve patient outcomes [13] - iRhythm's strategy includes a commitment to quality and operational excellence, with ongoing remediation activities to address regulatory compliance [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory despite macroeconomic uncertainties, highlighting strong demand for Zio services [22][31] - The company raised its full-year 2025 revenue guidance to $690 million to $700 million, reflecting strong Q1 performance and durable volume growth [28] - Management emphasized the importance of upstream intervention in healthcare, aligning with current trends towards cost-effective solutions [22] Other Important Information - iRhythm surpassed 10 million cumulative patient reports, underscoring its commitment to superior patient care [11] - The company is actively working on FDA submissions for new products, including the Zio MCT, expected to be filed in Q3 2025 [30][74] - iRhythm is addressing potential supply chain concerns and cost implications due to tariffs, implementing strategies to mitigate these impacts [21][29] 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 [39][41] Question: Japan Market and Reimbursement - Management acknowledged disappointment with the reimbursement rate in Japan but emphasized the strategic importance of the market and plans to generate clinical evidence for higher reimbursement [45][48] Question: Zio AT Momentum - Management attributed Zio AT's success to strong word-of-mouth and the product's superior features compared to competitors [52][56] Question: Epic Integration Impact - Early results from Epic integration showed a high 20% increase in prescribing patterns in integrated accounts, indicating positive early signs [60][61] Question: Volume from Innovative Channels - Management indicated that volume from innovative channels is in the low single digits but is growing, with significant potential for future expansion [64][67] Question: Multi-parameter Sensor Opportunities - Management expressed interest in multi-parameter sensing capabilities and potential M&A opportunities, while emphasizing internal innovation [69][70] Question: FDA Conversations and Facility Inspection - Management expressed confidence in submitting Zio MCT to the FDA in Q3 2025 and ongoing progress with remediation efforts [73][76]

Core Viewpoint - iRhythm Technologies has launched its Zio long-term continuous ECG monitoring system in Japan, offering up to 14 days of uninterrupted ECG monitoring, which is a significant improvement over existing options in the market [1][4]. Company Overview - iRhythm Technologies, Inc. is a leading digital health care company focused on creating solutions that detect, predict, and prevent disease through wearable biosensors and cloud-based data analytics [14]. - The company has a strong commitment to improving patient outcomes, supported by over 125 original research manuscripts and insights from more than 2 billion hours of curated heartbeat data [7]. Product Details - The Zio ECG Recording and Analysis System includes a patch-based ECG monitoring device that can be worn for up to 14 days and utilizes a deep-learned AI algorithm approved by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) [3][5]. - The system demonstrates 99% patient compliance with prescribed wear time and 99% analyzable data, providing high-quality, actionable insights [5]. - The Zio service is associated with the highest diagnostic yield and lowest likelihood of retesting compared to other monitoring services, including Holter monitoring [5]. Market Opportunity - Japan is the second largest ambulatory cardiac monitoring market globally, with an estimated 1.6 million tests prescribed annually, a number expected to rise due to the aging population and increasing prevalence of cardiac arrhythmias [10][11]. - The launch of the Zio system is timely, addressing the growing demand for early and accurate detection of arrhythmias in Japan [4]. Clinical Validation - The clinical value of the Zio LTCM service has been validated through studies, including the CAMELOT study, which found it to be associated with the highest yield of specified arrhythmia diagnosis and the lowest likelihood of repeat testing [6][8]. - The Zio service combines advanced AI with expert clinical review to support accurate and timely diagnoses, enhancing patient care [8]. Distribution and Availability - The Zio ECG Recording and Analysis System will be available to healthcare customers in Japan starting May 2025, with nationwide availability expected by July 2025, through Senko Medical Instrument, the exclusive distribution partner [12].

Core Viewpoint - iRhythm Technologies, Inc. reported strong financial results for Q1 2025, with revenue growth exceeding 20% year-over-year, driven by increased demand for its Zio services and expansion into new markets, including Japan [3][4]. Financial Highlights - Revenue for Q1 2025 was $158.7 million, a 20.3% increase from $131.9 million in Q1 2024 [4][8]. - Gross profit for Q1 2025 was $109.2 million, up 24.8% from $87.5 million in Q1 2024, with a gross margin of 68.8%, an increase from 66.3% in the same period last year [5][8]. - Operating expenses for Q1 2025 were $141.8 million, compared to $125.7 million in Q1 2024, primarily due to funding innovation and serving a growing patient volume [6][8]. - The net loss for Q1 2025 was $30.7 million, or a diluted loss of $0.97 per share, an improvement from a net loss of $45.7 million, or a diluted loss of $1.47 per share, in Q1 2024 [7][8]. Operational Highlights - The company achieved a milestone of 10 million patient reports since its inception, indicating strong market penetration and demand for its services [3]. - iRhythm's recent commercial launch in Japan is part of its strategy to expand its global reach, now operating in six markets outside the U.S. [3][8]. - The company presented findings at ACC.25 showing that traditional Holter monitoring often misses actionable arrhythmias, highlighting the effectiveness of its Zio long-term continuous monitor [8]. Guidance and Future Outlook - iRhythm projects full-year 2025 revenue between $690 million to $700 million, with an adjusted EBITDA margin expected to range from approximately 7.5% to 8.5% [10][8]. - The company is optimistic about future growth driven by innovative value-based care accounts and increasing demand for Zio AT services in the U.S. and the U.K. [3][8].

Core Viewpoint - iRhythm Technologies, Inc. is actively participating in the Bank of America Securities 2025 Health Care Conference, showcasing its commitment to advancing digital health solutions [1][2]. Company Overview - iRhythm Technologies, Inc. is a leading digital health care company focused on creating solutions that detect, predict, and prevent disease through the use of wearable biosensors and cloud-based data analytics [3]. - The company utilizes proprietary algorithms to transform data from millions of heartbeats into clinically actionable information, aiming to enhance patient care and health outcomes [3]. Event Participation - iRhythm's management is scheduled to present at the conference on May 13, 2025, at 3:40 p.m. Pacific Time, with a live and archived webcast available for interested parties [2].

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]

Core Viewpoint - iRhythm Technologies, Inc. will release its financial results for Q1 2025 on May 1, 2025, followed by a conference call to discuss the results [1]. Company Overview - iRhythm Technologies is a leading digital health care company focused on creating solutions that detect, predict, and prevent disease [3]. - The company utilizes wearable biosensors and cloud-based data analytics combined with proprietary algorithms to transform data from millions of heartbeats into clinically actionable information [3]. - iRhythm's vision emphasizes improving patient care through better data, insights, and health outcomes [3]. Conference Call Details - The conference call will begin at 1:30 p.m. PT / 4:30 p.m. ET on the same day as the financial results release [1]. - Interested parties can access a live and archived webcast of the conference call on the company's investor website [2].

Core Insights - iRhythm Technologies, Inc. has published its 2024 Corporate Sustainability Report, showcasing its commitment to sustainability and inclusivity in healthcare [1][2] Quality and Sustainable Technology Innovation - The company has enhanced its quality systems and improved customer experience through Electronic Health Record (EHR) integration and innovative product launches [5] - A strategic licensing agreement has been secured to advance connected patient care [5] - An Artificial Intelligence (AI) Governance Steering Committee has been formed to address AI risks and opportunities [5] Access and Health Equity - iRhythm has expanded globally by launching commercially in four European countries: Austria, the Netherlands, Spain, and Switzerland [5] - The company received regulatory approval from the Japanese Pharmaceutical and Medical Device Agency for the Zio 14-day, long-term continuous ECG monitoring system [5] Workforce and Inclusion - The company has refreshed its core values to shape its desired workplace culture [5] - The code of conduct has been revised to provide employees with resources and guidance for operating with integrity [5] - New recognition opportunities have been introduced to celebrate employees who embody the company's values [5] Environmental Impact - iRhythm completed an inventory of Scope 3 greenhouse gas emissions [5] - The company achieved 89.5% landfill waste diversion across its operations [5] - iRhythm obtained ISO 14001:2015 Environmental Management Systems Certification [5] - A life cycle analysis (LCA) of its products has been completed [5] - The company was named to Newsweek's list of America's Greenest Companies for 2025 [5]

Core Insights - Two large studies involving over 1.1 million patients indicate that short-term Holter monitoring often fails to detect actionable arrhythmias, even in patients with reported daily symptoms, highlighting the limitations of current monitoring practices [1][4][7] Group 1: Study Findings - 64% of patients with daily symptoms and actionable arrhythmias were undetected within the first 48 hours of monitoring, suggesting that short-term Holter monitoring is inadequate [6][9] - Non-daily symptom patients had a higher arrhythmia yield of 80.9% compared to 69.1% for daily-symptom patients, indicating that symptom frequency does not correlate with arrhythmia burden [6] - The mean time to the first detected arrhythmia episode exceeded 48 hours across all types, reinforcing the inadequacy of short-term monitoring [6][9] Group 2: Clinical Implications - The findings challenge the assumption that frequent symptoms justify short-duration monitoring and emphasize the need for long-term continuous monitoring (LTCM) for better detection of arrhythmias [4][7] - Zio LTCM provides uninterrupted monitoring for up to 14 days, which can lead to more accurate and timely detection of actionable arrhythmias compared to Holter monitoring [7][8] - The CAMELOT study supports that Zio LTCM has the highest yield for arrhythmia diagnosis and the lowest likelihood of repeat testing among monitoring services [7] Group 3: Economic Impact - Approximately 16 million Americans experience arrhythmias, with undiagnosed atrial fibrillation alone costing the U.S. $3 billion annually, highlighting the financial burden of undetected arrhythmias [5] - The economic rationale for long-term continuous monitoring is underscored by the projected costs of heart failure reaching $70 billion by 2030 [5] Group 4: Company Background - iRhythm Technologies is a leading digital health care company focused on creating solutions for disease detection and prevention, utilizing wearable biosensors and cloud-based analytics [11]