iRhythm Technologies (NasdaqGS:IRTC) FY Conference December 04, 2025 09:10 AM ET Company ParticipantsDan Wilson - CFOConference Call ParticipantsVijay Kumar - Life Science Diagnostic and Med Device AnalystVijay KumarGreat. Good morning, everyone. Thanks for joining us. I'm Vijay Kumar, the Life Science Diagnostic and Med Device Analyst at Evercore. Pleasure to have this iRhythm. We have CFO Dan Wilson, and we have Lisa Pecora, SVP of Finance. Dan and Lisa, thanks for the time this morning.Dan WilsonApprecia ...

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iRhythm Technologies (NasdaqGS:IRTC) FY 2025 Conference December 03, 2025 01:00 PM ET Company ParticipantsDan Wilson - CFOConference Call ParticipantsJoanne Wuensch - Medical Technology AnalystJoanne WuenschWell, good afternoon, everybody, and thank you for joining us for the post-lunch first meeting. I'm still Joanne Wuensch, the medical technology analyst here at Citibank, and thrilled to have the management of iRhythm with us, including Dan Wilson, and I was just trying to figure out when you became the ...

Financial Data and Key Metrics Changes - The company reported over 30% growth in the most recent quarter, indicating strong performance and momentum in the business [66][67] - Preliminary revenue guidance for 2026 is projected in the high teens percentage range, reflecting a thoughtful approach to setting expectations [65][66] Business Line Data and Key Metrics Changes - The long-term continuous monitoring segment, which the company pioneered, is growing at high teens percentage year over year, outpacing the overall market growth [8][19] - The company has gained one to two points of market share in the long-term continuous monitoring segment, now holding approximately 70% of that market [19][20] Market Data and Key Metrics Changes - The overall ambulatory cardiac monitoring market in the U.S. is estimated at 6.7 million tests annually, growing at mid-single digits, while the long-term continuous monitoring segment is experiencing faster growth [8][10] - The aging population is a significant tailwind for the market, with more individuals entering Medicare and increasing the risk of cardiac arrhythmias [10] Company Strategy and Development Direction - The company is focusing on expanding its presence in the primary care market, with a goal to increase the percentage of XT patches used by primary care physicians from 30% to potentially over 40% [12][14] - The company is investing in innovative channel partnerships that allow for proactive monitoring of patients, which is expected to enhance market penetration [22][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to capitalize on market opportunities, particularly in the context of improving therapies and increasing consumer awareness [10][11] - The company is optimistic about its international expansion efforts, having launched into five new markets, including Japan, and expects meaningful contributions from these markets in the future [55][56] Other Important Information - The company is currently working through the FDA review process for Zio MCT, with no expected contributions to revenue in 2026 [40][41] - Recent updates indicate that Medicare reimbursement rates for long-term continuous monitoring will increase by approximately 8% next year, which is a positive outcome for the company [76] Q&A Session Summary Question: What is the current state of the ambulatory cardiac monitoring market? - The market is healthy, with the long-term continuous monitoring segment growing at high teens percentage year over year, driven by factors such as improved therapies and increased consumer awareness [8][10] Question: How is the company addressing the primary care market? - The company has seen an increase in the percentage of XT patches used by primary care physicians and believes this trend will continue to expand [12][14] Question: What is the status of the FDA submission for Zio MCT? - The company submitted Zio MCT to the FDA in September and is currently addressing comments received, with no expected revenue contribution in 2026 [40][41] Question: How is the international business progressing? - The company has launched into five new markets and is optimistic about future contributions, particularly from Japan, which is a significant market for ambulatory cardiac monitoring [55][56] Question: What is the company's approach to setting revenue guidance? - The company aims to provide thoughtful guidance based on high confidence in certain areas while leaving out less predictable factors [66][67]

Core Viewpoint - Halper Sadeh LLC is investigating potential breaches of fiduciary duties by certain officers and directors of iRhythm Technologies, Inc. (NASDAQ: IRTC), urging shareholders to take action promptly due to possible limited time to enforce their rights [1]. Group 1: Shareholder Rights and Legal Options - Long-term shareholders of iRhythm may seek corporate governance reforms, return of funds, court-approved financial incentives, or other benefits [2]. - The firm operates on a contingent fee basis, meaning shareholders would not incur out-of-pocket legal fees or expenses [2]. Group 2: Importance of Shareholder Participation - Shareholder involvement is crucial for improving company policies, practices, and oversight, which can lead to enhanced transparency, accountability, and ultimately, increased shareholder value [3]. Group 3: Firm's Background and Achievements - Halper Sadeh LLC represents global investors affected by securities fraud and corporate misconduct, having successfully implemented corporate reforms and recovered millions for defrauded investors [4].

Core Insights - iRhythm Technologies presented new data at the 18th Asia Pacific Heart Rhythm Society and Japanese Heart Rhythm Society Joint Scientific Session, highlighting the performance of its Zio long-term continuous ECG monitoring system in diverse patient populations [1][7]. Group 1: Study Overview - The study, led by Dr. Hiro Kawata, analyzed 408,470 U.S. patients monitored between 2018 and 2022, comparing device compliance, performance, and arrhythmia detection between Asian and non-Asian populations [2][5]. - The analysis aimed to determine if racial and cultural differences impact the effectiveness of ambulatory cardiac monitoring [3]. Group 2: Key Findings - The findings indicated no significant differences in wear time, analyzable time, or arrhythmia detection yield between Asian and non-Asian patients, supporting the reliability of the Zio system across diverse populations [5][6]. - Median wear time was 13.6 days for Asian patients compared to 13.0 days for non-Asian patients, while analyzable ECG duration was 12.9 days for Asians versus 12.2 days for non-Asians [8]. - The arrhythmia detection rates were comparable, with Asian patients showing a 14.0% detection rate for atrial fibrillation compared to 14.3% for non-Asians [8]. Group 3: Implications for Japan - As Japan's population ages, the demand for advanced cardiac monitoring is increasing, with approximately 1.6 million tests prescribed annually [9]. - iRhythm's Zio ECG system, which allows for up to 14 days of continuous monitoring, represents a significant advancement over traditional monitoring options in Japan [10]. - The company is collaborating with local investigators to expand evidence and support the adoption of the Zio system in Japanese clinical practice [11]. Group 4: Supporting Evidence - The analysis adds to the growing body of evidence supporting the Zio LTCM service, which has been validated in previous studies such as CAMELOT and AVALON [12]. - iRhythm has generated over 2 billion hours of curated heartbeat data and more than 12 million patient reports, reinforcing its commitment to improving cardiac arrhythmia detection and management [13].

iRhythm Technologies Conference Summary Company Overview - **Company**: iRhythm Technologies (NasdaqGS: IRTC) - **Industry**: Digital healthcare focused on cardiac monitoring - **Event**: Jefferies London Healthcare Conference, November 20, 2025 Key Points Product and Technology - iRhythm's Zio platform combines hardware, software, and services for cardiac monitoring [2][4] - The Zio Monitor is a patented wearable biosensor that can be worn for up to 14 days, capturing an average of 1.5 million heartbeats [3][4] - The company has developed a second-generation FDA-cleared deep-learning algorithm, with a third generation in development [4] Financial Performance - Reported revenue for Q3 was $192.9 million, representing a year-over-year growth of 30.7% [5][23] - The company serves over 2 million patients annually and has a 30% share in its core market [5] - Guidance for full-year revenue is between $735 million and $740 million, indicating a 24-25% year-over-year growth [24] Market Opportunity - iRhythm identifies a total addressable market (TAM) of 27 million patients who are candidates for Zio monitoring [5][12] - The U.S. market for long-term continuous monitoring is approximately 3 million tests, where iRhythm holds over 70% market share [9] - Internationally, the company is targeting 5 million tests in prioritized countries, including the U.K., Japan, and several Western European nations [10][11] Clinical Evidence and Research - iRhythm has published 125 scientific manuscripts demonstrating the clinical and economic superiority of the Zio platform [6] - The company has a database of 2.5 billion hours of curated ECG data, enhancing the effectiveness of its AI tools [6] Strategic Initiatives - The company is pursuing a "Land and Expand" strategy to penetrate primary care markets [14][15] - EHR integration is a key focus, with over 50% of volume running through EHR systems, enhancing workflow efficiency [20][21] - iRhythm is developing a multivitals platform to gather additional patient data, targeting adjacent markets such as sleep monitoring [22][23] Financial Health and Future Outlook - Gross margin expanded to 71.1% in the most recent quarter, with a long-term target of 72-73% by 2027 [24] - Adjusted EBITDA margin was 11.2%, with a target of 15% by 2027 [24] - The company expects to be free cash flow positive for the first time in 2025, marking a significant milestone [25] Conclusion - iRhythm Technologies is well-positioned for sustainable growth, with significant market expansion opportunities and a strong focus on innovation and operational efficiency [26]

Summary of iRhythm Technologies Conference Call Company Overview - **Company**: iRhythm Technologies (NasdaqGS: IRTC) - **Industry**: Medical Devices, specifically focused on ambulatory cardiac monitoring Key Points and Arguments Industry Concerns - Recent concerns regarding Medicare Administrative Contractors (MACs) and their draft Local Coverage Decisions (LCDs) for ambulatory cardiac monitoring were addressed. The company reassured stakeholders that a national coverage decision supersedes local decisions, and they are confident in the process of public comments and industry feedback to ensure favorable outcomes [4][5][6][11]. Financial Performance - iRhythm's 2025 revenue guidance is projected to be 8% higher than the original midpoint, driven by strong performance across multiple channels, including XT monitors and AT products [13][14]. - The company has seen significant growth in the AT segment, with a notable competitive disruption benefiting their market position [14][24]. Market Dynamics - The rise of technologies such as pulse field ablation (PFA) and increased consumer awareness of atrial fibrillation (AFib) are contributing positively to iRhythm's performance. The company is well-positioned to capitalize on these market tailwinds [16][20]. - iRhythm holds over 70% market share in long-term continuous monitoring and approximately 15% in mobile cardiac telemetry (MCT), indicating substantial growth opportunities in the MCT segment [30][31]. Innovative Channel Partners (ICPs) - The company is focusing on innovative channel partners, which are value-based care entities that manage patient risk and have direct patient contact. This strategy is expected to enhance patient monitoring and diagnosis [32][33]. - The economic argument for proactive monitoring is strong, with potential cost savings of $15,000-$17,000 for hospital events compared to $250-$300 for home monitoring [35]. Future Outlook - iRhythm anticipates continued growth in 2026, with core business performance expected to remain strong. The company has not provided formal guidance but is comfortable with current market expectations [30][31]. - The next-generation MCT device is in the pipeline, with a 510(k) submission made in September. The company is cautious about timelines due to potential delays from the FDA [52][53]. International Market Challenges - International revenue is currently low, with challenges primarily related to securing premium reimbursement in markets like Japan. The company is conducting studies to support their reimbursement applications [67]. Operational Efficiency - The company has successfully executed its FDA remediation plan and is undergoing an independent audit of its quality management system, which is a priority for the organization [65][66]. Additional Important Insights - The company is seeing a demographic shift with over 4 million patients aging into Medicare annually, which could increase the demand for their monitoring services [45]. - iRhythm is developing algorithms to identify patients who may benefit from monitoring based on risk factors, enhancing their proactive monitoring capabilities [46]. This summary encapsulates the key discussions and insights from the iRhythm Technologies conference call, highlighting the company's strategic positioning, market dynamics, and future growth potential.

Core Insights - Kuehn Law is investigating potential breaches of fiduciary duties by officers and directors of iRhythm Technologies, Inc. [1] - A federal securities lawsuit alleges that insiders at iRhythm misrepresented the Zio AT monitor's intended use and market potential, leading to artificially inflated stock prices [2] Company Overview - iRhythm Technologies, Inc. is facing scrutiny regarding its Zio AT monitor, which was marketed as an innovative product for high-risk patients [2] - The company’s stock was reportedly traded at inflated prices due to misleading information provided by insiders [2] Legal Context - Shareholders who purchased iRhythm stock prior to November 11, 2022, are encouraged to contact Kuehn Law for potential legal action [3] - Kuehn Law offers to cover all case costs for investors, emphasizing the importance of shareholder participation in maintaining market integrity [4]

Core Viewpoint - Rosen Law Firm is investigating potential breaches of fiduciary duties by the directors and officers of iRhythm Technologies, Inc. (NASDAQ: IRTC) [1] Company Summary - The investigation pertains to the governance practices of iRhythm Technologies, Inc. and the responsibilities of its directors and officers [1] Legal Context - The announcement highlights the role of Rosen Law Firm as a global investor rights law firm, indicating a focus on protecting shareholder interests [1]