Summary of iRhythm Technologies FY Conference Call (December 04, 2025) Company Overview - **Company**: iRhythm Technologies (NasdaqGS: IRTC) - **Industry**: Life Science Diagnostics and Medical Devices - **Key Products**: - **Zio Monitor**: Long-term continuous cardiac monitoring device, capable of monitoring for 14 days and collecting an average of 1.5 million heartbeats [3][4] - **Zio AT**: Mobile cardiac telemetry product launched in 2019, providing near real-time monitoring [5] Market Insights - **Market Size**: 6.7 million ambulatory cardiac monitoring tests in the U.S. annually, with long-term continuous monitoring being the largest and fastest-growing segment [6] - **Market Growth**: Long-term continuous monitoring is growing at a high teens percentage year-over-year [6] - **Market Share**: iRhythm holds over 70% market share in long-term continuous monitoring and approximately 15% in mobile cardiac telemetry [5][30] Competitive Landscape - **Key Competitors**: Traditional Holter monitors and event monitors, which still account for 2 million tests annually [6] - **Differentiation**: iRhythm emphasizes clinical and operational superiority, with a focus on AI tools for data analysis and high physician agreement rates (99%) on reports generated [8][9] Regulatory Environment - **NCD and LCD**: iRhythm has a National Coverage Determination (NCD) that is 20 years old, with recent concerns regarding proposed Local Coverage Determinations (LCDs) that may affect service level requirements [10][11] - **Industry Support**: The Heart Rhythm Society and other industry partners have provided feedback supporting iRhythm's position on the differentiation between long-term continuous monitoring and mobile cardiac telemetry [14] Financial Performance - **Revenue Growth**: Fiscal 2025 saw a revenue acceleration of 500 basis points over fiscal 2024, with growth attributed to the success of Zio AT, innovative channels, and EHR integration [18][19] - **Future Guidance**: Preliminary outlook for fiscal 2026 is 16%-18% growth, reflecting a step down from the previous year's performance due to difficult comparisons [65][66] Product Development - **Next-Gen MCT**: A new mobile cardiac telemetry product is in development, expected to extend monitoring to 21 days, which is anticipated to enhance market share [30][32] - **FDA Submission**: A traditional 510(k) submission was made for the new product, with ongoing discussions with the FDA regarding cybersecurity [32][34] Innovative Channels - **Strategy**: Focus on proactive monitoring for patients at risk of undiagnosed arrhythmias, with a target market of 27 million patients [46] - **Partnerships**: Currently working with 18 partners, with plans to expand to 40, emphasizing the importance of data-driven decision-making in identifying at-risk patients [45][51] EHR Integration - **Volume Uplift**: Accounts with EHR integration have seen a 25% increase in volume, with over 50% of orders now processed through EHR systems [58][61] - **Integration Benefits**: Streamlined workflows for clinicians, allowing for more efficient patient monitoring and report generation [58][60] Margin and Profitability - **Gross Margin Targets**: Long-term gross margin target of 72%-73% by 2027, with expectations for initial neutrality in margins from the new MCT product [40][41] - **EBITDA Expansion**: Aiming for 300-400 basis points of EBITDA expansion annually, with a target of 15% adjusted EBITDA by 2027 [68] Conclusion - **Overall Outlook**: iRhythm Technologies is positioned for continued growth in the cardiac monitoring market, with strong product offerings, a focus on innovation, and strategic partnerships aimed at capturing a larger share of the market while maintaining profitability [19][68]

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] - Preliminary revenue guidance for 2026 is projected in the high teens, 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 percent year-over-year, outpacing the overall market growth [9][10] - The company has gained one to two points of market share in the long-term continuous monitoring segment, now holding a low 70% share 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, growing at mid-single digits, while the long-term continuous monitoring segment is experiencing faster growth [8][9] - The aging population is a significant tailwind for the market, increasing the risk of cardiac arrhythmias and the need for monitoring [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][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's positioning to capitalize on market opportunities, particularly with the increasing awareness of cardiac arrhythmias and advancements in therapies [10][11] - The company is committed to maintaining profitable growth while investing in innovation, aiming for a 400 basis points expansion in adjusted EBITDA year-over-year [64] Other Important Information - The company is actively working on international expansion, having launched into five new markets, including Japan, which presents a significant opportunity for growth [54][55] - The company is addressing FDA comments regarding cybersecurity as part of the review process for Zio MCT, with no expected contribution to 2026 revenue [41][42] Q&A Session Summary Question: What is driving the accelerated growth in the ambulatory cardiac monitoring market? - Management highlighted several factors, including the shift to primary care, increased consumer awareness, and the aging population as key drivers of growth [10][11] Question: How is the company leveraging its channel partners? - The company has seen success with 18 active channel partners, with all pilot programs transitioning to full commercial programs, indicating strong value propositions [34][35] Question: What is the status of the FDA submission for Zio MCT? - The company received comments from the FDA and is working through the review process, with no expected revenue contribution from Zio MCT in 2026 [41][42] Question: Can you provide an update on the international business? - The company is making progress in international markets, particularly in Japan, and expects to see meaningful contributions starting in 2027 [54][55] Question: What are the reimbursement updates for the monitoring services? - Medicare rates for long-term continuous monitoring are expected to increase by approximately 8% next year, while rates for MCT may see a slight decrease [76]

Financial Data and Key Metrics Changes - For Q3 2025, revenue was $192.9 million, reflecting a year-over-year growth of 31% [5][19] - Adjusted EBITDA margin was 11.2%, compared to a negative 13.5% in Q3 2024 [22][24] - Adjusted net loss decreased to $2 million, or $0.06 per share, from an adjusted net loss of $39.2 million, or $1.26 per share in Q3 2024 [22][24] - Gross margin improved to 71.1%, an increase of 230 basis points year-over-year [20][24] Business Line Data and Key Metrics Changes - Record performance was noted in both Zio Monitor and Zio AT, contributing to overall revenue growth [5][13] - New store growth accounted for approximately 60% of year-over-year volume growth, with home enrollment for Zio services steady at around 23% [19][20] - The Zio AT business saw year-over-year unit growth more than double the corporate average [13] Market Data and Key Metrics Changes - The U.S. market continues to show strong adoption in both hospital and ambulatory settings, with 76 of the top 100 customers now EHR integrated [6][7] - In Japan, 13 systems are live, with positive feedback from physicians regarding Zio's capabilities [16] - The UK private market is experiencing strong growth, supported by clinical evidence and key opinion leader engagement [17] Company Strategy and Development Direction - The company is focusing on expanding into primary care and innovative health channels, leveraging EHR integrations to enhance clinician efficiency [6][8] - A partnership with Lusum Health aims to enhance clinical AI capabilities for identifying undiagnosed patients at risk of cardiac arrhythmias [12] - The company is transitioning from a device-enabled service to a comprehensive digital health platform powered by data and AI [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to generate positive free cash flow for the first time in its history, expecting to be free cash flow positive for the full year 2025 [24][25] - The outlook for full-year 2025 revenue has been raised to $735 to $740 million, indicating continued strong volume growth [23][24] - Management highlighted the importance of proactive monitoring and AI-driven risk stratification in reducing healthcare costs and improving patient outcomes [10][11] Other Important Information - The company is advancing development in sleep diagnostics, recognizing the overlap between cardiac arrhythmias and sleep apnea [15][49] - The FDA has requested to pause remediation efforts until after the government shutdown, which management views as a positive sign [38][40] Q&A Session Summary Question: What is driving the new account openings and volume growth? - Management noted that the ability to scale and absorb entire networks of new customers from day one has been a significant factor in growth [28] Question: What is driving the outperformance expected in Q4? - The outperformance is primarily attributed to the core monitor business, with healthy contributions from AT and innovative channels [31] Question: How should growth cadence for MCT be considered? - Management indicated that while they are optimistic about the AT business, they are cautious about forecasting MCT contributions until FDA approval is secured [33] Question: What is the sales cycle for innovative channel partners? - The sales cycle varies significantly by customer, with some partners scaling quickly while others take longer [36] Question: Any updates on FDA remediation efforts? - There has been limited communication from the FDA, but management is optimistic about resuming discussions post-shutdown [38][40] Question: What is the incremental patient pool in the innovative channel? - The focus is on monitoring asymptomatic, undiagnosed populations, with a significant opportunity identified among patients with comorbid conditions [41][43]

Core Insights - iRhythm Technologies, Inc. (NASDAQ:IRTC) is recognized as one of the top medical device stocks, with Freedom Capital Markets initiating coverage with a Buy rating and a price target of $205 [1] Market Position - iRhythm holds a 70% market share in long-term cardiac monitoring, with its Zio Monitor being described as a "category killer" that has disrupted traditional 48-hour Holter monitors [2] - The company has a 12% market share in continuous monitoring through its Zio AT product, which can be worn for up to 14 days, and is expected to increase its market share with the upcoming release of a 21-day device [2] Sales Growth and Strategy - iRhythm has expanded its sales channels into the primary care market and has secured larger accounts, exceeding expectations and increasing projections over the last two quarters [3] - The company specializes in the design and commercialization of device-based technologies for ambulatory cardiac monitoring [3]

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].

Financial Data and Key Metrics Changes - iRhythm reported Q2 2025 revenue of $186.7 million, reflecting a year-over-year growth of over 26% [7][21] - Adjusted EBITDA margin improved by 500 basis points to 8.4% compared to the previous year [19][24] - Adjusted net loss decreased to $10.2 million, or $0.32 per share, from an adjusted net loss of $18.8 million, or $0.61 per share in the prior year [23][24] Business Line Data and Key Metrics Changes - The core long-term continuous monitoring business saw significant growth, with record new account openings and strong performance from the Zio AT product line [7][10] - New store growth accounted for approximately 68% of year-over-year volume growth, with home enrollment for Zio Services in the U.S. at about 23% of volume [22] Market Data and Key Metrics Changes - International markets showed strong demand, particularly in the UK and Japan, with a broad commercial launch in Japan contributing positively [7][17] - The company has 12 partners under contract covering approximately 2 million potential patients, with a robust pipeline of 40 active discussions for future partnerships [11] Company Strategy and Development Direction - iRhythm's strategic focus is on moving prescribing to primary care physicians, which has increased capacity for specialists and enabled proactive monitoring [7][8] - The company is investing in partnerships and technology, including a recent collaboration with Lusim Health to enhance early detection of arrhythmias using AI [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory, citing strong performance across core business and innovative channels [32] - The company anticipates continued momentum in the second half of 2025, despite a slight expected decline in Q3 revenue due to seasonality [25][71] Other Important Information - iRhythm is raising its full-year 2025 revenue guidance to $720 million to $730 million, reflecting first-half outperformance [25] - The company expects to remain slightly free cash flow negative for 2025 but anticipates becoming free cash flow positive in 2026 [28] Q&A Session Summary Question: Guidance and Drivers of Growth - Management acknowledged strong momentum across the business, with the core business being the primary driver of outperformance in Q2 [40][41] Question: Volume Contribution from Innovative Channel Partners - Management indicated that innovative channel partners contributed positively, with a significant increase in prescribing physicians [46] Question: Integration with Epic Accounts - Management reported a 20% increase in prescribing patterns post-integration with Epic accounts, indicating strong potential for future growth [53][54] Question: Impact of Innovative Partnerships - Key partnerships with Signify and CenterWell were highlighted as significant contributors to growth, with expectations for repeat monitoring opportunities [63][65] Question: Seasonality Impact on Q3 Revenue - Management explained that Q3 revenue is expected to decline slightly due to seasonality, but overall momentum remains strong [72][74] Question: Market Growth and Share Gains - Management noted that growth is driven by a combination of market expansion, share gains, and increased prescribing in primary care settings [81][84]

Summary of iRhythm (IRTC) FY Conference Call - June 04, 2025 Company Overview - iRhythm is a digital healthcare company focused on cardiac monitoring, having launched over a decade ago and changing the standard of care from traditional short-term Holter monitors to long-term monitoring solutions [7][8] - The company utilizes a proprietary technology platform that combines wearable biosensors, sophisticated AI tools, and a digital platform to deliver seamless services to clinicians [8][12] Financial Performance - For Q1 2025, iRhythm reported revenue of $158.7 million, representing over 20% year-over-year growth, marking the second consecutive quarter of such growth [13][52] - The company serves over 2 million patients annually, capturing approximately 30% of its core market of 6.5 million tests [14] - Gross margin improved to 68.8%, with a 250 basis point year-over-year increase, while adjusted EBITDA margin showed a 750 basis point improvement [53] Market Opportunity - The total addressable market (TAM) for cardiac monitoring is estimated at 27 million patients in the U.S., with only 6.5 million tests currently being performed annually [22][27] - iRhythm has a significant opportunity to expand internationally, with 5 million tests available outside the U.S. [20][23] - The company holds over 70% market share in long-term continuous monitoring, a segment it pioneered [18] Growth Strategy - iRhythm is focusing on a "land and expand" strategy, initially introducing its products through cardiology and electrophysiology departments and then expanding into primary care and other specialties [30] - The company is also targeting innovative channels, including value-based entities that manage patient risk, to capture a larger share of the market [31][34] Technological Advancements - AI is a core component of iRhythm's operations, enabling the analysis of vast amounts of ECG data collected from patients [36][46] - The company is developing additional vital sign monitoring capabilities through partnerships, which will enhance its product offerings and competitive position [43] Regulatory and Compliance Updates - iRhythm is addressing an FDA warning letter, with 80% of remediation activities completed as of the call date [49] - The company is also complying with a DOJ subpoena, providing requested documents while maintaining transparency with investors [50] Future Outlook - iRhythm has raised its revenue guidance for the year to between $690 million and $700 million, with adjusted EBITDA expected to be between 7.5% and 8.5% [55] - The company is committed to maintaining profitable growth while investing in R&D and operational infrastructure to support long-term growth [58] Key Takeaways - iRhythm is well-positioned to capitalize on the shift towards personalized medicine and preventative care, leveraging its advanced technology and market leadership [3][4] - The company is focused on expanding its market share and improving patient outcomes through innovative monitoring solutions [17][32]

Summary of iRhythm (IRTC) Conference Call Company Overview - **Company**: iRhythm Technologies, Inc. (IRTC) - **Industry**: Medical Devices, specifically cardiac monitoring solutions Key Points and Arguments Q1 Performance and Guidance - Q1 revenue beat expectations by $5 million, leading to a $15 million increase in guidance for 2025 [3][4] - Achieved over 20% year-over-year growth for the second consecutive quarter, indicating strong business momentum [4][5] - The primary driver for the Q1 performance was the significant growth of the Zio AT product, which is expected to sustain through 2025 [5][6] Seasonality and Revenue Distribution - Revenue distribution for 2025 is expected to follow historical seasonality: approximately 22.5% in Q1, 25% in Q2, 25% in Q3, and 27.5% in Q4 [6][7] Competitive Landscape - iRhythm capitalized on competitive disruptions in late Q3 and Q4 of 2024, gaining new accounts [8][9] - Despite competitors returning to the market, iRhythm has maintained a significant portion of the business acquired during the disruption [9] Market Share and Product Performance - iRhythm holds a 70% market share in the Zio monitoring segment, with expectations of continued share growth [11][12] - The Zio Monitor, launched 18 months ago, has been well-received, contributing to the company's strong competitive positioning [12] Gross Margin and Tariff Impact - Gross margin guidance for the year is flat, with an anticipated negative impact of 50 to 75 basis points from tariffs, primarily affecting imports from China and Taiwan [13][14] - The company is exploring mitigation strategies to reduce tariff exposure, which may lead to gross margin expansion in 2025 [15][17] FDA Submissions and Future Products - iRhythm plans to submit the next-generation Zio MCT product for FDA approval in Q3 2025, which is expected to enhance market share [20][21] - The company aims for a faster launch of Zio MCT compared to previous product transitions [22] Primary Care Strategy - The partnership with Epic is expected to enhance clinician workflows and has already shown a 20% average volume uplift in pilot accounts [26][28] - Over one-third of Q1 volume came from primary care prescribers, up from approximately 20% in 2023, indicating a successful land-and-expand strategy [33][35] Innovative Channel Partnerships - Innovative channel partnerships are beginning to contribute to volume, with low single-digit percentages of overall volume but showing growth from near zero [37] Financial Outlook - iRhythm anticipates slightly negative free cash flow for 2025, with expectations to turn positive in 2026 [53][54] - Long-term goals include achieving 15% EBITDA margins at $1 billion in revenue, with potential for mid-20% margins beyond that [49] International Market and Reimbursement - The Japanese market remains strategically important despite disappointing reimbursement rates, with plans to generate in-country clinical evidence for future reimbursement cycles [55][57] Pricing Strategy - A low single-digit pricing headwind is expected for the year, consistent with past trends, while the company focuses on volume growth [59] Additional Important Insights - iRhythm is committed to operational excellence and efficiency improvements, leveraging automation and global infrastructure to enhance profitability [41][44] - The company is actively investing in R&D for adjacent market opportunities, including multi-sensing capabilities [50][52]