Company Overview - iRhythm Holdings, Inc. is a digital healthcare company specializing in innovative cardiac monitoring solutions, with its core offering being the Zio platform that utilizes wearable biosensors and advanced analytics for improved arrhythmia detection and diagnosis [5] - The company generates revenue primarily through sales of its Zio service, which combines device sales with subscription-based monitoring and diagnostic services for healthcare providers [8] - As of the latest financial data, iRhythm reported a total revenue of $747.1 million and a net income of -$44.6 million [3] Recent Developments - RTW Investments disclosed a new position in iRhythm Holdings, acquiring 1,181,990 shares valued at approximately $210 million during the fourth quarter of 2025 [1] - This new position represents 2.1% of RTW's total 13F-reported portfolio, indicating a significant commitment from the fund [6][7] - As of March 19, 2026, shares of iRhythm Holdings were priced at $117.78, reflecting a one-year price change of 14.2%, which underperformed the S&P 500 by 3.5 percentage points [7] Market Position - iRhythm Holdings operates at the intersection of medical devices and digital health, with its flagship Zio patch being a discreet, wearable cardiac monitor that has established a strong niche in ambulatory ECG monitoring [10] - The Zio system collects continuous data over days or weeks, providing physicians with a comprehensive view of a patient's heart rhythm, which enhances its value compared to traditional Holter monitors [10] - The combination of hardware, software, and services allows iRhythm to maintain a recurring revenue model that is potentially more stable than simple device sales [10]

Core Insights - iRhythm Technologies reported a "breakout year" for 2025, with significant revenue growth, margin expansion, and its first positive net income quarter [4][6][9] Financial Performance - Fourth-quarter 2025 revenue was $208.9 million, a 27.1% increase year over year, while full-year revenue reached $747.1 million, up 26.2% compared to 2024 [3][6] - Gross margin for Q4 was 70.9%, up 90 basis points year over year, and full-year gross margin was 70.6%, an increase of 170 basis points [1][6] - Operating expenses in Q4 rose to $145.8 million from $119.2 million a year earlier, with full-year operating expenses totaling $584.7 million, up 11.8% [7] - The company achieved its first positive quarterly net income of $5.6 million in Q4, while recording a full-year net loss of $44.6 million [7][9] Market Positioning - iRhythm holds approximately 72% market share in long-term monitoring and over one-third of volume from primary care, with strong EHR integration [5][10] - The company serves around 40,000 primary care physicians, emphasizing a complementary approach to cardiology [11] Product Development - The next-generation mobile cardiac telemetry (MCT) device is under FDA review, expected to launch in H1 2027, featuring a mobile gateway [15][16] - The current MCT offering, Zio AT, has shown unit growth exceeding 50% for the year [14] International Expansion - iRhythm is operational in the U.K., select E.U. markets, and Japan, with plans for growth in these regions expected to outpace overall company growth in 2026 [17][18] 2026 Guidance - Management guided for 2026 revenue of $870 million to $880 million, representing 16% to 18% growth, with an adjusted EBITDA margin of 11.5% to 12.5% [6][20][21] - Pricing is expected to remain flat in 2026, with Medicare rates for long-term monitoring increasing but MCT category rates slightly decreasing [22] Regulatory Considerations - Management addressed concerns regarding heightened scrutiny of chart-derived diagnoses, suggesting that iRhythm's services could reduce audit exposure [23]

Financial Data and Key Metrics Changes - iRhythm reported Q4 2025 revenue of $208.9 million, representing a 27.1% year-over-year growth, and full year 2025 revenue of $747.1 million, reflecting a 26.2% growth compared to 2024 [19][20] - The company achieved its first positive net income in Q4 2025, amounting to $5.6 million, or $0.17 per diluted share, while the full year net loss was $44.6 million, or a loss of $1.39 per diluted share [22] - Adjusted EBITDA for Q4 was $34.3 million, or 16.4% of revenue, marking a 470 basis point improvement year-over-year, and full year adjusted EBITDA was $68.9 million, or 9.2% of revenue, an improvement of over 1,000 basis points compared to 2024 [23] Business Line Data and Key Metrics Changes - The growth in Q4 was primarily driven by sustained volume demand across customer bases, with new store growth accounting for approximately 68% of year-over-year volume growth [20][21] - The Zio AT offering performed exceptionally well, with unit growth running more than twice the company average for the year [12][13] - The company holds approximately 15% market share in the MCT market, compared to 72% in long-term cardiac monitoring [14] Market Data and Key Metrics Changes - iRhythm serves approximately 40,000 primary care physicians, with more than one-third of volume originating from primary care settings [9] - The company is now commercial in the U.K., select E.U. markets, and Japan, where it holds less than 1% market share, indicating significant growth potential [14][15] - The U.K. market saw the largest quarter of volume ever for iRhythm, and the company is participating in NHS pilots [14] Company Strategy and Development Direction - iRhythm aims to shift from episodic detection to proactive, integrated, and predictive care, addressing the need for long-term continuous monitoring [8] - The company plans to focus on durable, volume-led growth across cardiology, primary care, and innovative channels, while expanding margins through operational efficiencies [16] - The strategic direction includes advancing platform innovation, scaling international markets, and maintaining operational excellence [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver durable growth while expanding profitability, emphasizing the importance of addressing rising clinical needs and constrained access in healthcare [28][29] - The company anticipates revenue for 2026 to be in the range of $870 million-$880 million, representing 16%-18% year-over-year growth [24] - Management highlighted the importance of integrating EHR systems and predictive AI capabilities to enhance patient care and operational efficiency [10][11] Other Important Information - 2025 marked the first year of positive adjusted EBITDA and free cash flow in the company's history, demonstrating profitable growth [23][24] - The company is actively working on a next-generation MCT device, expected to be released in the first half of 2027, which will feature a 21-day wear time and enhanced algorithms [13][56] - iRhythm is positioned at the intersection of several trends, including an aging population and increasing demand for proactive health management [15] Q&A Session Summary Question: Concerns about the elimination of chart-derived diagnosis from CMS - Management addressed concerns by stating that Zio provides confirmatory diagnoses, which is crucial for integration into patient records and audit processes [32][33] Question: Guidance on gross and operating margins for 2026 - Management provided guidance for adjusted EBITDA margin of 11.5%-12.5% for 2026 and expected gross margin improvement of 80-100 basis points relative to 2025 [37] Question: Potential tailwind from CMS proposals regarding chart scraping - Management indicated that the confirmatory diagnosis provided by Zio could serve as a tailwind, as partners are focused on improving documentation and reducing costs [40][41] Question: International growth assumptions for 2026 - Management expects international growth to slightly exceed overall company growth, with significant potential in newly opened markets [43] Question: AI concerns and billing implications - Management expressed confidence in their closed platform and the quality of data, emphasizing that AI capabilities must fit within existing workflows [48][49] Question: Updates on the MCT product timeline and enhancements - Management confirmed that the MCT product is on track for a first half 2027 release, with significant enhancements including a mobile gateway and improved algorithms [55][56]

Financial Data and Key Metrics Changes - iRhythm reported Q4 2025 revenue of $208.9 million, representing a 27.1% year-over-year growth, and full year 2025 revenue of $747.1 million, reflecting a 26.2% growth compared to 2024 [19][20] - Gross margin for Q4 was 70.9%, an increase of 90 basis points year-over-year, while full year gross margin was 70.6%, an improvement of 170 basis points year-over-year [21] - The company achieved its first positive net income in Q4 2025, amounting to $5.6 million, or $0.17 per diluted share, while the full year net loss was $44.6 million, or a loss of $1.39 per diluted share [22] - Adjusted EBITDA for Q4 was $34.3 million, or 16.4% of revenue, marking a 470 basis point improvement year-over-year, and full year adjusted EBITDA was $68.9 million, or 9.2% of revenue, representing an improvement of over 1,000 basis points compared to 2024 [23][24] Business Line Data and Key Metrics Changes - The growth in Q4 was driven by sustained volume demand across all channels, with new store growth accounting for approximately 68% of year-over-year volume growth [20] - The Zio AT offering performed exceptionally well, with unit growth running more than twice the company average for the year [12][14] - The company serves approximately 40,000 primary care physicians, with more than one-third of volume originating in primary care settings [9] Market Data and Key Metrics Changes - iRhythm holds a 72% market share in long-term continuous monitoring, with the segment growing in the high teens [7] - International markets represent a significant growth opportunity, with the company now commercial in the U.K., select E.U. markets, and Japan, where it holds less than 1% market share [14][15] - The U.K. delivered the largest quarter of volume ever for iRhythm, and the company is participating in pilots under the NHS Supply Chain's value-based procurement program [14] Company Strategy and Development Direction - The company aims to shift from episodic detection to proactive, integrated, and increasingly predictive care, addressing the need for long-term continuous monitoring [8] - iRhythm's strategy includes expanding margins through operational efficiencies, advancing platform innovation, and scaling international and adjacent markets [16] - The company is focused on delivering durable, volume-led growth across cardiology, primary care, and innovative channels while maintaining operational excellence [16][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver another year of durable, volume-led growth while expanding profitability [29] - The company is well-positioned to lead market expansion, driven by trends such as an aging population and increasing prevalence of arrhythmias [15][16] - Management highlighted the importance of confirmatory diagnoses in the context of recent regulatory scrutiny and expressed optimism about the potential tailwinds from these changes [17][41] Other Important Information - 2026 marks iRhythm's twentieth anniversary, with a goal to become a billion-dollar company by 2027 [18] - The company expects revenue for full year 2026 to be in the range of $870 million-$880 million, representing 16%-18% year-over-year growth [24][25] Q&A Session Summary Question: Concerns about the elimination of chart-derived diagnosis from CMS - Management addressed concerns by emphasizing that Zio provides confirmatory diagnoses, which is crucial for compliance and documentation [32][34] Question: Guidance on gross and operating margins for 2026 - Management provided guidance for adjusted EBITDA margin of 11.5%-12.5% for 2026 and expected gross margin improvement of 80-100 basis points relative to 2025 [37] Question: Potential tailwind from CMS proposals regarding chart scraping - Management indicated that the confirmatory diagnosis aspect of Zio could serve as a tailwind, although no specific assumptions were factored into forward-looking expectations [40][41] Question: AI concerns and potential impact on billing - Management expressed confidence in their unique data and regulatory position, stating that their platform's closed nature and established workflows would mitigate risks associated with AI adoption [48][49] Question: Updates on MCT product timeline and features - Management confirmed that the next-generation MCT device is expected to launch in the first half of 2027, featuring a mobile gateway and enhanced algorithms [56][57] Question: Guidance on international growth for 2026 - Management indicated that international growth is expected to slightly outpace overall company growth, with significant potential in newly opened markets [43]

Financial Data and Key Metrics Changes - iRhythm reported Q4 2025 revenue of $208.9 million, a 27.1% year-over-year growth, and full year 2025 revenue of $747.1 million, reflecting a 26.2% increase compared to 2024 [17][18] - Gross margin for Q4 was 70.9%, up 90 basis points year-over-year, while full year gross margin was 70.6%, an improvement of 170 basis points [18] - The company achieved its first positive net income in Q4 2025, amounting to $5.6 million, or $0.17 per diluted share, while the full year net loss was $44.6 million [19] - Adjusted EBITDA for Q4 was $34.3 million, representing 16.4% of revenue, and for the full year, it was $68.9 million, or 9.2% of revenue, marking a significant improvement [20] Business Line Data and Key Metrics Changes - Growth in Q4 was driven by sustained volume demand across all channels, with new store growth accounting for approximately 68% of year-over-year volume growth [17][18] - The Zio AT offering performed exceptionally well, with unit growth running more than twice the company average for the year [10][11] - The company holds a 15% market share in the MCT market, compared to a 72% share in long-term cardiac monitoring [12] Market Data and Key Metrics Changes - iRhythm serves approximately 40,000 primary care physicians, with more than one-third of volume originating from primary care settings [8] - The company is now commercial in the U.K., select E.U. markets, and Japan, where it holds less than 1% market share [12] - In the U.K., iRhythm delivered its largest quarter of volume ever and is participating in NHS pilots [12] Company Strategy and Development Direction - The company aims to shift from episodic detection to proactive, integrated, and predictive care, addressing the growing need for long-term continuous monitoring [7][14] - iRhythm's strategy includes expanding margins through operational efficiencies, advancing platform innovation, and scaling international markets [14][26] - The company is focused on maintaining operational excellence and compliance in a rapidly evolving healthcare environment [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver durable, volume-led growth while expanding profitability in 2026 [26] - The company anticipates revenue for 2026 to be in the range of $870 million to $880 million, representing 16%-18% year-over-year growth [21] - Management highlighted the importance of addressing the challenges in arrhythmia detection and the need for proactive care models [25] Other Important Information - 2025 marked the first year of positive adjusted EBITDA and free cash flow in the company's history [20][21] - The company is actively working on its next-generation MCT device, which is currently under FDA review and expected to be released in the first half of 2027 [11][12] Q&A Session Summary Question: Concerns about chart-derived diagnosis elimination from CMS - Management addressed concerns about chart-derived diagnosis, emphasizing that Zio provides confirmatory diagnoses, which is crucial for integration into workflows and patient records [30][31] Question: Guidance on gross and operating margins for 2026 - Management provided guidance for adjusted EBITDA margin of 11.5%-12.5% for 2026 and expected gross margin improvement of 80-100 basis points relative to 2025 [35][37] Question: Potential tailwind from CMS proposal regarding chart scraping - Management indicated that the confirmatory diagnosis from Zio could serve as a tailwind, as providers seek to bolster documentation in patient records [39][40] Question: AI concerns and customer willingness to perform analysis - Management expressed confidence in their unique data and regulatory position, stating that their platform's closed nature and established workflows would protect against potential AI competition [45][46] Question: Updates on MCT product timeline and enhancements - Management confirmed confidence in the MCT product's timeline for the first half of 2027, highlighting necessary enhancements and the transition to a mobile gateway [51][56] Question: Guidance on partnerships and their scaling - Management noted the addition of incremental partners and emphasized a cautious approach to guidance for the innovative channel business, which is still emerging [65][66]

iRhythm Technologies (NasdaqGS:IRTC) FY Conference Summary Company Overview - **Company**: iRhythm Technologies - **Industry**: MedTech, specifically in cardiac monitoring and arrhythmia detection - **Conference Date**: January 12, 2026 Key Points and Arguments Financial Performance - iRhythm achieved over **$740 million** in revenue for 2025, exceeding guidance and marking the first profitable year in the company's history [10][35] - The company expects **$870-$880 million** in revenue for 2026, representing a growth of **17%-18%** [35] - For the first time, iRhythm will be **free cash flow positive** in 2025, with an expected **11.5%-12.5%** adjusted EBITDA margin for 2026 [35][36] Market Opportunity - There are **27 million undiagnosed individuals** with cardiac arrhythmias in the U.S., representing a significant market opportunity [5][11] - iRhythm currently holds **72% market share** in long-term cardiac monitoring (LTCM) and aims to expand its presence in the **Mobile Cardiac Telemetry (MCT)** space, where it has only **15% market share** [13][24] - The company is targeting a **30 million test** market opportunity, including both undiagnosed patients and international markets [12][13] Product and Technology - iRhythm's **Zio** monitoring system allows patients to wear a device for **14 days**, capturing nearly **1.5 million heartbeats** [8] - The company is developing a **third-generation algorithm** for arrhythmia detection, which is currently with the FDA [9] - iRhythm is leveraging **AI** to analyze **3 billion hours** of heartbeat data, enhancing predictive capabilities for undiagnosed arrhythmias [22][27] Strategic Initiatives - The company is focusing on expanding into **primary care**, with over **20% of prescribing** now coming from this channel [17] - iRhythm is collaborating with **innovative channel partners** to target comorbid disease states, which overlap significantly with arrhythmias [20] - The company is also exploring opportunities in adjacent markets such as **sleep apnea**, where there is a high correlation with arrhythmias [32][33] Competitive Landscape - iRhythm has a competitive advantage due to its established product in LTCM, while competitors primarily focus on MCT, making it difficult for them to penetrate the primary care market [52][53] - The company has been successful in integrating with **EHR systems**, which has led to a **20%-25% increase** in volume post-integration [30] Research and Evidence Generation - iRhythm has published over **135 research manuscripts**, with nearly **40 peer-reviewed**, establishing a strong evidence base for its products [11][12] - The company emphasizes the cost savings associated with early arrhythmia detection, estimating **$15-$17 million** in savings for every **1,000 patients** identified [32] Future Outlook - iRhythm is optimistic about its growth trajectory, with plans to continue investing in technology and market expansion while maintaining profitability [36][59] - The company aims to achieve **15% adjusted EBITDA margins** as it approaches **$1 billion** in revenue [37] Additional Important Insights - The company is addressing **capacity constraints** in the healthcare system by moving monitoring to primary care, where there is a significant shortage of cardiologists [6][17] - iRhythm's proactive approach to identifying undiagnosed patients through AI and data analysis is seen as a game changer in the industry [23][27] - The company is currently working on enhancing its MCT product to meet market demands for longer monitoring durations [24][46] This summary encapsulates the key points discussed during the iRhythm Technologies FY Conference, highlighting the company's financial performance, market opportunities, product innovations, strategic initiatives, competitive landscape, and future outlook.

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]

Core Insights - iRhythm Technologies Inc. reported a third-quarter loss of 6 cents per share, significantly better than the analysts' expectation of a 31-cent loss [1] - The company achieved sales of $192.88 million, representing a 30.7% year-over-year increase, surpassing the consensus estimate of $184.74 million [1] Financial Performance - The third quarter of 2025 saw record quarterly revenue driven by strong performance in the core long-term continuous monitoring business, sustained demand for Zio AT, and contributions from international markets [2] - Gross profit reached $137.1 million, up 35.1%, with a gross margin of 71.1%, reflecting a 230-basis point improvement [2] Demand and Operational Efficiency - The increase in gross profit was primarily due to higher demand for Zio services, leading to greater volume [3] - The improvement in gross margin was attributed to volume leverage and operational efficiencies, although partially offset by higher blended costs per unit from a greater Zio AT product mix [3] Guidance and Future Outlook - iRhythm raised its fiscal 2025 sales guidance from a range of $720 million-$730 million to $735 million-$740 million, compared to the consensus of $726.42 million [4] - The adjusted EBITDA margin for the full year 2025 is expected to be approximately 8.25% to 8.75% of revenues [4] Analyst Sentiment - William Blair noted that the company is demonstrating strong growth and has a durable growth outlook, with positive expectations for future integrations and product launches [5] - BTIG and Needham analysts maintained a Buy rating on iRhythm, with price forecasts raised to $215 and $244, respectively [6] - Following these developments, IRTC stock increased by 3.19% to $190 [6]

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]

Financial Performance - iRhythm's revenue for Q3 2025 reached $192.9 million, a 30.7% increase compared to $147.5 million in Q3 2024[3, 5] - Gross profit for Q3 2025 was $137.1 million, up 35.1% from $101.5 million in Q3 2024, with a gross margin of 71.1%, a 230-basis point increase[6] - Net loss for Q3 2025 was $5.2 million, or a diluted loss of $0.16 per share, compared to a net loss of $46.2 million, or a diluted loss of $1.48 per share, in Q3 2024[8] - Adjusted EBITDA for Q3 2025 was $21.559 million, compared to $(19.886) million for Q3 2024[25] - Unrestricted cash, cash equivalents, and marketable securities totaled $565.2 million as of September 30, 2025[3, 9] Future Outlook - iRhythm projects full-year 2025 revenue between $735 million and $740 million[11] - The company anticipates an adjusted EBITDA margin for full-year 2025 ranging from approximately 8.25% to 8.75% of revenues[3, 11]