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

Financial Data and Key Metrics Changes - 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 margin improved to negative 1.7% in Q1 2025 from negative 9.2% in Q1 2024, reflecting a 750 basis points improvement [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] - Home enrollment for Zio Services in the U.S. was approximately 23% of volume in Q1 2025 [24] Market Data and Key Metrics Changes - iRhythm's international business showed strong demand, particularly in the UK, where record volume was achieved [15] - The company launched its services in Japan, marking its entry into the second-largest ambulatory cardiac monitoring market globally [16] - The U.S. market has approximately 27 million patients who may be unaware of potential cardiac arrhythmias, representing a significant opportunity for growth [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][14] - 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 products [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][71] - 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 [38][40] Question: Japan Market and Reimbursement - Management acknowledged disappointment with reimbursement rates in Japan but emphasized the strategic importance of the market and plans to generate clinical evidence for higher rates [44][46] Question: Zio AT Momentum and Market Share - Management indicated that Zio AT's success is due to both new account growth and retention of existing customers, with positive word-of-mouth contributing to market share gains [50][82] Question: Epic Integration Impact - Early results from Epic integration showed a high 20% increase in prescribing patterns in integrated accounts, although no incremental benefit was baked into guidance yet [58][59] Question: Volume from Innovative Channels - Management reported that volume from innovative channels is in the low single digits but is growing, with a significant opportunity in primary care [62][64] Question: Multi-parameter Sensor Opportunities - Management expressed interest in multi-parameter sensing capabilities and potential M&A opportunities, while remaining focused on internal innovation [66] Question: FDA Conversations and Facility Inspection - Management confirmed confidence in submitting Zio MCT to the FDA in Q3 2025, with ongoing remediation efforts progressing well [71][73]

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]