Core Viewpoint - Kahn Swick & Foti, LLC is investigating iRhythm Technologies, Inc. following a Warning Letter from the FDA regarding non-conformities in medical device regulations and subsequent legal actions against the company and its executives [1][2][3]. Group 1: FDA Warning and Compliance Issues - On May 30, 2023, iRhythm Technologies received a Warning Letter from the FDA concerning non-conformities related to the Zio AT System, specifically addressing deficiencies in medical device reporting and quality system requirements [2]. - The FDA's concerns included undisclosed risks to patients, such as limitations in the transmission of arrhythmia or heart irregularity events [2]. Group 2: Legal Actions and Investigations - Following the FDA's Warning Letter, iRhythm and certain executives were sued in a securities class action lawsuit for failing to disclose material information, violating federal securities laws [3]. - The court has denied the company's motion to dismiss the case, allowing the lawsuit to proceed, while KSF's investigation focuses on potential breaches of fiduciary duties by iRhythm's officers and directors [3].

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.

SAN FRANCISCO, June 17, 2025 /PRNewswire/ -- Schubert Jonckheer & Kolbe LLP advises iRhythm Technologies, Inc. investors that the firm is investigating potential legal claims relating to alleged false statements exaggerating the capabilities of iRhythm's wearable Zio AT heart event monitor. Current shareholders are encouraged to contact the firm.On June 3, 2025, Judge Jacqueline Scott Corley of the U.S. District Court for the Northern District of California issued an order allowing key claims in a securitie ...

Summary of iRhythm (IRTC) FY Conference Call - June 10, 2025 Company Overview - **Company**: iRhythm Technologies, Inc. (IRTC) - **Industry**: Cardiac monitoring and diagnostics Key Points Market Dynamics - The overall ACM (Arrhythmia Cardiac Monitoring) market is approximately 6.5 million tests annually, with about 3 million tests attributed to long-term cardiac monitoring patches, where iRhythm holds a 70% market share [3][4] - iRhythm gained approximately 2% market share in 2024 within the patch segment [3] - There is a significant opportunity for growth as studies indicate over 64% of arrhythmias are detected after 48 hours of monitoring, suggesting a shift from short-term to long-term monitoring is necessary [4][5] - The undiagnosed population with potential arrhythmias is estimated to be over 27 million patients, indicating a substantial market expansion opportunity [5][46] Business Drivers and Growth - The company has seen consecutive quarters of over 20% growth, driven by successful integration into accounts and the performance of the Zio AT product [21][25] - iRhythm is focusing on expanding its presence in primary care settings to address capacity challenges in cardiology [9][10] - Innovative channel partnerships are being developed, with 12 agreements currently active and a pipeline of 40 in discussions [23] Competitive Landscape - iRhythm has invested over $500 million to build its infrastructure, creating high barriers to entry for smaller competitors [13][15] - Regulatory challenges have increased, but iRhythm is navigating these effectively and is on track to complete its commitments to the FDA [54][56] - The company is optimistic about its competitive position, especially with the upcoming MCT (Mobile Cardiac Telemetry) product launch [22][40] Financial Performance and Guidance - iRhythm expects to turn free cash flow positive in 2026 and is targeting an EBITDA margin of 7.5% to 8.5% for the current year [63][68] - The company is cautious in its guidance, projecting a growth rate of 16% to 18% for the year, while remaining motivated to achieve 20% growth [48][49] - Gross margins are expected to remain flat year-over-year due to various cost pressures, but operational efficiencies are being pursued [65][66] Regulatory and Compliance Updates - iRhythm is nearing completion of its remediation efforts with the FDA, with a positive relationship developing [55][56] - The company is preparing to submit its new MCT product for approval in Q3 2025 [61][62] Strategic Outlook - iRhythm is considering M&A opportunities that align with its strategic goals, particularly in expanding into adjacent markets [78][79] - The company is focused on leveraging its strong balance sheet to support growth initiatives and enhance its product offerings [75][78] Conclusion - iRhythm is positioned for significant growth in the cardiac monitoring market, with strong momentum, innovative products, and a clear strategy to capture a larger share of the undiagnosed patient population [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]

Cautionary statement re forward-looking statements, non-GAAP measures and other matters Certain data in this presentation was obtained from various external sources, and neither "iRhythm Technologies, Inc. ("iRhythm" or the "Company") nor its affiliates, advisers or representatives has verified such data with independent sources. Accordingly, neither the Company nor any of its affiliates, advisers or representatives makes any representations as to the accuracy of that third-party data or undertakes to updat ...

iRhythm (IRTC) Q1 2025 Earnings Call May 01, 2025 04:30 PM ET Company Participants Stephanie Zhadkevich - Director of Investor RelationsQuentin Blackford - President, CEO & DirectorDaniel Wilson - CFOAllen Gong - Vice PresidentMacauley Kilbane - Equity Research AssociateSuraj Kalia - Managing DirectorJon Young - DirectorRichard Newitter - Managing Director Conference Call Participants Kallum Titchmarsh - AnalystNone - AnalystNathan Treybeck - AnalystDavid Rescott - Senior Research AnalystDavid Saxon - Senio ...

iRhythm (IRTC) Q1 2025 Earnings Call May 01, 2025 04:30 PM ET Speaker0 afternoon. Thank you for attending the iRhythm Technologies Inc. First Quarter twenty twenty five Earnings Conference Call. My name is Cameron, and I'll be your moderator for today. All lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end. Again, due to the interest of time, we ask that you ask one question and to re queue for any follow-up questions. I would now like to ...

iRhythm (IRTC) Q1 2025 Earnings Call May 01, 2025 04:30 PM ET Company Participants Stephanie Zhadkevich - Director of Investor RelationsQuentin Blackford - President, CEO & DirectorDaniel Wilson - CFOAllen Gong - Vice PresidentMacauley Kilbane - Equity Research AssociateSuraj Kalia - Managing DirectorJon Young - DirectorRichard Newitter - Managing Director Conference Call Participants Kallum Titchmarsh - AnalystNone - AnalystNathan Treybeck - AnalystDavid Rescott - Senior Research AnalystDavid Saxon - Senio ...