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iRhythm and Lucem Health Partner to Introduce Predictive AI Solution for Early Detection of Arrhythmias in Patient Populations with Comorbid Conditions
Globenewswire· 2025-07-31 20:10
Core Insights - iRhythm Technologies has formed a strategic partnership with Lucem Health to enhance early detection of undiagnosed arrhythmias in high-risk patient populations [1][2][3] - The collaboration aims to shift from reactive to proactive healthcare, utilizing AI to identify arrhythmia risks before symptoms manifest [2][3] - The partnership targets over 27 million individuals in the U.S. who could benefit from proactive cardiac monitoring [2][8] Company Overview - iRhythm Technologies is a digital health leader focused on solutions that detect, predict, and prevent disease, utilizing wearable biosensors and cloud-based analytics [18] - Lucem Health specializes in AI-driven early disease detection, aiming to improve clinical outcomes and resource allocation in healthcare [19] Partnership Details - The collaboration will leverage Lucem Health's AI platform and iRhythm's diagnostic services to enable earlier identification of arrhythmia risks [2][3] - The first commercial offering will focus on patients with conditions like Type 2 diabetes, chronic kidney disease, chronic obstructive pulmonary disease, and coronary artery disease [4][6] Clinical Impact - Early pilot testing indicates improved targeting of patient populations at risk for arrhythmias, facilitating earlier clinical engagement [7] - The predictive AI solution is expected to enhance arrhythmia detection among an estimated 27 million undiagnosed patients in the U.S., potentially reducing healthcare resource utilization and costs [8][15] Economic Considerations - Cardiac arrhythmias affect approximately 1 in 20 U.S. adults, and untreated cases can lead to severe health complications, emphasizing the need for early detection [9][11] - Research shows that patients with arrhythmias incur significantly higher healthcare costs, reinforcing the economic case for earlier detection and intervention [13][14]
iRhythm(IRTC) - 2025 Q2 - Quarterly Results
2025-07-31 20:09
[Financial & Operational Highlights](index=1&type=section&id=Financial%20%26%20Operational%20Highlights) iRhythm Technologies reported a record second quarter for 2025, with revenue growth exceeding 26% to $186.7 million, driven by its diversified growth strategy. Key operational achievements include a strategic AI partnership with Lucem Health to enhance early arrhythmia detection and the presentation of positive clinical study results at ADA 2025, reinforcing the value of early cardiac monitoring in at-risk populations | Metric | Q2 2025 | Change vs Q2 2024 | | :--- | :--- | :--- | | Revenue | $186.7 million | +26.1% | | Gross Margin | 71.2% | +130 bps | - The company's growth momentum is attributed to three main areas: accelerating its core monitoring business, increasing the adoption of Zio AT, and expanding with value-based care partners[4](index=4&type=chunk) - A strategic partnership was executed with Lucem Health to use AI for earlier identification of undiagnosed arrhythmias in patients with comorbid conditions[9](index=9&type=chunk) - Results from two large-scale studies presented at ADA 2025 highlighted the opportunity for early cardiac detection in at-risk cardiometabolic populations, showing arrhythmias often precede major adverse cardiovascular events (MACE)[9](index=9&type=chunk) [Detailed Financial Performance](index=1&type=section&id=Detailed%20Financial%20Performance) In Q2 2025, revenue grew 26.1% year-over-year to $186.7 million, fueled by strong demand for Zio services. Gross margin improved to 71.2% from 69.9% due to volume leverage and operational efficiencies. Despite a rise in operating expenses to $151.6 million to support growth, the company successfully narrowed its GAAP net loss to $14.2 million from $20.1 million in the prior-year period, demonstrating improved operating leverage | Financial Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Revenue | $186.7M | $148.0M | +26.1% | | Gross Profit | $132.9M | $103.5M | +28.4% | | Gross Margin | 71.2% | 69.9% | +1.3 ppt | | Operating Expenses | $151.6M | $126.5M | +19.8% | | Net Loss | ($14.2M) | ($20.1M) | +29.4% (Improvement) | | Diluted Loss Per Share | ($0.44) | ($0.65) | +32.3% (Improvement) | - The increase in gross margin was primarily driven by volume leverage and operational efficiencies, which was partially offset by a higher product mix of Zio AT[6](index=6&type=chunk) - Adjusted operating expenses increased to **$145.2 million**, mainly due to funding for development activities and costs associated with serving a growing global patient volume[7](index=7&type=chunk) [Financial Position](index=2&type=section&id=Financial%20Position) As of June 30, 2025, iRhythm maintained a strong liquidity position with $545.5 million in unrestricted cash, cash equivalents, and marketable securities. The company's total assets grew to $964.0 million from $931.4 million at the end of 2024, while total liabilities also increased slightly - The company held **$545.5 million** in unrestricted cash, cash equivalents, and marketable securities as of June 30, 2025[10](index=10&type=chunk) | Balance Sheet Item (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total current assets | $663,917 | $645,819 | | Total assets | $964,030 | $931,449 | | Total current liabilities | $132,211 | $110,920 | | Total liabilities | $860,370 | $840,541 | | Total stockholders' equity | $103,660 | $90,908 | [2025 Annual Guidance](index=2&type=section&id=2025%20Annual%20Guidance) Following strong first-half performance, iRhythm has increased its full-year 2025 guidance. The company now projects revenue to be in the range of $720 million to $730 million and expects the adjusted EBITDA margin to be between 8.0% and 8.5% of revenues | 2025 Full Year Guidance | Projected Range | | :--- | :--- | | Revenue | $720 million to $730 million | | Adjusted EBITDA Margin | 8.0% to 8.5% of revenues | [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, shows total assets of $964.0 million, an increase from $931.4 million at year-end 2024. This was driven by increases in marketable securities and property and equipment. Total liabilities rose to $860.4 million, primarily due to higher accrued liabilities, while stockholders' equity improved to $103.7 million | Selected Balance Sheet Items (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $309,105 | $419,597 | | Marketable securities | $236,435 | $115,956 | | Total assets | $964,030 | $931,449 | | Long-term senior convertible notes | $648,007 | $646,443 | | Total liabilities | $860,370 | $840,541 | | Total stockholders' equity | $103,660 | $90,908 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2025, iRhythm reported revenue of $186.7 million and a net loss of $14.2 million, or ($0.44) per share. This represents a significant improvement from the same period in 2024, which saw revenue of $148.0 million and a net loss of $20.1 million, or ($0.65) per share. For the six-month period, revenue grew to $345.4 million and net loss narrowed to $44.9 million Three Months Ended June 30 (in thousands) | Account | 2025 | 2024 | | :--- | :--- | :--- | | Revenue, net | $186,687 | $148,047 | | Gross profit | $132,857 | $103,471 | | Loss from operations | ($18,708) | ($22,981) | | Net loss | ($14,218) | ($20,107) | | Net loss per share | ($0.44) | ($0.65) | Six Months Ended June 30 (in thousands) | Account | 2025 | 2024 | | :--- | :--- | :--- | | Revenue, net | $345,364 | $279,976 | | Gross profit | $242,073 | $190,987 | | Loss from operations | ($51,264) | ($61,119) | | Net loss | ($44,918) | ($65,774) | | Net loss per share | ($1.41) | ($2.12) | [Reconciliation of GAAP to Non-GAAP Financial Information](index=7&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Financial%20Information) The company provides non-GAAP financial measures, including adjusted EBITDA, adjusted net loss, and adjusted operating expenses, to offer a clearer view of its core operational performance. These measures exclude items such as stock-based compensation, impairment charges, business transformation costs, and certain litigation expenses. For Q2 2025, these adjustments reveal a significant improvement in underlying profitability compared to the prior year - Non-GAAP measures are used for internal decision-making and period-to-period comparisons, excluding items like stock-based compensation, impairment charges, business transformation costs, and certain litigation expenses[15](index=15&type=chunk)[16](index=16&type=chunk) [Adjusted EBITDA and Net Loss Reconciliation](index=7&type=section&id=Adjusted%20EBITDA%20and%20Net%20Loss%20Reconciliation) For Q2 2025, iRhythm's adjusted EBITDA was $15.7 million, a substantial turnaround from $5.0 million in Q2 2024. The improvement was driven by higher revenue and operating leverage. Adjusted net loss also narrowed significantly to $10.2 million, or ($0.32) per share, compared to an adjusted net loss of $18.8 million, or ($0.61) per share, in the prior-year quarter. Key adjustments included stock-based compensation ($22.8 million) and intellectual property litigation costs ($3.0 million) Q2 Non-GAAP Reconciliation (in thousands) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Loss (GAAP) | ($14,218) | ($20,107) | | Stock-based compensation | $22,827 | $21,821 | | Adjusted EBITDA | $15,696 | $4,991 | | Adjusted Net Loss | ($10,224) | ($18,811) | | Adjusted Net Loss per Share | ($0.32) | ($0.61) | [Adjusted Operating Expenses Reconciliation](index=8&type=section&id=Adjusted%20Operating%20Expenses%20Reconciliation) Adjusted operating expenses for Q2 2025 were $145.2 million, compared to $125.2 million in Q2 2024. The non-GAAP figure is derived by excluding $2.5 million in impairment charges, $0.9 million in business transformation costs, and $3.0 million in intellectual property litigation costs from the GAAP operating expenses of $151.6 million Operating Expenses Reconciliation (in thousands) | Line Item | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Operating Expenses (GAAP) | $151,565 | $126,452 | | Less: Impairment charges | ($2,479) | — | | Less: Business transformation costs | ($925) | ($1,296) | | Less: IP litigation costs | ($2,956) | — | | Adjusted Operating Expenses | $145,205 | $125,156 |
iRhythm Technologies Announces Second Quarter 2025 Financial Results
Globenewswire· 2025-07-31 20:05
Core Insights - iRhythm Technologies reported a record revenue of $186.7 million for Q2 2025, reflecting a 26.1% increase compared to $148.0 million in Q2 2024, driven by strong demand for Zio services and market penetration of Zio AT [4][8] - The company achieved a gross profit of $132.9 million, up 28.4% from $103.5 million in the same quarter last year, with a gross margin of 71.2%, an increase from 69.9% [5][8] - iRhythm's net loss narrowed to $14.2 million, or a diluted loss of $0.44 per share, compared to a net loss of $20.1 million, or a diluted loss of $0.65 per share in Q2 2024, attributed to revenue growth and operational efficiencies [7][8] Financial Performance - Revenue for Q2 2025 was $186.7 million, a 26.1% increase from $148.0 million in Q2 2024 [4][8] - Gross profit reached $132.9 million, a 28.4% increase from $103.5 million in the same period last year, with a gross margin of 71.2% [5][8] - Operating expenses for Q2 2025 were $151.6 million, up from $126.5 million in Q2 2024, with adjusted operating expenses at $145.2 million compared to $125.2 million [6][8] Strategic Developments - The company executed a strategic partnership with Lucem Health to enhance early identification of undiagnosed arrhythmias, leveraging AI for predictive and preventive care [8] - iRhythm's annual revenue guidance for 2025 has been increased to a range of $720 million to $730 million, with an expected adjusted EBITDA margin of approximately 8.0% to 8.5% [10][8] Cash Position - As of June 30, 2025, iRhythm reported unrestricted cash, cash equivalents, and marketable securities totaling $545.5 million [9][8]
Will iRhythm Technologies (IRTC) Report Negative Earnings Next Week? What You Should Know
ZACKS· 2025-07-24 15:07
Core Viewpoint - iRhythm Technologies (IRTC) is anticipated to report a year-over-year increase in earnings driven by higher revenues, with the actual results being a significant factor influencing its near-term stock price [1][2]. Earnings Expectations - The upcoming earnings report is expected to be released on July 31, with a consensus estimate of a quarterly loss of $0.53 per share, reflecting a year-over-year change of +13.1% [3]. - Revenues are projected to be $173.71 million, which is an increase of 17.3% compared to the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has remained unchanged over the last 30 days, indicating that analysts have not significantly altered their initial estimates during this period [4]. - For iRhythm Technologies, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -3.00%, suggesting a bearish outlook from analysts [12]. Earnings Surprise Prediction - The Zacks Earnings ESP model compares the Most Accurate Estimate to the Zacks Consensus Estimate, with a positive Earnings ESP indicating a higher likelihood of an earnings beat [8][10]. - However, the current combination of a negative Earnings ESP and a Zacks Rank of 3 makes it challenging to predict an earnings beat for iRhythm Technologies [12]. Historical Performance - In the last reported quarter, iRhythm Technologies was expected to post a loss of $0.89 per share but actually reported a loss of -$0.95, resulting in a surprise of -6.74% [13]. - Over the past four quarters, the company has beaten consensus EPS estimates two times [14]. Conclusion - While the potential for an earnings beat exists, iRhythm Technologies does not currently appear to be a compelling candidate for such an outcome, and investors should consider additional factors before making investment decisions [17].
iRhythm Technologies to Report Second Quarter 2025 Financial Results on July 31, 2025
Globenewswire· 2025-07-17 20:30
Core Viewpoint - iRhythm Technologies, Inc. will release its financial results for Q2 2025 on July 31, 2025, followed by a conference call to discuss the results [1] Company Overview - iRhythm Technologies is a leading digital health care company focused on creating solutions that detect, predict, and prevent disease [3] - The company utilizes wearable biosensors and cloud-based data analytics combined with proprietary algorithms to transform data from millions of heartbeats into clinically actionable information [3] - iRhythm aims to enhance patient care by providing better data, insights, and health outcomes [3] Conference Call Details - The conference call will begin at 1:30 p.m. PT / 4:30 p.m. ET on the same day as the financial results release [1] - Interested parties can access a live and archived webcast of the conference call on the company's investor website [2]
IRHYTHM INVESTIGATION CONTINUED BY FORMER LOUISIANA ATTORNEY GENERAL: Kahn Swick & Foti, LLC Continues to Investigate the Officers and Directors of iRhythm Technologies, Inc. - IRTC
Prnewswire· 2025-07-12 02:12
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].
iRhythm Technologies Announces Board Member Retirements and New Director Appointments
GlobeNewswire News Room· 2025-07-07 12:30
Core Insights - iRhythm Technologies, Inc. announced the retirement of two long-serving board members, Mark Rubash and Ralph Snyderman, M.D., effective July 7, 2025, and appointed Karen McGinnis and Kevin O'Boyle to the board of directors [1][2][4] Group 1: Board Member Changes - Mark Rubash served on the board since 2016, contributing extensive experience in finance, accounting, and strategy [2] - Ralph Snyderman, M.D., joined the board in 2017, providing clinical expertise and guidance during early digital technology challenges [2] - The new board members, Karen McGinnis and Kevin O'Boyle, bring significant financial and operational experience from the medical and biotechnology sectors [3][4] Group 2: New Board Members' Background - Karen McGinnis has over 30 years of experience in leading international companies across various industries, including biotechnology and technology, and previously served as Chief Accounting Officer at Illumina, Inc. [5][6] - Kevin O'Boyle has over 20 years of executive leadership experience, notably as CFO at NuVasive, where he significantly increased the company's market capitalization [9][10] Group 3: Company Vision and Strategy - iRhythm Technologies focuses on creating solutions that detect, predict, and prevent disease through wearable biosensors and cloud-based data analytics [12] - The company aims to deliver better data, insights, and health outcomes for patients globally [12]
New Data Presented at ADA 2025 Highlights Burden and Risk Associations of Cardiac Arrhythmias in Patients with Type 2 Diabetes and Chronic Kidney Disease
Globenewswire· 2025-06-23 12:30
Core Insights - iRhythm Technologies, Inc. presented findings indicating that cardiac arrhythmias are prevalent and often occur early in patients with type 2 diabetes (T2D), particularly those with chronic kidney disease (CKD), suggesting a need for improved early detection strategies in at-risk populations [1][5][11] Group 1: Study Findings - The studies analyzed longitudinal claims data from over 30 million U.S. adults, revealing that arrhythmias frequently appear before or shortly after diagnoses of CKD or major adverse cardiovascular events (MACE) in T2D patients [2][10] - In a cohort of 8.8 million T2D individuals, over 1.1 million were diagnosed with major arrhythmias, with 47% occurring after diabetes diagnosis and a median time of 496 days to arrhythmia detection [8][10] - Among 3.2 million T2D patients who received a CKD diagnosis, 670,003 (21%) developed major arrhythmias, with 59% of these occurring before CKD diagnosis [8][11] Group 2: Clinical Implications - Cardiac arrhythmias are a significant public health concern, affecting approximately 1 in 20 adults in the general U.S. population, but are more frequent and earlier in T2D and CKD patients [3][4] - Early detection of arrhythmias is critical as undetected conditions can lead to severe complications such as stroke, heart failure, and hospitalization [4][9] - The findings emphasize the importance of monitoring patients based on unique risk factors rather than solely on symptoms, as fewer than one in five patients experience symptoms during arrhythmic episodes [9][10] Group 3: Recommendations for Future Research - The studies suggest a need for innovative diagnostic approaches, including continuous ambulatory EKG monitoring, to facilitate early intervention and precision therapies for patients with T2D and CKD [11][12] - Further investigations are warranted to explore strategies for early diagnosis, risk stratification, and intervention in patients at risk of arrhythmias and MACE [10][11]
DOCS vs. IRTC: Who Will Win High-Stakes AI Showdown in Digital Health?
ZACKS· 2025-06-19 12:26
Core Insights - Doximity (DOCS) and iRhythm Technologies (IRTC) are prominent players in AI-powered healthcare, with Doximity focusing on clinician engagement and workflow, while iRhythm specializes in AI-driven cardiac monitoring [2][4] - Doximity reported fiscal 2025 revenues of $570.4 million, a 20% increase year-over-year, and a 48% rise in operating cash flow [2] - iRhythm Technologies achieved full-year 2024 revenues of $591.8 million, reflecting a 20.1% year-over-year growth [3] Company Overview - Doximity serves over 80% of U.S. physicians with a platform that includes telehealth and workflow tools [5] - iRhythm Technologies focuses on AI-driven cardiac monitoring through its Zio platform, which provides clinically validated diagnostics [5] Financial Performance - Doximity's fourth quarter of fiscal 2025 saw revenues of $138.3 million and net income of $62.5 million, with a 56% increase in free cash flow [7] - iRhythm's first-quarter 2025 revenues reached $158.7 million, a 20.3% year-over-year increase, despite a net loss of $30.7 million [10] Stock Performance - Year-to-date, Doximity's share price increased by 6.9%, while iRhythm's surged by 61.4% [6][9] - Doximity's stock performance is impacted by risks related to drug-pricing reforms and changes in pharmaceutical advertising budgets [6] AI Integration - Doximity has integrated AI into clinical workflows, notably with Doximity GPT, which automates documentation [11] - iRhythm employs AI for diagnostics through its Zio platform, supported by the ZEUS AI system for interpreting cardiac data [13] Growth Outlook - Doximity anticipates fiscal 2026 revenues between $619 million and $631 million, with adjusted EBITDA of $333-$345 million [14] - iRhythm raised its revenue outlook for the full year to $690-$700 million, with EBITDA margins projected at 7.5-8.5% [14] Investment Appeal - Doximity is viewed as a stable investment with profitability and a large user base, appealing to risk-averse investors [19] - iRhythm presents a higher-risk, higher-reward opportunity driven by innovative diagnostics and expanding clinical applications [19]
Robbins LLP Informs iRhythm Technologies, Inc. (IRTC) Investors That the Class Action Beat the Motion to Dismiss
GlobeNewswire News Room· 2025-06-18 00:48
Group 1 - A class action lawsuit has been filed against iRhythm Technologies, Inc. on behalf of shareholders who purchased stock between January 11, 2022, and May 30, 2023 [1] - The lawsuit alleges that iRhythm misrepresented the capabilities of its Zio AT monitor, claiming it was a real-time monitor for high-risk patients, while its main product, Zio XT, was intended for non-critical patients without real-time reporting [2] - The stock price of iRhythm was artificially inflated due to these representations, and it declined when the truth about the product's capabilities was revealed [2] Group 2 - On June 3, 2025, Judge Jacqueline S. Corley partially granted and denied the defendants' motion to dismiss, allowing litigation against iRhythm and its CEO to proceed [3] - Shareholders of iRhythm Technologies, Inc. have legal options available to them following the class action filing [3]