iRhythm(IRTC)

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iRhythm(IRTC) - 2024 Q3 - Quarterly Results
2024-10-30 20:10
Exhibit 99.1 iRhythm Technologies Announces Third Quarter 2024 Financial Results SAN FRANCISCO, October 30, 2024 - iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, today reported financial results for the three months ended September 30, 2024. Third Quarter 2024 Financial Highlights • Revenue of $147.5 million, an 18% increase compared to third quarter 2023 • Gross margin of 68.8%, a 260-basis po ...
Newly Published Research Shows 14-Day Monitoring Detected Almost Three Times More Nonsustained Ventricular Tachycardia Than Standard 48-Hour Monitoring in Patients with Hypertrophic Cardiomyopathy
GlobeNewswire News Room· 2024-10-28 12:02
Hypertrophic cardiomyopathy (HCM) is a genetic heart condition affecting about 1 in 500 people and is one of the leading causes of sudden cardiac death (SCD) in people under 35, including among athletes.1 NSVT (nonsustained ventricular tachycardia), a known marker for increased risk of SCD in HCM, was detected in nearly 50% of HCM patients in the study undergoing long-term continuous ambulatory ECG monitoring of up to 14 days with a Zio® XT LTCM ECG patch device; 63% of NSVT episodes detected only after 48 ...
With FDA Approval iRhythm May Be Able To Lift Regulatory Overhang, Investor Skepticism, Analyst Says
Benzinga· 2024-10-22 17:18
Core Viewpoint - The FDA has approved iRhythm Technologies, Inc.'s 510(k) submission for the Zio AT device, marking a significant step in the company's regulatory progress and commercial availability in the U.S. [1] Group 1: FDA Approval and Product Details - The FDA granted approval for iRhythm's Zio AT device, which is a prescription-only outpatient cardiac telemetry device used for mobile cardiac telemetry services [1] - The Zio AT system includes a patch that records ECG data for up to 14 days and a wireless gateway for data transmission [1] Group 2: Future Expectations and Market Position - iRhythm's management anticipates a second 510(k) approval in the near future, potentially by October, aligning with their internal goals [2] - The introduction of mobile cardiac telemetry technology is expected to enhance iRhythm's competitive position by extending wear time closer to 30 days and functioning as an event monitor [2] Group 3: Stock Performance and Analyst Ratings - The analyst maintains an Outperform rating on iRhythm Technologies stock, which has seen a price increase of 20.30%, reaching $74.70 [3]
iRhythm's Zio ECG System Gets Approval in Japan, Stock Falls
ZACKS· 2024-09-13 15:55
iRhythm Technologies, Inc. (IRTC) has received regulatory approval from Japan's Pharmaceutical and Medical Device Agency for its Zio long-term continuous ECG monitoring (LTCM) system. The Zio system, which provides 14 days of continuous heart monitoring, combines a wearable patch device with AI-powered analysis through Zio ECG Utilization Software for high diagnostic accuracy to help doctors make the right diagnosis the first time. With this approval, iRhythm aims to secure reimbursement from Japan's Minist ...
iRhythm Technologies Announces Japanese Regulatory Approval of the Zio® ECG Monitoring System, the First Product to Deliver Arrhythmia Monitoring Service Utilizing Artificial Intelligence
GlobeNewswire News Room· 2024-09-11 12:05
Zio ECG monitoring system is the only fourteen-day cardiac monitoring service in its category to receive Japanese regulatory approval as an improved device without a clinical trial Zio ECG monitoring system previously received Japanese high medical needs designation, a unique distinction reflecting positive recommendation by the Japanese Heart Rhythm Society (JHRS) iRhythm will continue working towards reimbursement to enable market access in Japan, the world's second largest medical device market Japan is ...
iRhythm Stock May Gain on Its Latest Deal With BioIntelliSense
ZACKS· 2024-09-09 16:01
Core Viewpoint - iRhythm Technologies (IRTC) has signed an exclusive license agreement with BioIntelliSense to develop and commercialize patented technology in ambulatory cardiac monitoring (ACM) [1][2]. Company Summary - The agreement allows iRhythm to utilize BioIntelliSense's multiparameter sensing technologies, enhancing its platform capabilities and potentially enabling entry into adjacent indications like obstructive sleep apnea [2]. - The licensing agreement is expected to boost iRhythm's business and revenue growth in the ACM segment, attracting investor interest and potentially increasing share price [3]. - iRhythm will pay an upfront fee and additional payments based on regulatory milestones and technology validation, with royalties from net sales related to home sleep testing [7]. Financial Outlook - iRhythm reaffirmed its 2024 financial guidance, projecting revenue growth of approximately 18% to 20%, amounting to $580 million to $590 million [9]. - The gross margin for 2024 is expected to be between 68.5% and 69%, with an adjusted EBITDA margin of approximately 3.5% to 4% of revenues [9][10]. - The company anticipates no significant incremental development expenses in 2024, aside from the acquired in-process research and development (IPR&D) expense related to the agreement [10]. Industry Insights - The ambulatory cardiac monitoring market was valued at $5.8 billion in 2022 and is projected to grow at a CAGR of 10.4% from 2023 to 2030, indicating strong market potential for iRhythm's new agreement [11]. - iRhythm's stock has performed well, gaining 29.8% over the past six months, outperforming the industry growth of 8.9% and the S&P 500's gain of 17.3% during the same period [12].
iRhythm Technologies Launches Zio Monitoring Across Europe
ZACKS· 2024-08-30 16:21
Core Insights - iRhythm Technologies, Inc. (IRTC) has launched its Zio monitor and long-term continuous ECG monitoring service in Austria, the Netherlands, Spain, and Switzerland, emphasizing its commitment to global patient-centered digital healthcare solutions [1][6] - The Zio monitor offers up to 14 days of uninterrupted ECG monitoring, significantly improving the detection and management of cardiac arrhythmias, particularly atrial fibrillation, which is on the rise in Europe [3][5] Product Significance - Cardiac arrhythmias can lead to severe health risks, including stroke and death, making early detection and treatment essential for improving patient outcomes [2] - The Zio system provides extended monitoring capabilities that surpass traditional methods, enhancing diagnostic accuracy and streamlining clinical workflows [3][4] Market Expansion - iRhythm Technologies plans to begin shipping the Zio monitor in the mentioned European countries starting in September, with widespread availability expected by 2025 [6] - The Zio monitor, along with its mobile cardiac telemetry services, is already available in the United States and the UK, marking a significant step in expanding access to advanced cardiac monitoring solutions [6] Market Prospects - The ECG devices market is projected to grow from $6.03 billion in 2024 to $14.5 billion by 2036, with a CAGR of 7%, driven by an aging population and increasing heart disease rates [7][8] - The demand for accurate cardiac diagnosis is reflected in the rising exports of ECG devices, indicating a robust growth trajectory for the industry [8] Recent Developments - The Zio monitor received CE mark certification under the EU's Medical Device Regulation, confirming its compliance with EU standards for performance, quality, safety, and efficacy [9] - The new Zio monitor features a thinner, lighter, and smaller design, improving patient wearability and compliance, and integrates with iRhythm's ZEUS AI algorithm for enhanced ECG data capture [10] Stock Performance - iRhythm Technologies' stock has declined by 32.3% this year, contrasting with the industry's 11.9% decline and the S&P 500's 17.2% increase [11]
iRhythm Technologies to Participate in Upcoming Investor Conferences in September
GlobeNewswire News Room· 2024-08-21 20:05
SAN FRANCISCO, Aug. 21, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, announced today that the company will present at the following investor conferences in September: Morgan Stanley 22nd Annual Global Healthcare Conference on Wednesday, September 4, at 3:20 pm Eastern Time Wells Fargo 2024 Healthcare Conference on Thursday, September 5, at 8:45 am Eastern Time Baird 20 ...
All You Need to Know About iRhythm Technologies (IRTC) Rating Upgrade to Buy
ZACKS· 2024-08-07 17:00
Core Viewpoint - iRhythm Technologies (IRTC) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system highlights the strong correlation between changes in earnings estimates and near-term stock price movements, making it a valuable tool for investors [2][4]. - The recent upgrade reflects optimism about iRhythm Technologies' earnings outlook, potentially leading to increased buying pressure and a rise in stock price [3][5]. Earnings Estimate Revisions - For the fiscal year ending December 2024, iRhythm Technologies is projected to earn -$2.97 per share, representing a 26.5% change from the previous year's reported figure [8]. - Over the past three months, the Zacks Consensus Estimate for iRhythm Technologies has increased by 7.9%, indicating a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks based on earnings estimates into five groups, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - The upgrade to Zacks Rank 2 places iRhythm Technologies in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].
iRhythm(IRTC) - 2024 Q2 - Earnings Call Transcript
2024-08-02 12:06
Financial Data and Key Metrics Changes - The company achieved revenue of $148 million in Q2 2024, representing a 19.3% growth compared to the prior year [6][22]. - Adjusted net loss for Q2 2024 was approximately $18.8 million, or a loss of $0.61 per share, compared to an adjusted net loss of $13.1 million, or $0.43 per share in Q2 2023 [27]. - Adjusted EBITDA for Q2 2024 was $5 million, or 3.4% of revenue, compared to 3.5% in Q2 2023 [27]. - Gross margin for Q2 2024 was 69.9%, ahead of expectations, benefiting from operational efficiencies and one-time items [24][25]. Business Line Data and Key Metrics Changes - New store growth accounted for approximately 40% of year-over-year volume growth, with home enrollment for Zio services in the U.S. at approximately 22% of volume in Q2 [22]. - The market access team successfully negotiated six greenfield contracts, opening coverage for Zio for an incremental 2.9 million covered lives [23]. Market Data and Key Metrics Changes - The company is expanding into primary care, estimating over 15 million patients with cardiac-related palpitations visiting physicians annually [8]. - The anticipated commercial launch in Western Europe could represent an incremental market opportunity of 1.5 million patients benefiting from Zio each year [16]. Company Strategy and Development Direction - The company is focused on expanding its core business while also exploring new opportunities, including international markets and adjacent indications like obstructive sleep apnea [15][18]. - The strategic pillars for future growth include enhancing operational efficiencies and expanding market access through favorable payer negotiations [15][24]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum of the business, raising the 2024 revenue outlook to between $580 million and $590 million [28]. - The company anticipates continued volume growth in its core U.S. market and plans to maintain a focus on operational efficiency and financial sustainability [36]. Other Important Information - The company is addressing observations from the FDA inspections and is committed to resolving the issues noted [14][42]. - A transition in the CFO role was announced, with Daniel Wilson stepping into the position [20][32]. Q&A Session Summary Question: Observations from FDA inspections - Management indicated that they will respond to the FDA's observations within 15 days and emphasized that the discussions are focused on quality systems rather than product safety or efficacy [39][42]. Question: Revenue guidance and drivers - Management noted that the revenue guidance increase reflects strong momentum across new store growth and primary care contributions [44]. Question: Gross margin improvements - Management explained that one-time benefits from procurement efficiencies and logistical savings contributed to the gross margin, but these will not repeat in the future [47][49]. Question: DOJ investigation scope - Management stated that the DOJ's inquiry appears to focus primarily on the Zio AT product, but the document requests have been broad [51][66]. Question: Sleep market evaluation - Management clarified that the market evaluation for obstructive sleep apnea will not require significant incremental investment and will leverage third-party sleep tests initially [56][57].