iRhythm Technologies Inc (IRTC) 2025 Q1 法說會逐字稿

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  • Operator

    Operator

  • Good afternoon. Thank you for attending the iRhythm Technologies Inc. First Quarter 2025 Earnings Conference Call. My name is Cameron, and I'll be your moderator for today. (Operator Instructions)

    午安.感謝您參加 iRhythm Technologies Inc. 2025 年第一季財報電話會議。我叫卡梅倫,今天我將擔任主持人。(操作員指示)

  • I would now like to pass the conference over to your host, Stephanie Zhadkevich, Director of Investor Relations.

    現在,我想將會議交給主持人、投資者關係總監 Stephanie Zhadkevich。

  • Stephanie Zhadkevich - Senior Director of Investor Relations

    Stephanie Zhadkevich - Senior Director of Investor Relations

  • Thank you all for participating in today's call. Earlier today, I released financial results for the First Quarter ended March 31, 2025. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical fact, should be deemed to be forward-looking statements. These are based upon our current estimates and various assumptions and reflect management's intentions, beliefs, and expectations about future events, strategies, competition, products, operating plans, and performance. These statements involve risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.

    感謝大家參加今天的電話會議。今天早些時候,我發布了截至 2025 年 3 月 31 日的第一季財務業績。在我們開始之前,我想提醒您,管理層將在本次電話會議中發表聲明,其中包括根據 1995 年《私人證券訴訟改革法案》的安全港條款符合聯邦證券法含義的前瞻性聲明。本電話會議中包含的任何非歷史事實陳述均應被視為前瞻性陳述。這些基於我們目前的估計和各種假設,反映了管理層對未來事件、策略、競爭、產品、營運計劃和績效的意圖、信念和期望。這些聲明涉及風險和不確定性,可能導致實際結果或事件與這些前瞻性聲明預期或暗示的結果或事件有重大差異。

  • Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risk factors section of our most recent annual and quarterly reports on Form 10-K and Form 10-Q, respectively, filed with the Securities and Exchange Commission. Also, during the call, we will discuss certain financial measures that have not been prepared in accordance with US GAAP with respect to our non-GAAP and cash-based results, including adjusted EBITDA, adjusted operating expenses, and adjusted net loss. Unless otherwise noted, all references to financial metrics are presented on a non-GAAP basis. The presentation of this additional information should not be considered an isolation of, as a substitute for, or superior to results prepared in accordance with GAAP. Please refer to the tables on our earnings release in Form 10-Q for reconciliation of these measures to their most directly comparable GAAP financial measures.

    因此,您不應過度依賴這些聲明。有關與我們的業務相關的風險和不確定性的清單和說明,請參閱我們向美國證券交易委員會提交的最新年度和季度報告(表格 10-K 和表格 10-Q)中的風險因素部分。此外,在電話會議中,我們將討論有關非公認會計準則和現金業績的某些未按照美國公認會計準則編制的財務指標,包括調整後的 EBITDA、調整後的營業費用和調整後的淨虧損。除非另有說明,否則所有財務指標均以非 GAAP 為基礎。這些附加資訊的呈現不應被視為孤立、替代或優於根據 GAAP 編制的結果。請參閱 10-Q 表格中的收益報告表格,以了解這些指標與最直接可比較的 GAAP 財務指標之間的對帳情況。

  • Unless otherwise indicated, all references to financial measures in this call other than revenue refer to non-GAAP results. This conference call contains time sensitive information and is accurate only as is a live broadcast today, May 1, 2025. I disclaim the intention or obligation, except as required by law to update a revised new financial projections or forward-looking statements, whether because of new information, future events, or otherwise. And with that, I'll send the call over to Quentin Blackford, iRhythm President and CEO.

    除非另有說明,本次電話會議中除收入之外的所有財務指標均指非公認會計準則結果。本次電話會議包含時間敏感訊息,並且僅在 2025 年 5 月 1 日今天的現場直播中準確。我否認有任何意圖或義務,除非法律要求更新修訂後的新財務預測或前瞻性聲明,無論是由於新資訊、未來事件或其他原因。說完這些,我將把電話轉給 iRhythm 總裁兼執行長昆汀布萊克福德 (Quentin Blackford)。

  • Quentin Blackford - Independent Director

    Quentin Blackford - Independent Director

  • Thank you, Stephanie. Good afternoon and thank you all for joining us today. Dan Wilson, our Chief Financial Officer, is joining me on today's call. My remarks will cover our business performance during the first quarter of 2025 and our outlook for the remainder of the year. I will then turn the call over to Dan to provide a detailed review of our first quarter financial results and updated guidance for 2025.

    謝謝你,斯蒂芬妮。下午好,感謝大家今天的參加。我們的財務長 Dan Wilson 將參加今天的電話會議。我的發言將涵蓋我們 2025 年第一季的業務表現以及今年剩餘時間的展望。然後,我將把電話轉給丹,讓他詳細回顧我們的第一季財務表現並更新 2025 年的指導。

  • IRhythm has begun 2025 in an exceptionally strong position with near record revenue unit volume, despite what is typically a meaningful seasonal sequential decline, resulting in robust top line results of $158.7 million representing more than 20% growth compared to the first quarter of 2024. This growth was driven by continued market penetration in our core US business, increasing appreciation of Zio's value proposition in national value-based care accounts, continued expansion into the undiagnosed arrhythmia market segment, and strong demand in our international business.

    IRhythm 在 2025 年伊始就處於非常強勁的地位,儘管通常會出現明顯的季節性連續下滑,但收入單位數量接近創紀錄水平,最終實現了 1.587 億美元的強勁盈利,與 2024 年第一季度相比增長了 20% 以上。這一成長得益於我們核心美國業務的持續市場滲透、Zio 在國家價值型醫療帳戶中的價值主張的不斷提升、未確診心律失常市場領域的持續擴張以及我們國際業務的強勁需求。

  • Following record new accounts on boarding achieved during 2024, we were very pleased to observe significant volume demand throughout the first quarter of 2025 for both Zio Monitor and Zio AT. Demand within our Zio Monitor product line originated from cardiologists, electrophysiologists, and primary care physicians, and we were encouraged to see another large national innovative health channel partner begin implementing the Zio Monitor for their population. Additionally, the strong Zio AT demand noted in the fourth quarter of last year continued throughout the first quarter, and we continued to welcome a substantial number of new accounts to the iRhythm family.

    繼 2024 年創下新帳戶數量紀錄後,我們非常高興地看到,2025 年第一季 Zio Monitor 和 Zio AT 的需求量都很大。我們的 Zio Monitor 產品線的需求源自心臟病專家、電生理學家和初級保健醫生,我們很高興看到另一個大型國家創新健康通路合作夥伴開始為其人口實施 Zio Monitor。此外,去年第四季出現的強勁 Zio AT 需求持續整個第一季度,我們繼續迎來大量新客戶加入 iRhythm 大家庭。

  • Marking a momentous occasion in iRhythm's history, during the first quarter, we surpassed 10 million cumulative patient reports since the company's inception, underscoring our unwavering commitment to delivering superior patient care. In our long-term continuous monitoring service line, momentum remains robust as we continue our strategic expansion into upstream care pathways, deepening our presence in existing cardiology and electrophysiology accounts, and drive further ACM modality mix shift away from short-term and event monitoring. We estimate that there are approximately 27 million patients in the United States who either present to their primary care provider with cardiac palpitations or are at a high risk to have cardiac arrhythmias due to patient specific risk factors but remain unaware that an arrhythmia may be present. Many of these patients have comorbid chronic diseases and frequently misattribute arrhythmia symptoms. By implementing ZEAL long-term continuous monitoring earlier in the care pathway, we can reduce time to diagnosis, eliminate unnecessary specialist referrals where capacity is limited, and facilitate timely patient care.

    第一季度,iRhythm 歷史上迎來了一個重要時刻,自公司成立以來,我們的累計患者報告數量已超過 1000 萬份,這凸顯了我們堅定不移地致力於提供卓越的患者護理。在我們的長期連續監測服務線中,隨著我們繼續向上游護理途徑進行策略性擴張,深化我們在現有心臟病學和電生理學帳戶中的存在,並進一步推動 ACM 模式組合從短期和事件監測轉變,我們的發展勢頭依然強勁。我們估計,美國大約有 2700 萬名患者,他們要么向初級保健醫生報告心悸,要么由於患者特定的風險因素而面臨發生心律失常的高風險,但卻沒有意識到可能存在心律失常。許多患者同時患有慢性疾病,並且經常錯誤地描述心律不整症狀。透過在護理途徑早期實施 ZEAL 長期持續監測,我們可以縮短診斷時間,消除容量有限的情況下不必要的專家轉診,並促進及時的患者護理。

  • Furthermore, recent scientific evidence demonstrates that these improvements lead to reductions in hospitalizations, enhanced clinical outcomes, and decreased healthcare system costs. At large integrated delivery networks, our upstream expansion into primary care has been facilitated by our land and expand strategy of creating awareness, education, and clinical champion engagement to drive earlier monitoring in the care journey and enabling better targeting of patients in need of further referral to specialists.

    此外,最近的科學證據表明,這些改進可減少住院人數、改善臨床效果並降低醫療保健系統成本。在大型綜合配送網絡中,我們透過土地和擴大策略促進了向初級保健的上游擴展,該戰略旨在提高認識、開展教育並促進臨床冠軍參與,從而推動護理過程中的早期監測,並更好地定位需要進一步轉診給專科醫生的患者。

  • By enabling more efficient workflow and an earlier accurate diagnosis, we have the potential to drive additional capacity for specialists like cardiologists and electrophysiologists to see better qualified patients, which in time also may result in additional monitoring. Fueling this focus to move more broadly across large integrated delivery networks is the advancement of our epic aura partnership, which is in the very early innings and demonstrating success with our first health systems on the platform already realizing the expected IT and operational efficiency gains and dozens more health systems either in progress or planning to kick off an aura integration this quarter.

    透過實現更有效率的工作流程和更早準確的診斷,我們有可能為心臟病專家和電生理學家等專家提供額外的能力,以治療更合格的患者,這也可能帶來額外的監測。推動這一重點在大型綜合交付網絡中更廣泛地推廣的是我們史詩級光環合作夥伴關係的進展,該合作夥伴關係尚處於起步階段,並已取得成功,我們平台上的首批醫療系統已實現預期的 IT 和運營效率提升,另有數十個醫療系統正在進行中或計劃於本季度啟動光環整合。

  • Furthermore, our progress with large value-based innovative channel partners who understand the importance of upstream identification of clinically actual arrhythmias continues to advance successfully. The majority of these organizations focus on earlier detection within targeted at-risk populations, recognizing that earlier identification often results in lower downstream cost of care and contributes to improved patient outcomes. Based upon recent real world retrospective claims analysis performed by our partner Eversana, for every 1,000 patients with certain comorbid conditions who are diagnosed with an arrhythmia earlier in the care pathway, it may result in over $10 million in downstream cost avoidance by preventing events that could increase healthcare resource utilization, such as emergency department visits or hospitalizations.

    此外,我們與大型基於價值的創新通路合作夥伴的合作進展順利,這些合作夥伴了解上游識別臨床實際心律不整的重要性。這些組織中的大多數都專注於針對高風險族群的早期檢測,他們認識到早期識別通常可以降低下游護理成本並有助於改善患者的治療效果。根據我們的合作夥伴 Eversana 最近進行的真實世界回顧性索賠分析,每 1,000 名患有某些合併症並在護理過程中早期被診斷出患有心律失常的患者,通過預防可能增加醫療資源利用率的事件(例如急診就診或住院治療),可以避免超過 1000 萬美元的下游成本。

  • During the first quarter of 2025, we drove the strongest revenue contribution to date from these innovative channel partners originating from undiagnosed arrhythmia monitoring. Our pipeline of interest from these accounts remains robust, and we are uniquely positioned to capture this emerging market opportunity due to our leadership and long-term continuous monitoring, our scalability, our industry leading AI that contributes to superior clinical reporting, and our extensive repository of clinical evidence demonstrating improved outcomes.

    2025 年第一季度,我們從這些源自未確診心律不整監測的創新通路夥伴那裡獲得了迄今為止最強勁的收入貢獻。我們從這些帳戶中獲得的興趣管道依然強勁,並且由於我們的領導地位和長期持續監控、我們的可擴展性、我們行業領先的有助於提供卓越臨床報告的人工智能以及我們廣泛的臨床證據庫證明結果得到改善,我們在抓住這一新興市場機遇方面具有獨特的優勢。

  • The execution of our multi-pronged approach to move further up the care pathway and open the primary care channel by implementing our land and expand strategy and partnering with value-based innovative channel partners has resulted in tremendous progress. Coming out of the first quarter, nearly one-third of our long-term continuous monitoring volumes now originate from primary care physician channels where healthcare providers continue to recognize the value that iRhythm is uniquely positioned to deliver. In addition to the strong demand for long-term continuous monitoring, iRhythm's mobile cardiac telemetry service achieved its strongest quarter in our history. With our commercial teams driving continued Zio AT momentum in accounts acquired during the fourth quarter of last year. As well as another strong quarter of new account additions in Quarter 1.

    我們採取多管齊下的措施,透過實施土地和擴張策略以及與基於價值的創新通路合作夥伴合作,進一步推進護理途徑並打通初級護理管道,取得了巨大進展。從第一季開始,我們長期持續監測量的近三分之一來自初級保健醫生管道,醫療保健提供者繼續認識到 iRhythm 的獨特優勢所提供的價值。除了對長期連續監測的強勁需求外,iRhythm 的行動心臟遙測服務還實現了我們歷史上最強勁的季度表現。在我們的商業團隊的推動下,Zio AT 在去年第四季獲得的帳戶中繼續保持成長勢頭。第一季新帳戶數量也再次呈現強勁成長。

  • Zio AT as a proportion of revenue volume reached its highest level to date, and the year over year revenue growth rate continued to significantly outpace our overall corporate average. The sustained momentum in Zio AT represents a good portion of our improved revenue outlook for 2025, and we continue to look forward to submitting our new Zio MCT with the FDA in the third quarter of this year.

    Zio AT 佔收入的比例達到了迄今為止的最高水平,並且同比收入增長率繼續大幅超過我們整個公司的平均水平。Zio AT 的持續發展勢頭在很大程度上代表了我們 2025 年收入前景的改善,我們繼續期待在今年第三季度向 FDA 提交新的 Zio MCT。

  • Beyond our core US business, we continue to make steady progress in bringing the Zio service to potentially millions more patients globally. In Europe, our commercial team in the United Kingdom has achieved another quarter of record volume while we continue to navigate reimbursement dynamics with the National Health Service. In Switzerland, Austria, the Netherlands, and Spain, our commercial teams continue to make progress with a solid pipeline of account activations and increasing clinician appreciation for Zio across an expanding hospital footprint.

    除了我們的核心美國業務之外,我們還將繼續穩步推進,將 Zio 服務帶給全球數百萬患者。在歐洲,我們在英國的商業團隊又實現了創紀錄的季度業績,同時我們繼續與國家醫療服務體系協調報銷事宜。在瑞士、奧地利、荷蘭和西班牙,我們的商業團隊繼續取得進展,擁有穩固的帳戶活化管道,並在不斷擴大的醫院範圍內提高臨床醫生對 Zio 的認可度。

  • Additionally, we announced today our commercial launch in Japan as the first ambulatory cardiac monitoring solution to utilize a 14-day PMDA cleared artificial intelligence in arrhythmia detection. As the demand for effective long-term monitoring grows, we believe the introduction of Zio in Japan represents an opportunity to enhance patient care and support evolving clinical needs in cardiac monitoring, an impact also recognized by our esteemed partners at the Japanese Heart Rhythm Society.

    此外,我們今天宣佈在日本進行商業發布,這是第一個利用 14 天 PMDA 批准的人工智慧進行心律不整檢測的動態心臟監測解決方案。隨著對有效長期監測的需求不斷增長,我們相信在日本推出 Zio 代表著一個機會,可以加強患者護理並支持心臟監測不斷變化的臨床需求,這一影響也得到了日本心律學會尊敬的合作夥伴的認可。

  • Our entry into the 2nd largest ambulatory cardiac monitoring market globally follows a recent decision by the Japanese Ministry of Health, Labor and Welfare to reimburse you at the established Holter monitoring rate. While this initial reimbursement decision is not ideal, we understand the necessity of demonstrating superiority against existing market products, which are predominantly Holter-style monitors. With this launch, we intend to generate additional clinical evidence through real world studies and local IRB approved research to support future reimbursement applications that better reflect and see a long-term continuous monitoring's value proposition.

    我們進入了全球第二大動態心臟監測市場,這是在日本厚生勞動省最近決定按照既定的 Holter 監測費率向您報銷之後做出的。雖然這個初步的報銷決定並不理想,但我們明白有必要證明其優於現有市場產品(主要是 Holter 式監視器)。透過此次發布,我們打算透過真實世界研究和當地 IRB 批准的研究來產生額外的臨床證據,以支持未來的報銷申請,更好地反映和了解長期持續監測的價值主張。

  • We look forward to continuing our collaboration with clinicians and working alongside Senco Medical Instruments, our distribution partner, to expand access to advanced cardiac monitoring services. In support of these efforts, we have continued to expand our already substantial repository of clinical evidence demonstrating the benefits of Zio ambulatory cardiac monitoring for improved patient outcomes, enhanced clinician efficiency, and optimized healthcare resource utilization. At the American College of Cardiology conference in March, our scientific evidence teams presented two large real-world studies encompassing over 1 million patients. Demonstrating that short term Holter duration monitoring frequently fails to detect actionable arrhythmias. And that patient reported symptoms are unreliable predictors of arrhythmic events. Specifically, among patients with daily or more frequent symptoms who were diagnosed with actual arrhythmias, nearly two-thirds remained undetected through the first 48 hours of monitoring, indicating that 24 to 48-hour monitoring, such as with Holter, would have failed to identify these conditions.

    我們期待繼續與臨床醫生合作,並與我們的分銷合作夥伴 Senco Medical Instruments 一起擴大先進心臟監測服務的覆蓋範圍。為了支持這些努力,我們繼續擴大我們已經豐富的臨床證據庫,證明 Zio 動態心臟監測對改善患者預後、提高臨床醫生效率和優化醫療資源利用的益處。在三月的美國心臟病學會會議上,我們的科學證據團隊展示了兩項涉及 100 多萬名患者的大型真實世界研究。證明短期 Holter 持續時間監測經常無法偵測到可操作的心律不整。且患者報告的症狀不能可靠地預測心律不整事件。具體來說,在被診斷為實際心律不整的、具有每日或更頻繁症狀的患者中,近三分之二的患者在前 48 小時的監測中未被發現,這表明 24 至 48 小時的監測(例如使用 Holter)無法識別這些情況。

  • In the US market, approximately $1.5 million.24 to 48-hour monitors, or nearly $400 million of market value, continue to be prescribed annually, representing a significant opportunity to continue to improve patient care within the current ambulatory cardiac monitoring market. More recently at the Heart Rhythm Society conference this past week, data was presented from the Avalon study of more than 400,000 patients showing that railroad claims within a commercially insured patient population demonstrated once again that Zio long-term continuous monitoring resulted in the highest diagnostic yield, lowest retest rate, and lowest risk of cardiovascular events during a one year follow up period compared to alternative ambulatory cardiac monitoring modalities and competitor brands. These results confirmed our earlier Camelot study, but within a younger, healthier, and commercially insured population. Collectively, these studies have now examined both Medicare and commercially insured railroad claims of more than 700,000 patients and provide important evidence of the clinical superiority of 14-day cardiac monitoring with Zio and contribute to the growing body of evidence supporting guideline updates and improved market access.

    在美國市場,每年約有 150 萬美元、24 至 48 小時監測器的處方量,或近 4 億美元的市場價值,這代表著在當前的動態心臟監測市場中繼續改善患者護理的重要機會。最近,在上週舉行的心律學會會議上,Avalon 對 40 多萬名患者進行了研究,結果表明,商業保險患者群體中的鐵路索賠再次證明,與其他動態心臟監測方式和競爭品牌相比,Zio 長期連續監測在一年的隨訪期內具有最高的診斷率、最低的重測率和最低的心血管事件風險。這些結果證實了我們先前對 Camelot 的研究,但研究對像是更年輕、更健康且擁有商業保險的人。總的來說,這些研究現在已經審查了超過 70 萬名患者的醫療保險和商業保險鐵路索賠,並為使用 Zio 進行 14 天心臟監測的臨床優勢提供了重要證據,並為支持指南更新和改善市場准入的越來越多的證據做出了貢獻。

  • Fundamental to delivering these results has been our continued transformation toward becoming a best in-class organization committed to quality, integrity, and operational excellence. This dedication was recognized through several recent third -party awards for Zio monitor, including the 2025 Red Dot Award and a Bronze Edison Award in the cardiovascular health diagnostics and monitoring category. We also reaffirm this commitment to excellence in our latest corporate sustainability report, which details our progress across four key pillars of corporate impact quality and sustainable technology innovation, access and health equity, workforce and inclusion, and environmental matters.

    實現這些成果的根本是我們不斷轉型,致力於成為一流的組織,致力於品質、誠信和卓越營運。Zio 監測器的這項奉獻精神已獲得了近期多個第三方獎項的認可,其中包括 2025 年紅點獎和心血管健康診斷與監測類別的愛迪生銅獎。我們還在最新的企業永續發展報告中重申了對卓越的承諾,該報告詳細介紹了我們在企業影響品質和永續技術創新、獲取和健康公平、勞動力和包容性以及環境問題四大關鍵支柱方面取得的進展。

  • An essential component of our commitment to excellence is our organizational focus on quality systems. Throughout the first quarter of 2025, regulatory and quality matters have remained our highest corporate priority, and we continue to make significant progress on our remaining remediation and compliance activities. These initiatives will remain our priority throughout the year, and we are progressing well against the timelines we have committed regarding the warning letter and 483 observations. We remain dedicated to exceeding the FDA's expectations and are on track to complete these additional compliance efforts by the end of 2025. As previously communicated, we will allocate all necessary resources to ensure best in class quality standards and are committed to addressing the FDA's warning letter and observations to their complete satisfaction.

    我們致力於追求卓越的一個基本要素是我們的組織對品質系統的關注。在整個 2025 年第一季度,監管和品質問題仍然是我們公司的最高優先事項,我們在剩餘的補救和合規活動方面繼續取得重大進展。這些舉措仍將是我們的全年重點,我們正在按照警告信和 483 條意見所承諾的時間表順利推進。我們將繼續致力於超越 FDA 的期望,並預計在 2025 年底之前完成這些額外的合規工作。正如之前所傳達的,我們將分配所有必要的資源,以確保一流的品質標準,並致力於完全滿意地處理 FDA 的警告信和意見。

  • Finally, I want to address the topics of tariffs. iRhythm is well positioned to navigate this uncertainty. Our number one priority remains our patients and physicians, and we are fully committed to ensuring uninterrupted access to our critical products and services. Our teams have implemented robust mitigation strategies that address potential supply chain concerns and cost implications. Importantly, iRhythm's unique value proposition aligns perfectly with healthcare's current focus on upstream intervention. Our ability to identify cardiac issues earlier in the care pathway directly supports reduced downstream cost and improved outcomes. This positioning becomes even more valuable in an environment where healthcare systems are seeking cost effective solutions that deliver meaningful clinical impact. We remain confident in our ability to execute our growth strategy while managing these external challenges. With that, I'll turn the call over to Dan to discuss our recent financial performance.

    最後,我想談談關稅問題。 iRhythm 已做好準備應對這種不確定性。我們的首要任務仍然是我們的患者和醫生,我們全力致力於確保不間斷地獲得我們的關鍵產品和服務。我們的團隊已經實施了強有力的緩解策略,以解決潛在的供應鏈問題和成本影響。重要的是,iRhythm 的獨特價值主張與醫療保健當前對上游幹預的關注完美契合。我們在護理過程中更早發現心臟問題的能力直接有助於降低下游成本並改善治療效果。在醫療保健系統尋求能夠帶來有意義的臨床影響的經濟有效的解決方案的環境中,這種定位變得更加有價值。我們對自己在應對這些外部挑戰的同時執行成長策略的能力充滿信心。說完這些,我將把電話轉給丹,討論我們最近的財務表現。

  • Daniel Wilson - Executive Vice President - Corporate Development, Investor Relations

    Daniel Wilson - Executive Vice President - Corporate Development, Investor Relations

  • Thank you, Quentin. As a reminder, unless otherwise noted, the financial metrics that I discussed today will be presented on a non-GAAP basis. Reconciliations to GAAP can be found in today's earnings release and on our IR website. Our first quarter of 2025 results were once again reflective of our continued focus on profitable growth. We are pleased to have delivered a second consecutive quarter of greater than 20% year over year revenue growth while driving 750 basis points of improvement to adjusted EBITDA margin. On the top line, our teams continued to drive impressive momentum in our core markets as we achieved revenue of $158.7 million, representing 20.3% year over year growth. These results were driven by robust volume growth across both product lines with an especially strong mixed contribution from Zio AT and volume growth from new account launches. New store growth with new store defined as accounts that have been open for less than 12 months accounted for approximately 65% of our year over year volume growth. Home enrollment for Zio services in the US was approximately 23% of volume in the first quarter.

    謝謝你,昆汀。提醒一下,除非另有說明,我今天討論的財務指標將以非 GAAP 為基礎呈現。您可以在今天的收益報告和我們的 IR 網站上找到與 GAAP 的對帳。我們 2025 年第一季的業績再次反映出我們對獲利成長的持續關注。我們很高興連續第二季實現了同比增長超過 20%,同時調整後的 EBITDA 利潤率提高了 750 個基點。在營收方面,我們的團隊繼續在核心市場保持強勁成長勢頭,實現了 1.587 億美元的營收,年增 20.3%。這些結果是由兩條產品線的強勁銷售成長所推動的,其中 Zio AT 的混合貢獻尤為強勁,新帳戶推出的銷售成長也起到了推動作用。新店成長(新店定義為開幕時間少於 12 個月的帳戶)約占我們年銷售額成長的 65%。第一季度,美國 Zio 服務的家庭註冊量約佔總註冊量的 23%。

  • Moving down the P&L, gross margin for the first quarter was 68.8%, slightly ahead of our expectations. Compared to the first quarter of 2024, the improvement to gross margin was driven by volume leverage, as well as the realized benefits from operational efficiencies that we have been driving over the prior year, partially offset by higher blended cost per unit from an increased Zio AT product mix. First quarter adjusted operating expenses were $140.4 million and 11.8% increase year over year, primarily driven by our ongoing remediation activities and funding of innovation and commercial growth initiatives. These purposeful investments were enabled by savings generated from operational excellence initiatives which demonstrate our ability to deliver top line growth while generating meaningful operating leverage. Adjusted net loss in the first quarter of 2025 was $30.3 million or an adjusted net loss of $0.95 per share compared to an adjusted net loss of $38.1 million or an adjusted net loss of $1.23 per share in the first quarter of 2024. Adjusted EBITDA in the first quarter of 2025 was negative $2.6 million or negative 1.7% of revenue compared to an adjusted EBITDA margin of negative 9.2% in the first quarter of 2024. This 750 basis point improvement in adjusted profitability is the direct result of thoughtful and intentional initiatives that our teams have implemented to drive sustainable efficiency at scale.

    從損益表中可以看出,第一季的毛利率為 68.8%,略高於我們的預期。與 2024 年第一季相比,毛利率的提高是由銷售槓桿以及我們在過去一年中一直在推動的營運效率所帶來的實際收益所推動的,但部分被 Zio AT 產品組合增加導致的單位混合成本上升所抵消。第一季調整後的營運費用為 1.404 億美元,年增 11.8%,主要得益於我們正在進行的補救活動以及對創新和商業成長計畫的資助。這些有目的的投資是透過卓越營運計畫產生的節省來實現的,這些計畫證明了我們有能力實現營收成長,同時產生有意義的營運槓桿。2025 年第一季調整後淨虧損為 3,030 萬美元,即每股調整後淨虧損 0.95 美元,而 2024 年第一季調整後淨虧損為 3,810 萬美元,即每股調整後淨虧損 1.23 美元。2025 年第一季調整後 EBITDA 為負 260 萬美元,即負 1.7% 的收入,而 2024 年第一季調整後 EBITDA 利潤率為負 9.2%。調整後獲利能力提高 750 個基點,是我們的團隊為推動大規模可持續效率而實施的深思熟慮和有意識的舉措的直接結果。

  • As noted in prior quarters, we continue to incur incremental legal and consulting fees as well as other company expenses related to FDA remediation efforts and DOJ subpoena activities. We continue to expect these incremental remediation expenses to be approximately $15 million for the full year. Beginning in the first quarter of 2025, we have excluded third party attorneys' fees and expenses associated with the patent litigation with Baxter from our non-GAAP results, including adjusted EBITDA. In the quarter we incurred approximately $0.8 million of IP litigation expenses associated with the Baxter litigation.

    如前幾季所述,我們繼續產生增量的法律和諮詢費用以及與 FDA 補救措施和 DOJ 傳票活動相關的其他公司費用。我們繼續預計全年增量補救費用約為 1500 萬美元。從 2025 年第一季開始,我們將與 Baxter 專利訴訟相關的第三方律師費和費用排除在非 GAAP 業績(包括調整後的 EBITDA)之外。本季度,我們因 Baxter 訴訟而產生了約 80 萬美元的智慧財產權訴訟費用。

  • Turning the guidance, we are raising full year 2025 revenue guidance to $690 million to $700 million to account for our outperformance during the first quarter and the durable volume growth we are seeing across both Zio monitor and Zio AT. This outlook continues to contemplate significant US volume growth along with low single digit percentage pricing headwind.

    轉向指引,我們將 2025 年全年營收指引上調至 6.9 億美元至 7 億美元,以反映我們在第一季度的出色表現以及 Zio Monitor 和 Zio AT 上看到的持久銷量成長。這一前景繼續考慮到美國銷售的大幅增長以及低個位數百分比的定價阻力。

  • For the 2nd quarter of 2025, we expect revenue to be consistent with historical averages, with approximately 25% of full year revenue generated during the second quarter. We continue to expect that gross margin will be flat for the full year 2025 with improvements from clinical operations and manufacturing efficiencies largely offset by proposed tariffs of global imports. As a reminder, we contemplated approximately 50 to 75 basis points of negative impact from tariffs in our original guidance. Based on current tariff rates, we anticipate the impact to continue to be within that range, and we are actively exploring potential opportunities to offset a portion of this impact through various supply chain strategies. As a reminder, our Zio devices are manufactured and assembled at our facility in California, and we have a widely distributed supplier base, including suppliers in Mexico, China, and other APAC countries. Our highest priority is ensuring continued supply to meet the growing demand for our Zio services.

    對於 2025 年第二季度,我們預計收入將與歷史平均水平保持一致,全年收入的約 25% 將在第二季度產生。我們仍然預計,2025 年全年毛利率將保持平穩,因為臨床營運和製造效率的提高將在很大程度上被全球進口的擬議關稅所抵消。提醒一下,我們在最初的指導中考慮了關稅帶來的約 50 至 75 個基點的負面影響。根據目前的關稅稅率,我們預計影響將繼續在該範圍內,並且我們正在積極探索透過各種供應鏈策略抵消部分影響的潛在機會。提醒一下,我們的 Zio 設備是在加州的工廠製造和組裝的,我們擁有廣泛分佈的供應商基礎,包括墨西哥、中國和其他亞太地區的國家的供應商。我們的首要任務是確保持續供應以滿足對 Zio 服務日益增長的需求。

  • Accordingly, we have begun to invest to strategically build up our inventory of raw materials for future finished goods and expect a slight headwind of free cash flow while we ensure that we have sufficient inventory to mitigate any potential unforeseen supply chain disruptions. On adjusted EBITDA margin, we are raising our full year 2025 guidance range to between 7.5% and 8.5% of full year revenues, inclusive of assumed acquired IP R&D charges and the impact of tariffs noted previously. We continue to anticipate normal seasonality in our adjusted operating expense profile with higher expenses coming through in the earlier half of the year due to spend associated with corporate activities and payroll expenses. We expect adjusted EBITDA margin in the second quarter of 2025 to range between 6% and 7%.

    因此,我們已開始投資,策略性地建立未來成品的原材料庫存,並預計自由現金流將略有逆風,同時確保我們有足夠的庫存來減輕任何潛在的不可預見的供應鏈中斷。就調整後的 EBITDA 利潤率而言,我們將 2025 年全年指導範圍上調至全年收入的 7.5% 至 8.5% 之間,其中包括假設獲得的 IP 研發費用以及先前提到的關稅的影響。我們繼續預期調整後的營運費用狀況將呈現正常的季節性,由於與公司活動和薪資支出相關的支出,上半年的費用將會增加。我們預計 2025 年第二季調整後的 EBITDA 利潤率將在 6% 至 7% 之間。

  • Finally, we ended the first quarter in a strong financial position with $520.6 million in unrestricted cash on hand. For full year 2025, we continue to anticipate being slightly free cash flow negative and anticipate becoming free cash flow positive for full year 2026. This expectation takes into consideration the cash flow impact from the inventory buildup of raw materials as discussed previously. As well as prioritized investments into the build out of next generation technology platforms.

    最後,我們以強勁的財務狀況結束了第一季度,手頭上有 5.206 億美元的非限制現金。對於 2025 年全年,我們繼續預期自由現金流將略為負值,並預計 2026 年全年自由現金流將變為正值。這項預期考慮了前面討論過的原物料庫存增加對現金流的影響。以及優先投資建置下一代技術平台。

  • In closing, we are pleased with our financial results to begin 2025 and our updated outlook for the remainder of the year. The resiliency of our in markets, a balanced set of near and long-term growth drivers, and a focus on operational excellence that yields sustainable profitability is positioning iRhythm to continue to grow our business and serve millions more patients into the future. I will now turn the call back to Clinton for closing remarks.

    最後,我們對 2025 年初的財務業績以及今年剩餘時間的最新展望感到滿意。我們在市場的彈性、均衡的近期和長期增長動力以及對產生可持續盈利能力的卓越運營的關注,使 iRhythm 能夠繼續發展我們的業務並在未來為數百萬患者提供服務。現在我將把電話轉回給柯林頓,請她作最後發言。

  • Quentin Blackford - Independent Director

    Quentin Blackford - Independent Director

  • Thanks, Dan, and thank you all for your continued support of iRhythm today. As we begin 2025 amid economic uncertainty, I want to highlight iRhythm's compelling value proposition that benefits multiple healthcare stakeholders. While reaching our 10 million patient report milestone represents significant progress, the ambulatory cardiac monitoring market remains largely untapped with substantial growth potential. Zio's clinically validated physician trusted platform uniquely positions us to transform cardiac care through earlier detection that enables truly preventative interventions before serious cardiac events occur.

    謝謝,丹,也謝謝大家今天對 iRhythm 的持續支持。當我們在經濟不確定的環境中開始 2025 年時,我想強調 iRhythm 引人注目的價值主張,它使多個醫療保健利益相關者受益。雖然達到 1000 萬份患者報告的里程碑代表著重大進步,但動態心臟監測市場仍有很大的發展潛力。Zio 經過臨床驗證且醫生信賴的平台使我們能夠透過早期檢測來改變心臟護理,從而能夠在嚴重心臟事件發生之前進行真正的預防性幹預。

  • Our technology empowers healthcare providers to deliver proactive care by identifying subtle rhythm abnormalities that might otherwise go undetected, while our AI powered analytics enable precision care pathways tailored to individual patient needs. This approach has the potential to substantially reduce health care costs by shifting diagnosis earlier in the care journey, preventing costly emergency interventions and hospitalizations while also addressing the capacity challenges that plague our system today.

    我們的技術使醫療保健提供者能夠透過識別可能無法檢測到的細微節律異常來提供主動護理,而我們的人工智慧分析則可以根據個別患者的需求量身定制精準護理途徑。這種方法有可能透過在護理過程的早期進行診斷來大幅降低醫療保健成本,避免昂貴的緊急幹預和住院治療,同時解決當今困擾我們系統的容量挑戰。

  • We're expanding into new channels and international markets with capabilities to incorporate additional vital signs monitoring over time. Our Technology Foundation enables scalability that will support future clinical insights and ultimately allow iRhythm to contribute to value-based population health management, the direction healthcare is evolving toward in the coming decade. We are accomplishing this with an efficient operating model featuring strong and improving gross margins, improving adjusted EBITDA performance, and a path of sustainable free cash flow. This combination of elements creates long term shareholder value while advancing healthcare quality, and we're grateful to you and our global partners for your ongoing support, operator, we're now ready for questions.

    我們正在拓展新的通路和國際市場,並有能力隨著時間的推移納入額外的生命徵象監測。我們的技術基礎具有可擴展性,將支持未來的臨床洞察,並最終使 iRhythm 能夠為基於價值的人口健康管理做出貢獻,這是未來十年醫療保健的發展方向。我們透過高效的營運模式實現這一目標,該模式具有強勁且不斷提高的毛利率、不斷改善的調整後 EBITDA 業績以及可持續的自由現金流路徑。這些因素的結合在提高醫療保健品質的同時創造了長期股東價值,我們感謝您和我們的全球合作夥伴的持續支持,接線員,我們現在準備好回答問題了。

  • Operator

    Operator

  • Thank you. We will now begin the question-and-answer session. (Operator Instructions)

    謝謝。我們現在開始問答環節。(操作員指示)

  • Allen Gong, JP Morgan

    艾倫龔,摩根大通

  • Allen Gong - Analyst

    Allen Gong - Analyst

  • Hi team, thanks for the question and congrats on the good quarter. I guess just the first question on the outlook, clearly you had a much stronger than expected quarter to start off the year, but when we look at the guide, especially in light of, as you yourself said, a bit of an uncertain macro backdrop, it's definitely good to see you kind of raising the outlook for the balance of the year and access of the beat. So I guess what are you seeing, in the quarter so far, what did you see in April that really gives you the confidence to kind of raise that kind of range and how should we think about, room for upside or like kind of what gets you to the high end of that range or the bottom of that range in light of the ongoing macro environment.

    大家好,感謝你們的提問,恭喜本季取得良好業績。我想第一個問題是關於前景的,很顯然,今年第一季的業績比預期要強勁得多,但是當我們看指南時,特別是考慮到您自己所說的有點不確定的宏觀背景,我們非常高興地看到您提高了對今年剩餘業績和節拍的展望。所以我想問一下,到目前為止,在本季度中,您在 4 月份看到了什麼,真正讓您有信心提高這種範圍,我們應該如何考慮上行空間,或者像什麼能讓您達到該範圍的高端或低端,考慮到當前的宏觀環境。

  • Daniel Wilson - Executive Vice President - Corporate Development, Investor Relations

    Daniel Wilson - Executive Vice President - Corporate Development, Investor Relations

  • Yeah, thanks Allen for the comment there and for the question. This is Dan, I can start and Quentin can add anything he'd like to. I think as we thought about the guide, obviously you called out that we're raising guidance above the beat in Quarter 1, and that's reflective of kind of the momentum we're seeing in the business. We've seen Zio AT grow really nicely now for two quarters in a row and have high confidence that that's going to sustain for the remainder of the year. So we've baked that into guidance. I would say from an overall approach standpoint, no change as we think about how to set guidance. We want to continue to be thoughtful. We don't want to get ahead of ourselves, and I want to make sure we're putting something out there that's well balanced in terms of upside drivers. You heard us talk about undiagnosed monitoring and our innovative channel partners that is contributing nicely to the business. We see a really nice pipeline of potential, contribution there on the horizon, but at the same time that is a new business that's emerging for us. There's kind of different selling cycles, different prescribing patterns, and until we have, higher visibility into that, we're going to hold back from taking too much of that into the guide. So again, overall approach to guidance hasn't changed a lot of momentum in the business which is reflected. In the updated guide.

    是的,感謝艾倫的評論和提問。我是丹,我可以開始,昆汀可以添加任何他想添加的內容。我認為,當我們考慮指南時,顯然您提到我們將在第一季提高指導值,這反映了我們在業務中看到的勢頭。我們已經看到 Zio AT 連續兩個季度實現了良好的成長,我們非常有信心這種成長勢頭將在今年剩餘時間內持續下去。因此我們將其納入指導之中。我想說,從整體方法的角度來看,當我們考慮如何設定指導時,沒有任何變化。我們希望繼續深思熟慮。我們不想超越自己,我想確保我們推出的產品在優勢驅動因素方面是均衡的。您聽到我們談論未診斷的監控以及為業務做出良好貢獻的創新通路合作夥伴。我們看到了非常好的潛在管道和即將出現的貢獻,但同時,這對我們來說也是一個正在出現的新業務。有不同的銷售週期、不同的處方模式,在我們對此有更高的了解之前,我們將不會在指南中包含太多內容。因此,整體指導方法並沒有改變業務中反映出的許多勢頭。在更新的指南中。

  • Quentin Blackford - Independent Director

    Quentin Blackford - Independent Director

  • The only thing I would add to that is certainly we don't want to get ahead of ourselves here, Allen, we're two quarters into growth north of 20%. As you think about the revised guide and a bit of an increase in the remaining three quarters beyond just the beat in Quarter 1, it still has. Growing roughly 15% to 17% in those three quarters compared to what we've seen in the last two quarters of north of 20%. So, I feel really good about where we're at, as Dan said, a lot of really good momentum in the business, a lot of things that we're excited about, but also some things that we just want to see play out before we start to make those into the expectations.

    我唯一想補充的是,艾倫,我們當然不想超越自己,我們已經連續兩個季度實現了 20% 以上的成長。當你考慮修訂後的指南以及除第一季之外剩餘三個季度的略有增長時,它仍然有。這三個季度的成長率約為 15% 至 17%,而過去兩個季度的成長率則超過 20%。因此,我對我們目前的狀況感到非常滿意,正如丹所說,業務上有很多非常好的發展勢頭,很多事情讓我們感到興奮,但也有一些事情我們只是想先看到結果,然後再開始將其納入預期。

  • Allen Gong - Analyst

    Allen Gong - Analyst

  • Thanks. And then a quick follow up just on Japan, I think, I'm sure you're disappointed that you didn't get kind of differentiated reimbursement from traditional holders, especially since I think the kind of body language you're getting with the high medical needs designation. Seem to point to the potential for that. So when I think about, in the near term while you're working to hopefully improve upon that, how should we think about the contribution you've previously been contemplating for this year and how confident are you in your ability to improve reimbursement and what kind of timeline will that take? Thank you very much.

    謝謝。然後快速跟進一下日本的情況,我想,我確信您會對沒有從傳統持有者那裡獲得差異化報銷感到失望,特別是因為我認為您在高醫療需求指定方面得到的那種肢體語言。似乎指出了這一點的潛力。因此,當我考慮在短期內您希望改善這一點時,我們應該如何考慮您之前為今年做出的貢獻,以及您對改善報銷的能力有多大信心,以及這需要什麼樣的時間表?非常感謝。

  • Daniel Wilson - Executive Vice President - Corporate Development, Investor Relations

    Daniel Wilson - Executive Vice President - Corporate Development, Investor Relations

  • Yeah, Allen, I can take the first part of that question as it relates to what's incorporated in the guide. If you recall in our call back in February when we gave guidance initially, we did say Japan, we expected $2 million of contribution to growth for the full year with the reimbursement rates where they landed. That will be a bit below, that original $2 million dollar expectation, and that's obviously reflected in the guide, but obviously a strategically important market for us. We will be launching in there to generate the clinical evidence needed to ultimately land to that higher reimbursement rate, and I'll let Quentin.

    是的,艾倫,我可以回答這個問題的第一部分,因為它與指南中的內容有關。如果您還記得我們 2 月最初給出指導意見時說過,我們確實提到了日本,我們預計其全年增長貢獻為 200 萬美元,報銷率也達到了當時的水平。這將略低於最初 200 萬美元的預期,這顯然反映在指南中,但顯然對我們來說是一個具有戰略重要性的市場。我們將在那裡啟動並產生最終達到更高報銷率所需的臨床證據,我會讓昆汀來做。

  • Quentin Blackford - Independent Director

    Quentin Blackford - Independent Director

  • Yeah, I think without question, Allen, a bit disappointed in where the rate got set considering, all the support around the high medical needs designation, and I think the understanding from the Japanese Heart Rhythm Society, sort of the differentiation of our product relative to other products that are out in the market. But to be specific, we don't have head-to-head sort of comparable data in the local Japanese market, and it's clear that that's what they're looking for to differentiate sort of reimbursement. And so we're committed to moving down that path. We've got a great number of hospitals sort of that are right on the verge of contracting with us and getting started. We've got a great deal of reps that are dedicated to selling Zio into that market, and we've got studies sort of designed in a way that's going to allow us to show that head-to-head analysis. And if we look back at any of the data that's come out of the Camelot study or the recent Avalon study where we show Zio specifically head-to-head against competitor brands or Holter monitors, we know that we're going to show a superior results. So, we need some time to build that in the local market, but we will be back with the reimbursement agency to argue for a higher rate that reflects the value that we're going to bring into that market. So we're excited about it, second largest market in the world, tremendous opportunity. But we're going to need to work through sort of that process to ultimately get to the right rate.

    是的,我認為毫無疑問,艾倫對費率的設定感到有點失望,考慮到所有圍繞高醫療需求指定的支持,我認為日本心律學會的理解,我們的產品相對於市場上其他產品的差異化。但具體來說,我們在日本當地市場沒有面對面的可比較數據,很明顯,這就是他們所尋求的區分報銷方式。因此,我們致力於沿著這條道路前進。有很多醫院即將與我們簽約並開始提供服務。我們有大量銷售代表致力於將 Zio 推銷到該市場,並且我們設計了某種研究,以便我們能夠進行面對面的分析。如果我們回顧 Camelot 研究或最近的 Avalon 研究得出的任何數據,我們將 Zio 與競爭品牌或 Holter 監視器進行正面對比,我們知道我們將展示出更優異的結果。因此,我們需要一些時間在當地市場建立這種模式,但我們會與報銷機構協商,爭取更高的費率,以反映我們將為該市場帶來的價值。所以我們對此感到很興奮,這是世界第二大市場,有著巨大的機會。但我們需要完成這樣的過程才能最終達到正確的利率。

  • Operator

    Operator

  • Kallum Titchmarsh, Morgan Stanley

    摩根士丹利的卡勒姆·蒂奇馬什

  • Kallum Titchmarsh - Analyst

    Kallum Titchmarsh - Analyst

  • Great, thanks guys for taking the question. Just on the AT momentum and you know obviously you kept a fair amount of the share you gained in the back half of 2024. Why do you think that was? Why don't you think they went back to your competitor? And then I guess how do you think that frames you for the MCT launch? Do you now think that that could be accelerating quicker than your expectations before, given your AT customer base is broader? Thanks a lot.

    太好了,謝謝大家回答這個問題。僅從 AT 的勢頭來看,您顯然保留了 2024 年下半年獲得的相當一部分份額。您認為這是為什麼呢?您認為他們為什麼不回到您的競爭對手那裡?那麼我想您認為這對 MCT 的推出有何影響?鑑於您的 AT 客戶群更加廣泛,您現在是否認為這一成長速度可能比您之前的預期更快?多謝。

  • Quentin Blackford - Independent Director

    Quentin Blackford - Independent Director

  • Yeah, I don't want to get ahead in terms of expectations around the new Zio MCT product just yet. But we're certainly very excited by the new features that that product's going to bring and believe it's a superior product to Zio AT. But clearly, Zio AT is having success in the market. And I think what you saw play out over the back part of last year and certainly in the first quarter here is that we're in the vast majority of these accounts already with our Zio monitor, our long-term continuous monitor. And we have our MCT or Zio AT product on the shelf already, so it's very easily for our customers to try the Zio AT product, and I think in that process of trying Zio AT they realize just how good of a product it is. The reality is there are some features to that Zio AT product that are superior to even products that are in the market today. As an example, having 14 days of continuous wear on an MCT product is really unlike any other product that's out there today. You're wearing multiple patches even to get to 14 days with most competitors. So I think there are aspects that customers began to learn around Zio AT, realizing that maybe it was better than what they initially anticipated or hadn't tried it yet. Once they tried it, they've decided to stick with it. And I think what's encouraging to me is that we saw that momentum from accounts that we're already in. We know there's tremendous opportunity having 70% of the long-term cardiac monitoring market, yet only having call it 10% to 12% of the MCT market, but being in those accounts already. So, when our own MCT or enhanced MCT product does come to market, I think there's going to be a real right to win in that opportunity, but we'll wait to get that to market and talk about the expectations at that point.

    是的,我現在還不想對新的 Zio MCT 產品抱持太高的期望。但我們確實對該產品即將帶來的新功能感到非常興奮,並相信它是一款優於 Zio AT 的產品。但顯然,Zio AT 在市場上取得了成功。我認為,從去年下半年以及今年第一季的情況來看,我們已經對絕大多數帳戶進行了 Zio 監控,即長期連續監控。而且我們的 MCT 或 Zio AT 產品已經上架,因此我們的客戶可以非常輕鬆地嘗試 Zio AT 產品,而且我認為在嘗試 Zio AT 的過程中,他們會意識到這款產品有多麼優秀。事實上,Zio AT 產品的一些功能甚至比當今市場上的產品還要優越。例如,MCT 產品可連續使用 14 天,這與當今市面上的任何其他產品都不同。與大多數競爭對手一樣,您甚至需要佩戴多個貼片才能達到 14 天的防護時間。因此我認為客戶開始了解 Zio AT 的某些方面,意識到它可能比他們最初預期的或從未嘗試過的要好。一旦他們嘗試了,他們就決定堅持下去。我認為令我感到鼓舞的是,我們從已有的帳戶中看到了這種勢頭。我們知道,長期心臟監測市場擁有龐大的商機,佔了 70% 的份額,但我們只佔據了 MCT 市場的 10% 到 12%,而且我們已經進入了這些市場。因此,當我們自己的 MCT 或增強型 MCT 產品進入市場時,我認為我們將真正有權贏得這個機會,但我們會等待將其推向市場,然後在那時談論預期。

  • Operator

    Operator

  • Macauley Kilbane, William Blair

    麥考利·基爾班,威廉·布萊爾

  • Macauley Kilbane - Analyst

    Macauley Kilbane - Analyst

  • Hi everyone, this is Mcauley on for Margaret tonight. Thanks for taking our question and congrats on the strong start to the year here. Want to ask on the epic integration which the feedback sounds quite positive so far and understand we're still early in that roll out, but other than those the natural workflow efficiencies you've talked to, can you just help quantify the impact those integrated accounts are seeing. Whether that be volume growth, versus non-integrated accounts, the cost reductions or other metrics you're tracking within these accounts.

    大家好,今晚我是為瑪格麗特主持的麥考利。感謝您回答我們的問題,並祝賀我們今年取得了良好的開端。想問一下關於史詩級整合的問題,到目前為止,反饋聽起來非常積極,並且我們了解我們還處於推出的早期階段,但是除了您談到的自然工作流程效率之外,您能否幫助量化這些集成帳戶所看到的影響。無論是交易量成長,與非整合帳戶相比,成本降低還是您在這些帳戶中追蹤的其他指標。

  • Quentin Blackford - Independent Director

    Quentin Blackford - Independent Director

  • Look, we've been very pleased with the early stages of the epic integration, and I think it's met our expectations. Certainly the workflow efficiencies, the IT efficiencies, reducing the amount of time for integration is all being realized. And I think we're only going to continue to get better in and around those opportunities and those efforts. The pipeline that sits out in front of us relative to the ability to bring new accounts on board is really strong. And frankly, when we look at the overall pipeline of new customer accounts that we're on boarding over the next several months, the vast majority are or accounts, some existing customers, some greenfield opportunities for us. It's early in terms of being able to speak with a high degree of confidence around what the incremental benefit might be from Epic. I will tell you in the handful of accounts that have been integrated now for multiple months, we've seen on average, a high 20% increase in the prescribing pattern of those accounts on their daily averages. Versus pre-integration with some of those pushing almost 40%. So we want to see that play out before we start to bake it into expectations. Our guide does not anticipate any incremental benefit from the epic integrations in terms of post-integration uplift, but early signs are positive around that, and we're certainly encouraged by what we're seeing.

    看,我們對史詩整合的早期階段感到非常滿意,我認為它滿足了我們的期望。當然,工作流程效率、IT 效率以及減少整合時間都正在實現。我認為我們只會在這些機會和努力中不斷進步。相對於吸引新客戶的能力而言,我們眼前的管道確實很強大。坦白說,當我們查看未來幾個月內我們將接納的新客戶帳戶總體情況時,絕大多數都是新客戶,有些是現有客戶,有些對我們來說是全新的機會。現在還無法自信地談論 Epic 可能帶來的增量效益。我要告訴你們的是,在已經整合了數月的少數帳戶中,我們平均看到這些帳戶的每日平均處方模式增加了 20%。與整合前相比,其中一些國家的比例接近 40%。因此,我們希望先看到其發展情況,然後再將其納入預期。我們的指南並不預期史詩級整合在整合後提升方面會帶來任何增量收益,但早期跡像是積極的,我們對所看到的情況感到鼓舞。

  • Operator

    Operator

  • Joanne Wuensch with Citigroup. He may proceed.

    花旗集團的 Joanne Wuensch。他可以繼續。

  • Unidentified Participant 1 - Analyst

    Unidentified Participant 1 - Analyst

  • Hey, good afternoon. This is Anthony on for Joanne. Thanks for taking our question. Is there anything you could break out or quantify how much volume now is coming out of these, volume based, accounts? It sounds like they're really starting to become a much bigger piece of the pie. Thank you.

    嘿,下午好。這是喬安妮的安東尼。感謝您回答我們的問題。您能否詳細說明或量化目前這些基於交易量的帳戶的交易量是多少?聽起來他們確實開始佔據更大的份額。謝謝。

  • Quentin Blackford - Independent Director

    Quentin Blackford - Independent Director

  • We haven't disclosed that yet. I'll give you some color. It's it's in the low single digits that's a percent of total volume in the quarter, but it's growing quite nicely. So when you think about, the staff that I put out there, nearly a third of our prescriptions in the quarter have now come through primary care. It's still a very small single digit percent of total volume that's coming from the innovative channels, which ultimately means that a lot of the primary care move is coming from our existing IDNs where cardiologists and EPs are recommending prescribing earlier in the care pathway at their primary care. Physician's office, which is incredibly encouraging. We want to see that play out, but I do think the bigger opportunity long term is going to be in the innovative channels and you know I mentioned we signed up one new innovative channel partner in the first quarter. We're certainly very excited to get them going. The partner that we had in the 4th quarter, didn't prescribe a tremendous amount in the first quarter, did begin to patch again and we'll patch over the course of the year. So we're excited to see that go again. I think this is really how we expand the market from 6 million tests per year to call it 27 million patients showing up in primary care. This is going to be a big part of that lever, and we're certainly very excited about it, but we're in the very, early stages. We're in the top of the first inning. Just demonstrates the amount of runway that's in front of us.

    我們尚未透露此事。我會給你一些顏色。該數字佔本季總量的百分比僅為個位數,但成長相當不錯。所以,想想看,我派出的工作人員,本季我們近三分之一的處方都是透過初級保健開出的。來自創新管道的藥物仍只佔總量的一小部分,這最終意味著,許多初級保健舉措都來自我們現有的 IDN,心臟病專家和 EP 建議在初級保健的護理途徑早期開處方。醫生辦公室,這令人難以置信地鼓舞人心。我們希望看到這項成果,但我確實認為,長期來看,更大的機會在於創新管道,你知道我提到過,我們在第一季簽約了一個新的創新管道合作夥伴。我們當然非常高興他們能夠開始行動。我們在第四季度的合作夥伴在第一季並沒有開出大量處方,但確實開始再次進行修補,我們將在今年內進行修補。所以我們很高興再次看到這種情況。我認為這才是我們真正擴大市場的方式,從每年 600 萬次測試擴大到每年 2700 萬名接受初級保健的患者。這將成為該槓桿的重要組成部分,我們對此感到非常興奮,但我們還處於非常早期的階段。我們正處於第一局的上半場。這只是顯示我們面前的跑道有多長。

  • Operator

    Operator

  • David Roman, Goldman Sachs

    高盛集團戴維羅曼

  • Unidentified Participant 2 - Analyst

    Unidentified Participant 2 - Analyst

  • Hi guys, you've got Daniel here for David tonight. Thanks for taking the question. After attending HRS, something we observed was the number of companies that are pursuing the multi-parameter sensor opportunity, although none of them have the equivalent infrastructure that you guys have built up over time. So how do you think about that opportunity here both with your own pipeline but also potential M&A given your balance sheet capacity?

    大家好,今晚丹尼爾 (Daniel) 來為大衛 (David) 做客。感謝您回答這個問題。參加 HRS 之後,我們觀察到許多公司都在尋求多參數感測器機會,儘管它們都沒有像你們這樣隨著時間的推移而建立起來的同等基礎設施。那麼,考慮到您的資產負債表容量,您如何看待這個機會,既有您自己的管道,也有潛在的併購機會?

  • Quentin Blackford - Independent Director

    Quentin Blackford - Independent Director

  • Well, I think you hit on something that's very important to us over our 3 to 5 year horizon. It's a big part of why we did the BioIntellisense transaction in the mid part of last year. It brings some incremental capabilities onto our platform that we believe are truly differentiated pbut ultimately gets us to that multi-parameter sensing platform off of a single device. That's really what we're ultimately building at the company. We're making great progress towards it. I think if we saw technology out there that really captured our attention, and I think we've got a good robust process to evaluate those sorts of things, look, we're in a good position to be able to bring that into the company, but we're going to be very thoughtful around that sort of opportunities. I'm bullish on what we have the opportunity to develop and innovate within our four walls. But if we could speed things up and evaluation was right, we certainly would look at those opportunities, but it would have to be right down the middle of the fairway from a strategic perspective for us to look that way because I'm very bullish on our ability to innovate within the four walls of the company.

    嗯,我認為你談到了對我們未來 3 到 5 年而言非常重要的事情。這在很大程度上解釋了我們去年年中開展 BioIntellisense 交易的原因。它為我們的平台帶來了一些增量功能,我們相信這些功能是真正差異化的,但最終讓我們透過單一設備實現了多參數感測平台。這確實是我們公司最終要打造的目標。我們正在朝著這個目標不斷前進。我認為,如果我們看到真正吸引我們注意力的技術,並且我認為我們有一個非常好的流程來評估這些事情,那麼我們就有條件將其引入公司,但我們會非常認真地考慮這類機會。我對我們有機會在公司內部進行開發和創新充滿信心。但如果我們可以加快速度,並且評估是正確的,我們肯定會考慮這些機會,但從戰略角度來看,這些機會必須位於球道的正中央,因為我非常看好我們在公司內部進行創新的能力。

  • Operator

    Operator

  • Nathan Treybeck, Wells Fargo

    內森·特雷貝克(Nathan Treybeck),富國銀行

  • Nathan Treybeck - Analyst

    Nathan Treybeck - Analyst

  • Hi, thanks for taking the question and congrats on a good quarter. So, you said that you still assume you're going to file for Zio MCT in Quarter 3. I guess can you talk about the conversations that you've had with the FDA and have they given you any indication that they would do the facility reinspection as part of the approval process? Thanks.

    您好,感謝您回答這個問題,並祝賀您本季取得了良好的業績。所以,您說您仍然假設您將在第 3 季申請 Zio MCT。我想您能談談您與 FDA 的對話嗎?他們是否表示他們會在審批過程中對設施進行重新檢查?謝謝。

  • Quentin Blackford - Independent Director

    Quentin Blackford - Independent Director

  • Hey, Nathan, thanks for the comments. With respect to the FDA around MCT, there's nothing at this point that gives us any concern around the ability to get that submitted in the 3rd quarter. I have a high degree of confidence that we've been able to make that happen and frankly the vast majority of that sits within our own control and we control our own destiny from that sense. So I feel good about that based upon what we know right now and there has been back and forth with the FDA and there's been nothing that they've indicated to us that would give us any reason to think differently than that Quarter 3 time frame. So, I feel good about continuing to expect MCT on file in Quarter 3. In terms of sort of their inspection of facilities to close out the warning letter, I can't give you any color around it. I don't know what to advise around that. I can tell you we have good discussions with the FDA. We continue to make great progress on the remediation efforts. We are on time and on track with all of the remediation. Activities that we identified and committed to the agency, and we will continue to close those out and I expect by the mid part of the year we will have finished all of our remediation activities specific to the warning letter and specific to the 483s. And keep in mind we're not going to stop there. We've committed ourselves to go above and beyond those efforts on our own doing to continue to rebuild and revamp that QMS that will take place in the back half of the year. So those things within our control I feel very good about. What I can't tell you is when the FDA might get back out here. I think with all the turnover within the agency, it's a little bit difficult to predict exactly what that might look like, and I think we're just going to need some time and clearly some direction from them on what they expect. I don't see in any way, Nathan, that that holds up anything that we're trying to do as a company. It doesn't hold up remediation efforts, doesn't hold up, new innovation, doesn't hold up our ability to submit new submissions for new product approvals. We're going to continue to move down the pathway as we have and they've given no indication at all of disruption there.

    嘿,Nathan,謝謝你的評論。關於 FDA 關於 MCT 的問題,目前我們並不擔心能否在第三季提交。我非常有信心我們能夠實現這一目標,坦白說,其中絕大多數都在我們的掌控之中,從這個意義上講,我們掌握著自己的命運。因此,根據我們目前所了解的情況,我對此感到滿意,並且我們已經與 FDA 進行了反覆溝通,他們沒有向我們表明任何理由讓我們有理由考慮與第三季度的時間框架不同的方案。因此,我很高興能夠繼續期待 MCT 在第三季的存檔。關於他們為結束警告信而對設施進行的檢查,我無法給你任何詳細資訊。我不知道該對此提出什麼建議。我可以告訴你,我們與 FDA 進行了良好的討論。我們的補救工作持續取得重大進展。我們按時、按計畫完成了所有補救工作。我們已確定並承諾向該機構開展的活動,我們將繼續完成這些活動,我預計到今年年中,我們將完成針對警告信和 483 的所有補救活動。請記住,我們不會就此止步。我們承諾將竭盡全力繼續重建和改進將於今年下半年實施的品質管理系統。因此,我對我們能控制的事情感到非常滿意。我無法告訴你的是 FDA 什麼時候會回來。我認為,考慮到該機構內部的人員流動,要準確預測未來會是什麼樣子有點困難,而且我認為我們需要一些時間,並且需要他們明確指示他們的期望。內森,我看不出這有任何阻礙我們公司所嘗試做的事情。它不會阻礙補救措施,不會阻礙新的創新,不會阻礙我們提交新產品審批的能力。我們將繼續按照既定路線前進,他們沒有表現出任何中斷的跡象。

  • Operator

    Operator

  • David Rescott, Baird

    大衛雷斯科特,貝爾德

  • David Rescott - Analyst

    David Rescott - Analyst

  • Oh great. Thanks for taking the questions and congrats on the quarter here. I wanted to ask, on the upside, in the quarter and then in the obviously raised guidance above the beat. That you had so far, when we think about the Quarter 4 number, I think maybe we assumed about half of the upside you had at Quarter 4 was around these innovative channel partners coming online, maybe about half from the share gain in MCT, when you think about the guide what's taken in the guidance for the second half, or you know. If you buy it for this year, is it still a similar mix where you have a, maybe relatively split benefit of these newer innovative channel partners in the MCT kind of share gain or is one of those starting to, become a bigger contributor into what you baked into this upside, for the rest of the year.

    哦,太好了。感謝您回答問題並祝賀本季取得的成績。我想問的是,從好的方面來看,本季的業績預期明顯高於預期。到目前為止,當我們考慮第四季度的數字時,我想我們可能認為第四季度大約一半的增長來自於這些創新通路合作夥伴的上線,大約一半來自於 MCT 的份額增長,當你考慮指南時,你會想到下半年的指導,或者你知道的。如果您今年購買它,它是否仍然是一個類似的組合,您可能會從這些較新的創新管道合作夥伴那裡獲得相對分割的利益,這些合作夥伴在 MCT 類型的份額增長中,或者其中一個是否開始成為您在今年剩餘時間內融入這一優勢的更大貢獻者。

  • Daniel Wilson - Executive Vice President - Corporate Development, Investor Relations

    Daniel Wilson - Executive Vice President - Corporate Development, Investor Relations

  • Yeah, thanks for the question, David. This is Dan. I think maybe a couple comments that will be helpful for you. In terms of how we would characterize the beat in Quarter 1, we would say that was primarily from Zio AT. We do see contribution from undiagnosed monitoring and our innovative channel partners as we've been talking about. But really that performance, the outperformance in Quarter 1, we would tie that to primarily to Zio AT and I'll say that's kind of how we thought about updated guidance as well in terms of the raise of guidance that is mostly reflective of Zio AT and that performance that we've seen now for the last two quarters with the expectation that will continue and that will sustain for the remainder of the year. Yes, undiagnosed monitoring is part of that mix as well and is contributing to the guide, but again that's something that's early. It's a little less predictable in terms of how and when these new accounts come on. When they come on, they can come on in a big way, but again, want to make sure that plays through before, taking that into the guide and make sure we're not getting ahead of ourselves.

    是的,謝謝你的提問,大衛。這是丹。我想也許一些評論會對你有幫助。就我們如何描述第一季的節拍而言,我們會說這主要來自 Zio AT。正如我們一直在談論的,我們確實看到了未確診監測和創新通路合作夥伴的貢獻。但實際上,第一季的出色表現主要歸功於 Zio AT,我想說,這也是我們對更新後的指導的看法,指導的提高主要反映了 Zio AT 的表現,我們已經看到了過去兩個季度的表現,預計這種表現將持續下去,並將在今年剩餘時間內保持下去。是的,未確診的監測也是其中的一部分,並且有助於指導,但這還處於早期階段。這些新帳戶的出現方式和時間就沒那麼可預測了。當他們上場時,他們可以大舉進攻,但再次強調,我們要確保之前已經做好準備,將其納入指導方針,確保我們不會操之過急。

  • Operator

    Operator

  • David Saxon, Needham & Company

    大衛‧薩克森(David Saxon),尼德漢姆公司

  • David Saxon - Analyst

    David Saxon - Analyst

  • Oh great, good afternoon, thanks for taking my question and congrats on the quarter and strong guys. So just wanted to follow up on that last question around Zio AT. So, can you give us a sense for like how much of the AT strength is driven by that competitor being off the market and that dynamic, or are you seeing traction in accounts that weren't with that that player? Thanks so much.

    哦,太好了,下午好,感謝您回答我的問題,並祝賀本季度取得的成績和各位強者。所以只是想跟進 Zio AT 的最後一個問題。那麼,您能否讓我們了解 AT 的實力在多大程度上是由競爭對手退出市場以及這種動態所驅動的,或者您是否看到了與該玩家無關的帳戶的吸引力?非常感謝。

  • Quentin Blackford - Independent Director

    Quentin Blackford - Independent Director

  • I think it's a bit of the latter, to be honest with you. I mean we certainly see accounts that we on-boarded in the 4th quarter continuing to grow nicely, but the number of new accounts being added to the company in the first quarter was right there, near another record high. So I think what's happening is word of mouth within the local market is starting to be made around the value and the ability of the Zio AT product, and folks are trying it, learning that it's quite good and they're sticking with it. One thing that's interesting, while the MCT category is typically prescribed for up to 30 days of monitoring, you can see in the data very clearly our competitors MCT products are worn on average about 12.8 days out of 30 days. We know that when they get a single Zio AT put on, they're going to wear it for 13.8 days. They're going to wear it nearly 14 days. So, we're giving folks, something that's very comparable, if not better than what they're currently experiencing, and I think once they try it and see it, they stick with it and then we see the nice growth. We're excited by it. Obviously, we get the new Zio MCT product into the market. I think the success that we're having with Zio AT currently is only going to give us higher degree of confidence that Zio MCT is going to be just as successful in the market as well.

    老實說,我認為有點後者。我的意思是,我們確實看到我們在第四季度接納的帳戶繼續良好增長,但第一季公司新增帳戶的數量就在那裡,接近另一個歷史新高。所以我認為,當地市場正在發生的情況是,人們開始口耳相傳 Zio AT 產品的價值和功能,人們正在嘗試它,發現它非常好,並且堅持使用它。有趣的是,雖然 MCT 類別通常規定最多 30 天的監測,但您可以從數據中非常清楚地看到,我們競爭對手的 MCT 產品在 30 天內平均佩戴時間為 12.8 天。我們知道,當他們穿上一件 Zio AT 時,他們將穿著它 13.8 天。他們要戴它近14天。因此,我們為人們提供的東西與他們目前所體驗到的東西非常相似,甚至更好,我認為一旦他們嘗試並看到它,他們就會堅持下去,然後我們就會看到良好的成長。我們對此感到很興奮。顯然,我們將新的 Zio MCT 產品推向了市場。我認為,我們目前在 Zio AT 上的成功只會讓我們更有信心,Zio MCT 也將在市場上取得同樣的成功。

  • Operator

    Operator

  • Saraj Kalia, Oppenheimer

    薩拉吉·卡利亞(Saraj Kalia),奧本海默

  • Suraj Kalia - Analyst

    Suraj Kalia - Analyst

  • Quentin, Dan, can you hear me all right?

    昆汀,丹,你們聽得到我說話嗎?

  • Quentin Blackford - Independent Director

    Quentin Blackford - Independent Director

  • We got you. That's right.

    我們抓到你了。這是正確的。

  • Suraj Kalia - Analyst

    Suraj Kalia - Analyst

  • Gentlemen, congrats on a great quarter. Gentlemen, a lot of numbers have been thrown around. I was wondering if you could distill it for us and forgive me if I haven't gotten some of this. So then, if I give you three buckets Legacy Zio XT versus Zio AT. The second bucket is growth in the legacy channel versus PCP, and the third bucket is large IDNs versus the non-IDNs. Can you quantify for us, just help us dissect a bit more. What are the moving parts, how is relative growth in these three buckets? It would be greatly appreciated. Thank you for taking my questions.

    先生們,恭喜你們取得了一個出色的季度業績。先生們,已經有很多數字被提出來了。我想知道您是否可以為我們提煉它,如果我沒有得到一些,請原諒我。那麼,如果我給你三桶 Legacy Zio XT 對上 Zio AT。第二個桶子是傳統通路相對於 PCP 的成長,第三個桶子是大型 IDN 相對於非 IDN 的成長。你能為我們量化一下嗎,幫助我們進一步分析。移動部件有哪些?這三個部分的相對成長如何?我們將不勝感激。感謝您回答我的問題。

  • Daniel Wilson - Executive Vice President - Corporate Development, Investor Relations

    Daniel Wilson - Executive Vice President - Corporate Development, Investor Relations

  • Yeah, Suraj, let me see if I can be helpful, to that. So just to clarify, Legacy XT, I'm assuming you mean the monitor as well as, we've moved most of that long term continuous monitoring business now to XT. And again, maybe a couple comments that are helpful. AT has outpaced overall company growth, fairly meaningfully in the last two quarters, so that is now call it 14% of overall revenue. Quentin made a couple of remarks in his prepared comments. Primary care is now over a third of our prescriber base in terms of percent of volume, and I think that gives you an appreciation for how that segment has grown for us. We gave that number, call it a year and a half ago when it was in the low 20s. So that's been a nice contributor to us. The undiagnosed monitoring, that innovative channel we referred to as value-based care group we commented earlier. That is low single digits in terms of percent of volume in Quarter 1 2025. That really was kind of zero 18 months ago. So, that has been a nice grower for us and as Quentin noted, we're really in the very, very early innings for that. So, I would expect that to continue to grow as a percent of our revenue. So hopefully those comments kind of help you get a little better visibility into the sources of growth for us.

    是的,蘇拉傑,讓我看看我是否能幫上忙。因此,為了澄清起見,Legacy XT,我假設您指的是監視器,我們現在已經將大部分長期連續監視業務轉移到 XT。再次強調,也許有幾條評論是有幫助的。在過去兩個季度中,AT 的成長速度明顯高於公司整體的成長速度,因此現在其佔總收入的 14%。昆汀在準備好的評論中發表了幾點評論。就處方量百分比而言,初級保健現在占我們處方量的三分之一以上,我認為這讓您了解我們這一領域的成長情況。我們給出這個數字是在一年半前,當時它只有 20 多一點。所以這對我們而言是一個很好的貢獻。未確診的監測,即我們之前評論過的基於價值的護理組的創新管道。就 2025 年第一季的交易量百分比而言,這一數字僅為個位數。18 個月前,這一數字確實為零。所以,這對我們來說是一個很好的成長點,正如昆汀所說,我們真的處於非常非常早期的階段。因此,我預計這一比例將繼續增長。所以希望這些評論能夠幫助您更了解我們的成長來源。

  • Operator

    Operator

  • John E. Young, Cannacord Genuity

    Cannacord Genuity 的 John E. Young

  • John E. Young - Analyst

    John E. Young - Analyst

  • Our questions and congrats on the great quarter. I also wanted to ask on just the AT strength here. You're continuing to see is the overall MCT market growing here pretty rapidly and are you seeing just a benefit in the MCT from the post ablation monitoring, especially if ESA expands just the number of catheter ablations here in the US? Thanks.

    我們對此提出疑問並對本季所取得的成績表示祝賀。我還想問問這裡的 AT 強度。您是否繼續看到這裡的整體 MCT 市場正在快速增長,並且您是否看到 MCT 從消融後監測中獲益,特別是如果 ESA 擴大美國的導管消融數量?謝謝。

  • Quentin Blackford - Independent Director

    Quentin Blackford - Independent Director

  • I think the latter part of that question, it's very hard for us to identify sort of what volume benefits might be coming from PFA. We can't see it in the data. It's not as clear. There's no question. I think we're probably getting some benefit, but to be honest with you, PFAs aren't being done by primary care physicians, and to see the growth coming in the primary care the way that we are, we know that that's not specific to it. And I don't think that our MCT utilization is being driven by that either. I think it's much more competitive conversion, taking share in the existing accounts that we already have Zio long term continuous monitoring in, and then getting the opportunity with Zio AT product. In terms of the overall category, I tend to believe that that MCT category is going to be, slightly flat over time. I think that there continues to be a nice healthy market there, but we know that price has been under a bit of pressure from CMS for the last 2 years. I suspect that will continue to be the case, but it's going to continue to be a nice, attractive market for a player like us where we only have call it 10% to 12% market share and call it 70% market share in the long-term continuous monitoring segment. I don't think we ever replicate the 70% market share. Most of our competitors are entrenched in that MCT category. But I think our recent success demonstrates we can have success taking share in the existing accounts we're already in. And for every 10 points of market share gain, that's $80 to $100 million of incremental revenue. So, if we could get our market share position to 25%, 30%, 40%, it's tremendous growth for the company over the next few years.

    我認為這個問題的後半部分,我們很難確定 PFA 可能帶來哪些數量效益。我們無法在數據中看到它。情況不太清楚。毫無疑問。我認為我們可能得到了一些好處,但老實說,PFA 不是由初級保健醫生進行的,而且我們看到初級保健的增長方式,我們知道這並不是它獨有的。我也不認為我們的 MCT 利用率會受到此影響。我認為這是一種更具競爭力的轉換,在我們已經擁有 Zio 長期持續監控的現有帳戶中佔有份額,然後獲得 Zio AT 產品的機會。就整體類別而言,我傾向於相信 MCT 類別隨著時間的推移會略微持平。我認為那裡的市場仍然健康,但我們知道過去兩年來價格一直受到 CMS 的壓力。我認為這種情況會持續下去,但對於我們這樣的參與者來說,這將繼續是一個良好且具有吸引力的市場,我們在長期連續監控領域只佔有 10% 到 12% 的市場份額,佔有 70% 的市場份額。我認為我們永遠無法複製 70% 的市場份額。我們的大多數競爭對手都深陷 MCT 類別。但我認為我們最近的成功表明我們可以成功搶佔現有客戶的份額。每增加 10 個百分點的市場份額,就會帶來 8,000 萬至 1 億美元的增量收入。因此,如果我們能夠將市場份額提高到 25%、30%、40%,那麼未來幾年公司將實現巨大的成長。

  • Operator

    Operator

  • Sam Eiber, BTIG.

    Sam Eiber,BTIG。

  • Sam Eiber - Analyst

    Sam Eiber - Analyst

  • Hey, good afternoon. This is Sam on for Marie. Thanks for taking the questions here. Maybe I can ask a tariff question, and Dan, you talked about some of the mitigation strategies and pulling forward inventory, but wondering if there's any opportunity also to pass along price to customers maybe as contracts come up for renegotiations here.

    嘿,下午好。這是 Sam 為 Marie 拍攝的。感謝您在這裡回答問題。也許我可以問一個關稅問題,丹,你談到了一些緩解策略和提前庫存,但想知道是否有機會將價格轉嫁給客戶,也許在合約重新談判的時候。

  • Daniel Wilson - Executive Vice President - Corporate Development, Investor Relations

    Daniel Wilson - Executive Vice President - Corporate Development, Investor Relations

  • Yeah, hey, Sam, thanks for the question. I would, referring to my prepared remarks, I was referring more to kind of supply chain strategies in terms of moving things around and other opportunities to offset a bit of that impact from a pricing standpoint we'll certainly look at that and evaluate that. I would say that's not the first place we will look. We do want to continue to drive volume and continue to grow our share of the overall market. So we'll look at those opportunities as they come, but also see, supply chain strategies to really offset the tariff impact that we that we are guiding to.

    是的,嘿,薩姆,謝謝你的提問。我想,根據我準備好的發言,我更多地指的是供應鏈策略,即在移動物品和其他機會方面從定價的角度來抵消一些影響,我們肯定會考慮並評估這一點。我想說這不是我們首先要看的地方。我們確實希望繼續提高銷量並繼續擴大我們在整個市場中的份額。因此,我們會抓住這些機會,同時也看到供應鏈策略如何真正抵消我們所引導的關稅影響。

  • Operator

    Operator

  • Richard Newitter, Truist

    理查德·紐伊特(Richard Newitter),Truist

  • Richard Newitter - Analyst

    Richard Newitter - Analyst

  • Alright, thanks for taking the questions and congrats on the quarter. Wanted to just ask, going back to the FDA, Quentin, I appreciate that, there's a lot of moving parts there going on in the backdrop. I'm just curious if the people that you're dealing with at the FDA remain consistent with kind of who you were talking to, the guidance you were getting, and kind of the benchmarks and the goals that were laid out, where you were tracking towards. What do you think the FDA wanted? So just, are the players the same, is the first question.

    好的,感謝您回答問題並祝賀本季取得的成績。只是想問一下,回到 FDA,昆汀,我很感激,背景中有很多活動部件在進行。我只是好奇,您在 FDA 打交道的人是否與您交談的對象、您獲得的指導以及您制定的基準和目標以及您追蹤的方向一致。您認為 FDA 想要什麼?那麼,球員是否一樣,這是第一個問題。

  • Quentin Blackford - Independent Director

    Quentin Blackford - Independent Director

  • Yeah, good question, Rich. They are the most senior leaders are absolutely the same folks. We have not seen turnover in that. That relationship continues to be the same, so no change there, which we do, very favorably, and we're encouraged by that. We're hearing that you know deeper down in the agency there are folks who may have been part of the review that maybe aren't with the agency any longer. I will tell you those aren't folks that we had direct access to necessarily on a daily basis, but those folks who we've been working with directly, the more senior folks at the agency in charge of our engagement, those are the same people, same faces, same names.

    是的,問得好,Rich。他們是最資深的領導人,絕對是同一批人。我們還沒有看到這方面的營業額。這種關係保持不變,因此沒有變化,我們對此非常滿意,並對此感到鼓舞。我們聽說,您知道,在該機構的深處,有些人可能參與了審查,但可能已經不在該機構工作了。我要告訴你,這些人並不是我們每天都能直接接觸的人,但那些我們一直直接合作的人,那些負責我們合作的機構裡的高級官員,都是同樣的人,同樣的面孔,同樣的名字。

  • Richard Newitter - Analyst

    Richard Newitter - Analyst

  • Okay, thanks. And then, just on the primary care, where can that 30% percentage get to or maybe you've disclosed that in the past where your longer-term goal is, if you could just remind us.

    好的,謝謝。然後,僅在初級保健方面,這 30% 的比例可以達到什麼程度,或者也許您過去已經透露過您的長期目標是什麼,如果您可以提醒我們的話。

  • Quentin Blackford - Independent Director

    Quentin Blackford - Independent Director

  • Well, I don't think we've ever put out a specific goal. But Rich, I continue to be more bullish than ever that our market is not 6.5 million ACM tests being prescribed a year, which is predominantly coming out of cardiology and EP. I believe that there are 27 million folks who are presenting in the primary care channel today that either have cardiac palpitations already in their medical records, we can see it very clearly, or they're unaware that they have an arrhythmia many times confusing sort of comorbid disease states and symptoms with arrhythmias. And I think when you look at that total population, call it somewhere around 27 million folks, you have to be up in primary care to look for those opportunities, and that's exactly where we're moving the business and I have a high degree of confidence that's where it's going to go. I couldn't be more bullish on the opportunity to open that up. Some of the data that we're seeing coming out of our efforts to work with partners where we can look into their data sets, review medical history of their clients on a de-identified basis, identify markers, and then put patches on those patients. Take a diabetic population as an example. We've run some early trials here with a meaningful number of folks. They yield on actionable arrhythmias coming out of that trial on folks who had no idea they had an arrhythmia was north of 90%. And another one it was north of 80%. So, we know that we're able to dial in sort of through an AI approach exactly where these patients likely sit and then we just need to get patches on them, and that's going to happen through the primary care channel more so than anywhere else. So what the overall prescription pattern looks like in terms of PCP as a percent of total volume. I don't know. I think the market is much larger than what it is today, and if we can open up that 27 million patient market, the vast majority is going to be prescribed through primary care. So we'll watch it as we go, but I'm very encouraged by what we're seeing in these early days of building up capability to target patients who are at high risk of arrhythmias and being able to find them.

    嗯,我認為我們從來沒有提出過具體的目標。但是 Rich,我比以往任何時候都更看好我們的市場,因為我們的市場每年不會出現 650 萬次 ACM 測試,這些測試主要來自心臟病學和 EP。我相信,今天在初級保健管道中出現的 2700 萬人要么在他們的醫療記錄中已經有心悸的記錄,我們可以非常清楚地看到這一點,要么他們沒有意識到自己患有心律失常,很多時候將合併症狀態和症狀與心律失常混淆。我認為,當你看到總人口約 2700 萬人時,你必須在初級保健領域尋找這些機會,這正是我們業務發展的方向,我非常有信心這就是我們的發展方向。我非常看好這個開拓機會的機會。我們看到的一些數據來自於我們與合作夥伴的努力,我們可以查看他們的數據集,在匿名的基礎上審查其客戶的病史,識別標記,然後為這些患者貼上補丁。以糖尿病人群為例。我們已經與相當多的人進行了一些早期試驗。他們對可操作的心律不整進行了試驗,結果表明,90% 以上的患者都不知道自己患有心律不整。另一個則超過了 80%。因此,我們知道我們能夠透過人工智慧方法準確地找到這些患者可能坐的位置,然後我們只需要為他們貼上補丁,而這將透過初級保健管道比其他任何地方都更容易實現。那麼,就 PCP 佔總量的百分比而言,整體處方模式是什麼樣的呢?我不知道。我認為市場比現在大得多,如果我們能夠開放這 2700 萬患者市場,絕大多數患者將透過初級保健獲得處方。因此,我們會持續關注此事,但我對早期看到的進展感到非常鼓舞,我們正在增強針對心律不整高風險患者的能力,並能夠找到他們。

  • Operator

    Operator

  • There are no additional questions waiting at this time. I would like to pass the conference back over to the management team for any closing remarks.

    目前沒有其他問題。我想將會議交還給管理團隊,讓他們做最後的總結演講。

  • Quentin Blackford - Independent Director

    Quentin Blackford - Independent Director

  • Great. Well, thank you for your time and thank you to our iRhythm team. It's a great start to the year and it's hard to imagine a time when we've been more excited about the future that sits in front of us. And we look forward to continuing to execute against our strategic plan to unlock the tremendous potential that sits ahead. Thanks again for your time. Thanks again to the teams, and we'll see you all soon on the road. Take care.

    偉大的。好吧,感謝您抽出時間,也感謝我們的 iRhythm 團隊。這是新的一年的一個好開端,我們很難想像還有什麼時刻比現在更讓我們對未來感到興奮。我們期待繼續執行我們的戰略計劃,釋放未來的巨大潛力。再次感謝您的時間。再次感謝各團隊,我們很快就會在路上見到你們。小心。

  • Operator

    Operator

  • That concludes the iRhythm Technologies Inc. First Quarter 2025 Earnings Conference Call.

    iRhythm Technologies Inc. 2025 年第一季財報電話會議到此結束。

  • Thank you for your participation.

    感謝您的參與。