使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Hello, everyone. Thank you for joining us, and welcome to iRhythm Holdings Q1 2026 Earnings Conference Call. (Operator Instructions)
各位好。感謝各位加入,歡迎參加 iRhythm Holdings 2026 年第一季財報電話會議。(接線員指示)
I will now hand the call over to Lisa Pecora, Senior Vice President of Finance and Investor Relations, for opening remarks.
現在我將把電話交給財務與投資人關係資深副總裁 Lisa Pecora,由她進行開場致詞。
Lisa Pecora - Senior Vice President of Finance and Investor Relations
Lisa Pecora - Senior Vice President of Finance and Investor Relations
Thank you, operator, and thank you all for joining iRhythm's first-quarter 2026 earnings call. With me today are Quentin Blackford, iRhythm's President and Chief Executive Officer; and Dan Wilson, our Chief Financial Officer.
謝謝接線員,也謝謝各位參加 iRhythm 2026 年第一季財報電話會議。今天與我一同出席的有 iRhythm 總裁暨執行長 Quentin Blackford,以及我們的財務長 Dan Wilson。
Before we begin, please note that management will make forward-looking statements within the meaning of federal securities laws under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding our intentions, beliefs and expectations about future events, strategy, competition, products, operating plans and performance.
在開始之前,請注意管理團隊將依據 1995 年《私人證券訴訟改革法》之「安全港」條款,在聯邦證券法意義下作出前瞻性陳述。這些前瞻性陳述包括但不限於:關於我們對未來事件、策略、競爭、產品、營運計畫與績效之意圖、信念與預期的陳述。
Forward-looking statements on this call are based on current estimates and assumptions involve risks and uncertainties, and actual results may differ materially. These statements are made as of today, April 30, 2026, and are time sensitive. We undertake no obligation to update or revise them, except as required by law. Accordingly, you should not place undue reliance on these statements. For a discussion of risks and uncertainties, please refer to our most recent annual report on Form 10-K, quarterly reports on Form 10-Q, and other filings with the SEC.
本次電話會議中的前瞻性陳述係基於目前的估計與假設,並涉及風險與不確定性,實際結果可能有重大差異。這些陳述截至今日(2026 年 4 月 30 日)為止,且具有時效性。除法律要求外,我們不承擔更新或修訂之義務。因此,您不應過度依賴這些陳述。關於風險與不確定性的討論,請參閱我們最新的 Form 10-K 年度報告、Form 10-Q 季度報告,以及向美國證券交易委員會(SEC)提交的其他文件。
Additionally, during the call, we will discuss certain financial measures that have not been prepared in accordance with GAAP. Unless otherwise noted, all references to financial measures on this call are presented on a non-GAAP basis. These non-GAAP measures should not be considered in isolation or as a substitute for or superior to GAAP results. Reconciliations to the most directly comparable GAAP measures can be found in our earnings release and the slides accompanying today's call.
此外,在本次電話會議中,我們將討論若干未依 GAAP 編製的財務衡量指標。除非另有說明,本次電話會議中所有財務衡量指標之提及均以非 GAAP 基礎呈現。這些非 GAAP 指標不應被單獨考量,亦不應被視為 GAAP 結果之替代、或優於 GAAP 結果。與最直接可比之 GAAP 指標的調節表可見於我們的財報新聞稿及今日電話會議隨附的簡報投影片。
With that, I'll turn the call over to Quentin.
接下來,我把電話交給 Quentin。
Quentin Blackford - President, Chief Executive Officer, Director
Quentin Blackford - President, Chief Executive Officer, Director
Good afternoon, everyone, and thank you for joining us. I'm pleased to be here to discuss our first quarter 2026 performance and outlook for the balance of the year. I will begin with an overview of the quarter, our strategic progress and our outlook for 2026 and beyond. Dan will then talk about our financial performance and guidance in more detail.
各位下午好,感謝各位加入。我很高興在此與各位討論我們 2026 年第一季的表現,以及今年其餘期間的展望。我將先概述本季表現、我們的策略進展,以及對 2026 年及更長期的展望。接著 Dan 會更詳細說明我們的財務表現與財測指引。
We delivered a strong first quarter, exceeding expectations on both the top and bottom line. Revenue grew 26% year over year, driven by volume, and we continue to execute on our profitability improvement commitments as we expanded margins. Importantly, our performance was broad-based across Zio Monitor and Zio AT and across each of our key growth pillars, including cardiology, primary care, innovative channels and international. Our results reflect both strong execution in the core business and continued progress against the strategic priorities we believe will support durable growth over time.
我們交出強勁的第一季成績,營收與獲利皆優於預期。營收年增 26%,主要由量的成長帶動;同時,隨著毛利率擴張,我們持續落實提升獲利能力的承諾。重要的是,我們的表現涵蓋面廣,Zio Monitor 與 Zio AT 皆有貢獻,且在各項關鍵成長支柱上均有進展,包括心臟科、基層醫療、創新通路與國際市場。我們的成果反映了核心業務的強勁執行力,以及在我們認為可長期支持穩健成長的策略優先事項上持續取得進展。
At the center of that strategy is our effort to expand the long-term continuous monitoring market by redefining arrhythmias are diagnosed once patients enter the diagnostic pathway. A growing body of clinical evidence now spanning more than 140 publications consistently shows that nearly two-thirds of arrhythmias are often detected only after 48 hours of monitoring, reinforcing the limitations of short duration monitoring. Yet nearly 2 million short-duration holter and event monitors are still prescribed annually in the US, representing a significant opportunity to upgrade care.
該策略的核心,是我們致力於擴大長期連續監測市場,透過重新定義患者進入診斷流程後心律不整的診斷方式。目前累積超過 140 篇出版物的臨床證據一致顯示,近三分之二的心律不整往往要在監測超過 48 小時後才會被偵測到,凸顯短時間監測的限制。然而,美國每年仍開立近 200 萬次短時間 Holter 與事件監測器處方,代表升級照護的重大機會。
By continuing to shift clinical practice towards longer duration monitoring, we believe iRhythm is not only gaining share but actively growing the market by increasing diagnostic yield and improving patient outcomes. Zio Monitor remains the foundation of our platform, supported by consistent prescribing trends, broad clinical adoption and continued growth across new channels and international markets.
透過持續推動臨床實務轉向更長時間的監測,我們相信 iRhythm 不僅在提升市占,更是在透過提高診斷檢出率與改善病患預後來積極擴大市場。Zio Monitor 仍是我們平台的基礎,並受惠於穩定的開立處方趨勢、廣泛的臨床採用,以及在新通路與國際市場的持續成長。
Zio AT also continued to advance this quarter, taking share with new account wins and expanding utilization within existing accounts. That progress came despite a challenging prior year comparison and reinforces our view of the MCT category as a durable and increasingly important contributor to the platform. One of the most important drivers of our long-term opportunity is our continued move upstream in the patient pathway. We estimate that more than 27 million people in the US are at risk for arrhythmias, many of whom are first evaluated in primary care settings.
Zio AT 本季也持續推進,透過新客戶導入取得市占,並在既有客戶中擴大使用量。即使面臨去年同期較具挑戰的比較基期,這些進展仍強化了我們對 MCT 類別的看法:其具備持久性,且將成為平台日益重要的貢獻來源。我們長期機會最重要的驅動因素之一,是持續在病患就醫路徑中往更上游移動。我們估計美國有超過 2,700 萬人具有心律不整風險,其中許多人最初是在基層醫療環境接受評估。
As a result, primary care is becoming an increasingly important entry point for earlier detection and more proactive management. We continue to expand our reach and engagement within primary care, helping clinicians rule arrhythmias in or out while enabling cardiology to focus more efficiently on the highest acuity patients. This is not a shift away from cardiology. Rather, it expands the overall market and improves patient flow, diagnostic efficiency, and care coordination across settings.
因此,基層醫療正成為更早期偵測與更主動管理的日益重要入口。我們持續擴大在基層醫療的觸及與互動,協助臨床醫師判定是否存在心律不整,同時讓心臟科能更有效率地聚焦於病情最嚴重的患者。這並非從心臟科轉移重心。相反地,這將擴大整體市場,並改善跨場域的病患流動、診斷效率與照護協調。
A key enabler of this strategy is workflow integration. Approximately 53% of our volume now flows through EHR integrated accounts and more than 3/4 of our top 100 customers are now integrated. This level of integration is particularly valuable in primary care, where once embedded, we partner closely with our customers to help them develop best-in-class clinical pathways rather than just a transactional tool.
推動此策略的關鍵助力之一是工作流程整合。目前約 53% 的量來自已與 EHR 整合的客戶,且我們前 100 大客戶中已有超過 3/4 完成整合。這種整合程度在基層醫療中特別有價值;一旦嵌入後,我們會與客戶緊密合作,協助其建立同級最佳的臨床路徑,而不僅僅是提供一個交易型工具。
We continue to see traction across innovative care channels with growth supported by a broad and expanding set of value-based primary care and population health partners. Activity remains consistent and repeatable, driven by both new account wins and expanding utilization within existing relationships. Importantly, as certain programs mature, we're seeing adoption broaden across both symptomatic and asymptomatic populations, reinforcing the relevance and durability of the Zio platform as care delivery continues to shift upstream and toward value-based models.
我們在創新照護通路方面持續看到進展,成長動能來自廣泛且持續擴大的價值導向基層醫療與族群健康合作夥伴。相關活動維持一致且可複製,動能同時來自新客戶導入與既有合作關係中的使用量擴張。重要的是,隨著部分專案逐步成熟,我們看到採用範圍擴大至有症狀與無症狀族群,進一步印證 Zio 平台的相關性與持久性;同時,照護模式也持續往更上游與價值導向模式轉移。
International remains another emerging source of opportunity. In the UK, we had our best quarter in company history, reflecting growing traction and validation of our model in a cost-constrained health system. In Japan, we recently received an update to the reimbursement framework that introduces a modest supplemental payment for longer duration monitoring. While the economics remain early and are not a meaningful contributor today, we view this as a positive signal that reflects growing recognition of the long-term continuous monitoring and reinforces the pathway to more favorable reimbursement as we generate local head-to-head clinical evidence.
國際市場仍是另一個新興的機會來源。在英國,我們創下公司史上最佳單季表現,反映在成本受限的醫療體系中,我們的模式正獲得更強的動能與驗證。在日本,我們近期收到給付架構更新,針對較長時間的監測引入小幅的補充給付。雖然目前經濟效益仍在早期階段,且尚未成為今日的重要貢獻來源,但我們視此為正向訊號,反映對長期連續監測的認知正在提升,並在我們產出在地的頭對頭臨床證據之際,強化通往更有利給付的路徑。
We are also making progress in adjacent markets. In sleep, our pilots continue to produce encouraging early feedback and reinforce the meaningful opportunity ahead in a US market of nearly 40 million sleep apnea patients, of which there is significant overlap with arrhythmia populations. Sleep is another good example of why workflow integration matters. Sleep diagnostics today remain highly fragmented across primary care, cardiology, sleep specialists, sleep labs, home testing, interpretation, and follow-up and often across disconnected systems. Our focus is not simply on introducing a new device or algorithm, but on building a streamlined end-to-end clinical workflow that simplifies how sleep diagnostics are ordered, interpreted, and acted upon.
我們也在相鄰市場取得進展。在睡眠領域,我們的試點計畫持續帶來令人鼓舞的早期回饋,並凸顯美國近 4,000 萬名睡眠呼吸中止症患者市場中的重大機會,其中與心律不整族群有顯著重疊。睡眠也是工作流程整合重要性的另一個良好例證。目前睡眠診斷在基層醫療、心臟科、睡眠專科、睡眠實驗室、居家檢測、判讀與追蹤等環節高度分散,且往往分布於彼此不相連的系統之中。我們的重點不僅是導入新的裝置或演算法,而是建立一套精簡的端到端臨床工作流程,簡化睡眠診斷的開立、判讀與後續處置方式。
As we have done in cardiac monitoring, we believe workflow simplification can create meaningful value for both providers and the healthcare system, particularly as care continues to shift upstream. From a clinical perspective, recent evidence continues to support our position and reinforces the significant opportunity ahead of us.
如同我們在心臟監測領域所做的,我們相信簡化工作流程能為醫療服務提供者與整體醫療體系創造具意義的價值,特別是在照護持續往上游移動之際。從臨床角度來看,近期證據持續支持我們的觀點,並強化我們面前龐大的機會。
At ACC, we shared new real-world evidence showing Zio's high diagnostic yield for clinically actionable arrhythmias across cardiometabolic risk populations, including increased risk in chronic kidney disease and rising atrial fibrillation detection with obesity. We also launched iRhythm Academy, which scales high-quality on-demand education to help clinicians adopt best practices and new advances more efficiently.
在 ACC 上,我們分享了新的真實世界證據,顯示 Zio 對於可採取臨床行動的心律不整在心代謝風險族群中具有很高的診斷檢出率,包括慢性腎臟病患者風險增加,以及肥胖族群心房顫動檢出率上升。我們也推出 iRhythm Academy,提供可擴展的高品質隨選教育,協助臨床醫師更有效率地採用最佳實務與最新進展。
At HRS, we presented new data reinforcing the superiority of Zio after AF ablation and in pregnancy. In addition, we published two peer-reviewed studies highlighting the clinical and utilization advantages of long-term continuous monitoring using Zio. The data show that traditional short-term monitoring often misses actionable arrhythmias and that Zio enables earlier diagnosis with fewer repeat tests across both Medicare and commercially insured patients.
在 HRS 上,我們發表了新的數據,進一步強化 Zio 在心房顫動消融術後以及妊娠期間的優越性。此外,我們發表了兩篇同儕審查研究,突顯使用 Zio 進行長期連續監測在臨床與使用面向的優勢。數據顯示,傳統短期監測經常漏掉可採取行動的心律不整,而 Zio 能在 Medicare 與商業保險患者中,以較少的重複檢測達成更早診斷。
Taken together, these efforts reinforce 3 points. Zio long-term monitoring improves diagnostic yield. It expands relevance across broader patient populations, and it can reduce inefficiency and downstream cost, all of which are critical as we continue to expand beyond traditional symptomatic populations and move further upstream into earlier detection with the potential to lower downstream costs for the healthcare system.
綜合而言,這些努力強化了三點。Zio 長期監測可提升診斷檢出率。它能將適用性擴展至更廣泛的病患族群,並可降低低效率與下游成本;在我們持續從傳統有症狀族群向外擴張、並更進一步往上游推進至更早期偵測(有望降低醫療體系下游成本)之際,這些都至關重要。
Consistent with that clinical expansion, recent CMS policy developments continue to emphasize objective diagnosis, quality, and measurable outcomes over documentation-driven strategies. The final 2027 Medicare Advantage Rate Announcement reflects funding stability alongside continued tightening around risk adjustment and coding practices. This policy trajectory reinforces the importance of confirmatory diagnostics that drive accurate diagnosis and appropriate care and positions Zio well as healthcare continues to shift towards value-based models.
與此臨床擴張一致,近期 CMS 政策發展持續強調以客觀診斷、品質與可衡量的結果為重點,而非以文件導向的策略。最終版 2027 年 Medicare Advantage 費率公告反映在資金穩定的同時,持續收緊風險調整與編碼作法。此一政策走向強化了能帶來精準診斷與適切照護的確認性診斷之重要性,並在醫療持續轉向價值導向模式之際,使 Zio 具備良好定位。
With our vision to scale beyond traditional arhythmia monitoring, our ability to execute is supported by an integrated AI-enabled platform. We now have more than 3 billion hours of curated ECG data, and we continue to build on that foundation by combining internal and external data sets, including claims and EHR data to improve detection, identify at-risk patients earlier and enhance clinical workflows.
在我們將願景擴展至傳統心律不整監測之外之際,我們的執行能力由一個整合式、AI 賦能的平台所支撐。我們目前擁有超過 30 億小時的精選心電圖(ECG)資料,並持續在此基礎上結合內外部資料集(包括理賠與 EHR 資料),以提升偵測能力、更早識別高風險病患並強化臨床工作流程。
As we continue to advance our AI predictive capabilities, we are now in our first health system deployment of predictive identification workflows integrated with iRhythm monitoring solutions, and we have an active pipeline for additional health systems to follow. Early pilots show more than 85% accuracy in pre-identifying patients with clinically relevant arrhythmias, reinforcing our conviction that iRhythm is positioned not just to detect disease, but also help predict risk earlier and ultimately prevent it.
隨著我們持續推進 AI 預測能力,我們已在第一個醫療體系部署與 iRhythm 監測解決方案整合的預測式識別工作流程,並且有更多醫療體系的後續導入管線正在進行中。早期試點顯示,在預先識別具有臨床相關心律不整的病患方面,準確率超過 85%,進一步強化我們的信念:iRhythm 不僅能偵測疾病,也能更早協助預測風險,並最終達到預防。
Our initial programs focus on high-risk populations, including patients with diabetes, CKD, CAD, COPD, sleep disorders, and heart failure, where arrhythmias are both common and costly. These initiatives are designed to improve efficiency, quality and reduce cost of care delivery, and we look forward to real-world data being published later this year.
我們的初期計畫聚焦於高風險族群,包括糖尿病、CKD、CAD、COPD、睡眠障礙與心衰竭患者,這些族群中心律不整既常見且成本高昂。這些倡議旨在提升效率與品質並降低照護提供成本,我們也期待今年稍晚能發布真實世界數據。
More broadly, iRhythm's durability in an AI-driven environment is grounded in the fact that healthcare value is not created by algorithms alone. It is created by operating an end-to-end AI-embedded FDA-regulated, clinically integrated and reimbursed service at scale. Our platform is deeply embedded across leading health systems and supported by deep workflow integration, broad reimbursement, extensive clinical evidence, and a proprietary ECG data set that continues to grow significantly. Coupled with the operational complexity of device programs, specialized clinical support, and high regulatory scrutiny, our platform will continue to compound in value over time, particularly as we expand beyond cardiovascular into a multi-specialty intelligence platform.
更廣泛而言,iRhythm 在 AI 驅動環境中的持久性,根基在於醫療價值並非僅由演算法創造。價值來自於以規模化方式營運端到端、內嵌 AI、受 FDA 監管、臨床整合且可獲償付的服務。我們的平台深度嵌入於領先的醫療體系,並由深度工作流程整合、廣泛償付、豐富臨床證據,以及持續顯著成長的專有 ECG 資料集所支撐。再加上裝置計畫的營運複雜度、專業臨床支援與高度法規審查,我們的平台價值將隨時間持續累積,特別是在我們從心血管領域擴展至多專科智慧平台之際。
I'm pleased to share that same foundation is helping drive progress as we expand our AI capabilities with our new next-generation AI algorithm. Leveraging our large proprietary multibillion-hour data set, we believe this next-generation algorithm, which will be used across our entire platform of Zio Monitor, Zio AT, and our future Zio MCT can reduce clinical technician review time by as much as half over time, which would improve efficiency, support future margin expansion and further strengthen our competitive position as we increase the clinical value to our patients and physicians. We submitted the 510(k) for this next-generation AI algorithm to the FDA last year alongside, albeit separate from our Zio MCT 510(k) submission.
我很高興分享,同樣的基礎也正協助推動我們以新一代 AI 演算法擴展 AI 能力的進展。憑藉我們龐大的專有數十億小時資料集,我們相信這個將應用於 Zio Monitor、Zio AT 以及未來 Zio MCT 全平台的新一代演算法,隨時間可將臨床技術人員的審閱時間最多降低一半,從而提升效率、支持未來毛利率擴張,並在我們提升對病患與醫師的臨床價值之際,進一步強化競爭地位。我們去年已向 FDA 提交此新一代 AI 演算法的 510(k),並與(但獨立於)我們的 Zio MCT 510(k) 申請一併提交。
Next, I'd like to provide an update on our regulatory progress. As you know, we remain subject to an FDA warning letter. As part of our remediation efforts, we committed to address all of the agency's concerns. We also elected to go beyond the specific actions requested by the FDA, which included conducting a comprehensive review of our entire quality management system to identify and implement further improvements, which we have now completed.
接下來,我想更新我們的法規進展。如各位所知,我們仍受 FDA 警告信所約束。作為補救工作的一部分,我們承諾解決該機構提出的所有疑慮。我們也選擇超越 FDA 所要求的具體行動,包括對我們整體品質管理系統進行全面審查,以識別並落實進一步改善;此項工作現已完成。
Consistent with our commitments to the agency, we also engaged an independent third-party to conduct a comprehensive review of our quality management system. That review was completed in the first quarter and did not identify any material observations. We believe this outcome reflects both the seriousness with which we have approached this work and the substantial progress we have made. While the timing of any action by the FDA remains with the agency, we believe the work completed to-date positions us well as the agency continues its review.
依照我們對該機構的承諾,我們也聘請獨立第三方對我們的品質管理系統進行全面審查。該審查已於第一季完成,且未發現任何重大觀察事項。我們相信此結果反映了我們對此工作的嚴肅態度,以及我們已取得的實質進展。雖然 FDA 任何行動的時程仍由該機構決定,但我們相信迄今完成的工作使我們在該機構持續審查之際具備良好條件。
With respect to our next-generation MCT program, we've made a lot of progress over the past few months and are happy to reaffirm our first half 2027 release timeline. As we noted on our last earnings call, we identified a clear path to our next-generation MCT clearance, including the determination that it was in our best long-term interest to move to a new mobile gateway sooner, which would require some additional work and data to be submitted to the FDA.
就我們的新一代 MCT 計畫而言,過去幾個月我們已取得大量進展,並很高興重申 2027 年上半年推出的時程。如同我們在上次財報電話會議中所提到的,我們已確認取得新一代 MCT 核准的明確路徑,包括判定為了長期最佳利益,我們應更早轉向新的行動閘道(mobile gateway),這將需要額外工作與數據提交給 FDA。
As we continue to work collaboratively with the FDA, they have clarified that rather than submit additional data on a rolling basis, the preferred path is to provide a complete package once all elements are finalized later this year. We had anticipated this might be one outcome for how we might update our submission, so it falls within our previously communicated clearance and launch time frame. We believe this collaborative approach, enabling us to stay on track with our approval and launch time lines while also advancing an enhanced next-generation AI algorithm for clearance at a potentially earlier time point is a clear sign that all of our hard work over the past few years to improve our relationship with the FDA has been paying off.
在我們持續與 FDA 協作的過程中,FDA 已釐清:相較於以滾動方式提交額外資料,其偏好的路徑是在今年稍晚所有要素定案後一次提供完整資料包。我們原先就預期這可能是更新申請的一種結果,因此仍落在我們先前對外溝通的核准與上市時程範圍內。我們相信這種協作方式,使我們能在維持核准與上市時程進度的同時,也推進強化版新一代 AI 演算法,並有機會在更早時間點取得核准;這清楚顯示我們過去幾年為改善與 FDA 關係所付出的努力正在產生回報。
Looking ahead, our priorities remain clear: to drive durable volume-led growth across cardiology, primary care and innovative channels; continue expanding margins through operating discipline, efficiency, and scale; advance our innovation road map, including next-generation MCT and predictive AI; build international and adjacent markets with discipline and maintain high standards of operational excellence and compliance in a rapidly evolving healthcare environment.
展望未來,我們的優先事項仍然明確:推動在心臟科、基層醫療與創新通路的可持續、以量為主導的成長;透過營運紀律、效率與規模持續擴大利潤率;推進我們的創新路線圖,包括新一代 MCT 與預測式 AI;以紀律建立國際與相鄰市場;並在快速演變的醫療環境中維持高標準的營運卓越與法規遵循。
With that, I'll turn the call over to Dan.
接下來,我把電話會議交給 Dan。
Daniel Wilson - Chief Financial Officer
Daniel Wilson - Chief Financial Officer
Thank you, Quentin. iRhythm delivered continued strong financial performance in the first quarter of 2026, reflecting durable demand for iRhythm's ambulatory cardiac monitoring services and disciplined execution across the organization. Our results demonstrate once again our focus on profitable growth as we recorded another quarter of strong year-over-year revenue growth, while driving 880 basis points of improvement to adjusted EBITDA margin. We are encouraged to see the continued growth in the business while driving strong operating leverage.
謝謝你,Quentin。iRhythm 在 2026 年第一季持續交出強勁的財務表現,反映出市場對 iRhythm 門診心臟監測服務的穩健需求,以及全公司上下有紀律的執行力。我們的成果再次展現我們對獲利性成長的聚焦:在營收年增持續強勁的同時,調整後 EBITDA 利潤率提升了 880 個基點。我們很高興看到業務持續成長,同時帶動強勁的營運槓桿。
We delivered revenue of $199.4 million, representing 25.7% year-over-year growth. Performance was driven primarily by sustained volume demand across our customer base, reflecting continued strength in our core business and contributions from newer growth channels. Volume remained the primary driver of year-over-year revenue growth, while we also benefited from improvements with our estimated collections reserves related to our market access, contracting and collection efforts. These results were supported by continued engagement across a broad and expanding prescriber base, reinforcing the durability of volume demand.
我們實現營收 1.994 億美元,年增 25.7%。表現主要由客戶群中持續的量能需求所帶動,反映核心業務的延續性強勁,以及較新成長通路的貢獻。量能仍是營收年增的主要驅動因素;同時,我們也受惠於與市場准入、合約簽訂與收款努力相關的預估收款準備金改善。這些成果亦受到廣泛且持續擴大的開立處方醫師基礎之持續參與所支持,進一步強化量能需求的持久性。
New store growth, with new store defined as accounts that have been opened for less than 12 months, accounted for approximately 64% of our year-over-year volume growth. Home enrollment for Zio Services in the US remained consistent from prior quarters at approximately 23% of volume in the first quarter.
新店成長(新店定義為開戶未滿 12 個月的帳戶)約占我們年對年量能成長的 64%。美國 Zio Services 的居家註冊占比與前幾季一致,第一季約占量能的 23%。
Moving down the P&L. Gross margin in the first quarter was 70.9%, an increase of 210 basis points year over year. This sustainable improvement was driven by continued operational efficiencies, including manufacturing automation and workflow optimization as well as scale benefits from higher volumes. First- quarter 2026 adjusted operating expenses were $153.5 million compared to $140.4 million in the prior year period, an increase of 9.3% year over year, primarily driven by an increase in volume-related costs to serve, litigation-related expenses, and investments to drive future revenue growth. We invested purposefully in the business to fuel near, mid- and long-term growth while delivering strong operating leverage with revenue growing meaningfully faster than operating expenses.
接著往下看損益表。第一季毛利率為 70.9%,年增 210 個基點。這項可持續的改善來自持續的營運效率提升,包括製造自動化與工作流程最佳化,以及更高量能帶來的規模效益。2026 年第一季調整後營業費用為 1.535 億美元,較去年同期的 1.404 億美元年增 9.3%,主要由與量能相關的服務成本增加、訴訟相關費用,以及推動未來營收成長的投資所致。我們有目的地投資於業務,以驅動短、中、長期成長;同時在營收成長顯著快於營業費用成長的情況下,展現強勁的營運槓桿。
On the bottom line, GAAP net loss for the first quarter was $13.9 million or a net loss of $0.43 per diluted share compared to a GAAP net loss of $30.7 million or a net loss of $0.97 per diluted share in the first quarter of 2025. Adjusted net loss for the first quarter was $11.3 million or a net loss of $0.35 per diluted share compared to an adjusted net loss of $30.3 million or a net loss of $0.95 per diluted share in the first quarter of 2025. Adjusted EBITDA for the first quarter was $14.1 million or 7.1% of revenue, representing an 880 basis point improvement year over year and a significant improvement in profitability, demonstrative of the operating leverage inherent in our business.
在最終損益方面,第一季 GAAP 淨損為 1,390 萬美元,或每股稀釋後淨損 0.43 美元;相較之下,2025 年第一季 GAAP 淨損為 3,070 萬美元,或每股稀釋後淨損 0.97 美元。第一季調整後淨損為 1,130 萬美元,或每股稀釋後淨損 0.35 美元;相較之下,2025 年第一季調整後淨損為 3,030 萬美元,或每股稀釋後淨損 0.95 美元。第一季調整後 EBITDA 為 1,410 萬美元,或占營收 7.1%,年增改善 880 個基點,獲利能力顯著提升,展現我們業務內含的營運槓桿。
Free cash flow during the first quarter was negative $33 million, in line with normal seasonality attributable to annual compensation payments and working capital seasonality. We ended the quarter with $549.6 million in cash, cash equivalents and marketable securities, a strong cash position that provides us with substantial flexibility to support future growth initiatives.
第一季自由現金流為負 3,300 萬美元,符合因年度薪酬支付與營運資金季節性所致的正常季節性波動。季末我們持有 5.496 億美元的現金、約當現金與有價證券;強勁的現金部位為我們支持未來成長計畫提供了相當大的彈性。
Looking ahead, we are raising full-year 2026 revenue guidance to $875 million to $885 million, representing 17% to 18% year-over-year growth. This outlook reflects sustained demand across our core business, while maintaining a disciplined approach to forecasting newer and emerging channels. On a full-year basis, we continue to expect pricing to be approximately flat overall to 2025, with revenue growth driven by continued volume growth across core Zio Monitor, Zio AT, innovative channels, and international.
展望未來,我們上調 2026 全年營收指引至 8.75 億至 8.85 億美元,代表年增 17% 至 18%。此展望反映核心業務的持續需求,同時我們對較新與新興通路的預測仍維持審慎且有紀律的做法。以全年來看,我們仍預期整體定價相較 2025 年大致持平,營收成長將由核心 Zio Monitor、Zio AT、創新通路與國際市場的持續量能成長所驅動。
In the second quarter of 2026, we anticipate revenue to be in the range of $218 million to $220 million, consistent with typical revenue seasonality. For gross margin, we expect the clinical operations and manufacturing efficiencies we've driven will continue to incrementally improve our gross margin profile for the full-year 2026. We believe that these sustainable improvements will continue to lower our cost to serve as we leverage our fixed cost infrastructure over a higher volume of patients over time and introduce new artificial intelligence and workflow tools. Regarding the current geopolitical situation, we have cost containment initiatives in place and do not expect a material impact to gross margin.
2026 年第二季,我們預期營收將落在 2.18 億至 2.20 億美元區間,符合典型的營收季節性。就毛利率而言,我們預期已推動的臨床營運與製造效率將在 2026 全年持續逐步改善毛利率結構。我們相信,隨著時間推進,透過在更高的病患量上攤提固定成本基礎設施,並導入新的人工智慧與工作流程工具,這些可持續的改善將持續降低我們的服務成本。關於目前的地緣政治情勢,我們已採取成本控管措施,且不預期對毛利率造成重大影響。
From a profitability standpoint, we are raising our full-year 2026 adjusted EBITDA margin guidance to 12% to 13%, reflecting increased operating leverage and a balanced approach to investing in our key priorities, including product innovation, commercial initiatives, international expansion, and platform capabilities. For the second quarter 2026, we anticipate adjusted EBITDA margin to be between 11.5% and 12.5%. We continue to expect full-year free cash flow in 2026 to grow versus 2025 with free cash flow more heavily weighted in the second half of the year due to normal operating seasonality.
在獲利能力方面,我們上調 2026 全年調整後 EBITDA 利潤率指引至 12% 至 13%,反映更高的營運槓桿,以及在關鍵優先事項上採取平衡的投資策略,包括產品創新、商業計畫、國際擴張與平台能力。2026 年第二季,我們預期調整後 EBITDA 利潤率介於 11.5% 至 12.5%。我們仍預期 2026 全年自由現金流將較 2025 年成長,且由於正常的營運季節性,自由現金流將更偏重於下半年。
In summary, our first quarter results demonstrate the resilience of our business model and the progress we are making in scaling our platform with disciplined investment. We are seeing increasing validation of the value our services deliver, particularly in their ability to help lower downstream healthcare utilization. This dynamic reinforces demand for our solutions, especially as healthcare systems remain focused on efficiency and cost-effective care delivery. We similarly remain focused on growing the number of patients we serve while operating efficiently and investing in the opportunities we believe will drive sustainable growth in our business.
總結來說,我們第一季的成果展現了商業模式的韌性,以及我們在有紀律投資下擴大平台規模所取得的進展。我們看到外界對我們服務所帶來價值的認可日益增加,特別是在其有助於降低後續醫療資源使用方面。這樣的趨勢強化了對我們解決方案的需求,尤其是在醫療體系仍聚焦於效率與具成本效益的照護交付之際。我們同樣持續專注於在高效率營運的同時,擴大我們服務的病患人數,並投資於我們認為能推動業務可持續成長的機會。
I will now turn the call back to Quentin for closing remarks.
接下來我把電話交回給 Quentin 作結語。
Quentin Blackford - President, Chief Executive Officer, Director
Quentin Blackford - President, Chief Executive Officer, Director
In the first quarter, we were pleased with our start to the year with strong top line growth, continued margin expansion, and ongoing investments in the capabilities that support durable long-term value creation. As we enter iRhythm's 20th year, our performance reflects the strength of our platform, the discipline of our execution and the relevance of the problem we are solving.
第一季我們對今年的開局感到滿意,營收端強勁成長、利潤率持續擴張,並持續投資於支持長期可持續價值創造的能力。隨著 iRhythm 邁入第 20 年,我們的表現反映了平台的實力、執行的紀律,以及我們所解決問題的關鍵性。
Arrhythmias remain a significant clinical and economic challenge. They are often episodic, asymptomatic, or misattributed to other conditions and are often missed by short-duration diagnostics. Delayed or misdiagnosis can lead to worse patient outcomes and avoidable costs across the healthcare system.
心律不整仍是重大的臨床與經濟挑戰。其往往呈間歇性、無症狀,或被誤認為其他病況,且常因短時間的診斷工具而被漏診。延遲診斷或誤診可能導致更差的病患預後,並在整體醫療體系中造成可避免的成本。
iRhythm sits at the intersection of several powerful trends, an aging population, increasing prevalence of arrhythmias, growing cost pressure, cardiology capacity constraints, and the shift towards value-based proactive care. We believe the market opportunity ahead is significantly larger than it has historically been recognized and that our platform positions us well to lead that expansion to create long-term value for patients, physicians, providers, payers, and shareholders. Our focus remains on disciplined execution. We are driving volume-led growth by expanding access through primary care and integrated networks, advancing our platform through AI and workflow innovation and investing selectively where we see clear clinical and economic return.
iRhythm 位於多項強勁趨勢的交會點:人口老化、心律不整盛行率上升、成本壓力增加、心臟科量能受限,以及朝向以價值為導向的主動式照護轉移。我們相信,未來的市場機會顯著大於過去歷來所被認知的規模,而我們的平台使我們具備良好定位,能引領這一擴張,為病患、醫師、醫療服務提供者、支付方與股東創造長期價值。我們的重點仍是有紀律的執行。我們正透過擴大初級照護與整合式網絡的可及性來推動以量能為主導的成長,並透過 AI 與工作流程創新推進平台,同時在我們看到明確臨床與經濟回報之處進行選擇性投資。
Looking ahead, the opportunity is not only about expanding the market, it's about strengthening our platform advantage. Our growing clinical data set, AI capabilities, and deep body of clinical validation increasingly differentiate iRhythm. As healthcare increasingly prioritizes accuracy, evidence, and efficiency, we believe validated data-driven diagnostics will be increasingly important in improving outcomes and lowering system cost, attractively positioning iRhythm to create long-term value for all stakeholders.
展望未來,機會不僅在於擴大市場,更在於強化我們的平台優勢。我們不斷成長的臨床資料集、AI 能力,以及深厚的臨床驗證基礎,正日益使 iRhythm 脫穎而出。隨著醫療照護愈發重視準確性、證據與效率,我們相信經驗證、以資料驅動的診斷在改善臨床結果並降低系統成本方面將愈加重要,這也使 iRhythm 具備有利定位,能為所有利害關係人創造長期價值。
Before we move to Q&A, I want to briefly touch on a couple of items that are often top of mind. With respect to the DOJ, we have not received any request for additional information since the CID issued in December and continue to cooperate fully. Separately, regarding finalization of the local coverage determination, we have not yet heard back from the MACs. As expected, timing remains uncertain given the current official silent period.
在進入問答之前,我想簡要提及幾個經常被關注的事項。就 DOJ 而言,自 12 月發出 CID 以來,我們尚未收到任何額外資訊的要求,並將持續全力配合。另外,關於地方給付決定(local coverage determination)的定案,我們尚未收到 MACs 的回覆。如預期所示,鑑於目前官方的靜默期,時程仍不確定。
With that, we're now happy to take your questions.
那麼,我們現在很樂意回答各位的問題。
Operator
Operator
(Operator Instructions)
(接線員指示)
Allen Gong, JPMorgan.
Allen Gong,摩根大通。
Allen Gong - Analyst
Allen Gong - Analyst
Just the first one is going to be on the guide. You're coming off of a quarter where I think you came in $5 million or so above consensus. You raised the full-year by that amount, but then the rest of the year implies a bit of a deceleration from there. Help me understand how much of that is conservatism? How much of that is informed by what you're seeing so far in April?
第一個問題是關於指引。你們剛結束的一季,我認為營收大約比市場共識高出 500 萬美元左右。你們把全年上調了同樣的幅度,但接下來一年其餘期間的隱含成長似乎有些放緩。請幫我理解:其中有多少是保守?又有多少是基於你們目前在 4 月看到的情況?
Daniel Wilson - Chief Financial Officer
Daniel Wilson - Chief Financial Officer
Yeah. Thanks, Allen, for the question. I guess maybe to start, as always, we don't like to get ahead of ourselves. It is early in the year, and we want to be thoughtful around how we set up the year. Certainly, a great start to the year in the quarter.
是的。謝謝你,Allen,這個問題。我想先說,一如既往,我們不希望操之過急。現在仍是年初,我們希望在年度規劃上更審慎。當然,這一季確實是非常好的開局。
We talked about momentum kind of across the different business. Really encouraged about what we're seeing and the trends that we expect to see for the remainder of the year.
我們談到在不同業務面向的動能。對於我們所看到的情況以及我們預期今年剩餘期間將延續的趨勢,我們感到非常鼓舞。
I would point the back part of the year, in particular, starts to have some pretty difficult comps given the performance that we had in 2025. Again, feel really good about what we're seeing in the business. There's certainly potential upside that we're not going to bake into the guide given the early part of the year, and that's a similar approach that we've taken previously. If those play through, that's great, but there's a reason we leave them outside the guide to start. Like what we're seeing in the business, a lot of good contribution across the different growth drivers in the business.
我會指出,尤其是下半年,因為我們在 2025 年的表現,將面臨相當艱難的比較基期。再次強調,我們對目前業務所見的狀況感覺非常好。鑑於年初時點,我們不會把某些潛在上行空間納入指引,這也是我們過去一貫採取的做法。如果那些上行因素實現了,那當然很好,但我們一開始把它們排除在指引之外是有原因的。我們喜歡目前業務的表現,各項成長驅動因素都有不少正向貢獻。
Quentin Blackford - President, Chief Executive Officer, Director
Quentin Blackford - President, Chief Executive Officer, Director
Allen, I'll just jump in. This is Quentin. In terms of what we're seeing in April, we're encouraged by what we're seeing there, good results. We feel good about that. Obviously, we can contemplate that in the reiteration of the guide and the increase in the guide as well.
Allen,我補充一下。我是 Quentin。就 4 月目前看到的情況而言,我們對所見結果感到鼓舞,表現不錯。我們對此感覺良好。當然,我們也會在重申指引以及上調指引時一併納入考量。
One last point I'd just make with respect to what Dan had commented on and your point on the slower growth rates in Q2, Q3 and Q4. When you look at things on a stacked growth comp basis, the momentum is very, very strong, and so despite the tougher comps we're running into year over year in the next few quarters here, which we contemplate, the overall momentum in the business continues to be really strong.
最後再補充一點,回應 Dan 的評論以及你提到的 Q2、Q3 和 Q4 較慢的成長率。如果以疊加式成長比較(stacked growth comp)的角度來看,動能其實非常、非常強;因此,儘管未來幾季我們將面臨較嚴峻的年對年比較基期(我們也已納入考量),整體業務動能仍然非常強勁。
Allen Gong - Analyst
Allen Gong - Analyst
Then just as a follow-up, I think one of the pressures on the broader medtech space recently has been a fear around AI. Looking at your business, it does seem as though you might be a little bit more exposed to that even more so than other medtech companies. You're talking about this new algorithm that you're planning to launch.
接著追問一下,我認為近期整體醫療科技(medtech)領域的一個壓力來源,是市場對 AI 的擔憂。從你們的業務來看,似乎你們相較其他醫療科技公司可能更暴露在這個議題之下。你們也提到計畫推出新的演算法。
But when we think about potential competition from outside of the traditional medtech sphere, how concerned are you about that? How do you position yourself to better compete against those kinds of entrants?
但當我們思考來自傳統醫療科技圈以外的潛在競爭時,你們對此有多擔心?你們如何定位自己,以更好地與這類新進者競爭?
Quentin Blackford - President, Chief Executive Officer, Director
Quentin Blackford - President, Chief Executive Officer, Director
Yeah, it's a fair question. It's one that we get a lot. It's one that I feel very good about in terms of our defensibility and the moat that we've built in the business. I think you have to keep in mind, we're not simply just offering a software capability or an algorithm. It's much more than that.
是的,這是個合理的問題。我們也經常被問到。就我們的可防禦性以及我們在業務中建立的護城河而言,我其實非常有信心。我認為你必須記住,我們提供的不只是軟體能力或一個演算法而已。遠不止如此。
It's running an end-to-end program for these customers of ours around cardiac monitoring and ultimately arrhythmia diagnosis, which includes, for sure, AI capabilities that we've now got 20 years of experience behind us, a 3 billion hour data set that's curated ECG data that we can build off of.
我們為客戶運行的是一套端到端的方案,涵蓋心臟監測並最終用於心律不整診斷;其中當然包含 AI 能力,而我們在這方面已有 20 年經驗,並擁有 30 億小時的資料集——這是經整理的 ECG 心電圖資料,可作為我們持續建構的基礎。
Frankly, that's been part of what's enabled us to move into spaces like predictive capabilities, and we're excited to be launching our first commercial predictive AI collaboration that I mentioned in prepared remarks. It's also what's enabled us to advance our next-gen algorithm that will reduce our technician review time by nearly half over the next several years, which is going to be a meaningful financial contributor. It's the power of that data that allows us to move quickly in those spaces but also the broader end-to-end program that we enable these customers to be able to run without worry, whether that's a hardware device on the front end, like our patch that has incredible patient compliance. 98% of our folks will wear the patch up to 14 days. We know duration of monitoring is important.
坦白說,這也是我們能夠進入預測能力等領域的原因之一;我們也很期待推出我在事先準備的講稿中提到的第一個商業化預測型 AI 合作。同時,這也讓我們能推進下一代演算法,未來幾年可將技術人員的審閱時間減少近一半,這將帶來顯著的財務貢獻。正是資料的力量讓我們能在這些領域快速前進;但同樣重要的是,我們提供的更廣泛端到端方案,讓客戶能無後顧之憂地運作——無論是前端的硬體裝置,例如我們的貼片,病患配戴依從性極高:98% 的使用者可配戴貼片長達 14 天。我們知道監測時長很重要。
Getting a longer duration wear period is important, which is more than just an algorithm. That's a form factor in a hardware component.
取得更長的配戴期間很重要,而這不只是演算法而已。這涉及硬體元件的外形設計(form factor)。
There's the intake process of receiving these things, downgrading the data or -- downloading the data, sorry, coupling it with the patient context that's provided with it. There's many times that you look at feedback and there might not be any arrhythmia in the ECG data, but the patient feedback in the diary or the electronic digital-facing app is meaningful. The physician wants to know that. You're not going to capture all that in just an algorithm alone.
還有收件流程:接收這些裝置、降級資料或——抱歉,是下載資料,並將其與隨附的病患情境資訊結合。很多時候你看回饋,ECG 資料裡可能沒有任何心律不整,但病患在日記或電子化、面向使用者的 App 中提供的回饋卻很有意義。醫師會想知道這些。僅靠一個演算法無法把這些都捕捉到。
Then on top of that, it's got to be clinically validated and upheld to the FDA scrutiny from a quality perspective or you could go on to reimbursement. There's a massive market access component to ensuring that your solution is reimbursed, and that takes tremendous effort. I think we're up to 93% of all lives in the US are now covered with respect to access to Zio. That takes time and effort with other solutions.
此外,它還必須經過臨床驗證,並在品質層面經得起 FDA 的審查,否則就無法進一步談到給付。要確保你的解決方案能獲得給付,還需要龐大的市場准入(market access)工作,而這需要極大的投入。我想目前美國約有 93% 的受保人群在取得 Zio 的可近性方面已納入保障。這需要時間與努力,其他解決方案亦然。
There's a lot that goes into it. It's not just simply an AI capability. It's an end-to-end program that's being run that we have mastered over the years, and we have a market-leading position for a reason, and we will continue to defend that well.
其中牽涉很多環節。不僅僅是 AI 能力。而是一套我們多年來已經精通的端到端運作方案;我們之所以能成為市場領導者是有原因的,而且我們也會持續把這個優勢守得很好。
I think the platform we've built ultimately gives us the ability to drop incremental AI capabilities on and through the large integration platform that we have with the vast majority of our customers enable them to have access to some of these capabilities seamlessly on their side. They're not having to integrate multiple times over. They have a single point of integration with iRhythm. We can bring to them several of these solutions and give them very quick, easy access. I'm excited by the position we have.
我認為我們所建構的平台,最終讓我們能夠在我們與絕大多數客戶所擁有的大型整合平台之上與之中,逐步加入更多 AI 能力,讓他們在其端能夠無縫取得其中一些能力。他們不需要一再進行多次整合。他們只需要與 iRhythm 進行單一整合。我們可以把其中幾項解決方案帶給他們,並讓他們非常快速、容易地取得使用。我對我們目前所處的位置感到振奮。
We'll continue to move quickly, and we're bullish on the position we have here.
我們會持續快速推進,而且我們對目前在這裡所處的位置持樂觀態度。
Operator
Operator
Stephanie Elghazi, BofA.
Stephanie Elghazi,美國銀行(BofA)。
Stephanie Piazzola Elghazi - Analyst
Stephanie Piazzola Elghazi - Analyst
I wanted to ask on the EBITDA margin in the quarter was pretty strong at 7% and better than your guide of 3% to 4%. Just curious what drove that outperformance? Then you raised the guide slightly to 12% to 13%. Just curious why not raise more. Maybe it's just early in the year, but yes, curious your thinking on that.
我想問一下,本季 EBITDA 利潤率相當強勁,達到 7%,也優於你們指引的 3% 到 4%。想請教是什麼因素帶動了這個超預期表現?另外你們把全年指引小幅上調到 12% 到 13%。也想了解為什麼不再多上調一些。也許只是因為年初還早,但想聽聽你們的思考。
Daniel Wilson - Chief Financial Officer
Daniel Wilson - Chief Financial Officer
Yeah. Thanks, Stephanie, for the question. Maybe the second part of your question first there. Yes, we are raising the guide essentially by the magnitude of the beat in the quarter. Again, early in the year, I don't want to get ahead of ourselves, but certainly seeing the profitability flow through nicely in the business and saw a nice result there in the quarter.
好的。謝謝你,Stephanie,提問。我先回答你問題的第二部分。是的,我們上調指引,基本上就是把本季超出預期的幅度反映進去。同樣地,因為年初還早,我不想操之過急,但我們確實看到獲利能力在業務中良好地傳導,本季也看到不錯的結果。
I would just comment really continued strong execution across our teams. We've seen gross margin continue to step up nicely. A lot of efficiencies being driven within our clinical operations team, our manufacturing teams and the automation that we've implemented. Certainly, continued opportunity there as we leverage our scale, leverage technology, our next-generation algorithm, as we mentioned, and have a nice road map there to continue to drive efficiencies and operating leverage.
我想補充的是,我們各團隊持續展現強勁的執行力。我們看到毛利率持續穩健提升。臨床營運團隊、製造團隊以及我們已導入的自動化,都在推動大量效率提升。隨著我們運用規模、運用技術、以及如我們提到的下一代演算法,未來仍有持續機會推動效率與營運槓桿,我們也有一個很好的路線圖來持續推進。
Below gross margin, I'd say similar efficiencies and automation. Then maybe we'll just call out some of the maybe more underappreciated aspects of our business that can drive nice operating leverage. That we've talked about innovative channel, the one-to-many selling model that is present in that channel, and that has real operating leverage that's playing through.
在毛利率以下的費用方面,我會說同樣也來自效率提升與自動化。另外,我們也想點出一些可能較不被市場充分理解、但能帶來良好營運槓桿的業務面向。我們談過的創新通路(innovative channel),其中存在一對多的銷售模式,而這確實正在帶來實質的營運槓桿。
You think about our land and expand model as we open an account and then expand in the primary care and other prescriber bases, and we can do that really, really efficiently. Related to that, EHR integration, integration drives operating leverage on an account level basis and really allows us to expand prescribers in a really efficient way. Then certainly, within G&A, we've been hard at work there, very disciplined and a lot of opportunities to continue to drive leverage there. Really excited about what we've driven to over the last couple of years but see a lot of opportunity in front of us to continue to drive profitability expansion.
你可以想想我們的「先落地再擴張」(land and expand)模式:我們先開發一個帳戶,接著在基層醫療與其他開立處方的醫師族群中擴張,而我們能以非常、非常高效率做到這點。與此相關的是,EHR 整合會在帳戶層級帶來營運槓桿,並真正讓我們能以非常有效率的方式擴大開立處方的醫師數。此外,在 G&A(一般與行政費用)方面,我們也一直努力推進,保持高度紀律,且仍有許多機會持續提升槓桿。我們對過去幾年所推動的成果感到非常振奮,同時也看到前方仍有大量機會持續擴大利潤。
Stephanie Piazzola Elghazi - Analyst
Stephanie Piazzola Elghazi - Analyst
Then just wanted to follow-up on the next-gen algorithm. I think that was a new positive update, and you mentioned some of the efficiency benefits it can bring. I was wondering if anything else you can share on the features of this next-gen algo?
接著我想追問一下下一代演算法。我認為這是新的正面更新,你們也提到它能帶來一些效率效益。想請問你們是否還能分享更多關於這個下一代演算法的功能特性?
Then just to confirm, you said it's a separate filing from MCT, but submitted at a similar time. Could we be expecting FDA approval in the coming months? Then what's the plan for rolling that out once you get approval?
另外想確認一下,你們說它是與 MCT 分開送件,但提交時間相近。那我們是否可以期待在接下來幾個月內獲得 FDA 核准?以及一旦核准後,推出(rollout)的計畫是什麼?
Quentin Blackford - President, Chief Executive Officer, Director
Quentin Blackford - President, Chief Executive Officer, Director
Yeah, Stephanie, this is Quentin. In terms of the financial lever, there's probably not a larger financial lever that we have in the business, quite honestly, than this next-generation algorithm when it gets implemented. We're excited by what that will bring. Our view is it has the opportunity to cut review time by nearly half, if not more, over time, which is going to allow us to scale very, very efficiently into the future, and so as we do some of the math around it over the next five years or so, it's well north of $100 million of value on a cumulative basis that we expect to be delivered from this. This is a meaningful lever for us that we're excited to get into the company and start to realize the benefit from it.
好的,Stephanie,我是 Quentin。就財務槓桿而言,坦白說,當這個下一代演算法導入後,可能沒有比它更大的財務槓桿了。我們對它將帶來的影響感到興奮。我們的看法是,隨著時間推進,它有機會把審閱時間縮短將近一半,甚至更多,這將使我們未來能非常、非常有效率地擴張;因此我們在做未來約五年的推算時,預期它在累計基礎上帶來的價值將遠超過 1 億美元。這對我們而言是一個重要的槓桿,我們很期待把它導入公司並開始實現其效益。
To your point, we did submit it last year alongside MCT. It continues to run independent and on its own time line. We would expect approval later this year. We'll be sure to keep you updated when that approval comes. In terms of implementing it, we will implement it alongside MCT, when MCT is approved and implemented in the first half of '27.
如你所說,我們去年與 MCT 一起提交了它。它會持續獨立運作,並依照自己的時程推進。我們預期會在今年稍晚獲得核准。一旦核准,我們一定會向各位更新。至於導入方面,我們會在 MCT 核准並於 27 年上半年導入時,與 MCT 一起導入。
There's some work from the development teams to integrate that algorithm onto the production side. We will team that up with the MCT launch as well and keep those coupled. That's how we're thinking about it.
開發團隊還需要做一些工作,把該演算法整合到量產端。我們也會把這部分與 MCT 的上市推進配套進行,並讓兩者保持綁定。這就是我們目前的規劃。
Operator
Operator
Vijay Kumar, Evercore ISI. We will move on to the next question.
Vijay Kumar,Evercore ISI。我們將進入下一個問題。
Brandon Vazquez, William Blair. Please stand by while we look at this issue. Brandon Vazquez, your line is now open.
Brandon Vazquez,William Blair。請稍候,我們正在處理這個問題。Brandon Vazquez,您的線路現在已開通。
Unidentified Participant
Unidentified Participant
It's Max on for Brandon. You guys have a handful of innovative channel partners that have been with you for a few quarters now. Can you guys just touch on what you've learned from the more tenured relationships and how that's helping you guys as you approach some of the newer accounts?
我是 Max,代替 Brandon 發言。你們有幾家創新通路合作夥伴,已經與你們合作了好幾個季度。能否談談你們從這些較成熟的合作關係中學到了什麼,以及這如何幫助你們在接觸一些較新的帳戶時更順利?
Quentin Blackford - President, Chief Executive Officer, Director
Quentin Blackford - President, Chief Executive Officer, Director
Yeah. One of the things that's most encouraging with our innovative channel partners is that every single one of these partners who patched with us in 2025 is up and patching consistently in 2026. We're starting to see more consistency in that channel. Quite honestly, there will continue to be lumpiness at that customer level, but overall, we're seeing more consistency in it. We're encouraged by that.
好的。我們的創新通路合作夥伴最令人鼓舞的一點是:所有在 2025 年開始與我們貼片(patch)合作的夥伴,在 2026 年都已上線並持續穩定地貼片。我們開始在這個通路看到更高的一致性。坦白說,在單一客戶層級仍會持續有波動,但整體而言,我們看到更高的一致性。我們對此感到鼓舞。
We continue to sign up some new partners over the course of Q1. The pipeline is incredibly healthy as we head into Q2, same with Q3. We're excited by what innovative channel partners will bring to us. We're starting to see a bit more consistency around it. We want to see that continue to play out into the future before we start to get ahead of ourselves, but we're starting to see what we anticipated we might in those areas.
我們在第一季期間也持續簽下新的合作夥伴。進入第二季時,管線非常健康,第三季也是如此。我們對創新通路合作夥伴將為我們帶來的貢獻感到興奮。我們開始看到一些更高的一致性。在我們開始過度樂觀之前,我們希望先看到這樣的趨勢在未來持續發展,但我們確實開始看到我們先前在這些面向所預期可能出現的情況。
The other thing that's really encouraging is what we're seeing in that channel partner business is most of these customers start with us on the asymptomatic side or maybe better described as undiagnosed, unaware arrhythmia patients. These are folks who generally have symptoms in their medical records. They're just not aware of them or they're being confused with other disease states like type 2 diabetes or COPD, CKD, sleep, you go down the list. What's encouraging in what we're seeing with our innovative channel partners is that folks who started on the asymptomatic side are actually starting to use the device much more on the symptomatic side of their business as well.
另一個非常令人鼓舞的點是:在這個通路合作夥伴業務中,我們看到多數客戶一開始是從無症狀端切入,或更貼切地說,是從尚未診斷、未察覺的心律不整患者切入。這些人通常在其病歷中其實有症狀記錄。只是他們自己沒有察覺,或被與其他疾病狀態混淆,例如第二型糖尿病或 COPD、CKD、睡眠問題等等,清單可以列很長。令人鼓舞的是,我們看到那些一開始從無症狀端開始的客戶,也開始在其業務中更大量地把裝置用在有症狀端。
I think part of that comes back to the attributes of the Zio product itself. These folks are learning through their own real-world data that longer duration monitoring produces a higher diagnostic yield. It doesn't miss the arrhythmias. Where in the past, maybe their symptomatic patients were using a traditional Holter short duration sort of monitor, they're missing them, and they're realizing that and they're starting to patch with longer duration. A lot of really interesting, encouraging trends coming out of that part of the business.
我認為其中一部分要回到 Zio 產品本身的特性。這些客戶正透過自身的真實世界數據學到:監測時間越長,診斷檢出率就越高。它不會漏掉心律不整。過去也許他們的有症狀患者使用的是傳統 Holter 這種短時間監測器,結果會漏診;他們意識到這點後,開始改用更長時間的貼片式監測。這塊業務出現了許多非常有趣、令人鼓舞的趨勢。
We're very bullish on what that means for the future and opening up the 27 million patient TAM that we think is out there. It's still early, but we've been encouraged by what we're seeing.
我們對這對未來的意義非常樂觀,並將有助於打開我們認為存在的 2,700 萬名患者的 TAM(總可服務市場)。目前仍在早期階段,但我們對所看到的情況感到鼓舞。
Unidentified Participant
Unidentified Participant
Then, Quentin, you previously talked about how MCT can eventually drive share closer towards that 40% to 50% range over time. How should we think about that market share ramp once MCT launches in first half of '27? I understand AT continues to take share. Should we see that MCT launch as a continuation of that trend? Then how does the next-gen algorithm with MCT play into that?
接著,Quentin,你先前談到 MCT 最終可在時間推移下把市占率推升到更接近 40% 到 50% 的區間。當 MCT 於 2027 年上半年上市後,我們應該如何看待那個市占率爬升的節奏?我理解 AT 仍在持續拿下市占。我們是否應將 MCT 的上市視為這一趨勢的延續?那麼,搭配 MCT 的下一代演算法在其中扮演什麼角色?
Quentin Blackford - President, Chief Executive Officer, Director
Quentin Blackford - President, Chief Executive Officer, Director
Yeah. Look, I think the right way to think about it is a continuation of the trend. We know that the new MCT product closes a lot of the competitive gaps that our current ZAT product has, but I think we're going to want to see that product play in the market before we're going to guide to something different. I think the right way to think about it right now is a continuation of the trend that we see with Zio AT with a lot of excitement that it has the potential to do even better than that. That's probably not how we're going to set expectations out of the gate.
是的。你看,我認為正確的理解方式是把它視為趨勢的延續。我們知道新的 MCT 產品補上了我們目前 ZAT 產品存在的許多競爭缺口,但我認為在我們對外給出不同的指引之前,我們會希望先看到該產品在市場上的實際表現。就目前而言,正確的看法是:延續我們在 Zio AT 上看到的趨勢,同時也非常興奮,因為它有潛力表現得比那更好。但這大概不會是我們一開始就設定的市場預期。
I would say with Zio AT's performance, we continue to demonstrate the ability to take share with an inferior product. We're just all the more excited by the ability to get MCT into the product -- or sorry, into the market. With respect to getting the algorithm into the product, it's going to drive meaningful gross margin benefit. One of the nice things about Zio MCT is it's coming on the same form factor that our Zio Monitor is already on, which is going to enable us to leverage a lot of the automation from a manufacturing perspective that we already have. We were already going to see a nice benefit from AT into MCT.
我會說,就 Zio AT 的表現而言,我們持續證明即使產品相對較弱,仍有能力搶下市占。因此,我們對把 MCT 推向產品——抱歉,是推向市場——的能力更感到興奮。至於把演算法導入產品,這將帶來顯著的毛利率效益。Zio MCT 的一個優點是,它採用與我們現有 Zio Monitor 相同的外形規格(form factor),這讓我們能從製造端沿用既有的大量自動化能力。從 AT 轉到 MCT,我們原本就會看到不錯的效益。
Now that we are able to drop the next-gen algorithm onto that platform as well, it's going to really enhance the gross margin profile. We're excited by that. I would note, though, that next-gen algorithm, while we'll bring it to market alongside Zio MCT, it will apply across our entire platform. It's going to be immediately applied against Zio Monitor and the large presence that we have there.
現在我們也能把下一代演算法放到同一平台上,將會大幅提升毛利率結構。我們對此感到興奮。不過我也要指出,下一代演算法雖然會與 Zio MCT 同步推向市場,但它會適用於我們整個平台。它將立即應用在 Zio Monitor 上,以及我們在那裡的龐大裝機基礎。
We'll continue to run on the Zio AT product as we work through those inventory levels and migrate towards Zio MCT and we'll also be on the MCT product. It's a complete platform application of that new algorithm that we're excited by.
在我們消化那些庫存水位並逐步轉向 Zio MCT 的同時,我們會持續運行 Zio AT 產品,並且也會在 MCT 產品上運行。這是一個我們非常期待的新演算法在整個平台上的全面應用。
Operator
Operator
Vijay Kumar, Evercore ISI.
Vijay Kumar,Evercore ISI。
Unidentified Participant
Unidentified Participant
Hi. Can you hear me clearly?
嗨。你們聽得清楚嗎?
Quentin Blackford - President, Chief Executive Officer, Director
Quentin Blackford - President, Chief Executive Officer, Director
We got you. Sorry, we missed you earlier.
聽得到。抱歉,我們剛才漏掉你了。
Unidentified Participant
Unidentified Participant
Great. No worries. This is Kevin on for Vijay. Just the one on the DOJ CID request. I know you mentioned there has not been any request for additional information. Can you just update us on what exactly asked for so far? Looking forward, do you have maybe a preliminary view on what the range of outcomes might be here from this request?
太好了。沒事。我是 Kevin,代 Vijay 發問。我只有一個問題,關於 DOJ 的 CID 要求。我知道你提到目前沒有要求提供額外資訊。你能否更新一下,到目前為止他們究竟要求了哪些內容?往前看,你是否對這項要求可能導致的結果範圍有初步看法?
Quentin Blackford - President, Chief Executive Officer, Director
Quentin Blackford - President, Chief Executive Officer, Director
Yeah. No, the request for information in that CID was very consistent with the original subpoena that dates back to 2023. It seems very clear that they're focused in and around the AT product line and really specific to dates back in the '17 to '21, '22 time frame. That's what we can infer from the line of questions and the information request.
是的。沒有,該 CID 中的資訊要求與可追溯至 2023 年的原始傳票內容非常一致。看起來很明確,他們的重點聚焦在 AT 產品線周邊,且相當具體地指向大約 2017 到 2021、2022 年那段期間。這是我們從問題脈絡與資訊要求中所能推斷的。
To go beyond that, it would be hard for us to do. There's not much more clarity we can give. It just seems like for the breadth of their review and investigation has been focused in that area and tied into those time frames.
要再超出這些去解讀,對我們來說會很困難。我們能提供的清晰度不多。看起來他們審查與調查的範圍主要就集中在那個領域,並且與那些時間區間相關。
As we have more clarity, we'd be happy to share it with you. Obviously, Zio AT was not a big part of our portfolio back in those early days. It was newly launched and was growing over time. It's hard to size up anything along those lines though, and that's not something we would speculate on.
如果我們有更明確的資訊,我們很樂意與各位分享。顯然,在那些早期年份,Zio AT 並不是我們產品組合中的重要部分。它當時才剛推出,並隨時間逐步成長。不過要就此評估任何可能性仍然很困難,而這也不是我們會去臆測的事情。
Operator
Operator
(Operator Instructions) Nathan Treybeck, Wells Fargo.
(接線員指示)Nathan Treybeck,Wells Fargo。
Nathan Treybeck - Equity Analyst
Nathan Treybeck - Equity Analyst
Are you beginning to see any benefits flow through from reconfirmations for chart-derived diagnoses? Are you anticipating any benefit in your guidance?
你們是否開始看到「圖表衍生診斷(chart-derived diagnoses)」的重新確認(reconfirmations)帶來任何效益反映?你們是否預期在指引中會有任何正面效益?
Quentin Blackford - President, Chief Executive Officer, Director
Quentin Blackford - President, Chief Executive Officer, Director
We haven't contemplated anything in the guide, Nathan, in particular. We continue to believe that we're in a very good position relative to the focus around the chart-derived mention that has been made out there and the increased scrutiny around it.
Nathan,我們在指引中特別沒有納入任何相關影響。我們仍然相信,針對外界提到的「圖表衍生」以及其所帶來的更高審視力度,我們相對處於非常有利的位置。
From our perspective, our partners consistently use Zio to get to a confirmed diagnosis, which is exactly what CMS is trying to get to is ensure that there's a real confirmed diagnosis versus just speculation of the chart-derive nodes, and so we like the position. We haven't seen a change in behavior necessarily. To be honest with you, most all of our channel partners are using the product to get to that confirmatory diagnosis, and that's what they've been using from the beginning of the relationship.
從我們的角度來看,我們的合作夥伴一貫使用 Zio 來取得「已確認的診斷」,這正是 CMS 想要達成的目標:確保是真正被確認的診斷,而不是僅僅根據病歷圖表衍生節點的推測;因此我們喜歡我們所處的位置。我們不一定看到行為出現改變。坦白說,我們幾乎所有的通路合作夥伴都是用這個產品來取得確認性診斷,而且從合作一開始就是如此。
We'll continue to monitor it and watch it. We think this is a nice tailwind in the business and I expect that's how it will play out, but we haven't adjusted anything in guidance at this point for.
我們會持續監測並觀察。我們認為這對業務是一股不錯的順風,我也預期最終會如此發展,但目前我們尚未因此調整任何指引。
Operator
Operator
David Rescott, R.W. Baird.
David Rescott,R.W. Baird。
David Rescott - Senior Research Analyst
David Rescott - Senior Research Analyst
Congrats on a good start to the year here. I wanted to ask about the sleep market. It sounds like there's some pilots that are ongoing but would be curious to hear maybe from our perspective, when we should expect to maybe hear something more on sleep, when we should be thinking about this potentially becoming some type of opportunity that you're more meaningfully moving into.
恭喜今年開局表現不錯。我想問一下睡眠市場。聽起來目前有一些試點正在進行中,但我想從你們的角度了解,我們大概何時能聽到更多關於睡眠方面的進展?以及我們應該何時開始把它視為你們可能更有意義地切入的一類機會?
Then when you think about the competitive offerings that are out there, what value do you think iRhythm can bring to that market with not only a hardware component, but also just the broader service offering longer term?
另外,當你們看待目前市場上的競品方案時,你們認為 iRhythm 能為該市場帶來什麼價值——不僅是硬體元件,也包括更長期、更廣泛的服務方案?
Quentin Blackford - President, Chief Executive Officer, Director
Quentin Blackford - President, Chief Executive Officer, Director
Yeah. Look, I think you're going to hear us continue to talk about sleep over the course of the year, David. It's an important strategic opportunity for us and one that our pilots are validating to us is real. In terms of meaningful contribution, we'll talk about that as we get out into '27. I don't see it as being something that's going to move the needle in a significant way just yet, but as we get more confidence in it and lean into it, we'll keep you apprised of that, and we'll speak to it when that time comes.
是的。你看,David,我認為你會在今年接下來的時間裡持續聽到我們談論睡眠。這對我們而言是一個重要的策略性機會,而且我們的試點也向我們驗證這確實存在。至於是否能帶來有意義的貢獻,我們會在接近 2027 年時再談。我不認為它目前就會以顯著方式帶動整體表現,但隨著我們對此更有信心並加大投入,我們會持續向你更新,並在時機成熟時再進一步說明。
I do think that we have a real opportunity to disrupt this space. It's more than about simply a home sleep device, and it's more about an algorithm that can identify and detect sleep disease. This is very similar to what we did with cardiac arrhythmias. We disrupted an entire marketplace by providing an easier end-to-end solution to identify, monitor and diagnose these patients. Right now, sleep patients are being lost in their journey, whether it's getting referred from primary care on to cardiology, on to a sleep practice to a sleep lab to a home sleep test that they never receive or don't send back, like the entire system is just very fractured and one that we believe we can bring a lot of organization to and make it as simple as when that physician wants to order a sleep test.
我確實認為我們有一個真正的機會去顛覆這個領域。這不僅僅是關於一個居家睡眠裝置,更重要的是一套能夠辨識並偵測睡眠疾病的演算法。這與我們在心律不整方面所做的非常相似。我們透過提供更容易的端到端解決方案來識別、監測並診斷這些病患,顛覆了整個市場。目前,睡眠病患在就醫旅程中常常被遺漏,無論是從基層醫療轉介到心臟科、再到睡眠門診、到睡眠實驗室、到居家睡眠檢測(結果他們可能根本沒收到或沒有寄回),整個系統非常破碎;而我們相信我們可以帶來大量的組織化,讓流程簡化到醫師想要開立睡眠檢測時就像下單一樣簡單。
It's as easy as hitting a button in our digital tools, Zio Suite, we get a device to that patient, could either be in the clinician's office. It could be through home enrollment just like we do today with cardiac arrhythmias. The they wear the device. We get the information back. We can provide a report right through an IDTF capability and provide that report right back through the digital tool to that physician where it ends up being incredibly seamless and all that back-end effort is invisible to the physician.
這就像在我們的數位工具 Zio Suite 裡按一下按鈕一樣簡單,我們就能把裝置送到病患手上,可以是在臨床醫師的診間。也可以像我們今天在心律不整業務所做的一樣,透過居家註冊。然後他們配戴裝置。我們把資訊收回來。我們可以透過 IDTF 的能力直接提供報告,並透過數位工具把報告回傳給醫師,整體流程非常無縫,而所有後端的工作對醫師而言都是看不見的。
We think that is a real opportunity to disrupt in this space. We know from our market channel checks that our customers are prescribing home sleep tests already or would be more than willing to prescribe home sleep test. I think that as we continue to move further up the care pathway, as you see the proliferation of even GLP-1s into the marketplace to treat sleep disease, you're going to see more prescribing in primary care. We can make this very seamless and very easy for the physician. We're excited by that.
我們認為這是在這個領域實現顛覆的一個真正機會。從我們的市場通路調查來看,我們知道客戶已經在開立居家睡眠檢測,或是非常願意開立居家睡眠檢測。我認為,隨著我們持續往照護路徑的更上游推進,且你看到甚至 GLP-1 類藥物在市場上擴散、用於治療睡眠疾病,你會看到在基層醫療端有更多的開立。我們可以讓這件事對醫師而言非常順暢、非常容易。我們對此感到興奮。
I think it's much more than just a home sleep test itself. It's about the workflow efficiencies that we can create and I don't think there is a single competitor out there who's able to disrupt and provide an offering in the market like we can. There's nobody else who brings that end-to-end solution like we do today. There's a lot of mom-and-pop one-off sleep practices or sleep IDTFs, but nobody is integrated seamlessly in a workflow like we can be, particularly through the large presence of system integrations that we already have, I think there's a real opportunity to disrupt this.
我認為這遠不只是居家睡眠檢測本身。重點在於我們能創造的工作流程效率,而我不認為市場上有任何競爭對手能像我們一樣顛覆並提供這樣的產品/服務。沒有其他人能像我們今天這樣提供端到端的解決方案。市場上有很多小型、零散的睡眠診所或睡眠 IDTF,但沒有人能像我們一樣在工作流程中做到無縫整合,特別是透過我們既有的大量系統整合佈局;我認為這裡有一個真正的顛覆機會。
Operator
Operator
Marie Thibault, BTIG.
Marie Thibault,BTIG。
Unidentified Participant
Unidentified Participant
This is Alex on for Marie. Congrats on a nice quarter. I just wanted to ask some questions on the international business. You guys mentioned in the prepared remarks that you recently got an update to the reimbursement framework with a supplemental payment.
我是代替 Marie 的 Alex。恭喜本季表現不錯。我想就國際業務問幾個問題。你們在事先準備的發言中提到,最近在報銷架構方面有更新,並新增了補充性支付。
I was just curious on if you could provide any more detail on that? Is there any more ongoing work to try to continue getting the reimbursement rate further up there?
我想請問你們是否能提供更多細節?是否還有任何持續進行的工作,試圖把報銷費率再往上提高?
Daniel Wilson - Chief Financial Officer
Daniel Wilson - Chief Financial Officer
Yeah. Thanks, Alex, for the question. We did see -- and that's specifically in Japan, we did see a small increase in the reimbursement rate there. It is still below what we think is ultimately the value that we are bringing to the market, and we are still running the head-to-head study and collecting that data to ultimately secure more favorable reimbursement in that market.
是的。謝謝你,Alex,這個問題。我們確實看到——而且這特別是在日本——那裡的報銷費率有小幅上調。但它仍低於我們認為我們最終為市場帶來的價值;我們仍在進行正面對照研究並收集數據,以便最終在該市場爭取更有利的報銷。
We will continue to work towards that -- that's likely a 2027 event, but we're looking to collect that data and ultimately get to more favorable reimbursement. Encouraging that we saw a bit of a step-up here recently, but again, I don't believe that reflects the value that we're bringing into that market, and we're going to continue to pursue that premium reimbursement.
我們會持續朝這個方向努力——這很可能會是 2027 年的事件,但我們希望收集這些數據,最終取得更有利的報銷。近期看到些許上調令人鼓舞,但同樣地,我不認為這反映了我們為該市場帶來的價值,我們會繼續爭取溢價報銷。
Operator
Operator
Richard Newitter, Truist Securities.
Richard Newitter,Truist Securities。
Unidentified Participant
Unidentified Participant
This is Filipe on for Rich. Just on the proposed LCD for ACM, if you could just help us understand if that was finalized today in its current state, what are your expectations for just potential impact or implications?
我是代替 Rich 的 Filipe。關於 ACM 的擬議 LCD,想請你們協助我們理解:如果今天就以目前的狀態定案,你們對於可能的影響或意涵有何預期?
Just second question upfront. Just on the electrophysiology opportunity, I guess, can you help us understand like what inning of penetration you are in there? Maybe how does the MCT approval unlock patients you're maybe not getting to?
第二個問題先問在前面。關於電生理(electrophysiology)的機會,我想請你們協助我們理解你們目前的滲透率大概在第幾局?另外,MCT 的核准如何解鎖你們可能尚未觸及的病患?
Quentin Blackford - President, Chief Executive Officer, Director
Quentin Blackford - President, Chief Executive Officer, Director
I'll address the first one on the LCD. I'm not sure I exactly follow the second question there, but I'll give it a shot. With respect to the LCD, to your, I guess, specific question of it's implemented as written today, what would that impact be or what we would see. The reality is, as it's written today, it would move just about everything into an MCT category because it's requiring continuous monitoring with 24-hour monitoring, I think, is exactly what the language is in the LCD has currently awarded.
我先回答第一個關於 LCD 的問題。第二個問題我不確定我是否完全理解,但我會試著回答。就 LCD 而言,針對你提出的具體問題:如果今天就按目前文字實施,會造成什麼影響、我們會看到什麼。現實是,按目前的文字,它幾乎會把所有項目都移到 MCT 類別,因為它要求連續監測並包含 24 小時監測——我想這正是 LCD 目前核定文字中的表述。
If that were the case, you're going to be moving a significant amount of LTCM monitoring business into the MCT category, which would have a significant uplift from a revenue perspective on the company, which I don't believe is probably the intention of what the 3 MACs who are putting that proposed language forward.
如果是那樣,你會把相當大一部分 LTCM 監測業務移到 MCT 類別,從公司營收角度看將帶來顯著上行;但我不認為這會是提出該擬議文字的 3 家 MAC 的本意。
Now we have engaged directly with the MACs. Nearly all of industry has engaged with the MAC. I think we're all pretty consistent in our recommendation with respect on how to clarify that language, and we expect that we'll see that get revised in some sort in the final language that they put into that LCD. I think if you look at the LCD as it's currently written, it would start to really confuse or even contradict some of what's in the national coverage decision that is out there, which that is not the intent of the LCDs. I think they're trying to provide more clarity around what they want to see within the MCT category, but as currently written, it starts to restrict the ability to provide the other modalities of monitoring, and I just don't believe that that's what they're after.
目前我們已直接與 MAC 溝通。幾乎整個產業也都與 MAC 溝通過。我認為我們在如何釐清該文字方面的建議相當一致,我們預期在他們放入該 LCD 的最終文字中,會以某種方式進行修訂。我認為如果你看目前 LCD 的寫法,它會開始讓人困惑,甚至與現有的全國性給付決定(national coverage decision)中的部分內容相矛盾,而這並不是 LCD 的目的。我認為他們是想更清楚界定他們希望在 MCT 類別中看到什麼,但以目前的寫法,它開始限制提供其他監測方式的能力,而我不相信那是他們真正想要的。
We'll continue to engage with them on the opportunities where they present themselves. They're in a quiet period as we speak, and so we're waiting to see what comes out of that.
我們將持續就相關機會與他們保持互動。他們目前正處於靜默期,因此我們在等待看看之後會有什麼結果。
I think there are other LCDs that are out there who have -- that have been written to sort of clarify around ambulatory cardiac monitoring. Novitas is one of those. I think they did a pretty nice job of providing that clarity. You might end up seeing the 3 MAC here end up with something closer to that. That's speculation.
我認為外面還有其他LCD——已經發布,用以釐清門診心臟監測相關內容。Novitas就是其中之一。我認為他們在提供這種釐清方面做得相當不錯。你可能會看到這裡的3個MAC最後推出更接近那樣的內容。這只是推測。
I don't know exactly. As currently written, it would move the majority of the market into an MCT style monitor, and that cannot be what the intent is of the cost of monitoring for the overall healthcare system would be increased dramatically.
我不確定具體情況。按目前的文字表述,它會把市場的大多數推向MCT類型的監測器,而這不可能是其本意,因為整體醫療體系的監測成本將會大幅上升。
Operator
Operator
Suraj Kalia, Oppenheimer.
Suraj Kalia,Oppenheimer。
Suraj Kalia - Analyst
Suraj Kalia - Analyst
Hi, Quentin and Dan, congrats on a nice start to the year. Can you hear me all right?
嗨,Quentin和Dan,恭喜今年開局不錯。你們聽得到我說話嗎?
Quentin Blackford - President, Chief Executive Officer, Director
Quentin Blackford - President, Chief Executive Officer, Director
Yeah. Thanks, Suraj
聽得到。謝謝你,Suraj。
Suraj Kalia - Analyst
Suraj Kalia - Analyst
Quentin, a number of calls going on. Forgive me if you've already talked about this two-part question. I'll pose it right upfront, Quentin.
Quentin,現在有不少電話在進行。如果你已經談過這個兩部分的問題,請見諒。我就直接把問題先拋出來,Quentin。
Where do you think the current monitoring market stands? I know there are numbers of 5 million, 6 million that historically we have used, but you guys continue on this solid growth trajectory, which means the overall pie is shifting. Can you quantify just in terms of where currently the long-term monitoring is versus the MCT, at least in terms of the US patient, that would be great.
你認為目前監測市場處於什麼位置?我知道過去我們常用的數字是500萬、600萬,但你們仍在這條穩健的成長軌道上,這意味著整體市場規模正在改變。你能否量化一下,至少就美國患者而言,目前長期監測相對於MCT各自的占比?那就太好了。
Quentin, the second part of my question, if I could pose, there has been a lot of chatter about EP slowdown. I know this is derivative, but are you also picking it up in Zio scripts in post-ablation hospital monitoring?
Quentin,我問題的第二部分,如果可以的話:最近有很多關於EP(電生理)放緩的討論。我知道這是衍生性的指標,但你們在消融術後的院內監測中,是否也在Zio處方量(scripts)上看到這種情況?
Quentin Blackford - President, Chief Executive Officer, Director
Quentin Blackford - President, Chief Executive Officer, Director
Yes. Good question. With respect to the monitoring market, our view is that monitoring market is somewhere around 6.5 million to 7 million tests today in the US, of which probably 3.5 million of those tests are long-term cardiac monitoring or patch-based longer duration monitors, of which we have probably 72% of that market is sort of what our market share estimate is based upon the last data points that we had.
是的。好問題。就監測市場而言,我們的看法是:目前美國的監測市場大約每年650萬到700萬次檢測,其中大概350萬次屬於長期心臟監測或貼片式較長時間的監測器;在這部分市場中,根據我們掌握的最新數據點,我們估計市占率約為72%。
There's also about 1 million MCT tests that are being performed in the US market. That's a rough estimate, but that's what our data is telling us. Just in terms of framing up the market, that's how we think about those two modalities. I do think that we are expanding the market, though.
另外,美國市場大約有100萬次MCT檢測在進行。這是個粗略估計,但我們的數據顯示大致如此。就市場框架而言,我們就是用這兩種模式來看待。不過我確實認為我們正在擴大市場。
We're very excited by the fact that we think the market is much larger than anywhere close to the 6.5 million tests being performed today. There's 27 million folks at least in the US, who most likely have arrhythmias just have been undiagnosed and unfortunately, are confusing the symptoms of those arrhythmias with other comorbid disease states.
我們非常振奮,因為我們認為市場規模遠大於目前每年約650萬次檢測的水準。僅在美國,至少有2,700萬人很可能有心律不整但尚未被診斷出來;不幸的是,他們把心律不整的症狀與其他共病狀態混淆了。
It's our intent to go open the market and find those folks, and that's a big part of why the predictive algorithm capabilities that we've built and are now implementing in our first commercial relationship are so important to us. We know we can find these patients. Importantly, we find them and get them monitored because when you diagnose early, the downstream reduction in cost is proving to be very clear and very significant, and we know we can bend that cost curve.
我們的目標是去開拓市場並找出這些人;這也是我們所建立、並且現在在第一個商業合作關係中開始導入的預測演算法能力,對我們如此重要的原因之一。我們知道我們能找到這些患者。更重要的是,我們找到他們並讓他們接受監測,因為越早診斷,後續成本的下降已被證明非常清楚且非常顯著,而我們知道我們可以讓那條成本曲線下降。
In terms of your point on the EP slowdown, I would say there's nothing in our data that would give us that indication at this point. We'll pay close attention to it. It's a little bit of an interesting dynamic. The data continues to sort of coalesce around the fact that longer duration monitoring even post-ablation is quite important. The current guidelines today, I believe, for post-monitoring of a PFA procedure is somewhere around 2 to 3 months out, you're generally monitoring with a short duration monitor and then you're monitoring on an annual basis as well with a short duration monitor.
至於你提到的EP放緩,我會說目前我們的數據沒有任何跡象支持這個判斷。我們會密切關注。這是一個有點有趣的動態。數據持續逐步匯聚到一個結論:即使在消融術後,較長時間的監測也相當重要。我理解目前的指引是:PFA手術後的監測大約在術後2到3個月時,通常使用短期監測器,之後也會以短期監測器按年度進行監測。
The data would tell us that I think we're missing 25% to 30% of arrhythmias that are present as a result of not using longer duration monitoring in those particular procedures. That becomes quite important, even dangerous because if you're starting to change anticoagulation prescribing off of a short-duration monitoring and you're missing the arrhythmias, you may be stopping too soon on this, which puts the patient at risk, and so that data continues to build. We had some interesting data that was put out at HRS.
數據告訴我們:由於在這些特定手術中未使用較長時間的監測,我們可能漏掉了25%到30%原本存在的心律不整。這會變得非常重要,甚至危險,因為如果你根據短期監測結果來調整抗凝藥物的處方,而又漏掉心律不整,你可能會過早停藥,讓患者承擔風險;因此相關數據仍在累積。我們在HRS上也發布了一些有趣的數據。
What I suspect you could see and we might be seeing, I don't know, Suraj, is if there is a slowdown, we might -- maybe we end up seeing an offsetting mix switch towards longer duration monitoring at mask that. I don't have anything to indicate a slowdown at this point in time. Our data wouldn't tell us that either, but I do think we're in a nice position here to increase the amount of monitoring post PFA procedures.
我猜測你可能會看到、而我們也可能正在看到的情況是——我不確定,Suraj——如果真的出現放緩,我們可能會看到一個相互抵消的組合轉換,轉向較長時間的監測來掩蓋它。就目前而言,我沒有任何跡象顯示有放緩。我們的數據也沒有顯示,但我確實認為我們在PFA術後提高監測量方面處於很好的位置。
Operator
Operator
Gene Mannheimer, Freedom Capital Markets.
Gene Mannheimer,Freedom Capital Markets。
Gene Mannheimer - Analyst
Gene Mannheimer - Analyst
Congrats on a good quarter and outlook. Along some of the lines that were discussed, kind of running ahead of guidance and raising it, have you contemplated any change to your long-term financial targets? Follow-up would be, could you just remind us the percent of registrations coming from primary care lately?
恭喜本季表現和展望都不錯。延續剛才討論的一些方向——你們的表現有點超前於指引並上調了指引——你們是否考慮過調整任何長期財務目標?追問一下:能否提醒我們,最近註冊量中有多少百分比來自基層醫療(primary care)?
Daniel Wilson - Chief Financial Officer
Daniel Wilson - Chief Financial Officer
Yeah. Gene, thanks for the questions. We have not updated the -- our long-term guidance that's out there for 2027 revenue, gross margin and adjusted EBITDA margin. Certainly, the guidance that we have for 2026 puts us on pace to deliver those targets as we get a bit closer we'll think about potentially updating those but continue to feel really good about ultimately delivering on that long-range guidance that we set back in 2022.
好的。Gene,謝謝你的問題。我們尚未更新目前對外的長期指引——也就是2027年的營收、毛利率以及調整後EBITDA利潤率。當然,我們對2026年的指引讓我們有望達成這些目標;隨著時間更接近,我們會考慮是否更新,但我們仍然非常有信心最終能達成我們在2022年所設定的長期指引。
On the second part of your question, we continue to see primary care increase as a percent of volume. That is a big part of the growth that we're driving and moving upstream into primary care.
至於你問題的第二部分,我們持續看到基層醫療在總量中的占比提升。這是我們推動成長、並將觸角往上游延伸到基層醫療的一大部分。
Last quarter, we mentioned over 40,000 primary care prescribers. We see that number continue to increase. We gave a metric at one point, call it, roughly one-third or a little bit over 30% of our volume coming from primary care, and that has been steadily upticking as well. That will remain a growth driver for the business, and we're excited about what that means.
上個季度,我們提到有超過40,000名基層醫療開立者(prescribers)。我們看到這個數字仍在持續增加。我們曾提供一個指標,大約三分之一、或略高於30%的量來自基層醫療,而這個比例也在穩步上升。這仍將是業務的成長驅動力,我們也對其意義感到振奮。
Operator
Operator
Bill Plovanic, Canaccord Genuity.
Bill Plovanic,Canaccord Genuity。
Unidentified Participant
Unidentified Participant
It's Zachary on for Bill. What you were just speaking about with longer-term monitoring showing that arrhythmias can be missed even after ablation because of shorter-term monitoring. I understand that you're generating data around it, but is there any interaction with societies about switching the protocols for these studies? Or I think someone asked before about interaction with EPs, but in those post-ablation patients, is there any penetration you guys can pick up from there?
我是 Zachary,代替 Bill 發言。你剛才提到較長期的監測顯示,即使在消融術後,因為短期監測的限制,仍可能漏掉心律不整。我理解你們正在產出相關數據,但你們是否有與學會團體互動,討論是否要調整這些研究的監測方案?或者我想之前也有人問過與電生理醫師(EPs)的互動,但在這些消融術後病人族群中,你們是否能看到任何滲透率提升的跡象?
Quentin Blackford - President, Chief Executive Officer, Director
Quentin Blackford - President, Chief Executive Officer, Director
I think it's certainly an approach and one that we would be very interested in pursuing and certainly be moving down that pathway. Clearly, you need data and you need real data. I think that data is just coming together. This was the first study that was published here recently, and we'll continue to add to that and accrue the data behind it to make it even more powerful. Ultimately, you would love to see those guidelines change.
我認為這當然是一種做法,而且我們會非常有興趣去推進,並且確實會沿著這條路徑前進。很明顯,你需要數據,而且需要真實世界數據。我認為這些數據正在逐步到位。這是最近剛發表的第一項研究,我們會持續補充並累積更多數據,讓證據力更強。最終,你會希望看到那些指引能夠改變。
I mean the guidelines today just frankly, leads to a situation where you may be putting patients at greater risk than what you could be if you were using a better modality of monitoring. We know that, that monitoring is there. We know that Zio is it. If we can change guidelines, we will certainly lean in to try to do that.
我的意思是,坦白說,現行指引會導致一種情況:如果你採用更好的監測方式,本可以降低風險,但現在可能反而讓病人承擔更高風險。我們知道那樣的監測工具是存在的。我們知道 Zio 就是那個工具。如果我們能推動指引改變,我們一定會全力以赴去做。
Operator
Operator
David Roman, Goldman Sachs.
David Roman,高盛。
Unidentified Participant
Unidentified Participant
This is David on for David, all by myself this afternoon. I wanted just to ask about the profitability here, maybe as I look at the $5 million raise in revenue for the year, you're also putting through roughly a $5 million raise on EBITDA. The incremental gross margin continues to go up, I think, now approaching something like 80% if you look at Q1.
我是 David,代替 David 發言,今天下午就我一個人。我想問一下獲利能力:我看到你們把全年營收上調了 500 萬美元,同時也大約把 EBITDA 上調了 500 萬美元。增量毛利率持續上升,我想如果看第一季,現在接近 80% 左右。
Maybe you could help us just think through some of the factors contributing to the improved P&L here, the drop-through rate you're seeing? Then as you reflect on the margin upside, where are some of the biggest opportunities for incremental investment here?
你能否協助我們理解一下,哪些因素促成了損益表(P&L)的改善,以及你們看到的利潤落地率(drop-through rate)?另外,當你回頭看毛利率的上行空間時,哪些是最重要、最值得追加投資的機會?
Daniel Wilson - Chief Financial Officer
Daniel Wilson - Chief Financial Officer
Yeah. Thanks, David. I appreciate the question, and we are really excited about what we're seeing in the business in terms of profitability. It does start with gross margin, and we've seen nice leverage there and continued gross margin expansion and see a good kind of road map to continue to drive that. We've talked about manufacturing automation and subsequent phases there continuing to drive efficiencies on, call it, the device side of our cost of service.
是的。謝謝你,David。我很感謝這個問題,我們對於業務在獲利能力方面的表現感到非常振奮。這確實從毛利率開始,我們在那裡看到了很好的槓桿效應,毛利率持續擴張,而且我們也看到一個相當清晰的路線圖,可以繼續推動改善。我們談過製造自動化,以及後續階段將持續帶來效率提升,主要是在我們服務成本中、可稱為裝置端的部分。
Within the clinical operations, opportunities there to continue to drive efficiencies with our next-generation algorithm and clinical kind of workflow tools, and we're making those investments now, have been making those investments, and we'll look to implement those to continue to drive gross margin leverage.
在臨床營運方面,也有機會透過我們的下一代演算法與臨床工作流程工具,持續提升效率;我們現在正在做這些投資,也一直在投入,並將推動落地實施,以持續帶動毛利率槓桿。
Then on the rest of the P&L from an OpEx standpoint, we do feel really good that we have a balanced approach here, where as we drive upside in revenue and grow revenue year over year, we are letting some of that play through and land at the bottom line while reinvesting back into the business. There isn't a shortage of things that get us excited about in terms of investing into the business. Zio MCT, certainly, the next-generation algorithm, as I mentioned. Clinical evidence has always been something we want to invest in. We'll continue to invest in.
接著從營業費用(OpEx)的角度看損益表其他部分,我們確實覺得目前採取的是一個很平衡的方法:當我們推動營收上行、並讓營收逐年成長時,我們會讓其中一部分直接反映到最終獲利,同時也把資金再投回業務。在投資業務方面,能讓我們感到興奮的事情並不缺。例如 Zio MCT,當然還有我剛提到的下一代演算法。臨床證據一直是我們希望投入的方向。我們也會持續投資。
We have a nice road map there as we look at the back part of this year. There's a lot we can do from a marketing standpoint. Opportunities there to invest into programs there.
當我們看今年下半年時,我們在那方面有一個不錯的路線圖。在行銷層面我們也有很多可以做的事。也有機會投資相關計畫。
International is an opportunity we're investing in to open up as is innovative channel, as is sleep. A lot of opportunities for -- and I don't think I named them all. A lot of opportunities to make investments in the business, and that's what gets us excited and drives us to be as disciplined and as efficient as we can in the spend that we control. We afford ourselves the opportunity to invest in those items that I mentioned.
國際市場是我們正在投入、準備打開的機會;創新通路也是;睡眠領域也是。還有很多機會——而且我想我也沒有把所有都列完。有很多機會可以對業務進行投資;這也是讓我們感到興奮的地方,並驅使我們在可控支出上盡可能保持紀律與效率。如此一來,我們就能為自己創造空間,去投資我剛才提到的那些項目。
Operator
Operator
There are no further questions at this time. I will now turn the call back over to Quentin Blackford, President and CEO, for closing remarks.
目前沒有其他問題。我現在把電話交回給總裁兼執行長 Quentin Blackford,請他做結語。
Quentin Blackford - President, Chief Executive Officer, Director
Quentin Blackford - President, Chief Executive Officer, Director
Well, thank you. As we close another strong quarter, I want to once again thank our iRhythm employees around the world. Their execution has been very good, and our results are a direct reflection of their hard work. Our future has never been brighter, and our market continues to expand around us with many meaningful drivers.
好的,謝謝。在我們結束又一個強勁的季度之際,我想再次感謝全球的 iRhythm 員工。他們的執行表現非常出色,而我們的成果也直接反映了他們的辛勤付出。我們的未來從未如此光明;同時,我們所處的市場也在我們周遭持續擴張,並有許多重要的成長驅動因素。
As we enter our 20th year, I couldn't be more proud of the team, and I couldn't be more confident in the future that we will achieve together. Thanks for your time. I'll see you guys all soon. Take care.
在我們邁入第 20 個年頭之際,我對這個團隊感到無比自豪,也對我們將共同實現的未來充滿信心。感謝各位撥冗。很快再與各位見面。保重。
Operator
Operator
This concludes today's call. Thank you for attending. You may now disconnect.
今天的電話會議到此結束。感謝各位參與。您現在可以掛線。