iRhythm Technologies Inc (IRTC) 2023 Q4 法說會逐字稿

Good afternoon, and thank you for joining the iRhythm Technologies Q4 2023 earnings conference call. (Operator Instructions)

下午好，感謝您參加 iRhythm Technologies 2023 年第四季財報電話會議。（操作員說明）

I would now like to turn the call over to Stephanie Zhadkevich, Director of Investor Relations at iRhythm. You may proceed.

我現在想將電話轉給 iRhythm 投資者關係總監 Stephanie Zhadkevich。您可以繼續。

Thank you all for participating in today's call. Earlier today, iRhythm released financial results for the fourth quarter and full year ended December 31, 2023.

感謝大家參加今天的電話會議。今天早些時候，iRhythm 發布了截至 2023 年 12 月 31 日的第四季度和全年財務業績。

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.

在我們開始之前，我想提醒您，管理層將在本次電話會議期間發表聲明，其中包括根據 1995 年《私人證券訴訟改革法案》安全港條款聯邦證券法含義內的前瞻性聲明。

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.

本次電話會議中包含的任何非歷史事實陳述的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。

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. Accordingly, you should not place undue reliance on these statements.

這些陳述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陳述預期或暗示的結果或事件有重大差異。因此，您不應過度依賴這些陳述。

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 report on Form 10-K and Form 10-Q, respectively, filed with the Securities and Exchange Commission.

有關與我們業務相關的風險和不確定性的清單和描述，請參閱我們分別向美國證券交易委員會提交的表格 10-K 和表格 10-Q 的最新年度報告和季度報告的風險因素部分。

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 in isolation of, as a substitute for, or superior to results prepared in accordance with GAAP.

此外，在電話會議期間，我們將討論某些未根據美國公認會計準則針對我們的非公認會計準則和現金業績編制的財務指標，包括調整後的EBITDA、調整後的營運費用和調整後的淨虧損。除非另有說明，所有對財務指標的引用均以非公認會計原則為基礎。這些附加資訊的呈現不應被視為孤立、替代或優於根據 GAAP 準備的結果。

Please refer to the tables in our earnings release and 10-K for a reconciliation of these measures to their most directly comparable GAAP financial measures. Unless otherwise noted, all references to financial measures in this call, other than revenue, refer to non-GAAP results.

請參閱我們的收益報告和 10-K 中的表格，以了解這些指標與其最直接可比較的 GAAP 財務指標的對帳情況。除非另有說明，本次電話會議中所有提及的財務指標（除收入外）均指非 GAAP 業績。

This conference call contains time-sensitive information and is accurate only as of the live broadcast today, February 22, 2024. iRhythm disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise.

本次電話會議包含時間敏感信息，僅截至今天（2024 年 2 月 22 日）直播時準確。除法律要求外，iRhythm 不承擔任何更新或修改任何財務預測或前瞻性陳述的意圖或義務，無論是因為新資訊、未來事件還是其他原因。

And with that, I'll turn the call over to Quentin Blackford, iRhythm's President and CEO.

接下來，我會將電話轉給 iRhythm 總裁兼執行長 Quentin Blackford。

Thank you, Stephanie. Good afternoon, and thank you all for joining us. Brice Bobzien, our Chief Financial Officer; and Dan Wilson, our EVP of Corporate Development and Investor Relations, join me on today's call.

謝謝你，斯蒂芬妮。下午好，感謝大家加入我們。Brice Bobzien，我們的財務長；我們的企業發展和投資者關係執行副總裁 Dan Wilson 與我一起參加今天的電話會議。

My prepared remarks today cover business updates during the fourth quarter of 2023, as well as a 2024 outlook and initiatives. I'll then turn the call over to Brice to provide a detailed review of our fourth-quarter financial results and 2024 guidance.

我今天準備的演講涵蓋 2023 年第四季的業務更新以及 2024 年的展望和舉措。然後，我會將電話轉給 Brice，詳細審查我們的第四季財務業績和 2024 年指引。

You heard from us in January that 2023 was a transformational year for iRhythm on multiple fronts. We drove a banner year, reaccelerating our unit volume growth with a record number of new accounts, advanced our penetration into the primary care channel, introduced groundbreaking clinical evidence of superiority, continued market access traction, and opened our global business services center in the Philippines, all while introducing greater operational discipline across the organization and launching the most successful product in the history of our company in the Zio monitor.

您在一月份聽到我們說 2023 年對 iRhythm 來說是多方面轉型的一年。我們度過了輝煌的一年，以創紀錄的新客戶數量重新加速了我們的單位銷售增長，推進了對初級保健渠道的滲透，引入了突破性的優越性臨床證據，持續的市場准入牽引力，並在菲律賓開設了我們的全球商業服務中心，同時在整個組織中引入更嚴格的營運紀律，並在 Zio 監視器中推出了我們公司歷史上最成功的產品。

This fueled our performance in the fourth quarter that led to full-year revenue of $493 million or growth of 20% versus the prior year, in line with our long-range plan, exceeding the high end of our guidance range, and reflecting momentum across multiple channels. In the fourth quarter, we continued building upon the solid execution of the first nine months of 2023.

這推動了我們第四季度的業績，全年收入達到 4.93 億美元，比上年增長 20%，符合我們的長期計劃，超出了我們的指導範圍的上限，並反映了整個行業的勢頭多個渠道。第四季度，我們在 2023 年前 9 個月的紮實執行基礎上繼續前進。

We were pleased to see strong volume contributions from both new and existing accounts exiting the year. While nearly 70% of registration growth came from existing accounts, the fourth quarter was the second strongest quarter of new account openings in our history, setting up nicely as we move into 2024.

我們很高興看到今年退出的新帳戶和現有帳戶都貢獻了強勁的交易量。雖然近 70% 的註冊成長來自現有帳戶，但第四季度是我們歷史上新開戶數量第二強勁的季度，在進入 2024 年時表現良好。

The ease of use, accuracy, and simple workflow of Zio monitor and ZioSuite digital products is resonating within the primary care channel, which represented approximately 21% of total US Zio XT registrations during 2023, a figure that has grown consistently over the past few years and was driven by innovative PCP network account activations, as well as continued emphasis on our land-and-expand strategy within integrated health networks.

Zio 監視器和ZioSuite 數位產品的易用性、準確性和簡單的工作流程在初級保健管道中引起了共鳴，該管道在2023 年約占美國Zio XT 註冊總數的21%，這一數字在過去幾年中持續成長其推動力是創新的 PCP 網路帳戶激活，以及對綜合衛生網路內的土地擴張策略的持續重視。

Zio monitor, which launched last September, has also progressed faster than planned, now representing nearly 70% of registrations for our long-term continuous monitoring services. We believe the combination of the Zio monitor form factor with its smaller profile and high rate of patient compliance, as well as our refreshed MyZio app, has continued to contribute to an improved device return rate of approximately 0.5% thus far in our product launch cycle.

去年 9 月推出的 Zio Monitor 的進度也比計畫更快，目前占我們長期持續監控服務註冊量的近 70%。我們相信，Zio 顯示器外形尺寸較小、患者依從性高，加上我們更新的 MyZio 應用程序，將繼續有助於提高我們產品發布週期中迄今為止約 0.5% 的設備退貨率。

While in the early stages, Zio monitor has also improved the patient journey, resulting in fewer calls into our customer care teams from patients. In addition, we have seen that patients who are digitally engaged via the MyZio app have a much higher compliance rate, especially for home enrollment patients.

在早期階段，Zio Monitor 也改善了患者的旅程，從而減少了患者致電我們客戶服務團隊的次數。此外，我們還發現，透過 MyZio 應用程式進行數位參與的患者的依從率要高得多，特別是對於在家登記的患者。

As we continue to transition all in-clinic accounts to Zio monitor throughout the first half of 2024, we are excited to see how the largest launch in the history of our company could catalyze additional momentum in the business. To further improve clinician workflow efficiencies, to streamline access to Zio services, and to enable healthcare provider access to patients' electronic health information, we also remain committed to investments in the service aspects of our systems, such as electronic health record integration offerings.

隨著我們在 2024 年上半年繼續將所有診所內帳戶過渡到 Zio 監控，我們很高興看到我們公司歷史上最大規模的發布將如何促進業務的額外發展勢頭。為了進一步提高臨床醫生的工作流程效率，簡化對Zio 服務的訪問，並使醫療保健提供者能夠訪問患者的電子健康信息，我們還繼續致力於對我們系統的服務方面進行投資，例如電子健康記錄集成產品。

During 2023, we implemented new bi-directional EHR integrations across nearly 950 customer locations and have now received more than 1.5 million all-time registrations for Zio services through EHR-integrated accounts. EHR integrations are intended to allow for an administratively simpler process and integrate Zio into existing workflows of our customers and their staff.

2023 年，我們在近 950 個客戶地點實施了新的雙向 EHR 集成，目前已透過 EHR 集成帳戶收到了超過 150 萬個 Zio 服務註冊。EHR 整合旨在簡化管理流程，並將 Zio 整合到我們客戶及其員工的現有工作流程中。

By embedding the Zio experience into the native EHR platform of a health system or practice, these integrations allow streamlined access for ordering, document review, and billing, thereby enabling our customers and their staff to spend more time with patients throughout the care pathway.

透過將Zio 體驗嵌入到醫療系統或實踐的本地EHR 平台中，這些整合可以簡化訂購、文件審查和計費的訪問，使我們的客戶及其員工能夠在整個護理過程中將更多時間花在患者身上。

Moreover, we know from experience that EHR integration accelerates same-store growth, such as making Zio directly available to primary care and non-cardiology specialists. The operational efficiencies we can drive for our customers is a clear differentiator, as we expect to have more exciting announcements on this front as we move through 2024 and beyond.

此外，我們從經驗中得知，EHR 整合可加速同店成長，例如使 Zio 直接可供初級保健和非心臟病專家使用。我們可以為客戶提高營運效率，這是一個明顯的優勢，因為我們預計在 2024 年及以後在這方面會發布更多令人興奮的公告。

In our Zio AT business, we continue to work diligently and collaboratively with the FDA to remediate concerns noted in their warning letter to us last year. We have now submitted two 510(k) applications. One is a catch-up for changes previously made as letter to file to the Zio AT system before our receipt of the warning letter; and a second 510(k) to capture changes to design features and labeling updates following our interaction with the FDA.

在我們的 Zio AT 業務中，我們繼續與 FDA 勤奮合作，以糾正他們去年向我們發出的警告信中指出的問題。我們現已提交兩份 510(k) 申請。一是在我們收到警告信之前，對先前以信函形式向 Zio AT 系統提交的更改進行追趕；第二個 510(k) 用於捕捉我們與 FDA 互動後設計特徵和標籤更新的變化。

While we believe that our next-generation Zio MCT device will further strengthen our competitive positioning in this space, we still believe that there are meaningful market share gains to be made with our Zio AT product compared to the approximate 7% penetration that we currently hold in the mobile cardiac telemetry category. In the MCT category, we estimate that every 10 points of share gain represents roughly $80 million to $100 million of incremental revenue to iRhythm, a significant opportunity for growth as we aim to deliver on our $1 billion revenue target in our long-range plan.

雖然我們相信我們的下一代 Zio MCT 設備將進一步加強我們在該領域的競爭地位，但我們仍然相信，與我們目前約 7% 的滲透率相比，我們的 Zio AT 產品將獲得有意義的市場份額在移動心臟遙測類別中。在MCT 類別中，我們估計每10 個百分點的份額成長代表iRhythm 約8,000 萬至1 億美元的增量收入，這是一個重要的成長機會，因為我們的目標是實現長期計畫中10 億美元的收入目標。

As we continue to progress our product innovation roadmap, we have also continued to build upon our substantial body of clinical evidence with strong fourth-quarter publication output in top-tier medical journals and at conferences. The mSToPs cost effectiveness data was published in November 2023 and demonstrated that proactive monitoring for atrial fibrillation in an at-risk population with the iRhythm Zio XT patch, provided high value from a health economic perspective.

在我們繼續推進產品創新路線圖的同時，我們也繼續以大量臨床證據為基礎，在頂級醫學期刊和會議上第四季度發表了強勁的出版物。mSTOPs 成本效益數據於 2023 年 11 月發布，顯示從健康經濟角度來看，使用 iRhythm Zio XT 貼片對高危險群主動監測心房顫動具有很高的價值。

The CAMELOT study, which has been part of our commercial narrative for much of 2023, was published in the American Heart Journal in December. The manuscript, with independent statistical analysis, extends the initial findings in several ways.

CAMELOT 研究已於 2023 年大部分時間成為我們商業敘述的一部分，並於 12 月發表在《美國心臟雜誌》上。手稿透過獨立的統計分析，以多種方式擴展了最初的發現。

One, it shows Zio's long-term cardiac monitor superiority for highest odds of arrhythmia-encountered diagnosis and lowest odds of retesting not only across different categories of monitoring, such as Holter and event recorders, but directly against specific competitor products and services. And two, it showcases Zio's long-term cardiac monitor performance and clinical superiority for specific critical arrhythmias, such as heart block and ventricular tachycardia, which can have major clinical consequences if missed.

第一，它顯示了Zio 的長期心臟監測儀在心律不整診斷幾率最高和重新測試幾率最低方面的優勢，不僅在不同的監測類別（如動態心電圖和事件記錄儀）上，而且直接針對特定的競爭對手產品和服務。第二，它展示了 Zio 的長期心臟監視器性能以及針對特定嚴重心律不整（例如心臟傳導阻滯和室性心動過速）的臨床優勢，如果漏診，可能會產生重大臨床後果。

This peer-reviewed publication continues the long history of evidence that the Zio long-term continuous monitoring service provides high value and performance, with the highest diagnostic yield and lowest likelihood of retesting across a wide range of ambulatory cardiac monitoring services.

這份經過同行評審的出版物延續了悠久的證據，證明 Zio 長期連續監測服務提供高價值和性能，在各種動態心臟監測服務中具有最高的診斷率和最低的重新測試可能性。

We also continue to make strides in AI. The December publication in Nature Digital Medicine by the Scripps Research Translational Institute, in collaboration with our team, demonstrated the performance of developed AI to identify patients at risk of near-term AFib based on patients who had no AFib on their initial Zio patch. This early work could help identify which patients should have repeat testing.

我們在人工智慧方面也持續取得進展。史克里普斯研究轉化研究所與我們的團隊合作在《自然數位醫學》雜誌上發表的12 月文章展示了開發的人工智慧的性能，可以根據最初Zio 貼片上沒有出現AFib 的患者來識別有近期AFib 風險的患者。這項早期工作可以幫助確定哪些患者應該進行重複檢測。

Additionally, research from our collaboration with the Duke Clinical Research Institute, presented at November's American Heart Association meeting, demonstrated the ability to more robustly predict heart failure hospitalization when adding Zio ECG features to existing clinical risk models.

此外，我們與杜克臨床研究所合作的研究成果在11 月的美國心臟協會會議上發表，該研究表明，將Zio ECG 功能添加到現有臨床風險模型中時，能夠更穩健地預測心臟衰竭住院情況。

Both studies advance our thesis that 14 days of continuous uninterrupted Zio monitoring has valuable biometric information that can classify and predict conditions or risks well beyond the arrhythmias we diagnose with ECG monitoring today. These insights demonstrate feasibility of adjacent market opportunities and validate our ability to provide novel insights through our platform for future value creation.

這兩項研究都推進了我們的論點，即14 天連續不間斷的Zio 監測具有有價值的生物識別信息，可以對病情或風險進行分類和預測，遠遠超出我們今天通過心電圖監測診斷的心律失常。這些見解證明了鄰近市場機會的可行性，並驗證了我們透過我們的平台為未來價值創造提供新穎見解的能力。

These are also being proven from a business model perspective by our teams. We were excited to see our first Know Your Rhythm pilot launch this quarter, aimed at identifying arrhythmias in asymptomatic populations. And while early, we are seeing very encouraging data supportive of the value proposition.

我們的團隊也從商業模式的角度證明了這些。我們很高興看到本季推出第一個「了解你的節律」試點項目，旨在識別無症狀人群的心律不整。儘管還處於早期階段，我們還是看到了支持這一價值主張的非常令人鼓舞的數據。

Similarly, we are seeing several national primary care networks employing proactive screening approaches with targeted populations, aimed at finding arrhythmias sooner and avoiding the devastating downstream cost of care that come from patients unaware of existing arrhythmias.

同樣，我們看到幾個國家初級保健網絡對目標人群採用主動篩檢方法，旨在更快地發現心律失常，並避免因不知道現有心律失常的患者而產生的毀滅性下游護理成本。

iRhythm is uniquely well positioned to address the macro shift in healthcare towards value-based care for an aging population, as cardiac monitoring with Zio adds value to all five objectives of the quintuple aim of healthcare. We look forward to sharing more details on these initiatives as they progress.

iRhythm 具有獨特的優勢，可以解決醫療保健向老齡化人口基於價值的護理的宏觀轉變，因為 Zio 心臟監測為醫療保健五重目標的所有五個目標增加了價值。我們期待隨著這些舉措的進展分享更多細節。

We also expect to be launching our very first pilot into the sleep space in the coming months. With deep relationships with cardiologists, electrophysiologists, and primary care physicians, as well as our experience with remote diagnostic services, iRhythm is well positioned to validate our belief that there is a need for a streamlined diagnostic pathway into what we have heard can feel like a fragmented and disjointed sleep diagnostic journey for both patients and clinicians.

我們也預計在未來幾個月內將我們的第一個試點項目引入睡眠空間。憑藉與心臟病專家、電生理學家和初級保健醫生的深厚關係，以及我們在遠端診斷服務方面的經驗，iRhythm 能夠很好地驗證我們的信念，即需要一個簡化的診斷途徑來實現我們所聽到的感覺對於患者和臨床醫生來說，這是一條支離破碎、脫節的睡眠診斷之旅。

Today, the process of referring a patient to a sleep specialist, prescribing a sleep lab, or a home sleep test, all the way through to a formal diagnosis, can be a cumbersome experience. Our initial pilot will be aimed at exploring the value of a process from the ordering of a sleep test to the delivery of the interpreted results and diagnostic report to the prescribing physician via a streamlined integration with a single portal, such as our ZioSuite platform. We see sleep as an important adjacent market and have multiple initiatives in place to explore how we can bring our innovative capabilities into this space for the benefit of clinicians and patients.

如今，將患者轉診給睡眠專家、開立睡眠實驗室處方或家庭睡眠測試，一直到正式診斷的過程可能會很麻煩。我們最初的試點旨在探索從訂購睡眠測試到透過與單一入口網站（例如我們的 ZioSuite 平台）的簡化整合向處方醫生提供解釋結果和診斷報告的過程的價值。我們將睡眠視為一個重要的鄰近市場，並採取了多項措施來探索如何將我們的創新能力帶入這一領域，以造福臨床醫生和患者。

Turning towards our international efforts, we were thrilled to have received CE mark under European Union Medical Device Regulation or EU MDR for Zio monitor and the ZEUS system at the end of 2023. This marks the jumping-off point to introduce our innovative technology into more European markets and enable further global expansion.

談到我們的國際努力，我們很高興在 2023 年底為 Zio 監視器和 ZEUS 系統獲得了歐盟醫療器材法規或歐盟 MDR 規定的 CE 標誌。這標誌著將我們的創新技術引入更多歐洲市場並實現進一步全球擴張的起點。

Importantly, the EU MDR is arguably one of the most stringent regulatory frameworks for product approvals globally. And receipt of this certification demonstrates our commitment to providing the highest-quality products and services. With CE mark in hand, we are continuing market access evaluation and market expansion efforts in prioritized countries across Europe, including four countries targeted for entry in 2024, where there are approximately 800,000 ambulatory cardiac monitoring tests performed annually.

重要的是，歐盟 MDR 可以說是全球最嚴格的產品審批監管框架之一。獲得此認證表示我們致力於提供最優質的產品和服務。有了 CE 標誌，我們將繼續在歐洲優先國家進行市場准入評估和市場擴張工作，其中包括計劃於 2024 年進入的四個國家，這些國家每年進行約 800,000 次動態心臟監測測試。

In preparation for these launches, our market access teams have been hard at work with various countries on our roadmap. And encouragingly, Switzerland has just released an updated national reimbursement decision for long-term ECG examinations in excess of CHF1,000.

為了準備這些發布，我們的市場准入團隊一直在與各個國家/地區就我們的路線圖進行努力合作。令人鼓舞的是，瑞士剛剛發布了最新的國家報銷決定，對超過 1,000 瑞士法郎的長期心電圖檢查進行報銷。

We have also continued to pursue national reimbursement in the UK. As we continue to progress with the public health systems while we await a decision on national reimbursement by the National Health System, we continue to advance our efforts within the UK private payer sector that demonstrated significant growth in 2023.

我們也繼續在英國尋求國家報銷。在等待國家衛生系統就國家報銷做出決定的同時，我們繼續推進公共衛生系統的發展，同時我們繼續推動英國私人支付部門的努力，該部門在 2023 年實現了顯著增長。

Through The Artificial Intelligence in Health and Care Award from the NHS England in September 2020, real-world evaluation of Zio XT at scale across the NHS Trust has shown that Zio service has an overwhelmingly positive impact on patient waiting times, hospital resource utilization, clinical diagnostic yield, and pathway cost savings. We will continue to work through contracting at private UK sites where this message is clearly resonating.

透過2020 年9 月英國NHS 頒發的健康與護理人工智慧獎，NHS 信託基金對Zio XT 進行的大規模實際評估表明，Zio 服務對患者等待時間、醫院資源利用率、臨床治療等方面產生了壓倒性的正面影響。診斷率和途徑成本節省。我們將繼續透過與英國私人網站簽訂合約來開展工作，這些資訊顯然在這些網站上引起了共鳴。

In Japan, we continue to be excited about the upcoming entry into the second largest cardiac monitoring market in the world, with approximately 1.5 million ACM tests being prescribed per year. Recall that we received a high medical needs designation from the Japanese MHLW last year. And it is important to note that this designation is not specific to long-term patching but is instead specific to Zio.

在日本，我們仍然對即將進入世界第二大心臟監測市場感到興奮，每年約有 150 萬次 ACM 測試。回想一下，我們去年獲得了日本厚生勞動省的高醫療需求指定。值得注意的是，這個名稱並不是專門針對長期補丁的，而是專門針對 Zio 的。

This designation, at the recommendation of the Japanese Heart Rhythm Society, has created significant interest with potential commercial partners. And we are pleased that after thorough search, we have identified our distribution partner for Zio in Japan. We are actively collaborating with them to prepare for the launch in early 2025, while we continue to engage with the Japanese PMDA on a regulatory dossier in parallel.

在日本心律協會的推薦下，這項指定引起了潛在商業夥伴的濃厚興趣。我們很高興經過徹底的搜索，我們找到了 Zio 在日本的分銷合作夥伴。我們正在積極與他們合作，為 2025 年初的推出做準備，同時我們繼續與日本 PMDA 就監管檔案進行接觸。

Lastly, but very importantly, we are committed to continue driving operational efficiency and financial sustainability through an intense focus on organizational discipline, as we work towards achieving our adjusted EBITDA targets stated in our long-range plan. While there is still work to do to achieve the 15% adjusted EBITDA margin goal we set for ourselves for 2027, I have been pleased by our ability to drive 1,000 basis points of improvement over the past two years.

最後但非常重要的是，我們致力於透過高度關注組織紀律，繼續提高營運效率和財務可持續性，努力實現長期計劃中規定的調整後 EBITDA 目標。雖然要實現我們為自己設定的 2027 年 15% 調整後 EBITDA 利潤率目標仍有工作要做，但我對我們在過去兩年中推動 1,000 個基點的改進的能力感到高興。

The performance of the newly minted global business services center in Manila has exceeded our expectations thus far. And the process excellence this group has driven will be a key enabler for the global growth towards which we are striving in the years to come.

迄今為止，馬尼拉新成立的全球商業服務中心的表現超出了我們的預期。該團隊推動的卓越流程將成為我們未來幾年努力實現的全球成長的關鍵推動力。

Additionally, within the first half of 2024, we anticipate implementing automation in our production lines for Zio monitor, that will drive scale, reduce our cost to manufacture, and serve as the basis for our next-generation Zio MCT platform. We are excited about these initiatives and others that continue to create leverage throughout our P&L. And we are energized to drive programs that will allow us to serve more patients more efficiently around the globe.

此外，我們預計在 2024 年上半年在 Zio 顯示器生產線中實現自動化，這將擴大規模，降低製造成本，並作為我們下一代 Zio MCT 平台的基礎。我們對這些舉措以及其他繼續在我們的損益表中創造影響力的舉措感到興奮。我們充滿活力地推動項目，使我們能夠更有效地為全球更多患者提供服務。

With that, I'll now turn the call over to Brice to discuss our recent financial performance.

現在，我將把電話轉給 Brice，討論我們最近的財務表現。

Thanks, Quentin. As a reminder, unless otherwise noted, the financial metrics that I'd discuss 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.

謝謝，昆汀。提醒一下，除非另有說明，否則我今天討論的財務指標將在非公認會計原則的基礎上呈現。您可以在今天的收益報告和我們的投資者關係網站上找到 GAAP 的調整表。

Fourth-quarter 2023 results demonstrated continued strength in our core markets, as revenue grew to $132.5 million, representing 6% sequential and 18% year-over-year growth. As Quentin mentioned, this was driven by strong volumes from new accounts opened in the prior 12 months, continued penetration of existing accounts, and reduced account churn.

2023 年第四季的業績顯示我們的核心市場持續強勁，營收成長至 1.325 億美元，季增 6%，較去年同期成長 18%。正如 Quentin 所提到的，這是由於過去 12 個月新開帳戶的強勁數量、現有帳戶的持續滲透以及帳戶流失的減少所推動的。

New store/same store mix, with new store defined as accounts that have been open for less than 12 months, accounted for approximately 34% of our year-over-year volume growth. Home enrollment for Zio services was approximately 21% of volume in the fourth quarter. Average selling prices during the fourth quarter were down approximately 400 basis points year over year and down slightly quarter over quarter.

新店/同店組合（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 34%。第四季 Zio 服務的家庭註冊量約佔數量的 21%。第四季平均售價年減約 400 個基點，較上季略有下降。

Moving down the rest of the P&L, gross margin for the fourth quarter was 66% and for the full-year 2023 was 67.3%. As previously discussed, we expected temporary gross margin pressure in the back half of 2023, primarily driven by costs associated with the transition from Zio XT to the new Zio monitor. We continue to see positive marketplace reaction to Zio monitor.

向下移動損益表的其餘部分，第四季的毛利率為 66%，2023 年全年毛利率為 67.3%。如前所述，我們預計 2023 年下半年將出現暫時的毛利率壓力，這主要是由從 Zio XT 過渡到新 Zio 顯示器相關的成本所驅動的。我們繼續看到市場對 Zio 監視器的積極反應。

This has resulted in a faster than anticipated transition from Zio XT and has created near-term pressure on the gross margin due to the accelerated recognition of costs for our legacy XT components. This accelerated transition does not yet have the benefit of automation and scale, which resulted in an increased cost per unit. We believe that this will be mitigated once automation lines for Zio monitor are implemented.

這導致 Zio XT 的過渡速度快於預期，並且由於我們對傳統 XT 組件成本的加速認識，對毛利率造成了短期壓力。這種加速轉型尚未帶來自動化和規模化的好處，導致單位成本增加。我們相信，一旦 Zio 監視器的自動化生產線投入使用，這種情況將會得到緩解。

Finally, we completed the current phase of building our center of excellence in our San Francisco IDTF in the fourth quarter. We've incurred costs related to scaling and training newly onboarded clinical cardiac technicians that resulted in inefficiencies in the short term.

最後，我們在第四季度完成了舊金山 IDTF 卓越中心建設的當前階段。我們產生了與擴展和培訓新入職的臨床心臟技術人員相關的成本，導致短期內效率低下。

These investments were important to ensure the quality of our services provided to our patients. And we expect the associated costs to abate as the team come up to speed over the next couple quarters.

這些投資對於確保我們為患者提供的服務品質非常重要。我們預計，隨著團隊在接下來的幾季加快步伐，相關成本將會減少。

Fourth-quarter adjusted operating expenses were $113.8 million, up 6.2% sequentially and 17.2% year over year. Full-year adjusted operating expenses were $430 million, up 18.2% compared to 2022.

第四季調整後營運費用為 1.138 億美元，季增 6.2%，年增 17.2%。全年調整後營運費用為 4.3 億美元，較 2022 年成長 18.2%。

Sequentially, the increased spend was driven by legal, regulatory, and professional fees. Compared to the fourth-quarter 2022, this increase in adjusted operating expenses was primarily due to increased personnel to scale operations, as well as the previously mentioned professional fees.

隨後，支出的增加是由法律、監管和專業費用所推動的。與 2022 年第四季相比，調整後營運費用的增加主要是由於擴大營運規模所需的人員增加以及前面提到的專業費用。

During 2023, we incurred approximately $9 million of legal and consulting fees, as well as other company expenses related to the FDA warning letter and DOJ subpoena. Despite these temporary expenses and rolling out the most significant product launch in the company's history, we were able to drive 120-basis-point improvement in adjusted operating expenses as a percentage of revenue.

2023 年，我們產生了約 900 萬美元的法律和諮詢費用，以及與 FDA 警告信和 DOJ 傳票相關的其他公司費用。儘管有這些臨時費用並推出了公司歷史上最重要的產品，我們仍然能夠推動調整後的營運費用佔收入的百分比提高 120 個基點。

Adjusted net loss in the fourth quarter was approximately $25.8 million or a loss of $0.84 per share, compared to an adjusted net loss of $17.9 million or an adjusted net loss of $0.59 per share in the fourth quarter of 2022. Adjusted net loss for the full-year 2023 was approximately $96.5 million or $3.16 per share, compared to an adjusted net loss of $84.5 million or a loss of $2.82 per share during 2022.

第四季調整後淨虧損約 2,580 萬美元，即每股虧損 0.84 美元，而 2022 年第四季調整後淨虧損為 1,790 萬美元，即每股虧損 0.59 美元。2023 年全年調整後淨虧損約 9,650 萬美元，即每股虧損 3.16 美元，而 2022 年調整後淨虧損為 8,450 萬美元，即每股虧損 2.82 美元。

Fourth-quarter 2023 business transformation costs were $1.8 million, bringing full-year 2023 business transformation costs to $15.9 million, in line with guidance as we finalize the transition to our global business services center. Additionally, we recorded an impairment charge of $11.1 million, related to the capitalized value of our San Francisco office, as a result of the continued declining commercial real estate market conditions within San Francisco.

2023 年第四季業務轉型成本為 180 萬美元，使 2023 年全年業務轉型成本達到 1,590 萬美元，符合我們完成向全球業務服務中心過渡時的指導。此外，由於舊金山商業房地產市場狀況持續下滑，我們記錄了與舊金山辦事處資本價值相關的 1,110 萬美元減損費用。

Adjusted EBITDA in the fourth-quarter 2023 was $2.4 million, reflecting an increase of $2 million sequentially and an increase of $1.3 million year over year. Adjusted EBITDA for the full-year 2023 was minus $4.9 million, representing 180-basis-point improvement to adjusted EBITDA margin compared to 2022. Absent the expenses related to legal and advisory fees, as well as other company expenses associated with the FDA warning letter and DOJ subpoena, adjusted EBITDA margin would have been approximately 0.8%.

2023 年第四季調整後 EBITDA 為 240 萬美元，季增 200 萬美元，年增 130 萬美元。2023 年全年調整後 EBITDA 為負 490 萬美元，與 2022 年相比，調整後 EBITDA 利潤率提高了 180 個基點。如果沒有與法律和諮詢費相關的費用，以及與 FDA 警告信和 DOJ 傳票相關的其他公司費用，調整後的 EBITDA 利潤率約為 0.8%。

Turning to guidance, we are reiterating our 2024 outlook as presented earlier this year and anticipate full-year revenue of approximately $575 million to $585 million, driven predominantly by volume growth in our core markets. As we think about the first quarter, we did see weather-related impacts in January. However, we've seen registrations rebound nicely thus far in February.

談到指導，我們重申了今年稍早提出的 2024 年展望，預計全年營收約為 5.75 億至 5.85 億美元，主要由我們核心市場的銷售成長推動。當我們思考第一季時，我們確實在一月份看到了與天氣相關的影響。然而，到目前為止，我們已經看到二月的註冊量出現了良好的反彈。

We believe that the first-quarter revenue trend will be closer to 22% of full-year revenues, considering weather-related impacts in January of approximately $1 million to $2 million. Excluding this, we would have expected to see first-quarter 2024 in line with historical averages at approximately 22.5%.

考慮到 1 月份天氣相關影響約為 100 萬至 200 萬美元，我們認為第一季收入趨勢將接近全年收入的 22%。如果排除這一點，我們預計 2024 年第一季的成長率將與歷史平均值保持一致，約為 22.5%。

Turning to gross margin, we are providing full-year 2024 gross margin guidance in the range of 68% to 69%, an improvement of approximately 120 basis points at midpoint. During the first half of 2024, we anticipate continued direct and indirect costs from the transition to Zio monitor, natural inefficiencies from the implementation of automation to produce Zio monitor at scale, and the optimization of our center of excellence in San Francisco.

談到毛利率，我們提供的 2024 年全年毛利率指引為 68% 至 69%，中位數提高約 120 個基點。在 2024 年上半年，我們預計過渡到 Zio 監視器會產生持續的直接和間接成本，實施自動化以大規模生產 Zio 監視器會導致自然效率低下，以及優化我們位於舊金山的卓越中心。

We expect the first half to be relatively consistent with the 2023 gross margin exit rate. In the back half of the year, however, we anticipate an improvement in gross margin due to the majority of our business being transitioned to the new Zio monitor platform, initial ramp of automation lines to produce Zio monitor, and our clinical operations team in San Francisco operating at full capacity.

我們預期上半年與2023年毛利率退出率相對一致。然而，在今年下半年，我們預計毛利率將有所改善，因為我們的大部分業務已過渡到新的 Zio 監視器平台、生產 Zio 監視器的自動化生產線的初步提升以及我們在聖保羅的臨床營運團隊弗朗西斯科滿載運轉。

For 2024, we anticipate adjusted EBITDA margin to range between 3% and 4% of revenues, which would represent a 400-basis-point to 500-basis-point improvement compared to 2023, in line with our stated path to adjusted EBITDA targets in 2027 and driven by our focus on sustainable operating leverage improvements throughout the P&L. As a reminder, adjusted EBITDA will continue to exclude impairment and restructuring costs, business transformation costs, and stock-based compensation expenses.

對於 2024 年，我們預計調整後 EBITDA 利潤率將在營收的 3% 至 4% 之間，這將比 2023 年提高 400 個基點至 500 個基點，符合我們在 2020 年調整後 EBITDA 目標的既定路徑。 2027 年，我們專注於整個損益表中永續營運槓桿的改進。需要提醒的是，調整後的 EBITDA 將繼續不包括減損和重組成本、業務轉型成本和股票補償費用。

We have contemplated in our adjusted EBITDA guidance approximately $8 million to $10 million of legal, consulting, and other company expenses in 2024, as we continue to remediate findings associated with the FDA warning letter and navigate responses to the DOJ subpoena. As we make progress on these two issues, the vast majority of these costs will come out of the P&L in the future.

隨著我們繼續糾正與 FDA 警告信相關的調查結果並引導對 DOJ 傳票的回應，我們在調整後的 EBITDA 指導中考慮了 2024 年約 800 萬至 1000 萬美元的法律、諮詢和其他公司費用。隨著我們在這兩個問題上取得進展，未來這些成本的絕大多數將來自損益表。

Finally, we ended 2023 in a strong financial position, with approximately $133.8 million of cash and short-term investments. As you're aware, we improved our capital position at the beginning of 2024, with the introduction of financing with Braidwell to mature our capital structure ahead of our next phase of growth.

最後，我們在 2023 年結束時財務狀況強勁，擁有約 1.338 億美元的現金和短期投資。如您所知，我們在 2024 年初改善了我們的資本狀況，引入了 Braidwell 融資，以在下一階段的增長之前完善我們的資本結構。

As a reminder, year-end cash and short-term investments balance does not include the repayment of $35 million to Silicon Valley Bank or the $75 million term loan drawn down from Braidwell at the beginning of 2024. As we continue to grow and mature, we will evaluate our capital structure to ensure financial flexibility in alignment with shareholder interests.

需要提醒的是，年終現金和短期投資餘額不包括向矽谷銀行償還的 3,500 萬美元或 2024 年初從 Braidwell 提取的 7,500 萬美元定期貸款。隨著我們不斷成長和成熟，我們將評估我們的資本結構，以確保財務靈活性與股東利益保持一致。

With that, I'd like to turn it back to Quentin before we open it up for questions.

在我們開始提問之前，我想把它轉回給昆汀。

Thanks, Brice. Looking into 2024, we couldn't be more excited about the position that we are in. We have multiple levers for revenue growth as we continue to go deeper and broader within our existing accounts, with our land-and-expand strategy, capitalize on the significant pipeline of new accounts waiting to come on board, and rapidly expanding in the primary care channel.

謝謝，布萊斯。展望 2024 年，我們對目前的處境感到無比興奮。隨著我們繼續在現有客戶範圍內深入和擴大，透過我們的土地擴張策略，利用大量等待加入的新客戶，並在初級保健領域迅速擴張，我們擁有多種收入成長槓桿管道。

Furthermore, we're in the early innings with our international business, which we expect will contribute nearly a point of growth in 2024. We're in the very early stages of value being realized in proactive screening of at-risk patients and the significant workflow efficiencies that can be enabled by our products and services, which has the potential to multiply the current market we serve.

此外，我們的國際業務正處於早期階段，我們預計該業務將在 2024 年貢獻近一個百分點的成長。我們正處於主動篩選高風險患者以及透過我們的產品和服務實現顯著工作流程效率方面實現價值的早期階段，這有可能擴大我們目前服務的市場。

As a reminder, nearly 15 million patients show up in their primary care physician offices each year with heart palpitations noted in their medical records. Zio has the potential to provide the right answer, the first time for those patients, and better inform the care pathways for those individuals, potentially reducing downstream clinical events, while lowering the future cost of care and addressing the growing capacity challenges within the health networks we serve.

提醒一下，每年有近 1500 萬名患者出現在初級保健醫生辦公室，其病歷中記錄有心悸。Zio 有潛力在第一時間為這些患者提供正確的答案，並更好地為這些患者提供護理途徑，從而有可能減少下游臨床事件，同時降低未來的護理成本並解決衛生網絡內日益增長的能力挑戰我們服務。

And importantly, we see a clear line of sight to deliver an increase of 400 basis points to 500 basis points in our adjusted EBITDA margin, a meaningful improvement in our profitability profile. Long term, we are building the cardiac monitoring product and services portfolio of the future. And we are uniquely positioned to address the quintuple aim of health care within ACM.

重要的是，我們看到了一個明確的目標，即調整後的 EBITDA 利潤率將增加 400 個基點至 500 個基點，這對我們的獲利狀況來說是一個有意義的改善。從長遠來看，我們正在建立未來的心臟監測產品和服務組合。我們擁有獨特的優勢來實現 ACM 醫療保健的五重目標。

With significant accomplishments in 2023 and so many opportunities in the months and years ahead, I could not be more excited for our future at iRhythm. With that, Brice, Dan, and I would like to now open the call for questions. Operator?

憑藉 2023 年取得的重大成就以及未來數月乃至數年的眾多機會，我對 iRhythm 的未來感到無比興奮。布萊斯、丹和我現在想開始提問。操作員？

(Operator Instructions) Allen Gong, JPMorgan.

（操作員指令）Allen Kong，摩根大通。

Thanks for the question. Just to start off, I had one on the guidance for the year. You're reiterating the full year, but you're talking to some weather-related headwinds in first quarter.

謝謝你的提問。首先，我有一個關於今年的指導。您重申了全年的情況，但談到了第一季與天氣相關的一些不利因素。

So when I think about the fact that you're taking a couple -- $1 million to $2 million out of first quarter by reiterating the guide, could we think about that as a recapture dynamic, with those sales being pushed out to maybe second quarter? Or are you just seeing stronger momentum in February so far that you're expecting to continue through the balance of the year?

因此，當我想到透過重申該指南，您將在第一季度獲得100 萬至200 萬美元的收入這一事實時，我們是否可以將其視為一種重新奪回動力，而這些銷售可能會被推遲到第二季？或者您只是在 2 月看到了迄今為止更強勁的勢頭，您預計這一勢頭將持續到今年剩餘時間？

Hey, Allen, good question. Yeah. We did see a bit of pressure in the month of January. However, recovery has been incredibly nice in February.

嘿，艾倫，好問題。是的。一月份我們確實看到了一些壓力。然而，二月份的恢復情況非常好。

And so we're thinking more of it as a recapture as we get into the later periods of the year. And for us, there's no reason to adjust for those weather-related impacts, especially with the beat we had in Q4. So we felt like reiterating was the appropriate result in this situation.

因此，當我們進入今年下半年時，我們更多地將其視為一種重新捕獲。對我們來說，沒有理由對這些與天氣相關的影響進行調整，尤其是考慮到我們在第四季的表現。因此，我們認為在這種情況下重申是適當的結果。

And keep in mind, Allen, those registration volumes have improved really nicely over the course of February and have come together well. With our revenue recognition model, those devices go out.

艾倫，請記住，二月的註冊量確實有了很大的提高，並且整合得很好。透過我們的收入確認模型，這些設備就會被淘汰。

They've got to come back to us before we can recognize that revenue as we process the report. So there ends up being a bit of timing there in the strength that we saw back in February.

他們必須回到我們身邊，然後我們才能在處理報告時確認收入。因此，我們在二月看到的強勁勢頭最終出現了一些時機。

Got it. And then just as a quick follow-up, gross margins this quarter, I think, relative to your expectations, came in a little bit disappointing, as you're transitioning to Zio monitor and continuing to invest back into the business.

知道了。然後，作為快速跟進，我認為，相對於您的預期，本季的毛利率有點​​令人失望，因為您正在過渡到 Zio 監視器並繼續投資回業務。

When we think about, not just 2024, but also 2025, with international coming on to the stage, how should we think about international's impact on gross margin? What should we think about that as maybe adding a little bit of further pressure, potentially offset by MCT coming on to the same platform? Just how to think about your gross margin progression beyond 2024? Thank you.

當我們思考，不僅是2024年，也是2025年，隨著國際化的登場，我們該如何思考國際化對毛利率的影響？我們應該如何看待這可能會增加一點進一步的壓力，並可能被進入同一平台的 MCT 所抵消？如何看待 2024 年後的毛利率進展？謝謝。

Yeah, Allen, and -- this is Quentin here. But when we think about the pressure in the fourth quarter -- and Brice can speak a bit more to it -- obviously, you had a bit of pressure coming from the transition from XT onto monitor, which is moving faster than what we had anticipated and ultimately, a good thing for us. Because we know monitor has a better gross margin profile, particularly after we get automation put in place.

是的，艾倫，還有──這是昆汀。但當我們想到第四季度的壓力時——Brice 可以多說一點——顯然，從 XT 到顯示器的過渡帶來了一些壓力，這比我們預期的要快最終，這對我們來說是一件好事。因為我們知道顯示器具有更好的毛利率，特別是在我們實施自動化之後。

But we also had tremendous progress made in the fourth quarter with our hiring efforts to build out our center of excellence in San Francisco, hiring well over 100 people in the fourth quarter, which is far in excess of the pace we had been able to achieve through the first nine months of the year.

但我們在第四季度也取得了巨大進展，我們在舊金山建立卓越中心的招聘工作也取得了巨大進展，第四季度招聘了 100 多名員工，這遠遠超過了我們能夠實現的速度今年的前九個月。

And so when we saw that opportunity in the fourth quarter with the hiring momentum, we didn't want to relent on that. Because that opens up the ability into the future to continue to build out the center of excellence in San Francisco, which has a nice benefit to it. So the right investment decisions certainly being made within the fourth quarter.

因此，當我們在第四季度看到招募勢頭帶來的機會時，我們不想放棄這一點。因為這開啟了未來繼續在舊金山建立卓越中心的能力，這對它有很大的好處。因此，正確的投資決策肯定會在第四季內做出。

Longer term though, to your point on international, I actually think with the countries that we have on the roadmap, they should be accretive to the gross margin profile. Obviously, it depends on where reimbursement comes in.

但從長遠來看，就您關於國際的觀點而言，我實際上認為，對於我們路線圖上的國家，它們應該會增加毛利率。顯然，這取決於報銷的來源。

But if you think about Switzerland, which just approved reimbursement at north of a CHF1,000, which is more than a USD1,000 per ACM test, that's going to contribute a nice gross margin profile for us. Japan pricing's yet to be set. But we know they generally use a reference pricing model with the UK and the US and in other countries. And so that ought to be a pretty attractive price point as well that we're looking forward to.

但如果你考慮一下瑞士，它剛剛批准了 1,000 瑞士法郎以上的報銷，這比每次 ACM 測試超過 1,000 美元，這將為我們貢獻一個不錯的毛利率。日本定價尚未確定。但我們知道他們通常使用英國、美國和其他國家的參考定價模型。因此，這應該是一個非常有吸引力的價格點，也是我們所期待的。

So I think that it can be accretive over the planning horizon. We'll continue to evaluate that. And as we go broader into other markets, we'll have to look at each one on a one-off basis. But I do think that international can contribute nicely to the gross margin profile over time.

所以我認為它可以在規劃範圍內發揮作用。我們將繼續對此進行評估。當我們更廣泛地進入其他市場時，我們必須一次性地審視每個市場。但我確實認為，隨著時間的推移，國際業務可以對毛利率做出巨大貢獻。

And then to your point, Zio MCT, when we get it onto the monitor platform, is going to bring with us some nice benefits that we aren't realizing today. So again, feel good about where the gross margin is progressing towards and the line of sight we have to get into that low-to-mid 70s profile that we put out there with the long-range plan. There was a bit of noise in the fourth quarter. But those were primarily investments made to set us up for the long term.

然後就您的觀點而言，當我們將 Zio MCT 放到監控平台上時，它將為我們帶來一些我們今天尚未意識到的好處。因此，再次對毛利率的進展以及我們必須進入 70 年代中低水平的視線感到滿意，這是我們在長期計劃中提出的。第四節出現了一些噪音。但這些主要是為我們的長期發展所做的投資。

David Saxon, Needham.

大衛‧撒克遜，李約瑟。

Great. Thanks. Good afternoon. Thanks for taking my questions. Maybe I'll start with Brice. So the OpEx in '23 was, I guess, 18% growth year on year.

偉大的。謝謝。午安.感謝您回答我的問題。也許我會從布萊斯開始。因此，我認為 23 年的營運支出年增了 18%。

But by my math, the guidance is implying mid-single-digit OpEx growth in '24. So I guess, is that the duplicative cost kind of rolling out of the model, or what's really driving that leverage?

但根據我的計算，該指導意味著 24 年營運支出將實現中個位數成長。所以我想，這是模型推出的重複成本，還是真正推動這種槓桿作用的因素？

Yeah. So as I think about it, David, it's not quite that low as you're talking about. Remember, in 2023, we had business transformation-related costs. But we also had some of those -- the one-time item with regards to the impairment of the right-of-use asset in San Francisco.

是的。所以我想，大衛，它並不像你所說的那麼低。請記住，在 2023 年，我們有與業務轉型相關的成本。但我們也有一些——關於舊金山使用權資產減損的一次性項目。

Those two will not repeat. They're not out there. But when you look at what we call adjusted operating expenses, it's more in that 15% or so range.

這兩個就不再重複了。他們不在那裡。但當你看看我們所說的調整後營運費用時，你會發現它更多地在 15% 左右的範圍內。

There's about 250 basis points of OpEx leverage baked into the guidance range as it stands. And a lot of that leverage is coming from that global business services center that we stood up in Manila. And we're starting to see the benefits.

目前的指導範圍內約有 250 個基點的營運支出槓桿。其中很大一部分影響力來自我們在馬尼拉設立的全球商業服務中心。我們開始看到好處。

I will tell you, this is phase one of the benefits you can ultimately see from this. And that's on top of investments we're making in the company. So this is going to be a real lever for us moving forward. But it's about 250 basis points of op margin leverage that we see from '23 to '24, removing some of those one-time items.

我會告訴你，這是你最終可以從中看到的第一階段好處。這是我們在公司進行的投資的基礎上。因此，這將成為我們前進的真正槓桿。但從 23 年到 24 年，我們看到營運保證金槓桿約為 250 個基點，刪除了其中一些一次性項目。

Okay. Great. Thanks for that. And then maybe for Quen, so you talked about the EHR connection benefiting the utilization. So I wanted to ask what portion of the new accounts are also doing that EHR connection? And how should we think about the utilization ramp of those new accounts relative to what you've seen with prior cohorts of new accounts? Thanks so much.

好的。偉大的。感謝那。然後，也許對於 Quen 來說，您談到了 EHR 連接有利於利用率。所以我想問新帳戶的哪一部分也在進行 EHR 連線？與您之前看到的新帳戶群相比，我們應該如何考慮這些新帳戶的使用率上升？非常感謝。

Yeah. Thanks, David. Look, our focus with integrated accounts is not any different with new accounts as it is with existing accounts. And I think as we really increase the focus on EHR and then we've got a program inside the company to get it north of 50% and we're making good progress towards it, that means we're working to drive integrations in our existing accounts just like we are with the new accounts.

是的。謝謝，大衛。看，我們對綜合帳戶的關注與新帳戶和現有帳戶沒有任何不同。我認為，隨著我們真正加大對EHR 的關注，然後我們在公司內部製定了一個計劃，將其提高到50% 以上，並且我們正在朝著這個方向取得良好進展，這意味著我們正在努力推動我們的EHR 整合現有帳戶就像我們使用新帳戶一樣。

So I would say it's a balanced effort between the two. But we know that it's a very, very important aspect of how we partner with our customers. When we can get EHR integrations put in place, the ease of ordering the product, the ease of reviewing the reports, and for the physician to ultimately make the diagnosis from it and improve the overall experience has been tremendous. And we see the growth really take off once we get these integrations complete.

所以我想說這是兩者之間的平衡努力。但我們知道，這是我們與客戶合作的一個非常非常重要的面向。當我們能夠實現 EHR 整合時，訂購產品的便利性、查看報告的便利性以及醫生最終根據報告做出診斷並改善整體體驗都是巨大的。一旦我們完成這些整合，我們就會看到成長真正起飛。

But what's also exciting about it, particularly with our push into primary care, is that once you get integrated with these large networks, not only is it the cardiologist and the electrophysiologist who is now able to easily get access to Zio within their integrated platform, primary care can easily get into it. Nephrology can easily get into it.

但令人興奮的是，特別是隨著我們進入初級保健領域，一旦與這些大型網路集成，不僅心臟病專家和電生理學家現在能夠在其集成平台中輕鬆訪問 Zio，初級保健很容易進入其中。腎內科很容易進入。

These other specialties can easily access the Zio product. And we start to see quite a bit of increase in subscriptions or prescriptions of the product come from these other adjacent specialties and other channels within their network. So that is quite encouraging. And I think it's a big part of how we think about continuing to expand within our existing accounts but also with new accounts.

這些其他專業人士可以輕鬆存取 Zio 產品。我們開始看到該產品的訂閱或處方大量增加來自這些其他相鄰專業和其網路內的其他管道。所以這是相當令人鼓舞的。我認為這是我們考慮如何繼續擴大現有客戶以及新客戶的重要組成部分。

And I think that the more that we spend time there increasing or enhancing that opportunity to streamline the integration effort, the more value we're going to see pay off. And you should expect to hear us talk a lot more about this into the future. Because it's such a big enabler of unlocking the potential within the accounts we're in.

我認為，我們花的時間越多，增加或增強簡化整合工作的機會，我們就會看到更多的價值回報。您應該期待在未來聽到我們更多地談論這個問題。因為它是釋放我們所在帳戶潛力的重要推動者。

Great. Thanks so much.

偉大的。非常感謝。

Margaret Kaczor, William Blair.

瑪格麗特·卡佐爾，威廉·布萊爾。

Hi, everyone. This is Macauley, on for Margaret tonight. Thanks for taking our question. In terms of just PCP momentum and kind of the success you saw last year, obviously, that was ahead of your initial expectations. And you mentioned the 21% of registrations last year within the channel.

大家好。我是麥考利，今晚替瑪格麗特發言。感謝您提出我們的問題。就 PCP 的勢頭和您去年看到的成功而言，顯然超出了您最初的預期。您提到去年該通路內的註冊量為 21%。

So I guess, what's assumed in terms of PCP registration growth, specifically, within the guide and the mid-teens volume growth within XT and monitor?

所以我想，就 PCP 註冊增長而言，具體而言，在指南中以及 XT 和監視器中的十幾歲左右的數量增長方面，假設是什麼？

Yeah. Hey, Macauley. Thanks for the question. You can imagine PCPs will continue to be a larger portion of the growth profile of the company moving forward. Won't give the exact amount that's contemplated here.

是的。嘿，麥考利。謝謝你的提問。您可以想像，PCP 將繼續成為公司未來成長的重要組成部分。不會給出這裡考慮的確切金額。

What I would say is the 21% -- and this has been growing nicely over the last several years. And that penetration level continues to increase. What gets me really excited is the 21% of our total registrations that comes through the PCP channel right now is really the integration with these large integrated health systems, right?

我想說的是 21%——這個數字在過去幾年一直在快速成長。而且滲透率還在不斷提高。讓我真正興奮的是，目前透過 PCP 管道進行的總註冊量中有 21% 確實是與這些大型綜合健康系統的集成，對嗎？

And so in a lot of cases, it's pushing this up the care continuum. And ultimately, the prescription comes from the PCP versus cardiologist. So there's a bit of cannibalization in there.

因此，在許多情況下，它正在將其推向護理連續體。最終，處方來自 PCP 與心臟科醫生。所以那裡有一些蠶食。

However, as we get further integrated within these large PCP networks, the ones we've talked about, the Oak Streets of the world, et cetera, that's where you really start to see a TAM expander. And we've talked about 6 million ACM tests per year that are done right now, a small percentage of those in the PCP channel, but 15 million patients that go to the PCPs that have heart palpitations, right?

然而，當我們進一步整合到這些大型 PCP 網路（我們所討論的網路、世界橡樹街等）中時，您才真正開始看到 TAM 擴展器。我們已經談到，目前每年進行 600 萬次 ACM 測試，這只是 PCP 頻道中的一小部分，但有 1500 萬患者因心悸而去 PCP 就診，對吧？

That's where you can start to see this TAM expansion happening. And we have these contacts now that we hadn't had in the past. And in our long-range plan, we baked in, call it, 3% to 4% increase in our overall TAM from that 6 million ACM tests.

從這裡您可以開始看到 TAM 擴充功能的發生。我們現在有了這些過去沒有的連結。在我們的長期計劃中，我們將 600 萬次 ACM 測試的整體 TAM 提高了 3% 到 4%。

We think this could go a whole lot faster once we get further integrated within these PCP networks. So from a guide perspective, we have a growing north of that of cardiology, as you can imagine. We haven't put that percentage out there. But we believe this is a real tailwind for us moving forward.

我們認為，一旦我們進一步整合到這些 PCP 網路中，這一切就會變得更快。因此，從指南的角度來看，正如您可以想像的那樣，我們的心臟病學水平正在不斷提高。我們還沒有公佈這個百分比。但我們相信這對我們前進來說是真正的順風。

That's helpful. Thanks for that. And then just want to quickly ask on the San Fran IDTF; obviously, doing a lot of hiring there and may take a few quarters.

這很有幫助。感謝那。然後我想快速詢問舊金山 IDTF；顯然，在那裡進行大量招聘可能需要幾個季度的時間。

But in terms of the tailwind assumptions for ASP this year, what in terms of percentage of volumes could we expect? I know you mentioned north of 50%, hopefully, exiting the year in '23. So how much growth in terms of volume should we be expecting there for the coming quarters?

但就今年平均售價的順風假設而言，我們可以預期銷售百分比是多少？我知道你提到 50% 以上，希望能在 23 年結束。那麼，我們預計未來幾季的銷售成長有多少？

Yeah. I think this could be a real nice tailwind for us heading into 2024. We mentioned the fact that we hadn't gotten to that 50% of total volumes going through San Francisco for the full year of 2023. Really, the contributing factor there was not being able to hire as fast as we were looking for.

是的。我認為這對我們進入 2024 年來說可能是一個真正好的順風。我們提到了這樣一個事實，即我們尚未達到 2023 年全年經過舊金山的總流量的 50%。事實上，造成這種情況的因素是我們無法像我們期望的那樣快速招募。

However, I will say we exited well north of that 50% in Q4. And we anticipate, especially as these folks get up and are scaling and able to read the reports consistently with what we're doing across the rest of the country, that volume is going to continue to grow.

然而，我想說的是，我們在第四季的退出率遠遠超出了 50%。我們預計，尤其是當這些人站起來並擴大規模並能夠與我們在全國其他地區所做的事情保持一致地閱讀報告時，這一數量將繼續增長。

We're not going to give the percentage per se. But what I would say, an important data point to understand this -- and we've talked about ASP for years here at this company. What we expect in 2024 is effectively flat ASP year over year. And there's some moving pieces when you get into it.

我們不會給出百分比本身。但我想說的是，這是理解這一點的一個重要數據點——我們在這家公司已經談論 ASP 多年了。我們預計 2024 年平均售價將同比持平。當你進入其中時，會有一些令人感動的部分。

You certainly know the CMS national rate was updated January 1. And that had, call it, 3% to 4% net of inflationary impacts of pressure. AT had some similar movements in that direction, the normal single-digit pricing on the commercial side. All of that is expected to be offset by the optimization and the utilization of our IDTF space. So that's kind of where we're at -- is we expect flat ASP year over year.

您當然知道 CMS 全國費率已於 1 月 1 日更新。扣除通貨膨脹壓力的影響，可以稱為 3% 到 4%。AT 在這個方向上也有一些類似的變動，商業上的正常個位數定價。所有這些預計都將透過 IDTF 空間的優化和利用來抵消。這就是我們目前的情況——我們預計平均售價將同比持平。

Awesome. Thanks again.

驚人的。再次感謝。

Thanks, Macauley.

謝謝，麥考利。

Marie Thibault, BTIG.

瑪麗蒂博，BTIG。

Good evening. Thanks for taking the questions. I wanted to ask here about the progress on the warning letter. Heard that you submitted the second 510(k). Congrats on that.

晚安.感謝您提出問題。我想在這裡詢問一下警告信的進展。聽說您提交了第二份 510(k)。對此表示祝賀。

Can you tell us a little bit more about what you've heard from the FDA, say, on the first 510(k), what we can expect timeline-wise going forward here, and when we might get a little more clarity on those clearances?

您能否告訴我們更多關於您從FDA 聽到的消息，例如，關於第一個510(k) 的消息，我們可以期待在時間表方面取得什麼進展，以及我們何時可以更清楚地了解這些內容間隙？

Hey, Marie. It's Quentin. So we now have both 510(k)s on file with the FDA. Keep in mind that we filed the first one right at the turn of the year. The second one got filed just a matter of weeks later.

嘿，瑪麗。這是昆汀。現在，我們已向 FDA 備案了兩份 510(k) 文件。請記住，我們是在年初提交第一份報告的。幾週後，第二份申請就提交了。

The first one really focused on the letter-to-file matters that we had made a decision on in history that we agreed to bring into a 510(k) process. And then the second one really on the design enhancements, design features that we've been working on with the FDA, which is really around patient notification, improving the ability for the patient to see on the patch itself if they're approaching, say, a max trigger limit, or for the physician to see it right in the ZioSuite tool.

第一個真正關注的是我們在歷史上做出的決定，我們同意將其納入 510(k) 流程。第二個真正是關於設計增強，我們一直在與 FDA 合作的設計功能，這實際上是圍繞患者通知，提高患者在接近時看到貼片本身的能力，比如說、最大觸發限制，或者讓醫生可以在ZioSuite 工具中直接查看。

Those have been submitted. We have not engaged with the FDA in any back and forth on those 510(k)s just yet. I would expect we'll get some questions back here shortly. But based upon all the dialogue that we've had to date, I feel very good about those submissions.

這些已經提交了。我們尚未與 FDA 就這些 510(k) 進行任何來回接觸。我希望我們很快就會收到一些問題。但根據我們迄今為止所進行的所有對話，我對這些意見感到非常滿意。

The FDA knows exactly what was going to be in those submissions, had worked with us on whether we should put them into one submission or split them into two submissions. And so I feel good about the fact that they're very much aware of what's in there. And there's been a great line of communication between the two of us.

FDA 確切地知道這些提交文件中的內容，並與我們合作決定是否應該將它們放入一份提交文件中或將它們分成兩份提交文件。因此，我對他們非常了解其中的內容感到高興。我們兩個人之間一直有很好的溝通。

I would expect somewhere around the mid-part of the year, just after going back and forth answering their questions, call it, roughly a six-month process, that we should see the formal approval of those two 510(k)s, which doesn't really change anything with respect to how we're positioning or selling the (technical difficulty) in the market, but certainly puts that aspect behind us in terms of closing out the 510(k) itself.

我預計在今年年中左右的某個時間，就在反覆回答他們的問題之後，稱之為大約六個月的過程，我們應該會看到這兩個 510(k) 的正式批准，這並沒有真正改變我們在市場上定位或銷售（技術難度）的方式，但肯定會在關閉510(k) 本身方面將這一方面拋在腦後。

The other thing that, I would say that, I just think, is clarifying and important, throughout this process of working with the FDA on the Zio AT product -- and we knew there were some questions earlier on around MCT. Through working with them, ultimately, they've created a new category code themselves, which is more or less deemed to be MCT for ambulatory cardiac monitoring. And we are the first product that's been put into that new category code.

我想說的另一件事是，我認為，在與 FDA 合作開發 Zio AT 產品的整個過程中，澄清和重要的事情 - 我們知道早些時候圍繞 MCT 存在一些問題。透過與他們合作，最終他們自己創建了一個新的類別代碼，或多或少被認為是用於動態心臟監測的 MCT。我們是第一個被納入新類別代碼的產品。

So again, through the collaboration of the teams, working with the FDA, answering the questions they had around it, I think that's a big first step as we step into this new category code, just being the first product into it, that demonstrates just the good progress that's taken place between the two entities, being the FDA and ourselves. So we're excited with what we're seeing there.

因此，透過團隊的合作，與 FDA 合作，回答他們圍繞它提出的問題，我認為這是我們邁入這個新類別代碼的第一步，只是成為其中的第一個產品，這證明了FDA 和我們這兩個實體之間取得的良好進展。所以我們對在那裡看到的一切感到興奮。

Okay. That's really helpful. And just as a quick follow-up there, does that mean some of your competitors on that side will also need to go through the same process?

好的。這真的很有幫助。就像快速跟進一樣，這是否意味著您那邊的一些競爭對手也需要經歷相同的過程？

Marie, I don't know exactly what they'll have to go through. I would imagine some of it might just be an administrative process where they're working with the FDA to get pulled into it.

瑪麗，我不知道他們到底要經歷什麼。我想其中一些可能只是一個行政程序，他們正在與 FDA 合作參與其中。

But I don't know enough to speak to that with certainty. Again, I believe some of it's probably just administrative. But we'll watch and see how they play that out.

但我還不夠了解，無法肯定地談論這一點。再說一遍，我相信其中一些可能只是行政方面的。但我們會觀察他們如何表現。

Okay. Fair enough. Thank you for being very clear. And then I wanted to ask about the sleep pilot. Sorry to sound a little naive, but what exactly sort of will you be -- the effort on iRhythm's part?

好的。很公平。謝謝你說得很清楚。然後我想問睡眠飛行員的狀況。抱歉，聽起來有點天真，但 iRhythm 的努力到底會是什麼樣的呢？

When could we sort of see this become a business or a revenue contributor? I realize it's just the first pilot. And thanks for taking the questions.

我們什麼時候才能看到這成為一項業務或收入貢獻者？我意識到這只是第一個飛行員。感謝您提出問題。

Yeah. This is something that we're really excited about. I would expect to be out in the pilot within the next 30 days to 60 days. It's coming together pretty well. And we know exactly how we're going to approach the pilot itself.

是的。這是我們非常興奮的事情。我預計將在接下來的 30 天到 60 天內參與試點。它結合得很好。我們確切地知道我們將如何處理試點本身。

I think it's important to understand, like, this whole space of getting to a sleep diagnosis is entirely fragmented. And it's an incredibly cumbersome process for the physicians and the patients today. And now you have a significant competitor who just recently has stepped out of the whole home sleep test space themselves.

我認為重要的是要理解，睡眠診斷的整個空間是完全支離破碎的。對於現今的醫生和患者來說，這是一個極為繁瑣的過程。現在你有了一個重要的競爭對手，他最近剛走出了整個家庭睡眠測試領域。

And I look at our position. We have this incredible opportunity to leverage the call point that we have, being the cardiologist, the EP, and now the primary care physician, which is where the initial prescription or referral onto a sleep specialist or a home sleep test or a sleep lab ultimately originates from.

我看看我們的立場。我們有這個難以置信的機會來利用我們所擁有的呼叫點，即心臟病專家、EP，現在是初級保健醫生，這是最初的處方或轉介給睡眠專家或家庭睡眠測試或睡眠實驗室的地方起源於.

And so we already have this call point. We've got tremendous experience from an IDTF perspective and understanding how that aspect works. And we can step in, I believe, and fill a tremendous void where we can make it very easy for the prescribing physician to prescribe -- the fact they want a home sleep test or a sleep lab.

所以我們已經有了這個呼叫點。我們從 IDTF 的角度獲得了豐富的經驗，並了解這方面的運作方式。我相信，我們可以介入，填補一個巨大的空白，讓處方醫生很容易開處方——事實上他們想要家庭睡眠測試或睡眠實驗室。

We can step into that process, ensure that that sleep test gets performed, interpret the report, and ultimately, hand the diagnostic report right back to the physician, making it incredibly seamless for them and the physician, where that physician can see that report and ultimately, make the final diagnosis.

我們可以介入這個過程，確保進行睡眠測試，解釋報告，最後將診斷報告直接交還給醫生，這對他們和醫生來說是非常無縫的，醫生可以看到該報告並最終做出最終診斷。

You can almost imagine, just making it as simple as having a single button in a single portal like ZioSuite, where they can prescribe the device. And the patient can get it at home, and ultimately, the report goes right back to the physician. So I think we can completely transform that entire space.

您幾乎可以想像，只需將其變成像 ZioSuite 這樣的單一入口網站中的單一按鈕一樣簡單，他們就可以在其中指定裝置。患者可以在家中獲得報告，最終報告會交回給醫生。所以我認為我們可以徹底改變整個空間。

The home sleep test market today is north of a $1 billion market by most estimates. 50% to 80% of AFib patients have sleep apnea. We're performing nearly 2 million tests a year. There's a huge percent of that population that are likely going on the sleep test of some sort. We think we can disrupt it and streamline it for the physicians and the patients.

大多數人估計，當今的家庭睡眠測試市場規模已超過 10 億美元。 50% 至 80% 的 AFib 患者患有睡眠呼吸中止症。我們每年進行近 200 萬次測試。其中很大一部分人可能會接受某種睡眠測試。我們認為我們可以打破它並為醫生和患者簡化它。

So we're super excited. We'll see what we learn in this initial pilot. But I think we're in a pretty interesting space here to leverage our product capabilities and our service capabilities to really deliver something that is transformational in this space.

所以我們非常興奮。我們將看看在這個初始試點中我們學到了什麼。但我認為我們正處於一個非常有趣的領域，可以利用我們的產品能力和服務能力來真正交付在該領域具有變革性的東西。

And the last thing I would add is, we spend a lot of time with our advisory boards. These are physician advisory boards out across the nation. And we listen for ideas of what we can do to streamline their practices or help make them more efficient. The number-one item that comes back to us is around sleep, finding a way to make that entire process more efficient for them. And I think this is a great way to do it.

我要補充的最後一件事是，我們花了很多時間與顧問委員會相處。這些是全國各地的醫生諮詢委員會。我們傾聽有關我們可以採取哪些措施來簡化他們的做法或幫助他們提高效率的想法。我們想到的首要問題是睡眠，找到一種方法使整個過程對他們來說更有效率。我認為這是一個很好的方法。

Thank you, Quentin.

謝謝你，昆汀。

Richard Newitter, Truist.

理查德·紐特，真理主義者。

Hi. It's Lee, on for Rich. Thank you for taking the question. So could you help us understand the cadence of growth margin throughout the year, and also how quickly can growth margin ramp once monitor transition is completed? Thank you.

你好。我是李，為里奇代言。感謝您提出問題。那麼，您能否幫助我們了解全年成長率的節奏，以及監控過渡完成後成長率的上升速度有多快？謝謝。

Yeah. Good question. Yeah. As we mentioned in the prepared remarks, we think the exit rate at that 66% or so rate is reasonable to think for the first couple quarters. And the reason that timing is important is there's a couple of different things.

是的。好問題。是的。正如我們在準備好的評論中提到的，我們認為前幾季的退出率在 66% 左右是合理的。時機之所以重要是因為有幾個不同的因素。

First of all, it takes about six months to nine months for a clinical cardiac technician to get fully up to speed and optimized. And we talked about hiring 100-plus or so in Q4. So it's going to take a little bit of time for them to get up and be efficient.

首先，臨床心臟技術人員大約需要六個月到九個月的時間才能完全跟上速度並進行最佳化。我們談到在第四季度招聘 100 多名左右。因此，他們需要一點時間才能站起來並提高效率。

The second one is -- we talked about automation. And automation comes into play in the back half of the year specific to Zio monitor. And remember, we had no automation in place for Zio XT. So that's all incremental efficiency that will ultimately be created with the new product line.

第二個是──我們談到了自動化。自動化將在今年下半年針對 Zio 顯示器發揮作用。請記住，我們沒有為 Zio XT 提供自動化。這就是新產品線最終將創造的所有增量效率。

So we're thinking the exit rate for Q1, Q2 is a reasonable spot to think, call it, the 66% or so margin. To get to 68% to 69%, you'll be able to do the math and you see how we're going to put up some really nice growth margin numbers in Q3 and Q4.

因此，我們認為第一季和第二季的退出率是一個合理的位置，可以稱之為 66% 左右的利潤率。為了達到 68% 到 69%，您可以進行數學計算，然後您會看到我們將如何在第三季和第四季提供一些非常好的成長利潤率數字。

With automation in place, efficiency within the San Francisco COE, scale with the Zio monitor, effectively 80% of our total volume will be on Zio monitor at the time; all of those will be nice levers for us in the back half for gross margin. And our exit rate is going to be at that 70% to north of 70% rate, which is some of the highest gross margins we've ever put up in the company's history.

隨著舊金山 COE 內自動化的到位、效率的提高以及 Zio 監視器的擴展，當時我們總產量的 80% 將在 Zio 監視器上進行；所有這些對於我們下半年的毛利率來說都是很好的槓桿。我們的退出率將達到 70% 到 70% 以上，這是我們公司歷史上最高的毛利率之一。

So it -- there's some investments in the short term. However, it comes with some really nice payback relatively quickly. So that's how we think about cadence for gross margin.

所以，短期內有一些投資。然而，它相對較快地帶來了一些非常好的回報。這就是我們對毛利率節奏的看法。

Nathan Treybeck, Wells Fargo.

內森·特雷貝克，富國銀行。

Thanks for taking the question. Can you talk about your guidance assumptions for competition, and where your 70% market share goes in 2024? And also, if you could just talk about the competitive dynamics in the PCP channel. Thanks.

感謝您提出問題。您能否談談您對競爭的指導假設，以及您 70% 的市佔率在 2024 年會去哪裡？另外，您能否談談 PCP 通路的競爭動態。謝謝。

Yeah. So when you think about 2023 -- and I mentioned the fact that it was a transformational year for us -- all of our data would tell us that over the course of the years, we saw our volume momentum really pick up and increase. And we increased unit volume growth in '23 relative to '22 in a pretty substantial way, that despite the fact that we have 70% of that long-term cardiac monitoring space, I actually think we picked up another couple points of share in that marketplace.

是的。因此，當你想到2023 年時——我提到了這一年對我們來說是轉型的一年——我們所有的數據都會告訴我們，在這些年的過程中，我們看到我們的銷售勢頭確實有所回升和增加。相對於 22 年，我們在 23 年的單位銷售成長幅度相當大，儘管事實上我們擁有 70% 的長期心臟監測空間，但我實際上認為我們在這方面又獲得了幾分市場。

That's a market that we had given a bit of share in the past as new competitors came into it. But on the heels of the CAMELOT data being out there on the move into the primary care channel, I'm convinced that we took share in the long-term cardiac monitoring space in 2023.

過去，隨著新競爭對手的進入，我們已經在這個市場上佔據了一些份額。但隨著 CAMELOT 數據進入初級保健管道，我確信我們將在 2023 年在長期心臟監測領域佔據份額。

And we hope to continue to find ways to do that into the future. But I think that's pretty remarkable in a market where you already have 70%. So I do think we're taking share there.

我們希望未來繼續尋找實現這一目標的方法。但我認為，對於已經擁有 70% 份額的市場來說，這是相當了不起的。所以我確實認為我們正在那裡分享。

With respect to primary care, I think we have a very unique and differentiated opportunity with primary care. Most of our competitors, they lead with the cardiologists and the electrophysiologists with an MCT-style product. And then they simply step down into a long-term cardiac monitor or an event Holter -- event recorder, extended Holter.

關於初級保健，我認為我們在初級保健方面擁有非常獨特和差異化的機會。我們的大多數競爭對手，他們以 MCT 風格的產品與心臟病專家和電生理學家一起領先。然後他們只需進入長期心臟監視器或事件動態心電圖——事件記錄器，擴展動態心電圖。

So we take a very different approach. We come right in with long-term cardiac monitoring. We have a very different cost profile. At that price point, we're able to deliver in the mid-60s to what's going to be, to Brice's comment he just made, 70% as we exit 2024, north of that on monitor alone.

所以我們採取了一個非常不同的方法。我們立即進行長期心臟監測。我們的成本狀況截然不同。在這個價格點上，我們能夠在 60 年代中期交付到 2024 年退出時的 70%（按照 Brice 剛剛發表的評論），僅在顯示器上就達到了 70%。

I just think we're in a very unique position to go in and compete for that primary care space. I've had a couple folks that I've been able to sit with competitors. And we talked about our success in the primary care channel.

我只是認為我們處於一個非常獨特的位置，可以進入並競爭初級保健領域。我有幾個人能夠與競爭對手坐在一起。我們談論了我們在初級保健管道的成功。

And they look at it a bit skeptical, I think, primarily from an economic perspective. But with our gross margin profile, we know that we can drive a very nice business there and expect to be able to build it pretty significantly.

我認為，他們主要是從經濟角度對此持懷疑態度。但根據我們的毛利率狀況，我們知道我們可以在那裡推動一項非常好的業務，並期望能夠顯著地建立它。

So I don't think a lot of competitors are trying to move to primary care at this point. That's why speed is of the essence, and we're going to move as fast as we can. But I think we have an opportunity to truly disrupt it and open it up, to Brice's point earlier, in a way that expands the market meaningfully versus just contributes to the overall market growth of 3% to 4% we've historically seen.

因此，我認為目前沒有很多競爭對手試圖轉向初級保健。這就是為什麼速度至關重要，我們將盡可能快地前進。但我認為我們有機會真正顛覆它並開放它，就像Brice 之前所說的那樣，以一種有意義地擴大市場的方式，而不是僅僅為我們歷史上看到的3% 到4% 的整體市場成長做出貢獻。

Okay. That's helpful. My follow-up -- so you talked about international contributing a point of growth in 2024. And this is before the Japan launch, which you expect in early 2025.

好的。這很有幫助。我的後續行動—你談到國際在 2024 年貢獻一個成長點。這是在日本推出之前，預計將於 2025 年初推出。

I guess, how should we think about that ramp in Japan? Can it be higher than a point of growth contribution from international in '25, and maybe just timing for reimbursement in Japan? Thanks.

我想，我們該如何看待日本的坡道呢？它能否高於 25 年國際貢獻的成長點，也許只是日本報銷的時機？謝謝。

Yeah. Maybe I'll take the first one with reimbursement first. We need to get through the regulatory approval of the product that's on file with them. We're actively engaged going back and forth, and that's moving quite well.

是的。也許我會先報銷第一個。我們需要獲得他們備案的產品的監管批准。我們積極地來來回回，進展順利。

I would expect that to get approved in the back half of the year, and then move directly into discussions around reimbursement, which probably take a couple of months. That should get us to the point where we're ready to introduce the product from a commercial perspective right around the turn of the year, early part of 2025. So that has us excited.

我預計該計劃將在今年下半年獲得批准，然後直接進入有關報銷的討論，這可能需要幾個月的時間。這應該會讓我們準備好在歲末即 2025 年初從商業角度推出產品。這讓我們很興奮。

When I think about '24 and the point of growth coming from international, we really didn't get any contribution to our growth profile in 2023 as we stepped through some of the NHS-related accounts in the UK and started to really focus in the private sector. But the majority of that growth in 2024, frankly, will come from that UK business now that we've anniversaried some of those challenges.

當我想到 24 世紀以及來自國際的成長點時，我們確實沒有對 2023 年的成長狀況做出任何貢獻，因為我們逐步瀏覽了英國的一些 NHS 相關帳戶，並開始真正關注私營部​​門。但坦白說，2024 年的大部分成長將來自英國業務，因為我們已經度過了其中一些挑戰的周年紀念日。

But I love the setup as I think about '24 and even more so into '25. You've got international where we're expanding with Japan. You've got Switzerland coming on board; Netherlands, Spain, Austria, right there on the roadmap.

但我喜歡這個設置，因為我想到了 24 年，甚至更喜歡 25 年。我們正在向日本拓展國際業務。瑞士也加入進來了；荷蘭、西班牙、奧地利，就在路線圖上。

And then you launch Japan in early '25 and should be launching a new and exciting MCT product as well in '25. I think the setup is terrific as we think about all the tailwinds that are in the business.

然後您在 25 年初在日本推出，並且應該在 25 年推出新的、令人興奮的 MCT 產品。我認為這個設置非常棒，因為我們考慮到了行業中的所有有利因素。

So we're excited with what's in front of us and feel like we've got a lot of good tailwinds that we can execute against. And I do think international will be another growth contributor, not only in '24, but, yes, again in '25.

因此，我們對眼前的事情感到興奮，並感覺到我們有很多可以執行的有利因素。我確實認為國際業務將成為另一個成長貢獻者，不僅在 24 年，而且在 25 年也是如此。

Thanks.

謝謝。

Bill Plovanic, Canaccord.

比爾·普洛瓦尼克，Canaccord。

Hey, Quen and Brice. It's John, on for Bill tonight. Thanks for taking our questions. I just wanted to focus on the pilot program for Know Your Rhythm that you mentioned on the call.

嘿，昆恩和布萊斯。今晚是約翰代替比爾。感謝您回答我們的問題。我只是想專注於您在電話中提到的“了解你的節奏”試點計劃。

Maybe just some more color on that, details on the revenue model, and risk sharing around that. And how much of that is being considered in '24 guidance? Thanks.

也許只是更多的顏色，收入模式的細節，以及圍繞它的風險分擔。'24 指南中考慮了多少內容？謝謝。

Yeah. So we haven't considered a whole lot of incremental revenue from Know Your Rhythm in the '24 guidance at this point. Our view has been let these models or these pilots play out.

是的。因此，我們目前尚未在 24 年指南中考慮來自「了解你的節奏」的大量增量收入。我們的觀點是讓這些模型或這些試點發揮作用。

And once they're validated -- and we know they're going to be a commercial success -- then we can start to bring those into the commercial -- sorry -- the revenue expectation. So we're going to let the pilot play out, and then we'll think about sort of how we think about revenue for the year.

一旦它們得到驗證——我們知道它們將取得商業成功——那麼我們就可以開始將它們帶入商業廣告——抱歉——收入預期中。因此，我們將先進行試點，然後我們將考慮如何看待今年的收入。

I will tell you the early indications in the pilot with [PCC] have been terrific. It's very, very early. Look, out of the first 300 patients that came through or that have gone through the pilot with the Zio patch -- and keep in mind; this is an asymptomatic population that we believe dangerous arrhythmias might be present -- nearly 200 of them have come back or 70% of the asymptomatic patients have been identified with having a dangerous arrhythmia. That's pretty phenomenal and well above where sort of that diagnostic rate needs to be for the pilot to be considered a success.

我會告訴你，[PCC] 試點的早期跡象非常好。現在還非常非常早。看，在前 300 名通過或已經接受 Zio 貼片試驗的患者中，請記住；我們認為這些無症狀族群可能有危險的心律不整——其中近 200 人已經康復，或 70% 的無症狀患者已被確定患有危險的心律不整。這是相當驚人的，遠高於該試點計畫成功所需的診斷率。

So early stages, but beyond our own expectations at this point in time and give us a lot of hope with respect to where Know Your Rhythm can go. In terms of the economic model, we're still working through what that can look like at full larger scale.

雖然還處於早期階段，但超出了我們目前的預期，讓我們對「了解你的節奏」的發展抱有很大的希望。就經濟模型而言，我們仍在研究更大規模的情況。

And so I won't get into the details of that just yet. But early indications are that we can be very good with our data, with our AI at identifying and targeting the right populations and finding these dangerous arrhythmias that frankly end up in a significant and a tremendous cost to our healthcare system if they go undiagnosed.

所以我現在不會詳細介紹這一點。但早期跡象表明，我們可以很好地利用我們的數據，利用我們的人工智慧來識別和瞄準正確的人群，並發現這些危險的心律失常，坦率地說，如果這些心律不整未被診斷出來，最終會為我們的醫療系統帶來巨大的成本。

Great. Thanks, Quentin. And then just as a follow-up, too, IDN has been a particular strength for you guys, too. How much greenfield opportunities left there when it comes to these integrated networks for you guys to penetrate and go into? Thanks again for taking our questions.

偉大的。謝謝，昆汀。作為後續行動，IDN 對你們來說也是一個特殊的優勢。當談到這些整合網路時，還有多少新機會可供你們滲透和進入？再次感謝您提出我們的問題。

Yeah. Well, I think that, with the IDNs, you got to look at it from two different angles. In several cases, we might be in a small part of a larger IDN that we have the opportunity to go much more expansive with. And there's other cases where we're just not in the IDN at all. And we can come in from sort of a top-down approach and be pushed down into their network.

是的。嗯，我認為，對於 IDN，您必須從兩個不同的角度來看待它。在某些情況下，我們可能只是較大 IDN 的一小部分，我們有機會對其進行更廣泛的擴展。在其他情況下，我們根本不在 IDN 中。我們可以透過某種自上而下的方法進入並被推入他們的網路。

I would say we're going at it from both ways. I was just reviewing the pipeline with the commercial team just yesterday. And it's as strong as we've ever seen it, including these large IDNs.

我想說我們將從兩個方面著手。昨天我剛剛與商業團隊一起審查了管道。它的強度是我們從未見過的，包括這些大型 IDN。

And what I love about it is some of the highest growers, as a matter of fact, some of our strongest growers through the first two months of this year, are coming from these new networks that we're opening up. That's pretty incredible. And I think it just speaks to the sort of opportunity that sits out there.

我喜歡的是一些最高的種植者，事實上，今年前兩個月我們最強大的種植者都來自我們正在開放的這些新網路。這太不可思議了。我認為這正好說明了存在的機會。

Great. Thanks again.

偉大的。再次感謝。

David Rescott, Baird.

大衛雷斯科特，貝爾德。

Hey. Thanks for taking the questions. I have two questions. I'm just going to ask them up front. First, on the -- I'm excited to hear some of the updates around the sleep program.

嘿。感謝您提出問題。我有兩個問題。我只是要提前問他們。首先，我很高興聽到有關睡眠計劃的一些更新。

I know at the Analyst Day a couple years ago, you talked about the expected spend baked into the longer-range plan. But some of the upside from revenue was not. So I'm wondering if that's still the case.

我知道在幾年前的分析師日上，您談到了納入長期計畫的預期支出。但收入帶來的一些好處卻沒有。所以我想知道情況是否仍然如此。

And then just on Japan, when you think about framing up the timing of that market, how should we think about the rollout into that international market, specifically Japan? Thank you.

然後就日本而言，當您考慮制定該市場的時機時，我們應該如何考慮向該國際市場（特別是日本）的推出？謝謝。

Yeah. So from the sleep perspective, that spend is in the base. It's in our guide that Brice has provided and gave you a bit of details around. So there's not any incremental spend there that we're thinking of at this point in terms of ramping up that sleep pilot.

是的。因此，從睡眠角度來看，這筆支出處於基​​數。Brice 在我們的指南中提供了一些詳細資訊。因此，我們目前沒有考慮在加強睡眠試點方面增加任何支出。

With success, we'll see just how much success we think we can drive and how fast. And we'll take a look at it. But I -- again, I think, there's a massive opportunity to disrupt that space, leveraging a lot of the existing infrastructure we already have put in place. And so we're going to look to do that to the greatest extent that we can.

有了成功，我們就會看到我們認為自己能達到多大的成功以及我們所取得的速度有多快。我們來看看。但我再次認為，利用我們已經建立的大量現有基礎設施，有一個巨大的機會來顛覆這個領域。因此，我們將盡最大努力做到這一點。

With respect to Japan, again, I think the timing, the right way to think about that is early part of 2025. We've got our partner identified. We're working very closely with them as we prepare from a commercial readiness perspective to be able to enter that market right after the turn of the year.

至於日本，我認為正確的時機和思考方式是 2025 年初。我們已經確定了我們的合作夥伴。我們正在與他們密切合作，從商業準備的角度做好準備，以便能夠在新年後立即進入該市場。

And then, I think, just in that Japanese market, it's probably prudent for us to think about relatively modest ramp as we go. I do think having a high medical needs designation specific to Zio puts us in a really unique position there. We know that patients need access to this product. But at the same time, we're not going to get ahead of ourselves with expectations.

然後，我認為，就在日本市場，我們考慮相對溫和的成長可能是謹慎的做法。我確實認為，針對 Zio 的高醫療需求指定使我們處於一個非常獨特的位置。我們知道患者需要使用該產品。但同時，我們不會超越自己的期望。

We're incredibly bullish on the market, being the second largest market in the world. But at the same time, we want to let the results sort of play out, get a little bit of experience under our feet. And then we'll think about the right way to really think about the cadence of growth.

我們非常看好這個市場，因為它是世界第二大市場。但同時，我們想讓結果發揮出來，在我們的腳下獲得一點經驗。然後我們將思考真正思考成長節奏的正確方法。

Michael Polark, Wolfe Research.

邁克爾·波拉克，沃爾夫研究中心。

Hey, good afternoon. Quick one, the weather impacts for the first quarter, I haven't heard that yet through reporting season. Was that cold weather, snow in January, or was there some large storm I missed? I guess, what specifically are you calling out there?

嘿，下午好。首先，天氣對第一季的影響，我在報告季節還沒有聽說這一點。是天氣寒冷，一月下雪，還是我錯過了一場大風暴？我想，你具體在喊什麼？

Yeah. It's a good question, David. What we did see is large storm impacts in the northeast and really across the country in certain respects. It's not a huge number. It's $1 million to $2 million. But we thought it was important to call out. And we certainly have heard others in the industry talk about that.

是的。這是個好問題，大衛。我們確實看到了東北部以及整個國家在某些方面受到了巨大的風暴影響。這不是一個龐大的數字。這是100萬到200萬美元。但我們認為大聲疾呼很重要。我們當然也聽到業內其他人談論過這一點。

It's not unique to us, and I would expect you'll continue to hear that as feedback. However, didn't change the overall guidance at $575 million to $585 million, just a little bit of timing issue there.

這並不是我們獨有的，我希望您會繼續聽到這樣的回饋。然而，並沒有將 5.75 億美元的整體指引改變為 5.85 億美元，只是存在一點時間問題。

Helpful. And then my question on Switzerland at USD1,000 per case stands out, obviously, as a high number. Is that for an MCT configuration, or is that more for an XT product? And if it's XT, how did they get there?

有幫助。然後我關於瑞士的問題是每箱 1,000 美元，顯然這是一個很高的數字。這是針對 MCT 配置的，還是針對 XT 產品的？如果是 XT，他們是如何到達那裡的？

Yeah. That's the long-term cardiac monitoring. So that's not the MCT product. And Mike, we have been in sort of market eval or, I guess, a focused evaluation with the University of Basel over there for a little while now.

是的。這就是長期心臟監測。所以這不是 MCT 產品。麥克，我們已經進行了某種市場評估，或者我猜，與巴塞爾大學進行了有針對性的評估已經有一段時間了。

And I think that -- you look at the CAMELOT data, you look at their own internal data in terms of the cost avoidance downstream that they're realizing from an earlier diagnosis, they see that the value of the product is far beyond just the initial diagnosis. It's the avoidance of downstream unnecessary costs.

我認為 - 你看看卡米洛特的數據，你看看他們自己的內部數據，從他們從早期診斷中意識到的下游成本規避的角度來看，他們發現產品的價值遠遠超出了初步診斷。這是避免下游不必要的成本。

And so they worked those models together. And they came up with their rates, and certainly, were pleased to see that value being recognized. Obviously, it's a very attractive rate. And it makes that Switzerland market, while the volumes aren't near as large as some of the other markets throughout Europe, that one's a pretty interesting one at those rates.

所以他們一起研究這些模型。他們提出了自己的費率，當然，他們很高興看到這一價值得到認可。顯然，這是一個非常有吸引力的利率。這使得瑞士市場雖然交易量不如歐洲其他一些市場那麼大，但以這些價格來看，這是一個非常有趣的市場。

Thank you.

謝謝。

Suraj Kalia, Oppenheimer.

蘇拉吉·卡利亞，奧本海默。

Hey. This is Shaymus on for Suraj. Thanks for taking our questions. I'll just ask both up front. For the Philippines IDTF, can you guys quantify what percentage of scripts are being sent there so far? What percentage of your commercial payer mix has agreed to be moved to the Philippines IDTF at this point?

嘿。這是 Shaymus 替補 Suraj。感謝您回答我們的問題。我就先問一下。對於菲律賓 IDTF，你們能量化到目前為止發送到那裡的腳本的百分比嗎？目前，您的商業付款人組合中同意轉移到菲律賓 IDTF 的比例是多少？

And then kind of following up, in the guide, can you give a little bit more color to the adjusted EBITDA build for '24? What are you assuming in terms of stock-based comp, transition costs, et cetera? Thank you.

然後，在指南中，您能否為 24 年調整後的 EBITDA 構建提供更多的色彩？您對基於股票的補償、轉型成本等有何假設？謝謝。

Yeah. So I'll hit the first one with the Philippines. Brice can jump in on the second one. The Philippines -- we set up that global business services center really focused on the back office more so than the clinical ops function, if you will, right?

是的。所以我將與菲律賓打第一球。布萊斯可以加入第二個。菲律賓—我們建立的全球商業服務中心實際上更專注於後台而不是臨床操作功能，如果你願意的話，對吧？

So think about that as finance, HR, IT, customer care, leveraging a bit of outsourced capabilities there. But that's really the intent of the global business services center.

因此，可以將其視為財務、人力資源、IT、客戶服務，並利用其中的一些外包功能。但這確實是全球商業服務中心的目的。

To your point, a lot of what we continue to process from a CCT or an IDTF perspective continues to be back here in the States. Unless we do get a consent from a payer, then we can leverage an offshore capability or a third-party capability.

就您而言，我們從 CCT 或 IDTF 角度繼續處理的許多內容仍然回到了美國。除非我們確實得到付款人的同意，否則我們可以利用離岸能力或第三方能力。

So Philippines is primarily those other back-office functions. And we've had great success getting that stood up, great success in terms of their focus on quality of work and the process -- excellence that they bring. And as Brice pointed out earlier, it's driving a nice improvement in the margin profile for us already here in '24 and will continue in '25.

菲律賓主要是其他後台職能。我們在這方面取得了巨大的成功，他們對工作品質和流程的關注——他們帶來的卓越——取得了巨大的成功。正如 Brice 早些時候指出的那樣，它已經在 24 年為我們帶來了利潤狀況的良好改善，並將在 25 年繼續下去。

Perfect. And maybe I'll take the second one there on the adjusted EBITDA build. This is the way we think about it. If we think about just walking down the P&L, gross margin, I gave in the prepared remarks, the 68% to 69%. When you get to midpoint, it's about 120 basis points or so of benefit that you're seeing from gross margin.

完美的。也許我會在調整後的 EBITDA 建置中採用第二個。這就是我們的思考方式。如果我們考慮損益表、毛利率，我在準備好的評論中給了 68% 到 69%。當達到中點時，您會看到毛利率大約有 120 個基點左右的收益。

On the OpEx side, it's about 250 basis points. And then if you start to do the math, where does the rest come from? The rest really comes from depreciation and amortization, and most notably, depreciation and amortization which is up in our standard operating expenses.

在營運支出方面，約為 250 個基點。然後如果你開始計算，剩下的從哪裡來？其餘的實際上來自折舊和攤銷，最值得注意的是，我們標準營運費用中的折舊和攤提。

However, it's non-cash. That's growing at a rate much north of what the rest of our operating expense is. So that's effectively 100 basis points, though that comes out of adjusted EBITDA -- from a pure adjusted EBITDA margin calculation.

然而，它不是現金。這一成長速度遠高於我們其他營運支出的成長速度。因此，這實際上是 100 個基點，儘管這是來自調整後的 EBITDA——來自純粹的調整後 EBITDA 利潤率計算。

So the other thing I would say, as you think about stock-based comp in 2024, we expect that to grow about in line with the rest of operating expense, maybe a point or two north of that. Again, it's removed from adjusted EBITDA. But that's the way I think about stock-based comp.

因此，我要說的另一件事是，當你考慮 2024 年基於股票的比較時，我們預計其成長將與其餘營運費用保持一致，可能會高出一兩點。同樣，它從調整後的 EBITDA 中刪除。但這就是我對股票比較的看法。

The other piece is, as I think about business transformation, we are exclusive -- we're effectively finished with our Philippines IDTF. And there's nothing specific that we're calling out from a business transformation expense standpoint that we're expecting to remove from results in 2024.

另一件事情是，當我考慮業務轉型時，我們是排他性的——我們實際上已經完成了我們的菲律賓 IDTF。從業務轉型費用的角度來看，我們沒有任何具體的要求從 2024 年的業績中刪除。

So no specific guidance there. We don't see much in the way of need at this point. However, we'll certainly bring you up to speed should anything change there.

所以沒有具體的指導。目前我們還沒有看到太多的需求。不過，如果有任何變化，我們一定會及時向您通報情況。

Thank you. At this time, we have no further questions remaining in the queue. So I will turn the call back over to the team for final closing remarks.

謝謝。目前，我們隊列中沒有其他問題了。因此，我會將電話轉回團隊進行最後的總結發言。

Great. Well, thank you for joining us today. 2023 was a transformational year for us. And I want to thank our team members for their hard work in transforming our company as we build the foundation to capitalize on the opportunities that sit in front of us.

偉大的。好的，謝謝您今天加入我們。 2023 年對我們來說是轉型的一年。我要感謝我們的團隊成員為公司轉型所做的辛勤工作，為我們奠定了基礎，以利用我們面前的機會。

We couldn't feel better about how we are positioned as we head into the year of 2024. We've got numerous tailwinds that exist in the business, including primary care, the sleep pilot, our Know Your Rhythm pilots, asymptomatic screening, a full year of monitor, ramping international growth, and CAMELOT continuing to become more and more popular in the marketplace. Our future has never been brighter.

進入 2024 年，我們對自己的定位感到非常滿意。我們的業務中存在許多順風車，包括初級保健、睡眠試點、我們的「了解你的節律」試點、無症狀篩檢、全年監測、國際成長的加速以及 CAMELOT 在全球越來越受歡迎。市場。我們的未來從未如此光明。

We look forward to connecting with many of you over the next couple of months, and we'll talk soon. Take care.

我們期待在接下來的幾個月內與你們中的許多人聯繫，我們很快就會進行交談。小心。

That concludes today's conference call. Thank you all for your participation, and you may now disconnect your lines.

今天的電話會議到此結束。感謝大家的參與，現在您可以斷開線路了。