iRhythm Technologies Inc (IRTC) 2024 Q4 法說會逐字稿

Good afternoon. Thank you for attending today's iRhythm Technologies Q4 2024 earnings conference call. My name is Cole, and I'll be the moderator for today's call. (Operator Instructions)

午安.感謝您參加今天的 iRhythm Technologies 2024 年第四季財報電話會議。我叫科爾，我將擔任今天電話會議的主持人。（操作員指令）

I'd now like to turn it over to Stephanie Zhadkevich. Please go ahead.

現在我想把發言權交給 Stephanie Zhadkevich。請繼續。

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, 2024.

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 2024 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. 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.

在我們開始之前，我想提醒您，管理層將根據 1995 年私人證券訴訟改革法案的安全港規定，在本次電話會議中發表包括聯邦證券法所定義的前瞻性聲明。本電話會議中包含的任何非歷史事實陳述均應被視為前瞻性陳述。這些基於我們目前的估計和各種假設，反映了管理層對未來事件、策略、競爭、產品、營運計劃和績效的意圖、信念和期望。

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. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our most recent annual and quarterly reports on Form 10-K and Form 10-Q, respectively, filed with the Securities and Exchange Commission.

這些聲明涉及風險和不確定性，可能導致實際結果或事件與這些前瞻性聲明預期或暗示的結果或事件有重大差異。因此，您不應過度依賴這些聲明。有關與我們的業務相關的風險和不確定性的清單和說明，請參閱我們向美國證券交易委員會提交的最新年度和季度報告（表格 10-K）和表格 10-Q 中的風險因素部分。

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.

此外，在電話會議期間，我們將討論有關非公認會計準則和現金業績的某些未按照美國公認會計準則編制的財務指標，包括調整後的 EBITDA、調整後的營業費用和調整後的淨虧損。除非另有說明，否則所有對財務指標的引用均以非 GAAP 為基礎。

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. 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 indicated, all references to financial measures on this call, other than revenue, refer to non-GAAP results.

這些附加資訊的呈現不應被視為與根據 GAAP 編制的結果無關的、替代的或優於結果的。請參閱我們的收益報告和 10-K 中的表格，以了解這些指標與最直接可比較的 GAAP 財務指標的對帳。除非另有說明，本次電話會議中除收入以外的所有財務指標均指非 GAAP 結果。

This conference call contains time-sensitive information and is accurate only as of the live broadcast today, February 20, 2025. 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（2025 年 2 月 20 日）的現場直播時準確無誤。

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

接下來，我將把電話轉給 iRhythm 總裁兼執行長昆汀布萊克福德 (Quentin Blackford)。

Thank you, Stephanie. Good afternoon and thank you all for joining us. Dan Wilson, our Chief Financial Officer, is joining me on today's call. My prepared remarks today cover business performance during the fourth quarter and full year of 2024 as well as our annual outlook for 2025. I'll then turn the call over to Dan to provide a detailed review of our 2024 financial results and 2025 guidance.

謝謝你，斯蒂芬妮。下午好，感謝大家的參與。我們的財務長 Dan Wilson 將參加我今天的電話會議。我今天的準備發言涵蓋了 2024 年第四季和全年的業務表現以及我們對 2025 年的年度展望。然後，我將把電話轉給丹，讓他詳細回顧我們 2024 年的財務表現和 2025 年的指引。

2024 was another transformational year for iRhythm, during which we achieved a significant number of accomplishments on our journey to become best in class across all areas of our business. The fourth-quarter 2024 capped a year of progressively accelerating year-over-year volume growth every quarter, with full-year 2024 revenue of over 20% driven by sustained volume demand across all customer channels.

2024 年是 iRhythm 的另一個轉型之年，在這一年中，我們在成為業務各個領域最優秀的過程中取得了大量成就。2024 年第四季標誌著每季銷售年增速逐步加快的一年，受所有客戶通路持續的銷售需求推動，2024 年全年營收將成長 20% 以上。

Our commercial teams drove another year of record new account openings within both long-term continuous monitoring and in a mobile cardiac telemetry. This was enabled by strong demand from national value-based care entities, continued momentum in our core commercial base business, and an uplift in Zio AT in the fourth quarter.

我們的商業團隊在長期連續監測和移動心臟遙測領域又創下了新帳戶開設記錄。這是由於來自國家價值型護理實體的強勁需求、我們核心商業基礎業務的持續發展勢頭以及第四季度 Zio AT 的提升所致。

Within long-term continuous monitoring specifically, we celebrated 1 million patients in 2024 registered for Zio Monitor, our newest long-term continuous monitor that is smaller, lighter, thinner and more breathable compared to our legacy Zio XT product. And we unveiled data demonstrating its superior real-world performance at HRX 2024 that helped contribute to this growth. Zio AT also performed very well throughout 2024, but we saw particular strength during the fourth quarter as there was a disruption for our competitor in the marketplace.

具體來說，在長期連續監測方面，我們慶祝了 2024 年有 100 萬名患者註冊了 Zio Monitor，這是我們最新的長期連續監測器，與我們傳統的 Zio XT 產品相比，它更小、更輕、更薄、更透氣。我們公佈的數據證明了它在 HRX 2024 上的卓越實際表現，這有助於實現這一成長。Zio AT 在整個 2024 年的表現也非常出色，但由於我們的競爭對手在市場上遭遇了乾擾，我們在第四季度看到了特別強勁的表現。

iRhythm has historically described our US market as the number of ambulatory cardiac monitoring tests that are prescribed each year, of which there are approximately 6.5 million tests being performed today in the US However, we are in the early stages of a marked shift towards broader clinician and payer adoption of monitoring strategies to triage an increasing cardiovascular disease burden globally, and to manage the health of an aging population.

iRhythm 過去曾將我們的美國市場描述為每年開出的門診心臟監測測試的數量，其中目前在美國進行的測試約為 650 萬次。

Including the associated cost and capacity burdens that these are placing upon the healthcare system, we estimate that there are approximately 27 million patients in the US who are either showing up to their primary care provider with cardiac palpitations or completely unaware that they likely have an arrhythmia present due to patient-specific risk factors.

包括這些對醫療保健系統帶來的相關成本和容量負擔，我們估計美國大約有 2700 萬名患者因心悸而去初級保健醫生處就診，或者完全沒有意識到自己可能由於患者特定的風險因素而出現心律失常。

To access these patients in the drive early detection and intervention, moving monitoring further upstream in the patient care journey to the primary care physician has been and will remain paramount to reduce time to diagnosis, reduce hospitalizations, improve clinical outcomes, and stem healthcare costs throughout the system. We believe that the ZIO Service is ideally positioned to win within this paradigm shift, and we are already seeing early signs in our business today that this TAM expansion is occurring.

為了在早期發現和介入的過程中接觸到這些患者，將患者護理過程中的監測進一步轉移到初級保健醫生那裡，這一直是、並將繼續是至關重要的，以減少診斷時間、減少住院治療、改善臨床結果，並降低整個系統的醫療保健成本。我們相信，ZIO 服務在這種模式轉變中處於有利地位，而我們今天的業務中已經看到了 TAM 擴展正在發生的早期跡象。

We have described our approach to opening this opportunity as two-pronged: one being through the large integrated delivery networks that we work within today, and two being from the top down through large national accounts. During 2024, we continued to drive traction within primary care channels at large integrated delivery networks, where cardiologists, EPs, and primary care physicians are approaching the utility of Zio as a workflow efficiency tool.

我們將抓住這一機遇的方法描述為雙管齊下：一是透過我們今天工作的大型綜合交付網絡，二是自上而下地通過大型國家帳戶。2024 年，我們將繼續在大型綜合交付網路中推動初級保健管道的發展，其中心臟病專家、EP 和初級保健醫生正在將 Zio 作為工作流程效率工具來使用。

We have seen in several of our accounts that moving Zio prescriptions upstream to primary care physicians has the potential to reduce time to clinical decision to three to four weeks versus what can be four to six months to be used as a rule-in or rule-out tool for further referral within the network, and ultimately, to amplify volumes in these systems by opening additional capacity for specialists to see qualified patients, where additional monitoring may take place.

我們已經在多個報道中看到，將 Zio 處方上行至初級保健醫生，有可能將臨床決策時間從四到六個月縮短至三到四周，以作為網絡內進一步轉診的納入或排除工具，並最終通過為專家看診合格患者提供額外的能力來擴大這些系統的數量，並在可能進行額外監測的情況下實現這一目標。

In 2024, we saw that north of 50% of the large independent delivery networks that we do business with now have at least one primary care physician prescribing Zios. This is further enabled by embedding Zio within electronic medical record systems at our accounts, and we were very pleased to cross the milestone of 2 million registrations through EHR-integrated accounts in 2024.

到 2024 年，我們發現，在與我們有業務往來的大型獨立配送網路中，超過 50% 的網路中現在至少有一名初級保健醫生開出 Zios 處方。透過將 Zio 嵌入我們帳戶的電子病歷系統中，我們進一步實現了這一點，我們非常高興在 2024 年透過 EHR 整合帳戶突破了 200 萬個註冊的里程碑。

Doubling down on this strategy, we have begun expanding the number of commercial accounts with EMR integration via our partnership with Epic Aura's diagnostic suite especially, and the reception thus far has been very positive. While still early in our broad commercial launch as part of our Epic collaboration, we've heard from staff at these clinics who have been very enthusiastic about the immediate efficiency gains in their workflow and their associated to spend more time with patients.

為了加倍實施這項策略，我們已開始透過與 Epic Aura 診斷套件的合作來擴大具有 EMR 整合的商業帳戶數量，到目前為止，反應非常積極。儘管作為我們與 Epic 合作的一部分，我們的廣泛商業發布仍處於早期階段，但我們已經聽到這些診所的工作人員表示，他們對工作流程的直接效率提升以及花更多時間在患者身上感到非常興奮。

This partnership has taken what used to be a major IT integration project and turned it into a low-effort IT initiative that allows us to focus more on clinical and operational workflow improvement, training and readiness, and quicker time-to-value initiatives. We have been thrilled to be able to work with Epic as an exceptional partner, and we look forward to further improving the customer experience with additional org integrations throughout 2025.

此次合作將原本重大的 IT 整合專案轉變為低投入的 IT 計劃，使我們能夠更加專注於臨床和營運工作流程的改進、培訓和準備以及更快的價值實現計劃。我們很高興能夠與 Epic 成為卓越的合作夥伴，我們期待在 2025 年透過更多的組織整合進一步改善客戶體驗。

2024 was also the year where we first really started to open several large national value-based care accounts, including a notable contribution from a new innovative partner in this channel added during the fourth quarter to drive cost-efficient top-line growth and open a significant TAM that we believe exists within ambulatory cardiac monitoring. Through early customer programs of this account type, iRhythm has validated a strong product market fit for risk factor guided monitoring approaches for undiagnosed arrhythmias, where incentives are aligned with value-based payers and providers.

2024 年也是我們真正開始開設幾個大型全國基於價值的護理帳戶的一年，其中包括第四季度增加的該通路新創新合作夥伴的顯著貢獻，以推動具有成本效益的營收成長，並開啟我們認為存在於門診心臟監測領域的重要 TAM。透過此類帳戶的早期客戶計劃，iRhythm 已驗證了針對未確診心律失常的風險因素引導監測方法的強大產品市場契合度，其中激勵措施與基於價值的付款人和提供者相一致。

Within a representative sample of five customer programs that we have recently opened, over 80% of patients monitored with Zio had at least one arrhythmia identified. This is great support for the overarching hypothesis that patients with underlying, undiagnosed arrhythmias, when they fall into certain inclusion criteria that our customers are already using, and we know from several scientific studies, including mSToPS, that identification of arrhythmias can enable lower downstream costs and contribute to better patient outcomes.

在我們最近啟動的五個客戶計畫的代表性樣本中，超過 80% 使用 Zio 監測的患者至少發現了一次心律不整。這有力地支持了以下總體假設：當患者患有潛在的、未確診的心律失常時，如果他們符合我們客戶已經在使用的某些納入標準，並且我們從包括 mSToPS 在內的多項科學研究中了解到，識別心律失常可以降低下游成本並有助於改善患者的治療效果。

Our customers have started recognizing this as well with one new partner now expanding the inclusion criteria into their COPD patient population to be monitored proactively with Zio. As external validation of the move towards proactive monitoring for cardiac arrhythmias, we are starting to see guideline recommendations updated and broadened.

我們的客戶也開始意識到這一點，現在有一位新合作夥伴將納入標準擴展到他們的 COPD 患者群體，以便使用 Zio 進行主動監測。作為對心律不整主動監測的外部驗證，我們開始看到指南建議的更新和擴展。

In the US, the 2024 ACC expert consensus decision statement on arrhythmia monitoring after stroke now recommends ambulatory cardiac monitoring of 14 or more days as the primary modality for use in detection of atrial fibrillation in cases of stroke of unknown origin. Zio long-term continuous monitoring was explicitly included as a monitoring option, and Zio was shown to be superior to Holter monitoring for detection of atrial fibrillation in post-stroke patients as part of their Early Prolonged Ambulatory Cardiac Monitoring and Stroke, or EPACS trial. Also, implantable loop recorders were recommended for a more limited pool of high-risk patients rather than as a routine strategy, representing a significant change from previously recommended use of ILRs for all post-stroke patients.

在美國，2024 年 ACC 關於中風後心律不整監測的專家共識決定聲明現在建議將 14 天或更長時間的動態心臟監測作為檢測不明原因中風病例心房顫動的主要方式。Zio 長期連續監測明確列為監測選項，並且作為早期長期動態心臟監測和中風 (EPACS) 試驗的一部分，Zio 在檢測中風後患者的心房顫動方面被證明優於 Holter 監測。此外，植入式循環記錄器被推薦用於更為有限的高風險患者，而不是作為常規策略，這與先前建議所有中風後患者使用 ILR 相比發生了重大變化。

In Europe, the European Society for Cardiology updated their 2024 practice guidelines for management of AFib to include recommended screening in all patients 75 years or older and for those 65 and older with additional risk factors. These updated guidelines and society recommendations are reflective of an evolving appreciation for the role of proactive cardiac monitoring and population health management and specifically highlight the importance of long-term patch-based monitoring to accomplish these goals.

在歐洲，歐洲心臟學會更新了其 2024 年 AFib 管理實踐指南，其中建議對所有 75 歲或以上的患者以及 65 歲及以上有其他風險因素的患者進行篩檢。這些更新的指南和社會建議反映了人們對主動心臟監測和人口健康管理的作用的持續認識，並特別強調了長期基於貼片的監測對於實現這些目標的重要性。

To advance this further, we are now working on a precision AI approach to better apply risk factor-based monitoring for atrial fibrillation and other arrhythmias in targeted patient populations, many that would not be identified with conventional criteria. This evidence is just starting to be generated by our team in anticipation of a market shift towards acceptance of these types of technology advancements.

為了進一步推進這一目標，我們目前正在研究一種精準的人工智慧方法，以便更好地在目標患者群體中應用基於風險因素的心房顫動和其他心律不整監測，其中許多患者無法透過常規標準進行識別。我們的團隊剛開始產生這些證據，以期預測市場將逐漸接受此類技術進步。

You've heard us talk in the past quite a bit about obstructive sleep apnea and heart failure, where there is an abundance of clinical literature pointing to the overlapping comorbidities of these disease with arrhythmias. Another great example of this was shared at the American Heart Association's 2024 scientific sessions this past November, demonstrating that the significant health economic benefits of early arrhythmia detection and often overlooked conditions like Type 2 diabetes, COPD, chronic kidney disease, and coronary artery disease.

您過去已經聽過我們多次談論阻塞性睡眠呼吸中止症和心臟衰竭，其中有大量臨床文獻指出這些疾病與心律不整有重疊的合併症。去年 11 月，美國心臟協會 2024 年科學會議上分享了另一個很好的例子，證明了早期心律不整檢測以及經常被忽視的 2 型糖尿病、慢性阻塞性肺病、慢性腎臟病和冠狀動脈疾病等疾病具有顯著的健康經濟效益。

Analysis of real-world claims data conducted by EVERSANA suggested that early detection with arrhythmia monitoring devices has the combined potential to help prevent serious outcomes like stroke and heart failure and significantly reduce acute care utilization and related cost in these populations. These data showed that arrhythmia patients were hospitalized more than twice as often as non-arrhythmia patients. And of those hospitalized, the patient length of stay increased by two to five days for arrhythmia patients with a combined cohort, compared to patients without arrhythmias, and the rate of emergency room visits that was more than twice for the arrhythmia cohort relative to the non-arrhythmia cohort.

EVERSANA 對現實世界索賠數據的分析表明，使用心律不整監測設備進行早期檢測有助於預防中風和心臟衰竭等嚴重後果，並顯著降低這些人群的急性護理利用率和相關費用。這些數據表明，心律不整患者的住院頻率是非心律不整患者的兩倍以上。對於住院患者，與無心律不整的患者相比，合併組中心律不整患者的住院時間增加了 2 至 5 天，心律不整組的急診室就診率是無心律不整組的兩倍多。

We believe that with precision-based AI approach to proactive monitoring, we can find these patients who are at high risk of cardiac arrhythmias ahead of catastrophic events taking place, leading to the potential to meaningfully reduce the cost of ER visits, hospitalizations, and increased cost of caring for these patients after a catastrophic event has occurred.

我們相信，透過精準的人工智慧方法進行主動監測，我們可以在災難事件發生之前發現這些心律不整風險高的患者，從而有可能大幅降低災難事件發生後急診室就診、住院治療的費用以及照顧這些患者的費用。

Outside our core US business, we made progress during 2024 to begin opening additional OUS markets and bring the ZIO Service to potentially millions more patients globally. In 2024, our UK team drove record billable registrations through private contracts as we continue to navigate reimbursement dynamics with the NHS.

在我們的核心美國業務之外，我們在 2024 年取得了進展，開始開拓其他 OUS 市場，並為全球數百萬名患者提供 ZIO 服務。2024 年，我們的英國團隊透過私人合約推動了創紀錄的可計費註冊，我們繼續與 NHS 協調報銷事宜。

Also in Europe, we continue to expand our global reach with our third quarter commercial launch of ZIO Services in Austria, the Netherlands, Switzerland and Spain. We believe the introduction of the ZIO Services in these countries will positively disrupt the monitoring paradigm to allow clinical practice with evidence and improved outcomes.

此外，在歐洲，我們繼續擴大全球影響力，在第三季在奧地利、荷蘭、瑞士和西班牙推出了 ZIO 服務。我們相信，在這些國家引入 ZIO 服務將會積極顛覆監測模式，使臨床實踐能夠有證據支持並取得更好的結果。

In Japan, we received Japanese PMDA regulatory approval for Zio monitor this past September, with Zio being the first product in Japan to deliver arrhythmia monitoring service utilizing artificial intelligence. With regulatory approval in hand and with support from our partners at the Japanese Heart Rhythm Society, we've been working with the Japan Ministry of Health, Labor and Welfare, or the MHLW, over the past few months towards a market access and reimbursement decision for Zio. We expect to hear back regarding the decision soon and are excited to commercially launch in the second-largest medical device market in the world.

在日本，我們在去年 9 月獲得了日本 PMDA 對 Zio 監測儀的批准，Zio 是日本第一款利用人工智慧提供心律不整監測服務的產品。在獲得監管部門批准並獲得日本心律協會合作夥伴的支持後，過去幾個月我們一直在與日本厚生勞動省 (MHLW) 合作，爭取 Zio 的市場准入和報銷決定。我們希望很快收到有關該決定的回复，並很高興在全球第二大醫療器材市場進行商業化推廣。

iRhythm's innovative technology platform underpins our service today but is foundational to how we think about enabling, adding additional vital signs, generating future clinical insights, and ultimately, influencing population health management across multiple disease states where healthcare is heading. As we announced in 2024, we are strategically approaching this by in-licensing technology that we believe may enable future hardware iterations containing multi-parameter sensing modalities with the long-term goal of monitoring multiple vital signs off the chest.

iRhythm 的創新技術平台支撐著我們今天的服務，但它是我們如何思考、添加額外的生命體徵、產生未來的臨床見解以及最終影響醫療保健正在發展的多種疾病狀態下的人口健康管理的基礎。正如我們在 2024 年宣布的那樣，我們正透過授權技術策略性地實現這一目標，我們相信這項技術可能使未來的硬體迭代包含多參數感測模式，長期目標是監測胸部的多個生命體徵。

We continue to believe the Zio patch form factors our winning solution for our future multi-sensing service and that adding new modalities may enable us to provide additional diagnostics within other adjacent indications such as sleep apnea, where additional vitals are required for diagnosis and reimbursement. To take advantage of these exciting opportunities ahead of us, we have driven significant transformation over the past couple of years, technological capabilities, diverse leadership experiences, functional maturation and increasing rigor into the way we operate as a company.

我們始終相信，Zio 貼片的形式因素是我們未來多感測服務的成功解決方案，並且添加新的模式可能使我們能夠在其他相鄰適應症（如睡眠呼吸中止症）中提供額外的診斷，在這些疾病中，診斷和報銷需要額外的生命體徵。為了抓住這些令人興奮的機遇，過去幾年來，我們推動了重大轉型，包括技術能力、多元化的領導經驗、功能成熟度以及公司運作方式的日益嚴謹。

With the established Zio Monitor as our next-generation hardware platform in 2023, we've launched the initial phase of our manufacturing automation plans in 2024, marking a significant corporate milestone intended to set the stage for future growth and innovation while also yielding substantial cost savings.

隨著 2023 年成熟的 Zio Monitor 作為我們的下一代硬體平台，我們已於 2024 年啟動了製造自動化計劃的初始​​階段，這標誌著企業的一個重要里程碑，旨在為未來的成長和創新奠定基礎，同時還可大幅節省成本。

Also during 2024, we enacted corporate activities that were executed to reduce management layers in the organization with the aim of increasing efficiency and effectiveness while delivering more than $25 million in savings in 2025. And in support of our global aspirations to serve millions more patients worldwide, we continue to globalize our workforce with our global business services center, leveraging the global operational infrastructure we have established over the last 24 months and enabling around-the-clock operations.

此外，在 2024 年，我們制定了旨在減少組織管理層級的公司活動，旨在提高效率和效力，同時在 2025 年節省超過 2,500 萬美元。為了支持我們為全球數百萬患者提供服務的全球願景，我們繼續透過全球業務服務中心實現員工隊伍的全球化，利用我們在過去 24 個月內建立的全球營運基礎設施，實現全天候營運。

These cumulative efforts have resulted in a corresponding financial transformation as we have improved our gross margin profile from 66% at the beginning of the year to 70% by the fourth quarter 2024 and have generated north of 500 basis points of improvement in adjusted EBITDA margin, excluding acquired IPR&D charges for the year. We remain committed to driving additional financial leverage within the business and to maturing our company further for the benefit of all stakeholders.

這些累積的努力已帶來相應的財務轉型，因為我們已將毛利率狀況從年初的 66% 提高到 2024 年第四季的 70%，並且調整後的 EBITDA 利潤率（不包括當年收購的 IPR&D 費用）提高了 500 個基點。我們將繼續致力於在業務中推動額外的財務槓桿，並進一步使我們的公司成熟，以造福所有利害關係人。

Lastly, while we are very excited for the opportunities ahead of us that we are driving in our commercial business, I want to remind everyone that regulatory and quality matters will remain our number one company priority throughout 2025. To this end, we continue to make significant progress towards our remediation and compliance activities and are tracking well against our timelines that we have committed to the FDA with respect to the FDA's warning letter and 483 observations.

最後，雖然我們對未來在商業業務中面臨的機會感到非常興奮，但我想提醒大家，在 2025 年，監管和品質問題仍將是我們公司的首要任務。為此，我們繼續在補救和合規活動方面取得重大進展，並很好地按照我們向 FDA 承諾的 FDA 警告信和 483 項觀察結果的時間表進行。

Also recall that we committed to going above and beyond what the FDA has signaled they expect, and we currently are on track to complete these additional compliance efforts by year-end 2025. As we have communicated in the past, we will allocate the necessary resources to ensure that we are best in class from a quality perspective, and we are committed to ensuring that the FDA's observations are remedied to their complete satisfaction.

還記得，我們​​致力於超越 FDA 所表達的期望，目前我們預計在 2025 年底前完成這些額外的合規工作。正如我們過去所傳達的那樣，我們將分配必要的資源，以確保我們在品質方面處於最佳水平，並且我們致力於確保 FDA 的觀察結果得到完全滿意的補救。

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

說完這些，我現在將電話轉給丹，討論我們最近的財務表現。

Thank you, Quentin. As a reminder, unless otherwise noted, the financial metrics that I 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.

謝謝你，昆汀。提醒一下，除非另有說明，我今天討論的財務指標將以非 GAAP 為基礎呈現。在今天的收益報告和我們的 IR 網站上可以找到與 GAAP 的對帳表。

Our fourth-quarter 2024 results were reflective of our focus on profitable growth. We are pleased to have delivered strong top-line growth while continuing to drive operating leverage through the P&L. On the top line, we saw significant momentum in our core markets as we achieved revenue of $164.3 million, representing 24% year-over-year growth. These results were driven by record volume demand from existing accounts, combined with another record quarter of new account openings for both Zio Monitor and Zio AT.

我們的 2024 年第四季業績反映了我們對獲利成長的關注。我們很高興能夠實現強勁的營收成長，同時繼續透過損益表推動營運槓桿。在營收方面，我們的核心市場表現出色，實現營收 1.643 億美元，年增 24%。這項業績主要得益於現有帳戶創紀錄的需求量，以及 Zio Monitor 和 Zio AT 再創紀錄的季度新開戶數量。

Encouragingly, growth continues to be well balanced across both Zio Monitor and Zio AT across our core symptomatic business as well as increasing adoption of undiagnosed monitoring and a mix of both new store and same-store growth. New store growth, with new store defined as accounts that have been opened for less than 12 months, accounted for approximately 56% of our year-over-year volume growth. Home enrollment for ZIO Services in the US was approximately 22% of volume in the fourth quarter.

令人鼓舞的是，在我們的核心症狀業務中，Zio Monitor 和 Zio AT 的成長持續保持良好平衡，未確診監測的採用率也不斷提高，新店和同店成長並存。新店成長（新店定義為開店時間少於 12 個月的帳戶）約占我們年比銷售成長的 56%。第四季度，美國 ZIO 服務的家庭註冊量約佔總註冊量的 22%。

Moving down the P&L. Gross margin for the fourth quarter was 70%, slightly ahead of our stated expectations. Compared to the third quarter of 2024 and compared to the fourth quarter of 2023, the improvement to gross margin was driven by volume leverage as well as ongoing benefits realized from sustainable clinical operations and manufacturing efficiencies.

降低損益表。第四季的毛利率為 70%，略高於我們的預期。與 2024 年第三季和 2023 年第四季相比，毛利率的提高得益於產量槓桿以及永續臨床營運和製造效率帶來的持續收益。

Fourth-quarter adjusted operating expenses were $116.7 million, up 2.6% year over year, primarily driven by our ongoing remediation activities as well as funding of innovation and commercial initiatives. These purposeful investments were enabled by savings generated from operational excellence initiatives, which demonstrate our ability to deliver top-line growth while generating meaningful operating leverage.

第四季調整後的營業費用為 1.167 億美元，年增 2.6%，主要由於我們正在進行的補救活動以及對創新和商業計劃的資助。這些有目的的投資是透過卓越營運計畫產生的節約來實現的，這表明我們有能力實現營收成長，同時產生有意義的營運槓桿。

Adjusted net income in the fourth quarter of 2024 was $0.2 million, or income of $0.01 per share, compared to an adjusted net loss of $25.8 million or an adjusted net loss of $0.84 per share in the fourth quarter of 2023. Adjusted EBITDA for the fourth quarter 2024 was $19.3 million or 11.7% of revenue, compared to an adjusted EBITDA margin of 1.8% in the fourth quarter of 2023.

2024 年第四季調整後淨收入為 0.2 百萬美元，或每股收益 0.01 美元，而 2023 年第四季調整後淨虧損為 2,580 萬美元，或每股調整後淨虧損 0.84 美元。2024 年第四季調整後 EBITDA 為 1,930 萬美元，佔營收的 11.7%，而 2023 年第四季調整後 EBITDA 利潤率為 1.8%。

Adjusted EBITDA for the full year 2024 was negative $7.7 million or negative 1.3% of revenue. Our adjusted EBITDA for the full year 2024 included $32.4 million of acquired IPR&D charges or 5.5% of revenue, which would have resulted in adjusted EBITDA margin of 4.2% of revenue without the acquired IPR&D charges. This represents an improvement of approximately 520 basis points compared to 2023 driven by sustainable improvements to our operating expense profile, specifically through disciplined spending in SG&A while still reinvesting in initiatives to fuel our future growth.

2024 年全年調整後 EBITDA 為負 770 萬美元，佔營收的負 1.3%。我們 2024 年全年的調整後 EBITDA 包括 3,240 萬美元的收購 IPR&D 費用，佔營收的 5.5%，如果不包括收購 IPR&D 費用，調整後的 EBITDA 利潤率為營收的 4.2%。與 2023 年相比，這提高了約 520 個基點，這得益於我們營運費用狀況的可持續改善，特別是透過嚴格控制銷售、一般和行政開支，同時仍對推動未來成長的計劃進行再投資。

As noted in prior quarters, we continue to incur incremental legal and consulting fees as well as other company expenses related to FDA remediation efforts and DOJ subpoena activities. Incremental expenses related to these activities were approximately $11.0 million for the full year 2024. The company increased its remediation activities in the fourth quarter, bringing on additional consulting support to rectify outstanding regulatory and quality-related items.

如前幾季所述，我們繼續產生增量的法律和諮詢費用以及與 FDA 補救工作和 DOJ 傳票活動相關的其他公司費用。2024 年全年與這些活動相關的增量費用約​​為 1,100 萬美元。該公司在第四季度加大了補救活動，帶來了額外的諮詢支持，以糾正未解決的監管和品質相關問題。

We expect these incremental remediation expenses to be approximately $15 million in 2025. Once we are through our remediation efforts, we expect most of these expenses to subside. And as noted previously, operational excellence initiatives executed in the back half of 2024 will help offset incremental FDA remediation expenses in the near term while positioning iRhythm to deliver sustainable profitability into the future.

我們預計到 2025 年這些增量補救費用將達到約 1,500 萬美元。一旦我們完成補救措施，我們預計大部分費用將會減少。如前所述，2024 年下半年實施的卓越營運計畫將有助於在短期內抵消 FDA 補救費用的增量，同時使 iRhythm 能夠在未來實現可持續的獲利能力。

Turning to guidance. We are reiterating full-year 2025 revenue guidance of $675 million to $685 million, as presented just a few weeks ago. We continue to believe that full-year revenue will be driven by sustained volume growth in our core US markets as we continue to drive utilization of long-term continuous monitoring upstream within primary care channels, drive continued adoption of undiagnosed monitoring and expand our market share within the mobile cardiac telemetry market. This outlook contemplates significant US volume growth along with a low single-digit percentage pricing headwind.

轉向指導。我們重申幾週前提出的 2025 年全年收入預期，即 6.75 億美元至 6.85 億美元。我們仍然相信，全年收入將受到我們核心美國市場持續銷售成長的推動，因為我們將繼續推動初級保健管道內上游長期連續監測的利用，推動未確診監測的持續採用，並擴大我們在行動心臟遙測市場的市場份額。這一前景考慮到了美國銷量的大幅增長以及低個位數百分比的定價阻力。

While we are in the early stages of our international commercial launches, we have contemplated international contributing approximately 1 point of growth in 2025, which includes approximately $2 million from the Japanese market. For the first quarter of 2025, we expect revenue to be consistent with historical averages with approximately 22.5% of full-year revenue generated during the first quarter.

雖然我們正處於國際商業發布的早期階段，但我們已經預計到 2025 年國際業務將貢獻約 1 個成長點，其中包括來自日本市場的約 200 萬美元。對於 2025 年第一季度，我們預計收入將與歷史平均水平保持一致，第一季產生的收入約佔全年收入的 22.5%。

For gross margin, we expect the clinical operations and manufacturing efficiencies we've driven over the past 18 months will continue to improve our gross margin profile. 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.

對於毛利率，我們預計過去 18 個月推動的臨床營運和製造效率將繼續改善我們的毛利率狀況。我們相信，隨著我們隨著時間的推移利用固定成本基礎設施來服務更多的患者，這些可持續的改進將繼續降低我們的服務成本。

We anticipate modest improvements to gross margin in 2025. However, we expect that these improvements will be largely offset by proposed tariffs of Mexico, Canada and China imports, which we estimate to be a 50 to 75 basis points negative impact should those move forward as planned.

我們預計 2025 年毛利率將略有改善。然而，我們預計這些改善將在很大程度上被墨西哥、加拿大和中國進口商品的擬議關稅所抵消，如果這些關稅按計劃推進，我們估計將產生 50 至 75 個基點的負面影響。

As a reminder, our cost to serve includes both device and manufacturing costs as well as clinical service costs. Our Zio devices are manufactured and assembled at our facility in California, and we have a widely distributed supplier base, including suppliers in both Mexico and China. We are monitoring the possible enactment of proposed tariffs, and we'll be pursuing opportunities to offset any headwinds associated with potential tariffs.

提醒一下，我們的服務成本包括設備和製造成本以及臨床服務成本。我們的 Zio 設備在加州的工廠生產和組裝，並且我們擁有廣泛分佈的供應商基礎，包括墨西哥和中國的供應商。我們正在監測擬議關稅可能實施的情況，並將尋找機會抵消與潛在關稅相關的任何不利因素。

For adjusted EBITDA margin, we expect full-year 2025 to range between 7% and 8% of full-year revenues, which includes the negative impact of potential tariffs as noted earlier. Our guidance does not contemplate potential acquired IPR&D expenses, which expensed amounts will depend on timing of milestone achievements.

對於調整後的 EBITDA 利潤率，我們預計 2025 年全年將在全年收入的 7% 至 8% 之間，其中包括前面提到的潛在關稅的負面影響。我們的指導不考慮潛在的獲得的智慧財產權和開發費用，費用金額將取決於里程碑實現的時間。

We continue to anticipate normal seasonality in our adjusted operating expense profile with higher expenses coming through in the earlier half of the year due to spend associated with corporate activities and payroll expenses. We anticipate that adjusted EBITDA margin for the first quarter of 2025 will be negative low- to mid-single digits.

我們繼續預期調整後的營業費用狀況將呈現正常的季節性，由於與公司活動和工資費用相關的支出，上半年的費用將會增加。我們預計 2025 年第一季的調整後 EBITDA 利潤率將為負低至中個位數。

Finally, we ended the fourth quarter in a strong financial position with approximately $535.6 million in unrestricted cash and short-term investments. During the fourth quarter, we continued to see further improvements in working capital, and we anticipate a more normalized DSO as we move into 2025.

最後，我們以強勁的財務狀況結束了第四季度，擁有約 5.356 億美元的無限現金和短期投資。在第四季度，我們繼續看到營運資本的進一步改善，並且我們預計進入 2025 年時 DSO 將更加正常化。

Also very encouragingly, we generated over $30 million in free cash flow during the last three quarters of 2024, demonstrative of our increasing focus on operational discipline and our drive to being free cash flow-positive. For full year 2025, we anticipate being slightly free cash flow-negative and anticipate becoming free cash flow-positive for full year 2026.

同樣令人鼓舞的是，我們在 2024 年最後三個季度產生了超過 3000 萬美元的自由現金流，這表明我們越來越注重營運紀律，並致力於實現自由現金流為正。對於 2025 年全年，我們預計自由現金流將略為負，而對於 2026 年全年，我們預計自由現金流將變為正值。

In closing, we are excited about the financial results demonstrated in the fourth quarter and the momentum in the business at the start of 2025. Our focus on profitable growth is positioning the company to continue to capitalize on our growth opportunities in the near and long term while delivering sustainable profitability.

最後，我們對第四季度的財務表現和 2025 年初的業務發展勢頭感到非常興奮。我們專注於獲利性成長，使公司能夠繼續利用近期和長期的成長機會，同時實現可持續獲利。

I will now turn the call back to Quentin for closing remarks.

現在我將把電話轉回給昆汀，請他作結束語。

Thanks, Dan, and thank you, all, here today for your support of iRhythm. Our accomplishments of the past 24 months are reflective of ongoing transformational changes within our organization to foster our commitment to excellence. We have made significant strides towards our stated long-range goals to create value for multiple stakeholders while continuing to foster innovation for the benefit of patient outcomes.

謝謝，丹，也謝謝今天在座的所有人對 iRhythm 的支持。我們過去 24 個月所取得的成就反映了我們組織內部不斷進行的變革，以促進我們對卓越的承諾。我們已朝著既定的長期目標邁出了重大步伐，為多個利益相關者創造價值，同時繼續促進創新，以改善患者的治療效果。

We are uniquely positioned to win in the marketplace with clinically accurate, trusted services, and the ability to scale into expanded channels in international markets and the capability to add additional vital signs to our innovative platform over time. We are generating more than $0.5 billion in revenue today and providing over 2 million reports for patients annually with expansive target market opportunities to bring value to multiple stakeholders in the healthcare ecosystem for many years to come.

我們憑藉臨床上準確、值得信賴的服務、擴展到國際市場管道的能力以及隨著時間的推移為我們的創新平台添加更多生命體徵的能力，在市場上佔據獨特的優勢。我們今天的收入超過 5 億美元，每年為患者提供超過 200 萬份報告，並擁有廣闊的目標市場機會，將在未來許多年為醫療保健生態系統中的多個利益相關者帶來價值。

iRhythm's innovative technology platform underpins our service that enables the scale. We'll support future clinical insight generation, and ultimately, we should be able to influence population health management where the future of healthcare is heading. And this is being achieved through a scalable, efficient operating company with an attractive gross margin profile and improving adjusted EBITDA margin profile and a transition towards sustainable free cash flow generation.

iRhythm 的創新技術平台為我們提供規模化服務奠定了基礎。我們將支持未來的臨床洞察力的產生，最終，我們應該能夠影響醫療保健未來發展的人口健康管理。而實現這一目標是透過一家可擴展、高效的營運公司來實現的，該公司擁有具有吸引力的毛利率狀況、不斷改善的調整後 EBITDA 利潤率狀況以及向可持續自由現金流生成的過渡。

We are proving our ability to execute with excellence across all facets of our business, and I'd like to thank our colleagues and partners globally who make this possible every single day. We appreciate your ongoing support of iRhythm as we continue our journey to disrupt healthcare.

我們正在證明我們有能力在業務的各個方面出色地執行，我要感謝我們全球的同事和合作夥伴，是他們每天都在努力實現這一目標。我們感謝您對 iRhythm 的持續支持，我們將繼續革新醫療保健事業。

And with that, we'd like to take any questions you may have. Operator?

因此，我們願意回答您可能提出的任何問題。操作員？

Great. (Operator Instructions)

偉大的。（操作員指令）

Macauley Kilbane, William Blair.

麥考利·基爾班，威廉·布萊爾。

Hi, everyone. This is Macauley on for Margaret tonight. Thanks for taking the questions. Congrats on a really strong finish to the end of the year here. I wanted to start with the guidance, and I appreciate any numbers you can put to guidance here. But as we look the (technical difficulty)

大家好。今晚，由麥考利為瑪格麗特主持。感謝您回答這些問題。恭喜您在今年底取得了圓滿的成績。我想從指導開始，我感謝您能在這裡提供任何可以作為指導的數字。但當我們回顧（技術難度）

Hey, Macauley, I'm having a really hard time picking you up with your connection. It might be worth jumping back in the queue.

嘿，麥考利，我很難透過你的聯絡方式接通你的電話。也許值得重新回到隊列中。

Okay. Will do. Thank you.

好的。會做。謝謝。

All right. I had you pretty clear right there, if you want to try again.

好的。如果你想再試一次，我已經跟你說得很清楚了。

Oh, sorry about that. Not sure what you hear, but wanted to start with the guidance. I appreciate the approach we've seen in the past with not getting ahead of things. But as we look at the multiple catalysts throughout the year with the record account openings, the PCP momentum continuing, if not accelerating, exiting the year, you have Epic integration, et cetera. I guess, looking at the guide, what's already implied in that high end? And what's kind of left out that could drive you closer to that 20% growth moving forward, especially with the 24% growth exiting the year?

噢，很抱歉。不確定你聽到了什麼，但想從指導開始。我很欣賞我們過去所見的不超前的做法。但是，當我們回顧全年的多個催化劑時，我們發現，創紀錄的開戶數量、PCP 的勢頭仍在持續（如果不是加速的話）、年底時、Epic 的整合等等。我想，看看指南，那個高端已經暗示了什麼？還有哪些因素可以讓您在未來更接近 20% 的成長率，尤其是在今年年底實現 24% 的成長率的情況下？

Hey, Macauley, thanks for that question. So as it relates to the 2025 guide, you are right, there is a number of potential levers that can drive the growth in the business. We talked about in the prepared remarks kind of that balanced growth and seeing contribution from multiple places in the business, so all very encouragingly.

嘿，麥考利，謝謝你提問。因此，就 2025 年指南而言，您說得對，有許多潛在的槓桿可以推動業務成長。我們在準備好的評論中談到了平衡成長和來自業務多個方面的貢獻，所以這一切都非常令人鼓舞。

As we look to 2025, we, of course, don't want to get ahead of ourselves. There are a couple additional headwinds in 2025. We did call out low single-digit pricing pressure in 2025. That was -- that's unique to 2025 versus 2024. And then in Q4, we did see some benefit from Zio AT as it related to some competitive disruption in the quarter as well as an innovative channel partner that turned on in a big way in Q4.

展望 2025 年，我們當然不想超越自己。2025年還會面臨一些額外的阻力。我們確實預測 2025 年的價格壓力將達到個位數以下。這是 2025 年相對於 2024 年的獨特之處。然後在第四季度，我們確實看到了 Zio AT 的好處，因為它與本季的一些競爭中斷以及第四季度大規模啟動的創新通路合作夥伴有關。

As we look at 2025, we want to make sure that those things continue into the year and make sure that those are contributing in the business in the same way before really baking that into the guide. So at the start of the year, trying to be balanced, but certainly love what we're seeing in the business and the momentum and encouraged about the setup for the year.

展望 2025 年，我們希望確保這些事情能夠延續到今年，並確保它們以相同的方式為業務做出貢獻，然後才真正將其納入指南。因此，在年初，我們試圖保持平衡，但當然我們也喜歡我們在業務中看到的以及這種勢頭，並對今年的安排感到鼓舞。

Allen Gong, JPMorgan.

摩根大通的艾倫龔（Allen Gong）。

Hi. This is actually Lili on for Allen. Thanks so much for taking the question. You, obviously, ended the year on a high note, really good momentum exiting 2024. So was hoping you could just share a bit of color on how that momentum has continued into 2025 so far and some of the trends that you've been seeing so far in the first quarter. Thank you.

你好。這實際上是 Lili 為 Allen 所做的。非常感謝您回答這個問題。顯然，你們以高調結束了這一年，2024 年的勢頭非常好。所以希望您能分享一下這種勢頭如何延續到 2025 年，以及您在第一季迄今為止看到的一些趨勢。謝謝。

Yeah. Thanks, Lili. Thanks for the question. As Dan mentioned and you heard in the prepared remarks, certainly very excited with the momentum that we saw over the course of '24. I would note, every single quarter, we saw growth increase. So I think it just speaks to the momentum that's building. And excitingly, coming from some of these new channels that we've been talking about around the primary care opportunity that we believe is how we open the market from 6.5 million tests a year to what we think is 25 million to 27 million patients seeing a primary care physician. So very, very encouraged.

是的。謝謝，莉莉。謝謝你的提問。正如丹所提到的，您在準備好的演講中聽到的那樣，我們對 24 年期間看到的勢頭感到非常興奮。我想指出的是，每個季度我們都看到成長。所以我認為這只是說明了正在形成的勢頭。令人興奮的是，透過我們一直在談論的有關初級保健機會的一些新管道，我們認為我們如何將市場從每年 650 萬次測試擴展到我們認為的每年 2500 萬至 2700 萬名看初級保健醫生的患者。非常非常受鼓舞。

Dan did mention within the fourth quarter, there was a little bit of a benefit from a new innovative channel partner that's opening up. We want to see that continue out into 2025. And I do believe that over time, it will, but it's not something that they've continued with here in the 1.5 months. But I do think they'll pick that up in the next several quarters.

丹確實提到，在第四季度，新的創新通路合作夥伴的開放帶來了一些好處。我們希望這種情況能夠持續到 2025 年。我確實相信，隨著時間的推移，這種情況會有所改變，但這並不是他們在過去 1.5 個月內堅持做的事情。但我確實認為他們會在接下來的幾個季度內實現這一目標。

So we don't want to get ahead of ourselves with that one. We'll wait and see that contribute, and then we'll start to roll that in.

因此，我們不想在這個問題上操之過急。我們將拭目以待，看看這項貢獻如何，然後我們才會開始實施。

On the Zio AT side, I can tell you, things continue to be very promising. Again, we're just a few months off of some of the disruption that we saw in the marketplace. I want to be sure that's going to stick in the business before we start to guide to figures that would contemplate that.

在 Zio AT 方面，我可以告訴你，事情繼續非常有希望。再說一次，我們距離市場上出現的一些混亂僅僅過去了幾個月。在我們開始指導考慮這個問題的數字之前，我想確保這一點能夠在業務中堅持下去。

So our guidance around Zio AT is sort of mid-20s from a growth rate perspective, which is pretty similar to how we were performing before the fourth-quarter disruption. With the fourth quarter, we were clearly above that. And if that sticks for all of 2025, then we should be in a very nice spot. But we want to see that play out for a little while longer.

因此，從成長率的角度來看，我們對 Zio AT 的預期是 25% 左右，這與我們在第四季中斷之前的表現非常相似。在第四季度，我們的表現明顯高於這一水平。如果這種狀況能持續到 2025 年，那麼我們將處於一個非常好的位置。但我們希望看到這一幕持續一段時間。

Kallum Titchmarsh, Morgan Stanley.

摩根士丹利的卡勒姆·蒂奇馬什 (Kallum Titchmarsh)。

Great. Thanks for taking the question, guys. Just on the 483 observations, and I think previously, you've mentioned to us that internally, you feel like you can remediate everything there that you've committed to by kind of mid-2025. So can you just refresh us and specify the changes you've made as it relates to the 483s and then what's left outstanding today? And then just any sense on how collaborative that process has been with the FDA on the 483s? Are they providing ongoing feedback, or has it been a pretty one-way communication channel at the moment? Thanks a lot.

偉大的。謝謝大家回答這個問題。僅就 483 條觀察結果而言，我想之前您曾向我們提到過，在內部，您覺得您可以在 2025 年中期之前補救您所承諾的一切。那麼您能否向我們簡單介紹一下您所做的與 483 相關的更改，以及今天還有哪些未完成的工作？那麼，您認為 483 流程與 FDA 的合作如何呢？他們是否提供持續的回饋，還是目前這是一個相當單向的溝通管道？多謝。

Yeah. Thanks, Kallum. Look, we're incredibly pleased with the progress that we're making. I'm super proud of the teams. As we've noted, this is the top priority for the company right now. And that's exactly what you would see if you were inside the four walls of iRhythm. So the teams have done a tremendous job. We're through the majority of those remediation activities. We continue to target sort of the mid-year of '25 being through the remediation-specific activities.

是的。謝謝，卡勒姆。看，我們對所取得的進展感到非常高興。我為這些球隊感到非常自豪。正如我們所說，這是公司目前的首要任務。如果您身處 iRhythm 內部，您將會看到這樣的景象。所以這些團隊已經完成了出色的工作。我們已經完成大部分補救活動。我們將繼續以 25 年中期為目標，進行針對性的補救活動。

Keep in mind, though, we're holding ourselves to a higher standard, right? We're going beyond just those items that the FDA identified, and we're looking more broadly and going wider. And we'll continue to make those improvements over the course of the entire year of 2025.

但請記住，我們對自己的要求更高，對嗎？我們的調查範圍不僅限於 FDA 認定的物品，我們的調查範圍將更加廣泛，涉及面更廣。我們將在 2025 年全年繼續做出這些改進。

In terms of the correspondence with the FDA, we continue on a monthly basis to provide them an update on exactly what we said we were going to do and how we're tracking to that. And I can tell you today, we've met every one of those deliverables that we've committed ourselves to. So we feel good about that.

就與 FDA 的通信而言，我們會繼續每月向他們提供最新信息，說明我們承諾要做的事情以及我們的跟踪情況。今天我可以告訴你們，我們已經實現了我們承諾的每一個目標。因此我們對此感到很高興。

There is some back and forth with the FDA, but most of it's more administrative, right, acknowledging receipt of what we're submitting to them. Not a lot of questions back to us on the remediation side. So I'm encouraged by what we're seeing, but we got a little bit of work yet to be done and feel good about being able to get through the remediation-specific items by the mid-part of the year and the holistic effort by the end of the year.

我們與 FDA 之間有一些來回溝通，但大部分都是行政方面的，對吧，確認收到我們提交的內容。在補救方面，我們收到的問題並不多。因此，我對我們所看到的情況感到鼓舞，但是我們還有一些工作要做，並且對能夠在今年年中完成具體補救項目並在年底前完成整體努力感到很高興。

The one thing that I would also comment on is, keep in mind, we agreed to bring a third party in from the outside to sort of audit or review all of the improvements we were making ourselves to hold us to that higher standard. Some of that review work will begin to happen here in Q2. So it just demonstrates the progress that we're making and beginning to turn on that independent review of what we're doing. But we feel good with where we're at and super happy and proud of the teams.

我還要評論的一件事是，請記住，我們同意從外部引入第三方來審計或審查我們自己所做的所有改進，以讓我們達到更高的標準。部分審查工作將在第二季開始進行。因此，這只是展示了我們正在取得的進展，並開始對我們所做的事情進行獨立審查。但我們對目前的狀況感到很滿意，並且為球隊感到非常高興和自豪。

Dino Weinstock, Wells Fargo.

富國銀行的迪諾溫斯托克 (Dino Weinstock)。

Hey, This is actually Nathan Treybeck. Just a question for you in terms of Zio MCT timeline, I think the last time you mentioned you expect to submit for approval around Q3 of this year. Is that still the timeframe? And I guess, would you wait for the 483s to be remediated before submitting for approval? Thanks.

嘿，這實際上是 Nathan Treybeck。關於 Zio MCT 時間表，我只想問您一個問題，我記得您上次提到您預計在今年第三季左右提交批准。時間範圍還是那麽嗎？我猜，您會等待 483 補救後再提交批准嗎？謝謝。

Nathan, no, we're still on track with the Zio MCT timeline, still expect to get on file with the FDA in the third quarter. We do not need clearance, if you will, of the 483 remediations or acknowledgment from the FDA to submit that. I think if you go back to the last earnings call that we had, I shared with you that we were prioritizing some of those remediation activities ahead of submitting MCT. And that was really to make sure that we began to make the progress against those things most critical and demonstrate to the FDA our seriousness around remedying those things.

內森，不，我們仍在按照 Zio MCT 時間表進行，仍有望在第三季向 FDA 提交文件。如果您願意的話，我們不需要 483 項補救措施的批准或 FDA 的承認來提交該補救措施。我想，如果你回顧我們上次的財報電話會議，我曾與你們分享過，在提交 MCT 之前，我們正在優先考慮一些補救活動。這實際上是為了確保我們在解決最關鍵的問題上取得進展，並向 FDA 表明我們在解決這些問題上的認真態度。

I feel very good about where that's at. But they don't need to be fully remediated before we could submit that MCT submission. So still tracking well, still thinking Q3 is the right way to think about that. No change with respect to MCT, and that will continue to be our focus as a team.

我對於現狀感到非常滿意。但我們無需完全補救這些問題即可提交 MCT 提案。因此仍然跟踪良好，仍然認為 Q3 是思考這個問題的正確方式。MCT 方面沒有變化，這將繼續成為我們團隊關注的重點。

David Roman, Goldman Sachs.

高盛的大衛‧羅曼（David Roman）。

Thank you. Good afternoon, everybody. I was hoping that you could go into a little bit more detail on how the Epic integration is going and how we could think about demand generation from accounts that are now on Epic. Like what you're seeing and how we should think about that contributing to incremental volume on a go-forward basis?

謝謝。大家下午好。我希望您能更詳細地介紹一下 Epic 整合的進展情況，以及我們如何考慮從現在的 Epic 帳戶產生需求。就像您所看到的一樣，我們應該如何看待這對未來增量的貢獻？

Yeah. We talk a lot about the partnership with Epic, and it's been nothing but a terrific partnership from day one. We've made great progress in integrating those accounts that we first had slated in the fourth quarter. They're up; they're running. They're producing nicely.

是的。我們談了很多與 Epic 的合作，從第一天起，我們的合作就一直非常愉快。我們在整合最初在第四季度安排的帳戶方面取得了巨大進展。他們起來了；他們正在奔跑。他們生產得很好。

Some of the feedback is pretty amazing really. It's funny to hear some of the folks who are working within the system make comments like, are you sure that we've got this correct? It can't be this easy. It seems like we're missing something.

有些回饋確實非常棒。聽到一些在系統內工作的人發表這樣的評論真是有趣，你確定我們理解的正確嗎？事情不可能這麼簡單。我們好像遺漏了什麼。

So it is having an absolute impact on workflow, which is the focus of this, and we want to continue to make sure we address that for our customer accounts. And we've got a whole slew of accounts that are slated to come on board here in the first quarter of 2025; some already done. Excitingly, we got one of our first big competitive conversions that moved our direction as a result of the Aura system, and they'll be going live momentarily.

所以它對工作流程有絕對的影響，這是這次的關注重點，我們希望繼續確保為我們的客戶帳戶解決這個問題。我們有大量帳戶計劃於 2025 年第一季加入；有些已經完成了。令人興奮的是，由於 Aura 系統的作用，我們獲得了首批重大競爭轉化，並且它們將立即上線。

So we're excited with what we see. I think we want to see that play out for a little while before we comment on what sort of volume trends we see in the business. I will tell you there's some anecdotal signs from some of these early accounts that you can see some volume uplift, but we need to see that play out across the broader group before we start to bake that into forward-looking expectations.

我們對所看到的結果感到非常興奮。我認為，我們希望先觀察一段時間這一情況，然後再評論業務量趨勢。我會告訴你，從這些早期帳戶中有一些軼事跡象表明你可以看到交易量有所提升，但在我們開始將其納入前瞻性預期之前，我們需要看到這種現像在更廣泛的群體中發揮作用。

But that is part of the value thesis with this whole integration is that if we can improve workflow, make it easier to prescribe our product to put our reports right back into the electronic health records, it allows our customers to focus more on the patients, and therefore, treat more patients. So we'll see if that plays out, but early signs are very positive.

但這是整個整合的價值論點的一部分，即如果我們可以改善工作流程，使我們的產品更容易開處方，將我們的報告直接放回電子健康記錄中，它可以讓我們的客戶更加關注患者，從而治療更多的患者。所以我們將看看結果如何，但早期跡象非常積極。

Marie Thibault, BTIG.

Marie Thibault，BTIG。

Hey, good afternoon. This is Sam on for Marie. Thanks for taking the questions here. Maybe I can move to OUS, and I appreciate the commentary on the point of growth in 2025. Would just love to hear any early transitioning in some of the new markets that you've opened up. And again, thoughts on Japan $2 million contribution. I assume that's more back half-loaded. Just any thoughts you have there? Thanks.

嘿，下午好。這是 Sam，代表 Marie。感謝您在這裡回答問題。也許我可以轉到 OUS，我很欣賞對 2025 年增長點的評論。我很想聽聽你們開拓的一些新市場的早期轉型情況。再次，我對日本 200 萬美元捐款的看法。我認為那是後半部分裝載的。您有什麼想法嗎？謝謝。

Yeah. Hey, Sam, this is Dan. I can take that question. So we launched into the four Western European countries in the back part of 2024. So still very early days there and making good progress. One market there is through a distributor, three markets are direct for us.

是的。嘿，山姆，我是丹。我可以回答這個問題。因此，我們在 2024 年下半年開始進軍西歐四國。因此，目前仍處於早期階段，但正在取得良好進展。其中一個市場是透過經銷商進行的，另外三個市場則是直接向我們銷售。

Japan, we do have the reimbursement decision on deck here. We intend to commercially launch in that country, call it, mid-part of 2025. So right now, we have a few countries starting to contribute to the growth here. I mentioned or called out that 1% of -- 1 point of growth, excuse me, in 2025. So encouragingly, moving in the right direction. Still believe it's early days for us from an international expansion standpoint.

日本，我們確實已經做出了償還決定。我們打算在 2025 年中期在該國進行商業發布。目前，我們有幾個國家開始為這裡的成長做出貢獻。我提到或說指出了 1%——對不起，1 個點的成長，是在 2025 年。令人鼓舞的是，我們正朝著正確的方向前進。仍然相信從國際擴張的角度來看我們還處於早期階段。

John Young, Canaccord Genuity.

Canaccord Genuity 的約翰楊 (John Young)。

Hey, guys. It's John on for Bill. Thanks for taking the question. Just want to go to the guidance and see if there's any sleep apnea contribution contemplated for 2025 in the revenue guidance today. And just how you're thinking about sleep apnea and some of the other adjacent areas that you highlighted on the prepared remarks contributing this year? Thanks.

嘿，大家好。約翰代替比爾上場。感謝您回答這個問題。只是想看看今天的收入指導中是否考慮到了 2025 年的睡眠呼吸中止症貢獻。您如何看待睡眠呼吸中止症以及您在今年的準備好的評論中強調的一些其他相關領域？謝謝。

Yeah. So we don't have any revenue contribution, John, in the '25 revenue guide at this point for sleep apnea. We do expect to make some good progress around the sleep apnea business model and getting that out into the market as we continue to expand what we believe is a real opportunity to win in that segment.

是的。因此，約翰，目前，在 25 年的收入指南中，我們還沒有為睡眠呼吸中止症帶來任何收入貢獻。我們確實希望在睡眠呼吸中止症業務模式方面取得一些良好進展，並將其推向市場，因為我們將繼續擴大我們認為在該領域取得成功的真正機會。

We continue to do a lot of market research, a lot of work with the customers. I think it's evident that as we continue to move further up the care pathway, up into primary care, as easy as we've made it to identify cardiac arrhythmia as if we can make it that simple to identify sleep disease, which we think we can do through our digital platform and the portal that we already have, we think we have a right to win in that space.

我們繼續做大量的市場研究，與客戶一起做大量工作。我認為，顯而易見的是，隨著我們繼續在護理途徑上進一步進步，進入初級護理，我們已經可以很容易地識別心律失常，就好像我們可以簡單地識別睡眠疾病一樣，我們認為我們可以通過我們已經擁有的數字平台和門戶網站來做到這一點，我們認為我們有權在這個領域獲勝。

And so we're going to continue to pursue it very diligently. But again, sort of the same approach we've taken some -- with some of these other activities, we want to see the revenue really show up, begin to contribute. And then we'll start to work it into our expectations, but nothing in the formal guidance at this time but do expect to make progress.

因此，我們將繼續非常努力地追求這一目標。但是，我們再次採取了類似的方法——透過其他一些活動，我們希望看到收入真正顯現出來，並開始產生貢獻。然後我們會開始將其納入我們的期望，但目前還沒有任何正式的指導，但確實期望取得進展。

Joanne Wuensch, Citigroup.

花旗集團的 Joanne Wuensch。

Hey, good afternoon. This is Anthony on for Joanne. Thanks for taking our question. So last time, you updated us on PCP volume. I believe you said it was north of 20% in 2024. Given that you're expanding these PCP and value-based care partnerships, where do you think that could go in 2025?

嘿，下午好。這是安東尼 (Anthony) 代替喬安妮 (Joanne)。感謝您回答我們的問題。上次您向我們更新了 PCP 數量。我相信您說過，到 2024 年，這一比例將超過 20%。鑑於您正在擴大這些 PCP 和基於價值的護理合作夥伴關係，您認為到 2025 年它們將如何發展？

Yeah. It's a good question. I absolutely believe primary care is going to continue to be a bigger and bigger mix of our business. And we certainly saw that continue to play out over the course of '24. I don't know that I'm prepared to give a specific mix figure at this point. It's probably something that we will update on in the future.

是的。這是個好問題。我絕對相信初級保健將會繼續成為我們業務中越來越重要的組成部分。我們確實看到這種情況在 24 年繼續上演。我不知道現在我是否準備好給出一個具體的混合數字。這可能是我們將來會更新的內容。

I think it's interesting with primary care. There's two pathways that we're going after that market, and both of them are doing very, very well. You think about our large IDNs that we've entered in the past through cardiology and EPs -- they're some of our best customers and our biggest proponents of Zio. They're now asking to bring their primary care physicians within network to the table to learn more about Zio and have them begin to prescribe earlier in the care pathway.

我認為初級保健很有趣。我們進軍該市場有兩條途徑，兩條路都進展得非常非常好。想想我們過去透過心臟病學和 EP 進入的大型 IDN —— 他們是我們最好的客戶和 Zio 的最大支持者。他們現在要求讓網絡內的初級保健醫生參與進來，以了解有關 Zio 的更多信息，並讓他們儘早開始在護理過程中開處方。

I hit on this in prepared remarks. When we see that happen, we can get a diagnosis to a patient within a matter of, call it, three to four weeks, which may have been four to six months historically if they were waiting to see a specialist. It's just continuing to sort of change the whole paradigm around care for these patients and getting them the answers that they need more quickly.

我在準備好的發言中提到了這一點。當我們看到這種情況發生時，我們可以在三到四周的時間內為患者提供診斷，而過去如果他們等待看專科醫生的話可能需要四到六個月的時間。這只是繼續改變對這些病人的整個護理模式，並讓他們更快地得到他們需要的答案。

And now, you look at our data sets, north of 50% of the IDNs that we have business with have a prescribing primary care physician within them. That's exciting to see and that's grown very nicely. Because once they move prescribing up to primary care and they get a better targeted patient into the cardiologist or EP, where they can focus on the right procedures, they end up getting monitored there again as well. And so overall volume really performs nicely in those accounts.

現在，您可以查看我們的資料集，與我們有業務往來的 IDN 中，超過 50% 的 IDN 都有開處方的初級保健醫生。看到這一點令人興奮，而且它發展得非常好。因為一旦他們將處方提升到初級保健水平，他們就會將更有針對性的病人送到心臟病專家或 EP 那裡，在那裡他們就可以專注於正確的程序，最終他們也會再次在那裡受到監測。因此這些帳戶的整體交易量確實表現良好。

And then if you look at it from the other angle, these large innovative primary care networks, many of them are taking risk and managing populations in a capitated risk model, if you will, they understand the value of proactively monitoring patients, diagnosing earlier in the care pathway and enabling the reduction of cost to care and stream because they avoid these catastrophic events. It's really incredible.

如果你從另一個角度來看，這些大型創新初級保健網絡，其中許多都在承擔風險，並按照人頭風險模型管理人群，如果你願意的話，他們了解主動監測患者、在護理途徑中早期診斷的價值，並能夠降低護理和流程成本，因為他們避免了這些災難性事件。這真是太不可思議了。

If you look at the data, many of these unaware, undiagnosed patients, you look at their medical history, you look at their medical records, unfortunately, when they first get diagnosed, ends up being in the ER, right? And it's always tied back to some cardiovascular event or a syncopal event, where there's a fall and a fracture. We believe we can impact that by finding these folks earlier.

如果你查看數據，你會發現，許多未意識到、未確診的患者，你查看了他們的病史，查看了他們的醫療記錄，不幸的是，當他們第一次被診斷出來時，最終都被送進了急診室，對嗎？它總是與某些心血管事件或暈厥事件有關，例如跌倒和骨折。我們相信，透過儘早找到這些人，我們可以對此產生影響。

And in some of these early pilots we've run, we find these patients to the tune of roughly 80%, meaning we identify what we think the population at risk looks like by looking through medical history records. You put a patch on them proactively and lo and behold, nearly 80% end up having arrhythmias that can begin to be treated proactively.

在我們進行的一些早期試驗中，我們發現這些患者約佔 80%，這意味著我們可以透過查看病史記錄來確定我們認為的高風險族群。如果你主動給他們貼上一個補丁，你會發現，幾乎 80% 的人最終都會出現心律不整，並且可以開始主動治療。

So very excited about where this is moving. It certainly is moving in primary care. To your point or to your question, it will become a bigger and bigger mix component of the business, but we haven't put that figure out there this year. And we'll find a place in the future to update on it.

我非常興奮於這項進展。它確實在初級保健領域取得了進展。對於您的觀點或問題，它將成為業務中越來越重要的組成部分，但今年我們還沒有公佈這個數字。我們以後會找個地方來更新。

David Rescott, Baird.

大衛雷斯科特，貝爾德。

Oh great. Thanks for taking the questions, and congrats on the strong finish to the year here. I wanted to ask about the two stronger points in the fourth quarter. I think one of them was the innovative channel partner that came on in Q4 and then the better-than-expected strength in the MCT business. And my guess, maybe that could have been 2 or 3 points to growth on the top line. So just curious on your thoughts on the math there.

哦，太好了。感謝您回答這些問題，並祝賀您今年取得了圓滿的成績。我想問一下第四節中兩點比較強的點。我認為其中之一是第四季度出現的創新通路合作夥伴，以及 MCT 業務優於預期的實力。我的猜測是，這或許會為營收帶來 2 到 3 個百分點的成長。所以只是好奇你對那裡的數學的看法。

But you did deliver the -- I think, the first positive net income number ever with that higher mix in MCT and then as well maybe the contribution from the innovative channel partner. So curious on what level of that upside on the top line was a benefit or fell through to the bottom line? And then when you think about the potential for MCT as a percentage of sales to be bigger in '25 and '26 and maybe the innovative channel partners coming on up here as well, should that be maybe an upside driver to the EBITDA kind of guidance that you have in '25 as well as when you think about in 2026?

但你們確實實現了——我認為，這是有史以​​來第一個正的淨收入數字，得益於 MCT 的更高組合，然後也可能是來自創新通路合作夥伴的貢獻。那麼好奇的是，這種收入成長在多大程度上是有益的，還是影響了利潤？然後，當您考慮到 MCT 在銷售額中所佔百分比在 25 年和 26 年有更大的潛力，並且創新通路合作夥伴也會出現在這裡時，這是否應該成為您在 25 年以及 2026 年對 EBITDA 預測的上行驅動力？

Yeah. David, thanks for the question. This is Dan. I'll answer that. So you're right to point to both Zio AT as well as the innovative channel partner in terms of the beat in Q4. That did also yield a beat on the bottom line, so beating top and bottom line. So really encouraged about what we're seeing there.

是的。大衛，謝謝你的提問。這是丹。我來回答這個問題。因此，就第四季度的業績而言，您正確地指出了 Zio AT 以及創新通路合作夥伴的業績。這也確實對底線產生了影響，因此超過了頂線和底線。我們在那裡看到的一切確實讓我們很受鼓舞。

I wouldn't put all of that profit beat on those two components. It certainly contributed. And we have talked about the leverage that we can see in these innovative channel spaces in kind of that one-to-many selling model. So we do like that from a profitability standpoint. As that grows in our business, that can be a source of leverage on the bottom line. And I think that is true for Zio MCT as well that we have talked about -- excuse me, Zio AT being slightly lower gross margin relative to Zio Monitor.

我不會把所有的利潤都放在這兩個部分。它確實有所貢獻。我們已經討論了在這些創新通路空間中我們可以看到的那種一對多銷售模式的槓桿作用。所以從獲利的角度來看我們確實喜歡這樣做。隨著我們業務的成長，這可以成為我們獲利的槓桿來源。我認為這對我們討論過的 Zio MCT 來說也是如此——對不起，Zio AT 的毛利率相對於 Zio Monitor 略低。

So wouldn't necessarily say that flows all the way to the bottom line. But we do like what is showing up on the bottom line. Certainly, innovative channel and Zio AT is contributing to that and believe, again, that's well set up for 2025 as those grow as a mix of our business, to your point.

因此並不一定會說這會一直流到底線。但我們確實喜歡底線所呈現的結果。當然，創新管道和 Zio AT 正在為此做出貢獻，並相信，隨著它們作為我們業務的組合不斷增長，這將為 2025 年做好充分準備，正如您所說。

David Saxon, Needham & Co.

撒克遜（David Saxon），Needham & Co.

Yeah. Thank you for taking our questions. This is Joseph on for David. Just looking at gross margin, I guess, excluding any potential impact from tariffs, are you guys expecting -- you said of -- improvement over 2025. But I guess, are you guys expecting a more sequential step-up? I was just kind of curious on the seasonality there.

是的。感謝您回答我們的問題。這是約瑟代替大衛。我想，僅從毛利率來看，排除關稅的潛在影響，你們是否預計 2025 年會有所改善？但我想，你們是否期待更連續的升級？我只是對那裡的季節性感到好奇。

And then maybe more broadly, just the gross impact -- a gross margin impact on the OUS launches more broadly? And that will be it. Thanks

然後也許從更廣泛的角度來看，只是總體影響 - 對 OUS 發布的毛利率有更廣泛的影響嗎？就這樣吧。謝謝

Yeah. Sure. I can take that question. So on -- as it relates to international contribution, that is contemplated in the gross margin guidance, we talked about the point of growth for international. So that will be -- and two of those markets being through distributors, as I mentioned earlier. So that will be at a lower gross margin, and that is contemplated in guidance.

是的。當然。我可以回答這個問題。因此 - 由於它與國際貢獻有關，這是在毛利率指導中所考慮的，我們討論了國際的成長點。所以這將是——其中兩個市場是透過分銷商，正如我之前提到的。因此毛利率會較低，這也是指導預期。

If you were to take all of our comments on gross margin for 2025 and kind of where that leads to, it is flat year to year from '24 to '25, really with the improvements that we're driving offset by those potential tariffs that we called out of 50 to 75 basis points. There is a price headwind as well that we mentioned, notably an 8% Medicare price decline for Zio AT that's working against us as well. But really driving nice efficiencies within our clinical operations teams, our manufacturing teams.

如果您要考慮我們對 2025 年毛利率的所有評論以及這將導致的結果，那麼從 24 年到 25 年，毛利率逐年持平，實際上，我們所推動的改進被我們預測的 50 到 75 個基點的潛在關稅所抵消。我們也提到了價格阻力，特別是 Zio AT 的醫療保險價格下降了 8%，這也對我們不利。但真正推動了我們的臨床營運團隊和生產團隊的效率。

And as we look beyond 2025, still believe in opportunities for gross margin expansion, in future years certainly. As we think about subsequent phases of manufacturing automation, we'll see another phase go live later in 2025 and 2026. Getting to that single hardware platform that we mentioned with Zio MCT, that will be a nice source of leverage as well and then again, just continued efficiencies from leveraging our global infrastructure.

展望 2025 年以後，我們仍然相信未來幾年肯定有毛利率擴大的機會。當我們思考製造自動化的後續階段時，我們將看到另一個階段在 2025 年和 2026 年稍後上線。我們在 Zio MCT 中提到的單一硬體平台也將成為一個很好的槓桿來源，而且，還能透過利用我們的全球基礎設施持續提高效率。

So flat for the year really offset -- those improvements offset by tariffs. As we look out longer term, we certainly see line of sight to continued gross margin expansion.

因此，今年的持平確實抵消了——這些改善被關稅所抵消。從長遠來看，我們肯定會看到毛利率繼續擴大的趨勢。

Suraj Kalia, Oppenheimer.

蘇拉傑‧卡利亞 (Suraj Kalia)、奧本海默 (Oppenheimer)。

Quentin and Dan, congrats on a nice finish to the year. Quentin, one question from my side, and maybe Dan can chime in also. Exiting Q4, our understanding is your Zio AT share was about 10% of the MCT market. Maybe you can give us an idea about how you're thinking about FY25 just in terms of shares or what the thought process is.

昆汀和丹，祝賀你們今年取得了圓滿的成績。昆汀，我有一個問題，也許丹也可以插嘴。退出第四季後，我們了解您的 Zio AT 份額約佔 MCT 市場的 10%。也許您可以告訴我們您對 FY25 的看法，僅僅是從股票的角度，或者思考過程是怎樣的。

Also in terms of direct sales versus service-based model for Zio AT, how do these respective buckets -- how should we think about that for FY25? Thank you for taking my question.

此外，就 Zio AT 的直銷模式與基於服務的模式而言，這兩個各自的領域如何——我們應該如何看待 FY25？感謝您回答我的問題。

I'm not sure I followed the last question on direct sales versus service-based, Suraj. Maybe I'll have you clarify that after I answer this. But I think from a market share perspective, we're somewhere probably around 11% - 12% of the MCT market. I think if you look back over the course of the last 12 to 24 months, we've probably gained 1 point to 2 points of market share a year, and our guidance would continue to contemplate that that's kind of the rate that we move at over the course of 2025.

蘇拉吉，我不確定我是否理解了關於直接銷售與基於服務的銷售的最後一個問題。我回答完這個問題之後也許會讓你澄清一下。但我認為從市場份額的角度來看，我們大概佔據 MCT 市場的 11% - 12% 左右。我認為，如果回顧過去 12 到 24 個月，我們的市場份額每年可能增加 1 到 2 個百分點，而我們的指導意見將繼續認為這是我們在 2025 年期間的發展速度。

Now if you look at the fourth quarter, I think we gained more share than that. And if this can stick and the performance of the fourth quarter sticks throughout all of 2025, then we'd probably pick up more than 1 to 2 points. But we're going to let that play out and just show up in the results of the business before we really get out in front and guide to it.

現在，如果你看第四季度，我認為我們獲得的份額比這還要多。如果這種情況能夠持續下去，而第四季的表現能夠持續到整個 2025 年，那麼我們可能會獲得超過 1 到 2 個百分點的收益。但我們會讓它發揮作用，並在業務結果中展現出來，然後我們才會真正走在前面並引導它。

I just -- I want to see that stick a little while longer. But I think the encouraging thing is you look at most of these accounts where we're picking up the Zio AT business based upon some of the disruption, it just validates -- we're already in these accounts anyhow with long-term cardiac monitoring. So it's the same prescribing physicians. Now they're just moving over to Zio AT. I think there's a real opportunity that sticks. But again, we want to let time play out a little bit longer before we start to bake that in.

我只是──我想再看看那根棍子。但我認為令人鼓舞的是，你看看大多數這些帳戶，我們根據一些中斷選擇了 Zio AT 業務，這只是驗證——無論如何，我們已經在這些帳戶中使用了長期心臟監測。因此，開處方的醫生是相同的。現在他們剛剛轉移到 Zio AT。我認為這確實是一個值得堅持的機會。但是我們再次強調，我們希望在開始烘焙之前讓時間再長一點。

Back to your point on direct sales or service, Dan, maybe you have --

回到你關於直接銷售或服務的觀點，丹，也許你有--

Perhaps you're asking about channel or customer mix. So Zio AT does have a higher mix within the Medicare population. That is something we report in terms of the revenue split. Sorry, Suraj, do you want to clarify?

也許您詢問的是頻道或客戶組合。因此，Zio AT 在醫療保險人口中確實佔有較高的比例。這就是我們在收入分成方面所報告的內容。抱歉，蘇拉吉，你想澄清一下嗎？

Dan, if I may -- Dan, forgive me, if I may. We get a lot of questions from clients saying, hey, competitor XYZ is selling patches for so and so for the MCT business, and they are letting the physicians collect the technical fee, which is not the case with the Zio AT.

丹，如果可以的話——丹，請原諒我。我們收到很多客戶的疑問，他們說，嘿，競爭對手 XYZ 正在為 MCT 業務銷售某某貼片，他們讓醫生收取技術費，而 Zio AT 的情況並非如此。

And as I understand it, you do sell the patches to a certain extent, but then the other part of the business is you'll collect the technical components just like you'll do Zio XT. So I was curious if you could just kind of give us an idea about how these two buckets look. How should we think about FY '25? Hopefully, that makes sense. Thank you.

據我了解，您確實在一定程度上銷售補丁，但業務的另一部分是您會收集技術組件，就像您收集 Zio XT 一樣。所以我很好奇您是否可以給我們簡單介紹一下這兩個桶的外觀。我們該如何看待25財年？希望這是有意義的。謝謝。

Understood. Yeah. Thank you, Suraj, for clarifying. So Zio MCT, as with Zio Monitor and Zio XT, we do deliver that end-to-end service. There's a -- sometimes a slightly different pricing model, direct bill versus client bill. And again, that's broken out from a revenue standpoint in our filings.

明白了。是的。謝謝蘇拉傑的澄清。因此，Zio MCT 與 Zio Monitor 和 Zio XT 一樣，我們確實提供端到端服務。有時會存在略微不同的定價模式，即直接計費與客戶計費。再次強調，這是我們在文件中從收入角度列出的。

But in terms of what we deliver to the customer is no different across each of those customer buckets, if you will. It's always the end-to-end service. We don't sell the device separate from the service. That is unlike some of our competitors, as you noted.

但就我們提供給客戶的產品而言，對於不同的客戶群來說，它們並沒有什麼不同。它始終是端到端的服務。我們不單獨出售與服務相關的設備。正如您所提到的，這與我們的一些競爭對手不同。

Richard Newitter, Truist.

理查德·紐伊特（Richard Newitter），Truist。

Hi. This is Felipe Lamar on for Rich. Just on tariffs, you guys were the first to really size that gross margin impact. So if you could just flesh out how you're coming up with the 50 to 75 bps. Maybe just give some more color, it would be helpful.

你好。這是 Felipe Lamar，代替 Rich 演出。僅就關稅而言，你們是第一個真正衡量其毛利率影響的人。因此，如果您可以詳細說明如何得出 50 到 75 個基點。也許只要提供更多顏色，就會有所幫助。

And then SG&A management in the quarter was significant. I guess, could you just help us think about how -- or just help us understand how we should think about like expense management cadence through 2025? Thanks so much for taking the questions.

本季的銷售、一般及行政開支管理 (SG&A) 非常重要。我想，您能否幫助我們思考一下——或者只是幫助我們理解我們應該如何思考 2025 年的費用管理節奏？非常感謝您回答這些問題。

Yeah. Sure, appreciate it. I'll start with your question on tariffs. So the 50 to 75 basis points, that is assuming the proposed tariffs do move forward early in March. We do, as I mentioned in the prepared remarks, have suppliers of certain components really in Mexico and China and would point to Mexico is kind of a good -- we're a good portion of that 50 to 75 basis point headwind orient, so would point you to Mexico there.

是的。當然，我很感激。我首先要回答關於關稅的問題。因此，50 到 75 個基點是假設擬議的關稅在 3 月初確實向前推進。正如我在準備好的發言中提到的那樣，我們確實在墨西哥和中國擁有某些零件的供應商，並且會指出墨西哥是一種很好的選擇——我們佔了 50 到 75 個基點逆風的很大一部分，所以會指出墨西哥的情況。

In terms of expense management in 2025, obviously, you got the EBITDA guide for 2025. We feel really good about the efficiencies that we're driving in the business. Quentin referenced the actions we took in Q3 of last year. We'll see a full year of benefit from that in 2025.

就 2025 年的費用管理而言，顯然，您可以獲得 2025 年的 EBITDA 指南。我們對於我們在業務中推動的效率感到非常滿意。昆汀提到了我們去年第三季採取的行動。2025 年我們將看到全年的收益。

At the same time, we want to continue to reinvest in the business to drive both near-term and future growth. And that can be investing in opening up undiagnosed monitoring, certainly driving to get Zio MCT on file and cleared, international expansion as well. So feel like that's the right balance in terms of driving additional profitability while reinvesting in the key priorities of the business.

同時，我們希望繼續對業務進行再投資，以推動近期和未來的成長。這可以投資於開放未確診的監測，當然也推動 Zio MCT 的備案和審批，以及國際擴張。因此，我覺得這是在提高盈利能力的同時再投資於業務的關鍵重點方面的正確平衡。

Paige Chamberlain, Wolfe Research.

佩奇·張伯倫（Paige Chamberlain），沃爾夫研究公司。

Guys, this is Paige on for Mike tonight. We're curious for an update on the use of the Philippines team. So do you have any key accomplishments in 2024 to highlight? And maybe what's the road map on that team for 2025? And then finally, can you just maybe remind us on how you think about the financial efficiency gains from projects like this? Thank you.

夥計們，今晚由佩奇代替麥克主持。我們非常好奇菲律賓隊的最新使用情況。那麼您在 2024 年有什麼值得強調的關鍵成就嗎？那麼該團隊 2025 年的發展路線圖是什麼呢？最後，您能否提醒我們一下，您如何看待這類專案帶來的財務效率效益？謝謝。

Yeah. I am incredibly pleased with the team in the Philippines. They've become a real asset for our company. Just the quality of work, the commitment, the buy into our culture, the values that they uphold, it's been neat to see. And we've got several hundred folks over there now across many functions. It's not just one or two functions. It's beyond counting on two hands the number of functions that are over there. So really pleased with it. I think the team has done a wonderful job.

是的。我對菲律賓的團隊非常滿意。他們已經成為我們公司的真正財富。看到他們所從事的工作的品質、所做的承諾、對我們企業文化的認同以及他們所秉持的價值觀，真是令人欣慰。現在我們在那裡有幾百名員工，負責多項職能。它不只是一兩個功能。那裡的功能數量用兩隻手都數不清。我對此非常滿意。我認為該團隊做得非常出色。

It is a nice efficiency lever for us from a financial perspective for sure, but it's also an enabler for around-the-clock operations of our business, which enhances our interaction with the patients, our customer service levels, you can go down the whole list. And as we continue to be a global company, trying to serve the European markets, trying to serve the Asian markets, having the capability to operate around the clock becomes very, very critical to us.

從財務角度來看，這對我們來說肯定是一個很好的效率槓桿，但它也是我們業務全天候運營的推動因素，它增強了我們與患者的互動，提高了我們的客戶服務水平，你可以列舉整個列表。隨著我們繼續成為一家全球性公司，試圖服務歐洲市場，試圖服務亞洲市場，擁有全天候營運的能力對我們來說變得非常非常關鍵。

So it's an asset that we've built. It's one that we're going to continue to lean into as we build our global company. And I couldn't be more pleased with the team that's over there. I think they're phenomenal.

所以這是我們建立的資產。在我們建立全球性公司的過程中，我們將繼續依靠這一點。我對那裡的團隊非常滿意。我認為他們非常出色。

So very happy with it. It's a big part of how we're driving the cost profile to be more efficient. I think if you look at our whole G&A spend, we're probably sitting down in the low 40%'s now and what used to be over 50% of revenue. And there continues to be a nice line of sight to drive that even further. So very happy with the progress being made there.

我對此非常滿意。這是我們提高成本效率的一個重要部分。我想，如果你看看我們整個的 G&A 支出，我們現在可能只佔收入的 40% 以下，而以前這個數字佔收入的 50% 以上。並且還有良好的前景可以推動這項進程。我對那裡的進展感到非常高興。

We have no additional questions in the queue. So I will pass the call back to the management team for any closing remarks.

我們沒有其他問題。因此，我會將電話轉回管理團隊，以便他們做最後發言。

Well, thank you, operator. And looking back on 2024, we were incredibly pleased with the progress made across the business, and I want to take the opportunity to thank each and every one of our tremendous teammates on their hard work and dedication to improving the lives of as many patients as possible as we continue to build a high-growth but a profitable business that's transforming healthcare.

好的，謝謝您，接線生。回顧 2024 年，我們對整個業務取得的進展感到非常高興，我想藉此機會感謝我們每一位出色的隊友，感謝他們的辛勤工作和奉獻精神，以改善盡可能多的患者的生活，我們將繼續建立一個高增長但盈利的業務，改變醫療保健。

2025 is set up to be an exciting year for us. We're looking forward to it and continue to execute against our strategic pillars. The future is bright. So thanks for your time, and we'll talk again soon.

2025 年對我們來說將會是激動人心的一年。我們對此充滿期待，並將繼續執行我們的策略支柱。未來是光明的。感謝您的時間，我們很快就會再聊。

That concludes today's call. Thank you all for your participation. You may now disconnect your line.

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。