iRhythm Technologies Inc (IRTC) 2024 Q3 法說會逐字稿

Hello, everyone, and welcome to iRhythm’s Third Quarter 2024 Earnings Call. My name’s Lydia, and I'll be your operator today. After the prepared remarks, you'll have the opportunity to participate in the Q&A with the management team. (Operator Instructions).

大家好，歡迎參加 iRhythm 2024 年第三季財報電話會議。我叫莉迪亞，今天我將擔任您的接線生。準備好發言後，您將有機會參與管理團隊的問答。（操作員說明）。

I'll now hand you over to Stephanie Zhadkevich, Director of Investor Relations at iRhythm to begin. Please go ahead, Stephanie.

現在我將把您交給 iRhythm 投資者關係總監 Stephanie Zhadkevich 開始。請繼續，史蒂芬妮。

Thank you all for participating in today's call. Earlier today, iRhythm released financial results for the third quarter ended September 30, 2024. 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.

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 9 月 30 日的第三季財務業績。在我們開始之前，我想提醒您，管理層將在本次電話會議期間發表聲明，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 facts 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 reports 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，請參閱我們向美國證券交易委員會提交的最新年度報告和季度報告（分別為 10-K 表格和 10-Q 表格）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 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。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-Q for a reconciliation of these measures to their most directly comparable GAAP financial measures. Unless otherwise indicated, 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-Q 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, October 30, 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 10 月 30 日）直播時準確。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. Dan Wilson, our Chief Financial Officer, is joining me on today's call. My prepared remarks today cover business updates during the Q3 of 2024 as well as our annual outlook. I'll then turn the call over to Dan to provide a detailed review of our Q3 financial results and updated 2024 guidance. Before diving into the specifics of the Q3, I'd like to address what I know is top of investors' minds regarding headwinds on our share price, especially regarding the status of iRhythm's remediation efforts in response to a 2023 warning letter from the FDA and their more recent 483 observations.

謝謝你，斯蒂芬妮。下午好，感謝大家加入我們。我們的財務長 Dan Wilson 將參加今天的電話會議。我今天準備的發言涵蓋 2024 年第三季的業務更新以及我們的年度展望。然後，我會將電話轉給 Dan，詳細審查我們第三季的財務業績和更新的 2024 年指引。在深入討論第三季的具體細節之前，我想先談談我所知道的投資者最關心的關於我們股價不利因素的問題，特別是關於 iRhythm 針對 FDA 2023 年警告信和他們最近的483 個觀察結果。

As many of you know, iRhythm is in the midst of a company transformation, maturing our US-focused business beyond a single product, single-market company into a profitable, scalable, global growth company with a multi-sensing platform addressing multiple large end markets.

正如你們許多人所知，iRhythm 正處於公司轉型之中，將我們以美國為中心的業務從單一產品、單一市場公司轉變為一家盈利、可擴展的全球成長型公司，擁有解決多個大型終端問題的多元感測平台市場。

Our accomplishments of the past 24 months are reflective of these ongoing transformational changes within our organization to foster a commitment to excellence, and we have made significant strides towards our stated long-range goals to create value for multiple stakeholders and continue to foster innovation for the benefit of patient outcomes.

我們過去24 個月的成就反映了我們組織內部持續進行的轉型變革，以促進對卓越的承諾，並且我們在實現既定長期目標方面取得了重大進展，為多個利益相關者創造價值，並繼續促進創新患者治療效果的益處。

I'll provide some specific examples of recent accomplishments a bit later on in my remarks. While we have made significant progress, we acknowledge that addressing ongoing and legacy quality and regulatory issues remain a significant challenge for our organization. First and foremost, iRhythm is committed to a culture of quality and sustainability from the top down, and remediation of these quality and regulatory matters have been and will continue to be iRhythm's top corporate priority from the board and executive level into every layer of our organization.

稍後我將在發言中提供一些最近取得的成就的具體範例。儘管我們取得了重大進展，但我們承認，解決持續存在的遺留品質和監管問題仍然是我們組織面臨的重大挑戰。首先也是最重要的是，iRhythm 致力於自上而下的品質和永續發展文化，這些品質和監管問題的補救已經並將繼續成為 iRhythm 從董事會和執行層到組織各個層面的首要企業優先事項。

Our current remediation efforts extend beyond addressing the focus of the warning letter from last year and the 43 observations from the July of this year. We are rebuilding our entire quality management system, touching every aspect of it, including areas that have not been part of the FDA's recent inspections with the intent of making our quality system truly best in class. iRhythm is committed to going above and beyond with our efforts intend to exceed the expectations of the FDA as we seek to rapidly accelerate the maturation of the quality organization and the broader culture of quality within our company. As one example, we have made significant resource investments in our regulatory and quality organizations from roughly 20 people 2 years ago to more than 100 individuals today.

我們目前的整治工作超越了解決去年警告信和今年 7 月 43 條觀察結果的重點。我們正在重建整個品質管理體系，涉及其各個方面，包括 FDA 最近檢查中未涉及的領域，目的是使我們的品質系統真正成為一流的。 iRhythm 致力於超越 FDA 的期望，我們力求快速加速公司內部品質組織和更廣泛的品質文化的成熟。舉個例子，我們對監管和品質組織進行了大量資源投資，從兩年前的約 20 人增加到今天的 100 多人。

Further, within the past month, we have hired a new leader of our quality function, which is now reporting directly into myself, who brings significant experience of having led companies through warning letter and 483 remediation efforts. Additionally, beyond the expert consultants already in place, we have engaged a highly reputable industry-recognized consulting firm that is known as a leader in navigating regulatory compliance matters to conduct periodic internal audits for progress against remediation efforts.

此外，在過去的一個月裡，我們聘請了一位新的品質職能領導者，該領導者現在直接向我匯報，他帶來了領導公司透過警告信和 483 補救措施的豐富經驗。此外，除了現有的專家顧問之外，我們還聘請了一家聲譽卓著、行業認可的諮詢公司，該公司在監管合規事務方面處於領先地位，定期進行內部審計，以了解補救措施的進展情況。

They will also be performing a full audit at the conclusion of our planned efforts around our entire quality management system, the scope of which will go beyond what the FDA commented on in last year's warning letter and the most recent 43 observations.

他們還將在我們圍繞整個品質管理系統的計劃工作結束時進行全面審核，其範圍將超出 FDA 在去年的警告信和最近的 43 條觀察中評論的範圍。

As we hope is abundantly clear, we are taking these regulatory and quality matters very seriously, and we'll allocate the necessary resources to ensure that we are best in class from a quality perspective and that the FDA's observations are remedied to their complete satisfaction.

正如我們所希望的那樣，我們非常認真地對待這些監管和品質問題，我們將分配必要的資源，以確保我們從品質角度來看是同類中最好的，並且FDA 的觀察結果得到糾正，使其完全滿意。

As a clear indication of progress in addressing the concerns expressed in the FDA warning letter, we have recently received FDA clearance for the first of two 510(k)s related to our Zio AT system. The first clearance is a catch up for changes previously made to the Zio AT system as a letter to file. Regarding the second 510(k), the agency specifically requested that the first 510(k) clearance be obtained before they perform final review of our second 510(k) submission, which contains design modifications to our Zio AT system. We are unaware of any further technical questions from the agency at this time.

作為解決 FDA 警告信中表達的擔憂方面取得進展的明確跡象，我們最近獲得了 FDA 對與我們的 Zio AT 系統相關的兩個 510(k) 中的第一個的批准。第一次許可是為了彌補先前以歸檔信函形式對 Zio AT 系統所做的更改。關於第二個510(k)，該機構特別要求在對我們的第二個510(k) 提交進行最終審查之前獲得第一個510(k) 許可，其中包含對我們的Zio AT 系統的設計修改。目前我們不知道該機構有任何進一步的技術問題。

At this time, we have submitted the recently received 510(k) clearance letter to the FDA and are awaiting a response from the agency regarding the clearance of our second 510(k) submission. We look forward to updating the investment community as soon as this milestone is reached.

目前，我們已向 FDA 提交了最近收到的 510(k) 批准函，並正在等待該機構對我們第二份 510(k) 提交的批准的答复。我們期待在達到這一里程碑後立即向投資界通報最新情況。

Considering the substantial efforts to accelerate the transformation of the quality organization, while undertaking the remediation efforts and redefining the standards with which we engage the FDA, we will be voluntarily delaying our regulatory submissions for the Zio MCT system, which were intended to support the company's next generation of our mobile cardiac telemetry product.

考慮到為加速品質組織轉型所做的巨大努力，同時採取補救措施並重新定義我們與 FDA 合作的標準，我們將自願推遲 Zio MCT 系統的監管提交，該系統旨在支持公司的我們的下一代移動心臟遙測產品。

Following the company's receipt of the recent 43 observations and our acceptance of the FDA's position regarding the inclusion of certain activities performed by the company's technicians as part of our system, we will take the time to ensure that our next generation MCT 510(k) filing encompasses all the necessary impacts of including the technicians as part of the system and expect to be on file with the agency in the third quarter of 2025.

在公司收到最近的 43 項觀察結果並接受 FDA 關於將公司技術人員執行的某些活動納入我們系統的立場後，我們將花時間確保我們的下一代 MCT 510(k) 備案涵蓋將技術人員納入系統的所有必要影響，預計將於2025 年第三季向該機構備案。

We're taking this proactive voluntary approach to continue to demonstrate our commitment to addressing the most recent questions and concerns of the FDA following their July inspection. This approach will result in our voluntary efforts to perform additional testing, and documentation ahead of time in anticipation of questions that the agency may ask and demonstrate to the FDA the rigor with which we plan to approach product submissions in the future.

我們採取這種積極主動的自願方式，繼續表明我們致力於解決 FDA 在 7 月檢查後提出的最新問題和擔憂。這種方法將導致我們自願努力提前進行額外的測試和記錄，以應對該機構可能提出的問題，並向 FDA 證明我們計劃在未來處理產品提交的嚴格性。

While we understand that this may be disappointing, we believe that this is what is required to ensure thoroughness and completeness of our FDA 510(k) application to the agency and the best approach to ensure we iRhythm up in a way to continually lead the field innovation for years to come.

雖然我們知道這可能會令人失望，但我們相信這是確保我們向該機構提交的 FDA 510(k) 申請的徹底性和完整性所需要的，也是確保我們 iRhythm 不斷領先該領域的最佳方法未來幾年的創新。

Shifting to iRhythm’s core business performance, we were pleased with the third quarter results as we achieved $147.5 million in revenue, representing 18.4% growth year-over-year. This solid quarter of execution was driven by record demand from existing accounts combined with another record quarter of new account openings.

轉向 iRhythm 的核心業務業績，我們對第三季的業績感到滿意，我們實現了 1.475 億美元的收入，同比增長 18.4%。這一季度的強勁執行力是由現有帳戶創紀錄的需求以及另一個創紀錄的新帳戶開設季度推動的。

Our teams continued to drive traction within primary care channels, penetrating deeper into large integrated delivery networks, and also expanding within our large national value-based care accounts during the third quarter that should drive substantial cost-efficient top line growth in future quarters. Both pilot programs mentioned in prior quarters are now beginning to expand beyond pilot phase into early commercial launch.

我們的團隊繼續推動初級保健管道的發展，更深入地滲透到大型綜合服務網絡，並在第三季度擴大我們基於國家價值的大型護理帳戶，這將在未來幾個季度推動經濟高效的營收大幅增長。前幾季提到的兩個試點計畫現在都開始從試點階段擴展到早期商業啟動。

Importantly, overall volume growth came not only from our Zio XT business, but also from our Zio AT business, where momentum has accelerated in recent months. The third quarter of 2024 represented the largest quarter of Zio AT registrations ever, fueled by a record number of new Zio AT account openings, something that we are on pace to top once again in the fourth quarter.

重要的是，整體銷售的成長不僅來自我們的 Zio XT 業務，還來自我們的 Zio AT 業務，近幾個月來該業務的勢頭有所加快。2024 年第三季是 Zio AT 註冊量有史以來最大的季度，這得益於創紀錄的 Zio AT 新開戶數量，我們預計在第四季度再次達到這一數字。

Overall, it is extremely exciting that one out of every 200 people in the US will wear a Zio this year, and there is a Zio going on a patient every 15 seconds. Exemplary of these efforts, we celebrated a number of milestones during the third quarter, and also had a number of exciting developments to better support our customers and better serve our patients.

總體而言，今年美國每 200 人中就有一人佩戴 Zio，並且每 15 秒就有一個 Zio 佩戴在患者身上，這是非常令人興奮的。作為這些努力的典範，我們在第三季度慶祝了許多里程碑，並取得了許多令人興奮的進展，以更好地支持我們的客戶並更好地服務我們的患者。

First, we celebrated our 1 millionth patient registered for Zio monitor, our newest generation long term continuous monitor, and unveiled data at HRX 2024, which we believe demonstrates Zio monitor's superior real-world performance.

首先，我們慶祝了第 100 萬名患者註冊了 Zio 監視器（我們最新一代的長期連續監視器），並在 HRX 2024 上公佈了數據，我們相信這證明了 Zio 監視器卓越的實際性能。

Zio monitor has demonstrated fewer early wear terminations, longer wear duration, longer analyzable time, and fewer patient complaints compared to our legacy Zio XT device. Additionally, this longer wear duration, which generally leads to greater analyzable time, may further improve diagnostic yield building upon Zio XT's superior yield among ACM devices as demonstrated by CAMELOT findings.

與我們的傳統 Zio XT 設備相比，Zio 監視器顯示出較少的早期磨損終止、更長的磨損持續時間、更長的可分析時間以及更少的患者投訴。此外，這種較長的磨損持續時間通常會導致更長的可分析時間，基於 Zio XT 在 ACM 設備中的卓越產量（如 CAMELOT 的研究結果所示），可以進一步提高診斷產量。

Additionally, we also celebrated that our teams have crossed the milestone of 2 million registrations through EHR integrated accounts and have launched our first health system on Aura, Epic's network to exchange orders and results across their community.

此外，我們還慶祝我們的團隊透過 EHR 整合帳戶完成了 200 萬次註冊的里程碑，並在 Epic 網路 Aura 上啟動了我們的第一個醫療系統，以在社區內交換訂單和結果。

iRhythm is the first medical device company to join the Epic community on their Aura platform. And through our collaboration with Epic, we estimate that organizations can save up to 75% of the time it typically takes to integrate Zio services into their local instance of Epic.

iRhythm 是第一家在其 Aura 平台上加入 Epic 社群的醫療設備公司。透過與 Epic 的合作，我們估計組織可以節省高達 75% 的時間，將 Zio 服務整合到其本地 Epic 實例中。

By streamlining access to Zio Services via each our integration, clinicians and health care systems can improve operational efficiency, which we believe can reduce cost to serve and allow health care providers to devote more time to what matters most, patient care.

透過我們的每次整合簡化對Zio 服務的訪問，臨床醫生和醫療保健系統可以提高營運效率，我們相信這可以降低服務成本，並使醫療保健提供者能夠將更多時間投入到最重要的事情— —病人照護上。

Furthermore, we believe that this collaboration can expand access to Zio services across the continuum of patient care with an integrated delivery networks from cardiology to primary care to emergency departments and beyond. We are very excited to begin offering this solution more broadly to existing and new Zio customers starting in early 2025.

此外，我們相信，此次合作可以透過從心臟病學到初級保健再到急診科等的綜合服務網絡，在患者護理的整個過程中擴大 Zio 服務的使用範圍。我們非常高興從 2025 年初開始向現有和新的 Zio 客戶更廣泛地提供此解決方案。

Lastly, during the Q3, our digital product development team celebrated the milestone of more than 1,000,000 patients having used the MyZio patient app and also released the latest iteration of Zio Suite for our customers. This latest software platform features an enhanced user experience relative to the legacy system.

最後，在第三季度，我們的數位產品開發團隊慶祝了超過 1,000,000 名患者使用 MyZio 患者應用程式的里程碑，並為我們的客戶發布了最新版本的 Zio Suite。相對於舊系統，這款最新的軟體平台具有增強的使用者體驗。

This has been a highly requested feature for the past few years from our commercial field team. For our customers, the latest Zio Suite update includes navigation updates and user management enhancements to improve workflow and experience. These milestones and developments are some of the latest examples of how iRhythm continues to lead through innovation and ingenuity, and I am incredibly proud of the collaboration of our internal teams as we achieve these important milestones. Turning to progress against our levers for long-term sustainable growth, we also made meaningful strides this past quarter in our international expansion efforts as well as our product innovation initiatives.

過去幾年來，這是我們商業領域團隊強烈要求的功能。對於我們的客戶來說，最新的 Zio Suite 更新包括導覽更新和使用者管理增強功能，以改善工作流程和體驗。這些里程碑和發展是 iRhythm 如何繼續透過創新和獨創性保持領先地位的最新例子，我為我們內部團隊在實現這些重要里程碑時的合作感到無比自豪。談到長期可持續成長的槓桿方面的進展，我們在上個季度的國際擴張努力以及產品創新舉措方面也取得了有意義的進展。

In the United Kingdom, our teams garnered more than 10,000 registrations in a single quarter for the first time ever, and we also enabled the introduction of the MyZio app to our UK patients, allowing them to log symptoms and access educational content digitally.

在英國，我們的團隊有史以來第一次在一個季度內獲得了超過 10,000 名註冊，我們還向英國患者推出了 MyZio 應用程序，使他們能夠記錄症狀並以數位方式訪問教育內容。

The clinical significance around MyZio usage and overall impact on symptom rhythm correlation is very clear. Patients using the MyZio app were 4 times more likely to record at least one symptom during an arrhythmia compared to patients using a paper log booklet. We have been thrilled with this expansion in our UK market and are excited to bring Zio to more patients there. Also, in Europe, we reached a critical company milestone during the Q3 with commercial launch in Austria, the Netherlands, Switzerland, and Spain, highlighting our continued commitment to bring our innovative digital health care solutions to millions of people worldwide.

MyZio 使用的臨床意義以及對症狀節律相關性的整體影響非常明確。與使用紙本日誌冊的患者相比，使用 MyZio 應用程式的患者在心律不整期間記錄至少一種症狀的可能性高出 4 倍。我們對英國市場的擴張感到非常興奮，並很高興將 Zio 帶給那裡的更多患者。此外，在歐洲，我們在第三季度實現了公司的一個重要里程碑，在奧地利、荷蘭、瑞士和西班牙進行了商業發布，突顯了我們繼續致力於為全球數百萬人提供創新的數位醫療保健解決方案。

We're in the very early stages and have started to receive physician orders, and we'll continue to ramp our commercial efforts, contracting with local hospitals, engaging key opinion leaders at leading academic centers, and generating clinical evidence to help physicians in these markets appreciate the value that Zio services can drive for their practices.

我們正處於早期階段，已經開始收到醫生的訂單，我們將繼續加大商業力度，與當地醫院簽訂合同，與領先學術中心的關鍵意見領袖合作，並生成臨床證據來幫助醫生解決這些問題市場讚賞Zio 服務為其實踐帶來的價值。

In Japan, we were also extremely excited to have received the Japanese PMDA regulatory approval for Zio monitor in September. Zio is the 1st product in Japan to deliver arrhythmia monitoring services utilizing artificial intelligence and the only 14-day cardiac monitoring service in its category to receive Japanese regulatory approval as an improved device without a clinical trial.

在日本，我們也非常高興 9 月獲得了日本 PMDA 監管機構對 Zio 監視器的批准。Zio 是日本第一個利用人工智慧提供心律不整監測服務的產品，也是同類產品中唯一獲得日本監管機構批准的 14 天心臟監測服務，作為未經臨床試驗的改良設備。

Our Japanese reimbursement dossier was submitted following regulatory approval, and we have already fielded a few questions from the MHLW regarding our application. As we navigate these negotiations, we continue to work with our planned distributor in Japan to get them ready for launch. We continue to anticipate commercial launch in 2025, representing our foray into the 2nd largest ambulatory cardiac monitoring market in the world. On the innovation front, we could not be more excited to have entered a technology licensing agreement with BioIntelliSense to incorporate medical-grade connected multi-sensor capabilities into our ACM products, positioning us to significantly expand the capabilities of our product platform over the next several years.

我們的日本報銷檔案是在監管部門批准後提交的，我們已經回答了厚生省有關我們申請的一些問題。在我們進行這些談判的過程中，我們將繼續與計劃在日本的經銷商合作，為它們的發布做好準備。我們繼續預計在 2025 年進行商業發布，這代表著我們進入全球第二大動態心臟監測市場。在創新方面，我們非常高興與 BioIntelliSense 簽訂了技術授權協議，將醫療級互聯多感測器功能納入我們的 ACM 產品中，這使我們能夠在未來幾年內顯著擴展我們產品平台的功能年。

While this is a long-term strategic play, we believe that incorporation of BioIntelliSense's proprietary technology into future iterations of the Zio platform, IntelliSense's proprietary technology into future iterations of the Zio platform could not only enable iRhythm to maintain premium positioning within our core ACM market, but also broaden our product platform capabilities to potentially serve additional channels and indications over time.

雖然這是一項長期策略，但我們相信，將BioIntelliSense 的專有技術納入Zio 平台的未來迭代中，將IntelliSense 的專有技術納入Zio 平台的未來迭代中，不僅可以使iRhythm 在我們的核心ACM 市場中保持優質定位，而且還擴大了我們的產品平台能力，隨著時間的推移，可能會服務於更多的管道和適應症。

Patch-based pulse oximetry, accelerometry-based heart rate and respiratory rate, and noninvasive blood pressure and capabilities represent natural complements to iRhythm's best in class ambulatory cardiac monitoring services and ECG data as these additional vitals provide a more holistic view into patient health, uncover risk factors in patients and optimize workflow efficiencies for overloaded hospital systems and physicians.

基於貼片的脈搏血氧飽和度、基於加速度的心率和呼吸頻率以及非侵入性血壓和功能是對iRhythm 一流的動態心臟監測服務和心電圖數據的自然補充，因為這些額外的生命體徵提供了對患者健康狀況的更全面的了解，發現病人的危險因子並優化超負荷的醫院系統和醫生的工作流程效率。

But we also believe that these platform capabilities will be necessary to ensure long-term positioning as we believe the ACM market may further develop to have progressively more multi-parameter sensing capabilities and deliver broader clinical insights.

但我們也相信，這些平台功能對於確保長期定位是必要的，因為我們相信 ACM 市場可能會進一步發展，逐漸擁有更多的多參數感測功能並提供更廣泛的臨床見解。

These naturally expanded capabilities may then enable us to enter other adjacent indications such as obstructive sleep apnea over the next several years in disease states where multiparametric vitals are important for clinical diagnosis. By utilizing our balance sheet to fund this type of technology development and partnering with an exceptional team of BioIntelliSense, I'm very excited to collaborate and accelerate the next chapter of connected patient care.

這些自然擴展的功能可能使我們能夠在未來幾年內進入其他鄰近的適應症，例如阻塞性睡眠呼吸中止症，多參數生命徵象對臨床診斷很重要。透過利用我們的資產負債表為此類技術開發提供資金，並與 BioIntelliSense 的傑出團隊合作，我非常高興能夠合作並加速互聯患者護理的下一章。

Finally, I'm so thrilled that our recent accomplishments are being recognized externally by a variety of third parties for our innovative technologies and population health improvements that our teams are committed to every day. In May, iRhythm was recognized on Newsweek's list of the World's Best Digital Health Companies for 2024. Its inaugural list that ranks the top 400 companies from over 35 different countries and evaluates companies' impact, financial performance, and online engagement.

最後，我很高興我們最近的成就得到了各種第三方的外部認可，因為我們的團隊每天都致力於創新技術和改善人口健康。5 月，iRhythm 入選《新聞周刊》2024 年全球最佳數位健康公司名單。其首份榜單對來自超過 35 個不同國家的 400 強公司進行了排名，並評估了公司的影響力、財務表現和線上參與度。

More recently, Newsweek also named iRhythm as one of America's Greenest Companies, a list that recognizes the top 500 companies in the US based on environmental sustainability and which scores companies on more than 25 parameters based on greenhouse gas, emissions, water usage, waste generation and data sustainability disclosure commitments.

最近，《新聞週刊》還將iRhythm 評為美國最環保公司之一，該名單根據環境永續性對美國500 強公司進行表彰，並根據溫室氣體、排放、用水、廢棄物產生等超過25 個參數對公司進行評分和數據可持續性揭露承諾。

Additionally, we are very happy to announce that we have been named one of the top four finalists for the 2024 Fierce Life Sciences Innovation Awards in the categories of Digital Health Solutions and Population Health Management and Patient Engagement Solutions. This is a major achievement in a highly competitive field with winners to be announced in December. As these recent accolades demonstrate, iRhythm is committed to driving significant growth in a responsible, sustainable, and profitable way for the benefit of all of our stakeholders.

此外，我們非常高興地宣布，我們已被提名為 2024 年 Fierce 生命科學創新獎數位健康解決方案、人口健康管理和患者參與解決方案類別的前四名決賽入圍者之一。這是競爭激烈的領域中的一項重大成就，獲獎者將於 12 月公佈。正如最近的這些榮譽所表明的那樣，iRhythm 致力於以負責任、可持續和盈利的方式推動顯著增長，以造福所有利益相關者。

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

現在，我將把電話轉給丹，討論我們最近的財務表現。

Thanks, 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. Our third quarter 2024 results demonstrated continued momentum in our core markets as we achieved revenue of $147.5 million representing 18.4% year-over-year growth.

謝謝，昆汀。提醒一下，除非另有說明，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。我們的 2024 年第三季業績顯示了我們核心市場的持續成長勢頭，我們實現了 1.475 億美元的收入，年增 18.4%。

As Quentin mentioned, these results were driven by record demand from existing accounts combined with another record quarter of new account openings. New store growth, with new store defined as accounts that have been opened for less than 12 months, accounted for approximately 36% of our year-over-year volume growth.

正如昆汀所提到的，這些結果是由現有帳戶創紀錄的需求以及新開戶數量再創新高所推動的。新店成長（新店定義為開設時間少於 12 個月的帳戶）約占我們同比銷量成長的 36%。

Home enrollment for Zio Services in the US was approximately 23% of volume in the third quarter. Gross margin for the third quarter was 68.8%, in line with our stated expectations. Compared to the second quarter 2024, the slight decrease was driven by the absence of some favorable onetime items noted during the prior quarter that benefited gross margin, while sustainable clinical operations and manufacturing efficiencies continued to benefit us in the third quarter.

第三季度，美國 Zio Services 的家庭註冊人數約佔數量的 23%。第三季毛利率為68.8%，符合我們預期。與2024 年第二季度相比，略有下降是由於上一季沒有出現一些有利的一次性項目，這些項目有利於毛利率，而可持續的臨床運營和製造效率在第三季度繼續使我們受益。

Compared to the prior year, gross margin improvement was driven by the advancement in automation and operational efficiency as well as reduced costs related to excess Zio XT inventory associated with the Zio monitor commercial launch in our third quarter 2023.

與前一年相比，毛利率的提高是由於自動化和營運效率的進步，以及與 2023 年第三季 Zio 顯示器商業發布相關的過剩 Zio XT 庫存相關成本的降低。

Third quarter adjusted operating expenses were $143.8 million up 14.9% sequentially and up 34.3% year-over-year. Compared to the third quarter of 2023, this increase in adjusted operating expenses was primarily driven by a $32.1 million charge for technology licensed that was recognized as acquired in process research and development expense during the third quarter.

第三季調整後營運費用為 1.438 億美元，季增 14.9%，年增 34.3%。與 2023 年第三季相比，調整後營運費用的增加主要是由於第三季在流程研發費用中確認為收購的 3,210 萬美元技術授權費用所致。

In alignment with SEC guidance around non-GAAP financial measures related to acquired IPR&D expense, iRhythm does not exclude acquired IPR&D expense from its non-GAAP results. Normalizing for this expense during the quarter, adjusted operating expenses would have been approximately $111.7 million or up approximately 4.3% year-over-year, demonstrating our continued progress toward realizing operating leverage within our P&L.

根據 SEC 關於與收購的 IPR&D 費用相關的非 GAAP 財務指標的指導，iRhythm 並未將收購的 IPR&D 費用排除在其非 GAAP 業績之外。在本季將此費用標準化後，調整後的營運費用約為 1.117 億美元，年增約 4.3%，這表明我們在實現損益表中的營運槓桿方面不斷取得進展。

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. The company increased its remediation activities in the Q3, bringing on additional consulting support, as Quentin noted previously. We now expect incremental expenses related to these activities to be approximately $11 million to $13 million in 2024 and a $15 million run rate per year going forward with these expenses continuing into 2025. Once we are through our remediation efforts, we expect the majority of these expenses to subside.

正如前幾季所指出的，我們繼續承擔增量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。正如昆汀之前指出的那樣，該公司在第三季度增加了補救活動，帶來了額外的諮詢支援。我們現在預計 2024 年與這些活動相關的增量費用約​​為 1,100 萬至 1,300 萬美元，並且每年運行費用為 1,500 萬美元，這些費用將持續到 2025 年。一旦我們完成補救工作，我們預計大部分費用將會減少。

Importantly, recent corporate actions intended to better align headcount resources to our corporate priorities and efficiently scale will help offset incremental FDA remediation expenses in the near term while positioning iRhythm to deliver sustainable profitability into the future.

重要的是，最近的公司行動旨在更好地將人員資源與我們的公司優先事項結合起來並有效擴大規模，這將有助於抵消近期FDA 增量補救費用，同時使iRhythm 能夠在未來實現可持續的盈利能力。

Adjusted net loss in the Q3 of 2024 was approximately negative $39.2 million or a loss of $1.26 per share compared to an adjusted net loss of $24.1 million or an adjusted net loss of $0.79 per share in the Q3 of 2023. Adjusted EBITDA in the Q3 of 2024 was negative $19.9 million or negative 13.5% of revenue compared to 0.3% in the Q3 of 2023 and 3.4% of revenue in the Q2 of 2024. Excluding the $32.1 million of acquired IPR&D, which was not contemplated in our previously issued guidance, adjusted EBITDA during the Q3 2024 would have been 8.3%.

2024 年第三季調整後淨虧損約為負 3,920 萬美元，即每股虧損 1.26 美元，而 2023 年第三季調整後淨虧損為 2,410 萬美元，即調整後每股淨虧損 0.79 美元。2024 年第三季調整後 EBITDA 為負 1,990 萬美元，佔營收的 13.5%，而 2023 年第三季為 0.3%，2024 年第二季為 3.4%。不包括我們先前發布的指導中未考慮的 3,210 萬美元收購的 IPR&D，2024 年第三季調整後的 EBITDA 將為 8.3%。

Turning to guidance. We are narrowing our 2024 revenue outlook as presented earlier this year and now anticipate full-year revenue to range between $582.5 million to $587.5 million. We continue to believe that the year will be driven by sustained volume growth in our core US market as we continue to drive penetration in both existing and new customer accounts. The Q4 of the year is historically our strongest of the year, and we have seen solid trends in the business to start the quarter.

轉向指導。我們正在縮小今年稍早提出的 2024 年收入預期，目前預計全年營收將在 5.825 億美元至 5.875 億美元之間。我們仍然相信，隨著我們繼續提高現有和新客戶帳戶的滲透率，今年將受到美國核心市場銷售持續成長的推動。從歷史上看，今年第四季是我們今年表現最強勁的季度，我們已經看到了本季伊始業務的穩健趨勢。

We are reiterating our full year 2024 gross margin guidance to a range of 68.5% to 69%, an improvement of approximately 150 basis points at midpoint compared to full year 2023. We have made significant progress year to date with clinical operations and manufacturing efficiencies and believe that these sustainable improvements will continue to lower our cost to serve over time.

我們重申 2024 年全年毛利率指引為 68.5% 至 69%，與 2023 年全年相比，中位數提高約 150 個基點。今年迄今為止，我們在臨床操作和製造效率方面取得了重大進展，並相信隨著時間的推移，這些可持續的改進將繼續降低我們的服務成本。

With respect to adjusted EBITDA margin, we now expect adjusted EBITDA margin for the full year 2024 to range from approximately negative 2% to negative 1.5% of full year revenues. As noted earlier, the charge for acquired IPR&D will not be excluded from our non-GAAP results. We expect the charge for acquired IPR&D to be in the range of $32.5 to $33.5 million for the full year. As noted earlier, we now anticipate legal and consulting fees related to FDA remediation efforts and DOJ matters will be approximately $11 million to $13 million for the full year.

關於調整後的 EBITDA 利潤率，我們目前預計 2024 年全年調整後的 EBITDA 利潤率將佔全年營收的約負 2% 至負 1.5%。如前所述，收購的智慧財產權與研發費用不會被排除在我們的非公認會計原則績效之外。我們預計全年收購的智慧財產權與研發費用將在 3250 至 3,350 萬美元之間。如前所述，我們現在預計全年與 FDA 補救工作和 DOJ 事務相關的法律和諮詢費用將約為 1,100 萬至 1,300 萬美元。

These expenses will be offset by the corporate activities that were executed to better align headcount resources to corporate priorities and to ensure efficient scaling into the future. Taken together, absent our transaction with BioIntelliSense, our adjusted EBITDA margin guidance would have been unchanged to prior guidance. Finally, we ended the Q3 in a strong financial position with approximately $522 million in unrestricted cash and short-term investments. During the Q3, we began to see improvements in working capital resulting from the recovery of delayed billings associated with the change health care cybersecurity incident in the Q1, and we anticipate further improvements to cash collections and normalized levels of DSO as we exit 2024.

這些費用將被為更好地將員工資源與公司優先事項結合並確保未來有效擴展而執行的公司活動所抵消。總而言之，如果沒有我們與 BioIntelliSense 的交易，我們調整後的 EBITDA 利潤率指引將與先前的指引保持不變。最後，我們在第三季結束時保持了強勁的財務狀況，擁有約 5.22 億美元的不受限制的現金和短期投資。在第三季度，我們開始看到因第一季醫療保健網路安全事件變化相關的延遲帳單恢復而帶來的營運資金改善，並且我們預計，隨著2024 年退出，現金收款和DSO 正常化水平將進一步改善。

To close, our financial accomplishments in the Q3 demonstrate continued commercial momentum in the business and solid operational execution by the iRhythm teams. We are in a strong financial position and are ensuring capital and resources are allocated to FDA remediation priorities while appropriately investing for the long-term growth of the business. And our teams are focused on implementing sustainable efficiencies to drive continued profitability expansion into the future.

最後，我們第三季的財務成就證明了業務的持續商業勢頭以及 iRhythm 團隊紮實的營運執行力。我們擁有強大的財務狀況，並確保將資本和資源分配給 FDA 的補救重點，同時適當投資於業務的長期成長。我們的團隊致力於實現可持續的效率，以推動未來獲利能力的持續擴張。

With that, we would like to now open the call for questions. Operator?

至此，我們現在開始提問。操作員？

Thank you, Dan. (Operator Instructions).

謝謝你，丹。（操作員說明）。

Alan Gong, J.P. Morgan.

龔艾倫，摩根大通。

Hi, thanks. So, I just want to start off with Zio AT or an MCT, right? So, disappointing to hear that the approval is being pushed back. Just kind of curious, when we think about, your decision to do this, how much of that was, you know, informed by conversations with the FDA. And how much of that was kind of your own decision to bolster the submission to ensure that you get approval in a timely fashion.

你好，謝謝。所以，我只想從 Zio AT 或 MCT 開始，對嗎？因此，聽到批准被推遲的消息令人失望。只是有點好奇，當我們想到你這樣做的決定時，你知道，其中有多少是透過與 FDA 的對話得知的。其中有多少是您自己決定支持提交以確保您及時獲得批准。

Hey, Allen Thanks for the question. This is Quentin here. Hey, before I jump in and answer that question, I wanted to share with our audience. This is a bit unusual, but we did learn that subsequent to starting our call this afternoon. We get notice from the FDA that they have cleared our second 510(k) submission with that Zio AT product for the design enhancements that we had put forward as part of our warning letter remediation efforts.

嘿，艾倫，謝謝你的提問。這是昆汀。嘿，在我回答這個問題之前，我想與我們的觀眾分享。這有點不尋常，但我們在今天下午開始通話後確實了解到了這一點。我們從 FDA 收到通知，他們已經批准了我們針對 Zio AT 產品提交的第二份 510(k) 申請，以改進我們在警告信補救工作中提出的設計改進。

So, I think another good sign that we continue to make good progress with the FDA down the path of remediation and certainly pleased to see that second 510(k) approval come through. So, I wanted to share that with the group as I think that's important information to get out there.

因此，我認為這是另一個好跡象，表明我們在 FDA 的補救道路上繼續取得良好進展，並且當然很高興看到第二次 510(k) 批准獲得通過。因此，我想與小組分享這一點，因為我認為這是需要傳達的重要訊息。

Allen, with respect to your question on MCT, I think it's very important to understand. This is completely our decision. It is a proactive voluntary decision on our part, coming out of the 483 observations here in July, as we certainly accept the FDA's position that the qualified technicians are a part of the product, as we brought new leadership on board with us and also engaged incremental outside experts to help us think through and navigate this position.

Allen，關於你關於 MCT 的問題，我認為理解這一點非常重要。這完全是我們的決定。這是我們根據7 月的483 項觀察結果做出的一項主動自願的決定，因為我們當然接受FDA 的立場，即合格的技術人員是產品的一部分，因為我們帶來了新的領導層，並參與其中不斷增加外部專家來幫助我們思考並掌握這一立場。

I think it's become very clear, that there are certain remediation efforts that we need to demonstrate some very quick progress against, just again in the spirit of understanding the FDA's position and making sure that they see that we are aligned to it.

我認為，很明顯，我們需要在某些補救措施上展示一些非常快速的進展，再次本著理解 FDA 立場並確保他們看到我們與其保持一致的精神。

But also knowing that with the qualified technician being part of the product, there is some incremental work that we can do to bolster that submission when we make it for MCT to head off any questions that we would expect are going to come from the FDA as part of that, now that the qualified technicians are in fact part of the product.

但也知道，隨著合格的技術人員成為產品的一部分，當我們向 MCT 提交產品時，我們可以做一些增量工作來支持提交，以阻止我們預期 FDA 提出的任何問題，因為其中一部分，現在合格的技術人員實際上是產品的一部分。

So, this is a proactive choice on our part. We understand it's disappointing that we're pushing the submission date out, but we think it'll be a much more robust submission. I think it sends all the right signals to the FDA that we acknowledge their point of view. We accept it and agree with it, and we're going to make sure our filing falls in line with that as well.

所以，這是我們主動的選擇。我們知道推遲提交日期令人失望，但我們認為這將是一個更穩健的提交。我認為這向 FDA 發出了所有正確的信號，表明我們承認他們的觀點。我們接受並同意它，我們將確保我們的備案也符合這一點。

Thanks. And then just a really quick follow-up on the guide. Sorry for sneaking this in, but when I look at kind of the midpoint of the guide, you're implying pretty strong $10 million step up into the fourth quarter. What really gives you kind of the confidence to reiterate the guide despite third quarter maybe being a little bit softer than your usual being raised cadence. Thank you very much.

謝謝。然後對指南進行快速跟進。抱歉偷偷透露了這一點，但是當我查看指南的中點時，您暗示第四季度將增加 1000 萬美元。儘管第三季的節奏可能比平常的節奏要軟一些，但真正讓您有信心重申指南的是什麼。非常感謝。

Yes, Thanks, Allen for the question. This is Dan. So, I think you heard from our prepared remarks, seeing really good momentum in the business, a lot of strength there. We talked about the new accounts onboarding in Q3. So, feel really good about what that means for future growth, and that really is nice and balanced across both XT and AT. So, feel like there's a good setup for the Q4 and our guidance reflects that.

是的，謝謝艾倫提出問題。這是丹.所以，我想您已經聽到了我們準備好的講話，看到了業務的良好勢頭，那裡有很大的實力。我們討論了第三季的新帳戶加入。因此，對這對未來成長意味著什麼感到非常滿意，這對於 XT 和 AT 來說確實是很好且平衡的。因此，感覺第四季度有一個很好的設置，我們的指導反映了這一點。

Macauley Kilbane, William Blair.

麥考利·基爾巴恩，威廉·布萊爾。

Hi, everyone. This is Macaulay on for Margaret tonight. Thanks for taking the question. Dan, maybe just to follow-up on that. I and, obviously, a record number of new accounts in the quarter, which is great to see. Could you just maybe talk about the profile, of the average account that that's coming on board, whether, these are competitive switches. I'd assume they're coming on with both monitor and AT, but just to level set us there.

大家好。這是麥考利今晚為瑪格麗特做的節目。感謝您提出問題。丹，也許只是為了跟進此事。顯然，本季新帳戶數量創歷史新高，這是很高興看到的。您能否談談即將加入的平均帳戶的概況，這些是否是有競爭力的交換器。我認為他們會同時配備顯示器和 AT，但只是為了讓我們保持水平。

And then as you mentioned, it feels like the accumulation of record ads here the last few quarters should allow you to accelerate that volume growth, to north of 20% as we look towards 2025. Just wondering, expectations as we look beyond Q4 and into next year.

正如您所提到的，過去幾季創紀錄的廣告累積應該會讓您加速銷售成長，展望 2025 年，銷售量將成長到 20% 以上。只是想知道，當我們展望第四季和明年時的期望。

Yes. Nicole, this is Dan. I could start and Quentin can add to it. So, you're right to point out the record number of new account adds in terms of a good indicator for future growth. The profile of those accounts, I think, is pretty consistent with where we're winning in the past, with maybe one exception being there are a number of large accounts that are recently won or in the pipeline. The timing of those accounts in terms of converting them into a full launch and how they really ramp is a bit longer to be honest, which you would naturally expect as these accounts are bigger, they're often launching with full EHR integration and that takes time.

是的。妮可，這是丹。我可以開始，昆汀可以補充。因此，您指出創紀錄的新帳戶數量是未來成長的良好指標，這是正確的。我認為，這些帳戶的概況與我們過去獲勝的情況非常一致，也許有一個例外，即有許多最近贏得或正在準備的大型帳戶。老實說，這些帳戶將其轉換為全面啟動以及它們如何真正提升的時間要長一些，您自然會期望這些帳戶更大，它們通常會與完整的 EHR 集成一起啟動，這需要時間。

It takes IT resources on their side to execute on that EHR integration. So, we are seeing the selling cycle a little bit extended as it relates to those accounts. Otherwise, the profile is pretty similar. You do know we're expanding more and more in the primary care, so naturally turning on more and more primary care accounts. We feel really good about what that means for future growth. As it relates to kind of going forward, in 2025, again, I think this sets us up well for 2025.

他們需要 IT 資源來執行 EHR 整合。因此，我們看到與這些帳戶相關的銷售週期有所延長。除此之外，個人資料非常相似。您確實知道我們在初級保健領域的擴張越來越多，因此自然會啟用越來越多的初級保健帳戶。我們對這對未來成長的意義感到非常滿意。因為它涉及 2025 年的未來，我認為這為我們 2025 年做好了良好的準備。

You did hear our comments on Zio MCT being pushed out the submission there and ultimately the commercial launch into 2026. We thought of that as kind of a $10 million plus incremental revenue opportunity in 2025. So that does need to be accounted for. And then you think about international, we're just getting started with the four European countries that we launched in the Q3. Those will take a bit of time to ramp. We'll see that start to contribute in 2025. And then of course, Japan launching, call it, mid-year next year, which will have a little bit of contribution to 2025.

您確實聽到了我們對 Zio MCT 被推遲提交並最終在 2026 年進行商業發布的評論。我們認為這是 2025 年 1000 萬美元以上增量收入的機會。所以這確實需要考慮。然後你想想國際市場，我們在第三季推出的四個歐洲國家才剛開始。這些需要一些時間才能完成。我們將在 2025 年看到它開始做出貢獻。當然，日本將於明年年中推出，這將為 2025 年做出一點貢獻。

I would just point out, Michael, our unit volume growth has accelerated every quarter this year. Each quarter, it stepped up from the prior quarter and in our guidance, our Q4 unit volume growth will step up once again. So, we continue to feel good about the momentum in the business. I think starting to see these Zio AT accounts come back online and adding at rates even faster than what they were prior to the warning letter being issued or the field advisory notice being put out there almost a year and a half ago is really encouraging to see, and I commented on the fact that we're seeing that in the Q4 as well.

我只想指出，邁克爾，我們今年每季的銷售成長都在加速。每個季度，它都比上一季度有所加快，根據我們的指導，我們第四季度的銷售成長將再次加快。因此，我們繼續對業務勢頭感覺良好。我認為，開始看到這些 Zio AT 帳戶重新上線，並以比發出警告信或發佈現場諮詢通知之前的速度更快的速度添加，大約一年半前，這確實令人鼓舞，我評論說我們在第四季也看到了這一點。

So, we're very bullish from that perspective. We're excited to see Epic Aura get implemented and begin to be launched here in the fourth quarter with a handful of accounts, but then turned on as we moved into 2025, to our entire commercial team. So, that excites us. But to Dan's point, MCT is going to be delayed and we want to make sure that we're thoughtful about that. But the AT business has been strong.

因此，從這個角度來看，我們非常看好。我們很高興看到 Epic Aura 得到實施，並在第四季度開始在少數帳戶中推出，但隨著我們進入 2025 年，我們的整個商業團隊才開始使用它。所以，這讓我們很興奮。但就 Dan 而言，MCT 將被推遲，我們希望確保我們對此深思熟慮。但 AT 業務一直很強勁。

Kallum Titchmarsh, Morgan Stanley.

卡勒姆·蒂奇馬什，摩根士丹利。

Great. Thanks for taking the question. I wanted to touch on the BioIntelliSense licensing agreement, and that push into vital signs beyond Zio's capabilities today. Maybe you could provide us more color around commercial aspirations for this deal. When could we see a product with these features out there in the market.

偉大的。感謝您提出問題。我想談談 BioIntelliSense 授權協議，以及該協議對生命體徵的推動超出了 Zio 目前的能力範圍。也許您可以為我們提供有關這筆交易的商業願望的更多資訊。我們什麼時候才能在市場上看到具有這些功能的產品。

And I know a competitor of yours in the remote monitoring space has talked about the inpatient opportunity from their multi-parameter patch. So, checking to see if that's somewhere you would like to push into at some point too. Thanks.

我知道您在遠端監控領域的競爭對手已經談到了他們的多參數貼片帶來的住院機會。因此，請檢查您是否也想在某個時候進入該領域。謝謝。

Yes, Kallum look, we're really excited about the BioIntelliSense partnership that we've been able to bring together. I think this is very much a longer-term strategic investment that we've made with the idea of bringing these multi-sensing capabilities on a single platform off of the chest.

是的，Kallum 看來，我們對 BioIntelliSense 合作夥伴關係感到非常興奮。我認為這在很大程度上是一項長期策略投資，我們的想法是立即將這些多感測功能帶到一個平台上。

And I think that their PPG capability is a bit unique differentiated, brings pulse oximetry opportunities to us off the chest, accelerometry, advanced accelerometry that gets us some heartbeat, respiratory rate, heart rate analysis, all things that are going to improve the overall offering that I think will help us continue to protect the ACM space, but ultimately go beyond that in the multivital sign monitoring.

我認為他們的PPG 功能有點獨特，差異化，為我們帶來了脈搏血氧測定的機會，加速測量，先進的加速測量可以讓我們獲得一些心跳、呼吸頻率、心率分析，所有這些都將改善整體產品我認為這將幫助我們繼續保護 ACM 領域，但最終將超越多生命徵象監測領域。

The inpatient setting, it's interesting to us. I think the real opportunity quite frankly is to disrupt the hospital into the home setting. And I think that we know how to do that in ambulatory setting better than anybody else. I think we bring a very large IDTF capability to it, which allows us to monitor remotely very well. And so, I think we have a real opportunity to disrupt that space and time, but that's going to be a few years out.

住院環境對我們來說很有趣。坦白說，我認為真正的機會是將醫院顛覆到家庭環境中。我認為我們比其他任何人都更知道如何在門診環境中做到這一點。我認為我們為其帶來了非常大的 IDTF 能力，這使我們能夠很好地進行遠端監控。因此，我認為我們確實有機會顛覆這個空間和時間，但這需要幾年的時間。

That will become a product that makes its way into our bag behind the MCT product that we're going to focus on 1st, but it's one that gets us very excited about. I think it also gives us a direct line into how we get to a home sleep test off of the chest that ultimately will benefit our sleep activities that we've talked about historically as well. So, a lot of strategic implications in there, a terrific partner. I look forward to what we're going to be able to do together.

這將成為我們首先關注的 MCT 產品之後進入我們袋子的產品，但它讓我們非常興奮。我認為它也為我們提供瞭如何進行家庭睡眠測試的直接途徑，這最終將有利於我們歷史上討論過的睡眠活動。所以，這裡面有很多戰略意義，是個很棒的合作夥伴。我期待著我們能夠一起做些什麼。

Marie Thibault, BTIG.

瑪麗蒂博，BTIG。

Hi. Good evening. Apologies for the background noise. Wanted to ask a little bit more detail on the remediation efforts, and bringing cardiac technicians into the fold. Can you talk a little bit about the processes that need to happen to take the IDTF folks into the kind of the quality assurance here.

你好。晚安.對背景噪音表示歉意。想詢問有關補救工作的更多細節，並讓心臟技術人員參與其中。您能否談談將 IDTF 人員帶入此處的品質保證所需的流程。

And as a second part follow-up, with the delay on MCT, are there any opportunities on R&D side to maybe further wear time on that product or make other improvements that you plan now that you have a few extra quarters to do it? Thanks.

作為第二部分後續行動，隨著 MCT 的延遲，研發方面是否有機會進一步延長該產品的磨損時間，或者進行您計劃的其他改進，因為您現在有幾個額外的季度來做這件事？謝謝。

Yes. Good question. I think from an IDTF perspective, and bringing them into the fold of our quality management system. I will tell you, there's not going to be any impact to the patients in terms of how they experience the product or the physicians and how they experience the product.

是的。好問題。我從 IDTF 的角度思考，並將它們納入我們的品質管理系統中。我會告訴你，就病人如何體驗產品或醫生以及他們如何體驗產品而言，不會有任何影響。

But it is internal workflow and how we think about documenting our quality management system, how we think about complaints, reporting, risk analysis, statistical analysis that we apply to it. All of those things are impacted as a result of bringing the technician into the product and service offering.

但這是內部工作流程以及我們如何考慮記錄我們的品質管理體系，我們如何考慮投訴、報告、風險分析、統計分析。所有這些事情都會因將技術人員引入產品和服務而受到影響。

It also means that it becomes part of any future submissions when we go to the FDA for new approvals, which is why the MCT product is going to be delayed a bit here as we work to bring into the submission, any and all implications that involving the technician now has with the product. So, I don't expect it to impact how it shows up in the marketplace and how the patient experiences it or how the physician experiences it, but it does have some internal process and documentation requirements that just take time to work through and get completed.

這也意味著，當我們向FDA 尋求新的批准時，它將成為任何未來提交的文件的一部分，這就是為什麼MCT 產品將在這裡稍微延遲，因為我們正在努力將涉及以下內容的任何和所有影響納入提交中：技術人員現在已經擁有該產品。因此，我預計它不會影響它在市場上的顯示方式以及患者或醫生的體驗方式，但它確實有一些內部流程和文件要求，只是需要時間來完成和完成。

I also do believe Marie that we're starting to see the broader industry begin to be impacted by some of this. I think there's other players in our space, who deal in the MCT space that are beginning to see how the FDA has worked through iRhythm and identified their strong point of view around the qualified technicians and their inclusion in the product. And now we're starting to see that play out with industry partners as well on a case by case basis. So, I do think this is broader industry, not just, iRhythm specific.

我也相信瑪麗，我們開始看到更廣泛的行業開始受到其中一些影響。我認為我們領域還有其他涉及 MCT 領域的參與者，他們開始了解 FDA 如何透過 iRhythm 開展工作，並確定了他們對合格技術人員及其在產品中的納入的強烈觀點。現在，我們開始看到這種情況與行業合作夥伴一起在具體案例的基礎上發揮作用。所以，我確實認為這是一個更廣泛的行業，而不僅僅是 iRhythm 特定的行業。

With respect to MCT, our wear time on the next generation of our Zio AT or what will now become Zio MCT will have a longer wear duration to it. That has been something that's been part of the design from the very get go. When we talk with our customers and we receive the feedback from the market, the most critical aspect of making Zio AT more competitive is the wear time. And so, we will extend that wear time in this next submission and continue to address those market needs with that product.

就 MCT 而言，我們新一代 Zio AT 或現在的 Zio MCT 的磨損時間將更長。這從一開始就是設計的一部分。當我們與客戶交談並收到市場回饋時，讓Zio AT更具競爭力的最關鍵方面是磨損時間。因此，我們將在下一次提交中延長佩戴時間，並繼續透過該產品滿足這些市場需求。

David Ryman. Goldman Sachs.

大衛萊曼.高盛。

Thank you and good afternoon everyone. I wanted maybe to talk a little bit about the expansion in the UK and internationally. You also got approval in Japan during the quarter. You talked about ramping up with your partner. But can you maybe help us think about the extent to which international represents an incremental contributor or perhaps helps offset some of the MCT delay in the $10 million that Dan referenced and how we should think about that ramp OUS?

謝謝大家，大家下午好。我也許想談談在英國和國際上的擴張。本季您還在日本獲得了批准。你談到了與你的伴侶一起進步。但是，您能否幫助我們思考國際在多大程度上代表了增量貢獻者，或者可能有助於抵消 Dan 提到的 1000 萬美元中的部分 MCT 延遲，以及我們應該如何考慮 OUS 的成長？

Yes. Well, we're certainly very excited about the international business. We've been in the UK market for a period of time now. We continue to work from a reimbursement perspective with the public health systems, but we're making very good progress on the private side, sort of in parallel. So, we're going after that market in two different ways. And then by opening up these new incremental European markets being Switzerland, Spain, Austria and the Netherlands. That certainly is exciting for us as we think about the product getting started there and we're already starting to see the first orders come through from those opportunities, but that's going to be our primary focus in the EU out of the gate.

是的。嗯，我們當然對國際業務感到非常興奮。我們進入英國市場已經有一段時間了。我們繼續從報銷的角度與公共衛生系統合作，但我們在私人方面也取得了非常好的進展，某種程度上是並行的。因此，我們將以兩種不同的方式來爭取這個市場。然後透過開放瑞士、西班牙、奧地利和荷蘭等新的增量歐洲市場。這對我們來說當然是令人興奮的，因為我們考慮到產品在那裡啟動，我們已經開始看到第一批訂單來自這些機會，但這將是我們在歐盟的主要關注點。

Japan is probably the most exciting international market out there for us. We couldn't be more excited about the fact that we do have the high medical needs designation. We're working with them from a reimbursement perspective now. We would expect that in the first part of 2025 and to be launching into that market commercially in the first half of 2025. So, how quickly that ramps is something that we're going to monitor. I don't expect, David, to get out ahead of ourselves there.

日本可能是我們最興奮的國際市場。我們確實擁有高醫療需求指定，這一事實讓我們感到無比興奮。我們現在正在從報銷的角度與他們合作。我們預計將於 2025 年上半年實現這一目標，並於 2025 年上半年投入商業市場。因此，我們要監控其成長速度。大衛，我不期待我們能夠超越自己。

We're going to want to see this play in the market and build some momentum and success before we start to really get ahead of ourselves there. But that's just something that we're going to have to learn with experience. But when you see the excitement that's growing in and around the Zio product in those international markets, just the brand awareness of the product, when you go to those international trade shows and meetings with the KOLs within the country, it's very clear of the awareness of Zio and I think it sets us up for some nice success early on.

我們希望在市場上看到這種遊戲，並在我們開始真正超越自己之前建立一些動力和成功。但這只是我們必須透過經驗來學習的東西。但是，當您看到這些國際市場上Zio 產品及其周圍日益增長的興奮感，以及產品的品牌知名度時，當您參加這些國際貿易展覽以及與國內KOL 的會議時，您會非常清楚地認識到該產品的品牌知名度Zio 的作品，我認為這為我們在早期取得一些不錯的成功奠定了基礎。

But we'll guide you the particular impact in 2025 As we get closer to it, it will be an incremental contributor. International, this year is, call it one, pushing on 2% of overall revenue. I think you're going to see that grow over the next 3%, 4%, 5 years to 8%, 9% of revenue.

但我們將引導您了解 2025 年的具體影響，隨著我們越來越接近它，它將成為增量貢獻者。國際業務，今年可以說是第一年，佔總收入的 2%。我認為你會看到它在未來 3%、4%、5 年成長到收入的 8%、9%。

David Rescott, Baird.

大衛雷斯科特，貝爾德。

Great. Thanks for taking the questions. I have a couple of just kind of clarification questions that I'll ask as my question. It sounds you heard the prepared remarks around the Q3 2025 submission for MCT. Then heard in the comments, the recent 510(k) clearance or that second clearance that we had been expecting.

偉大的。感謝您提出問題。我有幾個需要澄清的問題，我將作為我的問題提出。聽起來您已經聽到了有關 2025 年第三季 MCT 提交的準備好的評論。然後在評論中聽到最近的 510(k) 許可或我們一直期待的第二次許可。

It sounds like the delay of MCT is more based on some of the incorporations you're making from the updates we heard on the 43 earlier in the year and they were on the CCTs. So just the first question again is that correct? Is there no update or no change now to the Q3 2025 submission based on again this update around the second 510(k) clearance?

聽起來 MCT 的延遲更多是基於我們今年早些時候聽到的 43 更新中所做的一些合併，它們是在 CCT 上的。那麼第一個問題又是正確的嗎？基於第二次 510(k) 許可期間的更新，2025 年第三季提交的內容是否沒有更新或沒有更改？

And then, for the $10 million called out, of the maybe incremental impact from the delay? I'm just trying to get a sense for what the baseline of that would have been off of. I know the longer-term guide is the 20% on the top line. You're doing 18% to 19% this year.

那麼，對於所撥出的 1000 萬美元，延遲可能帶來的增量影響是什麼？我只是想了解它的基線是什麼。我知道長期指導是收入的 20%。今年你的成績是 18% 到 19%。

So it's a good way for next year to think about the impact of maybe 18%, 19% growth off of where you shake out this year. Take out maybe half or 70% of the $10 million and that's the baseline maybe or the outlook for next year. Thank you.

因此，這是明年考慮 18%、19% 的成長所帶來的影響的好方法。拿出 1000 萬美元中的一半或 70%，這可能是基線或明年的前景。謝謝。

Yes. We're not going to guide specifically, David, the 2025 just yet. I think the way you just described that is the right way to begin to think about it. When you think about the impact of MCT next year, obviously, this is a product that we think can really accelerate the AT profile.

是的。David，我們目前還不會具體指導 2025 年。我認為你剛才描述的方式是開始思考這個問題的正確方式。當你考慮明年 MCT 的影響時，顯然，這是我們認為能夠真正加速 AT 輪廓的產品。

We're very happy with how AT is performing right now, but I also have a very, very strong point of view that it's just not quite the right product for the market. And that when we do have that right product, it's going to be able to accelerate that growth profile. But I think that you're thinking about the way you just described there 2025 the right way when you think about adjusting for the MCT delay.

我們對 AT 目前的表現非常滿意，但我也有一個非常非常強烈的觀點，就是它不是適合市場的產品。當我們確實擁有合適的產品時，它將能夠加速這種成長。但我認為，當您考慮調整 MCT 延遲時，您正在考慮您剛剛在 2025 年描述的方式。

There are no changes in this MCT product submission from a design perspective or features perspective as a result of the 510(k) approvals that we've received with Zio AT. That has not been anything that the FDA has asked for.

由於我們透過 Zio AT 獲得了 510(k) 批准，因此從設計角度或功能角度來看，此 MCT 產品提交沒有任何變更。FDA 並沒有要求這樣做。

To be quite clear, the MCT product has design enhancements that were already in it that were designed to address some of the concerns that the FDA had in Zio AT to begin with. Think about that as the max trigger limit and how we reduce that even further, but those are already designed into the product.

需要明確的是，MCT 產品已經在設計上進行了改進，旨在解決 FDA 最初對 Zio AT 提出的一些擔憂。將其視為最大觸發限制以及我們如何進一步減少它，但這些已經設計到產品中。

What's very clear in working with the FDA is that by bringing the technician into the workflow and the defined product itself and service, there are a lot of questions of how the technicians interact with the software and ultimately get to the final report. So, there is human factor testing that we will perform, to provide in that submission to show the FDA exactly how that interaction works.

在與 FDA 合作的過程中非常清楚的是，透過將技術人員帶入工作流程以及定義的產品本身和服務，技術人員如何與軟體互動並最終獲得最終報告存在許多問題。因此，我們將進行人為因素測試，以便在提交的文件中向 FDA 準確地展示這種交互作用是如何發揮作用的。

But these are questions that they've been asking on the Zio AT submissions. And it's clear that they're most likely to ask these with Zio MCT as well now, and we need to go ahead and prepare that ahead of time and go ahead and submit it, which is going to take a bit of time to complete, but it's the right thing to do. And again, demonstrates our commitment to addressing the FDA's expectations and making sure that we do that in a satisfactory way.

但這些都是他們在 Zio AT 提交的資料中提出的問題。很明顯，他們現在也最有可能向 Zio MCT 詢問這些問題，我們需要提前準備好並提交，這將需要一些時間才能完成，但這是正確的做法。再次表明我們致力於滿足 FDA 的期望並確保我們以令人滿意的方式做到這一點。

Richard Newitter, Truist.

理查德·紐特，真理主義者。

Hi. Thanks for taking the questions. Quentin, I guess a couple for me. One is, you put a stake in the ground for 3Q 2025 for MCT, and you've identified the incremental spend that you need or that you think you need to remediate. This has been a bit of a challenge for you guys. Just the timelines and what is required and how much spend is required. I guess, what can you tell us to get confident that these are the right timelines and this is the right spending level and you have all the information you need to kind of start being able to make progress with the FDA versus having kind of ongoing delays?

你好。感謝您提出問題。昆汀，我想有幾個適合我。一是，您在 2025 年第三季為 MCT 投入了資金，並且您已經確定了您需要或您認為需要補救的增量支出。這對你們來說是一個不小的挑戰。只是時間表、需要什麼以及需要多少支出。我想，您能告訴我們什麼才能讓我們確信這些是正確的時間表，這是正確的支出水平，並且您擁有開始能夠與 FDA 取得進展而不是持續拖延所需的所有信息？

Yeah. Rich, I think it's a fair question. I think with respect to the spend, the $15 million of remediation, I think it's important to note, our remediation efforts at this point are going beyond what the FDA has identified in the warning letter, as well as the recent 43 observations. We have taken a step back and we're looking at the entire quality management system, every aspect of it, trying to anticipate where the FDA would look or may look if they were to come back and subsequent inspections. And we want to make sure that the entire quality management system is up to their expectation.

是的。里奇，我認為這是一個公平的問題。我認為就支出而言，1500 萬美元的補救措施，我認為重要的是要注意，我們目前的補救工作超出了 FDA 在警告信中確定的範圍，以及最近的 43 項觀察結果。我們後退了一步，正在研究整個品質管理系統的各個方面，試圖預測如果 FDA 回來進行後續檢查，他們會或可能會在哪裡進行檢查。我們希望確保整個品質管理系統達到他們的期望。

It's a big part of why we've engaged another outside expert who has experience in building and remedying these quality management systems, navigating through warning letters and even worse for companies. And we're having them perform periodic audits as we go through the process to ensure that progress is being made. And ultimately, they will audit the entire QMS, Quality Management System, at the end of this process here in 2025, looking at it from beginning to end, every aspect of it, to ensure that it's up to a level that we can all be happy with and that we can feel very confident if the FDA were to come in and want to look in that particular area, we would more than meet their need.

這就是為什麼我們聘請了另一位外部專家，他在建立和修復這些品質管理系統、應對警告信甚至對公司來說更糟糕的情況方面擁有豐富的經驗。我們讓他們在我們完成整個過程時進行定期審核，以確保取得進展。最終，他們將在 2025 年這一流程結束時審核整個 QMS（品質管理系統），從頭到尾檢查它的各個方面，以確保它達到我們都可以達到的水平。信心，如果FDA 介入並希望在該特定領域進行研究，我們將不僅僅滿足他們的需求。

So that has been our approach is to rather than just focus on addressing the FDA's concerns they've identified, let's go after the entire quality management system and look at the entire thing from a holistic perspective. That's why the spend will continue here throughout 2025 at about that $15,000,000 rate that Dan noted. I do want to point out, we've taken other corporate actions that will offset the $15,000,000 next year. So, from a profitability perspective, you're going to continue to see really nice improvements in the profit profile of the company, again in 2025, while we work through remediating this.

因此，我們的方法是，不要只專注於解決 FDA 所發現的問題，而是要專注於整個品質管理體系，並從整體角度來看待整個問題。這就是為什麼 2025 年的支出將繼續以 Dan 指出的 1500 萬美元左右的速度繼續。我確實想指出，我們已經採取了其他企業行動來抵消明年的 15,000,000 美元。因此，從獲利能力的角度來看，在我們努力解決這一問題的同時，您將在 2025 年繼續看到公司利潤狀況的真正良好改善。

And then ultimately, when that spend goes away, it will drop through to the bottom line. With respect to the timeline of Q3 2025, I think it's important to note, if we wanted to, we could submit the MCT submission in the very near term. The reality is, we know that there are going to be questions that are going to be asked and that there's work that needs to be done to address the aspect of involving and including the technicians as part of the product. We're going to take the time to go ahead and do the work necessary upfront and try to address those questions before they're asked.

最終，當這筆支出消失時，它就會下降到底線。關於 2025 年第三季的時間表，我認為值得注意的是，如果我們願意，我們可以在近期提交 MCT 提交。現實情況是，我們知道將會提出一些問題，並且需要做一些工作來解決將技術人員納入產品一部分的問題。我們將花時間提前做好必要的工作，並嘗試在這些問題被問到之前解決它們。

So, when we look at the timeframes internally, we'll be driving ourselves to something more aggressive than that Q3 timeframe. But I think the Q3 timeframe is the right way to set expectations, considering the moving pieces that we've seen in the past, and that's our best estimate to do it.

因此，當我們在內部審視時間框架時，我們將推動自己採取比第三季時間框架更激進的措施。但我認為，考慮到我們過去看到的變化，第三季的時間表是設定預期的正確方式，這是我們對此的最佳估計。

William Plovanic, Canaccord Genuity.

威廉‧普洛瓦尼克 (William Plovanic)，Canaccord Genuity。

Great. Thanks for taking my questions. Quentin, I was just hoping you could just help us with kind of cadence milestones to really measure against as you move forward. You've given us a point in time for the Q3 filing. But is there anything we need to see with the 483 letters, can that be come up warning letter? Do you expect that? Are there any milestones on the remediation that we could expect to see or should anticipate?

偉大的。感謝您回答我的問題。昆汀，我只是希望你能幫助我們制定節奏里程碑，以便在你前進時真正衡量。您已向我們提供了第三季備案的時間點。但是這483封信有什麼我們需要看的嗎？你期待嗎？我們可以期望看到或應該預期的補救措施是否有任何里程碑？

What are the mileposts or guideposts as you go forward on your way to the path to file that MCT filing? Thanks.

在您邁向提交 MCT 備案的道路上，有哪些里程碑或路標？謝謝。

Yeah. No, I can't speculate on where the FDA may or would go with this. Obviously, we're doing all that we can to demonstrate very clearly to them that we're committed to remedying their concern. But even beyond that, looking at the entire quality management system and rebuilding the entire thing from the ground up. And we've shared that directly with the FDA.

是的。不，我無法推測 FDA 可能或將會採取什麼行動。顯然，我們正在盡一切努力向他們清楚地表明我們致力於消除他們的擔憂。但除此之外，也要檢視整個品質管理系統並從頭開始重建整個系統。我們已直接與 FDA 分享了這一點。

And look, they're also very much familiar with the third parties that we brought in to help here. And they know the level of work that they hold their selves to or themselves to and the audit scrutiny that we're going to subject ourselves to as they perform their audits as we go across our against the progress that we're making.

看，他們也非常熟悉我們聘請來提供協助的第三方。他們知道他們自己要求的工作水平，以及當他們執行審計時我們將接受的審計審查，因為我們正在檢查我們正在取得的進展。

So, we're trying to demonstrate very clearly that there really is no cost that's going to prohibit us from remedying this situation with the FDA, and it is the top priority in our entire company. And I think that's very important to note.

因此，我們試圖非常清楚地證明，確實沒有任何成本可以阻止我們與 FDA 合作解決這種情況，這是我們整個公司的首要任務。我認為這一點非常需要注意。

With respect to progress along the way. I don't know that there's anything that's going to be very visible publicly with response to or with respect to the 483 observations. We report out to the FDA every single month against the commitments that we made to them, and the progress that we're making. And of course, it is a very important aspect that we stay on time with respect to those improvements.

關於一路走來的進步。我不知道有什麼會非常明顯地公開回應或涉及 483 意見。我們每個月都會向 FDA 報告我們向他們所做的承諾以及我們正在取得的進展。當然，我們按時完成這些改進是一個非常重要的方面。

I think there's updates we can provide to you along the way with respect to, are we on track or are we not on track with respect to the remediation efforts, and that's information that we would be willing to share as we get going. But that's probably the extent of how you're going to see it showing up in the public market is us giving you updates on the remediation efforts and the progress against the commitments to which we've made, and that's something we're willing to do.

我認為我們可以一路向您提供有關我們的補救工作是否步入正軌或未步入正軌的最新信息，這是我們願意在行動過程中分享的信息。但這可能是您在公開市場上看到的情況，我們向您提供有關補救措施的最新資訊以及我們所做的承諾的進展情況，這是我們願意做的事情。

Suraj Kalia, Oppenheimer.

蘇拉吉·卡利亞，奧本海默。

Quentin, can you hear me all right?

昆汀，你聽得到我說話嗎？

Yes, we got you.

是的，我們找到你了。

Perfect. Hey, Quentin, two questions. I'll post both of them upfront. So, on Zio MCT, I just want to make sure I understand this correctly. Will there still be some level of event trigger thresholds built into the system that the FDA would essentially say, yes, this is the right amount, go with this, given the form factor? That's one question.

完美的。嘿，昆汀，有兩個問題。我會預先發布它們。因此，在 Zio MCT 上，我只想確保我正確理解這一點。系統中是否仍會內建一定程度的事件觸發閾值，FDA 基本上會說，是的，考慮到外形因素，這是正確的數量，就這樣吧？這是一個問題。

The second question, Quintin, is multi-parameter testing, right? While I can appreciate the complementarities that you're talking about inpatient, otherwise, I get it. More so, Quintin, the multi-parameter testing that is being talked about, right? It's sort of commoditized and there are other companies with pretty broad IP portfolio.

第二個問題，Quintin，是多參數測試，對吧？雖然我可以理解你所說的住院病人的互補性，但除此之外，我明白了。更重要的是，昆廷，正在談論的多參數測試，對嗎？它有點商品化，而且還有其他公司擁有相當廣泛的智慧財產權組合。

What I'm trying to understand is think about going into more specialized areas. ECG is your domain and there are a lot of AI, whether it's valvular dysfunction, ventricular dysfunction, some cardiac death-based AI from ECG analysis. Help us understand the choice of multi-parameter testing that you talked about versus more novel specialized areas. Thank you for taking my questions.

我想要了解的是考慮進入更專業的領域。心電圖是你的領域，有許多人工智慧，無論是瓣膜功能障礙、心室功能障礙，還是來自心電圖分析的一些基於心因性死亡的人工智慧。幫助我們了解您談到的多參數測試與更新穎的專業領域的選擇。感謝您回答我的問題。

Yes. Thanks, Suraj. With respect to MCT, first of all, the Zio AT product that we just received final approval on both the catch up, and the design enhancements continues to have a trigger limit in it, right? And the FDA has gotten very comfortable with that feature being in the product.

是的。謝謝，蘇拉吉。關於MCT，首先，我們剛剛獲得最終批准的Zio AT產品無論是追趕還是設計增強仍然有觸發限制，對嗎？FDA 對產品中的這項功能感到非常滿意。

With Zio MCT, there will continue to be the potential of a trigger limit being met in it. But I can tell you the prevalence is dialed down significantly through better utilization of the AI capabilities that we have, the algorithm, but also power management. So, there is still a trigger limit potential in it, but the expectation of when it will be met is far, far less.

對於 Zio MCT，將繼續有可能滿足觸發限制。但我可以告訴你，透過更好地利用我們擁有的人工智慧功能、演算法和電源管理，這種流行率會顯著降低。所以，它仍然有一個觸發極限的潛力，但何時達到的預期要小得多。

But again, this is something that the FDA has demonstrated to us that they can get very comfortable with and we've seen it in the approvals. With respect to the multi-parameter sensing, I think there's a lot of different things that it opens up for us. But one thing that we've seen very clearly in our own market research and particularly dealing with our own customers being cardiologists, EPs, even moving into the primary care spaces, enriching the data that they have at their fingertips, even with their existing patients today becomes very valuable to them.

但同樣，FDA 已經向我們證明了這一點，他們可以對此感到非常滿意，我們已經在批准中看到了這一點。關於多參數感測，我認為它為我們帶來了很多不同的東西。但我們在自己的市場研究中清楚地看到了一件事，特別是與我們自己的客戶（心臟病專家、急診科醫生）打交道，甚至進入初級保健領域，豐富了他們觸手可及的數據，甚至是現有患者的數據今天對他們來說變得非常有價值。

I'll give you a good example of a cardiac rhythm patient that we're monitoring for an arrhythmia. If that physician sees or more importantly does not see an arrhythmia, but was able to identify that their oxygen levels were depleting during the wear of the sensor, they're going to want to still treat that patient. They're going to find a different way to treat the patient, but they never would have known that they needed to with the arrhythmia monitoring only. So, I think enriching the data that we can provide to that physician becomes very important. Sleep analysis is another one that becomes very interesting to us.

我將舉一個我們正在監測心律不整的心律不整患者的好例子。如果該醫生看到或更重要的是沒有看到心律失常，但能夠確定他們的氧氣水平在感測器佩戴期間耗盡，他們將仍然希望治療該患者。他們將找到一種不同的方法來治療患者，但他們永遠不會知道他們只需要心律不整監測。因此，我認為豐富我們可以提供給醫生的數據變得非常重要。睡眠分析是我們變得非常有趣的另一個分析。

We know that the majority of sleep patients ultimately originate from a cardiologist or an EP. I think in the future becomes even more common to see them originating out of a primary care physician's office. But if we can provide that information right off of the chest, off the patch that they're wearing for cardiac arrhythmia monitoring and identify that a patient is at high risk of sleep disease, I think it becomes a natural enabler for us to become sort of the company that can identify and diagnose sleep disease and then move the patient on forward through some therapy, some funnel of care, which that is not what's interesting to us.

我們知道，大多數睡眠患者最終都來自心臟科醫師或急診醫師。我認為將來它們來自初級保健醫生辦公室的情況會變得更加常見。但是，如果我們能夠立即從他們佩戴的用於心律不整監測的貼片上直接提供這些信息，並確定患者患有睡眠疾病的高風險，我認為這自然而然地促使我們變得更好該公司可以識別和診斷睡眠疾病，然後透過一些治療、一些護理管道讓患者繼續前進，這不是我們感興趣的。

We don't want to be a therapeutic company necessarily. We're not going to treat sleep disease, but if we can diagnose it on the front end, just like we do cardiac arrhythmias, that becomes very interesting to us. And I think there's a lot that we can do, with a multi parameter sensing capability that is very, very interesting to us. I would say, we hear a lot of talk around RPM. I am not too interested just in the remote patient monitoring space.

我們不一定想成為一家治療公司。我們不會治療睡眠疾病，但如果我們能夠在前端診斷它，就像我們診斷心律不整一樣，這對我們來說會變得非常有趣。我認為我們可以做很多事情，利用多參數感測功能，這對我們來說非常非常有趣。我想說，我們聽到了很多關於 RPM 的討論。我對遠距患者監護領域不太感興趣。

That doesn't get me excited, but what does get me excited is some of these other features that we can enrich and make more valuable for our existing customer base or find ways to monitor vital signs, remotely move care out of the hospital into the home and more important than RPM codes and reimbursement there is the ability to reduce the cost of care for these hospitals or these large networks that we're already partnering with, as they care for their patients.

這並不讓我興奮，但真正讓我興奮的是其他一些功能，我們可以豐富這些功能，為我們現有的客戶群創造更多價值，或者找到監測生命體徵的方法，將護理從醫院遠端轉移到醫院。

And I think that cost avoidance is where the real value is at.

我認為避免成本才是真正的價值。

We have no further questions in the queue. So, I'll turn the call back over to the management for any closing remarks.

我們隊列中沒有其他問題了。因此，我會將電話轉回給管理層以供結束語。

Thank you, operator. I would say, look, we're very pleased with the operational progress that we've made through the first 9 months of 2020 forward, and we're looking forward to a strong finish to the year. There are a lot of meaningful operational improvements that we're seeing beginning to play through and the momentum that we see in the growing business, it's exciting, particularly on the profitability side. However, our immediate and primary focus is completing the FDA remediation work and working collaboratively with them to address their concerns.

謝謝你，接線生。我想說的是，我們對 2020 年前 9 個月所取得的營運進展感到非常滿意，並期待今年取得強勁的成績。我們看到許多有意義的營運改善正在開始發揮作用，而且我們在業務成長中看到的勢頭令人興奮，特別是在獲利能力方面。然而，我們目前的首要重點是完成 FDA 的補救工作並與他們合作解決他們的擔憂。

And we look forward to providing further updates into the future. With that, again, thank you for joining us and we'll talk later. Goodbye.

我們期待未來提供進一步的更新。再次感謝您加入我們，我們稍後再談。再見。

This concludes our call today. Thank you for joining. Your line will now be disconnected.

我們今天的電話會議到此結束。感謝您的加入。您的線路現在將被斷開。