iRhythm Technologies Inc (IRTC) 2024 Q2 法說會逐字稿

Hello all and welcome to iRhythm Technologies second quarter 2024 earnings conference call. My name is Lydia, and I will be your operator today. (Operator Instructions)

大家好，歡迎參加 iRhythm Technologies 2024 年第二季財報電話會議。我叫莉迪亞，今天我將成為你們的接線生。（操作員說明）

I now hand you over to Stephanie Zhadkevich, Director of Investor Relations to begin. Please go ahead when you're ready.

現在請投資者關係總監 Stephanie Zhadkevich 開始。準備好後請繼續。

Thank you all for participating in today's call. Earlier today, iRhythm released financial results for the second quarter ended June 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 law 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 6 月 30 日的第二季財務業績。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 fact should be deemed to be forward-looking statements. These are based upon our current estimates and various assumptions and reflect management's intentions, beliefs and expectations about future events, strategies, competition, products, operating plans and performance.

本次電話會議中包含的任何非歷史事實陳述的陳述均應被視為前瞻性陳述。這些基於我們目前的估計和各種假設，反映了管理層對未來事件、策略、競爭、產品、營運計劃和績效的意圖、信念和期望。

These statements involve risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward looking statements. Accordingly, you should not place undue reliance on these statements.

這些陳述涉及風險和不確定性，可能導致實際結果或事件與這些前瞻性陳述預期或暗示的結果或事件有重大差異。因此，您不應過度依賴這些陳述。

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

有關與我們業務相關的風險和不確定性的清單和描述，請參閱我們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.

此外，在電話會議期間，我們還將討論某些未依照美國公認會計準則制定的財務措施。關於我們的非公認會計原則和現金為基礎的業績，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。

The presentation of this additional information should not be considered in isolation or as a substitute for or superior to results prepared in accordance with GAAP. 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.

這些附加資訊的呈現不應被孤立地考慮，也不應被視為替代或優於根據 GAAP 準備的結果。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。

Unless otherwise indicated, all references to financial measures in this call other than revenue refer to non-GAAP results. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 1, 2024.

除非另有說明，本次電話會議中所有提及的除收入以外的財務指標均指非公認會計準則績效。本次電話會議包含時效性訊息，僅截至今天（2024 年 8 月 1 日）直播時準確。

However, the 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.

然而，除非法律要求更新或修改任何財務預測或前瞻性陳述，無論是由於新資訊、未來事件或其他原因，否則本公司不承擔任何意圖或義務。

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

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

Thank you, Stephanie. Good afternoon and thank you all for joining us. Brice Bobzien, our Chief Financial Officer, and Dan Wilson, our EVP of Corporate Development and Investor Relations, join me on today's call. My prepared remarks today cover business updates during the second quarter of 2024 as well as our annual outlook.

謝謝你，斯蒂芬妮。下午好，感謝大家加入我們。我們的財務長 Brice Bobzien 和我們的企業發展和投資者關係執行副總裁 Dan Wilson 與我一起參加今天的電話會議。我今天準備的發言涵蓋 2024 年第二季的業務更新以及我們的年度展望。

I'll then turn the call over to Brice to provide a detailed review of our second quarter financial results and updated 2024 guidance. Finally, Brice and Dan will both discuss the CFO transition that we announced earlier today. Before I close out with final remarks.

然後，我會將電話轉給 Brice，詳細審查我們第二季的財務表現和更新的 2024 年指引。最後，布萊斯和丹將討論我們今天早些時候宣布的財務長的過渡。在我以最後的發言結束之前。

Once again, we realized strong results in the second quarter from our core business as we achieved revenue of $148 million, representing 19.3% growth versus the prior year. This success was driven by another quarter of record volume demand, along with a slight improvement in average selling prices.

第二季我們的核心業務再次取得了強勁的業績，營收達到 1.48 億美元，比上年增長 19.3%。這一成功得益於又一個季度創紀錄的需求量以及平均售價的略有改善。

Within our core business, our teams continued to drive growth from new accounts that were opened in the prior 12 months as well as penetration in existing accounts. And we have built a very strong pipeline, thanks to the growing recognition of Zio's value proposition.

在我們的核心業務中，我們的團隊繼續透過過去 12 個月內開設的新帳戶以及現有帳戶的滲透來推動成長。由於 Zio 的價值主張日益受到認可，我們已經建立了非常強大的管道。

The compelling CAMELOT real-world evidence data, demonstrating Zio superiority, both across categories and within categories directly against competitors for higher diagnostic yield and lowest retest rate continued to provide traction with clinicians and health systems.

令人信服的CAMELOT 真實世界證據數據證明了Zio 在跨類別和類別內直接與競爭對手相比的優勢，具有更高的診斷率和最低的複檢率，繼續為臨床醫生和衛生系統提供吸引力。

Payers have also responded favorably to our health economic data and CAMELOT, enabling our market access team to drive favorable negotiations with greenfield contracts and to drive updates to several existing coverage policies for improved patient access.

付款人也對我們的健康經濟數據和CAMELOT 做出了積極的反應，使我們的市場准入團隊能夠推動與綠地合約的有利談判，並推動更新幾項現有的保險政策，以改善患者的準入。

Our continued focus within the primary care channel has been successfully driving conversions from competitors as well as continued conversion of customers from traditional modalities such as short-term Holter monitoring with a steady stream of new evidence, demonstrating the value of 14 days of monitoring for a range of arrhythmias, not only AFib.

我們對初級保健管道的持續關注，成功推動了競爭對手的轉化，以及客戶從傳統方式（例如短期動態心電圖監測）的持續轉化，並提供了源源不斷的新證據，證明了14 天監測對於患者的價值。

In addition to winning competitive share and driving the mix shift towards long-term continuous monitoring iRhythm is driving accelerated expansion of the total ACM market by expanding into primary care, where we estimate that there are more than 15 million patients with cardiac related palpitations who visit their physicians each year.

除了贏得競爭性份額並推動向長期連續監測的組合轉變外，iRhythm 還通過擴展到初級保健來推動整個 ACM 市場的加速擴張，我們估計有超過 1500 萬患有心臟相關心悸的患者就診每年他們的醫生。

Zio's value proposition to address the quintuple aim of health care is clearly resonating with primary care providers in integrated delivery networks as well as large national primary care accounts, some of whom have begun to proactively monitor for arrhythmias, even if a patient does not symptomatic.

Zio 解決醫療保健五重目標的價值主張顯然引起了綜合服務網絡中的初級保健提供者以及大型國家初級保健帳戶的共鳴，其中一些帳戶已經開始主動監測心律失常，即使患者沒有症狀。

In large IDNs, cardiologist, EPs and primary care physicians have begun to appreciate the utility of Zio as a workflow efficiency tool, enabling them to diagnose the right patient the first time and alleviate some of the capacity constraints facing many cardiologist and EP practices by helping to identify the appropriate patients who should be seen by the specialty positions.

在大型IDN 中，心臟病專家、EP 和初級保健醫生已經開始認識到Zio 作為工作流程效率工具的實用性，使他們能夠在第一時間診斷出正確的患者，並透過幫助緩解許多心臟病專家和EP 實務所面臨的一些能力限制。

We believe that this trend towards pushing Zio earlier in the treatment care pathway will only accelerate with further appreciation of the Zio value proposition by primary care providers and with initiatives such as our Epic Aura EHR partnership, which will be introduced into the first accounts in the fourth quarter of this year and then launch it more broadly in 2025.

我們相信，隨著初級保健提供者對Zio 價值主張的進一步認可，以及我們的Epic Aura EHR 合作夥伴關係等舉措，這種推動Zio 更早進入治療護理途徑的趨勢只會加速，該合作夥伴關係將被引入到第一個帳戶中今年第四季度，然後在 2025 年更廣泛地推出。

Additionally, we have found solid traction and product market fit in the undiagnosed arrhythmia space, specifically in value-based primary care programs, which has been the combination of several factors we have been driving over the past few years.

此外，我們在未確診心律不整領域發現了堅實的吸引力和產品市場契合度，特別是在基於價值的初級保健計劃中，這是我們過去幾年一直在推動的幾個因素的結合。

The known increases in health care utilization and cost have been met with a focus on serving patients in lower cost settings of care. The ease of use for physicians and patients alike of our Zio monitor together with iRhythm's clinical evidence with mSToPS in other trials, demonstrate Zio's ability to identify undiagnosed arrhythmias and the cost effectiveness of a proactive arrhythmia monitoring approach.

醫療保健利用率和成本的已知增長已得到滿足，重點是在較低成本的護理環境中為患者提供服務。我們的 Zio 監視器對醫生和患者的易用性以及 iRhythm 在其他試驗中使用 mSToPS 的臨床證據證明了 Zio 識別未診斷心律不整的能力以及主動心律不整監測方法的成本效益。

In parallel, the CAMELOT data showed that long-term continuous monitoring is associated with the lowest healthcare utilization. With Zio, specifically having the highest diagnostic yield and lowest retest rates compared to competitors.

同時，CAMELOT 數據顯示，長期連續監測與最低的醫療保健利用率相關。與競爭對手相比，Zio 具有最高的診斷率和最低的重新測試率。

While we initially conceived as our know your rhythm program for the payer channels has been instead organically adopted by innovative value-based care organizations over the past few quarters to encapsulate proactive monitoring strategies.

雖然我們最初設想的是，我們知道您針對付款人管道的節奏計劃在過去幾個季度已被基於價值的創新護理組織有機採用，以封裝主動監控策略。

We've been excited by the early progress in this area, as we've seen some of our top customer accounts during the second quarter, prescribing Zio for proactive monitoring. Even more encouraging is that we signed a number of additional large national accounts during the second quarter with a strong pipeline that remains in place that we believe will be nice contributors of future growth.

我們對這一領域的早期進展感到興奮，因為我們在第二季度看到一些頂級客戶帳戶使用 Zio 進行主動監控。更令人鼓舞的是，我們在第二季度簽署了一些額外的大型國民帳戶，並且仍然存在強大的管道，我們相信這將成為未來成長的良好貢獻者。

Turning to Zio AT, we continued to make progress on the remediation activities of the FDA warning letter during the quarter and submitted the first of our responses to the FDA on the two 510(k) this week with the second plan to be submitted shortly.

談到 Zio AT，我們在本季度繼續在 FDA 警告信的補救活動上取得進展，並於本周向 FDA 提交了我們對兩項 510(k) 的第一份答复，第二份計劃即將提交。

Recall that we submitted two 510(k) filed in January of this year. One is a catch up for changes previously made the Zio AT system as a letter to file in the second 510(k) for design features and labeling updates to further address areas of focus noted in the FDA warning letter.

回想一下，我們在今年 1 月提交了兩份 510(k) 申請。其中之一是對 Zio AT 系統之前所做的更改的追趕，作為在第二個 510(k) 中提交的信函，以設計功能和標籤更新，以進一步解決 FDA 警告信中指出的重點領域。

The agency came back with a request for data that included incremental electromagnetic compatibility or EMC testing and human factors testing around design changes made to satisfy their request. We look forward to having provided these responses in the near term and will then wait to hear back from the FDA.

該機構要求提供數據，其中包括增量電磁相容性或 EMC 測試以及圍繞設計變更進行的人為因素測試，以滿足其要求。我們期待在短期內提供這些答复，然後等待 FDA 的回复。

With respect to the FDA, the agency was on-site at our San Francisco and Orange County facilities in the back half of July. The inspections concluded yesterday with several 43 observations noted. We are in the early stages of evaluating these and we intend to provide responses to the FDA in a timely fashion.

至於 FDA，該機構於 7 月下旬來到了我們舊金山和橘郡的工廠。檢查已於昨天結束，並提出了 43 項觀察結果。我們正處於評估這些的早期階段，我們打算及時向 FDA 提供答案。

At a high level the observations were primarily focused on our quality system and regulatory compliance, including complaint handling and medical device reporting. Risk analysis regarding the involvement of the Company's certified technicians to prepare the ECG reports and the CAPA process.

在較高層面上，觀察結果主要集中在我們的品質系統和監管合規性上，包括投訴處理和醫療器械報告。關於公司認證技術人員參與準備 ECG 報告和 CAPA 流程的風險分析。

We remain committed to our customers, patient safety quality and compliance, and we will continue to work diligently and collaboratively to resolve the warning letter to the FDA satisfaction. In parallel, our teams continue to work diligently to prepare for the subsequent filing of our next-generation MCT product, Zio MCT, and we continue to believe that 510(k) submission for that product will be submitted late in the second half of 2024 following clearance of the two 510(k) for Zio AT.

我們仍然致力於我們的客戶、病患安全品質和合規性，我們將繼續努力、協作地解決警告信，使 FDA 滿意。同時，我們的團隊繼續努力工作，為我們下一代 MCT 產品 Zio MCT 的後續備案做準備，我們仍然相信該產品的 510(k) 提交將在 2024 年下半年晚些時候提交Zio AT 獲得兩項510(k) 批准後。

Moving to our strategic pillars for future growth, we are also making significant strides to open up new opportunities outside of our core business beginning in the back part of this year. In Western Europe, we remain on track to launch commercial activities in four countries. The Netherlands, Austria, Switzerland and Spain. With first patient patching anticipated before year end 2024.

轉向未來成長的策略支柱，從今年下半年開始，我們還將取得重大進展，在核心業務之外開闢新的機會。在西歐，我們仍有望在四個國家開展商業活動。荷蘭、奧地利、瑞士和西班牙。預計在 2024 年底前對第一批患者進行修補。

We could not be more excited for the culmination of this enormous cross-functional effort that demonstrates iRhythm's commitment to introducing a better way to monitor for arrhythmias to millions more patients globally.

我們對這項巨大的跨職能努力的最終成果感到無比興奮，這表明 iRhythm 致力於為全球數百萬患者引入更好的心律不整監測方法。

As we move into 2025 and beyond commercial launch in these countries could constitute an incremental market opportunity of 1.5 million patients who could potentially benefit from Zio each year and also represents an important lever for growth towards our $1 billion revenue target in our 2027 long-range plan.

隨著我們進入2025 年及以後，在這些國家/地區的商業推出可能會帶來每年150 萬名患者的增量市場機會，這些患者可能會從Zio 中受益，同時也是實現我們2027 年長期收入10 億美元目標的重要成長槓桿計劃。

To support this broad commercial launch, we have completed two limited market evaluations in top five centers in Switzerland and Spain, continue to be very active at major European medical conferences with educational events and presentations. And that held an advisory board with 15 of Europe's leading KOLs to drive physician awareness of Zio.

為了支持這一廣泛的商業發布，我們在瑞士和西班牙的前五個中心完成了兩項有限的市場評估，並繼續積極參與歐洲主要醫學會議的教育活動和演示。該公司還成立了一個由 15 位歐洲頂尖 KOL 組成的顧問委員會，以提高醫生對 Zio 的認識。

In Japan, we continue to anticipate a regulatory decision by the PMDA in late 2024, representing the first step of our foray into the second largest medical device market in the world with approximately 1.6 million ACM tests being prescribed per year.

在日本，我們繼續預期 PMDA 將於 2024 年底做出監管決定，這是我們進軍全球第二大醫療器材市場的第一步，該市場每年開出約 160 萬次 ACM 測試。

Recall that we received a high medical need designation from the Japanese MHLW last year and that this distinction is specific to Zio. Granted at the recommendation of the Japanese Heart Rhythm Society, this designation has created significant interest with potential commercial partners and also has informed our regulatory submission with the PMDA.

回想一下，我們去年從日本厚生勞動省獲得了高醫療需求指定，而這個差異是 Zio 特有的。該頭銜是在日本心律協會的推薦下獲得的，引起了潛在商業合作夥伴的濃厚興趣，也為我們向 PMDA 提交監管報告提供了資訊。

As we continue to engage with the Japanese PMDA, we have finalized our reimbursement dossier that will be submitted to the MHLW immediately following a regulatory decision. We are also pleased to note that we have now signed a letter of intent with our distribution partner in Japan.

隨著我們繼續與日本 PMDA 合作，我們已經完成了報銷檔案，該檔案將在監管決定後立即提交給 MHLW。我們也很高興地註意到，我們現在已與日本的分銷合作夥伴簽署了一份意向書。

We are actively collaborating with them to prepare for a limited market launch in the first half of 2025 and look forward to sharing more details as we make progress in the coming months. In potential new indications, we plan to move forward with the market evaluation in obstructive sleep apnea in the United States in 2025, representing our initial foray into an adjacent indication with significant overlap in arrhythmias and a sizable unaddressed patient population.

我們正在積極與他們合作，為 2025 年上半年的有限市場推出做準備，並期待在未來幾個月取得進展時分享更多細節。在潛在的新適應症中，我們計劃於 2025 年在美國推進阻塞性睡眠呼吸中止症的市場評估，這代表我們首次涉足心律不整和大量未解決患者群體的相鄰適應症。

Thus far, early results from the sleep pilot that we launched in February have indicated that physician demand is high for a service that could streamline the workflow to decrease current pain points in the diagnostic journey for OSA, including insurance validation, patient facilitation and comprehensive report delivery, all in an integrated digital platform.

到目前為止，我們在 2 月推出的睡眠試點計畫的早期結果表明，醫生對能夠簡化工作流程以減少 OSA 診斷過程中當前痛點的服務需求很高，包括保險驗證、患者便利和綜合報告交付，全部在整合數位平台中進行。

Market research performed to date associate with this project has confirmed that cardiologists are likely to be early adopters of a service that combines in OSA and ACM diagnostic. A frictionless ordering process, high-quality report with clear insights and seamless integration between the two tests were cited as key features physicians would look for in this type of service.

迄今為止與該計畫相關的市場研究已證實，心臟病專家可能是 OSA 和 ACM 診斷相結合的服務的早期採用者。無摩擦的訂購流程、具有清晰見解的高品質報告以及兩種測試之間的無縫整合被認為是醫生在此類服務中尋求的關鍵功能。

These learnings have validated our views of the value of a technology and service platform that can serve multiple patient indications. We plan to continue building a potential product and service offering that we can then launch in the market evaluation beginning in 2025.

這些經驗驗證了我們對可服務多種患者適應症的技術和服務平台價值的看法。我們計劃繼續打造潛在的產品和服務，然後在 2025 年開始的市場評估中推出。

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

現在，我將把電話轉給 Brice，討論我們最近的財務表現。

Thanks, Quentin. Before discussing the quarter, I wanted to briefly address my upcoming transition from the CFO role at iRhythm. I've resided in Southern California for the past 12 plus years, but I'm originally from the Midwest where much of my immediate and extended family currently resides.

謝謝，昆汀。在討論本季之前，我想先簡單介紹一下我即將從 iRhythm 財務長職位過渡的情況。過去 12 年多來，我一直在南加州居住，但我來自中西部，我的大部分直系親屬和大家庭目前都住在那裡。

Like many of us, we have loved ones who are aging and have experienced health challenges. While working in residing out of the Midwest for the past couple of months, I've been able to help and support my family members directly.

像我們許多人一樣，我們的親人正在衰老，並且經歷過健康挑戰。在過去的幾個月裡，我在中西部以外的地方工作，我能夠直接幫助和支持我的家人。

While providing this support, it became apparent that my family needs my focused ongoing support firsthand, trying to evaluate how it could continue to support family needs while also balancing the work here at iRhythm, it was clear I needed to make a decision.

在提供這種支持的同時，我的家人顯然需要我的第一手持續關注支持，試圖評估如何繼續支持家庭需求，同時平衡 iRhythm 的工作，很明顯我需要做出決定。

With the changing landscape of my life, I've decided to step away from iRhythm to focus my attention on family. For most of my life, I have prioritized career the priority shift, and I need to attend to personal family matters in the near to midterm.

隨著我生活格局的變化，我決定離開 iRhythm，將注意力集中在家庭上。在我一生的大部分時間裡，我都將事業放在首位，並且我需要在近期到中期處理個人家庭事務。

Over the last couple of years, I have loved being a part of transforming and maturing this great company. And I'm so thankful for the truly world-class team we have built. There's so much opportunity here at iRhythm, and I am grateful to have been a part of it.

在過去的幾年裡，我很高興成為這家偉大公司轉型和成熟的一部分。我非常感謝我們建立的真正世界一流的團隊。iRhythm 有很多機會，我很高興能成為其中的一部分。

I will be transitioning out of my role as CFO on August 31, but will remain engaged for a period of time to ensure a seamless and effective transition. There are great days ahead here at iRhythm and I plan to have a front row seat to see us continue to be the leader in ambulatory cardiac monitoring.

我將於 8 月 31 日卸任財務長一職，但仍將繼續任職一段時間，以確保無縫、有效的過渡。iRhythm 未來的日子會很美好，我計劃坐在前排，見證我們繼續成為動態心臟監測領域的領導者。

Turning to the quarter, as a reminder, unless otherwise noted, the financial metrics that I discuss today will be presented on a non-GAAP. Reconciliations to GAAP can be found in today's earnings release and on our IR website.

談到本季度，提醒一下，除非另有說明，否則我今天討論的財務指標將按照非公認會計原則呈現。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。

Our second quarter 2024 results demonstrated continued traction in our core markets as we achieved revenue of $148 million, representing 19.3% year-over-year growth. These results were driven by strong revenue unit growth as well as expected improvement in our average selling price compared to the second quarter of 2023.

我們的 2024 年第二季業績證明了我們核心市場的持續吸引力，我們實現了 1.48 億美元的收入，年增 19.3%。這些業績的推動因素是營收單位的強勁成長以及平均售價與 2023 年第二季相比的預期改善。

New store growth with new store defined as accounts that have been opened for less than 12 months, accounted for approximately 40% of our year-over-year volume growth and home enrollment for Zio services in the US was approximately 22% of volume in the second quarter.

新店成長（新店定義為開戶時間少於 12 個月的帳戶）約占我們同比銷量增長的 40%，而美國 Zio 服務的入戶人數約佔全年銷量的 22%。

As we enhance our revenue growth strategy, our health policy teams have continued to achieve key wins that will enable expanded patient access to Zio services. During the second quarter, our market access team drove favorable negotiations with six greenfield contracts that will open up coverage for Zio for an incremental 2.9 million covered lives and have also driven updates to a number of existing coverage policies to be optimized for MCT utilization.

隨著我們加強收入成長策略，我們的健康政策團隊繼續取得關鍵勝利，這將使更多患者能夠獲得 Zio 服務。在第二季度，我們的市場准入團隊推動了與六份新建合約的有利談判，這些合約將為Zio 提供額外的290 萬覆蓋生命，並推動對許多現有保險政策進行更新，以優化MCT 的利用。

Additionally, our market access team in collaboration with our health economics and outcomes research group and supported by our CAMELOT data successfully drove a major policy shift by large national payer to provide favorable position for our Zio service.

此外，我們的市場准入團隊與我們的健康經濟學和結果研究小組合作，並在CAMELOT 數據的支持下，成功推動了大型國家付款人的重大政策轉變，為我們的Zio 服務提供了有利的地位。

This new policy now allows for 14 day long-term continuous monitoring or mobile cardiac telemetry as a step through to implantable loop recorders and also removes the need for step therapy or prior authorization as a prerequisite for MCT coverage.

這項新政策現在允許 14 天的長期連續監測或移動心臟遙測作為植入式循環記錄儀的一步，並且還消除了作為 MCT 覆蓋先決條件的分步治療或事先授權的需要。

This policy enables improved access to Zio products and services for over 25 million commercial and healthcare exchange members, which started June 1, 2024. In addition, to being a testament to our team's tireless efforts and continued passion for supporting patients. These critical successes are an important recognition of the value that Zio products and services bring for patients and health care systems alike.

自 2024 年 6 月 1 日起，這項政策使超過 2,500 萬名商業和醫療保健交易所會員能夠更好地獲得 Zio 產品和服務。此外，這也證明了我們團隊的不懈努力和對支持患者的持續熱情。這些重大成功是對 Zio 產品和服務為患者和醫療保健系統帶來的價值的重要認可。

Gross margin for the second quarter was 69.9% ahead of expectations. As anticipated, we have started to realize the benefit of optimized efficiency from our clinical operations team and specifically from our investments into our San Francisco Centre of Excellence. Additionally, we realized favorability from a couple of one-time items that we do not necessarily believe will reoccur in the future, but contributed nicely in the second quarter.

第二季毛利率為69.9%，超出預期。正如預期的那樣，我們已經開始從我們的臨床營運團隊，特別是我們對舊金山卓越中心的投資中認識到優化效率的好處。此外，我們也從一些一次性專案中獲得了青睞，我們認為這些專案不一定會在未來再次出現，但在第二季做出了很好的貢獻。

Furthermore, we achieved a significant operational milestone in May of 2024 with the launch of our initial phase of manufacturing automation. This project and subsequent phases of manufacturing automation will continue enhance manufacturing scalability and margin improvement as well as set the stage for future growth and innovation in the second half of 2024 and beyond.

此外，隨著製造自動化初始階段的啟動，我們在 2024 年 5 月實現了一個重要的營運里程碑。該專案和製造自動化的後續階段將繼續增強製造可擴展性和利潤率改善，並為 2024 年下半年及以後的未來成長和創新奠定基礎。

Second quarter adjusted operating expenses were $125.2 million, down 0.4% sequentially and up 25.5% year over year, in line with our expectations. Compared to the second quarter of 2023, this increase in adjusted operating expenses was primarily due to compensation related costs, development work for Zio MCT as we move the product closer to our regulatory submission, software development efforts to further enhance the functionality of our current and future product offerings, Epic Aura integration costs and revenue cycle management claims processing fees.

第二季調整後營運費用為 1.252 億美元，季減 0.4%，年增 25.5%，符合我們的預期。與 2023 年第二季相比，調整後營運費用的增加主要是由於補償相關成本、Zio MCT 的開發工作（隨著我們使產品更接近監管提交）、軟體開發工作以進一步增強我們當前和未來的產品供應、Epic Aura 整合成本和收入週期管理索賠處理費用。

We believe that these incremental investments will continue to support our growth in future quarters. Please note that we continue to incur incremental legal and consulting fees as well as other company expenses related to the FDA warning letter and DOJ subpoena.

我們相信這些增量投資將繼續支持我們未來幾季的成長。請注意，我們繼續產生增量法律和諮詢費用以及與 FDA 警告信和 DOJ 傳票相關的其他公司費用。

Adjusted net loss in the second quarter of 2024 was approximately $18.8 million or a loss of $0.61 per share compared to an adjusted net loss of $13.1 million or an adjusted net loss of $0.43 per share in the second quarter of 2023.

2024 年第二季調整後淨虧損約為 1,880 萬美元，即每股虧損 0.61 美元，而 2023 年第二季調整後淨虧損為 1,310 萬美元，即每股虧損 0.43 美元。

Adjusted EBITDA in the second quarter 2024 was $5 million or 3.4% of revenue compared to 3.5% in the second quarter of 2023 and minus 9.2% of revenue in the first quarter of 2024. This was ahead of the previously provided guidance and inclusive of funding important investments in the projects that we believe will continue to drive future growth.

2024 年第二季調整後 EBITDA 為 500 萬美元，佔營收的 3.4%，而 2023 年第二季為 3.5%，2024 年第一季為負 9.2%。這領先於先前提供的指導，並包括為我們認為將繼續推動未來成長的項目提供重要投資。

Turning to guidance, we are also raising our 2024 revenue outlook as presented earlier this year and now anticipate full year revenue to range between $580 million and $590 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 customers accounts. As in previous years, we believe that third quarter 2024 revenue will be in line with normal summer seasonality of approximately 25% of expected full-year revenue.

至於指導意見，我們也提高了今年稍早提出的 2024 年收入預期，目前預計全年收入將在 5.8 億美元至 5.9 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。與往年一樣，我們認為 2024 年第三季營收將符合正常夏季季節性，約為預期全年營收的 25%。

Turning to gross margin, we are raising 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 the full year of 2023. We made significant progress during the second quarter with regards to clinical operations and manufacturing efficiency and believe these are sustainable over time.

談到毛利率，我們將 2024 年全年毛利率指引上調至 68.5% 至 69%，與 2023 年全年相比，中位數提高約 150 個基點。我們在第二季度在臨床操作和製造效率方面取得了重大進展，並相信這些進展隨著時間的推移是可持續的。

However, it is important to note that we will need to continue to invest to enable future growth and do not believe that the onetime items noted previously will repeat. As such, we anticipate third quarter gross margin to be slightly down sequentially.

然而，值得注意的是，我們需要繼續投資以實現未來的成長，並且不相信先前提到的一次性項目會重複出現。因此，我們預計第三季毛利率將較上季略有下降。

However, we continue to believe this additional leverage will support our goal to reach 70%-plus gross margin as we exit 2024. We are also raising our adjusted EBITDA margin guidance to range between 3.5% and 4% of revenues, which would represent a 450 basis points to 500 basis points improvement compared to 2023, in line with our stated path to adjusted EBITDA margin targets by 2027 and driven by our focus on sustainable operating leverage improvements throughout the P&L.

然而，我們仍然相信，這額外槓桿將支持我們在 2024 年退出時達到 70% 以上毛利率的目標。我們也將調整後的EBITDA 利潤率指引提高至營收的3.5% 至4% 之間，這意味著與2023 年相比提高了450 個基點至500 個基點，符合我們規定的到2027 年調整後EBITDA利潤率目標的路徑，由我們對整個損益表中永續營運槓桿改善的關注所推動。

Looking at the cadence of margin expansion in the back half of this year, we expect to see third quarter adjusted EBITDA margin improve by approximately 150 basis points to 250 basis points compared to the second quarter before expanding further in the fourth quarter.

從今年下半年利潤率擴張的節奏來看，我們預計第三季調整後的 EBITDA 利潤率將比第二季提高約 150 個基點至 250 個基點，然後在第四季進一步擴張。

Along with anticipated progress in gross margin efficiency, operating expenses are historically more elevated in the first half of the year relative to revenue. As mentioned previously, we continue to believe that there will be approximately $8 million to $10 million of costs associated with the FDA warning letter and responses to the DOJ subpoena for the full year of 2024. As we navigate these two issues, the majority of these costs will come out of the P&L in the future.

隨著毛利率效率的預期進步，上半年營運費用相對於收入的比例歷來更高。如前所述，我們仍然認為 2024 年全年將有約 800 萬至 1000 萬美元的費用與 FDA 警告信和對 DOJ 傳票的回應相關。當我們解決這兩個問題時，這些成本的大部分將來自未來的損益表。

Finally, we ended the second quarter in a strong financial position with approximately $561.5 million in unrestricted cash and short-term investment. During the second quarter, we began to see improvements in working capital as anticipated.

最後，我們在第二季結束時擁有強勁的財務狀況，擁有約 5.615 億美元的不受限制的現金和短期投資。在第二季度，我們開始看到營運資金如預期有所改善。

We were pleased to see cash collection improvements in the second quarter resulting from the recovery of delayed billings associated with the change healthcare cybersecurity attack in the first quarter. We anticipate further improvements to cash collection and normalized levels of DSO as we exit 2024.

我們很高興看到第二季現金收款情況有所改善，這是由於第一季醫療網路安全攻擊變化導致的延遲帳單恢復所致。我們預計，隨著 2024 年的結束，現金收集和 DSO 的正常化水準將進一步改善。

I'd now like to turn the call over to Dan for a few remarks. Dan?

我現在想把電話轉給丹，請他發表幾句話。擔？

Thank you, Brice. I would like to start by expressing my excitement for the opportunity to step into the CFO role. I would like to thank Quentin, Brice and the rest of the iRhythm team and positioning me for success in ensuring a smooth transition.

謝謝你，布萊斯。首先，我想表達我對有機會擔任財務長一職的興奮之情。我要感謝 Quentin、Brice 和 iRhythm 團隊的其他成員，他們為我成功確保平穩過渡做好了準備。

In my five years with iRhythm, I have seen a tremendous amount of growth and progress, and I'm more excited than ever about what's in front of us. I am honored and looking forward to contributing to our next phase of growth and transformation.

在 iRhythm 的五年裡，我看到了巨大的成長和進步，我對我們面前的一切感到比以往任何時候都更加興奮。我很榮幸並期待為我們下一階段的成長和轉型做出貢獻。

As I step into the role, I am able to reflect on the engagement I have had with our investor base and covering analysts and have a good understanding of the strategic and financial expectations of iRhythm. My focus will be on supporting the company to drive continued top line growth and doing so profitably.

當我擔任這個角色時，我能夠反思我與投資者群體和分析師的互動，並對 iRhythm 的策略和財務預期有很好的了解。我的重點將是支持公司推動營收持續成長並實現獲利。

We have many initiatives in motion, and I'm excited to continue leading and supporting those efforts as we look to scale iRhythm and serve millions more patients in the future.

我們正在實施許多舉措，我很高興能夠繼續領導和支持這些努力，因為我們希望在未來擴大 iRhythm 並為數百萬患者提供服務。

Thank you. And I look forward to working with all of you in the new role.

謝謝。我期待在新的職位上與大家合作。

Thank you, Dan. Before closing, I'd like to thank Brice for his many contributions in helping us transform our company. While disappointed to see Brice step down, just as we're beginning to see the financial benefits of the significant transformation efforts we've embarked on over the last 30 months, I respect his decision as he deals with unfortunate personal matters at this time.

謝謝你，丹。在結束之前，我要感謝 Brice 在幫助我們公司轉型方面所做的許多貢獻。雖然對布萊斯下台感到失望，但正當我們開始看到我們在過去30 個月中開展的重大轉型工作所帶來的經濟效益時，我尊重他的決定，因為他此時正在處理不幸的個人事務。

Importantly, they'll be nearby as we work through this transition to Dan. Succession planning is something that we spend a good amount of time with here at iRhythm. And Dan has long been seen as a potential successor to Brice.

重要的是，當我們向丹過渡時，他們會在附近。在 iRhythm，我們花費了大量時間進行繼任計畫。長期以來，丹一直被視為布萊斯的潛在繼任者。

His strong strategic financial background, in-depth knowledge of our company and industry, together with a strong relationship to our investors, will allow for a seamless transition and ensure we remain on track to delivering on the long-term financial goals that we have laid out.

他強大的策略財務背景、對我們公司和行業的深入了解，以及與投資者的牢固關係，將實現無縫過渡，並確保我們繼續走上實現既定長期財務目標的軌道。

That path forward is as clear as ever. The strong financial performance in the second quarter and increasing our financial guidance across all metrics demonstrate the building momentum and confidence in where we are headed. I'd like to thank Brice for his many contributions to iRhythm and look forward to continuing to build upon that progress with Dan.

前進的道路一如既往地清晰。第二季度強勁的財務業績以及我們在所有指標上的財務指導的增加表明我們對前進方向的勢頭和信心正在增強。我要感謝 Brice 對 iRhythm 做出的許多貢獻，並期待與 Dan 繼續在這一進步的基礎上再接再厲。

Finally, I'd like to address recent activity around the Department of Justice's inquiry and iRhythm. As you'll recall, on April 4, 2023, we received an inquiry from the Civil Division of the United States Department of Justice or DOJ seeking information and documents regarding the company's products and services.

最後，我想談談最近圍繞司法部調查和 iRhythm 開展的活動。您還記得，2023 年 4 月 4 日，我們收到了美國司法部民事部門的詢問，要求提供有關該公司產品和服務的資訊和文件。

Since the DOJ's initial inquiry, we have been extremely responsive and collaborative, and we have produced a significant amount of materials with information responsive to their subpoena. In July, the DOJ filed a petition for order to show cause an application for enforcement of administrative subpoena seeking the production of certain documents that the company has withheld on the basis of legal privilege.

自從司法部初次調查以來，我們一直非常積極地回應和合作，並且根據他們的傳票，我們製作了大量包含資訊的資料。7 月，司法部提交了一份請願書，要求出示行政傳票執行申請的理由，要求出示該公司基於法律特權而扣留的某些文件。

The company disagrees with the DOJ's attempt to invade the attorney client privilege and the protection afforded to attorney work products. In partnership with our top-tier outside counsel, we determined that it is in the best interest of the company to continue to maintain our position that certain documents are privileged not only as it pertains to this case, but for the precedent It sets and other outstanding and future matters.

該公司不同意司法部試圖侵犯律師客戶特權和對律師工作產品的保護。我們與我們的頂級外部法律顧問合作，認為繼續維持我們的立場符合公司的最佳利益，即某些文件不僅與本案有關，而且與它所設定的先例和其他文件有關，因此享有特權。完成的和未來的事。

Our immediate next step in this process to prepare our opposition to the DOJ's petition, and we have negotiated a briefing schedule with them directly that pushes this matter into the fall. iRhythm's opposition brief is due on August 16, 2024 in the DOJ's reply is due September 6, 2024. At this time, we cannot speak with certainty on the focus of their investigation and prefer not to speculate.

我們在此過程中立即採取的下一步行動是準備反對司法部的請願書，並且我們已直接與他們協商了一份簡報時間表，將此事推遲到秋季。 iRhythm 的反對意見書將於 2024 年 8 月 16 日提交，司法部的答覆將於 2024 年 9 月 6 日到期。目前，我們無法確定他們調查的重點，也不願進行猜測。

In closing, we are very pleased with the results from the first half of this year and are incredibly excited for multiple milestones in the coming months that will enable capture the significant opportunities that lie ahead of us.

最後，我們對今年上半年的結果感到非常滿意，並對未來幾個月的多個里程碑感到非常興奮，這些里程碑將使我們能夠抓住擺在我們面前的重大機會。

As we work to transform the company, we're continuing to drive penetration in our core commercial markets while expanding the ACM market in the US more broadly. We're launching internationally in multiple countries across the globe.

在我們致力於公司轉型的同時，我們將繼續推動核心商業市場的滲透，同時更廣泛地拓展美國的 ACM 市場。我們正在全球多個國家/地區開展國際業務。

We're driving operational efficiency and financial sustainability, all while keeping the patients we serve and focus at all times. As multiple vital signs and digital data assets are increasingly combined to generate clinical insights.

我們正在提高營運效率和財務可持續性，同時始終以我們服務的患者為中心。隨著多種生命體徵和數位數據資產越來越多地結合起來以產生臨床見解。

We are excited to be a market leader in defining our monitoring can look in the next three, five or 10 years. iRhythm is building a digital health care portfolio of the future. And I could not be more pleased with our unique positioning to address the current doubling of health care in the years to come.

我們很高興能夠成為定義未來三年、五年或十年監控前景的市場領導者。 iRhythm 正在建立未來的數位醫療保健產品組合。我對我們在未來幾年應對當前醫療保健翻倍問題的獨特定位感到非常滿意。

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

現在我想開始提問。操作員？

(Operator Instructions)

（操作員說明）

Margaret Andrew, William Blair.

瑪格麗特·安德魯，威廉·布萊爾。

Hey, good afternoon, folks. Thanks for taking the questions. And first off, Brice, very sorry to hear you're leaving and wish you and your family the very best in the meantime. So wish you well. I guess just to start on the 483s threes, I know it's quite early, but anything that you can give us around what was in the observation?

嘿，大家下午好。感謝您提出問題。首先，布萊斯，很遺憾聽到你要離開，並祝你和你的家人一切順利。所以祝你一切順利。我想從 483 的三分球開始，我知道現在還為時過早，但是您能給我們提供有關觀察結果的任何資訊嗎？

Is it a few smaller operations that you feel confident to characterize maybe is minor observation, anything new or surprising? And then how quickly I know it's early again, but how quickly do you think that you can resolve those? Thanks.

您是否有信心描述一些較小的操作，也許只是細微的觀察，或者有什麼新的或令人驚訝的事情？然後我多久就知道現在又早了，但你認為你能多快解決這些問題？謝謝。

Hey, Margaret, thanks for the question. Well, look, we will respond to those observations within 15 days so that it's got our full attention at this point in time. And obviously where it goes from there I can't speculate at this point in time, but let me turn to give a little bit more clarity around that. I think it's clear that the FDA is trying to define, frankly, how to regulate this relatively new category.

嘿，瑪格麗特，謝謝你的提問。好吧，我們將在 15 天內對這些觀察結果做出回應，以便在此時得到我們的充分關注。顯然，目前我還無法推測接下來的發展方向，但讓我進一步澄清這一點。坦白說，我認為 FDA 顯然正在試圖定義如何監管這個相對較新的類別。

And I think as a market leader, discussions like this are going to be ongoing for a period of time. Keep in mind from the warning letter in these discussions as they continue to understand this category, a whole new code has been established as a result of those discussions.

我認為作為市場領導者，這樣的討論將持續一段時間。請記住，隨著他們繼續了解此類別，這些討論中的警告信中，這些討論的結果已經建立了一個全新的代碼。

At the end of the day, I think the fundamental issue sort of comes down to whether the IDTF, the CCTs that the well the clinical technicians are they part of the product or are they not? And I think from the beginning of time, we've said we view those as separate items.

歸根究底，我認為根本問題歸結為 IDTF、臨床技術人員的 CCT 是否是產品的一部分？我認為從一開始，我們就說過我們將這些視為單獨的項目。

And I think the FDA has a bit of a different perspective right now that we're working through. But when you start to think about those two things differently, meaning ourselves versus how the FDA may be looking at it, you start to land in different places when it comes to complaint handling or reporting or process controls and how you document those controls or how you go about your statistical techniques.

我認為 FDA 目前正在研究一些不同的觀點。但是，當您開始以不同的方式思考這兩件事時，即我們自己與FDA 可能如何看待它時，當涉及到投訴處理或報告或流程控制以及如何記錄這些控製或如何進行控制時，您就會開始陷入不同的境地。

I think it's important to know like if there is no conversations in here with the FDA in the course of these inspections around the overall safety or efficacy of our product, that's not being discussed, it's not like it was an initial warning letter where there were questions around, are you an MCT product or are you not? Or is AT a legally marketed product as a result of your letter to file approach or not.

我認為重要的是要知道，在這些檢查過程中，是否沒有與 FDA 就我們產品的整體安全性或有效性進行對話，這沒有被討論，這不像是一封最初的警告信，其中有問題是，您是MCT 產品還是不是？或根據您的提交信函的情況，AT 是否是合法銷售的產品。

Those issues are behind us. That's not being discussed any further. This is really about how we go about identifying what complaints to report or not to report how we document those things and the processes set around it. So nothing specific to safety or efficacy of the product whatsoever. It's more about now how we continue to build and make our quality systems more robust.

這些問題都已成為過去。這不再進一步討論。這實際上是關於我們如何確定要報告或不報告哪些投訴，我們如何記錄這些事情以及圍繞這些問題制定的流程。因此，與產品的安全性或功效無關。現在更多的是我們如何繼續建立並使我們的品質系統更強大。

Okay, that's helpful. And then as we look at revenue guidance, you raised a little bit more than the beat. How should we look at that outlook for the rest of the year on a sequential basis? And then maybe walk through the drivers of that increase? Is that TCP is that the contractor or something else? Thanks, guys.

好的，這很有幫助。然後，當我們查看收入指引時，您籌集的資金比預期多了一點。我們該如何看待今年剩餘時間的環比前景？然後也許可以回顧一下這種成長的驅動因素？TCP 是承包商還是其他什麼？謝謝，夥計們。

Yeah, thanks, Margaret. This is Dan. I can start on that. So hopefully you heard from our prepared remarks, we feel really good about the momentum in the business, the trends we're seeing and really seeing contributions from across the board.

是的，謝謝，瑪格麗特。這是丹.我可以從那裡開始。因此，希望您從我們準備好的發言中聽到，我們對業務的勢頭、我們看到的趨勢以及真正看到來自各個方面的貢獻感到非常滿意。

You heard new-store growth being 40% so seeing nice balanced contribution from new store, same store growth, both monitor and AT contributing. And then certainly primary care continues to open up nicely for us.

您聽說新店成長了 40%，因此看到新店、同店成長、顯示器和 AT 的貢獻非常平衡。當然，初級保健繼續為我們良好地開放。

So all of that is really contemplated in guidance and see that continuing to contribute through the course of the year. You heard our remarks on Q3 being 25% of full year revenue, which reflects normal seasonality for us.

因此，所有這些都在指導中得到了真正的考慮，並在這一年中繼續做出貢獻。您聽到了我們關於第三季收入佔全年收入 25% 的言論，這反映了我們的正常季節性。

Thank you.

謝謝。

(Operator Instructions)

（操作員說明）

Allen Gong, JP Morgan.

龔艾倫，摩根大通。

Thanks for the question. I just want to echo my condolences for your situation with family, and I hope everything gets better. So I guess I'll let kind of bundle my two questions together. The first starting with the financials, you mentioned that there were some one-timers that really helped gross margin. You still expect to end the year at around 70%, but it also looks like SG&A improved pretty significantly. What were the drivers of that and how should we think about sustainability there?

謝謝你的提問。我只是想對你和家人的情況表示哀悼，希望一切都會好起來。所以我想我會把我的兩個問題綁在一起。首先從財務方面開始，您提到有一些一次性產品確實有助於提高毛利率。您仍然預計年底會達到 70% 左右，但 SG&A 看起來也有相當顯著的改善。其驅動因素是什麼？

And then just a quick follow up on the DOJ investigation, whether or not you can kind of give us a better idea of kind of the scope of that. And we are seeing the value of this filing by now, but just kind of the scope of what the DOJ is looking into? Thank you.

然後快速跟進司法部的調查，無論您能否讓我們更了解調查的範圍。我們現在已經看到了這份文件的價值，但這只是司法部正在調查的範圍？謝謝。

Hey, Allen, thanks for the question. I appreciate the kind words. So first question on the one-timers that we talked about with regards to gross margins, really a couple of different things. We've talked to the investor community about just the focus and diligence that we've placed on procurement activities in indirect procurement, efficiencies that we've been drawing -- trying to drive as an organization.

嘿，艾倫，謝謝你的提問。我很欣賞這些客氣話。關於我們談到的一次性產品的第一個問題是毛利率，實際上是幾個不同的事情。我們已經與投資者社群討論了我們對間接採購採購活動的關注和勤奮，以及我們一直在努力提高組織效率的問題。

And the biggest thing was, frankly, some logistical savings that we were able to drive with regards to shipping vendors that we've been working with. We are able to get retrospective pricing getting back into Q4 of 2023 that ultimately came through in the way of a credit in the second quarter. So as you can imagine, that will sustain moving forward. But those couple of quarters of incremental benefit that we gained from that negotiation, not necessarily repeat moving forward.

坦白說，最重要的是，我們能夠為我們一直合作的運輸供應商節省一些物流費用。我們能夠獲得 2023 年第四季的追溯定價，最終在第二季以抵免的方式實現。正如你可以想像的那樣，這將持續向前發展。但我們從那次談判中獲得的這幾季的增量利益不一定會重複前進。

And then the other one I think that's relevant of talking about is the fact that we do have a component of our software organization that works on optimization and frankly, tweaks to the hedges on the solutions that are used by CCTs as well as our intake solution and frankly, manufacturing for that matter.

然後，我認為與談論相關的另一個事實是，我們的軟體組織中確實有一個致力於優化的組成部分，坦率地說，對 CCT 所使用的解決方案以及我們的攝入解決方案的對沖進行調整坦白說，製造業。

Our sales focus now from a software development standpoint has really been on the development of MCT and frankly getting it ready for that submission. That is right around the corner so we had very little of that work being done in Q2.

從軟體開發的角度來看，我們現在的銷售重點實際上是 MCT 的開發，坦白說，是為提交做好準備。那即將到來，所以我們在第二季幾乎沒有完成這些工作。

So that reduced the cost profile of it. We don't expect that to continue moving forward. We're going to continue to optimize those solutions that we have available to us. Both of those things contributed about 100 basis points of benefit in the quarter.

這樣就降低了它的成本。我們預計這種情況不會繼續發展。我們將繼續優化我們現有的解決方案。這兩件事為本季帶來了約 100 個基點的收益。

And then I talked about the fact that we will need to continue to hire resources as we continue to scale volumes. And as we saw in Q4, you hire those resources in preparation for future volumes and it takes a little bit of time to get them up to speed.

然後我談到了這樣一個事實：隨著我們繼續擴大產量，我們將需要繼續僱用資源。正如我們在第四季度所看到的，您僱用這些資源是為了為未來的產量做好準備，並且需要一點時間才能讓它們跟上進度。

So those are things that aren't necessarily anything to be surprised of or one-time in nature, but it's just investing ahead of the ultimate scale that you're going to get. So that's what was going on in the quarter. And we feel great about the progress that was made there.

因此，這些事情不一定是令人驚訝的，也不一定是一次性的，但它只是在你將獲得的最終規模之前進行投資。這就是本季發生的情況。我們對那裡的進展感到非常高興。

On the SG&A side, the biggest thing is and we talked about this, we do have some higher level costs specific to Q1 with regards to company meetings and some things that hit both selling as well as SG&A those things don't necessarily replicate. And we communicated that as we think about first half being a little bit higher than that of the back half.

在SG&A方面，最重要的事情是，我們談到了這一點，我們確實有一些特定於第一季度的更高水平的成本，涉及公司會議，以及一些影響銷售和SG&A的事情，這些事情不一定會複製。我們傳達了這一點，因為我們認為上半場比後半場更高。

And so you're seeing that play through in Q2 and certainly sustainable for the rest of the year, though there is some seasonality that we have to continue to consider as we move forward from models in '25 and beyond.

因此，您會在第二季度看到這種情況，並且在今年剩餘時間裡肯定會持續下去，儘管在我們從 25 年及以後的模型中前進時，我們必須繼續考慮一些季節性因素。

Hey, Allen, and with respect to the question on the scope of the DOJ, I don't think there's a whole lot more information frankly, that we can provide you at this point. I think the set of questions of the documents they requested are broad like we've always indicated, we haven't seen anything different over the last several months.

嘿，艾倫，關於司法部範圍的問題，坦白說，我認為我們目前無法向您提供更多資訊。我認為他們要求的文件的一系列問題很廣泛，就像我們一直指出的那樣，過去幾個月我們沒有看到任何不同的情況。

As a matter of fact, it had gone relatively quiet for a good period of time until they made the motion to compel these documents that we spoke to and to your point, with the filings being out there, those documents around quality systems, sort of design history files of the past back in the '16, '17, '18, '19, so that we feel very strongly that we needed to protect that attorney client privilege, not only for this case, but the precedent set with all of their cases that are out there.

事實上，它已經相對安靜了很長一段時間，直到他們提出動議，迫使我們談到的這些文件和你的觀點，這些文件都在那裡，那些圍繞質量體系的文件，有點像過去的設計歷史文件可以追溯到“16”、“17”、“18”、“19”，因此我們強烈地感覺到我們需要保護律師客戶的特權，不僅針對本案，而且針對所有案件的先例他們的案例就在那裡。

But we've been very cooperative with them and we produce many, many documents, everything that they've requested and all of them frankly, have topical matters that are the same as what's in the reports at every question as well.

但我們一直與他們非常合作，我們製作了很多很多文件，他們所要求的一切，坦白說，所有這些文件的主題問題都與報告中針對每個問題的內容相同。

So they have this information, but this is about protecting the attorney client privilege that we think we're entitled to. But I can't give you anything more specific than that right now, we'd be speculating and we're not going to speculate.

所以他們有這些訊息，但這是為了保護我們認為我們有權享有的律師委託人特權。但我現在不能給你比這更具體的訊息，我們會猜測，但我們不會猜測。

Marie Thibault, BTIG.

瑪麗蒂博，BTIG。

Hi. Thanks for taking the questions. Brice, thanks for your help the last couple of years and best wishes to you and your family. Dan, congrats on the new seat. Wanted to -- I use my one question here actually to latch on to what you talked about on the sleep space and efforts to launch into a market evaluation next year.

你好。感謝您提出問題。布萊斯，感謝您過去幾年的幫助，並向您和您的家人致以最美好的祝愿。丹，恭喜你獲得新席位。我想——我在這裡用我的一個問題實際上是為了了解你所談論的睡眠空間以及明年啟動市場評估的努力。

Can you talk a little bit more about what does that look like? Is that a reimbursable product? What parameters are being measured? And then is there spend or acquisition needed to get there into that market evaluation? Thanks for taking the questions.

能多談談它是什麼樣子的嗎？這是可報銷產品嗎？正在測量哪些參數？然後是否需要支出或收購才能進入市場評估？感謝您提出問題。

Thanks, Marie. So I think we can get to the market evaluation with lot of incremental investment or acquisitions to make that happen. In the market evaluation phase, it's really about building a brand and capability that makes it entirely seamless for the physician to ultimately identify the patient and order the product and behind the scenes and for the product gets to the patient the data received, we interpret it through an IDTF capability and provide a report back through a single digital portal to the physician.

謝謝，瑪麗。因此，我認為我們可以透過大量增量投資或收購來進行市場評估，以實現這一目標。在市場評估階段，實際上是建立一個品牌和能力，使醫生能夠完全無縫地最終識別患者並訂購產品，在幕後，為了讓產品到達患者手中，我們解釋收到的數據通過IDTF 功能，並通過單一數位入口網站向醫生提供報告。

So to the physician customer, it's incredibly seamless to the patient it's a much more efficient workflow. They don't have to leave the cardiology go see a sleep specialist or somebody else. We introduce them to a virtual fleet capability or a home sleep test.

因此，對於醫生客戶來說，這對患者來說是非常無縫的，這是一個更有效率的工作流程。他們不必離開心臟科醫生去看睡眠專家或其他人。我們向他們介紹虛擬車隊功能或居家睡眠測試。

Out of the gate, we will leverage a third party sleep test. While we continue to build our own capabilities to diagnose sleep disease on our own. So out of the gate, we'll leverage procuring a sleep device from a third party make that part of the iRhythm package, and ultimately provide that to the patient, collect the data, interpret the data and provide a report back to the position that will be packaged up as an iRhythm solution.

首先，我們將利用第三方睡眠測試。同時我們持續建立自己的能力來自行診斷睡眠疾病。因此，一開始，我們將利用從第三方購買的睡眠設備，將其作為 iRhythm 包的一部分，並最終將其提供給患者，收集數據，解釋數據並提供報告返回給患者將被打包為iRhythm 解決方案。

All of that can be reimbursed and the reimbursable rate is somewhere between $150 to $200 for that sleep tests and the service that we'll be providing back in the way of a report. And that rate sort of ranges between CMS and commercial payers. That's why there's a bit of a range between the $150 to $200. So that's for two to three days of call it home sleep test service and report generation.

所有這些都可以報銷，睡眠測試和我們將以報告的方式提供的服務的報銷率在 150 至 200 美元之間。該費率介於 CMS 和商業付款人之間。這就是為什麼價格在 150 美元到 200 美元之間有一點差距。這就是兩到三天的家庭睡眠測試服務和報告生成。

But that's how to think about it in terms of the financial model over time, it's our intent to continue to develop and ultimately deliver our own home sleep test capability right off of our single platform. So that will come further down the road and we'll step into that and really verticalize that entire offering in time. But that's not going to hold us up in the near term.

但這就是隨著時間的推移如何從財務模型的角度來思考它，我們的目的是繼續開發並最終在我們的單一平台上提供我們自己的家庭睡眠測試功能。因此，這將在未來的道路上走得更遠，我們將介入並及時真正垂直化整個產品。但這不會在短期內阻止我們。

David Rescott, Baird.

大衛雷斯科特，貝爾德。

Great. Thanks for taking the questions. Brice, obviously, echoing kind of the best wishes to you and your family under these circumstances. Dan, congrats on the new role. I'm looking forward to working with you even more going forward.

偉大的。感謝您提出問題。顯然，布萊斯在這種情況下向你和你的家人表達了最美好的祝愿。丹，祝賀你擔任新角色。我期待與您進一步合作。

I wanted to follow up just on the 483 comments first and then curious on how these new observations impact the recently submitted 510(k), whether or not that has any impact on the total kind of resolution of the warning letter or the ability to submit for Zio MCT?

我想先跟進 483 條評論，然後好奇這些新觀察結果如何影響最近提交的 510(k)，這是否對警告信的整體解決方案或提交能力有任何影響齊奧MCT？

And then just related to that, plus the DOJ comments, I think I heard the comments around the $8 million to $10 million of the incremental spend or the spend that's in the business today and wondering if these drag a little bit longer, if that's the case, whether or not that impacts the longer-term view around where the EBITDA margin can go longer term? Thank you.

然後與此相關的是，加上司法部的評論，我想我聽到了有關800 萬至1000 萬美元增量支出或當今業務支出的評論，我想知道這些是否會拖延更長的時間，如果這就是在這種情況下，這是否會影響 EBITDA 利潤率長期發展的長期觀點？謝謝。

Sure. So let me hit on the 483s and Brice or Dan, you guys could speak to longer term view around sort of the expense associated with this. But with respect to the 483s and the inspection that took place here in the back part of July, there's nothing in those discussions at all that gave us any indication or any direction to think differently around how we think about clearing the Zio AT product and those 510(k).

當然。因此，讓我談談 483、Brice 或 Dan，你們可以就與此相關的費用發表更長遠的看法。但就 483 和 7 月下旬在這裡進行的檢查而言，這些討論中根本沒有任何跡像或任何方向讓我們以不同的方式思考如何清理 Zio AT 產品和那些產品。

So back to my prepared remarks, we did file the response to the catch up 510(k) earlier this week. And frankly, the other response to the other 510(k) would have gone in as well had we not been addressing the inspection. So that got delayed just a little bit, but it's nearly ready to go.

回到我準備好的發言，我們確實在本週早些時候提交了對追趕 510(k) 的答复。坦白說，如果我們沒有解決檢查問題，對其他 510(k) 的其他回應也會納入其中。所以這只是延遲了一點，但幾乎已經準備好了。

So that will get on file likely by the end of next week or shortly thereafter. And that puts us right on track for sort of that September, October timeframe in terms of the approval of Zio AT. So nothing has changed from that perspective and the same with Zio MCT. There's been no indication given at all that we should think differently around the Zio MCT product.

因此，該文件可能會在下週末或不久後歸檔。這使我們在 9 月、10 月的 Zio AT 批准時間範圍內步入正軌。因此，從這個角度來看，一切都沒有改變，Zio MCT 也是如此。沒有任何跡象表明我們應該對 Zio MCT 產品進行不同的思考。

Of course, we do need to see Zio AT clear or get the two clearances there that will be the predicate for Zio MCT. But our expectation is that we continue to get Zio MCT on file before the end of the year. One of the things that I would know, skin irritation is something that has come up. The investors have asked about it, it's something that we pay close attention to.

當然，我們確實需要清楚 Zio AT 或獲得兩個許可，這將成為 Zio MCT 的謂詞。但我們的期望是在年底前繼續將 Zio MCT 歸檔。我知道的一件事是，皮膚刺激已經出現了。投資人都問到了，我們也很關注。

And frankly, we even had a discussion with the FDA around it. Overall, our skin irritation rate is right around 2%, which is well below published literature of what's acceptable in wearable devices. But we have seen it step up just a little bit over the last two years. One of the things the FDA proactively asked us about is how quickly can you move from Zio XT on the Zio monitor or once the Zio MCT gets approved, how quickly could you move Zio AT on the Zio MCT.

坦白說，我們甚至與 FDA 圍繞這個問題進行了討論。整體而言，我們的皮膚刺激率約為 2%，遠低於穿戴式裝置可接受的已發表文獻。但我們看到它在過去兩年中略有上升。FDA 主動詢問我們的一件事是，您可以多快地從 Zio 顯示器上的 Zio XT 轉移，或者一旦 Zio MCT 獲得批准，您可以多快地在 Zio MCT 上轉移 Zio AT。

Because we know that monitor which will be the platform for MCT has a much lower irritation rate. So again, that's a favorable indication of moving towards these new products. We've not been given any indication to think differently around the time frame at this point in time. If that changes, of course, we'll have those conversations with you. But from our perspective, nothing changes there and we stay on track.

因為我們知道作為 MCT 平台的顯示器的刺激率要低得多。再說一遍，這是轉向這些新產品的有利跡象。目前我們還沒有得到任何跡象表明我們會在時間範圍內進行不同的思考。當然，如果情況發生變化，我們會與您進行對話。但從我們的角度來看，那裡沒有任何變化，我們仍保持在正軌上。

Yeah. Hey, David, a question on the or the $8 million to $10 million. Based on everything we know now we believe that $8 million to $10 million is the appropriate way to think about it for 2024, so effectively no deviation. With regards to what that means moving forward, we'll certainly provide feedback.

是的。嘿，大衛，有一個關於 800 萬到 1000 萬美元的問題。根據我們現在所知道的一切，我們認為 800 萬至 1000 萬美元是考慮 2024 年的適當方式，因此實際上沒有偏差。至於這意味著什麼，我們肯定會提供回饋。

As of now. I don't see any indication that this is going to extend meaningfully longer now, should that something group into 2025, we'll certainly talk about that. But over time, we absolutely believe this $8 million to $10 million comes out of the spend profile and becomes meaningful contributor to adjusted EBITDA moving forward.

截至目前。我沒有看到任何跡象表明這種情況會有意義地延長更長的時間，如果這種情況持續到 2025 年，我們肯定會討論這個問題。但隨著時間的推移，我們絕對相信這 800 萬至 1000 萬美元會從支出情況中扣除，並成為調整後 EBITDA 向前發展的有意義的貢獻者。

Nathan Treybeck, Wells Fargo.

內森·特雷貝克，富國銀行。

Hi. Thanks for taking the question. Brice, it has been a pleasure working with you and Dan, congrats on the new role. I just wanted to touch on the DOJ subpoena and just one more time. The wording in the recent court document that was posted seems to suggest that it might just relate to Zio AT. Is there anything in the documentation that was requested from that would suggest the inquiry extents to Zio XT as well.

你好。感謝您提出問題。布萊斯，很高興與你和丹一起工作，祝賀你擔任新角色。我只是想再談談司法部的傳票。最近發布的法庭文件中的措辭似乎表明它可能只與 Zio AT 有關。所要求的文件中是否有任何內容顯示查詢範圍也適用於 Zio XT。

Nathan, we'd be speculating at best around it. I mean, from the very beginning, this seems to have been focused around the AT or even the MCT category, keep in mind, competitors of ours who have MCT product received a subpoena at the same time.

內森，我們最多只能猜測一下。我的意思是，從一開始，這似乎就集中在 AT 甚至 MCT 類別上，請記住，我們擁有 MCT 產品的競爭對手同時收到了傳票。

So we don't know that for certain, but certainly so much of the documents that have been requested focused in and around that, including what you're referring to and what was produced in that filing. But at the same time, I can't tell you with certainty that that's where it's focused right.

因此，我們不確定這一點，但可以肯定的是，所要求的許多文件都集中在這一點上，包括您所指的內容以及該文件中產生的內容。但同時，我無法肯定地告訴你這就是它的重點。

The request has been very broad and we've been very cooperative with them to produce everything they're asking for, so I can't speculate. That's where it seem to be focused to begin with, but at the same time the document request has been broad. So we can't -- I can't tell you for certainty -- for certain that that's where it's at.

要求非常廣泛，我們一直與他們非常合作，生產他們要求的一切，所以我無法推測。這似乎是它一開始關注的焦點，但同時文件要求也很廣泛。所以我們不能──我不能確定地告訴你──確定那就是它所在的地方。

Joanne Wuensch, Citigroup.

喬安妮‧文施 (Joanne Wuensch)，花旗集團。

Hi, guys. This is actually Anthony on for Joanne, and I'll just echo the well wishes for you and your family Brice. Dan, congrats on the new role. At a broker conference, I think back in June, you laid out some components in the back half of the year, driving the gross margin expansion at close 200 bps from the CCTs coming up to speed 100 bps from ramping up monitor and then another 100 bps from automation. Is that still how you're thinking about contribution from these components for margin in the back half of the year?

嗨，大家好。這實際上是安東尼為喬安妮代言，我只是向你和你的家人布萊斯表達良好的祝愿。丹，祝賀你擔任新角色。我記得在 6 月的一次經紀商會議上，您在今年下半年制定了一些組成部分，推動毛利率從 CCT 增長近 200 個基點，透過提高監控速度達到 100 個基點，然後再提高 100 個基點來自自動化的bps。您仍然是這樣考慮這些組件對下半年利潤的貢獻嗎？

Yeah, Anthony. Yeah, it is. That's the way we're thinking about it. Obviously, the performance in the second quarter, that efficiency with regards to the 200 basis points from the clinical operations team actually played through much more quickly than what we anticipated.

是的，安東尼。是的，確實如此。這就是我們思考的方式。顯然，第二季的表現，即臨床營運團隊 200 個基點的效率實際上比我們預期的要快得多。

We saw some incredibly nice work by that team and focused just operations from that team in the second quarter. And we saw that play through a bit earlier than we thought. The other thing that we saw was the manufacturing efficiency component not so much pure automation, but the efficiencies component played through as well in the quarter.

我們看到團隊做了一些令人難以置信的出色工作，並在第二季度專注於該團隊的運作。我們看到這場比賽比我們想像的要早一些。我們看到的另一件事是製造效率部分並不是純粹的自動化，但效率部分在本季也發揮了作用。

I alluded to the fact that there were a couple of things that contributed to the benefit in the second quarter. However, that doesn't take away that 400 basis points that we laid out and where we expect to be as we exit 2024 and frankly, as we move into 2025.

我提到有幾件事促成了第二季的收益。然而，這並沒有消除我們設定的 400 個基點，以及我們在 2024 年退出時，坦白說，在進入 2025 年時的預期。

Mike Polark, Wolfe Research.

麥克‧波拉克，沃爾夫研究中心。

Hi, good afternoon. If I could sneak into appreciate it. the easy one is R&D it looked to be in dollar terms, it's a little lumpy then -- a little higher than it has been. What is -- is there something new in there? Is that [$20 million] a quarter is a good run rate or do you expect a step back down in 2H?

嗨，下午好。如果我能潛入欣賞就好了。最簡單的是研發，它看起來以美元計算，當時有點不穩定——比以前高了一點。這裡面有什麼新東西嗎？每季 [2000 萬美元] 的運行率是否不錯，還是您預計 2H 內會有所回落？

And then the second question is my ears perked up around a major policy shift from a large national payer. I heard a couple of things in there step through for ILRs and removing step therapy. I guess it sounds different new, you're calling it out. Can you maybe spoon feed us what's going on there and what's changes? Thank you so much.

第二個問題是，我對一個大型國家支付機構的重大政策轉變豎起了耳朵。我聽到了一些關於 ILR 的逐步實施和取消逐步治療的內容。我想這聽起來很不一樣，是你喊出來的。你能用湯匙告訴我們那裡發生了什麼以及發生了什麼變化嗎？太感謝了。

Hey, Mike, thanks for the questions. On the R&D side, there's really no major deviation from trend moving forward. I will say the expenses were higher in the quarter, most notably for as we get the product ready, that being Zio MCT ready for regulatory submission, working through human factors, testing finalization of some work on the software solutions side and basically just getting in a position to ultimately file that regulatory submission.

嘿，麥克，謝謝你的提問。在研發方面，與未來的趨勢確實沒有重大偏差。我想說的是，本季的費用較高，最值得注意的是，當我們準備好產品時，Zio MCT 已準備好提交監管，透過人為因素進行工作，測試軟體解決方案方面的一些工作的最終結果，基本上只是進入最終提交該監管意見的立場。

The costs was a little bit higher in the second quarter. That's not something that we anticipate moving forward. We would expect to see that start to trend down in Q3 and then even further in Q4 as we get beyond that submission.

第二季度的成本略高。這不是我們預期會發生的事情。我們預計，隨著我們提交的內容完成，這一數字將在第三季度開始下降，然後在第四季度進一步下降。

Hey, Mike, it's Dan. I'll take the second question. So I'm glad you captured the nice wins the team drove there on the payer side and market access side. I think it highlights the clinical and economic evidence we continue to generate and that getting recognition from the payers there was a few different wins lumped in there, right, some new coverage, and we sized that up to be to 2.9 million new covered lives and then some coverage policy decisions that essentially make it easier for patients to get onto Zio.

嘿，麥克，我是丹。我來回答第二個問題。因此，我很高興您捕捉到了團隊在付款方和市場准入方面取得的良好勝利。我認為它強調了我們不斷產生的臨床和經濟證據，並且得到付款人的認可，其中有一些不同的勝利，對吧，一些新的保險，我們估計最多有 290 萬新的受保生命，然後是一些承保政策決定，這些決定本質上使患者更容易使用Zio。

So some really nice wins there. Those -- the impact of that doesn't necessarily show up immediately but yeah, we will see that start to show up in results and really benefit both volumes and ASPs through time. But ultimately, those coverage policy wins absolutely make it easier for patients to get access to Zio, and that will have a long-term benefit.

所以那裡有一些非常好的勝利。這些——其影響不一定會立即顯現出來，但是，是的，我們會看到這種影響開始顯現結果中，並且隨著時間的推移，銷量和平均售價都會真正受益。但最終，這些覆蓋政策的勝利絕對會讓患者更容易獲得 Zio，這將帶來長期利益。

Hey, Mike, one thing that I'll add to it, because I just think it is encouraging to see the impact that CAMELOT continues to have in this space. So many policies and time is required up to 30 days of monitoring before you can get onto an ILR.

嘿，Mike，我要補充一件事，因為我認為看到 CAMELOT 在這個領域繼續產生的影響是令人鼓舞的。在您獲得 ILR 之前，需要大量的政策和長達 30 天的監控時間。

They are proactively moving that down to 14 days directly in line with the Zio monitors where period and that comes back to the data that's being presented in these CAMELOT study. So again, I think it's resonating it's leading to incremental access. It's leading to reduced hurdle to get onto the product and it's opening up new channels, but CAMELOT has been a wonderful thing for us.

他們主動將這一時間縮短至 14 天，直接與 Zio 監測的週期一致，這又回到了這些 CAMELOT 研究中提供的數據。再說一次，我認為它引起了共鳴，導致了增量訪問。它減少了進入該產品的障礙，並開闢了新的管道，但 CAMELOT 對我們來說是一件很棒的事情。

Ravi Misra, Truist.

拉維‧米斯拉，真理主義者。

Hi, this is Ravi from Truist. Thanks for taking the questions. So just two questions on our end. First, just Quentin, it sounds like the 483 observations are more kind of around workflow issues and things like that. I was hoping you could maybe talk about what you envision around risk in terms of the discussions don't go the way you think they will.

大家好，我是來自 Truist 的 Ravi。感謝您提出問題。我們這邊只有兩個問題。首先，昆汀，聽起來 483 條觀察結果更多的是圍繞著工作流程問題和類似的事情。我希望你能談談你對風險的設想，因為討論不會按照你想像的方式進行。

They seem pretty benign so far, at least the way I've described them, what could that mean. And then secondly, just on undiagnosed revenue, I think it's something that you talked about last couple of calls, pilot program beginning this year. What's driving the patients into the channel right now? And what are you doing to kind of develop the market there? Thanks.

到目前為止，它們看起來相當溫和，至少從我描述它們的方式來看，這意味著什麼。其次，關於未診斷的收入，我認為這是您在最近幾次電話會議中談到的，今年開始的試點計劃。是什麼促使患者現在進入通路？你們正在做什麼來開發那裡的市場？謝謝。

[Yeah, so I'll hit the first one. I ask you to -- call the second one, I'll jump back]. But with respect to how you sort of qualify what you're hearing, I think you're hearing it correctly that certainly sort of how it feels in terms of the inspections and the observations much more around documentation, process control, how you think about quantifying risk and therefore what you deem to be reportable or not.

[是啊，所以我就打第一個。我請你—打電話給第二個，我會跳回來]。但關於你如何證明你所聽到的內容，我認為你聽到的是正確的，這肯定是在檢查和觀察方面的感覺，更多地圍繞文檔、過程控制、你如何思考量化風險以及你認為應報告或不應報告的風險。

Not about is there a safety question holistically about your product or service that is not the topic at all. So I'm with you there, I think you're thinking about it the right way. In terms of what's the risk to where it could go.

不是關於您的產品或服務是否存在根本不是主題的整體安全問題。所以我同意你的觀點，我認為你的思考方式是正確的。就其可能走向的風險而言。

Again, I'm not going to speculate at all here there's the opportunity that we have the chance to respond within the 15 days. And we navigate through this and that they don't think ours are response is sufficient could it lead to another warning letter. That's always a potential although we're going to do everything we can to avoid that.

再次強調，我不會猜測我們是否有機會在 15 天內回應。我們解決了這個問題，他們認為我們的反應不夠充分，可能會導致另一封警告信。儘管我們將盡一切努力避免這種情況，但這種情況始終存在。

But in no way, do I see this getting to the point and there's never been a discussion around whether the product survives in the market or should be marketed again, there are no questions around the safety or efficacy of the product serving the patient. It's more around how are you documenting these things or how are you quantifying the risk that leads to then what you report or don't report.

但無論如何，我認為這並沒有達到重點，而且從來沒有討論過該產品是否能在市場上生存或是否應該再次上市，也不存在關於該產品為患者服務的安全性或有效性的問題。更重要的是您如何記錄這些事情，或如何量化導致您報告或不報告內容的風險。

I mean, we've even had discussions during the course of the last several months with the FDA, where they've seen the MDR reporting, you guys have seen it as well we've been very transparent with what we're going to report to the point where they've even engage with us and said, look, you're over reporting in these particular areas.

我的意思是，我們甚至在過去幾個月裡與 FDA 進行了討論，他們看到了 MDR 報告，你們也看到了，我們對我們要做的事情非常透明報道到他們甚至與我們接觸並說，看，你在這些特定領域的報導過度了。

We're going to continue to choose that to report that we can find full alignment with them on exactly what should or shouldn't be reported. But those are the sort of the discussion topics that we're having right now. So navigating through that with respect to the undiagnosed arrhythmias, really what's driving this or sort of the high level entity plans to understand that proactively finding these patients with the Rhythmia before they show up in the emergency room or having some sort of event that drives meaningful dollars is beneficial to them.

我們將繼續選擇報告我們可以在應該或不應該報告的內容上與他們完全一致。但這些都是我們現在正在討論的話題。因此，對於未確診的心律不整，真正的推動因素是什麼或某種高層實體計劃了解，在這些患有心律不整的患者出現在急診室或發生某種有意義的事件之前，主動發現這些患者美元對他們有利。

The mSToPS data has been tremendous and identifying the opportunity there. But frankly, a lot of these plans that are putting in place, the proactive monitoring are opening up the aperture beyond even what mSToPS that identifies the criteria to sort of rule in somebody for proactive monitoring because they're identifying with higher yields sort of where these arrhythmias exist.

mSTOPS 數據非常巨大，並確定了其中的機會。但坦白說，許多正在實施的計劃，主動監控正在開闢超越 mSTOPS 的範圍，mSTOPS 確定了對某人進行主動監控的規則的標準，因為他們正在識別更高的收益這些心律失常是存在的。

So it's more of a top-down approach where these large entities are looking across their covered populations. They're looking for certain criteria in their patients, and they're proactively bringing those patients into the past, looking for these arrhythmias and ending up with very high yield rates associated with that work.

因此，這更像是一種自上而下的方法，這些大型實體正在審視其所涵蓋的人群。他們正在尋找患者的某些標準，並主動將這些患者帶入過去，尋找這些心律不整，並最終獲得與這項工作相關的非常高的收益率。

So that's how it's playing out at this point in time. And we'll see how it continues to move into the future. But we couldn't be more excited with what we're seeing in several of these players who have really adopted it.

這就是目前的情況。我們將看看它如何繼續走向未來。但我們對在一些真正採用它的玩家中看到的情況感到非常興奮。

William Plovanic, Canaccord Genuity.

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

Great. Thanks for taking my questions. Just wanted a little clarity. So a lot going on with mSToPS and CAMELOT really sounds like driving the plans, the policy changes and you talked about ASPs. How should we think about that from a future perspective? Is this a directional change because of this data, you're able to negotiate higher ASPs with the plans, and is that something you expect to go in the future? Thanks.

偉大的。感謝您回答我的問題。只是想要一點清晰度。mSToPS 和 CAMELOT 方面發生的許多事情聽起來確實像是推動計劃、政策變化以及您談到的 ASP。從未來的角度我們該如何思考？這是因為這些數據而導致的方向性變化嗎？謝謝。

Yeah, not so much, Bill. So many of these plans establish a rate for a particular category code and a lot of times in the broader industry is billing against that code. So take CMS, for example, we're all getting reimbursed the same level there.

是的，沒那麼多，比爾。許多此類計劃都針對特定類別代碼制定了費率，並且在更廣泛的行業中很多時候都是根據該代碼計費的。以 CMS 為例，我們都獲得相同等級的報銷。

But encouragingly, you saw in the proposed rule, long-term cardiac monitoring, frankly, was the only one at the cost elements increase meaningfully in this proposed rule. Now some of the physician fee adjustments and other adjusting factors bring that down a bit, but net-net in our pricing remained stable.

但令人鼓舞的是，您在擬議規則中看到，坦白說，長期心臟監測是該擬議規則中唯一以成本元素有意義增加的方式。現在，一些醫生費用調整和其他調整因素使這一點有所下降，但我們的定價中的淨淨值保持穩定。

So I do think in time where the opportunity presents itself is in these larger at risk, proactive monitoring programs, we have a bit of its ability to negotiate price differently because in those situations you may be selling directly into the payer plan at whatever price you negotiate with them.

因此，我確實認為，機會出現在這些風險較大的主動監控計劃中，我們有一定的能力以不同的方式協商價格，因為在這些情況下，您可能會以任何價格直接出售給付款人計劃。與他們談判。

And obviously, the more we can demonstrate the value that we're bringing to them, the more they're going to be willing to pay for this product as well. So we're in the process of collecting all of this data. Again, the yield rates have been incredible far surpassing what folks initially set out sort of targeting. And that's why you see these pilots begin to expand out more broadly.

顯然，我們越能向他們展示我們為他們帶來的價值，他們就越願意為該產品付費。所以我們正在收集所有這些數據。同樣，收益率令人難以置信，遠遠超出了人們最初設定的目標。這就是為什麼你會看到這些試點計畫開始更廣泛地擴展。

But I do think in time we start to gain a bit of pricing power in some of these sort of programs that historically we've been billing against codes where model starts to evolve a bit and probably opens up some flexibility for us.

但我確實認為，隨著時間的推移，我們開始在某些此類程序中獲得一定的定價權，這些程序在歷史上我們一直根據代碼進行計費，其中模型開始稍微發展，並可能為我們帶來一些靈活性。

David Saxon, Needham & Company.

大衛‧撒克遜，李約瑟公司。

Great. Good afternoon. Thanks for taking my question. I wanted to ask on MCT, and so, this is probably for Brice, but maybe for Dan. So it sounds like that can still launch in 2025, and maybe that can help you take share in the MCT market.

偉大的。午安.感謝您提出我的問題。我想詢問有關 MCT 的問題，因此，這可能是針對 Brice 的，但也可能是針對 Dan 的。所以聽起來它仍然可以在 2025 年推出，也許這可以幫助您在 MCT 市場中佔據份額。

But my understanding is MCT as a product category, it's lower margin, but higher dollars to when that product does launch and ramps, how should we think about the impact to margins and to dollar profitability? Will it be meaningfully different than what you're seeing with AT? Thanks so much.

但我的理解是，MCT 作為一個產品類別，它的利潤率較低，但當該產品推出並推出時，美元價格較高，我們應該如何考慮對利潤率和美元盈利能力的影響？它會與您在 AT 中看到的有顯著不同嗎？非常感謝。

Yeah, it's a good question. I appreciate that. And you're absolutely right from a revenue perspective, it is a higher dollars reimbursed product as it stands now. However, it's more, I would say, costly to service that product.

是的，這是一個好問題。我很欣賞這一點。從收入的角度來看，你絕對是對的，就目前而言，這是一種更高美元的報銷產品。然而，我想說的是，該產品的維修成本更高。

However, that was fully contemplated in the LRP as we designed it. And frankly, we have efficiencies that we're working on from a gross margin perspective, that's meant to not only offset any ASP pressures that we would have over time, but also that shift into the MCT category.

然而，我們在設計 LRP 時充分考慮了這一點。坦白說，我們正在從毛利率的角度提高效率，這不僅是為了抵消隨著時間的推移我們可能面臨的任何 ASP 壓力，也是為了向 MCT 類別轉變。

So we talked about that low 70s gross margin over time being where we believe we're able to go. Obviously, that requires us to drive incremental efficiencies in and above that as we absorb some of these things that ultimately cause a little bit of pressure there. However, we feel very good about the LRP that we put out in front of the investor community, and we're still run into that level.

因此，我們談到隨著時間的推移，我們相信我們能夠達到 70 年代的低毛利率。顯然，這要求我們在吸收其中一些最終會造成一點壓力的事情時提高效率。然而，我們對在投資者群體面前推出的 LRP 感覺非常好，而且我們仍然處於這個水平。

Suraj Kalia, Oppenheimer.

蘇拉吉·卡利亞，奧本海默。

Good afternoon, everyone. Thanks for taking my question. Brice it's been a pleasure working with you I hope all is well in the family front. And Dan, congrats on the new seat. I echo this sentiment. So, gentleman, a lot of questions have been asked.

大家下午好。感謝您提出我的問題。布萊斯，很高興與你合作，我希望家庭方面一切順利。丹，恭喜你獲得新席位。我贊同這種觀點。所以，先生，我們提出了很多問題。

Quentin, I'll just throw a couple quickly or way. This policy change of Zio being a precursor to ILR. I'm curious, is that a trend towards a little more, I don't know if coordination is the right word, but the larger players with ILRs and how should we think about the relationship in the field? That is one question.

昆汀，我很快就會丟出幾個。Zio 的這項政策變化是 ILR 的先驅。我很好奇，這是一種趨勢嗎？ 我不知道協調這個詞是否正確，但是擁有 ILR 的較大參與者以及我們應該如何考慮該領域的關係？這是一個問題。

And in terms of asymptomatic, the policy changes you're working with some of the IDNs and whatnot. Should we think about in the future a differential pricing system for asymptomatic versus symptomatic? Thank you for taking my questions.

就無症狀而言，政策會改變您正在使用的一些 IDN 等。我們是否應該考慮在未來對無症狀和有症狀的患者實施差別定價制度？感謝您回答我的問題。

Yeah, great question, Suraj. With respect to the coordination in the field around ILR and maybe longer duration monitoring being a step through into that, it will be interesting to see how that plays out with respect to relationships in the field. We don't operate an ILR. So for us, we have one value proposition to physicians, which is our Zio product and it doesn't compete against and ILR procedure.

是的，很好的問題，蘇拉吉。關於圍繞 ILR 進行現場協調，也許更長持續時間的監控是其中的一個步驟，看看這在現場關係方面如何發揮作用將會很有趣。我們不經營 ILR。因此，對我們來說，我們向醫生提出了一個價值主張，那就是我們的 Zio 產品，它不會與 ILR 手術競爭。

But what's interesting is ILRs are quite expensive procedures for payers. So they're inclined to look for a cheaper alternative, right? And I think that's where they get interesting and really looking at the data to see how beneficial are these other therapies versus going straight to an ILR, if I don't have to because they're quite expensive sort of products, if you will, or procedures that they're reimbursing for.

但有趣的是，ILR 對於付款人來說是相當昂貴的程序。所以他們傾向於尋找更便宜的替代品，對吧？我認為這就是他們感興趣的地方，並真正研究數據，看看這些其他療法與直接接受 ILR 相比有多麼有益，如果我不需要的話，因為它們是相當昂貴的產品，如果你願意的話，或他們報銷的程序。

So I actually think the payers are going to continue to be interested in this space. And ultimately how the other competitors or other players who have ILRs respond to it, we will see. I think what we're finding is requiring an MCT sort of product to be a step two therapy to an ILRs, frankly, not necessary. The data showing us that 14 days of monitoring can get you what you need. So we'll see how that plays out.

所以我實際上認為付款人將繼續對這個領域感興趣。最終其他競爭對手或其他擁有 ILR 的玩家會如何反應，我們拭目以待。我認為我們發現需要 MCT 類產品作為 ILR 的第二步療法，坦白說，沒有必要。數據告訴我們，14 天的監控可以滿足您的需求。所以我們將看看結果如何。

On the asymptomatic versus symptomatic and pricing discussions. I think it's too early to tell. We're still working diligently to trying to influence USPSTF to proactively recommend proactive monitoring, if you will, of a symptomatic that's still a big hurdle out there to get the full market to really turn.

關於無症狀與有症狀以及定價的討論。我認為現在說還為時過早。如果您願意的話，我們仍在努力影響 USPSTF 主動建議對症狀進行主動監測，這仍然是整個市場真正扭轉的一大障礙。

But I do think continuing to work with commercial payers is going to influence the overall market and get it to move well ahead of USPSTF even needing to make a recommendation. So we'll see where pricing models go into the future from that.

但我確實認為，繼續與商業付款人合作將影響整個市場，並使其遠遠領先於 USPSTF，甚至需要提出建議。因此，我們將了解定價模型未來的發展方向。

I think a lot of it comes back to your diagnostic yield. You have to be very effective at being able to identify the right patient population and ultimately result in a good yield out of targeting that to make these things worthwhile for the payers. So there's a lot that comes into play there as we learn more in this space and come back to pricing, but we'll have to see how it plays out. We couldn't be more encouraged.

我認為這很大程度取決於你的診斷率。您必須非常有效地識別正確的患者群體，並最終通過目標獲得良好的收益，使這些事情對付款人來說是值得的。因此，當我們在這個領域了解更多並回到定價時，會有很多因素發揮作用，但我們必須看看它的效果如何。我們深受鼓舞。

The fact is that two years ago, we were talking about the opportunity for proactive monitoring and seen a lot of it taking place yet. Now we're starting to see it take place and we're seeing players reach out proactively to inquire about it, ask about it and begin working on programs that they can put into their own network. So we'll see where it goes, but we're excited with it.

事實上，兩年前，我們正在談論主動監控的機會，並且已經看到很多這樣的事情正在發生。現在我們開始看到它的發生，我們看到玩家主動主動詢問它，詢問它並開始開發可以放入自己網路中的程式。所以我們會看看它會走向何方，但我們對此感到興奮。

Thank you. We have no further questions in the queue. So I'd like to turn the call back to management for any closing comments.

謝謝。我們隊列中沒有其他問題了。因此，我想將電話轉回管理層以獲取任何結束意見。

Well, thank you for joining us today. We couldn't be more pleased with the start of 2024, and we couldn't be more excited about the growing momentum in our business as we begin to explore opening new adjacencies like sleep or like a continued expansion into the primary care channel.

好的，謝謝您今天加入我們。我們對 2024 年開始感到非常高興，我們對業務的成長勢頭感到非常興奮，因為我們開始探索開設睡眠等新業務或繼續擴展初級保健管道。

The back half of the year as set up to demonstrate some significant financial leverage as we continue to progress in our efforts to become more operationally excellent as we grow. And in addition to that, we have multiple growth levers that remain in front of us, which are yet to contribute to our success, including a new innovative Zio MCT solution, further entry into the international markets, including the second-largest ACM market in the world being Japan and further expansion into that primary care opportunity.

今年下半年的目標是展示一些重要的財務槓桿，因為我們將繼續努力，隨著我們的成長而變得更加卓越。除此之外，我們面前還有多個成長槓桿，但尚未為我們的成功做出貢獻，包括新的創新 Zio MCT 解決方案、進一步進入國際市場，包括美國第二大 ACM 市場世界是日本，並進一步擴展到初級保健機會。

So our future has never been brighter we couldn't be more excited and we look forward to talking to you again in the near future. With that, take care. Thank you.

因此，我們的未來從未如此光明，我們非常興奮，並期待在不久的將來再次與您交談。有了這個，小心點。謝謝。

This concludes today's call. Thank you for joining. You may now disconnect your line.

今天的電話會議到此結束。感謝您的加入。現在您可以斷開線路。