iRhythm Technologies Inc (IRTC) 2022 Q4 法說會逐字稿

Good afternoon. Thank you for attending today's iRhythm, Inc. Q4 2022 Earnings Conference Call. My name is Bethany, and I will be the moderator for today's call. (Operator Instructions)

下午好。感謝您參加今天的 iRhythm, Inc. 2022 年第四季度收益電話會議。我叫 Bethany，我將擔任今天電話會議的主持人。 （操作員說明）

I would now like to pass the conference over to our host, Stephanie Zhadkevich, Director of Investor Relations. Please go ahead.

我現在想將會議轉交給我們的主持人，投資者關係總監 Stephanie Zhadkevich。請繼續。

Thank you all for participating in today's call.

感謝大家參加今天的電話會議。

Earlier today, iRhythm released financial results for the fourth quarter and full year ended December 31, 2022. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical 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. These statements involve risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our most recent annual and quarterly reports on Form 10-K and Form 10-Q, respectively, filed with the Securities and Exchange Commission.

今天早些時候，iRhythm 發布了截至 2022 年 12 月 31 日的第四季度和全年的財務業績。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，其中包括聯邦意義上的前瞻性聲明根據 1995 年《私人證券訴訟改革法案》的安全港條款遵守證券法。本次電話會議中包含的任何不屬於歷史事實陳述的陳述均應視為前瞻性陳述。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、戰略、競爭、產品、經營計劃和業績的意圖、信念和期望。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存在重大差異。因此，您不應過分依賴這些陳述。有關與我們業務相關的風險和不確定性的列表和描述，請參閱我們向美國證券交易委員會提交的 10-K 表格和 10-Q 表格的最新年度和季度報告的風險因素部分.

Also during the call, we will discuss certain financial measures that have not been prepared in accordance with U.S. GAAP with respect to our non-GAAP and cash-based results, including adjusted EBITDA, adjusted operating expenses and adjusted net loss. Unless otherwise noted, all references to financial metrics are presented on a non-GAAP basis. The presentation of this additional information should not be considered in isolation of, as a substitute for or superior to results prepared in accordance with GAAP. Please refer to the tables in our earnings release and 10-K for a reconciliation of these measures to their most directly comparable GAAP financial measures. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, February 23, 2023. 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.

同樣在電話會議期間，我們將討論某些未根據美國公認會計原則準備的關於我們非公認會計原則和基於現金的結果的財務措施，包括調整後的 EBITDA、調整後的運營費用和調整後的淨虧損。除非另有說明，否則所有對財務指標的引用均按非 GAAP 原則提供。這些額外信息的呈現不應孤立地視為、替代或優於根據 GAAP 編制的結果。請參閱我們的收益發布和 10-K 中的表格，以了解這些措施與其最直接可比的 GAAP 財務措施的調節情況。此電話會議包含時間敏感的信息，並且僅在 2023 年 2 月 23 日今天的現場直播時準確。除法律要求外，iRhythm 不承擔更新或修改任何財務預測或前瞻性陳述的任何意圖或義務，無論是因為新信息、未來事件或其他信息。

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

有了這個，我將把電話轉給 iRhythm 的總裁兼首席執行官 Quentin Blackford。

Thank you, Stephanie. Good afternoon, and thank you all for joining us.

謝謝你，斯蒂芬妮。下午好，感謝大家加入我們。

Brice Bobzien, our Chief Financial Officer; Doug Devine, our Chief Operating Officer; and Dan Wilson, our EVP of Corporate Strategy and Development, join me on today's call. My prepared remarks today cover progress we've made during the fourth quarter of 2022 and discuss the near-term growth initiatives for our business. I'll then turn the call over to Brice to provide a detailed review of our financial results.

我們的首席財務官 Brice Bobzien；我們的首席運營官 Doug Devine；我們的企業戰略與發展執行副總裁 Dan Wilson 和我一起參加了今天的電話會議。我今天準備好的發言涵蓋了我們在 2022 年第四季度取得的進展，並討論了我們業務的近期增長計劃。然後，我會將電話轉給 Brice，以提供對我們財務業績的詳細審查。

We are very pleased with our significant growth exiting 2022, recognizing $112.6 million in revenues for the fourth quarter and achieving 38% growth year-over-year. This was in line with expectations as registrations grew more than 20% compared to the fourth quarter of 2021, and we saw improvement in return device rates. For the second time in the last 3 quarters, we realized another record quarter of new account openings for Zio XT, reflecting strong demand for our Zio services and setting us up for success as we enter 2023. Our Zio AT service continued to grow nicely, albeit growth did slow as expected when compared to the first 9 months of 2022.

我們對 2022 年的顯著增長感到非常滿意，第四季度收入為 1.126 億美元，同比增長 38%。這符合預期，因為與 2021 年第四季度相比，註冊量增長了 20% 以上，而且我們看到設備退貨率有所提高。在過去 3 個季度中，我們第二次實現了 Zio XT 新開戶的季度創紀錄，反映了對我們的 Zio 服務的強勁需求，並為我們在進入 2023 年取得成功做好了準備。我們的 Zio AT 服務繼續良好增長，儘管與 2022 年前 9 個月相比，增長確實如預期的那樣放緩。

We continue to drive awareness and adoption with the cardiology and EP physician segments where we believe there is still significant greenfield opportunity. We are also continuing our push into primary care to deliver a complete ambulatory cardiac monitoring service to the right patients earlier in their treatment paradigm. As discussed in the past, we believe this opens up the potential for a vastly larger market opportunity with over 14 million patients showing up in their primary care provider with cardiac-related heart palpitations annually. Patients can benefit from ambulatory cardiac monitoring earlier in their diagnostic journey, and we believe our Zio services offer the right test the first time.

我們繼續提高心髒病學和 EP 醫師細分市場的知名度和採用率，我們認為這些領域仍有巨大的綠地機會。我們還在繼續推進初級保健，以便在治療模式的早期為合適的患者提供完整的動態心臟監測服務。正如過去所討論的那樣，我們相信這開闢了一個更大的市場機會的潛力，每年有超過 1400 萬患者因心臟相關的心悸出現在他們的初級保健提供者那裡。患者可以在他們的診斷過程中儘早受益於動態心臟監測，我們相信我們的 Zio 服務可以在第一時間提供正確的測試。

As an example of this strategic expansion, we recently announced a nationwide agreement with One Medical with whom we share a dedication to delivering technology-powered and patient-focused solutions. We are very pleased with the progress we are making in the primary care segment and see significant opportunities to deliver Zio services to patients earlier in their care journey, ultimately benefiting patient lives and the health care system.

作為這一戰略擴張的一個例子，我們最近宣布與 One Medical 達成一項全國性協議，我們與 One Medical 共同致力於提供技術驅動和以患者為中心的解決方案。我們對我們在初級保健領域取得的進展感到非常高興，並看到了在患者護理旅程的早期向患者提供 Zio 服務的重大機會，最終使患者的生活和醫療保健系統受益。

On the pricing front, in November 2022, CMS published the calendar year 2023 physician fee schedule final rule containing payment rates for the 2 main CPT code sets related to long-term continuous ECG monitoring and recording that we used to seek reimbursement for the Zio XT service and the Zio Monitor service. We were very pleased with the outstanding work by our teams and other industry groups working with CMS to enable this milestone. And importantly, this positions us to bring our innovative products to more patients.

在定價方面，CMS 於 2022 年 11 月發布了 2023 日曆年醫師費用表最終規則，其中包含與長期連續心電圖監測和記錄相關的 2 個主要 CPT 代碼集的支付費率，我們曾用於尋求 Zio XT 的報銷服務和 Zio Monitor 服務。我們對我們的團隊和其他行業團體與 CMS 合作實現這一里程碑的出色工作感到非常高興。重要的是，這使我們能夠將我們的創新產品帶給更多患者。

Through our continued focus on improving market access in 2022, approximately 75% of all Medicare and commercial patients eligible for coverage now have a $50 co-pay or less and approximately 25% of all Medicare and commercial patients eligible for coverage will not pay anything at all out of pocket for the Zio XT or Zio Monitor service. CMS national pricing also opens the opportunity to contract with state Medicaid programs and further expand market access for these patients who represent approximately 10% of the U.S. market. While the CMS national pricing for long-term continuous ECG monitoring provides stability in our core U.S. business, we continue to believe that CMS undervalues the clinical benefit that our service brings to Medicare beneficiaries. We look forward to continuing to partner with CMS in the coming years as our industry moves towards gaining increased recognition of the clinical value of innovative AI technologies.

通過我們在 2022 年繼續專注於改善市場准入，所有有資格獲得保險的醫療保險和商業患者中約有 75% 現在的共付額為 50 美元或更少，並且有資格獲得保險的所有醫療保險和商業患者中約有 25% 將不支付任何費用Zio XT 或 Zio Monitor 服務全部自掏腰包。 CMS 全國定價還為與州醫療補助計劃簽訂合同並進一步擴大這些代表美國市場約 10% 的患者的市場准入提供了機會。雖然 CMS 長期連續 ECG 監測的國家定價為我們的核心美國業務提供了穩定性，但我們仍然認為 CMS 低估了我們的服務為 Medicare 受益人帶來的臨床利益。我們期待在未來幾年繼續與 CMS 合作，因為我們的行業正朝著獲得對創新 AI 技術的臨床價值越來越多的認可的方向發展。

On the innovation front, the clinical and economic evidence for a Zio XT service continued to build during the fourth quarter with the mSToPS economic analysis presented at AHA in November 2022. One-year follow-up findings from this trial were published in Heart Rhythm O2 in 2020 and demonstrated that active monitoring with our Zio XT service led to A-fib being newly diagnosed in 6.6% of patients who are actively monitored versus 2.4% in the observational control group receiving routine care. Three-year follow-up findings of mSToPS published in PLOS One in 2021, further more demonstrated the active monitoring with Zio XT service led to a statistically significant reduction in the combined primary endpoint of death, stroke, systemic emboli or myocardial infarction versus standard clinical care. The mSToPS trial was the first study to observe the benefits of A-fib screening at 3 years.

在創新方面，Zio XT 服務的臨床和經濟證據在第四季度繼續積累，mSToPS 經濟分析於 2022 年 11 月在 AHA 上展示。該試驗的一年隨訪結果發表在 Heart Rhythm O2 2020 年，並證明通過我們的 Zio XT 服務進行主動監測導致 6.6% 接受主動監測的患者新診斷出房顫，而在接受常規護理的觀察對照組中這一比例為 2.4%。 2021 年在 PLOS One 上發表的 mSToPS 三年隨訪結果進一步證明，與標準臨床相比，使用 Zio XT 服務進行主動監測導致死亡、中風、系統性栓塞或心肌梗死等綜合主要終點在統計學上顯著降低關心。 mSToPS 試驗是第一項觀察 3 年房顫篩查益處的研究。

The economic outcomes analysis presented this past November demonstrated that targeted A-fib screening with our Zio XT service provides excellent value to the health care system by enabling early diagnosis. Over 3 years, individuals prescribe the Zio XT service were more likely than unmonitored individuals to have outpatient visits, including the cardiologists, but less likely to require emergency department visits or hospitalization. More specifically, the analysis showed an incremental cost effectiveness ratio of approximately $17,000 per quality adjusted life year gained, which is the academic standard for measuring how well medical interventions lengthen and/or improve patient lives.

去年 11 月發布的經濟成果分析表明，使用我們的 Zio XT 服務進行有針對性的房顫篩查通過實現早期診斷為醫療保健系統提供了卓越的價值。 3 年多來，開 Zio XT 服務的個人比未受監控的個人（包括心髒病專家）更有可能進行門診就診，但不太可能需要急診就診或住院治療。更具體地說，該分析顯示每增加一個質量調整生命年，增量成本效益比約為 17,000 美元，這是衡量醫療干預延長和/或改善患者生命的學術標準。

For reference, the USPSTF recommended in 2021 to begin proactively screening for lung cancer with an incremental cost effectiveness ratio of $72,000. According to ACC and AHA, incremental cost effectiveness ratios for diagnostics under $100,000 are viewed as attractive, while anything under $50,000 is viewed as highly valuable. We believe that this continues to support our value proposition to payers as we build out our Know Your Rhythm program to proactively monitor properly targeted at-risk populations.

作為參考，USPSTF 建議在 2021 年開始主動篩查肺癌，增量成本效益比為 72,000 美元。根據 ACC 和 AHA 的說法，診斷的增量成本效益比率低於 100,000 美元被認為具有吸引力，而任何低於 50,000 美元的東西都被認為具有很高的價值。我們相信，這將繼續支持我們對付款人的價值主張，因為我們建立了 Know Your Rhythm 計劃，以主動監測適當的目標高危人群。

Regarding product innovation, we are pleased to announce that we recently received FDA clearance for another set of software modifications to our ZEUS system. This 510(k) clearance includes the addition of A-fib burden estimates to be added to daily reports for our Zio AT service. Since entire A-fib burden has been associated with a higher risk of stroke as well as higher prevalence of heart failure, we believe this is a clinically important enhancement to our service offering. And importantly, this further demonstrates our ability to continue developing innovative solutions and enhancements to our existing services for patients and customers and set the stage for continued innovation around our Zio AT service.

關於產品創新，我們很高興地宣布，我們最近收到了 FDA 對我們 ZEUS 系統的另一套軟件修改的許可。此 510(k) 許可包括將房顫負擔估計值添加到我們 Zio AT 服務的每日報告中。由於整個房顫負擔與更高的中風風險和更高的心力衰竭患病率相關，我們認為這是對我們提供的服務的臨床重要改進。重要的是，這進一步證明了我們有能力繼續為患者和客戶開發創新解決方案和增強現有服務，並為圍繞 Zio AT 服務的持續創新奠定基礎。

Turning to 2023, I'm excited for the year ahead and expect to build on the solid momentum we've seen in the past few months. On a macro level, while health care systems did experience staffing challenges in 2022, we're seeing early signs of improvement in early 2023. The operational efficiency associated with our Zio service has been resonating with accounts and driving adoption by allowing clinicians to streamline their workflow and focus their time on patient care. With 99% physician agreement with the Zio report and 98% patient compliance, the value of our Zio services continues to be appreciated by clinicians and continues to underlie our competitive advantage. We continue to see a steady pace of new account openings thus far in 2023, and we are particularly pleased with the early progress in primary care volumes from recent account openings that continue to validate our belief that the primary care market will, in fact, open up and be a nice contributor to growth for years to come.

談到 2023 年，我對來年感到興奮，並希望在過去幾個月看到的強勁勢頭的基礎上再接再厲。在宏觀層面上，雖然醫療保健系統在 2022 年確實遇到了人員配備挑戰，但我們在 2023 年初看到了改善的早期跡象。與我們的 Zio 服務相關的運營效率一直與客戶產生共鳴，並通過允許臨床醫生簡化他們的工作流程來推動採用工作流程並將他們的時間集中在病人護理上。 99% 的醫生同意 Zio 報告，98% 的患者依從性，我們 Zio 服務的價值繼續受到臨床醫生的讚賞，並繼續成為我們競爭優勢的基礎。到 2023 年為止，我們繼續看到新開戶的步伐穩定，我們特別高興的是，近期開戶後初級保健業務量的早期進展繼續證實我們的信念，即初級保健市場實際上將開放並成為未來幾年增長的重要貢獻者。

We also anticipate significant catalysts over the next 18 months to drive our business forward and position us for success in both the near term and long term. Most importantly, we expect there will be significant data upcoming at ACC 2023 in New Orleans, including important information further demonstrating our value proposition with our Zio services compared to other ambulatory cardiac monitoring offerings in the ACM market. We look forward to speaking with you about them after the ACC presentation in the coming weeks.

我們還預計未來 18 個月將出現重要的催化劑，以推動我們的業務向前發展，並使我們在近期和長期取得成功。最重要的是，我們預計將在新奧爾良舉行的 ACC 2023 上發布重要數據，其中包括進一步證明我們的 Zio 服務與 ACM 市場上其他動態心臟監測產品相比的價值主張的重要信息。我們期待在未來幾週的 ACC 演示後與您討論它們。

On the product front, we continue to anticipate full commercial launch of our next-generation biosensors, the Zio Monitor to replace our current Zio XT patch form factor in the back half of 2023. As a reminder, this new patch is 72% smaller, 55% lighter and 20% thinner than our existing Zio XT form factor, all of which we believe has a positive impact on patient experience and may have an associated improvement in wear times and device return rates. The Zio Monitor is currently in limited U.S. commercial launch, and we are very excited to get this into the marketplace in the hands of physicians and their patients.

在產品方面，我們繼續預計我們的下一代生物傳感器 Zio Monitor 將在 2023 年下半年全面商業化發布，以取代我們目前的 Zio XT 貼片外形尺寸。提醒一下，這個新貼片小了 72%，比我們現有的 Zio XT 外形輕 55%，薄 20%，我們相信所有這些都會對患者體驗產生積極影響，並且可能會改善磨損時間和設備回收率。 Zio Monitor 目前在美國進行有限的商業發布，我們很高興能將其推向市場並交到醫生和他們的患者手中。

We also anticipate submissions to the FDA for an updated MCT service in the latter part of 2023 for potential commercial launch in 2024. There is significant runway ahead of us in the MCT market, where we have less than 10% market share today. The submission on the hardware side will include an upgrade to our new biosensor platform, which was built for automation and will, therefore, improve our scalability once volumes are ramped across all modalities. We also expect to submit software improvements to add enhanced detection features, monitoring flexibility within a single device and longer wear time optionality. We are excited about this next generation of our Zio AT product, which we believe will better position us to compete in this space and drive market share gains into the future.

我們還預計在 2023 年下半年向 FDA 提交更新的 MCT 服務，以便在 2024 年進行商業發布。在 MCT 市場上，我們還有很長的路要走，目前我們在該市場的份額不到 10%。硬件方面的提交將包括對我們新的生物傳感器平台的升級，該平台是為自動化而構建的，因此，一旦所有模式的數量都在增加，它將提高我們的可擴展性。我們還希望提交軟件改進，以添加增強的檢測功能、監控單個設備的靈活性和更長的佩戴時間可選性。我們對下一代 Zio AT 產品感到興奮，我們相信它將更好地定位我們在這個領域的競爭並推動未來市場份額的增長。

As we've discussed in the past, our Zio Watch is also expected to enter limited market evaluation in 2023. Using a continuous PPG AI-based algorithm, the Zio Watch not only detects A-fib, but also characterizes the amount of A-fib over time to calculate an A-fib burden estimate with accuracy compared to that of the Zio XT patch as a reference. This contextualization of patient A-fib presence or absence collected through the monitoring period is important and clinically meaningful to aid in a potential diagnosis. The Zio Watch is intended to be complementary to Zio patches by adding modality with longer wear times for patients who require long-term monitoring. The anticipated market evaluation in 2023 will enable us to gain real-world experience with the product and service to gather patient and physician feedback and to consider the appropriate reimbursement approach for this uniquely positioned prescription-based monitoring service.

正如我們過去討論的那樣，我們的 Zio Watch 也有望在 2023 年進入有限的市場評估。使用基於 PPG AI 的連續算法，Zio Watch 不僅可以檢測房顫，還可以表徵 A-與作為參考的 Zio XT 補丁相比，fib 隨著時間的推移計算房顫負擔估計的準確性。通過監測期間收集的患者房顫存在或不存在的這種背景化對於幫助潛在診斷很重要且具有臨床意義。 Zio Watch 旨在通過為需要長期監測的患者增加佩戴時間更長的方式來補充 Zio 貼片。預計在 2023 年進行的市場評估將使我們能夠獲得產品和服務的實際經驗，以收集患者和醫生的反饋，並為這種定位獨特的基於處方的監測服務考慮適當的報銷方法。

Finally, we've outlined previously how driving operational efficiency is an important strategic pillar for iRhythm to serve millions more patients across the globe in the future. After nearly 10 years, we served our 5 million patients in late 2022. With our current growth assumptions, we expect to serve our next 5 million patients in just a few short years. This requires us to think bigger than we have before. In anticipation of this, we are sharing 2 transformative steps that we are taking to advance our strategic plan and enhance our internal infrastructure to meet the significant demand ahead of us. These steps include the establishment of a global business services center located in Manila, Philippines, as well as efforts to enhance the experience that our physicians and patients have with iRhythm. These efforts will enable us to scale and develop our clinical, operational and administrative functions more quickly, thereby enabling us to continue providing excellent support to our patients and customers globally.

最後，我們之前概述了提高運營效率如何成為 iRhythm 未來為全球數百萬患者提供服務的重要戰略支柱。近 10 年後，我們在 2022 年底為 500 萬患者提供了服務。根據我們目前的增長假設，我們預計在短短幾年內為下一個 500 萬患者提供服務。這要求我們比以前想得更大。考慮到這一點，我們正在分享我們正在採取的 2 個轉型步驟，以推進我們的戰略計劃並加強我們的內部基礎設施，以滿足我們面前的巨大需求。這些步驟包括在菲律賓馬尼拉建立全球業務服務中心，以及努力提升我們的醫生和患者對 iRhythm 的體驗。這些努力將使我們能夠更快地擴大和發展我們的臨床、運營和管理職能，從而使我們能夠繼續為全球患者和客戶提供出色的支持。

In addition, we'll leverage third-party service providers where necessary that will allow us to grow and scale more aggressively over time. While we expand our operations internationally and leverage our new service providers to meet our operational goals, these actions will enable our ability to grow globally and add team members where they are needed, both in the U.S. and abroad. These transformative steps mark a defining moment in iRhythm's journey. We know that patients, especially those seeking access to the care they need as well as physicians rely on Zio services to help unlock opportunities for better care and improved outcomes. Removing friction and barriers to access is a critical part of our mission, and we need to ensure operations allow us to do this. The changes I just outlined will equip us to improve access for patients worldwide. With solid momentum in our core business and significant opportunities on the horizon, I'm truly excited about our future at iRhythm in 2023 and beyond.

此外，我們將在必要時利用第三方服務提供商，這將使我們能夠隨著時間的推移更積極地發展和擴展。在我們擴大國際業務並利用我們的新服務提供商來實現我們的運營目標的同時，這些行動將使我們能夠在全球範圍內發展並在美國和國外需要的地方增加團隊成員。這些變革性步驟標誌著 iRhythm 旅程中的決定性時刻。我們知道，患者，尤其是那些尋求獲得所需護理的患者以及醫生都依賴 Zio 服務來幫助釋放獲得更好護理和改善結果的機會。消除訪問障礙和摩擦是我們使命的關鍵部分，我們需要確保運營允許我們做到這一點。我剛才概述的變化將使我們能夠改善全球患者的可及性。憑藉我們核心業務的強勁勢頭和即將到來的重大機遇，我對 iRhythm 在 2023 年及以後的未來感到由衷的興奮。

I'll now turn the call over to Brice to discuss our financial results and 2023 guidance.

我現在將電話轉給 Brice，討論我們的財務業績和 2023 年的指導意見。

Thanks, Quentin.

謝謝，昆汀。

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.

提醒一下，除非另有說明，否則我今天討論的財務指標將在非 GAAP 基礎上呈現。可以在今天的收益發布和我們的 IR 網站上找到與 GAAP 的調節。

Fourth quarter results demonstrated solid momentum in our core business as revenue grew to $112.6 million, representing 8% sequential and 38% year-over-year growth. On a full year basis, we recognized $410.9 million in revenues, representing 27% growth compared to 2021, driven by both volume growth as well as ASP improvements. Looking at new store same-store mix, new store, defined as accounts that have been opened for less than 12 months, accounted for approximately 40% of our year-over-year growth. Home enrollment for Zio services was about 20% of volume in the fourth quarter.

第四季度業績表明我們的核心業務勢頭強勁，收入增長至 1.126 億美元，環比增長 8%，同比增長 38%。在全年的基礎上，我們確認了 4.109 億美元的收入，與 2021 年相比增長了 27%，這得益於銷量增長和平均售價的提高。從新店同店組合來看，新店（定義為開設少於 12 個月的賬戶）約占我們同比增長的 40%。 Zio 服務的家庭註冊量在第四季度約為總量的 20%。

Moving down the rest of the P&L. Gross margin for the fourth quarter was 69.9%, and through full year 2022 was 68.5% or the midpoint of our guidance range. Both sequential and year-over-year benefits were achieved through ASP improvements as we continue to optimize our pricing strategy, and we realized nice improvements to cost per unit as volumes scaled throughout the year.

向下移動剩餘的損益表。第四季度的毛利率為 69.9%，到 2022 年全年為 68.5% 或我們指導範圍的中點。隨著我們繼續優化我們的定價策略，通過 ASP 的改進實現了環比和同比收益，並且隨著全年銷量的擴大，我們實現了單位成本的顯著改善。

Fourth quarter adjusted operating expenses were $97.1 million, up 8% sequentially and up 16% year-over-year. Full year adjusted operating expenses were $363.7 million, up 16% compared to 2021. While higher on an absolute basis, this compares to year-over-year full year revenue growth of 27%, demonstrating our ability to realize leverage in the P&L. Our investments remain strong in R&D, and we have started to see efficiencies in our SG&A profile.

第四季度調整後的運營費用為 9710 萬美元，環比增長 8%，同比增長 16%。全年調整後的運營費用為 3.637 億美元，比 2021 年增長 16%。雖然絕對值更高，但與全年收入同比增長 27% 相比，這表明我們有能力在損益表中實現槓桿作用。我們在研發方面的投資依然強勁，我們已經開始看到我們的 SG&A 檔案的效率。

Adjusted net loss in the fourth quarter was $17.9 million or a loss of $0.59 per share compared to adjusted net loss of $19.1 million or a loss of $0.63 per share in the third quarter of 2022. This compares to adjusted net loss of $1.10 per share or a $0.51 improvement versus the fourth quarter of 2021. Adjusted net loss for the full year 2022 was $84.5 million or $2.82 per share compared to a net loss of $101.4 million or a loss of $3.46 per share during 2021.

第四季度調整後淨虧損為 1790 萬美元或每股虧損 0.59 美元，而 2022 年第三季度調整後淨虧損為 1910 萬美元或每股虧損 0.63 美元。相比之下，調整後每股淨虧損為 1.10 美元或與 2021 年第四季度相比改善了 0.51 美元。與 2021 年的淨虧損 1.014 億美元或每股虧損 3.46 美元相比，2022 年全年的調整後淨虧損為 8450 萬美元或每股虧損 2.82 美元。

We are beginning to realize value from an increased focus on operational discipline, achieving positive adjusted EBITDA of $1.1 million in the fourth quarter. This represents an improvement of $3.7 million sequentially and an improvement of $18.4 million year-over-year. Adjusted EBITDA for the full year 2022 was minus $11.3 million, representing an 830 basis point improvement to adjusted EBITDA margin compared to 2021.

我們開始通過更加關注運營紀律來實現價值，第四季度實現了 110 萬美元的正調整 EBITDA。這表示環比增加 370 萬美元，同比增加 1840 萬美元。 2022 年全年調整後的 EBITDA 為負 1130 萬美元，與 2021 年相比，調整後的 EBITDA 利潤率提高了 830 個基點。

We are focused on disciplined spending in our operating expenses, but also continuing to invest in strategic initiatives that we believe could enable future growth opportunities. Note that we did incur approximately $2.3 million of expenses related to business transformation activities in the fourth quarter, bringing our full year impairment, restructuring and business transformation costs to approximately $31.7 million in 2022. Very importantly, we are extremely pleased to announce that we have cleared the material weakness of our internal control environment.

我們專注於在我們的運營費用中有紀律的支出，但也繼續投資於我們認為可以帶來未來增長機會的戰略計劃。請注意，我們確實在第四季度產生了約 230 萬美元與業務轉型活動相關的費用，使我們的全年減值、重組和業務轉型成本在 2022 年達到約 3170 萬美元。非常重要的是，我們非常高興地宣布，我們有消除了我們內部控制環境的實質性弱點。

Over the past several years, we took actions designed to improve our internal controls and remediate deficiencies that led to our material weakness. These have included enhancing the depth and experience within our finance organization by hiring additional accounting and finance personnel with relevant expertise, providing additional management oversight over financial reporting, including the establishment of a SOC steering committee within our internal audit functions and implementing new controls and processes. We remain committed to advancing our culture of operational excellence and will continue to add skilled talent as complexities grow and needs arise.

在過去的幾年裡，我們採取了旨在改善內部控制和補救導致我們實質性弱點的缺陷的行動。這些措施包括通過聘用更多具有相關專業知識的會計和財務人員來增強我們財務組織的深度和經驗，對財務報告提供額外的管理監督，包括在我們的內部審計職能範圍內建立 SOC 指導委員會，以及實施新的控制和流程.我們將繼續致力於推進我們的卓越運營文化，並將隨著複雜性的增加和需求的增加，繼續增加技術人才。

Turning to guidance for 2023. We anticipate full year revenue growth of approximately 16% to 18% compared to 2022, representing a range of approximately $475 million to $485 million. This contemplates national CMS pricing in place beginning January 1, 2023, and we believe that our ASP in 2023 will be generally in line with what we experienced in 2022. With pricing stabilized, we believe that the volume contributions will be the main driver of revenue growth during the year.

轉向 2023 年的指導。與 2022 年相比，我們預計全年收入增長約 16% 至 18%，範圍約為 4.75 億美元至 4.85 億美元。這考慮了從 2023 年 1 月 1 日開始實施的全國 CMS 定價，我們認為我們 2023 年的平均售價將與我們在 2022 年的經歷基本一致。隨著定價穩定，我們認為銷量貢獻將成為收入的主要驅動力年內的增長。

We anticipate gross margin will range between approximately 69% and 70% for the full year. Continued gross margin improvements will be realized through volume growth contributions to our per unit cost as well as improvements to our fixed cost structure. Notably, our full year guidance contemplates a bit of pressure to gross margin as we launch our Zio Monitor service into the U.S. commercial marketplace, which will include an evaluation of our current XT inventory levels and will reflect underutilized cost for our Zio Monitor system.

我們預計全年毛利率將介於約 69% 至 70% 之間。通過對我們單位成本的銷量增長貢獻以及對我們固定成本結構的改進，將實現毛利率的持續改善。值得注意的是，隨著我們將 Zio Monitor 服務推向美國商業市場，我們的全年指引預計毛利率會受到一些壓力，這將包括對我們當前 XT 庫存水平的評估，並將反映我們 Zio Monitor 系統未充分利用的成本。

We believe that adjusted operating expenses in 2023 will range between approximately 415 and $425 million as we scale our business to meet increased volume demand.

我們認為，隨著我們擴大業務以滿足不斷增長的需求量，2023 年調整後的運營費用將介於約 415 至 4.25 億美元之間。

We believe that adjusted EBITDA margin in 2023 will range between approximately minus 0.5% and 0.5% of revenues. As a reminder, adjusted EBITDA will continue to exclude restructuring costs, transformation costs and stock-based compensation expense.

我們認為，2023 年調整後的 EBITDA 利潤率將介於收入的約負 0.5% 至 0.5% 之間。提醒一下，調整後的 EBITDA 將繼續不包括重組成本、轉型成本和股票補償費用。

In 2023, we do anticipate incurring approximately $15 million to $20 million of onetime non-GAAP business transformation and restructuring costs related to the ongoing globalization efforts to drive efficiency, improve scalability and provide continued high-quality customer and patient experience. We believe that expenses incurred related to these activities in 2023 will further enable operating leverage into the future, especially as we grow to serve more patients in our core markets and internationally. Please note that we also anticipate $8 million to $10 million of capital expenditures related to standing up new facilities and system solutions.

到 2023 年，我們確實預計將產生約 1500 萬至 2000 萬美元的一次性非 GAAP 業務轉型和重組成本，這些成本與正在進行的全球化努力相關，以提高效率、提高可擴展性並提供持續的高質量客戶和患者體驗。我們相信，2023 年與這些活動相關的費用將進一步提高未來的經營槓桿，特別是隨著我們成長為在核心市場和國際上為更多患者提供服務。請注意，我們還預計與建立新設施和系統解決方案相關的資本支出為 800 萬至 1000 萬美元。

In closing, we exited 2022 at a strong financial position with $213.1 million of cash on hand to drive continued growth from our core business, invest in innovation and lay the foundation for future expansion into new markets. We are excited for the strong momentum in our business to continue and look forward to upcoming catalysts that we anticipate can drive growth in 2023 and beyond.

最後，我們以 2.131 億美元的手頭現金以強勁的財務狀況結束了 2022 年，以推動我們核心業務的持續增長，投資於創新並為未來拓展新市場奠定基礎。我們很高興我們的業務繼續保持強勁勢頭，並期待即將到來的催化劑，我們預計這些催化劑可以推動 2023 年及以後的增長。

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

有了這個，昆汀、道格、丹和我現在想開始提問。操作員？

(Operator Instructions) Our first question comes from the line of Allen Gong with JPMorgan.

（操作員說明）我們的第一個問題來自摩根大通的 Allen Gong。

I just had a quick one and then a follow-up. When I think about the 16% to 18% guidance range you put out, I think in the past, you've talked about how the 20% LRP is still achievable for the year. You're coming in a step below that. I think in the past, you've said you do want to see more progress made some of the challenges you were experiencing at the tail end of 2022. So could you just provide an update on how those have really progressed and your confidence in that 20% number?

我只是有一個快速的，然後是一個跟進。當我想到你提出的 16% 到 18% 的指導範圍時，我想你過去曾談到今年 20% 的 LRP 仍然是可以實現的。您將比這低一步。我想在過去，你曾說過你確實希望看到更多進展，以應對你在 2022 年底遇到的一些挑戰。那麼你能否提供有關這些進展的最新情況以及你對此的信心20%的數字？

Allen, this is Quentin. I'll jump on that. Look, I think at this point, we feel really good about where things are at in the business. Clearly, we spoke about the return device rate with our XT business, and we knew that we had some of the growth headwinds with AT coming off the operational issues in the fourth quarter. I would say we've navigated through those pretty well. Our fourth quarter came in right in line with expectations, maybe showing a bit of opportunity to improve upon that. But the way we set up expectations for 2023 is that we'll continue with that return device rate more or less the way we exited the year. That will be into the low end of the guidance range and that the AT business continues to perform in line with what we saw coming off the fourth quarter as well.

艾倫，這是昆汀。我會跳上那個。看，我認為在這一點上，我們對業務中的情況感覺非常好。顯然，我們談到了 XT 業務的設備退貨率，並且我們知道隨著 AT 在第四季度擺脫運營問題，我們遇到了一些增長阻力。我會說我們已經很好地解決了這些問題。我們的第四季度符合預期，也許顯示出一些改進的機會。但我們設定 2023 年預期的方式是，我們將或多或少地以我們退出這一年的方式繼續保持設備退貨率。這將進入指導範圍的低端，並且 AT 業務的表現也與我們在第四季度看到的情況一致。

To the degree that we make progress over the course of the year, then you can start to see that step up beyond the 16% and ultimately get into that 18% range. And the assumption is that we've made that progress by sort of the mid part of the year. We can make that happen faster than great. There's further upside to where we're at. But that's how we thought about the guidance. And I do believe with progress made on the operational side, we can see our way back to the 20%, but it's early. We're 7, call it, 8 weeks into the new year. We're not going to get ahead of ourselves at this point in time, and we're going to go execute and ultimately deliver and we'll see where that takes us.

就我們在這一年中取得的進展而言，您可以開始看到這一比例超過 16%，並最終進入 18% 的範圍。並且假設我們已經在今年年中取得了進展。我們可以更快地實現這一目標。我們所處的位置還有進一步的好處。但這就是我們對指南的看法。而且我確實相信，隨著在運營方面取得的進展，我們可以看到回到 20% 的道路，但現在還為時過早。我們 7 歲，可以這樣稱呼，進入新的一年還有 8 週。我們不會在這個時候超越自己，我們將去執行並最終交付，我們會看到它會把我們帶到哪裡。

Got it. So just like kind of like touching on that a little bit more, when we think about how you're starting off the year, you kind of just qualitatively point towards the 16%. So should we think of that as basically assuming fairly usual seasonality or maybe a little bit of headwinds from labor and impacts from the device return rate, the improvement in AT and then transition into more growth in the balance of the year?

知道了。所以就像稍微多談一點，當我們考慮你如何開始這一年時，你只是定性地指向了 16%。那麼，我們是否應該將其視為基本上假設相當普遍的季節性，或者可能有一點來自勞動力的逆風和設備回報率的影響，AT 的改善，然後在今年餘下時間過渡到更多增長？

I think you're thinking about it the right way, Allen. Keep in mind, these efforts that we're putting forward with respect to the return device rate and getting the AT growth rate back to where we've seen it historically, those are efforts that are ongoing right now. But naturally, we would expect to see progression over the course of the year, which means you're going to start at your low point from a guidance perspective here in the first quarter and hope to see progress beyond that. And so that's how we think about it. I think that starting on the lower end of that here in the first quarter is the right way to think about it. And then as we make progress, we would expect to see that increase over time.

我認為你正在以正確的方式思考它，艾倫。請記住，我們在返回設備率和使 AT 增長率回到我們歷史上看到的水平方面所做的這些努力，這些努力現在正在進行中。但自然地，我們希望在一年中看到進展，這意味著你將從第一季度的指導角度從低點開始，並希望看到超越這一點的進展。這就是我們的想法。我認為從第一季度的低端開始是正確的思考方式。然後隨著我們取得進展，我們希望看到隨著時間的推移而增加。

Our next question comes from the line of Marie Thibault with BTIG.

我們的下一個問題來自 BTIG 的 Marie Thibault。

I wanted to ask one here, I guess, on the new sensor that's in limited launch right now. I would love to hear what you're learning so far in that launch? What will sort of trigger the move to a broader launch? And in particular, would love to hear if device return rates or compliance or physician opinions of the sensor are any different than the current generation?

我想我想在這裡問一個關於現在限量推出的新傳感器的問題。我很想听聽您到目前為止在那次發布中學到了什麼？什麼會觸發更廣泛的發布？特別是，想知道傳感器的設備返回率或合規性或醫生意見是否與當前一代有任何不同？

Yes. Marie, I would tell you one of the things I get most excited about over the course of 2023 is getting the Zio Monitor into a full commercial launch. The initial feedback that we've received around that device is that it's a transformational sort of technology in this space. Again, it's 72% smaller, it's 50% lighter, it's 20% thinner. It leads to a much better patient experience. And of course, when the patient experience is better, the physician experience ends up being better as well. And so we're excited by what we think that can bring in the back part of the year. We really haven't contemplated any sort of change in our guidance expectations with respect to having that new product out there. It's one of those things where we think about it as let's get into the market and then see how it performs, and we can adjust our expectations from that. But I'm very encouraged by what we're seeing and the feedback that we're seeing.

是的。瑪麗，我想告訴你，在 2023 年期間，我最興奮的事情之一就是讓 Zio Monitor 進入全面商業發布。我們收到的有關該設備的初步反饋是，它是該領域的一種變革性技術。同樣，它小了 72%，輕了 50%，薄了 20%。它會帶來更好的患者體驗。當然，當患者體驗更好時，醫生體驗最終也會更好。因此，我們對我們認為可以在今年下半年帶來的東西感到興奮。對於推出新產品，我們真的沒有考慮過對我們的指導預期進行任何形式的改變。這是我們在進入市場時考慮的事情之一，然後看看它的表現如何，我們可以從中調整我們的期望。但我對我們所看到的和我們所看到的反饋感到非常鼓舞。

There's actually going to be data at ACC that's going to be presented around Zio Monitor as well that demonstrates some of the improved patient experience and wearability factors associated with it, including the return device rate, which is a bit better than what we're seeing with the XT product. Now it's in a limited launch phase, if you will, or limited evaluation at this point. So the number of patients are not significant, but the early indicators are all very, very positive around this. So we're bullish on this. Our expectation is we'll roll it out in the back part of the year into a full commercial launch, and we'll step into it as quickly as we can, which will really be driven by how fast we can produce the product off of our line. So we're ramping up that capacity as we speak right now to be able to meet the demand once we go with the launch. But we're very excited by what we're going to see with Zio Monitor.

實際上，ACC 的數據也將圍繞 Zio Monitor 展示，這些數據展示了一些改進的患者體驗和與之相關的可穿戴性因素，包括返回設備率，這比我們看到的要好一些與 XT 產品。現在它處於有限的啟動階段，如果你願意的話，或者在這一點上進行有限的評估。所以患者數量並不多，但早期指標都非常非常積極。所以我們看好這一點。我們的期望是我們將在今年下半年推出全面商業發布，我們將盡快投入使用，這實際上取決於我們生產產品的速度我們的線。因此，我們現在正在提高容量，以便能夠在發布後滿足需求。但是我們對我們將在 Zio Monitor 上看到的東西感到非常興奮。

Okay. That's great to hear. And then if I could ask a follow-up here on the national rate with Medicare. I was curious about your comments on the possibility of working with Medicaid. Can you give us a sense of pricing discount or possible timing on when we might start to hear from some of the Medicaid organizations on that? And secondly, as part of that, where are we in the shift toward a San Francisco facility? Any chance you could give us any metrics on that?

好的。聽到這個消息我很高興。然後我是否可以在這裡詢問有關 Medicare 的全國率的後續行動。我很好奇您對與 Medicaid 合作的可能性的評論。您能否告訴我們定價折扣或可能的時間安排，我們什麼時候可以開始從一些醫療補助組織那裡聽到這方面的信息？其次，作為其中的一部分，我們在向舊金山工廠轉移的過程中處於什麼位置？你有沒有機會給我們任何指標？

Yes. I'll speak to this one as well. From a Medicaid perspective, it's a bit too early to get out ahead of what our expectations are there. I will tell you, really any progress that we make in and around Medicaid is going to be an incremental benefit to us. We serve a lot of those patients today without charging anything at all for the product when they can't afford it. And so once we get coverage in place, that will start to create a nice bit of a benefit for us just in the fact that we can begin to get reimbursed for some of those patients. But the reality was it was very hard to sit down and have discussions with any of these state Medicaid programs without having a CMS national rate in place. So now that it's in place, we can begin to have those conversations, early conversations have begun to be had. But in terms of where the pricing lands, it's too early to say exactly what that will look like, but just know that any pricing at this point would be upside to what we're getting right now and serving that Medicaid population.

是的。我也會和這個人談談。從醫療補助計劃的角度來看，現在超出我們的預期還為時過早。我會告訴你，我們在醫療補助計劃中和周圍取得的任何進展實際上都會給我們帶來增量收益。今天，我們為很多這樣的患者提供服務，而當他們買不起產品時，我們根本不收取任何費用。因此，一旦我們獲得保險，這將開始為我們創造一些好處，因為我們可以開始為其中一些患者報銷。但現實情況是，如果沒有 CMS 全國率，很難坐下來與這些州醫療補助計劃中的任何一個進行討論。所以現在它就位了，我們可以開始進行這些對話，早期的對話已經開始了。但就定價的落腳點而言，現在確切地說出它會是什麼樣子還為時過早，但只要知道此時的任何定價都會比我們現在得到的和為醫療補助人口服務的價格高。

On the San Francisco side, our expectation is that we'll have enough folks hired in the seat to do about 25% of the CMS XT volume in San Francisco here in the first quarter, first part of the year and then ramping beyond that in the back half of the year. Right now, that still feels like the right assumption. I think we're making good progress against our goals to hire relative to those percentage mixes in the early part of the year. But we've got a long way to go to get to where we want to in the back half of the year. So still a lot of hiring to be done, but good progress being made to date.

在舊金山方面，我們的期望是我們將在第一季度、今年上半年在舊金山僱用足夠多的人來完成大約 25% 的 CMS XT 量，然後在下半年。現在，這仍然是正確的假設。我認為，相對於今年年初的這些百分比組合，我們在實現招聘目標方面取得了良好進展。但我們還有很長的路要走，才能在今年下半年達到我們想要的目標。因此，仍有大量招聘工作要做，但迄今為止已取得良好進展。

Our next question comes from the line of David Rescott with Truist Securities. Our next question comes from the line of Cecilia Furlong with Morgan Stanley.

我們的下一個問題來自 Truist Securities 的 David Rescott。我們的下一個問題來自 Cecilia Furlong 與摩根士丹利的對話。

I wanted to ask a follow-up question on AT. If you could just speak to where you are at this point running through the legacy SKUs of the prior AT before the addition of the notice. And then looking forward to, as you think about just what is incorporated in that 16% to 18%, can you speak to how you're thinking at this point, at least about AT volumes recovering to a level or similar levels that you saw in '22 pre the issue?

我想問一個關於 AT 的後續問題。在添加通知之前，如果您可以直接說出您目前的位置，請瀏覽之前 AT 的遺留 SKU。然後期待，當你考慮這 16% 到 18% 中包含的內容時，你能否談談你在這一點上的想法，至少關於 AT 數量恢復到你看到的水平或類似水平在'22之前的問題？

Yes. I think from an AT perspective, coming off the fourth quarter and certainly how we thought about the guidance is that, that business is going to grow right around 30% for us. That's where we saw it in the fourth quarter. That compares to the first 9 months of last year being closer to the 50% growth range. And so we certainly have seen a difference in that growth profile coming out of that field advisory notice. Now we've made all the updates in the labeling that we need to do and in the packaging that we need to do. Now it's about just the confidence coming back in the commercial force and with the customers to see that growth return.

是的。我認為從 AT 的角度來看，從第四季度開始，當然我們對指導的看法是，我們的業務將增長 30% 左右。這就是我們在第四季度看到的地方。相比之下，去年前 9 個月的增長率接近 50%。因此，我們當然已經看到該領域諮詢通知的增長情況有所不同。現在我們已經對我們需要做的標籤和我們需要做的包裝進行了所有更新。現在，這只是對商業力量的信心恢復，以及與客戶一起看到增長回報的信心。

Our 16% growth expectation would assume that we sort of continue at the current rate over the course of the entire year, getting to 18%, the higher end of our guidance range would assume that around the midpoint of the year, we're seeing ourselves get back into those prior growth realms. And so that's how we thought about it. Obviously, if we can do better than that than that we'd be very pleased with it. But our focus is certainly on getting that business back to where we saw it historically. I think that the recent FDA approval with the AF burden, for example, that will make its way into that product certainly continues to position it is one that can be attractive in that space. But we want to see those results play out before we guide to them.

我們 16% 的增長預期假設我們在整個一年中繼續以目前的速度增長，達到 18%，我們指導範圍的較高端假設在今年中點左右，我們看到我們自己回到了以前的增長領域。這就是我們的想法。顯然，如果我們能做得更好，我們會非常高興。但我們的重點當然是讓該業務恢復到我們歷史上看到的水平。我認為最近 FDA 批准的 AF 負擔，例如，將進入該產品肯定會繼續定位它是一個在該領域具有吸引力的產品。但我們希望在指導之前看到這些結果。

Great. And if I could follow up on gross margins as well, how we should think about first half versus second half, especially as you launch the Zio Monitor to a greater scale and also into '24 with Zio the MCT service, just the impact from initially ramping those products versus the longer-term benefit from a COGS standpoint?

偉大的。如果我也可以跟進毛利率，我們應該如何考慮上半年和下半年，特別是當您更大規模地推出 Zio Monitor 以及 Zio 和 MCT 服務進入 24 世紀時，這只是最初的影響從 COGS 的角度來看，增加這些產品與長期利益？

Cecilia, a great question. Gross margin. So in our guide, the way we think about it is, as you probably have seen the seasonality of gross margin is a little bit softer in the early part of the year, call it first quarter because it's the lowest volume quarter of the year. So you'd expect to see something similar in 2023. The other thing I would note is with its scaling throughout the year, as it traditionally does as you push more volume through the system, there is a bit of a caveat in there, to your point, on the Zio Monitor side, where the launch of Zio Monitor will create a bit of inefficiency in the short run as we're less than optimally utilizing that machinery upfront. So you can expect a bit of a blip maybe in Q3 or so associated with it.

塞西莉亞，一個很好的問題。毛利率。因此，在我們的指南中，我們的思考方式是，正如您可能已經看到的那樣，今年年初毛利率的季節性有所減弱，將其稱為第一季度，因為它是今年銷量最低的季度。所以你預計在 2023 年會看到類似的情況。我要注意的另一件事是它在全年的擴展，就像傳統上那樣，當你通過系統推動更多的交易量時，這裡有一點警告，你的觀點，在 Zio Monitor 方面，Zio Monitor 的推出在短期內會造成一些低效率，因為我們沒有在前期充分利用該機器。因此，您可以預期在第三季度左右可能會出現一些波動。

And the real benefit of the Zio Monitor solution really come into play in 2024 as we're able to fully leverage that machinery and equipment we have in place. But also that's when the full automation will go into place as well. And honestly, at the back end of that MCT becomes or comes online as the same form factor as well. And that's where you'll really get that scale and efficiencies associated with the Zio Monitor. So the cadence, I would think about it a little bit softer in Q1 as it traditionally is from a seasonality standpoint. A little bit of pressure in Q3 and then the other 2 quarters relatively standard with what you've seen historically.

Zio Monitor 解決方案的真正優勢在 2024 年真正發揮作用，因為我們能夠充分利用現有的機器和設備。但那也是完全自動化也將到位的時候。老實說，在該 MCT 的後端，也以相同的外形尺寸變為或上線。這就是您真正獲得與 Zio Monitor 相關的規模和效率的地方。所以節奏，我會認為它在第一季度有點軟，因為它傳統上是從季節性的角度來看的。第三季度有點壓力，然後是其他兩個季度，與歷史上看到的情況相對標準。

Our next question comes from the line of David Saxon with Needham.

我們的下一個問題來自 David Saxon 與 Needham 的對話。

Maybe I wanted to start with a follow-up on guidance and just the assumptions around pricing being in line with '22. Just with the San Francisco facility getting to 25% of the volumes in the first quarter here and then ramping, I guess, why wouldn't there be upside from an ASP perspective relative to '22?

也許我想從指導的後續行動開始，只是關於定價的假設與 22 年一致。就在舊金山工廠在第一季度達到 25% 的產量然後逐漸增加的情況下，我想，為什麼從 ASP 的角度來看，相對於 22 年沒有上升空間？

Yes, David, I think that it's a good question. But keep in mind, over the course of '22, we had different dynamics playing out with respect to reimbursement around that XT product with the different MACs that we were able to contract with, right? And so over the course of the year, that rate got higher and higher as well. So the comp gets more difficult. So even as we increase the utilization of San Francisco in 2023 and might have a higher effective average selling price, that's being compared to a prior year that also had a higher effective selling price as we move throughout the course of the year.

是的，大衛，我認為這是一個很好的問題。但請記住，在 22 年的過程中，我們在 XT 產品的報銷方面有不同的動態，我們能夠與之簽約的不同 MAC，對吧？所以在這一年裡，這個比率也越來越高。所以比賽變得更加困難。因此，即使我們在 2023 年提高了舊金山的利用率並且可能有更高的有效平均售價，但與上一年相比，隨著我們在整個一年中的移動，上一年的有效售價也更高。

And so for the full year on average, we do think that XT price is going to be pretty comparable year-over-year. Maybe there's a little bit of a benefit now that the PayGo aspect has been resolved from our original expectation when we were saying the XT pricing was going to be relatively comparable. There's about a 4% benefit relative to that original expectation. But VAT pricing also came in a little bit lower in that final rule, which sort of negates the PayGo benefit. So net-net, you're about neutral year-over-year related to those items. So I hope that helps clarify it for you.

因此，就全年平均而言，我們確實認為 XT 價格與去年同期相比相當可比。當我們說 XT 定價將具有相對可比性時，PayGo 方面已經從我們最初的預期中得到解決，這也許有一點好處。相對於最初的預期，大約有 4% 的收益。但最終規則中的增值稅定價也略低一些，這在某種程度上否定了 PayGo 的好處。所以 net-net，你對這些項目的年同比持中立態度。所以我希望這能幫助你澄清它。

Yes. No, that's super helpful. And then maybe I'll follow up with maybe a longer-term question. You guys had a slide deck published in January that had a 25% EBITDA margin referenced in it. Just wanted to ask how we should think about that margin target relative to the LRP. Is that something you can hit in 2027, if you see contribution from some of these adjacent markets? Or is that more of a longer term post '27?

是的。不，那超級有用。然後也許我會跟進一個更長期的問題。你們在 1 月份發布了一張幻燈片，其中提到了 25% 的 EBITDA 利潤率。只是想問問我們應該如何考慮相對於 LRP 的保證金目標。如果您看到其中一些相鄰市場的貢獻，您是否可以在 2027 年實現這一目標？還是更長期的 27 年後？

It's a good question. Our LRP that we put out there around 2027 had us getting to roughly $1 billion in revenue at that point in time. It really didn't contemplate contribution coming from the adjacent market opportunities that we're certainly bullish on and hope to be able to open up. But the point of 15% was simply a point in time as we're going through that $1 billion market, still growing at, in our minds, roughly 20% or better. In no way would that be a point that we'd be happy to stop at though.

這是個好問題。我們在 2027 年左右推出的 LRP 使我們在那個時間點獲得了大約 10 億美元的收入。它真的沒有考慮來自我們肯定看好並希望能夠打開的相鄰市場機會的貢獻。但 15% 的點只是一個時間點，因為我們正在經歷這個 10 億美元的市場，在我們看來，它仍在以大約 20% 或更高的速度增長。無論如何，我們都不會樂意就此止步。

The business model here, when you think about it from a structural perspective and what is possible, there's no question that we can get into those mid-20s and even the upper 20s from an adjusted EBITDA perspective. When that happens, I'm not willing to sort of say exactly when that's going to happen, but I see that happening in the future of iRhythm. It's probably when we move north of that $1 billion in revenue, but it's something that can be achieved here. And that was the purpose of putting that out there is that we wouldn't be happy at 15%. That's just a point in time when we cross through that $1 billion mark, but the long-term trajectory ought to be able to get us into the mid-20s.

這裡的商業模式，當你從結構的角度考慮它以及什麼是可能的時候，毫無疑問，我們可以從調整後的 EBITDA 角度進入 20 多歲甚至 20 多歲。當這種情況發生時，我不願意確切地說出什麼時候會發生，但我看到 iRhythm 的未來會發生這種情況。這可能是我們向北移動 10 億美元收入的時候，但這是可以在這裡實現的。那就是把它放在那裡的目的是我們不會對 15% 感到滿意。這只是我們突破 10 億美元大關的一個時間點，但長期軌跡應該能讓我們進入 20 多歲。

Our next question comes from the line of Nathan Treybeck with Wells Fargo.

我們的下一個問題來自 Nathan Treybeck 與 Wells Fargo 的對話。

Can you comment on how far along you are in your EHR integration? And how much of a driver is this in your '23 guidance?

您能否評論一下您在 EHR 集成方面的進展情況？在您的 23 年指南中，這有多少驅動因素？

It's a great question because the EHR integration for us is such a critical aspect of how we think about creating stickiness with our accounts. I would tell you there is significant runway ahead of us as we continue to build out the EHR integration with our accounts. We are making good progress. It's been a focal point internally, and we know that once we get an account integrated with us, I couldn't give you an account throughout the history of iRhythm that once integrated from an EHR perspective has walked away from iRhythm. It creates a tremendous amount of stickiness. And at the same time, the growth trajectory hits an inflection point once you get to that point of EHR integration.

這是一個很好的問題，因為對我們來說，EHR 集成是我們考慮如何與我們的賬戶建立粘性的一個關鍵方面。我會告訴你，隨著我們繼續構建 EHR 與我們賬戶的集成，我們面前還有一條重要的跑道。我們正在取得良好進展。它一直是內部焦點，我們知道一旦我們獲得一個與我們集成的帳戶，我無法在整個 iRhythm 的歷史中給你一個帳戶，一旦從 EHR 的角度集成已經離開 iRhythm。它會產生巨大的粘性。同時，一旦達到 EHR 集成點，增長軌跡就會達到拐點。

In terms of the amount of accounts that are integrated, I don't think we've put that data point out there. It's well less than 50% and it's something that we are working to increase as quickly as we can.

就整合的賬戶數量而言，我認為我們沒有把那個數據點放在那裡。它遠低於 50%，我們正在努力盡快提高這一比例。

Great. And then can you comment on what you're seeing in your Know Your Rhythm commercial pilots? And is there any contribution in the guidance?

偉大的。然後你能評論一下你在 Know Your Rhythm 商業試播中看到的內容嗎？在指導中有什麼貢獻嗎？

Yes. We have not contemplated any contribution in our guidance relative to Know Your Rhythm at this point in the pilot. We expect to launch multiple pilots over the course of the year. But at this point, we're still building out the operational capabilities of how those pilots would work. So to be completely transparent that there aren't patients on our product in a Know Your Rhythm pilot just yet, that will start before too long. But right now, it's about getting the operational aspects of how we're going to work with our partner, get the devices on patients, capture the data. We're in the midst of nailing down the final growth of the operational aspects as we speak. That will ramp over the course of the year. And to the degree that there is contribution from it, it ultimately will end up being upside to expectations. That's how we thought about it at this point. We just -- we're not going to get out of ourselves with it.

是的。在試點的這一點上，我們還沒有考慮對我們關於了解你的節奏的指導做出任何貢獻。我們預計在一年內推出多個試點項目。但在這一點上，我們仍在構建這些飛行員如何工作的操作能力。因此，為了完全透明，我們的產品在 Know Your Rhythm 試點中還沒有患者，這將在不久之後開始。但現在，它是關於我們將如何與我們的合作夥伴合作的操作方面，讓患者使用設備，捕獲數據。正如我們所說，我們正在確定運營方面的最終增長。這將在一年中逐漸增加。就其貢獻的程度而言，它最終將超出預期。這就是我們此時的想法。我們只是 - 我們不會擺脫它。

Our next question comes from the line of David Rescott with Truist Securities.

我們的下一個問題來自 Truist Securities 的 David Rescott。

Can you guys hear me now?

你們現在能聽到我說話嗎？

Yes.

是的。

Great. Sorry about that. So I guess, first, just on the longer-range plan. You talked a little bit about PayGo essentially potentially being a slight tailwind. But just wondering on that long-range plan, if one that the kind of benefit that you have from PayGo going away or not being enacted this year, is potentially upside or whether or not that was included in the long-range plan or your initial view the long-range plan? And I guess the second part of that is, did your long-range plan from a top line growth perspective also account for maybe expansion to this Medicaid patient population?

偉大的。對於那個很抱歉。所以我想，首先，只是在長期計劃上。你談到了 PayGo 本質上可能是一個輕微的順風。但是只是想知道那個長期計劃，如果你從 PayGo 中獲得的那種好處在今年消失或沒有實施，是否有潛在的好處，或者它是否包含在長期計劃或你的初始計劃中查看長期計劃？我想第二部分是，從頂線增長的角度來看，您的長期計劃是否也可能擴大到這個醫療補助患者人數？

So on the PayGo aspect, in particular, we had assumed based upon what we knew at the time that PayGo would be in effect. In other words, it would be a headwind a bit in 2023. Ultimately, what we learned is that it wouldn't be right, and that we would get the benefit back. And so that was about a 4% benefit that we hadn't contemplated in pricing over the entire long-range plan. At the same time, we hadn't contemplated really that AT would be cut by CMS the way that it was. And so when you look at the 2 of those, I mean, literally, they offset each other almost to the $1 when you calculate the impact based on the mix in our business. And so I don't see PayGo really driving any difference in the long-range plan and as a result of the AT pricing being updated as well. So overall, I think the 2 of them net each other out.

因此，特別是在 PayGo 方面，我們根據當時所知假設 PayGo 會生效。換句話說，這在 2023 年會有點不利。最終，我們了解到這是不對的，我們會收回收益。因此，這大約是我們在整個長期計劃的定價中沒有考慮到的 4% 的收益。同時，我們也沒有真正考慮到 AT 會被 CMS 以這種方式削減。因此，當您查看其中的 2 個時，我的意思是，當您根據我們的業務組合計算影響時，它們幾乎相互抵消了 1 美元。因此，我認為 PayGo 並沒有真正推動長期計劃出現任何差異，而且 AT 定價也得到了更新。所以總的來說，我認為他們兩個互相淨胜負。

What was the second part of that question, again?

這個問題的第二部分又是什麼？

The assumption around Medicaid or expanding into Medicaid, whether or not that was included in the LRP?

圍繞 Medicaid 或擴展到 Medicaid 的假設，是否包含在 LRP 中？

No. We haven't really contemplated the incremental benefit that can come from Medicaid. Part of the challenge there is just to -- it alludes back to the question that was asked earlier, exactly what price are we able to establish in that population. That's something we're working through as we speak. And then how quickly can you get all the states that come along. We know that not all states are going to come out of the gate and it's going to take work on a one-off basis. And so the way we'll think about Medicaid contributing to that long-range plan is that we'll give you updates as coverage gets put in place, and then we can update our expectations in line with when that happens. But it's too early to try to anticipate and know exactly when that would happen. And then if we don't happen to get it exactly right, we're talking about a variant. So I'd rather let that play out and then roll it into expectations as we get it filed in.

不，我們還沒有真正考慮到醫療補助計劃可以帶來的增量收益。部分挑戰只是——它暗示了之前提出的問題，即我們能夠在該人群中確定的確切價格。這是我們正在努力解決的問題。然後你能多快得到所有出現的狀態。我們知道，並非所有州都會走出大門，而且它將一次性開展工作。因此，我們考慮醫療補助計劃為該長期計劃做出貢獻的方式是，我們會在覆蓋範圍到位時向您提供更新，然後我們可以根據發生這種情況更新我們的期望。但現在預測並確切知道這種情況何時會發生還為時過早。然後，如果我們碰巧沒有完全正確，我們就會談論一個變體。所以我寧願讓它發揮作用，然後在我們提交它時將其納入預期。

Okay. And then I'm not sure if I might have missed it earlier, but in the past, you had kind of talked about the way in which you improve those underlying return to XT is through potentially shifting some more home enrollment cases toward those inpatient or the case was for otherwise prescribed by a physician in the office. So wondering if that was a big driver of the improvements here. And then the second part of that would be if there is an increased rate of home enrollment as a portion of total revenue in order to kind of keep those lower returns at a higher level or back on the store levels. Does that incrementally add any type of expense that would make you think about essentially shifting the kind of overall view on how you're going to leverage the profitability profile of the company?

好的。然後我不確定我是否可能更早地錯過了它，但在過去，你曾談到提高 XT 潛在回報的方式是通過潛在地將更多的家庭註冊案例轉移到那些住院或該病例由辦公室的醫生另行規定。所以想知道這是否是這裡改進的重要驅動力。然後第二部分是，如果家庭入學率增加作為總收入的一部分，以便將那些較低的回報保持在較高水平或回到商店水平。這是否會逐漸增加任何類型的費用，使您考慮從根本上改變對如何利用公司盈利能力的總體看法？

Yes. I don't think -- nothing really came in much different than what we expected from a return device rate with respect to mix of volumes through home enrollment or in clinic or the newer sort of take-home model that we were seeing. I think that pretty much came in line right as we expected it would. And we made some improvements in that take-home model that was putting a bit of pressure on us throughout the course of the fourth quarter once we learned about it and could sort of adjust our approach to those patients and those physicians with a product that was -- we provided better indications for use, how to apply the device, follow-up calls, those sort of things, we were able to see some improvement in that return device rate. It's not in line with an in-clinic return device rate, but it has the potential that it could be better than a home enrollment return device rate.

是的。我不認為 - 與我們通過家庭註冊或診所或我們所看到的新型帶回家模型的混合卷返回設備率的預期沒有什麼不同。我認為這幾乎符合我們的預期。我們對帶回家的模型進行了一些改進，一旦我們了解到它，在整個第四季度的過程中給我們帶來了一些壓力，並且可以調整我們對那些患者和那些擁有產品的醫生的方法——我們提供了更好的使用說明，如何應用設備，後續電話，諸如此類的事情，我們能夠看到設備回收率有所提高。它與診所內設備回收率不一致，但它有可能比家庭註冊設備回收率更好。

I believe the home enrollment program for us is an opportunity to really deliver sort of a competitive differentiated solution experience for our patients. It's so easy to take this device, supply it at home and not have to be in the physician's office to have that done. And then to be able to provide the report back to the physician without the patient never really having had to come in. I think home enrollment can be a significant part of how we grow the business into the future. But at the same time, the return device rate with our home enrollment program is roughly 90% compared to, call it, 98% within clinic devices. I think there are some things we can do operationally that can improve that 90% over time and see us close that gap.

我相信我們的家庭註冊計劃是一個真正為我們的患者提供具有競爭力的差異化解決方案體驗的機會。攜帶這個設備非常容易，在家裡提供它，而不必在醫生辦公室就可以完成。然後能夠將報告提供給醫生，而無需患者真正進來。我認為家庭註冊可能是我們未來業務發展的重要組成部分。但與此同時，與診所設備中的 98% 相比，我們家庭註冊計劃的設備回收率大約為 90%。我認為我們可以在運營上做一些事情，隨著時間的推移可以提高 90%，並看到我們縮小差距。

But I think the value of home enrollment is that it can help us drive faster volume growth or faster adoption of the product, given the flexible model that it allows and it gives the physicians to utilize to address some of the capacity challenges they have in their own clinics. So while it has a lower return device rate, I think it has the potential to drive faster unit volume growth that can offset that lower device rate and then give us opportunity over time to operationally focus on improving the 90%. So I think home enrollment can be a significant driver of growth for us into the future when we think about some of the challenges we see in the market around capacity or just seeing patients or having to schedule them many weeks, if not months out. I think home enrollment can start to alleviate much of that. So I think it becomes a nice solution for us.

但我認為在家註冊的價值在於它可以幫助我們推動更快的銷量增長或更快地採用產品，因為它允許採用靈活的模式，並且它讓醫生可以利用它來解決他們在他們的工作中遇到的一些能力挑戰自己的診所。因此，雖然它的設備退貨率較低，但我認為它有可能推動更快的單位銷量增長，這可以抵消較低的設備率，然後隨著時間的推移讓我們有機會在運營上專注於提高 90%。因此，當我們考慮到我們在市場上看到的一些圍繞容量的挑戰，或者只是看病人，或者不得不安排他們數週甚至數月的時間時，我認為家庭註冊可能是我們未來增長的重要驅動力。我認為家庭入學可以開始緩解其中的大部分問題。所以我認為這對我們來說是一個很好的解決方案。

Our next question comes from the line of Joanne Wuensch with Citi.

我們的下一個問題來自花旗銀行的 Joanne Wuensch。

This is actually [Anthony] on for Joanne. Do you talk about how the international business performed this quarter and what your expectations are for this year? And then as a follow-up, can you just discuss any competitive dynamics you witnessed in the quarter?

這實際上是 [Anthony] 為 Joanne 準備的。能否談談本季度國際業務的表現以及對今年的預期？然後作為後續行動，你能談談你在本季度目睹的任何競爭動態嗎？

Yes. From an international perspective, the value continues to be realized quite nicely at what Zio can bring into the marketplace. So we continue to see volume growth there perform really, really well. I think one of the things that we have to navigate through in the U.K. business is coming off of the AI award and into formal NHS coverage of the product, right. And that's something that we continue to work through with them, and we continue to see great volume growth, but getting a permanent rate established by the NHS is something that's really going to open up the public sector for us into the future. So I expect it's going to continue to grow really well. Volumes are going to continue to grow really well for us as we get into the private sector. We've now entered into agreements with 3 of the largest private hospital groups in the U.K. That's going to continue to progress nicely for us. And over time, I think international is going to be a pretty significant contributor for us in total.

是的。從國際角度來看，Zio 可以為市場帶來的價值繼續得到很好的實現。因此，我們繼續看到那裡的銷量增長表現得非常非常好。我認為我們在英國業務中必須經歷的事情之一是擺脫 AI 獎項並進入產品的正式 NHS 覆蓋範圍，對吧。這是我們繼續與他們合作的事情，我們繼續看到巨大的銷量增長，但獲得 NHS 建立的永久費率確實會為我們打開公共部門的未來。所以我預計它會繼續很好地增長。隨著我們進入私營部門，我們的銷量將繼續增長。我們現在已經與英國 3 家最大的私立醫院集團達成協議。這對我們來說將繼續取得良好進展。隨著時間的推移，我認為國際將成為我們總體上非常重要的貢獻者。

From a competitive perspective, I would tell you there's nothing unique that we're seeing in the marketplace relative to the competition. We're very much aware of it. We pay close attention to it. We track it as well as we can through third-party market data that we have. I don't think that you're seeing any change in competitive trends over the course of the third quarter, the fourth quarter. Frankly, I think some of the challenges that we saw in the third and fourth quarter from a staffing perspective, I think they were felt industry-wide. I don't think they were specific to us based upon all the market data we were able to pull together. So I don't see any dynamics changing on the competitive front, although it is something that we pay very close attention to.

從競爭的角度來看，我會告訴你，我們在市場上看到的與競爭對手相比沒有什麼獨特之處。我們非常清楚這一點。我們密切關注它。我們通過我們擁有的第三方市場數據盡可能地跟踪它。我不認為你在第三季度、第四季度的過程中看到競爭趨勢有任何變化。坦率地說，我認為我們在第三和第四季度從人員配置的角度看到的一些挑戰，我認為他們在整個行業範圍內都感受到了。根據我們能夠收集到的所有市場數據，我認為它們並不是特定於我們的。所以我看不到競爭方面的任何動態變化，儘管這是我們非常關注的事情。

Our next question comes from the line of Bill Plovanic with Canaccord.

我們的下一個問題來自 Bill Plovanic 與 Canaccord 的對話。

It's [John] on for Bill tonight. Can I first start just on the PCP opportunity and maybe some more color around there. What are you seeing in terms of success? And how would you describe clinician comfort? And are these generally take home or home enrollment patients? And are you seeing any pushback from existing or ET or cardiology customers?

今晚 [John] 替 Bill 上場。我可以先從 PCP 的機會開始，也許還有更多的顏色嗎？你對成功有什麼看法？您如何描述臨床醫生的舒適度？這些通常是帶回家還是在家註冊的患者？您是否看到現有或 ET 或心髒病學客戶的任何阻力？

Yes. What was the middle question in there? You were asking about the success or what success looks like and then home enrollment, but I missed the...

是的。中間的問題是什麼？你問的是成功或成功是什麼樣子，然後是家庭入學，但我錯過了......

Just the permission, the PCP comfort around prescribing.

只是許可，PCP 就可以開處方。

Yes. No, a terrific question because it's a dynamic that we are learning to navigate through. I will tell you that the success around the primary care space, the GP space has been more than what I would have expected at this point in time. I mean getting partners like One Medical signed up has certainly helped move the needle. We've had a couple of other large network, PCP network folks sign up as well. We won't disclose those out of respect for their wishes, but we're certainly seeing the interest in the Zio product, making it way into that primary care space.

是的。不，這是一個了不起的問題，因為它是我們正在學習駕馭的動態。我會告訴你，初級保健領域的成功，全科醫生領域的成功超出了我此時的預期。我的意思是讓像 One Medical 這樣的合作夥伴簽約肯定有助於推動這一進程。我們還有其他幾個大型網絡，PCP 網絡人員也註冊了。出於對他們意願的尊重，我們不會透露這些信息，但我們確實看到了人們對 Zio 產品的興趣，並進入了初級保健領域。

And I think given the clinical data behind the product and just how easy it is to utilize both from a patient perspective as well as interpreting report, the comfort levels are quite high. And I think it just validates for me that we're absolutely going to open up the primary care space. And again, there's 14 million patients in their primary care physician today that already have cardiac-specific palpitations noted in their medical records. That compares to 5.5 million ACM tests being prescribed in the U.S. I remain convinced that you're going to see this market expand dramatically as we continue to push into the primary care setting, just given how easy it is to use the product, how accurate it is and the downstream benefits that you get with monitoring these patients sooner.

而且我認為，考慮到產品背後的臨床數據，以及從患者角度和解釋報告的角度來看，使用起來非常容易，舒適度相當高。而且我認為這對我來說只是證實了我們絕對會開放初級保健空間。而且，如今他們的初級保健醫生中有 1400 萬患者的醫療記錄中已經記錄了心臟特異性心悸。相比之下，美國規定進行 550 萬次 ACM 測試。我仍然相信，隨著我們繼續推進初級保健環境，您將看到這個市場急劇擴大，只要考慮到該產品使用起來多麼容易，多麼準確儘早監測這些患者會帶來下游收益。

It helps address so many of the capacity issues that we're hearing by the specialists, by the EPs, even to the point where there are networks that we're now working with, where we led into those networks by convincing the cardiologist or the EP of the value of Zio and they've been using the product, but they see how easy it is they used to where they're actually presenting within their networks to have the primary care physician begin to prescribe the product, have it placed on the patient and then let the cardiologist or the EP do the actual overread, which they can do very easily in our Zio suite and help streamline who they're actually spending time seeing versus not. So in many ways, the specialists have embraced the ease of use of this product and how it can impact their home practices and make it much more efficient and effective. And I think that's going to be a model that continues to really move into the future and drive some nice growth.

它有助於解決我們從專家、EP 那裡聽到的許多容量問題，甚至到了我們現在正在使用的網絡的地步，我們通過說服心髒病專家或Zio 的價值的 EP，他們一直在使用該產品，但他們看到他們習慣於在他們的網絡中實際展示的地方讓初級保健醫生開始開出產品處方，將其放在患者，然後讓心髒病專家或 EP 進行實際的過度閱讀，他們可以在我們的 Zio 套件中非常輕鬆地完成這些工作，並幫助簡化他們實際花時間看的人與不看的人。因此，在許多方面，專家們已經接受了該產品的易用性以及它如何影響他們的家庭實踐並使其更加高效和有效。而且我認為這將成為一種繼續真正走向未來並推動一些良好增長的模式。

Ultimately, the home enrollment model is the model that we would prefer to see utilize more than anything else in the primary care setting only because there are so many primary care specialists that are out there rather than sitting products on the shelf in every one of their offices, the home enrollment model just makes a whole lot more sense for us. At the same time, we want to see that return device rate improve beyond 90%. And so that's where we got operational efforts internal focused on enabling that and making that happen. But the home enrollment model is the way we want to think about serving that PCP or GP space.

歸根結底，家庭註冊模型是我們更希望看到在初級保健環境中使用最多的模型，因為那裡有太多的初級保健專家，而不是每個人都把產品放在貨架上辦公室，家庭註冊模式對我們來說更有意義。同時，我們希望看到設備退貨率提高到90%以上。因此，這就是我們在內部開展運營工作的地方，專注於實現這一目標並實現這一目標。但家庭註冊模式是我們考慮為 PCP 或 GP 空間提供服務的方式。

And then just as a follow-up, how should we think about the international contribution in 2023 outside of the U.K.? I know you talked about that a little bit, but the other European nations that you previously called out as target, any revenue contribution from there? And then have you submitted your Shonin application for Japan yet? And should we still expect approval late this year in reimbursement in 2024?

然後作為後續行動，我們應該如何考慮 2023 年英國以外的國際貢獻？我知道你談到了一點點，但你之前稱為目標的其他歐洲國家，從那裡有任何收入貢獻嗎？那麼你提交日本的上人申請了嗎？我們還應該期待今年晚些時候在 2024 年獲得報銷批准嗎？

Yes. In terms of the incremental international countries beyond the U.K., we still expect to be in to at least 3 of those countries selling product in the back part of this year. How quickly that goes is something that we'll monitor as we get into those countries, but we certainly expect to be in additional countries 3, at least by the end of the year. We probably go into the private sector first and then move into the public sector is how we think about that. It's not going to move the needle in a meaningful way with respect to growth for the overall company in 2023. I mean today, international, which is predominantly the U.K., is 1 point to 1.5 points. I think about 1.5 points or so of total revenue. And so that's not going to move the needle in a significant way, just yet. I do think international and tie-tin has an opportunity to be an incredible contributor to the overall size of the company and the growth profile of the company.

是的。就英國以外的增量國際國家而言，我們仍然預計在今年下半年至少有 3 個國家銷售產品。當我們進入這些國家時，我們將監控進展的速度，但我們當然希望至少在今年年底之前進入更多國家 3 。我們可能首先進入私營部門，然後進入公共部門，這是我們的想法。就 2023 年整個公司的增長而言，它不會以有意義的方式改變方向。我的意思是，今天，國際市場（主要是英國）是 1 點到 1.5 點。我認為總收入的 1.5 點左右。因此，這還不會以顯著的方式移動針頭。我確實認為國際和鐵錫有機會成為公司整體規模和公司增長前景的不可思議的貢獻者。

With respect to Japan, we've had initial discussions with them around the high medical needs assessment. Clearly, we want to go into that market with a high medical need designation, if we can. It will certainly help from a reimbursement perspective. We had that first meeting with them. There's a follow-up meeting that will happen here in the not-too-distant future. And right behind that, I would expect to submit for Shonin regulatory approval, which we would hopefully get towards the back of the year, if not right at the beginning of the new year and then ultimately get into discussions around reimbursement and hopefully have our product in that market in the back part of '24 some time.

關於日本，我們已經圍繞高醫療需求評估與他們進行了初步討論。顯然，如果可以的話，我們希望進入具有高醫療需求的市場。從報銷的角度來看，這肯定會有所幫助。我們與他們進行了第一次會面。不久的將來，這裡將舉行後續會議。緊接著，我希望提交 Shonin 監管部門批准，我們希望在今年年底獲得批准，如果不是在新年伊始，然後最終就報銷進行討論，並希望我們的產品在 24 世紀後期的那個市場上。

Our next question comes from the line of Suraj Kalia with Oppenheimer.

我們的下一個問題來自 Suraj Kalia 與 Oppenheimer 的對話。

Quentin, can you hear me all right?

昆汀，你能聽到我說話嗎？

We got you.

我們抓到你了。

Perfect. So Quentin, in one of your comments caught my attention, I believe it was for the next-gen XT for longer use, can you characterize that a bit more? Is the battery size bigger? Are you looking to accommodate 30-day usage? Just curious, given the past commentary, always look Zio AT is coming form is good enough for 14 days of use. If you just flesh out some additional details if you could.

完美的。所以 Quentin，在你的一條評論中引起了我的注意，我相信這是為了下一代 XT 的更長時間使用，你能描述一下嗎？電池尺寸更大嗎？您是否希望使用 30 天？只是好奇，鑑於過去的評論，總是看 Zio AT 即將到來，形式足以使用 14 天。如果可以的話，如果你只是充實一些額外的細節。

Yes. Suraj, our development teams have been -- they've done an incredible job with the Zio Monitor. I mean I continue to believe it's going to be a much bigger deal than what we've even anticipated as I hear feedback from it in the marketplace. And this is going to be the exact same form factor that we use on the next generation of the Zio AT product or the Zio MCT product. And you're going to find some data even at ACC with respect to the Zio Monitor that demonstrates sort of the wear experience we're getting out all the way up to 30 days, which is pretty encouraging and pretty remarkable. It's not larger size.

是的。 Suraj，我們的開發團隊——他們在 Zio Monitor 方面做得非常出色。我的意思是，我仍然相信這將比我們在市場上聽到的反饋所預期的要大得多。這將與我們在下一代 Zio AT 產品或 Zio MCT 產品上使用的外形完全相同。你甚至會在 ACC 上找到一些關於 Zio Monitor 的數據，這些數據展示了我們一直到 30 天的佩戴體驗，這是非常令人鼓舞和非常了不起的。它不是更大的尺寸。

As I mentioned, the form factor is 72% smaller than the existing form factor today. It's just really a testament to what the team has been able to do from a technology perspective, getting it much smaller, much lighter that allows it to stay adhered to the body for a longer period of time and generate a good patient experience. So we know that one of the gaps in our existing AT product is while we think we can -- and the data would tell you this, we can monitor as well as any product in the market during the course of those first 14 days, we know that a large part of the market is looking for something that goes beyond 14 days. And our first step will be to extend that out, and the Zio Monitor platform that you see is going to be that platform that will enable that with the AT product. So we're excited by what we can see or what we're going to realize there in time.

正如我所提到的，外形尺寸比目前現有的外形尺寸小 72%。這真的證明了團隊從技術角度所做的事情，讓它變得更小、更輕，使其能夠更長時間地粘附在身體上，並產生良好的患者體驗。所以我們知道，我們現有的 AT 產品的差距之一是我們認為我們可以 - 數據會告訴你這一點，我們可以在前 14 天的過程中監控市場上的任何產品，我們知道很大一部分市場正在尋找超過 14 天的東西。我們的第一步將是擴展它，您看到的 Zio Monitor 平台將成為支持 AT 產品的平台。所以我們對我們能看到的或我們將及時實現的東西感到興奮。

So forgive me, Quentin, for belaboring this point. So you're saying the new form factor with Zio Monitor form the AT application will have the same size battery. I presume it will -- it needs to have real-time connectivity. Just trying to understand to your comments, basically, you'll have real-time connectivity, but the form factor is not -- a battery form factor has not increased. Did I paraphrase that correctly?

昆汀，請原諒我對這一點的冗長解釋。因此，您是說來自 AT 應用程序的 Zio Monitor 的新外形將具有相同尺寸的電池。我想它會——它需要實時連接。只是想了解您的評論，基本上，您將擁有實時連接，但外形尺寸卻沒有——電池外形尺寸沒有增加。我的解釋正確嗎？

You're thinking of it correctly. That's right, Suraj. The battery life in the existing Zio Monitor, we believe can get out well beyond the 14 days that we're at today.

你的想法是正確的。沒錯，蘇拉吉。現有 Zio Monitor 的電池壽命，我們相信可以遠遠超過我們今天的 14 天。

Interesting. Okay. Quentin, one last question. So Quentin, one of the things that you'll be crystal clear in terms of OpEx leverage in terms of shifting between IDTFs of 50-25-25. And see as you exited '22, FY '22, can you set stage how was the IDTF distribution for your scripts so that as FY '23 and beyond progresses, we can just sort of compare and contrast and map it for our own modeling purposes?

有趣的。好的。昆汀，最後一個問題。所以 Quentin，就 50-25-25 的 IDTF 之間的轉換而言，您將在 OpEx 槓桿方面非常清楚的事情之一。看看你在 22 年、22 財年退出時，你能否為你的腳本設定 IDTF 分佈情況，以便隨著 23 財年及以後的進展，我們可以進行比較和對比，並將其映射到我們自己的建模目的？

Yes. I think maybe at the highest level, Suraj, we didn't have any contracts in place from a MAC perspective with IDTFs really outside of Novitas and then NGS in Chicago that we were utilizing. We did end up getting some additional contracts put in place over the course of '22, but knowing or expecting that we were going to be able to get a national rate put in place, it didn't make sense to set up physical facilities and hire people into these other locations. So we ended up managing most of the XT workflows through the Novitas and NGS MACs, if you will.

是的。我認為也許在最高級別，Suraj，從 MAC 的角度來看，我們沒有與真正在 Novitas 之外的 IDTF 和我們正在使用的芝加哥的 NGS 簽訂任何合同。在 22 年的過程中，我們確實最終獲得了一些額外的合同，但知道或期望我們能夠獲得全國利率，建立物理設施和僱人到這些其他地點。因此，如果您願意，我們最終通過 Novitas 和 NGS MAC 管理大部分 XT 工作流程。

Over the course of '23, as you know, we're hiring and expanding our presence in San Francisco and in that IDTF. Frankly, just the volume growth in the business requires us to hire more folks into the business just to keep up with the overall volume, we'll be hiring the majority of those folks into our San Francisco location that will be again to be able to do some of the XT product for us as well. Keep in mind, we've done AT out of San Francisco historically. Now we'll begin to do some of the XT. So in the prior year, in terms of the mix between the Novitas and NGS, I can't speak to that specifically off the top of my head, but we started off with Novitas and certainly move towards NGS over the course of the year here in 2023, about 25% will be in San Francisco in the first part of the year, and the expectation is to move north of 50% in the back part of the year as we hire out resources to do the work in San Francisco, keeping up with the overall volume growth in the business.

如您所知，在 23 年期間，我們正在招聘並擴大我們在舊金山和 IDTF 的業務。坦率地說，只是業務量的增長要求我們僱用更多的人來跟上整體業務量，我們將僱用這些人中的大多數人到我們的舊金山地點，這將再次能夠也為我們做一些 XT 產品。請記住，我們歷史上已經在舊金山以外的地方完成了 AT。現在我們將開始做一些 XT。所以在前一年，就 Novitas 和 NGS 之間的組合而言，我不能直接說出來，但我們從 Novitas 開始，肯定會在這一年裡轉向 NGS到 2023 年，大約 25% 將在今年上半年在舊金山，預計在今年下半年將超過 50%，因為我們會僱用資源在舊金山開展工作，保持隨著業務總量的增長。

Our next question comes from the line of Michael Polark with Wolfe Research.

我們的下一個問題來自 Michael Polark 與 Wolfe Research 的合作。

I'm curious on Manila timing over what period of time will this facility ramp up? And is this a facility for clinical operations, G&A functions, both? And is it going to be positioned to serve U.S. patients or designed to serve your future OUS growth opportunities?

我很好奇馬尼拉的時間安排，該設施將在多長時間內增加？這是用於臨床操作、G&A 功能的設施嗎？它的定位是為美國患者服務還是旨在為您未來的 OUS 增長機會提供服務？

I'll take that. Sorry, Quentin. Yes, I'll take that one. So it will ramp up over 2023. The biggest utilization there will be for our back office functions. There will be some clinical ops and customer ops functions that will roll through there as well. As you know, there's compliance aspects that we need to adhere to and we're very mindful of on the Medicare front. And so nothing that needs to be processed domestically. We'll move into those locations. That's not at all the plan. But for commercial contracts that have that ability to move over there, that's what we will do. So it's going to ramp up over 2023, and then it will be fully up and operational by the end of 2023.

我會接受的。對不起，昆汀。是的，我會拿那個。因此它將在 2023 年增加。最大的利用率將用於我們的後台功能。那裡也會有一些臨床操作和客戶操作功能。如您所知，我們需要遵守合規性方面的要求，並且我們非常注意醫療保險方面的問題。因此，沒有任何東西需要在國內加工。我們將搬進那些地方。這根本不是計劃。但對於有能力轉移到那裡的商業合同，這就是我們要做的。因此，它將在 2023 年之前逐步增加，然後到 2023 年底將全面投入運營。

That is helpful. For my follow-up, just to level set models, and there was some 1Q commentary already. But the pricing and volume has bounced around here through the COVID era and through the reimbursement cycle. I guess 1Q revenue in your plan versus 4Q down, flat or up sequentially? What's the best direction?

這很有幫助。對於我的後續行動，只是水平集模型，並且已經有一些 1Q 評論。但在 COVID 時代和整個報銷週期中，價格和數量已經在這裡反彈。我猜你計劃中的第一季度收入與第四季度相比下降、持平或上升？最好的方向是什麼？

Yes. So traditionally, if you look at the seasonality of the business, it steps back a bit. And if you work your way into the sort of the commentary of Q1 being on the lower end of that guidance range, it will help you get into the place that we think it's going to be from a Q1 perspective. And again, that's natural seasonality playing through the business. Nothing unique to this year than what we would expect outside of that. Now there is a bit of a tailwind as we talked about from original expectations with regards to PayGo and then XT there's a bit of tailwind there, but most of that is offset by the AT pricing pressure. So if you work your way into the bottom end of the guidance range there, you'll get the feel for what the seasonality looks like. And historically, let's call it, 22-ish percent and we don't think it's going to deviate much from that.

是的。所以傳統上，如果你看一下業務的季節性，它會退後一步。而且，如果您對 Q1 的評論處於該指導範圍的低端，它將幫助您進入我們認為從 Q1 角度來看的位置。再一次，這是貫穿整個業務的自然季節性。今年沒有什麼比我們預期的更獨特的了。正如我們從最初對 PayGo 和 XT 的預期中談到的那樣，現在有一點順風，那裡有一點順風，但其中大部分被 AT 定價壓力所抵消。因此，如果你努力進入指導範圍的底部，你就會感受到季節性的樣子。從歷史上看，我們稱之為 22%，我們認為它不會偏離太多。

There are no additional questions waiting at this time. I would like to pass the conference back to the management team for any closing remarks.

目前沒有其他問題等待您回答。我想將會議傳回給管理團隊，聽取任何閉幕詞。

Well, thank you.

嗯，謝謝。

And in closing, I want to take the opportunity to thank each of you for joining our call, and I want to thank each of our team members at iRhythm for the tremendous work that they do each and every day to make our company what it is. We have a tremendous future in front of us at iRhythm and look forward to an exciting year in 2023. We exited 2022 with strong registration volumes in both Q3 and Q4, including another record number of new account openings in the fourth quarter. And we have exciting clinical data that's going to be presented at ACC in just 1.5 weeks that continues to demonstrate the superiority of our Zio XT product and we're preparing for the launch of Zio Monitor, which will be the largest launch in our company's history.

最後，我想藉此機會感謝你們每個人加入我們的電話會議，我想感謝 iRhythm 的每一位團隊成員，感謝他們每天所做的大量工作，使我們的公司成為今天的樣子.在 iRhythm，我們擁有廣闊的未來，並期待 2023 年激動人心的一年。我們在第三季度和第四季度以強勁的註冊量結束了 2022 年，包括第四季度的新開戶數量再創新高。我們有令人興奮的臨床數據，這些數據將在短短 1.5 週後在 ACC 上展示，這些數據將繼續證明我們的 Zio XT 產品的優越性，我們正在為 Zio Monitor 的發布做準備，這將是我們公司歷史上最大規模的發布.

In addition, we're focused on getting the newly designed Zio AT on file with the FDA leading to a potential launch in '24 in a space that we are well underrepresented in today as well as submitting in the next few months for regulatory approval in Japan, the second largest market in the world. Our future has never been brighter, and I look forward to speaking to all of you again on our Q1 earnings call.

此外，我們專注於讓新設計的 Zio AT 向 FDA 備案，從而可能在 24 年在我們今天代表性不足的領域推出，並在接下來的幾個月內提交監管部門批准日本，世界第二大市場。我們的未來從未如此光明，我期待在第一季度財報電話會議上再次與大家交談。

Take care.

小心。

That concludes the iRhythm, Inc. Q4 2022 Earnings Conference Call. I hope you all enjoy the rest of your day. You may now disconnect your lines.

iRhythm, Inc. 2022 年第四季度收益電話會議到此結束。我希望你們都過得愉快。您現在可以斷開線路。