Boston Scientific Corp (BSX) 2023 Q4 法說會逐字稿

Good morning, and welcome to the Boston Scientific Fourth Quarter 2023 Earnings Call. (Operator Instructions) Please note this event is being recorded.

早安，歡迎參加波士頓科學公司 2023 年第四季財報電話會議。 （操作員說明）請注意此事件正在被記錄。

I would now like to turn the conference over to Lauren Tengler, Vice President, Investor Relations. Please go ahead.

我現在想將會議交給投資者關係副總裁 Lauren Tengler。請繼續。

Thank you, Drew. Welcome, everyone, and thanks for joining us today. With me on today's call are Mike Mahoney, Chairman and Chief Executive Officer; and Dan Brennan, Executive Vice President and Chief Financial Officer. We issued a press release earlier this morning announcing our Q4 and full year 2023 results, which included reconciliations of the non-GAAP measures used in the release. We have posted a copy of that release as well as reconciliations of the non-GAAP measures used in today's call to the Investor Relations section of our website under the heading Financials and Filings. The duration of this morning's call will be approximately 1 hour. Mike and Dan will provide comments on Q4 and full year performance as well as the outlook for the business, including 2024 guidance, and then we'll take your questions. During today's Q&A session, Mike and Dan will be joined by our Chief Medical Officer, Dr. Ken Stein.

謝謝你，德魯。歡迎大家，感謝您今天加入我們。與我一起參加今天電話會議的有董事長兼執行長 Mike Mahoney；執行副總裁兼財務長 Dan Brennan。今天早上早些時候，我們發布了一份新聞稿，宣布了 2023 年第四季度和全年業績，其中包括新聞稿中使用的非 GAAP 衡量標準的調整表。我們已在我們網站的「投資者關係」部分的「財務和文件」標題下發布了該新聞稿的副本以及今天電話會議中使用的非公認會計原則措施的調節表。今天上午的通話時間約為 1 小時。 Mike 和 Dan 將提供有關第四季度和全年業績以及業務前景的評論，包括 2024 年指導，然後我們將回答您的問題。在今天的問答環節中，我們的首席醫療官 Ken Stein 博士將與 Mike 和 Dan 一起參加。

Before we begin, I'd like to remind everyone that on this call, operational revenue growth excludes the impact of foreign currency fluctuations, and organic revenue growth further excludes acquisitions and divestitures for which there are less than a full period of comparable net sales. Relevant acquisitions and divestitures excluded for organic growth are Baylis Medical, which closed on February 14, 2022, the majority stake investment in Acotec Scientific Holding Ltd., Apollo Endosurgery and Relievant Medical (sic) [Relievant Medsystems], which closed in February, April, November 2023, respectively.

在開始之前，我想提醒大家，在這次電話會議中，營業收入成長排除了外匯波動的影響，有機收入成長進一步排除了少於完整時期可比淨銷售額的收購和剝離。有機成長排除的相關收購和剝離包括Baylis Medical（於2022 年2 月14 日完成）、Acotec Scientific Holding Ltd. 的多數股權投資、Apollo Endosurgery 和Relievant Medical（原文如此）[Relievant Medsystems]（於2 月、 4 月完成） 、 2023 年 11 月。

Divestitures include the endoscopy pathology business, which closed in April 2023. Guidance excludes the previously announced agreement to acquire Axonics, Inc., which is expected to close in the first half of 2024, subject to customary closing conditions. For more information, please refer to our financial and operating highlights deck, which may be found on our Investor Relations website.

剝離包括內視鏡病理業務，該業務於 2023 年 4 月關閉。指導意見不包括先前宣布的收購 Axonics, Inc. 的協議，該協議預計將於 2024 年上半年完成，但須符合慣例成交條件。欲了解更多信息，請參閱我們的財務和營運亮點，可在我們的投資者關係網站上找到。

On this call, all references to sales and revenue, unless otherwise specified, are organic. This call contains forward-looking statements within the meanings of federal securities laws, which may be identified by words like anticipate, expect, may, believe, estimate and other similar words. They include, among other things, statements about our growth and market share, new and anticipated product approvals and launches, acquisitions, clinical trials, cost savings and growth opportunities, our cash flow and expected use, our financial performance, including sales, margins and earnings as well as our tax rates, R&D spend and other expenses.

在這次電話會議中，除非另有說明，所有提及銷售和收入的內容都是有機的。本次電話會議包含聯邦證券法含義內的前瞻性陳述，可透過預期、期望、可能、相信、估計和其他類似詞語來識別。其中包括有關我們的成長和市場份額、新產品和預期產品批准和發布、收購、臨床試驗、成本節約和成長機會、我們的現金流量和預期用途、我們的財務表現（包括銷售額、利潤率和利潤）的聲明。收入以及我們的稅率、研發支出和其他費用。

If our underlying assumptions turn out to be incorrect or certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. Factors that may cause such differences include described in the Risk Factors section of our most recent 10-K and subsequent 10-Qs filed with the SEC. These statements speak only as of today's date, and we disclaim any intention or obligation to update them.

如果我們的基本假設被證明是不正確的，或者某些風險或不確定性成為現實，實際結果可能與我們的前瞻性聲明所表達或暗示的預期和預測有重大差異。可能導致此類差異的因素包括我們向 SEC 提交的最新 10-K 和後續 10-Q 的風險因素部分中所述的因素。這些聲明僅代表今天的情況，我們不承擔任何更新這些聲明的意圖或義務。

At this point, I'll turn it over to Mike.

此時，我會將其交給麥克。

Thanks, Lauren, and thank you, everyone, for joining us today. 2023 results were excellent, and our global performance represented one of the strongest years in company history, exceeding our financial goals that we set for the year. This performance is fueled by innovation and clinical evidence generation, commercial execution and the winning spirit of our global teams.

謝謝勞倫，也謝謝大家今天加入我們。 2023 年的業績非常出色，我們的全球業績是公司歷史上最強勁的年份之一，超越了我們當年設定的財務目標。這一業績得益於創新和臨床證據生成、商業執行以及我們全球團隊的必勝精神。

In fourth quarter '23, total company operational sales grew 15% and organic sales grew 14% versus fourth quarter '22, exceeding the high end of our guidance range of 8% to 10%. Full year '23 operational sales growth of 13% versus 2022. While organic sales grew 12%, exceeding our guidance of approximately 11% for the full year. Importantly, 6 of our 8 business units grew sales double digit in the fourth quarter and double digits for the full year 2023 and all of our regions also grew double digits in the fourth quarter and double digits full year 2023. This performance is a testament to our category leadership strategy and our focus on innovation bolstered by commercial excellence.

與 2022 年第四季相比，2023 年第四季公司總營業銷售額成長了 15%，有機銷售額成長了 14%，超過了我們指導範圍 8% 至 10% 的上限。 23 年全年營運銷售額較 2022 年成長 13%。有機銷售額成長 12%，超過我們全年約 11% 的指導。重要的是，我們的8 個業務部門中有6 個在第四季度實現了兩位數銷售額增長，在2023 年全年實現了兩位數銷售額增長，我們所有的地區在第四季度和2023 年全年銷售額也實現了兩位數成長。這項業績證明了我們的品類領先策略以及我們對卓越商業支援的創新的關注。

Fourth quarter adjusted EPS of $0.55 grew 24% versus 2022, exceeding the high end of our guidance range $0.49 to $0.52. Full year adjusted EPS of $2.05 grew 20% versus 2022, also exceeding the high end of our guidance range of $1.99 to $2.02. Q4 adjusted operating margin was 26.6% and full year '23 was 26.3%, which is exciting because it exceeds pre-pandemic levels. We generated full year cash flow of $1.8 billion and adjusted free cash flow of $2.5 billion, in line with our expectations.

第四季度調整後每股收益為 0.55 美元，與 2022 年相比增長 24%，超出了我們指導範圍 0.49 美元至 0.52 美元的上限。全年調整後每股收益為 2.05 美元，較 2022 年增長 20%，也超過了我們指導範圍 1.99 至 2.02 美元的上限。第四季調整後的營業利潤率為 26.6%，23 年全年為 26.3%，這令人興奮，因為它超過了大流行前的水平。我們全年現金流為 18 億美元，調整後自由現金流為 25 億美元，符合我們的預期。

Now for our 2024 outlook. We expect healthy procedure volumes to continue in our guidance to organic growth of 7% to 9% for first quarter 2024 and 8% to 9% for the full 2024. Our Q1 '24 adjusted EPS estimate is $0.50 to $0.52. We expect our full year adjusted EPS to be $2.23 to $2.27, representing growth of 9% to 11%. This guidance excludes the acquisition of Axonics, which is expected to close in the first half of '24.

現在我們展望 2024 年。我們預計，在我們的指導下，2024 年第一季的有機成長將繼續保持健康的狀態，2024 年第一季有機成長7% 至9%，2024 年全年有機成長8% 至9%。我們的24 年第一季調整後每股盈餘預估為0.50 美元至0.52 美元。我們預計全年調整後每股收益為 2.23 美元至 2.27 美元，成長 9% 至 11%。該指引不包括對 Axonics 的收購，該收購預計將於 24 年上半年完成。

Despite pressures on margins in '24 from FX headwinds as well as investments in manufacturing capacity and selling expenses to fuel our exciting launches, we remain committed to improving operating income margins in 2024 and to our goal of improving adjusted operating margin by 150 basis points in '24 to '26. And Dan will provide more details on those financials for both 2023 and 2024.

儘管24年的利潤率因外匯逆風以及為推動我們令人興奮的產品而對製造能力和銷售費用的投資而受到壓力，但我們仍然致力於提高2024年的營業利潤率，並實現將調整後的營業利益率提高150個基點的目標'24 至 '26。 Dan 將提供 2023 年和 2024 年財務數據的更多詳細資訊。

I'll now provide additional highlights on '23 results along with comments on our outlook. Regionally, on an operational basis, the U.S. grew 11% versus fourth quarter '22. Full year 2023 grew 10%, with particular strength in our WATCHMAN, EP, Endo and Uro business units. Europe, Middle East and Africa grew 12% on an operational basis versus Q4 '22 and 13% on a full year basis. This above market growth is supported by new and ongoing product launches across the portfolio, price discipline and strong commercial execution. We're excited about the year ahead with ongoing momentum across the region, particularly with our innovative EP portfolio, and further opportunity in our growth in emerging markets within the EMEA region.

我現在將提供有關 23 年業績的更多亮點以及對我們前景的評論。從地區來看，在營運基礎上，美國與 2022 年第四季相比成長了 11%。 2023 年全年成長 10%，特別是我們的 WATCHMAN、EP、Endo 和 Uro 業務部門。與 22 年第四季相比，歐洲、中東和非洲的營運成長了 12%，全年成長了 13%。上述市場成長得益於整個產品組合中新產品和持續產品的推出、價格紀律和強大的商業執行力。我們對未來一年該地區的持續發展勢頭感到興奮，特別是我們創新的EP產品組合，以及我們在歐洲、中東和非洲地區新興市場的進一步成長機會。

Asia Pacific grew 17% operationally versus Q4 in '19 versus the full year 2022, with all major markets growing strong double digits. Japan had a strong year, growing double digits for '22 with ongoing momentum from new products, most notably AGENT DCB, Rezum, POLAR FIT and WATCHMAN FLX. And on full year basis, China grew approximately 20% versus 2022. This consistent growth is fueled by the diverse portfolio, focus on innovation and strong commercial execution. Looking ahead, we expect China to be an accretive mid-teens grow over our '24 to '26 LRP and to achieve over $1 billion in sales in 2024, supported by new product launches, supply chain agility and sustained investments in our talent and capabilities. The team in Latin America grew 17% operationally versus both Q4 full year '22 with 7 of 8 business units growing double digits on a full year basis.

與 2022 年全年相比，亞太地區的營運較 19 年第四季成長了 17%，所有主要市場均實現了強勁的兩位數成長。日本市場表現強勁，22 年實現了兩位數的成長，其中最引人注目的是 AGENT DCB、Rezum、POLAR FIT 和 WATCHMAN FLX 等新產品的持續成長勢頭。與 2022 年相比，中國全年成長約 20%。這種持續成長是由多樣化的產品組合、對創新的關注和強大的商業執行力所推動的。展望未來，我們預計，在新產品發布、供應鏈敏捷性以及對人才和能力的持續投資的支持下，中國將在24 年至26 年的LRP 中實現十幾歲左右的增長，並在2024 年實現超過10 億美元的銷售額。與 2022 年第 4 季全年相比，拉丁美洲團隊的營運成長了 17%，其中 8 個業務部門中有 7 個業務部門的全年成長率達到兩位數。

I'll now provide some additional commentary on our BUs. Urology had an excellent quarter. 10% organic growth versus Q4 '22 and on a full year basis grew 11% organically. Full year growth was led by our Stone Management and Prosthetic Urology globally. And in 2023, we relaunched our direct-to-patient campaign, driving therapy awareness for erectile dysfunction and supporting double-digit growth within our Prosthetic Urology franchise. We're excited about the opportunities ahead in Urology included in our recently announced agreement to acquire Axonics, a medical technology company that offers innovative devices to treat urinary and bowel dysfunction. We look forward to bringing these commentary portfolios together and expanding access to differentiated technologies for physicians and patients.

我現在將對我們的業務部門提供一些額外的評論。泌尿科季度表現優異。與 22 年第 4 季相比有機成長 10%，全年有機成長 11%。全年成長由我們的全球結石管理和假體泌尿科引領。 2023 年，我們重新啟動了直接面向患者的活動，提高了對勃起功能障礙的治療意識，並支持我們的假體泌尿科特許經營業務實現兩位數增長。我們對泌尿科領域未來的機會感到興奮，其中包括我們最近宣布的收購 Axonics 的協議，Axonics 是一家提供治療泌尿和腸道功能障礙的創新設備的醫療技術公司。我們期待將這些評論組合整合在一起，並擴大醫生和患者獲得差異化技術的機會。

Endoscopy sales were also excellent in the quarter, growing 12% operationally and 11% organically versus fourth quarter '22 and the full year basis growing 12% operationally and 11% organically. Within the quarter, strong results were led by AXIOS and single-use scopes, both growing double digits. And on a full year basis, all regions grew double digits, supported by the broad and deep portfolio, new product innovation and focus on commercial excellence.

本季內視鏡銷售額也表現出色，與 2022 年第四季相比，營運成長 12%，有機成長 11%，全年營運成長 12%，有機成長 11%。本季度，AXIOS 和一次性瞄準鏡帶來了強勁業績，兩者均實現了兩位數成長。從全年來看，在廣泛而深入的產品組合、新產品創新和對商業卓越的關注的支持下，所有地區均實現了兩位數成長。

Neuromodulation sales grew 7% operationally and 3% organically versus fourth quarter '22 on a full year basis, 7% operationally and 5% organically versus '22. Our Brain franchise grew double digits both in the quarter and on a full year basis, driven by the Vercise Genus portfolio and our innovative image-guided programming, which is designed to improve the precision and efficiency of the deep brain stimulation procedure.

與 22 年第四季相比，神經調節銷售額全年營運成長 7%，有機成長 3%；與 22 年第四季相比，營運成長 7%，有機成長 5%。在 Vercise Genus 產品組合和創新的圖像引導程式設計的推動下，我們的大腦系列產品在本季度和全年均實現了兩位數增長，該編程旨在提高深部腦刺激程序的精度和效率。

In fourth quarter, on an organic basis, our Pain franchise was flat year-over-year, which was in line with our expectations. We expect our performance to improve in 2024 and with the recent launch of our U.S. WaveWriter Alpha DPN indication and the strong real-world data on FAST recently presented at NANS. Furthermore, with the completion of our Relievant Medsystems acquisition in the fourth quarter, we're excited about our ability to offer expanded pain portfolio that supports a comprehensive treatment algorithm, now including the novel Intracept system for the treatment of chronic low back pain.

在第四季度，從有機角度來看，我們的《痛苦》系列與去年同期持平，符合我們的預期。我們預計，隨著我們最近推出的美國 WaveWriter Alpha DPN 指示以及最近在 NANS 上展示的 FAST 強大的真實數據，我們的業績將在 2024 年有所改善。此外，隨著我們在第四季度完成對 Relievant Medsystems 的收購，我們對能夠提供支持全面治療演算法的擴展疼痛產品組合感到興奮，現在包括用於治療慢性腰痛的新型 Intracept 系統。

Peripheral Intervention sales were excellent also growing 12% operationally and 10% organically versus Q4 and a full year basis growing 13% operationally and 11% organically versus '22. Our Arterial growth was led by the performance of our drug-eluting portfolio both in Q4 and on a full year. This market remains underpenetrated with more than half the procedures still being used with bare-metal devices, underscoring the importance of our ongoing commitment to innovation and clinical evidence.

外圍幹預銷售額也非常出色，與第四季度相比，營運成長了 12%，有機成長 10%，全年營運成長 13%，有機成長 11%，與 22 年相比。我們的動脈增長是由我們的藥物洗脫產品組合在第四季度和全年的表現帶動的。市場仍然滲透不足，超過一半的程序仍在裸機設備上使用，這凸顯了我們持續致力於創新和臨床證據的重要性。

In Venous, Q4 (inaudible) growth was led by Varithena, our market-leading varicose vein technology. Additionally, in fourth quarter, EKOS growth was supported by REAL-PE, the largest real-world and near real-time data set evaluating advanced therapies for pulmonary embolism patients.

在靜脈領域，第四季（聽不清楚）的成長由我們市場領先的靜脈曲張技術 Varithena 引領。此外，第四季度 EKOS 的成長得到了 REAL-PE 的支持，REAL-PE 是評估肺栓塞患者先進療法的最大的真實世界和近即時數據集。

Our Interventional Oncology franchise performed extremely well in fourth quarter and in 2023, growing low double digits with strength across our portfolio of robust embolization technologies and cancer therapies. We continue to look to expand our clinical evidence and are pleased to have commenced enrollment in the ROWAN trial, which will access the safety and efficacy of use TheraSphere in combination with immunotherapy to treat HCC, the most common type of primary liver cancer.

我們的介入性腫瘤學專營權在第四季度和 2023 年表現非常出色，憑藉我們強大的栓塞技術和癌症治療組合的實力，實現了低兩位數的成長。我們繼續尋求擴大我們的臨床證據，並很高興開始參加 ROWAN 試驗，該試驗將了解使用 TheraSphere 聯合免疫療法治療 HCC（最常見的原發性肝癌類型）的安全性和有效性。

Cardiology delivered tremendous quarter -- delivered a tremendous fourth quarter and year, with both operational and organic sales growing 14% versus fourth quarter and for the full year 2022. Within Cardiology, Interventional Cardiology therapy sales grew 10% for the full year and -- for the quarter and full year. On a full year basis, the Coronary Therapies franchise growth was driven by strong performance in our international regions and our Imaging franchise globally. AGENT Drug-Coated Balloon continues to perform very well in Japan, and we now expect approval of the AGENT in the U.S. in the first half of 2024. AGENT DCB will be the first coronary drug-eluting balloon in the U.S. indicator for instant restenosis providing physicians and patient solution for this unmet clinical need.

心臟病學季度表現出色——第四季度和全年表現出色，營運銷售額和有機銷售額均較第四季和2022 年全年增長14%。在心臟病學領域，介入性心臟病學治療銷售額全年增長10%，並且－本季和全年。從全年來看，冠狀動脈治療特許經營業務的成長是由我們國際地區和全球影像特許經營業務的強勁表現所推動的。 AGENT 藥物塗層球囊在日本繼續表現良好，我們現在預計 AGENT 將於 2024 年上半年在美國獲得批准。AGENT DCB 將成為美國第一個冠狀動脈藥物洗脫球囊，可提供即時再狹窄指標醫生和患者解決這一未滿足的臨床需求。

Our Structural Heart Valves franchise grew double digits in both fourth quarter and on a full year basis, led by the performance of ACURATE neo2 in Europe, and we now have treated more than 70,000 patients to date with our ACURATE technology globally. As we look ahead, we anticipate approval of ACURATE Prime in Europe in 2025. However, after reviewing a planned interim analysis of the U.S. ACURATE IDE data, we will now wait for the full 1-year data from the RCT cohort of 1,500 patients to determine our regulatory strategy. Therefore, we no longer anticipate the approval of ACURATE Prime in the U.S. in 2024. Additionally, in alignment with the FDA, we are suspending enrollment in the single-arm continued access study while continuing to enroll in the randomized extended durability cohort. We expect to have more information in the second half of 2024 following the full data review.

在ACURATE neo2 在歐洲的表現的帶動下，我們的結構性心臟瓣膜特許經營權在第四季度和全年均實現了兩位數增長，迄今為止，我們已在全球範圍內使用ACURATE 技術治療了70,000多名患者。展望未來，我們預計 ACURATE Prime 將於 2025 年在歐洲獲得批准。然而，在審查了計劃對美國 ACURATE IDE 數據進行的中期分析後，我們現在將等待來自 1,500 名患者的 RCT 隊列的完整 1 年數據確定我們的監管策略。因此，我們不再預期 ACURATE Prime 將於 2024 年在美國獲得批准。此外，根據 FDA 的規定，我們暫停單臂持續訪問研究的招募，同時繼續參加隨機延長耐久性隊列。我們預計在全面數據審核後將在 2024 年下半年獲得更多資訊。

WATCHMAN sales grew 23% organically versus fourth quarter '22 and 25% on a full year basis. Q4 finished with record sales and strong utilization in all major markets, we have now treated over 400,000 patients globally with the WATCHMAN technology. U.S. Q4 growth of 23% was supported by the breadth of the portfolio and the initial launch of WATCHMAN FLX Pro, which we expect to move into full launch in the first quarter. We continue to expand the breadth of clinical evidence supporting this technology and are pleased with the pace of enrollment within our post-market HEAL-LAA trial, including our newly added cohort, which is studying in WATCHMAN FLX Pro and underrepresented patient populations. We also look forward to initiating our monotherapy trial, SIMPLIFY trial later this year, which will study WATCHMAN FLX Pro with a simplified post-implant drug regimen.

與 22 年第四季相比，《WATCHMAN》的銷售額有機成長了 23%，全年銷售額成長了 25%。第四季在所有主要市場均創下了創紀錄的銷售額和強勁的利用率，目前我們已使用 WATCHMAN 技術在全球治療了超過 40 萬名患者。美國第四季 23% 的成長得益於產品組合的廣度和 WATCHMAN FLX Pro 的首次推出，我們預計該產品將在第一季全面推出。我們繼續擴大支持該技術的臨床證據的廣度，並對我們的上市後HEAL-LAA 試驗的入組速度感到滿意，包括我們新添加的隊列，該隊列正在WATCHMAN FLX Pro 和代表性不足的患者群體中進行研究。我們也期待在今年稍後啟動我們的單一療法試驗 SIMPLIFY 試驗，該試驗將透過簡化的植入後藥物治療方案來研究 WATCHMAN FLX Pro。

Cardiac Rhythm Management sales grew 5% organically versus Q4 '22 and on a full year basis grew 6% organically versus '22. On a full year basis, our Diagnostics franchise grew double digits, outpacing market growth driven by broad portfolio and ongoing investments in innovation. In Core CRM, in both fourth quarter and on a full year basis, our high-voltage business grew low single digits and our low-voltage business grew mid-single digits. 2023 performance was driven by our differentiated high-voltage portfolio and shock polarity options. As we look ahead, we expect our Core CRM growth to be in line with the market performance in '24.

心律管理銷售額與 22 年第四季相比有機成長 5%，與 22 年全年有機成長 6%。全年來看，我們的診斷業務成長了兩位數，在廣泛的產品組合和持續創新投資的推動下超過了市場成長。在核心 CRM 領域，無論是第四季或全年，我們的高壓業務均實現低個位數成長，低壓業務實現中個位數成長。 2023 年的業績是由我們差異化的高壓產品組合和衝擊極性選項所推動的。展望未來，我們預期核心 CRM 的成長將與 24 年的市場表現保持一致。

Turning to Electrophysiology. Sales grew 43%, both operationally and organically versus fourth quarter '22 and the full year basis grew 37% operationally and 33% organically versus '22. U.S. fourth quarter sales grew 40% organically driven by our POLARx launch and ongoing win with our Access Solutions portfolio. Our international EP growth accelerated in the fourth quarter growing 46% organically, fueled by improved FARAPULSE console supply, and we now have treated over 40,000 patients globally with the FARAPULSE technology to date. And with the news this morning that we received FDA approval for FARAPULSE, we are thrilled to enter the U.S. market immediately.

轉向電生理學。與 22 年第四季相比，銷售額在營運和有機方面均成長了 43%，與 22 年第四季相比，全年銷售額成長了 37%，有機成長 33%。由於我們推出 POLARx 以及我們的接取解決方案組合不斷取得勝利，美國第四季銷售額成長了 40%。在 FARAPULSE 控制台供應改善的推動下，我們的國際 EP 成長在第四季度加速成長 46%，迄今為止，我們已經在全球範圍內使用 FARAPULSE 技術治療了 40,000 多名患者。今天早上我們收到 FDA 批准 FARAPULSE 的消息後，我們很高興能夠立即進入美國市場。

We continue to invest in clinical evidence to study new indications and support access to our FARAPULSE technology. Late last year, we initiated the AVANT GUARD trial to evaluate the safety and efficacy of the system as a first-line treatment for persistent AF compared to anti-arrhythmic drug therapy. Additionally, a real-world data was presented at AHA for more than 17,000 patients treated with FARAPULSE in the MANIFEST-17K registry, which reinforced the real-world safety profile of the FARAPULSE platform, with no reports of permanent phrenic nerve palsy or pulmonary vein stenosis, or esophageal injury and an overall major adverse rate -- event rate of less than 1%. We're excited to bring this innovative technology to more markets and expect approval of FARAPULSE in Japan -- China and Japan, likely in the second half of this year.

我們繼續投資臨床證據來研究新的適應症並支持使用我們的 FARAPULSE 技術。去年年底，我們啟動了 AVANT GUARD 試驗，以評估該系統作為持續性心房顫動一線治療與抗心律不整藥物治療相比的安全性和有效性。此外，在AHA 上，MANIFEST-17K 註冊表中還提供了超過17,000 名接受FARAPULSE 治療的患者的真實世界數據，這增強了FARAPULSE 平台的真實世界安全性，沒有關於永久性麻痺或肺靜脈麻痺的報告狹窄或食道損傷以及整體主要不良發生率－事件發生率低於 1%。我們很高興能夠將這項創新技術推向更多市場，並預計 FARAPULSE 可能會在今年下半年在日本（中國和日本）獲得批准。

In closing, I'm very proud of our global team, what we are able to accomplish in '23, resulting in full year organic sales growth of 12% and adjusted EPS growth of 20%. We're excited about the year ahead and remain focused on our talent and sustaining the culture that's motivated to drive differentiated performance and achieve our long-range plan goals. Those goals as a reminder, are sales an average of 8% to 10% over the 3-year period while expanding adjusted operating margin by 150 basis points, including double-digit adjusted EPS growth and improvement of our free cash flow conversion to approximately 70% in 2026.

最後，我為我們的全球團隊感到非常自豪，我們在 23 年所取得的成就，導致全年有機銷售額成長 12%，調整後每股收益成長 20%。我們對未來的一年感到興奮，並將繼續專注於我們的人才和維持推動差異化績效和實現我們長期計劃目標的文化。提醒一下，這些目標是在3 年內平均銷售額增長8% 至10%，同時將調整後的營業利潤率擴大150 個基點，包括兩位數的調整後每股收益增長以及將我們的自由現金流轉換率提高至約70 2026 年的百分比。

With all of that, I'll pass it over to Dan to provide more details on the financials.

完成所有這些後，我會將其轉交給 Dan，以提供有關財務狀況的更多詳細資訊。

Thanks, Mike. Fourth quarter 2023 consolidated revenue of $3.725 billion represents 14.9% reported growth versus fourth quarter 2022 and includes a 40-basis-point tailwind from foreign exchange, in line with our expectations. Excluding this $12 million tailwind from foreign exchange, operational revenue growth was 14.5% in the quarter. Sales from closed acquisitions and divestitures contributed 90 basis points resulting in 13.6% organic revenue growth, exceeding our guidance range of 8% to 10%. Q4 2023 adjusted earnings per share of $0.55 grew 24% versus 2022, exceeding the high end of our guidance range of $0.49 to $0.52 primarily driven by our strong sales performance.

謝謝，麥克。 2023 年第四季合併收入為 37.25 億美元，較 2022 年第四季報告成長 14.9%，其中包括外匯帶來的 40 個基點的推動力，符合我們的預期。排除這 1,200 萬美元的外匯推動因素，本季營運收入成長 14.5%。已完成收購和資產剝離的銷售額貢獻了 90 個基點，實現了 13.6% 的有機收入成長，超出了我們 8% 至 10% 的指導範圍。 2023 年第四季調整後每股收益為 0.55 美元，與 2022 年相比增長 24%，超出了我們指導範圍 0.49 美元至 0.52 美元的上限，這主要是由於我們強勁的銷售業績所致。

For the full year 2023 consolidated revenue of $14.240 billion represents 12.3% reported revenue growth versus full year 2022 and includes an 80-basis-point headwind from foreign exchange, again, in line with our expectations. Excluding this $104 million headwind from foreign exchange, operational revenue growth for the year was 13.1%. Sales from closed acquisitions and divestitures contributed 80 basis points resulting in 12.3% organic revenue growth, exceeding our guidance range of approximately 11%.

2023 年全年合併收入為 142.4 億美元，較 2022 年全年報告收入增長 12.3%，其中包括 80 個基點的外匯阻力，這再次符合我們的預期。排除外匯帶來 1.04 億美元的阻力，全年營運收入成長 13.1%。完成的收購和資產剝離帶來的銷售額貢獻了 80 個基點，實現了 12.3% 的有機收入成長，超出了我們約 11% 的指導範圍。

Full year 2023 adjusted earnings per share of $2.05 grew 20% versus 2022, exceeding the high end of our guidance range of $1.99 to $2.02. Adjusted gross margin for the fourth quarter was 70.4% resulting in full year 2023 adjusted gross margin of 70.7%, in line with our expectations and representing a 20-basis-point improvement versus full year 2022, inclusive of a 220-basis-point headwind from foreign exchange.

2023 年全年調整後每股收益為 2.05 美元，較 2022 年增長 20%，超出了我們 1.99 美元至 2.02 美元指導範圍的上限。第四季調整後毛利率為 70.4%，2023 年全年調整後毛利率為 70.7%，符合我們的預期，比 2022 年全年提高 20 個基點，其中包括 220 個基點的逆風來自外匯。

In 2024, we expect a mix benefit from our new launches with offsetting headwinds from FX and the incremental investment in our manufacturing capacity and as a result, we anticipate our full year 2024 adjusted gross margin will be at or slightly below our full year 2023 rate. Fourth quarter adjusted operating margin was 26.6% resulting in a full year 2023 adjusted operating margin of 26.3%, improving 70 basis points versus 2022. We expect to expand adjusted operating margin in 2024 by another 30 to 50 basis points balancing progress towards our long-range plan goal of 150 basis points over the 3 years 2024 to 2026 with flexibility for critical investments to support key launches. On a GAAP basis, the fourth quarter operating margin was 15.7%, resulting in a full year reported operating margin of 16.5%.

到2024 年，我們預計新產品的推出將帶來綜合效益，抵消外匯帶來的不利因素以及對製造能力的增量投資，因此，我們預計2024 年全年調整後毛利率將等於或略低於2023 年全年水準。第四季調整後營業利益率為26.6%，導致2023 年全年調整後營業利益率為26.3%，比2022 年提高70 個基點。我們預計2024 年調整後營業利潤率將再擴大30 至50 個基點，以平衡我們長期業務的進展。2024 年至 2026 年 3 年間，範圍計劃目標為 150 個基點，並可靈活進行關鍵投資以支持關鍵產品的推出。以 GAAP 計算，第四季營業利潤率為 15.7%，全年報告營業利潤率為 16.5%。

Moving to below the line, fourth quarter adjusted interest and other expenses totaled $79 million, resulting in full year adjusted interest and other expense of $331 million, in line with our expectations. On an adjusted basis, our tax rate for the fourth quarter was 10% and 11.2% for the full year 2023, including favorable discrete tax items and the benefit from stock compensation accounting. Our operational tax rate was 14.6% for the fourth quarter and 13.9% for the full year, again, in line with expectations.

線下，第四季調整後利息和其他費用總計 7,900 萬美元，全年調整後利息和其他費用為 3.31 億美元，符合我們的預期。調整後，我們第四季的稅率為 10%，2023 年全年的稅率為 11.2%，其中包括有利的離散稅收項目和股票補償會計的好處。我們第四季的營業稅率為 14.6%，全年營業稅率為 13.9%，再次符合預期。

Fully diluted weighted average shares outstanding ended at 1.477 billion shares in Q4 and 1.464 billion shares for full year 2023. Free cash flow for the quarter was $718 million, with $984 million from operating activities, less $267 million of net capital expenditures. Excluding special items, adjusted free cash flow was $913 million. Full year 2023 cash flow was $1.8 billion, and adjusted free cash flow was $2.5 billion both in line with expectations.

第四季完全稀釋加權平均已發行股數為14.77 億股，2023 年全年為14.64 億股。該季度自由現金流為7.18 億美元，其中9.84 億美元來自經營活動，減去2.67 億美元淨資本支出。不包括特殊項目，調整後自由現金流為 9.13 億美元。 2023 年全年現金流為 18 億美元，調整後自由現金流為 25 億美元，皆符合預期。

For 2024, we expect full year free cash flow to be in excess of $2 billion, which includes approximately $800 million of expected payments related to acquisitions, restructuring, litigation and other special items. As of December 31, 2023, we had cash on hand of $865 million and our gross debt leverage was 2.3x. We expect to fund the Axonics acquisition through a mix of cash on hand and new debt, which will be determined prior to or at the time of close. Our top capital allocation priority remains strategic tuck-in M&A followed by annual share repurchases to offset dilution from employee stock grants.

到 2024 年，我們預計全年自由現金流將超過 20 億美元，其中包括與收購、重組、訴訟和其他特殊項目相關的預計付款約 8 億美元。截至 2023 年 12 月 31 日，我們手頭現金為 8.65 億美元，總負債槓桿率為 2.3 倍。我們預計透過手頭現金和新債務的組合為 Axonics 收購提供資金，這將在交易完成之前或完成時確定。我們的首要資本配置優先事項仍然是策略性併購，然後是年度股票回購，以抵消員工股票授予帶來的稀釋。

Our legal reserve was $377 million as of December 31, a decrease of $30 million versus the prior quarter, $108 million of this reserve is already funded through our qualified settlement funds.

截至 12 月 31 日，我們的法定準備金為 3.77 億美元，比上一季減少 3,000 萬美元，其中 1.08 億美元的準備金已透過我們的合格結算基金提供資金。

Now I'll walk through guidance for the first quarter and the full year 2024. We expect full year 2024 reported revenue growth to be in a range of 8.5% to 9.5% versus 2023, excluding an approximate 50-basis-point headwind from foreign exchange, based on current rates, we expect full year 2024 operational revenue growth to be 9% to 10%, excluding a 100-basis-point contribution from closed acquisitions, we expect full year 2024 organic revenue growth to be in a range of 8% to 9% versus 2023.

現在我將介紹 2024 年第一季和全年的指引。我們預計 2024 年全年報告的收入增長將比 2023 年在 8.5% 至 9.5% 之間，不包括來自外國的大約 50 個基點的阻力換言之，根據目前匯率，我們預計2024 年全年營業收入成長率為9% 至10%，排除已完成收購帶來的100 個基點貢獻，我們預計2024 年全年有機收入成長率將在8% 範圍內與2023 年相比，下降% 至9%。

We expect first quarter 2024 reported revenue growth to be in a range of 7.5% to 9.5% versus first quarter 2023, excluding an approximate 100-basis-point headwind from foreign exchange based on current rates, we expect first quarter 2024 operational growth to be 8.5% to 10.5%, excluding a 150-basis-point contribution from closed acquisitions, we expect first quarter 2024 organic revenue growth to be in a range of 7% to 9% versus Q1 2023. We expect our full year 2024 adjusted below-the-line expenses to be approximately $330 million.

我們預計 2024 年第一季報告的營收成長將較 2023 年第一季在 7.5% 至 9.5% 之間，排除根據目前匯率約 100 個基點的外匯阻力，我們預期 2024 年第一季的營運成長為8.5％至10.5％，不包括已完成收購的150個基點貢獻，我們預計2024年第一季的有機收入增長將比2023年第一季在7％至9％之間。我們預計2024年全年調整如下：線路費用約為 3.3 億美元。

Under current legislation, including enacted laws and issued guidance under OECD Pillar Two rules, we forecast a full year 2024 operational tax rate of approximately 14% and an adjusted tax rate of approximately 13%. We continue to monitor tax legislation globally, including the currently drafted law to partially repeal U.S. R&D capitalization. If the law were to be passed as currently proposed we would expect a tailwind of approximately 100 basis points to our operational tax rate in 2024.

根據現行立法，包括根據經合組織第二支柱規則頒布的法律和發布的指南，我們預測 2024 年全年營業稅率約為 14%，調整後稅率約為 13%。我們繼續監控全球稅收立法，包括目前起草的部分廢除美國研發資本化的法律。如果該法律按照目前的提案獲得通過，我們預計 2024 年的營業稅率將提高約 100 個基點。

We expect full year adjusted earnings per share to be in a range of $2.23 to $2.27 representing 9% to 11% growth versus 2023, including an approximate $0.04 headwind from foreign exchange at current rates and existing hedging contracts, which will be recognized ratably through the year. We expect first quarter adjusted earnings per share to be in a range of $0.50 to $0.52. For more information, please check our Investor Relations website for Q4 2023 financial and operational highlights which outlines more details on Q4 and full year results and 2024 guidance.

我們預計全年調整後每股收益將在2.23 美元至2.27 美元之間，較2023 年增長9% 至11%，其中包括按當前匯率和現有對沖合約計算的外匯帶來的約0.04 美元的阻力，這將通過年。我們預計第一季調整後每股收益將在 0.50 美元至 0.52 美元之間。欲了解更多信息，請查看我們的投資者關係網站，了解 2023 年第四季度的財務和運營亮點，其中概述了有關第四季度和全年業績以及 2024 年指導的更多詳細信息。

In closing, I'm very proud of our 2023 performance and look forward to executing on our 2024 guidance of 8% to 9% organic revenue growth, 30 to 50 basis points of adjusted operating margin expansion and adjusted EPS growth of 9% to 11%.

最後，我對我們2023 年的業績感到非常自豪，並期待執行2024 年有機收入增長8% 至9%、調整後營業利潤率擴張30 至50 個基點以及調整後每股收益增長9% 至11 個基點的指導%。

Before I turn it back over to Lauren for the Q&A, I wanted to provide a quick update. A key part of our talent strategy is moving high potential individuals throughout the company to give them a broad set of experiences. As part of this, effective March 1, Lauren Tengler will become the Global Controller for our Urology business unit providing financial leadership to the global business. And importantly, playing a key role in the integration of the Axonics business. Lauren previously spent many years within our Urology business, making her uniquely qualified for this opportunity.

在我將其轉回勞倫進行問答之前，我想提供一個快速更新。我們人才策略的關鍵部分是在整個公司內調動高潛力人才，為他們提供廣泛的經驗。作為該計劃的一部分，自 3 月 1 日起，Lauren Tengler 將成為我們泌尿科業務部門的全球財務總監，為全球業務提供財務領導。重要的是，在 Axonics 業務整合中發揮關鍵作用。勞倫之前在我們的泌尿科業務領域工作了多年，這使她有資格獲得這個機會。

Following Lauren's transition, Jon Monson, currently our Chief Accounting Officer, will move to our Investor Relations function, leading (inaudible) and the rest of the team. I know the investment community will join me in thanking Lauren for her leadership and contributions and in welcoming Jon to the role.

勞倫調任後，現任首席會計官喬恩·蒙森 (Jon Monson) 將調任投資者關係職能部門，領導（聽不清楚）和團隊其他成員。我知道投資界將與我一起感謝勞倫的領導和貢獻，並歡迎喬恩擔任這一職位。

With that, I'll turn it back to Lauren, who will moderate the Q&A.

接下來，我會將其轉回勞倫，他將主持問答。

Thanks so much, Dan. Drew, let's open it up to questions for the next 30 minutes or so. (Operator Instructions) Drew, please go ahead.

非常感謝，丹。德魯，讓我們在接下來的 30 分鐘左右的時間內開放提問。 （操作員指示）德魯，請繼續。

(Operator Instructions) The first question comes from Robbie Marcus with JPMorgan.

（操作員說明）第一個問題來自摩根大通的 Robbie Marcus。

Great. Congrats on a really good quarter. And congratulations, Lauren, on the promotion. Wanted to ask on two of the biggest product drivers in 2024, WATCHMAN and FARAPULSE. FARAPULSE got approval today. Wanted to see what's included in guidance for this year? And how to think about phasing over the year? How long will it take to get into hospitals and approved on formularies? And then second on WATCHMAN, look, still had a very good quarter in fourth quarter, but growth slowed a little bit. How should we be thinking about the potential for WATCHMAN and 20% plus growth in 2024?

偉大的。恭喜您度過了一個非常好的季度。恭喜勞倫升職。想詢問 2024 年兩個最大的產品驅動因素：WATCHMAN 和 FARAPULSE。 FARAPULSE 今天獲得批准。想了解今年的指南包含哪些內容？以及如何考慮年內分階段進行？進入醫院並獲得處方集批准需要多長時間？然後看第二個守望者，第四季仍然有一個非常好的季度，但成長有點放緩。我們應該如何看待 WATCHMAN 的潛力以及 2024 年 20% 以上的成長？

Sure. Thanks, Robbie, for the comments. I'll start with WATCHMAN. It's just an excellent platform. With growth of 23% for the quarter, 25% for the full year, terrific work. And as you know, that product gets larger and larger for us. I had to cut the script back because the clinical investments we're making with WATCHMAN go on for a while, and we can touch on those if interested. But as you know, we continue to exceed likely 90% share in the U.S. We'll be rolling out WATCHMAN FLX Pro, more as a percent of our total mix in the U.S. in the first quarter and throughout the year. So you continue to see that, which is a differentiated platform. So with the clinical work that we're doing and the WATCHMAN FLX Pro and the [sterilizable sheet] likely to be in the market in 2024 as well. We continue to expect to gain share, and we aim to significantly widen the market opportunity through this clinical trial. So full steam ahead with WATCHMAN.

當然。謝謝羅比的評論。我將從守望者開始。這只是一個絕佳的平台。本季成長 23%，全年成長 25%，非常出色。如您所知，該產品對我們來說變得越來越大。我不得不削減劇本，因為我們對《守望者》的臨床投資會持續一段時間，如果有興趣的話我們可以接觸一下。但如您所知，我們在美國的份額可能會繼續超過 90%。我們將推出 WATCHMAN FLX Pro，第一季和全年將占我們在美國總份額的百分比。所以你繼續看到，這是一個差異化的平台。因此，根據我們正在進行的臨床工作，WATCHMAN FLX Pro 和 [可消毒床單] 也可能在 2024 年上市。我們繼續期望獲得份額，我們的目標是透過這項臨床試驗顯著擴大市場機會。與 WATCHMAN 一起全力以赴。

On FARAPULSE, maybe the most exciting day I've had in my career at Boston Scientific with this platform that we have based on the results that we've seen in Europe and the enthusiasm globally for our PFA platform and to receive approval today was really exciting. We did anticipate a first quarter approval for FARAPULSE. And as you might expect, we expect to impact FARAPULSE to be somewhat in the first quarter and much more significant as the year goes on as we work with contracting with hospitals, getting on contract and getting the capital approved and rolling it out. But we have a lot of experience in doing that through our European success that we've enjoyed. Our team is trained. We have (inaudible) team. We continue to invest in it. So we're really excited about aiming to disrupt the EP market with what we think is the premier PFA platform.

在FARAPULSE 上，也許是我在波士頓科學公司職業生涯中最激動人心的一天，我們基於我們在歐洲看到的結果以及全球對我們的PFA 平台的熱情而建立了這個平台，今天獲得批准真是太棒了令人興奮。我們確實預計 FARAPULSE 第一季會獲得批准。正如您所預料的那樣，我們預計對FARAPULSE 的影響在第一季度會有所影響，隨著時間的推移，隨著我們與醫院簽訂合約、簽訂合約、獲得資本批准並推出它，影響會更加顯著。但透過我們在歐洲的成功，我們在這方面擁有豐富的經驗。我們的團隊經過訓練。我們有（聽不清楚）團隊。我們繼續對其進行投資。因此，我們非常高興能夠透過我們認為最重要的 PFA 平台來顛覆 EP 市場。

The next question comes from Joanne Wuensch with Citi.

下一個問題來自花旗銀行的 Joanne Wuensch。

I don't want to leave FARAPULSE quite yet, and I suspect there will be a lot of questions on it this call. But if you're looking for China and Japan approval in the second half of '24, could you sort of outline what you think those opportunities may be? And then can you just give a quick highlight on some of the sort of higher profile cardiology companies such as POLAR and AGENT?

我還不想完全離開 FARAPULSE，而且我懷疑這次通話中會有很多問題。但如果您希望在 24 年下半年獲得中國和日本的批准，您能否概述一下您認為這些機會可能是什麼？那麼您能否快速介紹一下一些知名度較高的心臟科公司，例如 POLAR 和 AGENT？

Yes. So, Ken can help me out. But obviously, China and Japan represent significant opportunities in the EP market. They're the largest markets that we compete in, in those countries, and we currently are under scale, particularly in China. In Japan, we've built a lot of momentum over the last, call it, 18 months with our POLARx launch. So in Japan, that grew, I don't know, I think over 40% our EP business. And so we have a more scaled commercial team capabilities in Japan and the eventual approval in the second half of this year in Japan with FARAPULSE will really be the next leg of the growth stool in Japan for us.

是的。所以，肯可以幫助我。但顯然，中國和日本代表EP市場的重大機會。在這些國家，它們是我們競爭的最大市場，而我們目前的規模還不夠，特別是在中國。在日本，我們在過去 18 個月內透過 POLARx 的推出建立了巨大的動力。所以在日本，我不知道，我認為我們的 EP 業務成長了 40% 以上。因此，我們在日本擁有更大規模的商業團隊能力，今年下半年 FARAPULSE 最終在日本獲得批准，這將真正成為我們在日本成長的下一站。

So a lot of confidence there, the market in China may be even bigger. We're a bit more underscaled in China. So we'll be making a lot of investments there. We have a brand-new leader. We're excited about in China. It's around our EP business under June Chang, so we'll be making additional commercial investments, clinical investments and hope to have approval in the second half of the year in China. So those will be nice growth drivers for us in '24 more significant in 2025.

所以大家信心十足，中國的市場可能會更大。我們在中國的規模有點小。所以我們將在那裡進行大量投資。我們有一位全新的領導者。我們對中國感到興奮。這是圍繞著 June Chang 領導下的 EP 業務展開的，因此我們將進行額外的商業投資和臨床投資，並希望在今年下半年在中國獲得批准。因此，這些將成為我們 24 世紀良好的成長動力，到 2025 年更為重要。

And AGENT, Ken, do you want to comment a bit more on FARAPULSE? Dr. Stein?

特務 Ken，您想對 FARAPULSE 發表更多評論嗎？斯坦博士？

I'd love to comment on FARAPULSE. Again, it is a very exciting day. Joanne, in terms of questions specifically about Japan and China, right? I think we got to realize, I mean, AFib is a global disease. I hate to use the word pandemic, but it is pandemic. Now -- and we're really pleased about the strength of the clinical trial data that we have as well as the commercial experience in Europe with, as Mike said, greater than 40,000 patients already treated to date. And it's that strength of the clinical data, right, that led us to the really, I think, rapid approval that we got from the FDA and that has led us to update our anticipated approval times, both in Japan and China. Again, I think having said that, we look to those approvals in the second half. So I don't think we're going to expect to really see too much material out of that until we get into 2025, but they are both large and important markets and large and important patient populations that are currently really very much underserved in terms of access to ablation technology.

我很想對 FARAPULSE 發表評論。再說一遍，這是非常激動人心的一天。喬安妮，關於日本和中國的問題，對吧？我認為我們必須意識到，我的意思是，心房顫動是一種全球性疾病。我討厭使用流行病這個詞，但它確實是流行病。現在，我們對我們擁有的臨床試驗數據的強度以及歐洲的商業經驗感到非常高興，正如麥克所說，迄今為止已經有超過 40,000 名患者接受了治療。我認為，正是臨床數據的力量使我們獲得了 FDA 的真正快速批准，並導致我們更新了日本和中國的預期批准時間。再說一次，我認為話雖如此，我們期待下半年獲得這些批准。因此，我認為在進入 2025 年之前，我們不會真正看到太多的材料，但它們都是龐大而重要的市場，以及龐大而重要的患者群體，目前在服務方面確實非常不足。獲得消融技術的機會。

The next question comes from Larry Biegelsen with Wells Fargo.

下一個問題來自富國銀行的拉里·比格爾森。

Congrats on a strong finish here and the approval of FARAPULSE in the U.S. On FARAPULSE, can you talk about the manufacturing capacity for the catheter and console upon launch? And expectations for the EP business this year, you grew 43% in Q4 '23. Any reason why growth would be lower in '24? And I have to ask you to please clarify your comments around ACURATE neo2, it sounds like something happened with Prime, which is the larger size, what are the implications for the other sizes of neo2 in Europe and the U.S.?

恭喜FARAPULSE在這裡取得了優異的成績，並在美國獲得了批准。在FARAPULSE上，您能談談推出後導管和控制台的製造能力嗎？今年 EP 業務的預期在 23 年第 4 季成長了 43%。 24 年成長會放緩的原因是什麼？我必須請你澄清一下你對 ACURATE neo2 的評論，聽起來好像 Prime 發生了一些事情，它是更大的尺寸，對歐洲和美國其他尺寸的 Neo2 有什麼影響？

Thanks, Larry. Starting with FARAPULSE. Really very proud of the global supply chain team and what they've done over the past 18 months in the FARAPULSE group that we recently acquired a while ago. But they've done a tremendous in building the capabilities to supply this for the U.S. launch and to expand in Europe and eventually Asia, as we just highlighted. So we are now significantly improved our catheter and console supply. We opened numerous centers in Europe in the fourth quarter and we're ready to go. So we, at this point, don't anticipate supply being an issue to continue to support Europe or to facilitate the U.S. launch, given the capabilities and investments that we've made and approvals to manufacture in multiple locations. So great work by the supply chain team, and we're ready to launch this in the U.S.

謝謝，拉里。從 FARAPULSE 開始。對於我們不久前收購的 FARAPULSE 集團的全球供應鏈團隊以及他們在過去 18 個月中所做的一切感到非常自豪。但正如我們剛才強調的那樣，他們在建立能力方面付出了巨大努力，為美國的發射提供這種能力，並在歐洲乃至亞洲進行擴張。因此，我們現在顯著改善了導管和控制台的供應。我們在第四季度在歐洲開設了許多中心，我們已經準備好了。因此，考慮到我們已經進行的能力和投資以及在多個地點製造的批准，我們預計供應不會成為繼續支持歐洲或促進美國上市的問題。供應鏈團隊的工作非常出色，我們已準備好在美國推出此產品

On ACURATE neo2, as I mentioned in the earnings script, maybe just 2 overall points, we continue to do very well with ACURATE neo2 in Europe. Implanting, I think the number is 70,000 and continue to grow faster than the market in Europe. And we are on track for what we have is called Prime in Europe in 2025. So that continues to move forward as planned.

在 ACURATE neo2 上，正如我在收益腳本中提到的，也許總體上只有 2 個點，我們在歐洲的 ACURATE neo2 方面繼續表現出色。植入，我認為這個數字是70,000，並且繼續比歐洲市場增長得更快。我們正朝著 2025 年歐洲 Prime 的目標邁進。所以這將繼續按計劃向前推進。

With respect to the trial, as I mentioned in the script, based on the interim analysis, we now need to wait for the full 1-year follow-up of 1,500 patients. And as a result of that, we don't -- we will not be receiving approval for ACURATE neo in 2024, and we will wait until likely near the end of 2024 for the full readout of the ACURATE IDE study to determine our path forward.

關於試驗，正如我在腳本中提到的，根據中期分析，我們現在需要等待對 1,500 名患者進行 1 年的完整追蹤。因此，我們不會——我們不會在 2024 年獲得 ACURATE neo 的批准，我們將等到 2024 年年底，以獲得 ACURATE IDE 研究的完整結果，以確定我們的前進道路。

Congrats, Lauren.

恭喜，勞倫。

Thanks, Larry.

謝謝，拉里。

The next question comes from Vijay Kumar with Evercore ISI.

下一個問題來自 Evercore ISI 的 Vijay Kumar。

Congrats on a really strong finish year. Maybe just one on the guidance here, perhaps for Dan. Dan, the 8% to 9%, it looks like FARAPULSE, the prior guide assumed a back half launch. It's coming in a little bit ahead. Can you just walk us through that 8% to 9%? Is that right that FARAPULSE perhaps assumptions have changed? Any impact from VBP or days impact that we should be aware of? And what are you assuming for pricing in fiscal '24?

祝賀今年取得了非常強勁的成績。也許只是這裡的指導，也許是給丹的。 Dan，8% 到 9%，看起來像 FARAPULSE，先前的指引假設是後半發射。它會提前一點。能為我們介紹一下 8% 到 9% 的情況嗎？ FARAPULSE 的假設是否已經改變了？我們應該注意 VBP 或天數影響的任何影響嗎？您對 24 財年的定價有何假設？

Sure. So the VBP assumptions are the same as they've always been, really no change there. As you saw in December when we issued the press release on AVANT GUARD, we moved up the timing of expected FARAPULSE launch to Q1. So we've been anticipating Q1 launch and that 8% to 9% full year and the 7% to 9% for the first quarter in terms of revenue growth contemplated a Q1 approval of FARAPULSE. As Mike said, there's probably some contribution in Q1, but more of that contribution comes in Q2 to Q4. So the 8% to 9% has that contemplated in the overall guide. And then pricing. So what I would say on pricing is we were basically flat in 2023 and the goal is to be flat again in 2024. So likely no impact would be the goal in 2024 versus 2023.

當然。因此，VBP 假設與以往相同，實際上沒有任何變化。正如您在 12 月發布有關 AVANT GUARD 的新聞稿時所看到的，我們將 FARAPULSE 的預計發佈時間提前到了第一季。因此，我們一直預計第一季的推出以及全年 8% 至 9% 的營收成長和第一季 7% 至 9% 的營收成長預期 FARAPULSE 在第一季度獲得批准。正如麥克所說，第一季可能有一些貢獻，但更多的貢獻來自第二季到第四季。因此，總體指南中考慮了 8% 到 9% 的人。然後定價。因此，關於定價，我想說的是，我們在 2023 年基本上持平，目標是在 2024 年再次持平。因此，與 2023 年相比，2024 年的目標可能不會產生任何影響。

Sorry, on days, Dan. Any days impact here?

抱歉，這幾天，丹。這裡有幾天影響嗎？

No, all the days, there's a lot of -- obviously, a lot of noise and days around the world through the year. It's all contemplated in guidance, all in the 8% to 9% for the full year.

不，在所有的日子裡，一年中世界各地都有很多——顯然，很多噪音和日子。這一切都在指導中進行了考慮，全年都在 8% 到 9% 的範圍內。

The next question comes from Danielle Antalffy with UBS.

下一個問題來自瑞銀集團的 Danielle Antalffy。

Just a follow-up question on ACURATE neo2, Mike, if I could. So appreciate the comments that you did provide. Just curious, I mean, obviously, you're giving pretty strong guidance here for 2024. I mean is the right read here that regardless of what happens with ACURATE neo2 and timing there, you're sticking to your long-term sales growth guidance that you provide back in September. And sort of how do we think about this as a long-term growth contributor now given this little wrinkle here? And Lauren, we will miss you very much.

麥克，如果可以的話，我想問一個關於 ACURATE neo2 的後續問題。感謝您提供的評論。只是好奇，我的意思是，顯然，您在這裡為2024 年提供了相當強有力的指導。我的意思是，這裡的正確解讀是，無論ACURATE neo2 發生什麼情況以及時機，您都會堅持長期銷售增長指導您在九月提供的。考慮到這裡的這個小問題，我們如何看待它作為長期成長貢獻者？勞倫，我們會非常想念你。

Lauren is not leaving the company. She will be around. You're probably going to see her...

勞倫不會離開公司。她會在身邊。你可能會見到她...

We won't get to see her, so...

我們見不到她了，所以…

I'll work my way in.

我會努力進去的。

Okay. We'll work her way in, once in a while. We're excited for Jon to come in and Lauren to move out. No, no, I'm excited for Lauren to go to Urology.

好的。我們會時不時地幫她進去。我們很高興喬恩進來，勞倫搬出去。不，不，我很高興勞倫去泌尿科。

Yes. So to answer your question, we are fully committed to the 8% to 10% organic growth CAGR over the '24 to '26 period that we provided at Investor Day, absolutely no change in that outlook. And pleased with the '23 performance, as you know, where we grew 12%. So absolutely no change to those financial goals.

是的。因此，為了回答你的問題，我們完全致力於我們在投資者日提供的 24 至 26 年間 8% 至 10% 的有機複合年增長率，這一前景絕對沒有變化。如您所知，我們對 23 年的業績感到滿意，成長了 12%。因此，這些財務目標絕對不會改變。

ACURATE continues to do well in Europe. It's a product that's used every day by many European physicians, and we're excited about getting the larger size approved there. We are disappointed that we didn't get ACURATE over the goal line for approval in 2024. So at this point, we need to wait until the full data sets have been followed up for a year and read out likely for the end of this year in 2024, and we'll take it from there in terms of the U.S. launch. But we are disappointed we're not going to launch that really very end of this year and into the next. But absolutely no change to our financial guidance that we gave at Investor Day.

ACURATE 在歐洲繼續表現出色。這是許多歐洲醫生每天都使用的產品，我們很高興能在歐洲獲得更大尺寸的批准。我們感到失望的是，我們沒有在 2024 年獲得批准的準確目標線。因此，在這一點上，我們需要等到完整的數據集被追蹤一年，並可能在今年年底讀出2024 年，我們將從那時開始在美國推出。但令我們感到失望的是，我們不會在今年年底和明年推出這項服務。但我們在投資者日給予的財務指引絕對沒有改變。

Okay. Great. And also welcome, Jon. Sorry, I didn't mean to leave you out.

好的。偉大的。也歡迎，喬恩。抱歉，我不是故意要丟下你的。

Thanks, Danielle.

謝謝，丹妮爾。

The next question comes from Travis Steed with Bank of America.

下一個問題來自美國銀行的 Travis Steed。

Maybe one more follow-up on TAVR. Could you remind us what the interim look was? Was that just like a 6-month look at the data, now you need to wait for a 1-year data for the line to separate? I'm curious if you think what you saw in the interim look, are you still pretty confident that at 1 year, we could have a U.S. TAVR launch? Or does this put the whole U.S. TAVR launch at risk?

也許還有關於 TAVR 的後續行動。您能提醒我們臨時造型是什麼嗎？是不是就像看6個月的數據，現在要等1年的數據才能分線？我很好奇您是否認為您在中期觀察中看到的情況，您仍然對 1 年後我們可以在美國推出 TAVR 充滿信心嗎？或者這會讓整個美國 TAVR 的推出面臨風險？

All right. Are you able to hear us okay?

好的。你聽得到我們說話嗎？

Yes, I can hear you loud and clear.

是的，我可以清楚地聽到你的聲音。

Great. Dr. Sathananthan is our Chief Medical Officer, as you know, for ICTx and Structural Heart, maybe he could comment a bit.

偉大的。如您所知，Sathananthan 博士是我們 ICTx 和 Structural Heart 的首席醫療官，也許他可以發表一些評論。

Yes, I'll take the comment just about the data. So essentially, what happened in the trial was that as part of a planned interim analysis, we made the decision to await the full 1-year data. It is important just to note that the ACURATE IDE study is still an active clinical study with active clinical follow-up. And so as a result, we cannot disclose any data related to the trial at this time. We will expect, as Mike said, a readout of the study in the second half of 2024 following a full data review.

是的，我會接受有關數據的評論。因此，本質上，試驗中發生的情況是，作為計劃的中期分析的一部分，我們決定等待完整的一年數據。值得注意的是，ACURATE IDE 研究仍然是一項積極的臨床研究，並且有積極的臨床追蹤。因此，我們目前無法透露與試驗相關的任何數據。正如 Mike 所說，在全面的數據審查之後，我們預計將在 2024 年下半年公佈研究的結果。

The next question comes from Josh Jennings with TD Cowen.

下一個問題來自 TD Cowen 的 Josh Jennings。

Congratulations for a strong end of the year. I wanted to ask about the international cardiac ablation market. Boston has incredible fourth quarter, 40-plus percent growth, some of your competitors delivered really strong international growth in their Electrophysiology businesses as well. What's going on in the international market? I mean, are we seeing the promise of PFA driving market expansion this early? Or is there any pricing dynamics going on, but I think it's 20% almost market growth in internationally for cardiac ablation this year. Just wanted to get some details there and whether that could translate to PFA launches in the United States driving market expansion, which I think you guys have detailed in your Investor Day?

恭喜您在今年底取得了強勁的業績。我想問國際心臟消融市場。波士頓第四季實現了令人難以置信的 40% 以上的成長，您的一些競爭對手在其電生理學業務方面也實現了非常強勁的國際成長。國際市場正在發生什麼？我的意思是，我們這麼早就看到了 PFA 推動市場擴張的承諾嗎？或者是否有任何定價動態，但我認為今年國際心臟消融市場幾乎成長了 20%。只是想了解一些細節，以及這是否可以轉化為 PFA 在美國的推出，推動市場擴張，我想你們在投資者日已經詳細介紹了這一點？

Dr. Stein, do you want to take a shot at it?

史坦博士，你想嘗試嗎？

Yes, Josh. And thanks, Mike. I think it's a couple of factors here. And I don't think it's -- I don't know that I can parse out for you how much is getting contributed from each. But again, I think we just begin with the fact, right? That atrial fibrillation is an incredibly common arrhythmia. Again, as I said earlier, it is literally pandemic worldwide. I know, for instance, in the U.S., right? 1/4 of adults over the age of 40 will experience AFib at things in our live. And ablation even with legacy thermal technologies, things for us like StablePoint or POLARx is incredibly effective. It's more effective in drugs. But on a global scale, it is still really incredibly underpenetrated as a market. And much of the growth that you see really just reflects, I think, increasing realization in the cardiology community, the referring physician community about the relative efficacy and safety of all ablation technologies.

是的，喬許。謝謝，麥克。我認為這裡有幾個因素。我不認為——我不知道我能為你解析出每個人貢獻了多少。但我想我們還是從事實開始吧？心房顫動是一種極為常見的心律不整。正如我之前所說，它確實在全世界範圍內流行。我知道，例如在美國，對嗎？ 1/4 40 歲以上的成年人會在生活中遇到 AFib。即使使用傳統熱技術進行消融，StablePoint 或 POLARx 之類的技術對我們來說也非常有效。對藥物更有效。但在全球範圍內，它作為一個市場的滲透率仍然非常低。我認為，你所看到的大部分增長實際上只是反映了心臟病學界和轉診醫生界對所有消融技術的相對功效和安全性的認識不斷提高。

And then you layer on top of that the promise and the data with FARAPULSE, right? And FARAPULSE again takes a procedure that's already effective. It is at least as effective, it is clearly safer. And it's also much more efficient than thermal ablation. And so that enables Docs and medical centers to scale this out much better, right? And start to get into this underpenetrated population. So maybe a long-winded answer, but the short answer is, right? It's both a dramatically underpenetrated population to begin with. And then on top of that, you have the accelerated impact of FARAPULSE.

然後你用 FARAPULSE 將承諾和數據放在上面，對吧？ FARAPULSE 再次採用了已經有效的程序。它至少同樣有效，而且顯然更安全。而且它也比熱消融更有效。這使得醫生和醫療中心能夠更好地擴展這一點，對吧？並開始進入這個滲透率不足的人群。也許這是一個冗長的答案，但簡短的答案是，對嗎？首先，這兩個群體的滲透率都嚴重不足。最重要的是，FARAPULSE 的影響會加速。

The next question comes from Richard Newitter with Truist Securities.

下一個問題來自 Truist Securities 的 Richard Newitter。

Congrats on a really strong finish to the year. My first question is just going back to TAVR. At your Analyst Day, you had talked to an expectation and the level of confidence that you could disrupt that market in the U.S. relatively quickly out of the gate. I'm just curious with -- I guess something approaching 20% share of the market over time, which is what you've done in other markets with your disruption capabilities. I'm just curious, does anything change there with the indeterminate kind of view of what the next steps are for the U.S.? I'm just trying to focus on that commentary a bit. Does your outlook for the franchise in the U.S. change in TAVR? And then I have a follow-up.

祝賀今年取得了非常強勁的成績。我的第一個問題是回到 TAVR。在分析師日，您談到了一種期望和信心，即您可以相對較快地擾亂美國市場。我只是好奇——我猜隨著時間的推移，市場份額將接近 20%，這就是你們利用顛覆能力在其他市場所做的事情。我只是很好奇，對美國下一步行動的不確定看法是否會改變？我只是想稍微關註一下該評論。您對 TAVR 在美國特許經營權的展望是否會改變？然後我有一個後續行動。

Yes. Just a few clarifying points. Again, in Europe, where we set 70,000 valves and physicians use it routinely on an everyday basis. We continue to grow faster than the market there and have continued to done that for, I don't know, 10 quarters in a row. So we make nice progress, and we're excited about getting the large valve size approved in Europe. I believe 2025 is the time period.

是的。只是澄清幾點。同樣，在歐洲，我們設置了 70,000 個閥門，醫生每天都會定期使用它。我們的成長速度繼續快於那裡的市場，而且我不知道，我們已經連續 10 個季度這樣做了。所以我們取得了很大的進展，我們很高興能夠獲得歐洲批准大尺寸閥門。我相信2025年就是這個時段。

In the U.S., honestly, we -- first of all, I would state that we've never quoted a market share goal for TAVR in the U.S. So we never set 20%, I'm not sure if that was what you put in your models or not. But based on the results that we've seen in Europe, we've always been confident in our ability to have ACURATE be a meaningful growth driver in the U.S. as we stated at Investor Day.

在美國，老實說，我們——首先，我要聲明的是，我們從未提出過 TAVR 在美國的市場份額目標。所以我們從未設定過 20%，我不確定這是否是您提出的目標你的模型與否。但根據我們在歐洲看到的結果，我們始終相信我們有能力讓 ACURATE 成為美國有意義的成長動力，正如我們在投資者日上所說的那樣。

As a result of this, we are disappointed that we're not going to have this launched in 2024, as we talked about based on the data that we just highlighted in the script, and as Janar mentioned, we now need to wait for the full year data, the full 1-year follow-up on the 1,500 patients, and then working with the FDA and submitting that and having that data read out by year-end and we'll take it from there.

因此，我們對不會在 2024 年推出此功能感到失望，正如我們根據剛剛在腳本中強調的數據所討論的那樣，正如 Janar 提到的，我們現在需要等待全年數據，對1,500 名患者進行一年的完整隨訪，然後與FDA 合作並提交該數據，並在年底之前讀出該數據，我們將從那裡獲取數據。

So we -- as Janar said, the trial is still active. So we do not expect any of this news to alter our 8% to 10% organic growth over the 3-year period, we're coming off at 12%. We continue to grow faster than most all of our peers and drop EPS faster than our peer group. And we're still very committed to those financial targets. And we're hopeful that ACURATE will continue to be a big growth driver for us, but a lot of it depends on that data readout in fourth quarter '24.

因此，正如賈納爾所說，試驗仍在進行中。因此，我們預計這些消息不會改變我們 3 年期間 8% 至 10% 的有機成長，我們的有機成長為 12%。我們的成長速度持續快於大多數同行，每股盈餘下降速度也快於同行。我們仍然非常致力於實現這些財務目標。我們希望 ACURATE 將繼續成為我們的巨大成長動力，但這很大程度上取決於 24 年第四季的數據讀數。

Okay. And then maybe just on M&A, you've been active in 2023, and congrats on Relievant and more recently Axonics early this year. I'm just curious on kind of how we should think about how aggressive and opportunistic will be over the next 12 months? You mentioned, obviously, your first priority remains, deploying capital for tuck-ins but do we kind of think of you guys in a little bit of a digestion period or kind of steady as she goes, just as aggressive and opportunistic as you have been in the past?

好的。然後也許只是在併購方面，您在 2023 年一直很活躍，恭喜 Relievant 以及今年年初的 Axonics。我只是好奇我們該如何思考未來 12 個月的侵略性和機會主義程度？你提到，顯然，你的首要任務仍然是，部署資金用於進餐，但我們是否認為你們正處於消化期，或者像她一樣保持穩定，就像你們一樣積極進取和機會主義在過去？

Sure. I can take that one. So as you mentioned, Axonics, the most recent deal we did, super pleased with that. I think that is a classic tuck-in for Boston Scientific. It's one I think -- as you look back, these types of deals, we really do well with, and we're super excited to have that close and welcome the Axonics team into the BSE family.

當然。我可以接受那個。正如您所提到的，Axonics，我們最近完成的交易，對此非常滿意。我認為這是波士頓科學公司的經典。我認為，當您回顧這些類型的交易時，我們確實做得很好，我們非常高興能夠達成這一目標並歡迎 Axonics 團隊加入 BSE 大家庭。

As you said, we've been remarkably consistent over a long period of time. Tuck-in M&A is still the #1 capital allocation priority for us, and we'll continue to be active. In terms of the -- how active over the near to medium term, this is not a major event like a major delevering event that we need to do. This is take on a little bit of additional debt over a period of time and then over a very reasonable period of time. We'll be right back to where we are today relative to our leverage goals. So I'd look for us to continue to be active in the tuck-in M&A space in '24 and beyond.

正如你所說，我們在很長一段時間內一直非常一致。整合併購仍然是我們資本配置的第一要務，我們將繼續保持活躍。就中短期內的活躍程度而言，這不是我們需要做的重大去槓桿事件。這是在一段時間內承擔一點額外的債務，然後在一段非常合理的時間內承擔。相對於我們的槓桿目標，我們很快就會回到今天的水平。因此，我希望我們在 24 年及以後繼續積極參與併購領域。

Okay. Again, congrats on an outstanding 4Q.

好的。再次恭喜第四季的出色表現。

Thank you.

謝謝。

Thank you.

謝謝。

The next question comes from Patrick Wood with Morgan Stanley.

下一個問題來自摩根士丹利的派崔克‧伍德。

Congrats, Lauren. I'd like to stick with Axonics, if that's right. I appreciate it hasn't closed yet. But I'm just kind of curious, Urology in Boston has a very sizable distribution network across, I guess, primarily stone management, but a whole bunch of different areas. How are you thinking about the ability to drive adoption in OAB faster and like really push that asset? I'm guessing having just played with the numbers and correct me if I'm wrong, but some assumption of slightly faster growth once you've acquired Axonics and the Street previously had in there, at least that's where I end up with the numbers, feel free to correct me, but how are you thinking about the commercialization and really pushing that through the distribution network?

恭喜，勞倫。如果這是正確的話，我願意繼續使用 Axonics。我很感激它還沒有關閉。但我只是有點好奇，波士頓的泌尿科有一個非常龐大的分銷網絡，我想，主要是結石管理，但也有很多不同的領域。您如何看待更快地推動 OAB 的採用並真正推動該資產的能力？我猜只是玩弄了這些數字，如果我錯了，請糾正我，但一旦你收購了 Axonics 和華爾街之前的公司，就會有一些假設，認為增長會稍微快一點，至少這就是我最終得到的數字，請隨時糾正我，但是您如何考慮商業化並透過分銷網絡真正推動它？

Sure. Well, we haven't closed it yet. We hope to first half of this year. The team at Axonics has done an amazing job with this platform since starting the company years ago and taking significant share in what is a strong double-digit growth market. The team at Axonics, I can't speak too much for them, it hasn't closed yet, as also done a remarkable job in a few areas, one -- core technology where they gained -- leverage that to gain share. The clinical data that they have, the commercial excellence that they possess and also expanding the market through their direct-to-patient marketing and awareness. So this is a significant global opportunity and the patient awareness of this treatment is still early days. And so that's one reason why we acquired the company was the momentum they have, the technology and the long-term market CAGR that we see based on the global opportunity.

當然。嗯，我們還沒有關閉它。我們希望今年上半年。自幾年前成立公司以來，Axonics 團隊在該平台上取得了令人驚嘆的成績，並在強勁的兩位數成長市場中佔據了重要份額。 Axonics 的團隊，我不能為他們說太多，它還沒有關閉，在幾個領域也做了出色的工作，其中一個——他們獲得的核心技術——利用它來獲得份額。他們擁有的臨床數據、卓越的商業能力，以及透過直接面向患者的行銷和意識來擴大市場。因此，這是一個重要的全球機遇，而患者對這種治療的認識仍處於早期階段。因此，我們收購該公司的原因之一是他們擁有的動力、技術和我們基於全球機會所看到的長期市場複合年增長率。

The market today is nearly all of U.S. That's something we'll evaluate more in the future here as to would it make sense for us to bring this to select markets outside the U.S. given the data that we have.

今天的市場幾乎涵蓋了整個美國。根據我們掌握的數據，我們將來會更多地評估這一點，以了解將其帶到美國以外的特定市場是否有意義。

As you mentioned, we have a significant commercial channel in our Urology business through all of our different business units within Urology. So this is an ideal fit. It is an adjacency for us. We don't have any competitive product in this area. So it's a nice adjacency for us that will allow us to compete more competently with Urology customers. But we aim to take Axonics to the next level, but that team has done a terrific job to date.

正如您所提到的，我們透過泌尿科內的所有不同業務部門在泌尿科業務中擁有重要的商業管道。所以這是一個理想的選擇。對我們來說這是一個鄰接關係。我們在這個領域沒有任何有競爭力的產品。因此，這對我們來說是一個很好的毗鄰，這將使我們能夠更有能力與泌尿科客戶競爭。但我們的目標是將 Axonics 提升到一個新的水平，而該團隊迄今為止已經做得非常出色。

And just to verify, do we have time for one more question?

我想確認一下，我們還有時間再問一個問題嗎？

Yes. One last question please.

是的。最後一個問題。

That question will come from Michael Polark with Wolfe Research.

這個問題將由沃爾夫研究中心的邁克爾·波拉克提出。

I'll ask a gross margin question. Dan, I heard in the script for '24 flat to maybe slightly down year-on-year in the guide. The world seems to be calmer on price cost. But as we all know, the Middle East is flaring. And so I'm curious, one, have you built in any cushion for kind of cost push from those events? And two, in real time, are you seeing any impact in the field? And if so, what does that look like?

我會問一個毛利率問題。丹，我在指南中聽說《24》的劇本可能比去年同期略有下降。世界在價格成本上似乎更加平靜。但眾所周知，中東局勢正在緊張。所以我很好奇，第一，你們是否為這些事件帶來的成本推動建立了任何緩衝？第二，您即時看到該領域有任何影響嗎？如果是這樣，那是什麼樣子的？

Yes, I can give you the short answer and a little bit longer answer. So the short one is that we've contemplated all that. Our team is super close to everything relative to our global supply chain network. And so there everything that we have in the guidance that we gave contemplates what we know today and what -- and the guidance that they're giving us on that, which -- the impact is minimal.

是的，我可以給你簡短的答案和更長一點的答案。簡而言之，我們已經考慮了所有這些。我們的團隊非常接近與我們的全球供應鏈網路相關的一切。因此，我們提供的指導中的所有內容都考慮了我們今天所知道的內容以及他們就此向我們提供的指導，其影響是最小的。

Overall, on gross margin, a little bit longer answer. If you look at '23, we came in pretty much right where we expected at that 70.7%. And then as we said at the Investor Day in September, we said it would be a challenge to contribute to our margin expansion goals in '24, right, which that's probably going to prove out to be true. Because we're saying, we'll be either at or slightly below. But that's okay. As there are many other areas of the P&L. And as you know, we have a pretty solid track record over time of managing all those lines of the P&L to drive margin expansion. Most recently, that's 70 basis points last year.

總的來說，關於毛利率，答案有點長。如果你看看 23 年，我們的表現非常符合我們的預期，即 70.7%。然後，正如我們在 9 月的投資者日上所說，我們表示，為 24 年的利潤擴張目標做出貢獻將是一項挑戰，對，這可能會被證明是正確的。因為我們說，我們要么等於或略低於。但沒關係。因為損益表還有許多其他領域。如您所知，隨著時間的推移，我們在管理損益表的所有這些項目以推動利潤率擴張方面擁有相當可靠的記錄。最近的數據是去年的 70 個基點。

So for '24, I'd kind of point to 2 headwinds and 2 tailwinds that will play out and again, have us at that kind of at or slightly below the 70.7% we put up last year. And one is inflation. And that's probably a little bit of a tailwind, right? So it's -- the macro factors are improving in general relative to inflation and other things. But as a reminder, we enter into contracts for many elements of materials for '24 already last year. So we don't want to see that full benefit. But in '25 and '26, I'd like to believe there's even more benefit there, not only from the macro side of inflation, but also for gross margin in total.

因此，對於 24 年，我會指出 2 個逆風和 2 個順風將再次發揮作用，讓我們處於或略低於去年的 70.7%。一是通貨膨脹。這可能有點順風，對吧？所以，相對於通貨膨脹和其他因素，宏觀因素總體上正在改善。但提醒一下，我們去年就已經簽訂了 '24 材料的許多要素的合約。所以我們不想看到全部的好處。但在 25 年和 26 年，我相信那裡會帶來更多好處，不僅來自通貨膨脹的宏觀方面，而且還來自總毛利率。

And then our mix. So getting the FARAPULSE approval today, that's exciting because that's a great mix thing for the company and many of our other launches are as well. And then on the headwind side, foreign exchange was a headwind in '23 continue in '24. And as I said at Investor Day, a good problem to have, but we also need to make investments in manufacturing capacity to support the sales growth, growing 12% last year and then 8% to 9% this year. But we're absolutely committed to the 150 basis points over 3 years. Gross margin probably won't pay a lot of bills for us in '24 but I think it certainly will in '25 and '26. Recall, we used to be north of 72% back in 2019, and we are maniacally focused to get there. And then to get the overall operating margin kind of on the doorstep of '28 when we get to 2026 and that puts that 30% long-term goal that we've had kind of right in our line of sight as we're in 2026.

然後是我們的組合。因此，今天獲得 FARAPULSE 的批准，這是令人興奮的，因為這對公司來說是一個偉大的組合，我們的許多其他產品也是如此。然後在逆風方面，外匯在 23 年和 24 年都是逆風。正如我在投資者日所說，這是一個很好的問題，但我們還需要對製造能力進行投資，以支持銷售成長，去年成長 12%，今年成長 8% 至 9%。但我們絕對致力於在 3 年內實現 150 個基點。在 24 年，毛利率可能不會為我們支付很多賬單，但我認為在 25 年和 26 年肯定會。回想一下，我們在 2019 年曾經一度超過 72%，並且我們瘋狂地致力於實現這一目標。然後，當我們到 2026 年時，整體營業利潤率將在 28 年實現，這使得 2026 年我們已經實現的 30% 的長期目標就在我們的視線範圍內。

Thanks for joining us today. We appreciate your interest in Boston Scientific. If we were unable to get to your question or if you have any follow-ups, please don't hesitate to reach out to the Investor Relations team. Before you disconnect, Drew will give you all of the pertinent details for replay.

感謝您今天加入我們。我們感謝您對波士頓科學公司的興趣。如果我們無法解答您的問題或您有任何後續行動，請隨時聯絡投資者關係團隊。在斷開連接之前，Drew 將為您提供重播的所有相關詳細資訊。

Please note, a recording will be available in 1 hour by dialing either 1 (877) 344-7529 or 1 (412) 317-0088 using replay code 2394361 until February 7, 2024, at 11:59 p.m. Eastern Time. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

請注意，在 2024 年 2 月 7 日晚上 11:59 之前，撥打 1 (877) 344-7529 或 1 (412) 317-0088（使用重播代碼 2394361）即可在 1 小時內獲得錄音。東部時間。會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。