(BSX) 2024 Q1 法說會逐字稿

Good morning, and welcome to the Boston Scientific First Quarter 2024 Earnings Call. (Operator Instructions) Please note, this event is being recorded.

早安，歡迎參加波士頓科學公司 2024 年第一季財報電話會議。 （操作員說明）請注意，正在記錄此事件。

I would now like to turn the conference over to Jon Monson, Senior Vice President, Investor Relations. Please go ahead.

我現在想將會議交給投資者關係高級副總裁喬恩·蒙森 (Jon Monson)。請繼續。

Thank you, Drew, and 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.

謝謝你，德魯，歡迎大家，謝謝你們今天加入我們。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。

We issued a press release earlier this morning announcing our Q1 results, which included reconciliations of the non-GAAP measures used in the release. We have posted a link to 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 & Filings.

我們今天早上早些時候發布了一份新聞稿，宣布了我們第一季的業績，其中包括對新聞稿中使用的非公認會計準則衡量標準的調節。我們已經發布了該新聞稿的鏈接，以及今天電話會議中使用的非公認會計準則措施的鏈接，該電話會議位於我們網站的投資者關係部分，標題為“財務和文件”。

The duration of this morning's call will be approximately 1 hour. Mike and Dan will provide comments on Q1 performance as well as the outlook for our business, including Q2 and full year 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.

今天上午的通話時間約為 1 小時。 Mike 和 Dan 將提供第一季業績以及我們業務前景的評論，包括第二季和 2024 年全年指導，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 the 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.

在開始之前，我想提醒大家，在電話會議上，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收購和資產剝離，因為收購和資產剝離的可比淨銷售額少於整個時期。

Relevant acquisitions and divestitures excluded for organic growth are the majority stake investment in Acotec Scientific Holdings Limited and the acquisitions of Apollo Endosurgery and Relievant Medsystems, which closed in February, April and November 2023, respectively, as well as our acquisition of the endoluminal vacuum therapy portfolio from B. Braun, which closed in March 2024.

有機成長排除的相關收購和剝離包括對Acotec Scientific Holdings Limited 的多數股權投資，以及分別於2023 年2 月、4 月和11 月完成的Apollo Endosurgery 和Relievant Medsystems 的收購，以及我們對腔內真空治療的收購B. Braun 的投資組合，於 2024 年 3 月關閉。

Divestitures include the endoscopy pathology business, which closed in April 2023.

剝離的業務包括內視鏡病理業務，該業務於 2023 年 4 月關閉。

Guidance excludes the previously announced agreement to acquire Axonics, Inc., which is expected to close in the second half of 2024, subject to customary closing conditions.

該指引不包括先前宣布的收購 Axonics, Inc. 的協議，該協議預計將於 2024 年下半年完成，但須符合慣例成交條件。

For more information, please refer to our Q1 Financial and Operational Highlights deck, which may be found on our Investor Relations website.

欲了解更多信息，請參閱我們的第一季度財務和運營亮點甲板，該甲板可以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.

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。

This call contains forward-looking statements within the meaning of federal securities law, 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 of cash; our financial performance, including sales, margins and earnings; as well as our tax rates, R&D spend and other expenses.

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。除此之外，其中包括有關我們的成長和市場份額的聲明；新產品和預期產品的批准和發布；收購、臨床試驗；節省成本和成長機會；我們的現金流量和預期的現金用途；我們的財務業績，包括銷售額、利潤率和收益；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.

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。

Factors that may cause such differences include those described in the Risk Factors section of our most recent 10-K and subsequent 10-Qs filed with the SEC.

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。

These statements speak only as of today's date and we disclaim any intention or obligation to update them, except as required by law.

這些聲明僅代表今天的情況，除非法律要求，否則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. Mike?

此時，我會將其交給麥克。麥克風？

Thanks, Jon. Thank you to everyone for joining us today. Our first quarter results surpassed our expectations, fueled by our innovative portfolio, including the nearly 90 new products we launched globally in 2023, the execution of our category leadership strategy and the winning spirit of our global team.

謝謝，喬恩。感謝大家今天加入我們。我們第一季的業績超出了我們的預期，這得益於我們的創新產品組合，包括我們2023 年在全球推出的近90 款新產品、我們品類領先戰略的執行以及我們全球團隊的必勝精神。

In the first quarter '24, total company operational sales grew 15% and organic sales grew 13% versus first quarter '23, which exceeds the high end of our guidance range of 7% to 9%. Our strong growth continues to be diversified across businesses and regions. In the quarter, 6 of our 8 business units in all of our regions grew double digits. We believe that most business units grew faster than their respective markets with differentiated portfolios and strong commercial execution, supported by healthy procedural demand.

與 2023 年第一季相比，24 年第一季公司總營運銷售額成長了 15%，有機銷售額成長了 13%，超出了我們指導範圍 7% 至 9% 的上限。我們的強勁成長持續在各個業務和地區實現多元化。本季度，我們所有地區的 8 個業務部門中有 6 個業務部門實現了兩位數成長。我們相信，在健康的程序需求的支持下，大多數業務部門的成長速度快於各自的市場，具有差異化的產品組合和強大的商業執行力。

First quarter adjusted EPS was $0.56, which grew 21% versus 2023, which exceeds the high end of our guidance range of $0.50 to $0.52. First quarter adjusted operating margin was 26.2%.

第一季調整後每股收益為 0.56 美元，比 2023 年增長 21%，超出了我們 0.50 美元至 0.52 美元指導範圍的上限。第一季調整後營業利益率為 26.2%。

Turning to our second quarter and full year '24 outlook. We are guiding to organic growth of 10% to 12% for second quarter '24 and raising our full year guidance from 8% to 9% to 10% to 12%, reflecting momentum from our innovative portfolio, healthy procedural volumes and continued execution by our global team.

轉向我們對 24 年第二季和全年的展望。我們預計2024 年第二季的有機成長為10% 至12%，並將全年指引從8% 至9% 提高至10% 至12%，這反映了我們的創新投資組合、健康的程序量和持續執行的勢頭。

Our second quarter '24 adjusted EPS guidance is $0.57 to $0.59 and we expect our full year adjusted EPS to be $2.29 to $2.34, representing growth of 12% to 14%.

我們的 24 年第二季調整後每股盈餘指引為 0.57 美元至 0.59 美元，我們預計全年調整後每股盈餘為 2.29 美元至 2.34 美元，成長 12% 至 14%。

Dan will provide more details on our financials and I'll provide additional highlights on our first quarter, along with comments on our '24 outlook.

丹將提供有關我們財務狀況的更多詳細信息，我將提供有關我們第一季的更多亮點，以及對我們 24 年前景的評論。

Regionally, on an operational basis, the U.S. grew 13% versus first quarter with particular strength in EP, fueled by the launch of FARAPULSE midway through the quarter, as well as on our WATCHMAN ICTx Urology and Endoscopy business units.

從地區來看，在營運基礎上，美國較第一季成長了 13%，其中 EP 業務尤其強勁，這得益於本季中期 FARAPULSE 的推出以及我們的 WATCHMAN ICTx 泌尿科和內視鏡業務部門。

Europe, Middle East and Africa grew 13% on an operational basis versus first quarter '23. This above-market growth was led by exceptional performance in EP as well as double-digit growth in our Endoscopy, Urology and PI businesses. We expect to continue to outpace the market, driven by continued broad-based momentum across our business and investment in emerging markets.

與 2023 年第一季相比，歐洲、中東和非洲的營運成長了 13%。這一高於市場的成長得益於 EP 的出色表現以及內視鏡、泌尿科和 PI 業務的兩位數增長。在我們的業務和新興市場投資持續廣泛的勢頭的推動下，我們預計將繼續超越市場。

Asia Pac grew 26% operationally versus first quarter '23, led by strong double-digit performance in all of our Cardiovascular business units. Japan grew double digits driven by AGENT DCB, Rezum and our Access Solutions products. China delivered excellent results, growing strong double digits with 7 of our 8 business units growing double digits.

與 23 年第一季相比，亞太地區的營運成長了 26%，這得益於我們所有心血管業務部門強勁的兩位數業績。在 AGENT DCB、Rezum 和我們的 Access Solutions 產品的推動下，日本實現了兩位數的成長。中國取得了出色的業績，實現了強勁的兩位數成長，我們的 8 個業務部門中有 7 個實現了兩位數成長。

I'll now provide some additional commentary on our business units. In Urology, sales grew 10%, both operationally and organically versus first quarter '23, with double-digit growth in stone management as well as prosthetic urology. Rezum performed well in the quarter, both in the U.S. and internationally, and secured reimbursement status in France. We look forward to closing the previously announced acquisition of Axonics now expected in the second half of 2024.

我現在將對我們的業務部門提供一些補充評論。在泌尿科領域，與 23 年第一季相比，銷售額在營運和有機方面均成長了 10%，其中結石管理和修復泌尿科領域實現了兩位數成長。 Rezum 本季在美國和國際市場均表現良好，並在法國獲得了報銷地位。我們期待完成先前宣布的對 Axonics 的收購，目前預計將於 2024 年下半年完成。

Endoscopy sales grew 12% operationally and 10% organically versus first quarter '23. Strong first quarter results were driven by the breadth of our portfolio, underpinned by differentiated anchor products such as AXIOS and our single-use imaging products.

與 2023 年第一季相比，內視鏡銷售額營運成長 12%，有機成長 10%。第一季的強勁業績是由我們廣泛的產品組合推動的，並以 AXIOS 和我們的一次性成像產品等差異化主力產品為基礎。

Within the quarter, we also received CE Mark for our MANTIS Clip and NICE in the U.K. issued positive guidance for the ESG endoscopic bariatric surgery procedure, both expected to further momentum in our growing endoluminal surgery franchise.

在本季度內，我們的 MANTIS Clip 也獲得了 CE 標誌，英國 NICE 發布了對 ESG 內視鏡減重手術程序的積極指導，兩者都有望進一步推動我們不斷增長的腔內手術業務。

Neuromodulation sales grew 10% operationally and declined 1% organically versus first quarter '23. Our brain franchise grew high single digits in the quarter with low double-digit U.S. growth driven by our comprehensive directional stimulation offering enabled by image-guided programming.

與 23 年第一季相比，神經調節銷售額營運成長 10%，有機下降 1%。我們的大腦特許經營權在本季度實現了高個位數成長，而在我們透過影像引導程式實現的全面定向刺激產品的推動下，美國實現了低兩位數成長。

In the first quarter, our pain franchise grew low double digits operationally, but declined mid-single digits on an organic basis, with continued pressure in our U.S. SCS business.

第一季度，我們的疼痛專營業務在營運上實現了低兩位數成長，但在有機基礎上下降了中個位數，因為我們的美國 SCS 業務持續面臨壓力。

In the U.S., during the first quarter, we did receive FDA approval and recently launched the WaveWriter symptom (sic) [system] nonsurgical back pain indication and our next-generation FAST AutoDose.

在美國，第一季度，我們確實獲得了 FDA 的批准，並於最近推出了 WaveWriter 症狀（原文如此）[系統]非手術背痛適應症和我們的下一代 FAST AutoDose。

Importantly, the Relievant business continues to perform very well with steady expansion of payer coverage, and we expect sales from the novel Intracept procedure to grow about 50% in 2024.

重要的是，Relievant 業務繼續表現良好，付款人覆蓋範圍穩步擴大，我們預計新型 Intracept 手術的銷售額到 2024 年將增長約 50%。

Peripheral Intervention sales grew 16% operationally and 11% organically versus first quarter '23. Double-digit growth in arterial was bolstered by our drug-eluting portfolio supported by the strength of clinical evidence and global commercial execution.

與 2023 年第一季相比，外圍幹預銷售額營運成長 16%，有機成長 11%。動脈業務的兩位數成長得益於我們的藥物洗脫產品組合，以及強大的臨床證據和全球商業執行的支持。

In venous, we saw continued above-market growth from Varithena and clot management continued to perform well, in line with expectations.

在靜脈方面，我們看到 Varithena 的成長持續高於市場水平，且血栓管理持續表現良好，符合預期。

Our interventional oncology franchise grew strong double digits in the first quarter, driven by our broad offering of embolization devices, including the Embold coil family in cancer therapies.

在我們廣泛提供的栓塞設備（包括癌症治療中的 Embold 彈簧圈系列）的推動下，我們的介入腫瘤學業務在第一季度實現了兩位數的強勁增長。

In the quarter, TheraSphere also grew double digits and data from the real-world study, PROACTIF, was presented, demonstrating positive outcomes in patients with intermediate and advanced HCC who were treated with TheraSphere.

在本季度，TheraSphere 也實現了兩位數的成長，並且公佈了真實世界研究 PROACTIF 的數據，顯示接受 TheraSphere 治療的中度和晚期 HCC 患者取得了積極的結果。

Cardiology sales delivered another excellent quarter with both operational and organic sales growing 18% versus first quarter 2023.

心臟病學銷售再次表現出色，營運銷售額和有機銷售額與 2023 年第一季相比成長了 18%。

Within Cardiology, Interventional Cardiology Therapy sales grew an impressive 13% organically versus first quarter '23.

在心臟病學領域，介入性心臟病學治療銷售額較 2023 年第一季有機成長了 13%，令人印象深刻。

Growth in Coronary Therapies was driven by continued strength in our international regions, led by our imaging portfolio and AGENT DCB in Japan.

冠狀動脈治療的成長是由我們國際地區的持續實力推動的，其中以我們的影像產品組合和日本 AGENT DCB 為主導。

In the U.S., we're also pleased with the ongoing launch of AVVIGO+, which is our AI-guided imaging platform. We also received FDA approval of our AGENT DCB in first quarter, and we expect to initiate a limited launch in the second quarter as we ramp supply following the earlier-than-anticipated regulatory approval.

在美國，我們也對 AVVIGO+ 的持續推出感到高興，這是我們的人工智慧引導成像平台。我們也在第一季度獲得 FDA 對我們的 AGENT DCB 的批准，我們預計將在第二季度啟動有限的推出，因為我們在早於預期的監管批准後增加了供應。

Our Structural Heart Valves franchise once again grew mid-teens in first quarter, led by ACURATE neo2, which continues to see growth from both new and existing accounts. We have now submitted for CE Mark for our next-generation ACURATE Prime valve, which we continue to expect to launch in Europe in 2025.

在 ACURATE neo2 的帶領下，我們的結構性心臟瓣膜特許經營業務在第一季再次實現了十幾歲左右的成長，新客戶和現有客戶都在繼續成長。我們現在已為下一代 ACURATE Prime 閥門提交了 CE 標誌，我們預計將於 2025 年在歐洲推出。

WATCHMAN had another strong quarter, growing 19% organically and maintaining our market-leading share position. In the U.S., WATCHMAN FLX Pro moved into full launch and we received FDA clearance for the TruSteer steerable sheath, allowing physicians to achieve more optimal device positioning in the widest range of LAA anatomies.

WATCHMAN 又迎來了一個強勁的季度，有機成長了 19%，並保持了市場領先的份額地位。在美國，WATCHMAN FLX Pro 全面上市，我們的 TruSteer 可操縱護套獲得 FDA 批准，使醫生能夠在最廣泛的左心耳解剖結構中實現更優化的設備定位。

International growth was driven by ongoing momentum in -- ongoing momentum within the quarter, and we received approval and launched WATCHMAN FLX Pro in Japan and Canada, which will support continued growth in these markets.

國際成長是由本季持續成長勢頭推動的，我們在日本和加拿大獲得了批准並推出了 WATCHMAN FLX Pro，這將支持這些市場的持續成長。

Cardiac Rhythm Management sales grew 5% organically in the first quarter '23. In the first quarter, our Diagnostics franchise also grew double digits, led by strong market adoption of our second-generation LUX-Dx ICM device.

心律管理銷售額在 2023 年第一季有機成長了 5%。第一季度，由於我們的第二代 LUX-Dx ICM 設備的強勁市場採用，我們的診斷業務也實現了兩位數成長。

In core CRM, our low-voltage business grew mid-single digits and our high-voltage business grew low single digits. Our Emblem S-ICD continues to maintain its strong share position and we've seen very limited impact in Europe or the U.S. from a recent competitor's launch.

在核心 CRM 中，我們的低壓業務實現了中個位數成長，高壓業務實現了低個位數成長。我們的 Emblem S-ICD 繼續保持其強勁的市場份額，而且最近競爭對手的推出對歐洲或美國的影響非常有限。

We expect to remain the clear market leader in this space and look forward to the upcoming data presentation at HRS of MODULAR ATP, which is a pivotal trial studying the use of the Emblem S-ICD in conjunction with our EMPOWER leadless pacemaker to function as a single-chamber pacemaker, as well as to provide anti-tachycardia pacing when needed. We anticipate FDA approval of the modular CRM system and stand-alone EMPOWER leadless pacemaker in '25.

我們預計將繼續保持該領域明顯的市場領導者地位，並期待即將在MODULAR ATP 的HRS 上發布數據，這是一項關鍵試驗，研究如何將Emblem S-ICD 與我們的EMPOWER 無引線起搏器結合使用，以充當心臟起搏器的功能。我們預計 FDA 將在 25 年批准模組化 CRM 系統和獨立 EMPOWER 無引線心律調節器。

Electrophysiology sales grew 72% both operationally and organically versus first quarter '23 driven by the adoption of the transformative FARAPULSE platform.

由於採用變革性 FARAPULSE 平台，電生理學銷售額較 23 年第一季的營運和有機銷售額成長了 72%。

International first quarter sales grew 59%, with continued FARAPULSE account openings and robust utilization in Europe.

隨著 FARAPULSE 帳戶的持續開設和歐洲的強勁利用率，第一季國際銷售額成長了 59%。

U.S. first quarter sales grew 85% organically, propelled by the mid-first quarter launch of FARAPULSE. We have already made good progress entering to high-volume accounts, supported by compelling clinical evidence, commercial execution and investment in our supply chain.

受 FARAPULSE 第一季中期推出的推動，美國第一季銷售額有機成長 85%。在令人信服的臨床證據、商業執行和供應鏈投資的支持下，我們已經在進入大批量客戶方面取得了良好進展。

Early feedback on FARAPULSE has been extremely positive with rapid adoption from both RF and cryo users. Electrophysiologists appreciate FARAPULSE's unique safety profile, ease of use, effectiveness and efficiency of the procedure. We expect our broad EP portfolio, coupled with our other AF solutions, to drive significant global growth in '24 and beyond.

FARAPULSE 的早期回饋非常積極，射頻和低溫使用者迅速採用。電生理學家讚賞 FARAPULSE 獨特的安全性、易用性、手術的有效性和效率。我們預計我們廣泛的 EP 產品組合，加上我們的其他 AF 解決方案，將在 24 年及以後推動全球的顯著成長。

We also intend to extend our leadership in PFA by investing in innovation, clinical evidence and global capabilities. Within the quarter, we commenced enrollment of the NAVIGATE-PF clinical trial, studying integrated cardiac mapping with a FARAVIEW software and FARAWAVE non-enabled catheter, both of which are expected to launch in the U.S. during the second half of the year.

我們還打算透過投資創新、臨床證據和全球能力來擴大我們在 PFA 領域的領導地位。本季內，我們開始招募 NAVIGATE-PF 臨床試驗，研究使用 FARAVIEW 軟體和未啟用 FARAWAVE 導管的綜合心臟測繪，這兩種軟體預計將於今年下半年在美國推出。

We also completed enrollment of Phase II in the ADVANTAGE AF clinical trial, studying our FARAPOINT device for CTI ablations, which is expected to launch in the U.S. in 2025. And we also anticipate data from Phase I of the ADVANTAGE trial for persistent AF to be presented in fourth quarter 2024.

我們也完成了 ADVANTAGE AF 臨床試驗的 II 期註冊，研究用於 CTI 消融的 FARAPOINT 設備，該設備預計將於 2025 年在美國推出。 2024 年第四季發布。

We also look forward to our clinical late-breakers at the upcoming HRS meeting in May, which aims to highlight the unique capabilities of FARAPULSE.

我們也期待在 5 月即將舉行的 HRS 會議上展示我們的臨床遲到者，該會議旨在突出 FARAPULSE 的獨特功能。

Also of note, this week, we released our 2023 Performance Report, highlighting the company's actions to improve patient outcomes while prioritizing our environmental, social and governance goals. We continue to make progress in all 3 key areas: innovating care to meet patient needs, empowering people and shaping a healthier planet while performing with integrity. While we always have more to do, I know that our values-driven culture and the commitment of our global teams to challenge -- to this challenge of what's possible will continue to raise the bar.

另外值得注意的是，本週我們發布了 2023 年績效報告，強調了公司​​在優先考慮環境、社會和治理目標的同時改善病患治療效果的行動。我們繼續在所有 3 個關鍵領域取得進展：創新護理以滿足患者需求、賦予人們權力並在誠信行事的同時塑造更健康的地球。雖然我們總是有更多的事情要做，但我知道我們的價值觀驅動的文化和我們的全球團隊對挑戰的承諾——對可能的挑戰的承諾將繼續提高標準。

In closing, I'm very grateful to our global employees who work every day to advance science for life. We remain committed to investing for the long term while delivering top-tier financial performance in 2024 and beyond.

最後，我非常感謝我們的全球員工，他們每天都在努力推動生命科學的發展。我們仍致力於長期投資，同時在 2024 年及以後實現一流的財務表現。

And with that, I'll hand over to Dan to provide more details on the financials.

接下來，我將請丹提供有關財務狀況的更多詳細資訊。

Thanks, Mike. First quarter 2024 consolidated revenue of $3.856 billion represents 13.8% reported growth versus first quarter 2023 and includes a 120 basis point headwind from foreign exchange, in line with our expectations. Excluding this $40 million headwind from foreign exchange, operational revenue growth was 15% in the quarter. Sales from the closed acquisitions and divestitures contributed 190 basis points, resulting in 13.1% organic revenue growth, exceeding our first quarter guidance range of 7% to 9%.

謝謝，麥克。 2024 年第一季合併收入為 38.56 億美元，較 2023 年第一季報告成長 13.8%，其中包括 120 個基點的外匯阻力，符合我們的預期。排除這 4,000 萬美元的外匯阻力，本季營運收入成長 15%。已完成的收購和剝離帶來的銷售額貢獻了 190 個基點，實現了 13.1% 的有機收入成長，超出了我們第一季 7% 至 9% 的指導範圍。

Q1 2024 adjusted earnings per share of $0.56 grew 20.6% versus 2023 exceeding the high end of our guidance range of $0.50 to $0.52, primarily driven by our strong sales performance.

2024 年第一季調整後每股收益為 0.56 美元，與 2023 年相比增長 20.6%，超過了我們指導範圍 0.50 美元至 0.52 美元的上限，這主要是由我們強勁的銷售業績推動的。

Adjusted gross margin for the first quarter was 69.8%, which includes an approximate 30 basis point year-over-year headwind from foreign exchange. Adjusted gross margin was slightly lower than anticipated, primarily driven by inventory charges and less favorable product mix due to increased levels of capital placements in the quarter.

第一季調整後毛利率為 69.8%，其中包括年比約 30 個基點的外匯逆風。調整後的毛利率略低於預期，主要是由於本季資本配置水準增加導致庫存費用和較不有利的產品組合所致。

Despite a lower Q1, we continue to expect full year adjusted gross margin to be at or slightly below our 2023 full year rate, driven by increasing mix benefit from our new launches, lower inventory charges and the full recognition of our annual standard manufacturing cost improvements in the second half of the year.

儘管第一季較低，但我們仍然預計全年調整後毛利率將達到或略低於2023 年全年水平，這是由於我們的新產品推出帶來的混合效益增加、庫存費用降低以及對我們年度標準製造成本改善的充分認可所推動的下半年。

First quarter adjusted operating margin was 26.2%. We remain committed to expanding adjusted operating margin by 30 to 50 basis points in 2024 as we balance progress towards our long-range plan goal of 150 basis points of improvement from 2024 to 2026 with the flexibility to make critical investments to support key launches.

第一季調整後營業利益率為 26.2%。我們仍然致力於在2024 年將調整後營業利潤率擴大30 至50 個基點，同時我們在實現2024 年至2026 年提高150 個基點的長期計劃目標的進展與靈活地進行關鍵投資以支持關鍵產品發布之間取得平衡。

On a GAAP basis, first quarter operating margin was 17.5%.

以 GAAP 計算，第一季營業利潤率為 17.5%。

Moving to below the line. First quarter adjusted interest and other expenses totaled $80 million.

移至線下。第一季調整後利息和其他費用總計 8,000 萬美元。

On an adjusted basis, our tax rate for the first quarter was 10.7%, which includes favorable discrete tax items and the benefit from stock compensation accounting. Our operational tax rate was 13.7% for the quarter.

調整後，我們第一季的稅率為 10.7%，其中包括有利的離散稅收項目和股票補償會計的好處。本季我們的營業稅率為 13.7%。

Fully diluted weighted average shares outstanding ended at 1.482 billion shares in the first quarter.

第一季完全稀釋加權平均流通股數為14.82億股。

Free cash flow for the first quarter was a negative $15 million with $164 million from operating activities less $179 million in net capital expenditures, which includes payments of $251 million related to acquisitions, restructuring, litigation and other special items.

第一季自由現金流為負 1,500 萬美元，其中營運活動產生的 1.64 億美元減去淨資本支出 1.79 億美元，其中包括與收購、重組、訴訟和其他特殊項目相關的支出 2.51 億美元。

In 2024, we continue to expect full year free cash flow to exceed $2 billion, which includes approximately $800 million of expected payments related to special items.

到 2024 年，我們仍然預計全年自由現金流將超過 20 億美元，其中包括約 8 億美元的與特殊項目相關的預期付款。

As of March 31, 2024, we had cash on hand of $2.3 billion, inclusive of the $2 billion -- 2 billion euro-denominated senior note offering completed on February 27, which we intend to use to partially fund the Axonics acquisition.

截至 2024 年 3 月 31 日，我們手頭現金為 23 億美元，其中包括 2 月 27 日完成的 20 億美元（20 億歐元）高級票據發行，我們打算用這些現金為 Axonics 收購提供部分資金。

During the first quarter, we repaid approximately $500 million of senior notes upon maturity, and our gross debt leverage was 2.5x as of March 31.

第一季度，我們償還了約 5 億美元的到期優先票據，截至 3 月 31 日，我們的總債務槓桿率為 2.5 倍。

Our top capital allocation priority remains strategic tuck-in M&A, followed by annual share repurchases to offset dilution from employee stock grants. In alignment with our acquisition strategy, we recently closed the acquisition of the endoluminal vacuum therapy portfolio from B. Braun, which complements our existing endoscopy portfolio and is expected to be immaterial to earnings per share in 2024.

我們的資本配置首要任務仍然是策略性併購，其次是年度股票回購，以抵銷員工股票授予帶來的稀釋。根據我們的收購策略，我們最近完成了對貝朗腔內真空治療產品組合的收購，這補充了我們現有的內視鏡產品組合，預計對 2024 年每股收益影響不大。

Our legal reserve was $283 million as of March 31, a decrease of $94 million versus Q4 2023. And $71 million of this reserve is already funded through our qualified settlement funds.

截至 3 月 31 日，我們的法定準備金為 2.83 億美元，比 2023 年第四季減少了 9,400 萬美元。

I'll now walk through guidance for Q2 and the full year 2024. We expect full year 2024 reported revenue growth to be in a range of 11% to 13% 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 11.5% to 13.5%. Excluding a 150 basis point contribution from closed acquisitions, we expect full year 2024 organic revenue growth to be in a range of 10% to 12% versus 2023.

現在，我將介紹第二季和 2024 年全年的指引。 ，我們預計2024 年全年營業收入成長率為11.5% 至13.5%。排除已完成收購帶來的 150 個基點貢獻，我們預計 2024 年全年有機收入成長將較 2023 年在 10% 至 12% 之間。

We expect second quarter 2024 reported revenue growth to be in a range of 10.5% to 12.5% versus second quarter 2023. Excluding an approximate 100 basis point headwind from foreign exchange based on current rates, we expect second quarter 2024 operational revenue growth to be 11.5% to 13.5%. And excluding a 150 basis point contribution from closed acquisitions, we expect second quarter 2024 organic revenue growth to be in a range of 10% to 12% versus 2023.

我們預計，與2023 年第二季相比，2024 年第二季報告的營收成長率將在10.5% 至12.5% 之間。第二季的營運收入成長率為11.5% % 至 13.5%。排除已完成收購帶來的 150 個基點貢獻，我們預計 2024 年第二季的有機收入成長將較 2023 年在 10% 至 12% 之間。

We now expect full year 2024 adjusted below-the-line expense to be approximately $315 million.

我們現在預計 2024 年全年調整後的離線費用約為 3.15 億美元。

Under current legislation, including enacted laws and issued guidance under OECD Pillar 2 rules, we continue to forecast a full year 2024 operational tax rate of approximately 14% and an adjusted tax rate of approximately 13%.

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，我們繼續預測 2024 年全年營業稅率約為 14%，調整後稅率約為 13%。

We expect full year adjusted earnings per share to be in a range of $2.29 and to $2.34, representing 12% to 14% growth versus 2023, including an approximate $0.04 headwind from foreign exchange, which is unchanged from our previous expectations.

我們預計全年調整後每股收益將在 2.29 美元至 2.34 美元之間，較 2023 年增長 12% 至 14%，其中包括約 0.04 美元的外匯阻力，這與我們之前的預期相同。

We expect second quarter adjusted earnings per share to be in a range of $0.57 to $0.59.

我們預計第二季調整後每股收益將在 0.57 美元至 0.59 美元之間。

For more information, please check our Investor Relations website for Q1 2024 financial and operational highlights, which outlines more details on Q1 results and our 2024 guidance.

欲了解更多信息，請查看我們的投資者關係網站，了解 2024 年第一季度的財務和運營亮點，其中概述了有關第一季度業績和 2024 年指導的更多詳細信息。

And with that, I'll turn it back to Jon, who will moderate the Q&A.

接下來，我會將其轉回喬恩，他將主持問答。

Thanks, Dan. Drew, let's open it up for questions for the next 40 minutes or so (Operator Instructions) Drew, please go ahead.

謝謝，丹。德魯，讓我們在接下來的 40 分鐘左右開始提問（操作員說明）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 fantastic quarter. I guess with my one question, it has to be on FARAPULSE and EP in general. The beat was substantial, both U.S. and OUS. The doc feedback we hear is phenomenal on FARAPULSE PFA in general.

偉大的。恭喜您度過了一個精彩的季度。我想我的一個問題應該是關於 FARAPULSE 和 EP 的。無論是美國還是海外，這節拍都是巨大的。總的來說，我們聽到的關於 FARAPULSE PFA 的文檔回饋非常出色。

So I'd just love to get your view on what you're seeing in the field, the willingness to adopt the new technology, how fast it could go and how much of the guidance raise is just from FARAPULSE here and the opportunity.

因此，我很想了解您對這一領域所看到的情況、採用新技術的意願、新技術的發展速度以及有多少指導籌集來自 FARAPULSE 和機會的看法。

Yes. First, I want to shout out to early pioneering work by Chris O'Hara, the amazing work by the FARAPULSE team and really the work our team has done over multiple years. This is the most transformational product that I've seen in my career with the company. And Dr. Stein can comment on clinically, but we continue to invest significantly in the current platform and in future products and a significant amount of clinical science to really widen the gap in PFA with our FARAPULSE system.

是的。首先，我要讚揚 Chris O'Hara 的早期開創性工作、FARAPULSE 團隊的出色工作以及我們團隊多年來所做的工作。這是我在公司的職業生涯中見過的最具變革性的產品。 Stein 博士可以在臨床上發表評論，但我們將繼續對當前平台和未來產品以及大量臨床科學進行大量投資，以真正擴大 PFA 與我們的 FARAPULSE 系統的差距。

And as I mentioned in the script, we're seeing very rapid adoption from both RF and cryo users. We continue to invest in our commercial footprint in the U.S. And we're able to meet the demand thus far with our talented supply chain teams.

正如我在腳本中提到的，我們看到 RF 和冷凍用戶都非常迅速地採用該技術。我們繼續投資我們在美國的商業足跡，並且我們能夠透過我們才華橫溢的供應鏈團隊滿足迄今為止的需求。

But we're also excited about the ongoing momentum in Europe, where we've been live for a number of years. But we continue to increase utilization in Europe and open new centers now that they have a bit more supply than they did in 2023.

但我們也對歐洲的持續發展勢頭感到興奮，我們已經在歐洲開展了多年。但我們繼續提高歐洲的利用率並開設新的中心，因為它們的供應量比 2023 年要多一些。

And we're also working diligently with our teams in Asia, in Japan and China, to train them up so they can also take advantage of FARAPULSE really kind of more of a fourth quarter 2025 story in Asia.

我們也與亞洲、日本和中國的團隊努力合作，對他們進行培訓，以便他們也能利用 FARAPULSE，這更像是 2025 年第四季在亞洲的故事。

So it really -- it's a remarkable platform and we're seeing excellent safety results, ease of use, rapid adoption and excellent effectiveness. Dr. Stein, if you want to comment?

所以它確實是一個了不起的平台，我們看到了出色的安全結果、易用性、快速採用和卓越的有效性。史坦博士，您想發表評論嗎？

Yes. Thanks. Thanks, Mike. Thanks, Robbie. Maybe the one thing I'd add, I'd just -- the caution here is against thinking of PFA in general, that every PFA system is very different and I think everyone really needs to be evaluated on its own. So the results you get with PFA are just completely dependent on catheter design, on waveform and on dosing strategy. And as Mike said, what people see when they use FARAPULSE clinically, when people see the data and we've now got published data including randomized clinical trial data, registry data, total data at well over 18,000 patients have reported at this point, and as Mike said, it just has compelling advantages in terms of safety, in terms of efficacy, in terms of ease of use and in terms of efficiency. And that's what you see driving the rapid uptake, both in the U.S. and globally.

是的。謝謝。謝謝，麥克。謝謝，羅比。也許我要補充的一件事是——這裡要注意的是，不要普遍考慮 PFA，每個 PFA 系統都非常不同，我認為每個人都需要單獨進行評估。因此，使用 PFA 獲得的結果完全取決於導管設計、波形和給藥策略。正如Mike 所說，當人們在臨床上使用FARAPULSE 時，當人們看到數據時，我們會看到什麼，我們現在已經發布了數據，包括隨機臨床試驗數據、註冊數據、目前報告的超過18,000 名患者的總數據，以及正如麥克所說，它只是在安全性、功效、易用性和效率方面具有引人注目的優勢。這就是您所看到的推動美國和全球快速普及的因素。

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。

I echo Robbie's congratulations on a really strong quarter here. Just with my one question, I feel compelled to ask a big-picture question here. You updated your LRP in September of last year to 8% to 10% organic growth for 2024 to 2026. The assumption at the time was that growth in '25 would accelerate over 2024. You're guiding today to 10% to 12% organic growth.

我同意羅比對本季強勁表現的祝賀。就我的一個問題而言，我覺得有必要在這裡問一個大局問題。您在去年 9 月將 LRP 更新為 2024 年至 2026 年的有機增長 8% 至 10%。 當時的假設是 25 年的增長將在 2024 年加速。 。

So the question is, do you still expect growth to accelerate in 2025? And how should we think about the 8% to 10% CAGR in the context of this strong 2024 guidance?

那麼問題是，您仍然預期 2025 年成長會加速嗎？在這強而有力的 2024 年指導的背景下，我們應該如何看待 8% 至 10% 的複合年增長率？

Yes. So we outlined at Investor Day the 8% to 10% and our goal to be a very high-performing med tech company. And so we're super pleased with the first quarter results that also led to -- and the business momentum led to the guidance you referred to at 10% to $12. So we're pleased with taking our full year guidance up. We did also receive FARAPULSE earlier than we expected.

是的。因此，我們在投資者日概述了 8% 至 10% 的目標，以及成為一家業績非常出色的醫療科技公司的目標。因此，我們對第一季的業績非常滿意，這也導致了——業務勢頭導致了您提到的 10% 至 12 美元的指導。因此，我們很高興上調全年指導。我們也確實比我們預期的更早收到了 FARAPULSE。

So at this point, we'll hold off and look at our 2025 guidance later in the year. But we're super pleased with the momentum that we have across all regions and all business units. But at this point, we're not going to commit to accelerating growth in 2025. Certainly, our aim would be to do that, but it would be premature to confirm that at this point.

因此，目前我們將推遲並在今年稍後考慮我們的 2025 年指導。但我們對所有地區和所有業務部門的勢頭感到非常滿意。但目前，我們不會承諾在 2025 年加速成長。

The next question comes from Rick Wise with Stifel.

下一個問題來自 Stifel 的 Rick Wise。

I guess I'd focus on perhaps ACURATE neo. It sounds like it's performing well internationally. But can you maybe expand on where you are both internationally, the new product you spoke about and you're feeling about next steps in the United States? Are you feeling more optimistic, more cautious about timing? And just any incremental color would be just great.

我想我可能會專注於 ACURATE neo。聽起來它在國際上表現不錯。但您能否詳細介紹一下您在國際上的地位、您談到的新產品以及您對美國下一步行動的感受？您對時機是否更加樂觀、更加謹慎？任何增量顏色都會很棒。

Sure. Thanks, Rick. We're very pleased with the results in Europe. We continue to grow above market in Europe and have excellent adoption across most major countries in Europe. And importantly, as you said, we've invested quite a bit in this portfolio and we're excited about the Prime submission that we just recently did in Europe, which will enhance the valve further and provide additional valve sizes as well. So we expect that to go well in Europe.

當然。謝謝，瑞克。我們對歐洲的結果非常滿意。我們的成長繼續高於歐洲市場，並在歐洲大多數主要國家得到了良好的採用。重要的是，正如您所說，我們在這個產品組合上投入了大量資金，並且我們對最近在歐洲提交的 Prime 感到興奮，這將進一步增強閥門並提供額外的閥門尺寸。所以我們預計這在歐洲會進展順利。

In the U.S., there's really not going to be any new commentary that we haven't stated publicly. We are waiting for the full year follow-up. We also will be working with the regulators, and we'll communicate in the future date the timing of the release of that clinical data and our next steps in the U.S.

在美國，確實不會有任何我們沒有公開發表的新評論。我們正在等待全年的後續行動。我們還將與監管機構合作，我們將在未來溝通臨床數據的發佈時間以及我們在美國的下一步。

The next question comes from Joanne Wuensch with Citi.

下一個問題來自花旗銀行的 Joanne Wuensch。

Another nice quarter. A question on operating margins. I think your LRP was 450 basis points over -- was it over the 2-year period, I would assume? But anyway...

又一個美好的季度。關於營業利益率的問題。我認為你們的 LRP 超出了 450 個基點——我猜是在 2 年期間嗎？但不管怎麼說...

No, it was over -- it was -- not to interrupt you, Joanne. It was just over the 3-year period. 2024 to 2026 was 150 basis points.

不，已經結束了——是的——不是為了打擾你，喬安妮。時間剛剛過去3年。 2024年至2026年為150個基點。

Excellent. Thank you for that clarification. But as I'm looking at the quarter delivery, it looks like some of the leverage came from R&D, some of it came from SG&A. I'm just curious how you're thinking about providing that leverage over the 3-year period.

出色的。謝謝你的澄清。但當我查看季度交付情況時，看起來有些槓桿來自研發，有些來自銷售、管理和行政費用。我只是好奇你們如何考慮在三年期間提供這種槓桿作用。

Yes. I think over the 3-year period, all lines will contribute. And I think it's really a great part of the history of the company and the kind of the DNA of the margin expansion story is that at any given point in time, all lines can contribute. So gross margin at that 69.8%, I didn't love that this quarter, but I'm optimistic that, that improves through the year.

是的。我認為在三年期間，所有線路都會做出貢獻。我認為這確實是公司歷史的重要組成部分，而利潤擴張故事的 DNA 是，在任何給定的時間點，所有產品線都可以做出貢獻。毛利率為 69.8%，我不喜歡這個季度的毛利率，但我樂觀地認為，這種情況全年都會有所改善。

But we said at Investor Day and we reiterated it on our January call, that gross margin probably is not going to contribute this year to the 30 to 50 points. So this year, it's more of an OpEx leverage story. But absolutely, in '25 and '26, I think gross margin can contribute. Recall, we used to be at 72.4% gross margin back in 2019. We're maniacally focused on getting back and improving that from where it is today and have the plans to do that.

但我們在投資者日表示，並在 1 月的電話會議上重申，今年的毛利率可能不會達到 30 至 50 點。所以今年，更多的是關於營運支出槓桿的故事。但毫無疑問，在 25 年和 26 年，我認為毛利率可以做出貢獻。回想一下，2019 年我們的毛利率曾經是 72.4%。

So I think the summary is, as we look to improve the 150 basis points over the 3 years, it puts us kind of at the doorstep of 28% at the end of '26, which is a nice spot to be. It puts that 30% long-term goal that we have really in focus. And all lines of the P&L could contribute along that journey.

所以我認為總結是，當我們希望在 3 年內提高 150 個基點時，這使我們在 26 年底接近 28%，這是一個不錯的位置。它使我們真正關注的 30% 長期目標成為焦點。損益表的所有項目都可以在這過程中做出貢獻。

The next question comes from Vijay Kumar with Evercore ISI.

下一個問題來自 Evercore ISI 的 Vijay Kumar。

Congrats on really solid finish here. Mike, maybe my one question on the EP portfolio. The 70% overall growth, 85% in the U.S., how -- can you give us a little bit of color on was there any stocking dynamic? How much of this was driven by the account openings versus a procedure uptake?

恭喜你在這裡取得了非常紮實的成績。麥克，也許是我關於 EP 作品集的一個問題。整體成長 70%，美國成長 85%，您能給我們透露庫存動態嗎？其中有多少是由開戶與程序採用所推動的？

And sort of related to that, does new tech add-on payment, does it matter where we are on TPT?

與此相關的是，新技術附加支付對我們在 TPT 上的位置重要嗎？

Yes. So the results in the U.S., 85% as you mentioned, it was really a mid-quarter launch. So the teams moved pretty quickly to have some impact in the first quarter. And we look forward to good results, obviously, in the second quarter and the rest of the year based on momentum.

是的。因此，正如您所提到的，美國的結果為 85%，這實際上是季度中期的發布。因此，各支球隊的行動很快，在第一季就產生了一些影響。顯然，我們期待在第二季和今年剩餘時間內取得良好的業績。

So there's not any big onetime stocking. So this is driven by new account openings and I would say very rapid adoption of the technology, and therefore, continued utilization of the product once they have the platform. We're also seeing multiple hospitals buying their second console, which also is a great sign because it shows the adoption and using it routinely every day.

所以沒有什麼大的一次性庫存。因此，這是由新帳戶開設推動的，我想說的是，該技術的採用非常迅速，因此，一旦他們擁有該平台，就會繼續使用該產品。我們還看到多家醫院購買了他們的第二台控制台，這也是一個很好的跡象，因為它表明了它的採用和每天的例行使用。

And so it's really new account openings and increased adoption once they start using the platform, and that's driving the U.S. results.

因此，一旦他們開始使用該平台，就會開設新帳戶並增加採用率，這推動了美國的業績。

And as I mentioned, in Europe, which I think is impressive, now that they have a bit more supply, they continue to open more accounts and increase the utilization of existing accounts with the FARAPULSE platform.

正如我所提到的，在歐洲，我認為這令人印象深刻，現在他們有了更多的供應，他們繼續透過 FARAPULSE 平台開設更多帳戶並提高現有帳戶的利用率。

On the TPT, we think it's a bit less significant for FARAPULSE, but it's something we'll continue to evaluate. And we'll provide you updates as we see them. Dr. Stein?

在 TPT 上，我們認為這對 FARAPULSE 來說不太重要，但我們將繼續評估這一點。我們會及時向您提供最新情況。斯坦博士？

I described that, that's NTAP.

我描述過，那就是 NTAP。

I'm sorry.

對不起。

Yes. And Vijay, I think just important maybe to point out. First off, right, the NTAP applies to inpatient Medicare fee-for-service, which is really a small minority of AF ablations today. Having said that, we still do believe that FARAPULSE can use the proposed NTAP related to one of our customers.

是的。維傑（Vijay），我認為也許需要指出這一點很重要。首先，NTAP 適用於住院醫療保險按服務收費，這實際上只是當今 AF 消融的一小部分。話雖如此，我們仍然相信 FARAPULSE 可以使用與我們的一位客戶相關的建議 NTAP。

And actually, I think it's important from a physician perspective and a hospital perspective, that we're not in a position of having to create unique ICD-10 codes that are product-specific. That's really not helpful to either the physicians or the hospitals.

事實上，我認為從醫生和醫院的角度來看，我們不必創建特定於產品的獨特 ICD-10 代碼，這一點很重要。這對醫生或醫院來說確實沒有幫助。

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。

Congrats again on a good quarter. I wanted to ask about the new DRG for ablation and left atrial appendage closure. And then the overall LAC market, is that -- do you think that market can kind of sustain this 20%-plus growth through -- before the indication expansions? Or do you kind of need to see those indication expansions at some point sooner rather than later?

再次恭喜季度表現良好。我想詢問用於消融和左心耳封堵的新 DRG。那麼整個 LAC 市場，您認為在適應症擴張之前，市場能否維持 20% 以上的成長？或者您是否需要在某個時候盡快看到這些指示擴展？

I'll make comments and Dr. Stein. We're pleased with our WATCHMAN performance. We grew globally 19%. But keep in mind, that's coming off of nearly a 30% comp from first quarter 2023. And we still maintain, if not enhance, our strong share position.

我和史丹博士會發表評論。我們對《守望者》的表現感到滿意。我們的全球成長率為 19%。但請記住，與 2023 年第一季相比，這一比例下降了近 30%。

And we're excited not only with the share position but with the growth of WATCHMAN, but also some upcoming trials that can further highlight with OPTION and CHAMPION, which we believe, if successful, will significantly widen the market, TAM, for WATCHMAN. So Dr. Stein, if you want to comment on any of that and also the concomitant item.

我們不僅對份額地位感到興奮，而且對WATCHMAN 的成長感到興奮，而且還對一些即將進行的試驗感到興奮，這些試驗可以進一步突出OPTION 和CHAMPION，我們相信，如果成功，將顯著擴大WATCHMAN 的TAM 市場。斯坦博士，如果你想對其中任何一個以及伴隨的項目發表評論。

Yes. Thanks, Mike. Yes. So Travis, first on the trials, I mean, first of all, this is still a healthy market. This is still a very under-penetrated therapy when you look at patients who were at high risk for stroke and AF who stand to benefit from -- with the WATCHMAN procedure.

是的。謝謝，麥克。是的。特拉維斯，首先是試驗，我的意思是，首先，這仍然是一個健康的市場。當你觀察那些中風和心房顫動高風險患者，透過 WATCHMAN 手術可以受益時，這仍然是一種滲透率很低的療法。

The trials that Mike mentioned, right, the first one is the OPTION trial, that evaluates the use of WATCHMAN as an alternative to oral anticoagulants following ablation. And we hope to be able to present the results of that trial late this year or early next year. Then that's followed CHAMPION, which is the all-comers trial versus the novel oral anticoagulants. Again, we expect that to report out in 2026. So these are now -- in the relatively near term that we're going to see those data points.

Mike提到的試驗，對，第一個是OPTION試驗，評估消融後使用WATCHMAN作為口服抗凝血劑的替代品。我們希望能夠在今年年底或明年初公佈該試驗的結果。接下來是 CHAMPION，這是針對新型口服抗凝血劑的全民試驗。同樣，我們預計將在 2026 年發布報告。

Before that, right, I think it is worth talking a little bit about that concomitant DRG that's part of the proposed rule from CMS. We're really gratified to see that. This is something that's good for everyone. This is good for patients. This is good for hospitals. When you think of valve outpatients who are undergoing an ablation procedure, first off, I'll tell you even back when I was doing these procedures, almost every patient who came in before wanted to know would they be able to stop their oral anticoagulants, and that is still true today.

在此之前，我認為值得討論一下伴隨的 DRG，它是 CMS 提議的規則的一部分。我們真的很高興看到這一點。這對每個人來說都是一件好事。這對患者來說是有好處的。這對醫院來說是好事。當你想到正在接受消融手術的瓣膜門診患者時，首先，我會告訴你，甚至在我做這些手術的時候，幾乎每個進來的病人都想知道他們是否能夠停止口服抗凝血劑，今天仍然如此。

And when you think about it from a patient-centered perspective, right, being able to do this all at one setting and avoiding the incremental risks that you have in undergoing two procedures, it really just makes sense. It also makes sense from a hospital standpoint when you just look at the procedural efficiencies and how that's going to help hospitals improve capacity to be doing more AF ablations and doing more WATCHMAN procedures over time.

當你從以患者為中心的角度思考時，對吧，能夠在一個環境中完成這一切，並避免在進行兩次手術時所面臨的增量風險，這確實是有道理的。從醫院的角度來看，當您只專注於手術效率以及這將如何幫助醫院提高能力，隨著時間的推移進行更多房顫消融和更多 WATCHMAN 手術時，這也是有意義的。

So we're excited to see this. We think this is good for patients. We think this is good for hospitals. And we look forward to getting the data out from trials like OPTION and CHAMPION that's even going to further increase the impetus for doing these procedures.

所以我們很高興看到這一點。我們認為這對患者有好處。我們認為這對醫院有利。我們期待從 OPTION 和 CHAMPION 等試驗中獲得數據，這甚至會進一步增加執行這些程序的動力。

The next question comes from Danielle Antalffy with UBS.

下一個問題來自瑞銀集團的 Danielle Antalffy。

I'll also say congrats on a really strong quarter. For my one question, I wanted to look at some of the, I'll call them, legacy businesses, not sure if that's fair to describe the maybe slower-growth businesses.

我還要祝賀這個季度的強勁表現。對於我的一個問題，我想看看一些我稱之為遺留企業的企業，不確定這是否可以公平地描述可能成長較慢的企業。

I mean, a CRM mid-single-digit growth is very strong. Interventional Cardiology of double digits, very strong. Just curious about how to think about those sort of slower growth in Interventional Cardiology. I'm thinking more on the drug-eluting stent portfolio, obviously, and then CRM. Can they sustain these kinds of growth profiles given that the end markets, or from a volume perspective, are arguably probably some of your slower-growth end markets? And what needs to happen from an innovation perspective to sustain that sort of growth?

我的意思是，CRM 中個位數的成長非常強勁。介入性心臟病學兩位數，很強。只是好奇如何看待介入性心臟病學的這種緩慢增長。顯然，我更多地考慮的是藥物洗脫支架組合，然後是 CRM。鑑於終端市場或從銷售角度來看，它們可能是成長較慢的終端市場，他們能否維持這種成長態勢？從創新的角度來看，需要做些什麼才能維持這種成長？

Thanks, Danielle. Really appreciate you asking that question. I would say the innovation has already happened. Let me just explain a bit more. We call it ICTx, our interventional cardiology business essentially. And years ago, that was dominated by drug-eluting stents.

謝謝，丹妮爾。真的很感謝你問這個問題。我想說創新已經發生了。讓我再解釋一下。我們稱之為 ICTx，本質上是我們的介入性心臟病學業務。多年前，藥物洗脫支架占主導地位。

Today, drug-eluting stents, I think, represent close to 4% of our overall mix and likely will be 3% and 2% in the following years. So it's really a very small portion of Boston Scientific and a smaller portion of ICTx.

我認為，如今藥物洗脫支架占我們整體產品組合的近 4%，並且在接下來的幾年中可能會達到 3% 和 2%。所以它實際上只是波士頓科學公司的一小部分，也是 ICTx 的一小部分。

So what's driving the 13% growth within ICTx is our advanced imaging portfolio. So you're seeing more and more patients come with more complex calcium and the growing adoption of IVUS imaging, especially with our AVVIGO+ platform to identify that and help the effectiveness of these procedures.

因此，推動 ICTx 成長 13% 的是我們先進的影像產品組合。因此，您會看到越來越多的患者患有更複雜的鈣，並且越來越多地採用 IVUS 成像，特別是透過我們的 AVVIGO+ 平台來識別這一點並幫助提高這些手術的有效性。

So you're seeing wide adoption in Europe of our imaging platform, wide adoption in Asia and growing adoption in the U.S. based on this new platform. So it's really the imaging capabilities as well as our complex coronary capabilities to break calcium with Wolverine and our other products.

因此，您會看到我們的成像平台在歐洲被廣泛採用，在亞洲得到廣泛採用，並且基於這個新平台在美國得到越來越多的採用。因此，真正利用 Wolverine 和我們的其他產品分解鈣的能力是成像能力以及複雜的冠狀動脈能力。

And then in Asia, they've been very successful in launching our AGENT drug-coated balloon and we recently received approval for that. We'll have some minor benefit in the second quarter '24 from that product in the U.S., where we expect enhanced growth from that product in the second half of '24 and particularly in 2025.

然後在亞洲，他們非常成功地推出了我們的 AGENT 藥物塗層氣球，我們最近獲得了批准。我們將在 24 年第二季從該產品在美國獲得一些小收益，我們預計該產品在 24 年下半年，特別是 2025 年將實現強勁成長。

So the team there has really done a great job of completely revamping the portfolio and the growth trajectory of ICTx. Also included in that is our Structural Heart business in Europe.

因此，那裡的團隊在徹底改變 ICTx 的投資組合和成長軌跡方面確實做得非常出色。其中也包括我們在歐洲的結構心臟業務。

And CRM, that grew 5% and we kind of essentially grow in line, I would say, with the market with pacemakers and defibrillators. S-ICD business continues to be quite robust. But the bigger growth driver in our CRM business is our diagnostics business. And we invested in that many years ago with our Preventice platform and also with our -- now our second-generation loop recorder ICM device.

CRM 成長了 5%，我想說，我們基本上與起搏器和除顫器市場的成長一致。 S-ICD 業務仍然相當強勁。但我們的 CRM 業務更大的成長動力是我們的診斷業務。多年前，我們透過 Preventice 平台以及現在的第二代循環記錄器 ICM 設備進行了投資。

So we've really reshaped the portfolio significantly in both of those markets to continue to support the growth of the company.

因此，我們確實在這兩個市場上大幅調整了投資組合，以繼續支持公司的成長。

The next question comes from Josh Jennings with TD Cowen.

下一個問題來自 TD Cowen 的 Josh Jennings。

Wanted to ask about the EP business and just opening an update on your view of the diagnostic mapping opportunity. You initiated the NAVIGATE-PF study where the software module is going to be in play.

想詢問有關 EP 業務的信息，只是更新您對診斷繪圖機會的看法。您啟動了 NAVIGATE-PF 研究，其中軟體模組將發揮作用。

I guess the question is really are you seeing increased demand in these early stages of PFA launch for RHYTHMIA? And just how are you viewing the opportunity for Boston to take share in this diagnostic mapping segment of the EP world?

我想問題是，在 PFA 推出的早期階段，您是否看到 RHYTHMIA 的需求增加？您如何看待波士頓在 EP 領域的診斷繪圖領域分享的機會？

Dr. Stein, if you could take that one?

史丹博士，你可以拿走那個嗎？

Yes. It's still early in the launch. And I think one thing that I do want to sort of emphasize as you look at how things are playing out in the launch is we're really working with accounts to say don't change a lot of your workflow at the outset. Get used to using FARAPULSE, see how it works in your cases and then start modifying your workflow.

是的。現在還處於啟動初期。我認為，當您看到發布過程中的情況時，我確實想強調的一件事是，我們確實正在與客戶合作，表示不要從一開始就改變很多工作流程。習慣使用 FARAPULSE，了解它在您的案例中如何運作，然後開始修改您的工作流程。

So really, what we've seen early in launch really are deliberately not a big shift in whether or not people are mapping. Not a big shift in what mapping platform they're using.

因此，實際上，我們在發布初期所看到的情況確實是故意不讓人們在繪製地圖方面發生重大轉變。他們使用的地圖平台並沒有發生很大的變化。

Now having said that, right, we have deliberately built our next-generation product and that's the FARAWAVE Nav-enabled catheter, right, that interfaces with the FARAVIEW software. And as I think everyone has seen, we've initiated our first human use studies of that earlier this year.

話雖如此，我們特意打造了下一代產品，那就是支援 FARAWAVE Nav 的導管，對，它與 FARAVIEW 軟體互動。我想每個人都已經看到，我們已經在今年早些時候啟動了首次人類使用研究。

That really will bring some unique advantages to people who want to use a navigation system as they're using FARAPULSE. It is our desire and our belief, right, that there will be people who don't feel the need to use any mapping when they're doing pulmonary vein isolation with FARAPULSE who are adopting a very efficient workflow that's been used in a lot of centers in Europe. There will be others who want to continue to use a navigation mapping system. We have no intention of forcing people to use our system. We're not going to lock it down. But this new software platform really does bring some very compelling advantages to people who will use it.

這確實會給那些想要使用 FARAPULSE 的導航系統的人帶來一些獨特的優勢。這是我們的願望和信念，對吧，會有人在使用 FARAPULSE 進行肺靜脈隔離時感覺不需要使用任何映射，他們正在採用一種非常高效的工作流程，該工作流程已在許多項目中使用歐洲中心。還有其他人希望繼續使用導航地圖系統。我們無意強迫人們使用我們的系統。我們不會鎖定它。但這個新的軟體平台確實為使用它的人帶來了一些非常引人注目的優勢。

The next question comes from Chris Pasquale with Nephron Research.

下一個問題來自 Nephron Research 的 Chris Pasquale。

How are you thinking about the opportunity for AGENT in the U.S.? And you mentioned you're still working to ramp up manufacturing capacity. When do you expect to be in a position to move into a full launch with that product?

您如何看待美國代理商的機會？您提到您仍在努力提高製造能力。您預計什麼時候能夠全面推出產品？

Sure. So we have the NICE approval, excellent trial design by the clinical team and the product is doing extremely well in Japan and we have high hopes for the product has impact in the second half and more in 2025.

當然。因此，我們獲得了 NICE 的批准，臨床團隊出色的試驗設計，該產品在日本的表現非常好，我們對該產品在下半年乃至 2025 年產生影響寄予厚望。

So currently, we're really going through the contracting process with most of the big accounts in the U.S. and that's initiated. And that's going well, given there is a high unmet clinical need with in-stent restenosis and the deliverability that's been proven with AGENT. So there's high physician demand for it. But we are going through the contracting process with the major health systems now, and you'll start seeing some sales in the second quarter. And we expect that to ramp more significantly throughout the second half of the year and accelerate more in '25.

目前，我們正在與美國的大多數大客戶進行簽約流程，並且已經啟動。鑑於支架內再狹窄的臨床需求尚未滿足，且 AGENT 已證明其可輸送性，因此進展順利。所以醫生對它的需求很高。但我們現在正在與主要衛生系統簽訂合同，您將在第二季度開始看到一些銷售。我們預計這一趨勢將在今年下半年更加顯著成長，並在 25 年加速。

Yes. And Chris, and just to remind everyone, right? Our current label indication in the U.S. in-stent restenosis, that comprises approximately 10% of current PCI volume. Internationally, we also see DCBs used and we believe there is a potential use case outside of in-stent restenosis, small vessel disease, bifurcation lesions, potentially even some acute coronary syndrome. And once we launch in the U.S., we are evaluating opportunities to expand the label. And those expanded indications could potentially take us up to 20% of current PCI volume.

是的。還有克里斯，只是為了提醒大家，對吧？我們目前在美國的標籤適應症為支架內再狹窄，約佔目前 PCI 數量的 10%。在國際上，我們也看到 DCB 的使用，我們相信除了支架內再狹窄、小血管疾病、分叉病變，甚至可能是一些急性冠狀動脈綜合徵之外，還有潛在的用例。一旦我們在美國推出，我們就會評估擴大品牌規模的機會。這些擴大的適應症可能會佔到目前 PCI 數量的 20%。

The next question comes from Matthew O'Brien with Piper Sandler.

下一個問題來自馬修·奧布萊恩和派珀·桑德勒。

I don't have perfect numbers here, but in looking at the U.S. EP number in Q1, it looks like you did somewhere around $40 million in FARAPULSE revenue between the generator and the catheter itself. Is that roughly the right number?

我這裡沒有完美的數字，但看看第一季的美國 EP 數字，看起來您在發生器和導管本身之間的 FARAPULSE 收入約為 4000 萬美元。這個數字大致正確嗎？

And then when I start to carry this out through the rest of the year plus the guidance increase, I'm getting something more like $300 million to even $400 million of FARAPULSE this year. Is that around the right number? And can you manufacture enough product to support that?

然後，當我開始在今年剩餘時間執行此操作，再加上指導增加時，我今年將獲得大約 3 億美元甚至 4 億美元的 FARAPULSE。這個數字合適嗎？您能生產足夠的產品來支持這一點嗎？

Yes. We won't confirm your math. At this point, we're not going to be breaking out FARAPULSE cases, numbers, number of accounts, dollars and so forth yet. If you recall back to the WATCHMAN days, we really waited till it was about close to $1 billion platform before we provided that based on the materiality of the company.

是的。我們不會確認你的數學。目前，我們還不會透露 FARAPULSE 案例、數字、帳戶數量、美元等。如果你還記得《守護者》時代，我們真的等到平台價值接近 10 億美元後，才根據公司的重要性提供這個平台。

But it's going extremely well. And importantly, we made significant investments in the supply chain 2 and 3 years ago to be ready for where we are today. And the supply chain team continues to perform extremely well, and they're able thus far to meet the demand in Europe and the U.S. and the future in Asia.

但進展非常順利。重要的是，我們在兩三年前對供應鏈進行了大量投資，為今天的發展做好了準備。供應鏈團隊繼續表現出色，到目前為止他們能夠滿足歐洲和美國以及亞洲未來的需求。

The next question comes from Matt Taylor with Jefferies.

下一個問題來自傑弗里斯的馬特泰勒。

I actually wanted to follow up on your AGENT commentary. Two small questions. One is, can you talk about the materiality in Japan? And when you mentioned the indication expansions, could you talk about what those could look like and when we could see them in the U.S.?

我實際上想跟進你的特工評論。兩個小問題。一是，您能談談日本的物質性嗎？當您提到適應症擴展時，您能談談這些擴展會是什麼樣子以及我們什麼時候可以在美國看到它們嗎？

Just maybe really not a whole lot of new color in Japan. But they launched it last year and it was adopted very, very quickly and it's leading to the strong double-digit growth in Japan that we saw in the quarter.

只是日本可能真的沒有很多新顏色。但他們去年推出了它，並且很快就得到了採用，這導致了我們在本季度看到的日本強勁的兩位數增長。

In terms of indication expansion, Dr. Stein, do you want to take that one?

在適應症擴展方面，Stein博士，你想吃那個嗎？

Yes, Matt. Again, I think probably the first new indications we think about looking for would be small vessel bifurcation lesions. Still working through regulatory strategy on that. So not prepared to give you a time line for when we would initiate any of that work.

是的，馬特。同樣，我認為我們考慮尋找的第一個新適應症可能是小血管分叉病變。仍在為此制定監管策略。因此，我們不准備向您提供我們何時啟動任何一項工作的時間表。

The next question comes from Matt Miksic with Barclays.

下一個問題來自巴克萊銀行的馬特·米克西奇。

Just maybe one follow-up on the cadence for FARAPULSE this year in the U.S. and sort of how the RHYTHMIA adoption navigation kind of plays into that. Any color for what we can expect as you get into the rest of the quarters would be great.

也許只是今年 FARAPULSE 在美國的節奏的一個後續行動，以及 RHYTHMIA 採用導航如何發揮作用。當你進入剩下的季度時，我們可以期待的任何顏色都會很棒。

Thanks, Matt. Probably not too much new commentary here. I think in FARAPULSE overall, it's -- we're developing very strong capabilities to install, support and train doctors and really scale that up in the U.S., given the high demand for it. And we're able -- resource-wise, we put a lot of focus on that as we continue to expand that. And there obviously are a lot of strong relationships we have with those EPs given our WATCHMAN experience and our CRM experience. So it's a lot of resource planning and training and executing every day in the field to open up new accounts.

謝謝，馬特。這裡可能沒有太多新的評論。我認為 FARAPULSE 總體而言，我們正在開發非常強大的能力來安裝、支援和培訓醫生，並在美國真正擴大規模，因為對它的需求很高。我們有能力——在資源方面，我們在繼續擴展的過程中投入了大量精力。鑑於我們的 WATCHMAN 經驗和 CRM 經驗，我們顯然與這些 EP 建立了許多牢固的關係。因此，每天需要在現場進行大量的資源規劃、培訓和執行才能開設新帳戶。

Dr. Stein gave some commentary on the mapping. So today, some accounts don't use mapping when they're driving maybe optimal workflow and many accounts are using their existing mapping system. And we don't intend to force our customers to move away.

史丹博士對繪圖做了一些評論。因此，今天，一些帳戶在驅動可能最佳的工作流程時不使用映射，而許多帳戶正在使用現有的映射系統。我們並不打算強迫我們的客戶離開。

However, we do -- as Dr. Stein mentioned, based on what we've seen with the our mapping navigation system, we do think there will be incremental clinical benefits and productivity gains in using that.

然而，正如 Stein 博士所提到的，根據我們在地圖導航系統中所看到的情況，我們確實認為使用該系統將會帶來增量臨床效益和生產力提升。

So we are starting to see an increase in RHYTHMIA orders, and we anticipate enhanced RHYTHMIA -- FARAPULSE mapping orders as we go through the second half of this year because there will be clinical benefits from it. But as Dr. Stein mentioned, we really want to have hospitals choose the correct mapping system and FARAPULSE works excellent today with the competitors, but we would expect some enhanced benefit with ours.

因此，我們開始看到 RHYTHMIA 訂單的增加，並且我們預計今年下半年 RHYTHMIA - FARAPULSE 測繪訂單會有所增加，因為它將從中帶來臨床益處。但正如 Stein 博士所提到的，我們確實希望醫院選擇正確的測繪系統，FARAPULSE 目前與競爭對手的配合非常出色，但我們希望我們的系統能帶來一些更大的好處。

And just to verify, is there time for one last question?

我想確認一下，還有最後一個問題嗎？

Yes, Drew. We'll take one more, please.

是的，德魯。請我們再拿一張。

That will come from Michael Polark with Wolfe Research.

這將來自沃爾夫研究中心的邁克爾·波拉克（Michael Polark）。

I want to ask the gross margin commentary, the inventory charges, Dan. Can you quantify the impact in the quarter? And what's the nature of those charges? What's going on? And the other thing I heard was increased mix of capital in the quarter. I think it seems highly likely to be FARAPULSE generator driven, but if there's anything else underneath that comment, I'd welcome the color.

我想問毛利率評論，庫存費用，丹。您能否量化本季的影響？這些指控的性質是什麼？這是怎麼回事？我聽到的另一件事是本季資本組合的增加。我認為它似乎很可能是 FARAPULSE 發電機驅動的，但如果該評論下面還有其他內容，我會歡迎這種顏色。

Sure. Thanks for the question, Mike. We're not going to quantify the inventory charges, but it was much more than we're used to in a given quarter, and that's why we called it out and it has an impact.

當然。謝謝你的提問，麥克。我們不會量化庫存費用，但它比我們在特定季度所習慣的要高得多，這就是我們提出這一點並且它產生了影響的原因。

I will say a piece of it, not an insignificant piece of it, is kind of due to the success of FARAPULSE. So it's not kind of all bad per se relative to our results, but it's still inventory charges and it still reduced the gross margin in the quarter. But that's what gives me the confidence and the optimism that heading into the rest of the year, we won't see inventory charges at the level that we saw them in Q1 as we go through 2024.

我想說的是，其中一部分，而不是微不足道的一部分，是由於 FARAPULSE 的成功。因此，相對於我們的業績而言，這本身並不全然是壞事，但它仍然是庫存費用，並且仍然降低了本季的毛利率。但這讓我充滿信心和樂觀，在今年剩餘時間裡，我們不會看到 2024 年庫存費用達到第一季的水平。

On the capital, yes, a piece of that is related to FARAPULSE. But we also -- as Mike mentioned, we also have a really successful launch in our IVUS business, which has some capital with it. And not insignificantly as well, we have some in the Urology business associated with the Lumenis.

在首都，是的，其中一部分與 FARAPULSE 有關。但正如麥克所提到的，我們的 IVUS 業務也取得了非常成功的啟動，該業務擁有一些資本。同樣重要的是，我們在泌尿科業務中也有一些與 Lumenis 相關的產品。

So it was probably led by the launch of FARAPULSE, but we did have a little bit more in some of the other launches in some of the other businesses with respect to capital. But overall message should be 69.8%, a little lower than we would have liked, but still have a goal this year of getting back to that 70.7% or slightly below that for the year for gross margin.

因此，這可能是由 FARAPULSE 的推出帶動的，但我們在其他一些業務的其他一些推出中確實有更多的資本。但總體訊息應該是 69.8%，比我們希望的要低一些，但今年的目標仍然是毛利率回到 70.7% 或略低於今年的水平。

All right. Thanks, everyone, 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.

好的。謝謝大家今天加入我們。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。

Before you disconnect, Drew will give you all the pertinent details for the replay.

在您斷開連接之前，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 8726199 until May 1, 2024, at 11:59 p.m. Eastern Time.

請注意，在 2024 年 5 月 1 日晚上 11:59 之前，請使用重播代碼 8726199，撥打 1 (877) 344-7529 或 1 (412) 317-0088，在 1 小時內即可獲得錄音。東部時間。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

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。