Boston Scientific Corp (BSX) 2022 Q4 法說會逐字稿

Good morning, and welcome to the Boston Scientific Fourth Quarter 2022 Earnings Call. (Operator Instructions) Please note, this event is being recorded. I would now like to turn the conference over to Lauren Tengler, Vice President, Investor Relations. Please go ahead.

早上好，歡迎來到波士頓科學公司 2022 年第四季度財報電話會議。 （操作員說明）請注意，正在記錄此事件。我現在想將會議轉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.

謝謝你，德魯。歡迎大家，感謝您今天加入我們。與我一起出席今天電話會議的有董事長兼首席執行官邁克·馬奧尼 (Mike Mahoney)；執行副總裁兼首席財務官 Dan Brennan。

We issued a press release earlier this morning announcing our Q4 and full year '22 results, which includes 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.

我們今天早上早些時候發布了一份新聞稿，宣布了我們的第四季度和 22 年全年業績，其中包括對新聞稿中使用的非 GAAP 措施的調節。我們已經在我們網站的“投資者關係”部分的財務和備案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 GAAP 措施的對賬。今天上午的電話會議將持續約 1 小時。

Mike and Dan will provide comments on Q4 and full year performance as well as the outlook for our business, including 2023 guidance, and then we'll take your questions.

Mike 和 Dan 將就第四季度和全年業績以及我們的業務前景發表評論，包括 2023 年的指導，然後我們將回答您的問題。

During today's Q&A session, Mike and Dan will be joined by our Chief Medical Officer, Dr. Ian Meredith and Dr. Ken Stein.

在今天的問答環節中，我們的首席醫療官 Ian Meredith 博士和 Ken Stein 博士將加入 Mike 和 Dan。

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.

在我們開始之前，我想提醒大家，在電話會議上，營業收入增長不包括外匯波動的影響，有機收入增長進一步不包括收購和資產剝離，其可比淨銷售額少於整個時期。

Relevant acquisitions excluded for organic growth or Preventice, Farapulse and Lumenis Surgical, which closed in March, August and September of 2021, respectively, as well as Baylis Medical, which closed on February 14, 2022.

相關收購不包括有機增長或 Preventice、Farapulse 和 Lumenis Surgical，它們分別於 2021 年 3 月、8 月和 9 月關閉，以及 Baylis Medical，於 2022 年 2 月 14 日關閉。

Divestitures include the BTG Specialty Pharmaceuticals business, which closed on March 1, 2021. Guidance excludes the previously announced agreements to purchase a majority stake in M.I. Tech and Acotec as well as the acquisition of Apollo Endosurgery, which are all expected to close in the first half of 2023.

資產剝離包括 BTG Specialty Pharmaceuticals 業務，該業務於 2021 年 3 月 1 日關閉。指引不包括先前宣布的購買 M.I. 多數股權的協議。 Tech 和 Acotec 以及對 Apollo Endosurgery 的收購預計都將在 2023 年上半年完成。

For more information, please refer to our financial and operating highlights deck, which may be found on our Investor Relations website.

欲了解更多信息，請參閱我們的財務和運營亮點平台，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 the 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.

在這次電話會議上，除非另有說明，否則所有對銷售和收入的引用都是有機的。本次電話會議包含聯邦證券法含義內的前瞻性陳述，這些陳述可以用預期、預期、可能、相信、估計和其他類似詞語來識別。其中包括關於我們的增長和市場份額、新的和預期的產品批准和發布、收購、臨床試驗、成本節約和增長機會、我們的現金流和預期用途的聲明；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，則實際結果可能與我們的前瞻性陳述中表達或暗示的預期和預測存在重大差異。

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. These statements speak only as of today's date, and we disclaim any intention or obligation to update them. At this point, I'll turn it over to Mike.

可能導致此類差異的因素包括我們最近向美國證券交易委員會提交的 10-K 和後續 10-Q 的風險因素部分中描述的因素。這些聲明僅代表今天的日期，我們不承擔更新它們的任何意圖或義務。在這一點上，我會把它交給邁克。

Thanks, Lauren, and thank you to everyone for joining us today. 2022 represented a return to more durable and consistent procedural growth within the markets we serve, which provided a stronger base for our innovative portfolio.

謝謝勞倫，感謝大家今天加入我們。 2022 年代表著我們服務的市場將恢復更持久和一致的程序增長，這為我們的創新產品組合提供了更堅實的基礎。

I'm very proud of the resiliency and winning spirit of our global team, delivering on our sales and EPS goals despite the ongoing macroeconomic and supply chain challenges. Importantly, we delivered strong performance across all geographic regions and believe that most all of our business units gained or maintained market share throughout the year.

我為我們全球團隊的韌性和獲勝精神感到非常自豪，儘管面臨持續的宏觀經濟和供應鏈挑戰，我們仍實現了我們的銷售和 EPS 目標。重要的是，我們在所有地理區域都取得了強勁的業績，並且相信我們的大部分業務部門全年都獲得或保持了市場份額。

In fourth quarter '22, total company operational sales grew 9% and organic sales grew 7% versus fourth quarter '21, which was the low end of the guidance range. However, it's very important to note that these results include an unplanned sales reserve of $60 million, established for an Italian government payback provision which resulted in a headwind of approximately 200 basis points for the quarter.

22 年第四季度，與 21 年第四季度相比，公司總營業銷售額增長了 9%，有機銷售額增長了 7%，這是指導範圍的低端。然而，非常重要的是要注意這些結果包括 6000 萬美元的計劃外銷售儲備金，該儲備金是為意大利政府的回報條款而設立的，該條款導致本季度出現約 200 個基點的逆風。

The underlying fourth quarter performance was strong on both sales, operating margin increases and earnings per share. And without the impact of the Italian sales reserve, we would have achieved the high end of our organic sales guidance range of 7% to 9%.

第四季度的基本業績在銷售額、營業利潤率增長和每股收益方面都表現強勁。如果沒有意大利銷售儲備的影響，我們本可以實現 7% 至 9% 的有機銷售指導範圍的高端。

Full year '22 operational sales grew 11% versus '21, while organic sales grew 9%, in line with our guidance of approximately 9%.

與 21 年相比，22 年全年的運營銷售額增長了 11%，而有機銷售額增長了 9%，符合我們大約 9% 的指導。

Fourth quarter adjusted EPS of $0.45 declined minus 2% versus '21, and full year adjusted EPS of $1.71 grew 5% versus '21, both achieved in the low end of the guidance range. Once again, without the impact of the Italian sales reserve, we would achieve the high end of the guidance range for both fourth quarter and full year of $1.71 to $1.74.

第四季度調整後每股收益為 0.45 美元，與 21 年相比下降了負 2%，全年調整後每股收益為 1.71 美元，與 21 年相比增長了 5%，均處於指導範圍的低端。再一次，如果沒有意大利銷售儲備的影響，我們將在第四季度和全年達到 1.71 美元至 1.74 美元的指導範圍的高端。

We generated full year free cash flow of $950 million and adjusted free cash flow of $2.1 billion, in line with our expectations.

我們產生了 9.5 億美元的全年自由現金流，調整後的自由現金流為 21 億美元，符合我們的預期。

Now for outlook for 2023. We are guiding to organic growth of 6% to 8% for both first quarter '23 and full year '23, which excludes the acquisition of Apollo Endosurgery and the majority stake investments in M.I. Tech and Acotec, all of which are expected to close in the first half of 2023.

現在展望 2023 年。我們指導 23 年第一季度和 23 年全年有機增長 6% 至 8%，這不包括收購 Apollo Endosurgery 和對 M.I. 的多數股權投資。 Tech 和 Acotec，預計都將在 2023 年上半年關閉。

Our first quarter '23 adjusted EPS estimate is $0.42 to $0.44, and we expect our full year adjusted EPS to be $1.86 to $1.93. And despite the ongoing macroeconomic pressures and supply chain headwinds, we remain committed to our goal of plus 50 basis points of operating margin expansion and double-digit adjusted EPS growth in 2023.

我們 23 年第一季度調整後的每股收益估計為 0.42 美元至 0.44 美元，我們預計全年調整後的每股收益為 1.86 美元至 1.93 美元。儘管宏觀經濟壓力和供應鏈逆風持續存在，但我們仍然致力於實現我們的目標，即 2023 年營業利潤率增長 50 個基點，調整後每股收益實現兩位數增長。

Dan will provide more details on our '22 performance, the Italian sales reserve and our '23 outlook. I'll now provide some additional highlights on '22 results along with comments on our '23 outlook.

丹將提供更多關於我們 22 年業績、意大利銷售儲備和 23 年展望的詳細信息。我現在將提供一些關於 '22 結果的額外亮點以及對我們 '23 展望的評論。

Regionally, on an operational basis, the U.S. grew 10% versus fourth quarter '21. Full year '22 grew 11%, inclusive of a 300 basis point tailwind from acquisitions, with particular strength in our WATCHMAN, Endo and urology business units.

從地區來看，在運營基礎上，美國與 2021 年第四季度相比增長了 10%。 22 年全年增長 11%，包括收購帶來的 300 個基點的順風，我們的 WATCHMAN、Endo 和泌尿科業務部門尤其強勁。

Europe, Middle East and Africa grew 11% on an operational basis versus fourth quarter '21 and 12% on a full year basis. This above-market growth was supported by ongoing investments in emerging markets, new and ongoing product launches across the portfolio, pricing 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 with Baylis in the Access Solutions franchise.

與 2021 年第四季度相比，歐洲、中東和非洲在運營基礎上增長了 11%，全年增長了 12%。這種高於市場的增長得益於對新興市場的持續投資、整個產品組合中新產品和持續產品的發布、定價紀律和強大的商業執行力。我們對未來一年感到興奮，因為該地區的持續發展勢頭，特別是我們創新的 EP 產品組合以及 Baylis 在 Access Solutions 特許經營權方面的進一步機會。

Asia Pacific grew 10% operationally versus fourth quarter '21 and 12% for the full year. On a full year basis, 6 out of 8 business units grew double digits, supported by ongoing innovation across the region. Full year Japan growth was driven by new products, including POLARx, which has approximately 50% share in open accounts.

與 2021 年第四季度相比，亞太地區的運營增長了 10%，全年增長了 12%。在全年基礎上，在整個地區不斷創新的支持下，8 個業務部門中有 6 個實現了兩位數增長。日本全年增長是由新產品推動的，包括 POLARx，它在開放賬戶中佔有約 50% 的份額。

We look forward to 2023 with ongoing momentum from both new products and are excited about our recent approval and reimbursement received for AGENT DCB, which is a coronary drug-coated balloon for in-stent restenosis in small vessels.

我們期待著 2023 年這兩種新產品的持續發展勢頭，並對我們最近收到的 AGENT DCB 批准和報銷感到興奮，這是一種用於小血管支架內再狹窄的冠狀動脈藥物塗層球囊。

On a full year basis, China grew more than 20%, fueled by 13 new product launches, ongoing portfolio diversification and the team's resiliency and execution. We continue to expand our presence in the China market with the recently announced acquisition of a majority stake in Acotec.

在全年基礎上，中國增長超過 20%，這得益於 13 款新產品的發布、持續的產品組合多元化以及團隊的彈性和執行力。我們最近宣布收購 Acotec 的多數股權，繼續擴大我們在中國市場的影響力。

We believe this investment can create strategic value for both companies with opportunities to collaborate in R&D, manufacturing and commercial strategies. We also continue to expect China to be a double-digit grower in '23 despite ongoing VBP pressure and potential impact to procedure volumes in Q1 from COVID.

我們相信這項投資可以為兩家公司創造戰略價值，並有機會在研發、製造和商業戰略方面進行合作。我們還繼續預計中國將在 23 年實現兩位數的增長，儘管 VBP 壓力持續存在，並且 COVID 對第一季度手術量的潛在影響。

In Latin America, the momentum continued with operational sales growth of 16% versus fourth quarter '21 and full year growth of 28%, with all business units growing double digits versus '21.

在拉丁美洲，與 21 年第四季度相比，營業銷售額增長 16%，全年增長 28%，與 21 年相比，所有業務部門均實現兩位數增長，這一勢頭仍在繼續。

On the business units, starting with urology. Urology sales grew 12%, both operationally and organically versus fourth quarter '21 and on a full year basis. They grew 15% operationally and 10% organically versus '21. Within the quarter, all franchises grew double digits, fueled by new and ongoing product launches and continued global expansion.

在業務部門，從泌尿科開始。與 2021 年第四季度和全年相比，泌尿外科銷售額在運營和有機方面增長了 12%。與 21 年相比，他們的運營增長了 15%，有機增長了 10%。在本季度內，所有特許經營權都實現了兩位數的增長，這得益於新產品和持續推出的產品以及持續的全球擴張。

On a full year basis, global growth was driven by key products such as LithoVue, Rezum and SpaceOAR as well as the acquisition of the Lumenis and the Moses Laser Technology, further complementing the urology portfolio. Endoscopy sales grew 7% organically in the quarter, and on a full year basis grew 8% organically versus '21.

從全年來看，全球增長是由 LithoVue 、 Rezum 和 SpaceOAR 等關鍵產品以及對 Lumenis 和 Moses Laser Technology 的收購推動的，進一步補充了泌尿科產品組合。本季度內窺鏡銷售額有機增長 7%，與 21 年相比，全年有機增長 8%。

In '22, we had global success with innovative products such as AXIOS and Single-Use-Imaging, both growing over 20% and supporting strong growth across the globe. In the fourth quarter, we announced our intent to acquire Apollo Endosurgery, which will add a complementary and innovative endoluminal surgery portfolio.

22 年，我們憑藉 AXIOS 和 Single-Use-Imaging 等創新產品在全球取得了成功，兩者均增長了 20% 以上，並支持全球範圍內的強勁增長。在第四季度，我們宣布了收購 Apollo Endosurgery 的意向，這將增加一個互補和創新的腔內手術產品組合。

We look forward to closing this acquisition as well as our previously announced majority stake in M.I. Tech, which includes the innovative HANAROSTENT in the first half of '23. Neuromodulation sales grew 5% organically versus fourth quarter '21 and on a full year basis grew 3% organically versus '21.

我們期待完成此次收購以及我們之前宣布的 M.I. 多數股權。 Tech，其中包括 23 年上半年的創新 HANAROSTENT。與 21 年第四季度相比，神經調節銷售額有機增長 5%，與 21 年第四季度相比，全年有機增長 3%。

Globally, our spinal cord stimulation business grew 4% in the fourth quarter with continued physician enthusiasm for WaveWriter Alpha and FAST. We continue to invest in clinical evidence to expand indications and presented 3-month data from our nonsurgical back study, SOLIS, at NANS earlier this year. The study comparing SCS to conventional medical management met its primary endpoints, and we anticipate FDA approval for nonsurgical back indication by the end of '23.

在全球範圍內，由於醫生對 WaveWriter Alpha 和 FAST 的持續熱情，我們的脊髓刺激業務在第四季度增長了 4%。我們繼續投資於臨床證據以擴大適應症，並在今年早些時候在 NANS 上展示了我們的非手術回溯研究 SOLIS 的 3 個月數據。將 SCS 與傳統醫療管理進行比較的研究達到了其主要終點，我們預計 FDA 將在 23 年底前批准非手術背部適應症。

Our Brain franchise grew double digits in the quarter and low double digits on a full year basis. This strong performance is aided by continued momentum from new product launches in '22 as well as the recent launch of the Vercise 2-in-1 lead extension.

我們的 Brain 特許經營權在本季度增長了兩位數，全年增長了兩位數。這種強勁的表現得益於 22 年新產品發布的持續勢頭以及最近推出的 Vercise 2 合 1 領先擴展。

Peripheral Intervention sales grew 9% organically versus both fourth quarter '21 and full year '21. Within Arterial, we are pleased with the performance of our drug-eluting portfolio growing strong double digits for the full year and achieving the #1 global position -- I'm sorry, the #1 position within SFA in the U.S.

與 21 年第四季度和 21 年全年相比，外圍干預銷售額有機增長了 9%。在 Arterial 內部，我們很高興我們的藥物洗脫產品組合全年實現兩位數的強勁增長，並在全球排名第一——對不起，在美國 SFA 中排名第一。

On a full year basis, our Venous franchise was flat versus prior year with Varithena, our market-leading varicose vein offering, growing over 20% in 2022. Our Interventional Oncology franchise performed well in '22, growing low double digits, led by our portfolio of innovative cancer therapies and suite of embolization tools.

從全年來看，我們的靜脈特許經營權與上一年持平，我們市場領先的靜脈曲張產品 Varithena 在 2022 年增長了 20% 以上。我們的介入腫瘤特許經營權在 22 年表現良好，增長低兩位數，由我們的領導創新癌症療法組合和栓塞工具套件。

We continue to invest in expanding the potential applications of TheraSphere and enrolled our first patient in our early feasibility study, FRONTIER (inaudible) in the image of -- safety of image-guided intra-arterial delivery of TheraSphere GBM in patients with the reoccurring glioblastoma.

我們繼續投資擴大 TheraSphere 的潛在應用，並在我們的早期可行性研究 FRONTIER（聽不清）中招募了我們的第一位患者 - 圖像引導的 TheraSphere GBM 動脈內遞送在復發性膠質母細胞瘤患者中的安全性.

Cardiology delivered another excellent quarter, with operational sales growing 13% and organic sales growing 10% versus fourth quarter '21. On a full year basis, sales grew up 14% operationally and 10% organically. Our newly aligned cardiology group delivered strong growth across its 4 businesses, as we continue to invest in the higher growth segments and differentiated offerings for our customers that address the areas of greatest cardiac need for patients.

心髒病學又迎來了一個出色的季度，與 21 年第四季度相比，營業銷售額增長了 13%，有機銷售額增長了 10%。從全年來看，營業銷售額增長 14%，有機銷售額增長 10%。我們新調整的心髒病學集團在其 4 項業務中實現了強勁增長，因為我們繼續投資於更高增長的領域和為我們的客戶提供差異化產品，以滿足患者最大的心臟需求領域。

Within Cardiology, Interventional Cardiology Therapy sales grew 5% organically in fourth quarter and on a full year basis grew 8% organically versus '21. On a full year basis, the Coronary Therapies' franchise, which includes both drug-eluting stents and complex PCI grew 7%, driven by strong performance in our international regions and our imaging franchise.

在心髒病學領域，介入心髒病學療法銷售額在第四季度有機增長 5%，與 21 年相比全年有機增長 8%。在全年的基礎上，包括藥物洗脫支架和復雜 PCI 在內的冠狀動脈治療特許經營權增長了 7%，這得益於我們在國際地區和成像特許經營權的強勁表現。

Our structural Heart Valves franchise grew double digits in both fourth quarter and the full year basis, outpacing the market in Europe with our ACURATE Neo2 aortic valve. Ongoing clinical evidence to support growth throughout '22 and in the fourth quarter.

我們的結構性心臟瓣膜特許經營權在第四季度和全年均增長了兩位數，憑藉我們的 ACURATE Neo2 主動脈瓣超過了歐洲市場。持續的臨床證據支持整個 22 世紀和第四季度的增長。

Data from the ACURATE Neo2 PMCF study was presented as a late-breaker at PCR London Valves, demonstrating positive safety and 30-day outcomes with low PVL rates and best-in-class pacemaker implantation rates. Additionally, we enrolled our first patient in the ACURATE Prime XL Nested Registry, assessing the safety and efficacy of the ACURATE Prime Aortic Valve XL to treat patients with severe aortic restenosis who need a larger valve size for the TAVR procedure.

來自 ACURATE Neo2 PMCF 研究的數據作為 PCR London Valves 的晚期突破者提出，證明了積極的安全性和 30 天的結果以及低 PVL 率和一流的起搏器植入率。此外，我們在 ACURATE Prime XL 嵌套登記處登記了我們的第一位患者，以評估 ACURATE Prime 主動脈瓣 XL 治療需要更大尺寸瓣膜進行 TAVR 手術的嚴重主動脈再狹窄患者的安全性和有效性。

WATCHMAN sales grew 22% organically versus fourth quarter '21 and on a full year basis grew 24% organically versus '21. Q4 finished with record sales, strong utilization in the U.S. supported by the DAPT label expansion. Importantly, we completed the enrollment of our CHAMPION-AF trial way ahead of schedule. This head-to-head trial versus novel oral anticoagulation has the potential to more than triple the number of patients indicated for WATCHMAN FLX in 2027 and beyond.

WATCHMAN 銷售額與 21 年第四季度相比有機增長 22%，與 21 年第四季度相比有機增長 24%。第 4 季度在 DAPT 標籤擴張的支持下，銷售額創歷史新高，在美國的利用率很高。重要的是，我們提前完成了 CHAMPION-AF 試驗的註冊。這項與新型口服抗凝藥的面對面試驗有可能在 2027 年及以後使 WATCHMAN FLX 適應症患者數量增加三倍以上。

We remain excited about this outlook for this business and expect double-digit growth in 2023, fueled by innovation, ongoing clinical evidence and strong commercial execution. CRM sales grew 6%, both operationally and organically versus fourth quarter '21 and on a full year basis grew 8% operationally and 7% organically.

我們仍然對該業務的前景感到興奮，並預計在創新、持續的臨床證據和強大的商業執行力的推動下，2023 年將實現兩位數的增長。與 2021 年第四季度相比，CRM 銷售額在運營和有機方面增長了 6%，並且在全年的基礎上，運營增長了 8%，有機增長了 7%。

Our diagnostics franchise had a strong year, growing double digits versus '21. In core CRM, on the full year basis, our high-voltage business grew low single digits, and our low voltage business grew mid-single digits, and we expect that all major markets were in line or slightly above the market.

我們的診斷專營權在這一年表現強勁，與 21 年相比增長了兩位數。在核心 CRM 中，從全年來看，我們的高壓業務增長了低個位數，低壓業務增長了中等個位數，我們預計所有主要市場都與市場持平或略高於市場。

Electrophysiology sales grew 76% operationally and 25% organically versus fourth quarter '21 and on a full year basis grew 69% operationally and 18% organically versus '21. Importantly, our international EP business continues to outpace the market, growing over 40% organically versus fourth quarter '21.

與 21 年第四季度相比，電生理學銷售額在運營上增長了 76%，有機增長了 25%，與 21 年第四季度相比，全年在運營上增長了 69%，有機增長了 18%。重要的是，我們的國際 EP 業務繼續跑贏市場，與 21 年第四季度相比有機增長超過 40%。

POLARx continues to perform well in both Europe and Japan has now been treated to treat over 25,000 patients since launch. Momentum in FARAPULSE continues with another strong quarter of growth in Europe. And we continue to invest in clinical evidence and look forward to the readout of the randomized ADVENT U.S. IDE trial in the second half of '23 and are planning to initiate our ADVANTAGE-AF trial to these FARAPULSE patients with persistent AFib imminently.

POLARx 在歐洲和日本繼續表現良好，自推出以來已治療超過 25,000 名患者。 FARAPULSE 的勢頭繼續保持，歐洲又一個強勁的季度增長。我們繼續投資於臨床證據，並期待在 23 年下半年讀出隨機 ADVENT 美國 IDE 試驗，併計劃立即對這些持續性 AFib 的 FARAPULSE 患者啟動我們的 ADVANTAGE-AF 試驗。

We've been very pleased with the performance of our Baylis acquisition and the innovative VersaCross platform, which grew 2x faster than the market in '22. We launched our VersaCross Connect in '22, improving efficiencies in our WATCHMAN procedure.

我們對收購 Baylis 和創新的 VersaCross 平台的表現感到非常滿意，該平台的增長速度比 22 年的市場快兩倍。我們在 22 年推出了 VersaCross Connect，提高了 WATCHMAN 程序的效率。

Earlier this year, we shared our strategy consistent with years past. We continue to position ourselves to win in the markets we play through meaningful innovation by balancing our financial commitments. And in '22, we announced 4 acquisitions, invested 10% of our sales in internal R&D to fund sustainable growth and advance patient care.

今年早些時候，我們分享了與過去幾年一致的戰略。我們通過平衡我們的財務承諾，繼續通過有意義的創新在我們所參與的市場中取勝。在 22 年，我們宣布了 4 項收購，將銷售額的 10% 投資於內部研發，以資助可持續增長和推進患者護理。

We're extremely excited about the year ahead and remain focused on our people and sustaining a culture that is motivated to drive differentiated performance and achieve our long-term goals, continuing to grow sales faster than markets, continuing to expand operating margins and delivering double-digit adjusted EPS growth and strong adjusted free cash flow generation.

我們對未來的一年感到非常興奮，並將繼續關注我們的員工並維持一種積極推動差異化績效和實現我們長期目標的文化，繼續以高於市場的速度增長銷售額，繼續擴大營業利潤率並實現雙倍增長-數字調整後的每股收益增長和強勁的調整後自由現金流產生。

So before I turn it over to Dan, I want to share that with the retirement of Dr. Ian Meredith, Dr. Ken Stein will assume some of the global responsibilities that previously fell under Ian, including total company investor engagement, in addition to CRM, EP and WATCHMAN roles.

所以在我把它交給 Dan 之前，我想分享一下 Ian Meredith 博士的退休，Ken Stein 博士將承擔一些以前屬於 Ian 的全球責任，包括公司投資者的全面參與，以及 CRM , EP 和 WATCHMAN 角色。

Please join me in congratulating Ken, and thank Ian for his many contributions. With that, I'll pass it off to Dan to provide more details on the financials.

請和我一起祝賀 Ken，並感謝 Ian 所做的許多貢獻。有了這個，我會把它傳遞給 Dan，以提供有關財務的更多詳細信息。

Thanks, Mike. Fourth quarter consolidated revenue of $3.242 billion represents a 3.7% reported revenue growth versus the fourth quarter 2021 and reflects a $158 million headwind from foreign exchange, slightly favorable to our expectations as the U.S. dollar weakened throughout the quarter.

謝謝，邁克。第四季度的合併收入為 32.42 億美元，與 2021 年第四季度相比，報告的收入增長了 3.7%，反映了 1.58 億美元的外匯逆風，由於美元在整個季度走軟，略有利於我們的預期。

Excluding this 500 basis point headwind from foreign exchange, operational revenue growth was 8.7% in the quarter. Sales from the acquisition of Baylis contributed 160 basis points resulting in 7.1% organic revenue growth at the low end of our guidance range of 7% to 9% growth versus 2021, including an approximate 200 basis point impact associated with an unplanned sales reserve related to an Italian government payback provision, which was recorded in the fourth quarter of 2022.

排除外匯帶來的 500 個基點逆風，本季度營業收入增長 8.7%。收購 Baylis 的銷售額貢獻了 160 個基點，導致有機收入增長 7.1%，處於我們與 2021 年相比增長 7% 至 9% 的指導範圍的低端，包括與計劃外銷售儲備相關的約 200 個基點影響意大利政府的回報條款，記錄在 2022 年第四季度。

With the goal of recovering spending above the government's medical device budgets, this payback provision requires companies that have supplied medical devices to public hospitals in Italy to pay back a portion of these overrun amounts. While we and others in our industry, have appealed and will continue to challenge the enforceability of the law through the Italian court system.

為了收回超出政府醫療設備預算的支出，這項償還條款要求向意大利公立醫院提供醫療設備的公司償還部分超支金額。雖然我們和我們行業的其他人已經提出上訴，並將繼續通過意大利法院系統挑戰法律的可執行性。

We established a sales reserve of $60 million in the fourth quarter, representing our best estimates of amounts we could be required to pay back. Without the reserve, we would have achieved the high end of the organic revenue growth guidance range.

我們在第四季度建立了 6000 萬美元的銷售準備金，這是我們對可能需要償還的金額的最佳估計。如果沒有儲備，我們將達到有機收入增長指導範圍的高端。

Flow-through on the Italian sales reserve resulted in Q4 adjusted earnings per share of $0.45, at the low end of our range, representing a decline of 2% versus 2021. Without the reserve, we would have achieved the high end of our range for the quarter.

意大利銷售儲備的流轉導致第四季度調整後每股收益為 0.45 美元，處於我們範圍的低端，比 2021 年下降了 2%。如果沒有儲備，我們本可以達到我們範圍的高端季度。

Full year 2022 consolidated revenue of $12.682 billion represents 6.7% reported revenue growth versus full year 2021 and reflects a $524 million headwind from foreign exchange. Excluding this 440 basis point headwind from foreign exchange, operational revenue growth was 11.1% for the year.

2022 年全年合併收入為 126.82 億美元，與 2021 年全年相比報告收入增長 6.7%，反映了 5.24 億美元的外匯逆風。排除外匯帶來的 440 個基點逆風，全年營業收入增長 11.1%。

Sales from closed acquisitions contributed 240 basis points, resulting in 8.7% organic revenue growth, in line with expectations and inclusive of a 50 basis point impact associated with the Italian sales reserve. Full year 2022 adjusted earnings per share of $1.71 represents 4.8% growth versus 2021, achieving the low end of our guidance range of $1.71 to $1.74. Without the unplanned Italian sales reserve, we would have been at the high end of our full year guidance range.

已完成收購的銷售額貢獻了 240 個基點，導致 8.7% 的有機收入增長，符合預期，包括與意大利銷售儲備相關的 50 個基點影響。 2022 年全年調整後每股收益為 1.71 美元，比 2021 年增長 4.8%，達到我們 1.71 美元至 1.74 美元指導範圍的下限。如果沒有計劃外的意大利銷售儲備，我們將處於全年指導範圍的高端。

Adjusted gross margin for the fourth quarter was 70.5%, resulting in full year 2022 adjusted gross margin also of 70.5%, in line with our expectations. Full year adjusted gross margin improved versus 2021, driven by an FX tailwind of approximately 100 basis points related to our hedging contracts, partially offset by continued macroeconomic headwinds.

第四季度調整後毛利率為 70.5%，2022 年全年調整後毛利率也為 70.5%，符合我們的預期。與 2021 年相比，全年調整後的毛利率有所提高，這得益於與我們的對沖合約相關的外匯順風約 100 個基點，部分被持續的宏觀經濟逆風所抵消。

These headwinds were approximately $375 million versus 2019 and are predominantly from increased freight costs and unfavorable manufacturing variances primarily related to direct material cost and availability.

與 2019 年相比，這些不利因素約為 3.75 億美元，主要來自運費增加和主要與直接材料成本和可用性相關的不利製造差異。

Our 2023 guidance assumes macroeconomic and supply chain headwinds will be similar to 2022. Different from prior years, we expect first half 2023 gross margin to be higher than the second half, largely due to the timing of foreign exchange movements that occurred during 2022.

我們的 2023 年指引假設宏觀經濟和供應鏈逆風將與 2022 年相似。與往年不同，我們預計 2023 年上半年的毛利率將高於下半年，這主要是由於 2022 年發生的外匯變動時間。

Fourth quarter adjusted operating margin was 25.7% resulting in full year 2022 adjusted operating margin of 25.6%, improving 30 basis points versus 2021, inclusive of a 30 basis point negative impact from the unplanned Italian sales reserve.

第四季度調整後營業利潤率為 25.7%，2022 年全年調整後營業利潤率為 25.6%，比 2021 年提高 30 個基點，其中包括意大利計劃外銷售儲備帶來的 30 個基點負面影響。

As we look to 2023, we continue to focus on our goal of annual operating margin expansion. And despite our expectation of continued macroeconomic headwinds, our goal is to achieve approximately 26.4% adjusted operating margin for the full year 2023, representing 80 basis points of improvement versus the 2022 adjusted operating margin of 25.6% and importantly, 50 basis points of expansion compared to the full year 2022 adjusted operating margin without the impact of the Italian sales reserve.

展望 2023 年，我們將繼續專注於擴大年度營業利潤率的目標。儘管我們預計宏觀經濟將持續逆風，但我們的目標是在 2023 年全年實現約 26.4% 的調整後營業利潤率，與 2022 年調整後的營業利潤率 25.6% 相比提高了 80 個基點，重要的是，與 2022 年相比擴大了 50 個基點到 2022 年全年調整後的營業利潤率，不受意大利銷售儲備的影響。

On a GAAP basis, the fourth quarter operating margin was 12.4%, including $131 million in litigation-related expenses, which I'll provide detail on in a moment. Moving to below the line.

根據 GAAP，第四季度營業利潤率為 12.4%，其中包括 1.31 億美元的訴訟相關費用，稍後我將提供詳細信息。移動到線下。

Fourth quarter adjusted interest and other expense totaled $88 million, resulting in full year adjusted interest and other expense of $362 million, slightly higher than our expectations, driven in part by an FX loss from certain unhedged currencies.

第四季度調整後的利息和其他費用總計 8800 萬美元，導致全年調整後的利息和其他費用為 3.62 億美元，略高於我們的預期，部分原因是某些未對沖貨幣的外匯損失。

On an adjusted basis, our tax rate for the fourth quarter was 11.9% and 12.7% for the full year 2022 including discrete tax items and the benefit from stock compensation accounting. Our operational tax rate was 12% for the fourth quarter and 13.5% for the full year, slightly favorable to our expectations of approximately 14%.

在調整後的基礎上，我們第四季度的稅率分別為 11.9% 和 2022 年全年的 12.7%，包括離散稅項和股票薪酬會計的收益。我們第四季度的營業稅率為 12%，全年為 13.5%，略高於我們約 14% 的預期。

Fully diluted weighted average shares outstanding ended at 1.442 billion in Q4 and 1.440 billion for the full year 2022. Adjusted free cash flow for the quarter was $776 million, and free cash flow was $597 million with $807 million from operating activities less $210 million of net capital expenditures.

第四季度完全稀釋的加權平均流通股為 14.42 億股，2022 年全年為 14.40 億股。本季度調整後的自由現金流為 7.76 億美元，自由現金流為 5.97 億美元，其中 8.07 億美元來自經營活動減去 2.1 億美元的淨額資本支出。

Full year 2022 adjusted free cash flow was $2.1 billion, in line with expectations, and free cash flow was $949 million with $1.5 billion from operating activities less $576 million of net capital expenditures.

2022 年全年調整後的自由現金流為 21 億美元，符合預期，自由現金流為 9.49 億美元，其中 15 億美元來自經營活動減去 5.76 億美元的淨資本支出。

For 2023, we expect adjusted free cash flow in excess of $2.3 billion. As of December 31, 2022, we had cash on hand of $928 million. We continue to expect to close the acquisition of Apollo Endosurgery and the majority stake investments in M.I. Tech and Acotec with cash on hand or available credit lines in the first half of 2023.

到 2023 年，我們預計調整後的自由現金流量將超過 23 億美元。截至 2022 年 12 月 31 日，我們手頭現金為 9.28 億美元。我們繼續期望完成對 Apollo Endosurgery 的收購以及對 M.I. 的多數股權投資。 2023 年上半年擁有手頭現金或可用信貸額度的 Tech 和 Acotec。

Our top priority for capital allocation remains high-quality tuck-in M&A, and we'll continue to assess opportunities in conjunction with our financial goals. As of December 31, our leverage was 2.57x, in line with our expectations, and we were pleased to be upgraded to BBB+ with a stable outlook at both Fitch and Standard & Poor's within the quarter.

我們資本配置的首要任務仍然是高質量的併購，我們將繼續結合我們的財務目標評估機會。截至 12 月 31 日，我們的槓桿率為 2.57 倍，符合我們的預期，我們很高興在本季度內被惠譽和標準普爾評級上調至 BBB+，展望穩定。

Our legal reserve was $443 million as of December 31, an increase of $139 million from the prior quarter, primarily related to our mesh litigation. While our U.S. case count has remained materially the same over the past 3 years, we've increased our reserve to account for our latest estimates of the time and cost to resolve these claims as well as remaining probable and estimable global claims. I'll now walk through guidance for Q1 and the full year 2023.

截至 12 月 31 日，我們的法定儲備金為 4.43 億美元，比上一季度增加 1.39 億美元，主要與我們的網狀訴訟有關。雖然我們的美國案件數量在過去 3 年中基本保持不變，但我們增加了準備金，以反映我們對解決這些索賠的時間和成本的最新估計，以及剩餘的可能和可估計的全球索賠。我現在將介紹第一季度和 2023 年全年的指導意見。

And as a reminder, guidance excludes any acquisitions that have not yet closed. We expect full year 2023 reported revenue growth to be in a range of 5% to 7% versus 2022. Excluding an approximate 100 basis point headwind from foreign exchange, based on current rates, and a 20 basis point contribution from closed acquisitions, we expect full year 2023 organic revenue growth to be in a range of 6% to 8% versus 2022.

提醒一下，指南不包括任何尚未完成的收購。我們預計與 2022 年相比，2023 年全年報告的收入增長將在 5% 至 7% 之間。根據當前匯率，排除來自外彙的大約 100 個基點的逆風，以及來自已完成收購的 20 個基點的貢獻，我們預計與 2022 年相比，2023 年全年的有機收入增長將在 6% 至 8% 之間。

We expect first quarter 2023 reported revenue growth to be in a range of 3% to 5% versus Q1 2022. Excluding an approximate 350 basis point headwind from foreign exchange based on current rates and a 70 basis point contribution from closed acquisitions, we expect first quarter 2023 organic revenue growth to be in a range of 6% to 8%.

我們預計與 2022 年第一季度相比，2023 年第一季度報告的收入增長將在 3% 至 5% 之間。排除基於當前匯率的外匯逆風約 350 個基點和已完成收購的 70 個基點貢獻，我們預計首先2023 年季度有機收入增長將在 6% 至 8% 之間。

We expect our full year 2023 adjusted below-the-line expenses to be approximately $340 million. Under current legislation and forecasted geographic mix of sales, we forecast a full year 2023 operational tax rate of approximately 14%, with an adjusted tax rate of approximately 13% including the benefit of the accounting for stock compensation, which we expect will largely be recognized in the first quarter, resulting in a Q1 2023 adjusted tax rate of approximately 12%.

我們預計 2023 年全年調整後的線下支出約為 3.4 億美元。根據現行立法和預測的銷售地域組合，我們預測 2023 年全年的營業稅率約為 14%，調整後的稅率約為 13%，包括股票補償會計的收益，我們預計這將在很大程度上得到認可在第一季度，導致 2023 年第一季度調整後的稅率約為 12%。

We expect a fully diluted weighted average share count of approximately 1.447 billion shares for Q1 2023 and 1.464 billion shares for full year 2023, which includes the shares we expect to issue on June 1 this year related to our May 2020 mandatory convertible preferred stock offering. We expect the impact to adjusted earnings per share to be neutral with the preferred stock dividend ending at the time of conversion.

我們預計 2023 年第一季度的完全稀釋加權平均股數約為 14.47 億股，2023 年全年約為 14.64 億股，其中包括我們預計將於今年 6 月 1 日發行的與 2020 年 5 月強制性可轉換優先股發行相關的股票。我們預計對調整後每股收益的影響將與轉換時結束的優先股股息保持中性。

We expect full year adjusted earnings per share to be in a range of $1.86 to $1.93, representing 9% to 13% growth versus 2022. At current rates and existing hedging contracts, we anticipate a neutral impact from FX on full year 2023 adjusted earnings per share. We expect first quarter adjusted earnings per share to be in a range of $0.42 to $0.44. For more information, please check our Investor Relations website for Q4 2022 financial and operational highlights, which outlines more details on Q4 results and 2023 guidance.

我們預計全年調整後每股收益將在 1.86 美元至 1.93 美元之間，較 2022 年增長 9% 至 13%。按照當前匯率和現有對沖合約，我們預計外匯對 2023 年全年調整後每股收益的影響為中性分享。我們預計第一季度調整後每股收益將在 0.42 美元至 0.44 美元之間。有關更多信息，請查看我們的投資者關係網站，了解 2022 年第四季度的財務和運營亮點，其中概述了有關第四季度業績和 2023 年指導的更多詳細信息。

In closing, I'm very proud of the results that our global team achieved in 2022 with top-tier revenue performance and differentiated operating margin expansion despite a challenging macroeconomic environment, and I'm looking forward to continued momentum during 2023.

最後，我對我們的全球團隊在 2022 年取得的成果感到非常自豪，儘管宏觀經濟環境充滿挑戰，但我們的全球團隊仍取得了一流的收入表現和差異化的營業利潤率增長，我期待著 2023 年繼續保持增長勢頭。

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

有了這個，我會把它轉回 Lauren，他將主持問答。

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

謝謝，丹。德魯，讓我們在接下來的 30 分鐘左右開放提問。 （操作員說明）德魯，請繼續。

(Operator Instructions) The first question comes from Rick Wise with Stifel.

（操作員說明）第一個問題來自 Stifel 的 Rick Wise。

Great to see another excellent year from Boston Scientific. I guess to focus on 1 question, I'll start with your 2023 guidance. Obviously, the 6% to 8% guide is right in line with your long-term philosophy.

很高興看到波士頓科學公司又一個出色的一年。我想專注於 1 個問題，我將從您的 2023 年指南開始。顯然，6% 到 8% 的指導符合您的長期理念。

But you started in the same place in '22. You obviously, excluding the Italy issue, finished above 9% organically. Why again stick with the 6% to 8%? Is this conservatism, respect for lingering macro pressures or both? And maybe just as part of that, why model macro headwinds similar to '22?

但是你在 22 年從同一個地方開始。很明顯，不包括意大利問題，你有機地完成了 9% 以上。為什麼還要堅持 6% 到 8%？這是保守主義、對揮之不去的宏觀壓力的尊重，還是兩者兼而有之？也許只是作為其中的一部分，為什麼要模擬類似於 22 年的宏觀逆風？

The large-cap companies reporting to date, they're not Boston Scientific, but they're all in some way, shape or form highlighting the improving or less pressures from macro as they finish the year and start '23?

迄今為止報告的大型公司，它們不是波士頓科學公司，但它們都以某種方式、形狀或形式突出了宏觀壓力的改善或減輕，因為它們在今年結束並開始了 23 年？

It's Mike. Thanks for the compliments. Just to summarize your points, I guess. We're really happy with fourth quarter. Excluding that onetime Italy reserve grew plus 9%, basically high end of sales, high end of EPS. And as Dan said, really pleased that delivered top-tier revenue growth and I think one of the few companies that actually improved margins as well in '22.

是邁克。謝謝你的稱讚。我想只是總結一下你的觀點。我們對第四季度非常滿意。不包括曾經的意大利儲備增長 9%，基本上是銷售額的高端，EPS 的高端。正如丹所說，真的很高興實現了頂級收入增長，我認為這是少數幾家在 22 年實際提高利潤率的公司之一。

So we have a lot of momentum and we're excited, very bullish on '23 in the future here. On guidance, you don't win the day in February here. So we think the 6% to 8% guidance for full year is appropriate. For the full year, we're coming off a 9% growth comp in 2022.

所以我們有很大的動力，我們很興奮，非常看好未來的 23 年。根據指導，您不會在這裡贏得 2 月的一天。因此，我們認為全年 6% 至 8% 的指引是合適的。對於全年，我們將在 2022 年實現 9% 的增長。

And we obviously plan to grow as fast as we possibly can and continue to invest in the company. There are a couple of things that will be in -- there are pluses and minus. We're very bullish on the EP business, our momentum with WATCHMAN, with FARAPULSE. There's a couple of headwinds. We do believe on the CRM side. We grew about 6% or 7%, I guess, last year, 7% in a market that's low single digits when you include diagnostics. So we expect a little bit of a headwind there based on comps. China performed terrific for us in '22, and we expect them to deliver, again, excellent double-digit growth but potentially not quite as fast as they did in '22.

我們顯然計劃盡可能快地發展，並繼續投資於公司。有幾件事會出現——有優點也有缺點。我們非常看好 EP 業務，我們與 WATCHMAN 和 FARAPULSE 的勢頭。有一些不利因素。我們確實相信 CRM 方面。我猜，去年我們增長了大約 6% 或 7%，在一個包括診斷在內的市場中增長了 7%。因此，我們預計基於 comps 會有一些逆風。中國在 22 年的表現非常出色，我們預計他們將再次實現出色的兩位數增長，但可能不會像 22 年那樣快。

Also the underlying markets we compete at about 6%. So we think coming off a 9% comp, 6% to 8% full year estimate. This time of year is the smart prudent guidance to give, and we're going to push like to beat it.

此外，我們在基礎市場上的競爭約為 6%。因此，我們認為全年預期為 9%，6% 至 8%。每年的這個時候是明智而審慎的指導，我們將全力以赴擊敗它。

And then relative to the macroeconomic environment, Rick, the -- we kind of reiterated that $375 million that we saw in 2022 as being a similar headwind in 2023. As you saw through 2022, we have a pretty high-performing global supply chain organization that has been on top of this all through it, and which is the reason that we've been giving the updates at the level of specificity that we have.

然後相對於宏觀經濟環境，Rick，我們重申，我們在 2022 年看到的 3.75 億美元在 2023 年也是一個類似的逆風。正如你在 2022 年看到的那樣，我們有一個非常高效的全球供應鏈組織這一直是最重要的，這就是我們一直在我們所擁有的特異性水平上提供更新的原因。

So as you would imagine, as we went through our annual operating plan process and guidance preparation process, they really dug in at a detailed level to try and understand what 2023 could bring. There are some elements that look better, right? Freight does work better. You see fuel prices and oil prices coming down. So we're optimistic freight costs will be less.

因此，正如您想像的那樣，在我們完成年度運營計劃流程和指南準備流程時，他們真正深入挖掘，試圖了解 2023 年會帶來什麼。有些元素看起來更好，對吧？貨運確實效果更好。你會看到燃油價格和油價下降。所以我們樂觀地認為運費會降低。

The supply of materials and the cost of materials is still a bit uncertain and choppy and that direct labor piece that we had that in 2022, you've got to annualize that in 2023. So I think the prudent case right here, the prudent course for guidance in February is to assume that we don't get a lot of macroeconomic help in 2023, I'd love to be surprised as we go through the year that we get that help. But I think as we sit here in February, prudent to assume a similar headwind to what we saw last year.

材料供應和材料成本仍然有點不確定和波動，我們在 2022 年擁有的直接勞動力，你必須在 2023 年將其年化。所以我認為這裡的謹慎案例，謹慎的過程2 月份的指導是假設我們在 2023 年沒有得到很多宏觀經濟幫助，我很想在我們獲得這種幫助的這一年中感到驚訝。但我認為，當我們 2 月坐在這裡時，謹慎地假設與我們去年看到的情況類似的逆風。

The next question comes from Robbie Marcus with JPMorgan.

下一個問題來自摩根大通的 Robbie Marcus。

Congrats on a nice quarter. Maybe to start, Mike, at our conference last month, you were really bullish on FARAPULSE, and we saw EP have a nice beat in the quarter, particularly outside the U.S., where you have FARAPULSE and POLARx going now.

祝賀一個不錯的季度。也許首先，邁克，在我們上個月的會議上，你真的看好 FARAPULSE，我們看到 EP 在本季度表現出色，特別是在美國以外，你現在有 FARAPULSE 和 POLARx。

Maybe you could talk about your expectations what you saw in the quarter for FARAPULSE specifically and your expectations for it in 2023, especially after we get the data later in the back half of the year, assuming it looks good?

也許你可以談談你對 FARAPULSE 本季度的具體期望以及你對它在 2023 年的期望，尤其是在我們在今年下半年晚些時候獲得數據之後，假設它看起來不錯？

Sure. Yes, our EP business in the quarter grew 25% and it grew 40% or 50%, I think...

當然。是的，我們本季度的 EP 業務增長了 25%，增長了 40% 或 50%，我認為......

40% internationally.

國際 40%。

40% internationally and poorly in the U.S. because we don't have these products approved in the U.S. So that really drove the growth down to 25%. But I really look at the -- outside the U.S. growth as the key barometer for us.

國際上為 40%，而在美國則很差，因為我們沒有在美國批准這些產品，所以這確實將增長率降至 25%。但我確實將美國以外的增長視為我們的關鍵晴雨表。

And we're continuing to see great pickup with both our cryo platform and FARAPULSE. Cryo is a platform that is competing against a product that hasn't changed in a decade. And so physicians like the ease of use and the features of the cryo platform that we have in Japan and in Europe. So that's doing quite well, and we're hopeful to have approval for that second half of '23 in the U.S. here.

我們繼續看到我們的低溫平台和 FARAPULSE 的出色表現。 Cryo 是一個與十年未變的產品競爭的平台。因此，醫生喜歡我們在日本和歐洲擁有的冷凍平台的易用性和功能。所以這做得很好，我們希望在這裡獲得美國 23 年下半年的批准。

And then FARAPULSE is doing extremely well for both cryo users who have adopted FARAPULSE and point-to-point RF users, Dr. Stein is on the phone, so he can make some comments. But the utilization enthusiasm for FARAPULSE is extremely high, and we're very bullish as we look at 2023 in terms of our EP performance and outlook, especially in Europe and Japan.

然後 FARAPULSE 對於採用 FARAPULSE 的低溫用戶和點對點 RF 用戶來說都做得非常好，Stein 博士正在打電話，所以他可以發表一些評論。但 FARAPULSE 的使用熱情非常高，我們非常看好 2023 年的 EP 表現和前景，尤其是在歐洲和日本。

And if we can get some -- the approval of the cryo platform in the second half, the U.S. will perform quite well as well. And then we expect to see a big impact from FARAPULSE in '24. So the future of our EP business is very bright. We know it's a competitive field. We believe we have unique platforms in both FARAPULSE and cryo that are differentiated and showing that clinically where they're launched and we have an excellent commercial team ready to bring these to the U.S. So we don't give specific guidance for EP, but it's clearly a critical growth driver for us '23 and well beyond that. Dr. Stein, if you have any other comments?

如果我們能在下半年獲得一些——冷凍平台的批准，美國也會表現得很好。然後我們希望在 24 年看到 FARAPULSE 的巨大影響。因此，我們 EP 業務的未來非常光明。我們知道這是一個競爭激烈的領域。我們相信我們在 FARAPULSE 和 cryo 方面都有獨特的平台，這些平台是差異化的，並在臨床上展示了它們在何處推出，我們有一個優秀的商業團隊準備將這些帶到美國。所以我們沒有為 EP 提供具體指導，但它是顯然是我們 23 歲及以後的重要增長動力。 Stein 博士，您還有其他意見嗎？

Yes, absolutely. Thanks, Mike. Thanks, Robbie. Again, just we do believe that FARAPULSE is differentiated relative to other PFA technologies out there. I think it's important to reiterate that all PFA is not created equal and because it's a field effect, the results that you're going to see with any of the technologies are highly dependent the way actual catheter design and FARAPULSE is the only system in evaluation right now that was designed from the ground up to deliver PFA dependent on the waveform that's delivered and dependent on the dosing strategy.

是的，一點沒錯。謝謝，邁克。謝謝，羅比。同樣，我們確實相信 FARAPULSE 相對於現有的其他 PFA 技術是與眾不同的。我認為重要的是要重申，並非所有 PFA 都是一樣的，因為它是一種場效應，你將看到的任何技術的結果都高度依賴於實際導管設計的方式，而 FARAPULSE 是唯一的評估系統現在，它是從頭開始設計的，以根據交付的波形和劑量策略提供 PFA。

And as you said, we are really looking forward to presenting the results of our randomized FARAPULSE trial, ADVENT in the second half of this year as well as to initiate our persistent AF trial advantage imminently.

正如您所說，我們非常期待在今年下半年公佈我們的隨機 FARAPULSE 試驗 ADVENT 的結果，並立即啟動我們的持續性 AF 試驗優勢。

The only thing I'd add to what Mike said is I also think as you think about EP, I think it's really important also to consider the really extraordinary momentum that we've got with our transseptal access solutions from Baylis and continue to see above-market growth with that and continue to see increased use of the Baylis transseptal access solutions, the energy needle and VersaCross access, both in ablation procedures and in WATCHMAN and other structural heart procedures.

我唯一要補充的是 Mike 所說的是我也在考慮 EP，我認為考慮我們從 Baylis 的跨中隔訪問解決方案中獲得的真正非凡的勢頭也非常重要，並繼續看上面- 隨之而來的市場增長，並繼續看到 Baylis transseptal 通路解決方案、能量針和 VersaCross 通路在消融程序以及 WATCHMAN 和其他結構性心臟程序中的使用增加。

Great. And maybe just a quick follow-up. China has been an important growth driver for Boston Scientific, grew 22% in the year even with the difficult operating environment. So how should we be thinking about China coming out of the reopening here into first quarter? And what's your expectation for the year going forward?

偉大的。也許只是快速跟進。中國一直是波士頓科學公司重要的增長動力，即使在艱難的經營環境下，該年度仍增長了 22%。那麼我們應該如何看待中國從這裡重新開放到第一季度呢？您對未來一年有何期望？

Thank you. That team had a terrific '22 despite all the challenges with COVID and all the different pricing tenders that occur over there. So for China, in '23, we are very bullish again -- we do expect double-digit growth out of the China team for the full year. There'll likely be some pressure in first quarter given the challenges that they've had in China with COVID.

謝謝。儘管面臨著 COVID 的所有挑戰以及那裡發生的所有不同的定價招標，但該團隊在 22 年的表現非常出色。因此，對於中國，在 23 年，我們再次非常樂觀——我們確實預計中國團隊全年將實現兩位數的增長。考慮到他們在中國遇到的 COVID 挑戰，第一季度可能會面臨一些壓力。

So we expect potentially some sales growth challenges in Q1, but we do expect strong double digit for the full year, likely not at the same level as the 22% that we delivered in '22, but strong double digits nonetheless.

因此，我們預計第一季度可能會出現一些銷售增長挑戰，但我們確實預計全年會出現兩位數的強勁增長，可能與我們在 22 年實現的 22% 的水平不同，但仍會保持兩位數的強勁增長。

The next question comes from Larry Biegelsen with Wells Fargo.

下一個問題來自富國銀行的 Larry Biegelsen。

Congratulations on a strong end to the year here. I wanted to ask a 2-part question also on FARAPULSE. So maybe for Dr. Stein, you talked about your excitement for the ADVENT trial later this year. Can you help put the MANIFEST-PF data into context? How did that compare to prior RF and Cryo studies? And what would be a win for you in ADVENT for FARAPULSE?

祝賀你在這裡結束了這一年。我也想在 FARAPULSE 上問一個由兩部分組成的問題。所以也許對於 Stein 博士來說，你談到了你對今年晚些時候的 ADVENT 試驗感到興奮。你能幫忙把 MANIFEST-PF 數據放到上下文中嗎？與之前的 RF 和 Cryo 研究相比如何？在 ADVENT for FARAPULSE 中，您會贏得什麼？

And we're going to see -- the second part is we're going to see the Medtronic PulseSelect data at ACC, the J&J, Inspire data at Boston AF, I guess, this weekend. You talked about how FARAPULSE is differentiated. What should we be looking for in those studies that would support your comments earlier?

我們將看到——第二部分是我們將在 ACC 上看到 Medtronic PulseSelect 數據，我想這個週末在波士頓 AF 上看到強生和 Inspire 數據。您談到了 FARAPULSE 是如何與眾不同的。我們應該在那些支持您之前評論的研究中尋找什麼？

Yes. Thanks, Larry. And let me just sort of begin by reiterating what I said to Robbie here. As we look at the data, everyone just needs to bear in mind that every PFA technology really needs to be evaluated on its own.

是的。謝謝，拉里。讓我先重申一下我在這裡對羅比說的話。當我們查看數據時，每個人都需要記住，每項 PFA 技術確實需要單獨評估。

It's very much unlike RF ablation. When you're doing RF ablation, if you've got the same size RF catheter tip and you've got the same back patch and the same power that you're putting through, you get the same [Gleason].

它與射頻消融非常不同。當你進行射頻消融時，如果你有相同尺寸的射頻導管尖端並且你有相同的背部貼片和相同的功率，你會得到相同的 [Gleason]。

PFA is very different. Again, because it's an electric field effect, what happens is just intimately related to actually the catheter design that tells you the shape of the field that you're generating; the waveform, which tells you very much what kind of impact you're going to have from that field; and then your dosing strategy, how many applications of energy do you put in and where do you put them in.

PFA 非常不同。同樣，因為它是一種電場效應，所發生的事情實際上與導管設計密切相關，導管設計會告訴您所產生的場的形狀；波形，它非常清楚地告訴你你將從那個領域產生什麼樣的影響；然後是你的劑量策略，你投入了多少能量以及你將它們投入何處。

We're very confident that FARAPULSE is the industry leader in this. Again, based on having a catheter that was designed from the ground up to deliver PFA, based on a decade of preclinical and then really high-quality clinical data, validating the waveform and validating a dosing strategy with remap studies that creates durable isolation.

我們非常有信心 FARAPULSE 是這方面的行業領導者。同樣，基於從頭開始設計用於提供 PFA 的導管，基於十年的臨床前和真正高質量的臨床數據，驗證波形並通過重新映射研究驗證劑量策略，以創建持久的隔離。

And I say, the proof of the puddings in the eating, and we're really excited and looking forward to seeing the results of our randomized ADVENT trial. I'm glad that you mentioned MANIFEST, again, gives us a high degree of confidence in where we're going, right?

我說，吃布丁的證據，我們真的很興奮，期待看到我們的隨機 ADVENT 試驗的結果。很高興您再次提到 MANIFEST，讓我們對前進的方向充滿信心，對嗎？

So MANIFEST is a registry study of the earliest commercial cases following our CE Mark approval in Europe. So this is people's first experience climbing the learning curve and Vivek Reddy is reported out published initially under the first 1,700 cases and then some limited follow-up in about 1,400 of those patients.

因此，MANIFEST 是對我們在歐洲獲得 CE 標誌批准後最早商業案例的註冊研究。所以這是人們第一次攀登學習曲線的經歷，據報導，Vivek Reddy 最初是在前 1,700 例病例下發表的，然後對其中約 1,400 例患者進行了一些有限的隨訪。

And really what those data show really proves the advantages of using a system like FARAPULSE. Certainly, 1,700 patients, the safety promise of FARAPULSE was realized. No cases of esophageal injury, no cases of persistent phrenic nerve injury, no cases of pulmonary vein stenosis, so certainly being able to avoid most feared complications of AF ablation.

這些數據確實證明了使用像 FARAPULSE 這樣的系統的優勢。當然，1,700 名患者實現了 FARAPULSE 的安全承諾。無食管損傷病例，無持續性膈神經損傷病例，無肺靜脈狹窄病例，肯定能避免房顫消融最可怕的並發症。

Seeing efficacy results that for paroxysmal Afib are at least as good as what's reported in high-quality trials with conventional thermal ablation and seeing remarkable procedure efficiency. Now -- in commercial clinical use, now sort of routinely seeing these cases being done on the order of 30 minutes.

看到陣發性 Afib 的療效結果至少與傳統熱消融的高質量試驗報告的結果一樣好，並且看到了顯著的程序效率。現在——在商業臨床使用中，現在通常會看到這些病例在 30 分鐘左右完成。

And that kind of procedural efficiency is, it's good for the system as a whole, right? There are a lot of patients who needs to be treated dealing with staffing issues, et cetera, et cetera. Anything we can do an increased throughput is good. It's good for patients, though, too.

這種程序效率對整個系統都有好處，對吧？有很多患者需要處理人員配備問題等等，等等。我們可以做的任何增加吞吐量的事情都是好的。不過，這對患者也有好處。

The less time you're undergoing a procedure, the less number of things that can go wrong, honestly. And so basically, to some, right, the MANIFEST data validates what we see as all the differentiated advantages of FARAPULSE, a safer procedure avoiding the worst complications.

老實說，您接受手術的時間越少，可能出錯的事情就越少。所以基本上，對某些人來說，MANIFEST 數據驗證了我們所看到的 FARAPULSE 的所有差異化優勢，這是一種更安全的程序，可以避免最嚴重的並發症。

A procedure that is at least as effective as what you see with thermal ablation and a really efficient procedure, which benefits physicians, hospitals and patients.

一種至少與您在熱消融中看到的一樣有效的程序，並且是一種真正有效的程序，可以使醫生、醫院和患者受益。

The next question comes from Joanne Wuensch with Citibank.

下一個問題來自花旗銀行的 Joanne Wuensch。

I want to spend just a minute or 2 on the Urology and Pelvic Health business. I mean, that was up another 12% this quarter, 12.7% organically last quarter. What is driving that? And should we think of this more as a solid double-digit grower as we look forward? .

我只想花一兩分鐘時間了解泌尿科和盆腔健康業務。我的意思是，本季度又增長了 12%，上季度有機增長了 12.7%。是什麼推動了它？在我們期待的時候，我們是否應該將其更多地視為穩固的兩位數增長？ .

And my follow-up question, I'm going to just put it out there now, 50 basis points of operating margin expansion or at least 50 basis points this year, where is that coming from?

我的後續問題，我現在就把它放在那裡，今年營業利潤率增長 50 個基點或至少 50 個基點，這是從哪裡來的？

Great, Mike here. Thanks for asking the endo, uro. You didn't asked about endo, but I'll throw it in there because they continue just to really outperform and are getting quite sizable within our portfolio and both accretive nicely to margins and growth rate.

太好了，這裡是邁克。謝謝你問遠藤，烏羅。你沒有問過 endo，但我會把它放在那裡，因為它們繼續真正跑贏大盤，並且在我們的投資組合中變得相當可觀，並且都很好地增加了利潤率和增長率。

The urology results, I mentioned in the prepared words, it's a strong global performance around the world. This business has been predominantly a U.S. oriented business that grows faster in the U.S. accretive to Boston Scientific.

泌尿外科的結果，我在準備好的詞中提到，它在全球範圍內表現強勁。該業務主要是面向美國的業務，隨著波士頓科學公司在美國的增長速度更快。

Outside the U.S. has been very underpenetrated. But now with all the investments that we've made, commercial and through R&D and through acquisitions is strengthening our outside the U.S. business in urology extensively. And the combination of that global performance and I would say, a highly differentiated portfolio. We talked about category leadership within a service line, and we really have that with urology and with endoscopy.

在美國以外的地區滲透率很低。但現在，隨著我們所做的所有投資，商業化、研發和收購正在廣泛加強我們在美國以外的泌尿外科業務。以及這種全球表現的結合，我會說，一個高度差異化的投資組合。我們討論了服務線內的類別領導，我們在泌尿科和內窺鏡檢查方面確實擁有這一點。

So they have a very differentiated portfolio that's very comprehensive versus our competitive set and contracting capabilities with customers who want to work with us. And so urology continues to do quite well, and we expect similar results over the next few years here.

因此，他們擁有非常差異化的產品組合，與我們的競爭組合和與希望與我們合作的客戶簽訂合同的能力相比，該產品組合非常全面。因此泌尿外科繼續做得很好，我們預計未來幾年這裡也會有類似的結果。

And the integration of Lumenis has done well. So that's a terrific business. And I would say, along the same lines, most of the same words with endoscopy as well. In terms of margin improvement, Dan, do you want to hit that one?

而Lumenis的整合做得很好。所以這是一個了不起的生意。我會說，沿著同樣的思路，內窺鏡檢查也是大部分相同的詞。就提高利潤率而言，丹，你想達到那個目標嗎？

I can do that. Yes, so the commentary again was 50 basis points on top of the 2022 results, excluding the Italian sales reserve. So that would be more like 25.6% was the actual, and then there was a 30 basis point impact. So then add 50 basis points to that is where you get the 26.4% just to give you the math there.

我能做到。是的，所以評論再次比 2022 年的結果高出 50 個基點，不包括意大利銷售儲備。所以這更像是 25.6% 是實際的，然後有 30 個基點的影響。因此，然後將 50 個基點加到你得到 26.4% 的地方，只是為了給你那裡的數學。

And where does it come from? The short answer is, we believe all lines of the P&L. So gross margin will have a slight headwind from FX this year. Again, we said neutral to the EPS line, neutral to adjusted EPS for the year. But at the gross margin line, we're largely hedged for the year 2023.

它從哪裡來？簡短的回答是，我們相信所有損益表。因此，今年毛利率將受到外彙的輕微阻力。同樣，我們對每股收益線持中性態度，對今年調整後的每股收益持中性態度。但在毛利率線上，我們在很大程度上對沖了 2023 年的風險。

And with what we see with where rates are today, we think we'll have a slight headwind from FX in gross margin. But we still think gross margin itself can go north through a lot of the good activities that we have from our global supply chain team in terms of reducing cost and other volume improvement programs.

根據我們今天所看到的利率情況，我們認為我們將在毛利率方面受到外彙的輕微阻力。但我們仍然認為毛利率本身可以通過我們全球供應鏈團隊在降低成本和其他數量改進計劃方面開展的許多良好活動來實現。

And then tightly managing our discretionary spend within SG&A to ensure it's helping us achieve our strategic plan. And as we've always talked about, just really focused on R&D efficiencies and leverage. It all starts with a healthy top line. We think that 6% to 8% guidance versus that 9% comp last year is a good, solid, healthy top line, and that gives us leverage opportunities throughout the whole P&L. And we think each line of the P&L has the opportunity to contribute towards the goal in 2023.

然後嚴格管理我們在 SG&A 中的可自由支配支出，以確保它幫助我們實現我們的戰略計劃。正如我們一直在談論的那樣，真正專注於研發效率和槓桿作用。這一切都始於健康的頂線。我們認為 6% 至 8% 的指導與去年的 9% 相比是一個良好、穩固、健康的頂線，這為我們提供了在整個損益表中發揮槓桿作用的機會。我們認為損益表的每一行都有機會為 2023 年的目標做出貢獻。

The next question comes from Vijay Kumar with Evercore ISI.

下一個問題來自 Evercore ISI 的 Vijay Kumar。

Just some cleanup questions here on the guidance assumptions. Mike, the 6% to 8% organic, it is what it is, but can you just remind us what are the incremental tailwinds -- positive tailwinds here in '23 and any incremental headwinds versus '22? Some things if I can think of FARAPULSE becomes organic, maybe China has a little bit of a headwind, but can you just go through some of those drivers?

這裡只是關於指導假設的一些清理問題。邁克，6% 到 8% 的有機率，就是這樣，但你能提醒我們什麼是增量順風——23 年這裡的積極順風和與 22 年相比的任何增量逆風嗎？有些事情，如果我能想到 FARAPULSE 變得有機，也許中國有一點逆風，但你能通過其中的一些驅動因素嗎？

And again, on share count up [20] million, that seems are just given how we've seen share count progress throughout the year. Curious why -- what's behind the share count assumption for the year?

再一次，在股票數量增加 [20] 萬時，這似乎只是考慮到我們全年看到的股票數量進展情況。好奇為什麼 - 今年的股票數量假設背後是什麼？

Yes, sure. On the share count, just to take that clean up quickly and then Mike can take your revenue question. It's just a simple math of the converts that we have in -- during the year. So the increase is from the share count that will increase when we convert the mandatory preferred.

是的，當然。關於份額計數，只是為了快速清理，然後邁克可以回答你的收入問題。這只是一年中我們所擁有的皈依者的簡單數學。因此，增加來自我們轉換強制性優先股時將增加的股份數量。

Recall, we then lose the preferred dividend. So it's neutral to EPS, but the share count increases as those preferred holders will get common shares. That makes sense, Vijay?

回想一下，我們然後失去了優先股息。所以它對每股收益是中性的，但隨著優先股持有人將獲得普通股，股票數量會增加。這有道理，維杰？

That's helpful. Yes.

這很有幫助。是的。

Yes. So I mean the takeaway should be neutral EPS impact from share count related to the mandatory preferred conversion this year.

是的。所以我的意思是，今年與強制優先轉換相關的股票數量對 EPS 的影響應該是中性的。

Sure. And the headwinds and tailwinds, maybe just some of the headwinds: we like the fact we did 9% growth in '22, but that's a bit of a tighter tougher comp than normal. So that's one.

當然。還有逆風和順風，也許只是一些逆風：我們喜歡我們在 22 年實現了 9% 的增長，但這比正常情況下更嚴格。這就是一個。

I had mentioned China would be -- expect double-digit growth, but likely not the same growth as '22. And then also CRM coming off of a really exceedingly market growth quite a bit in '22, likely to grow more in line with the market in '23. So there's a couple of the headwinds, clearly, a bunch of tailwinds.

我曾提到中國將——預計兩位數的增長，但可能與 22 世紀的增長不同。然後 CRM 也從 22 年的市場增長中脫穎而出，很可能會在 23 年與市場保持一致。所以有一些逆風，很明顯，一堆順風。

The company performed -- continues to perform extremely well across the globe: Europe, LatAm, Asia-Pac and U.S. You saw really impressive growth across the company. WATCHMAN growing 24% for the year, Cardiology as a whole grouping grow 10%, PI grew 9%, Endo 8%, Euro 10%. So we have just very strong momentum across the businesses, which is obviously a bit of a tailwind given the momentum we have commercially.

該公司在全球範圍內的表現 - 繼續表現非常出色：歐洲，拉丁美洲，亞太地區和美國你看到整個公司的增長非常令人印象深刻。 WATCHMAN 全年增長 24%，心髒病學整體增長 10%，PI 增長 9%，Endo 增長 8%，Euro 增長 10%。因此，我們的業務勢頭非常強勁，考慮到我們在商業上的勢頭，這顯然有點順風。

And we have incrementally to that some of the questions today on EP. We expect to have a very strong year in EP in outside in Europe and in Japan. Potential tailwind would be depending on when cryo gets approved in the U.S. So I'm sure how much of an impact that will have in the U.S. depends on the approval date there.

我們已經逐步解決了今天關於 EP 的一些問題。我們預計在歐洲和日本以外的 EP 領域將有非常強勁的一年。潛在的順風將取決於 cryo 何時在美國獲得批准。所以我確定這對美國的影響有多大取決於那裡的批准日期。

Other products like WATCHMAN continue to do extremely well. We're really proud. We actually think we gained share in fourth quarter with WATCHMAN and ended the year just over 90% market share. So that business continues to do really well.

WATCHMAN 等其他產品繼續表現出色。我們真的很自豪。實際上，我們認為我們在第四季度通過 WATCHMAN 獲得了份額，並在年底結束了略高於 90% 的市場份額。因此，該業務繼續做得很好。

And the one that gets very little discussion by analysts, but lots internally and by physicians is ACURATE Neo2. We now have a large size. That business is doing extremely well in Europe, actually building momentum each quarter. And we're anxious to finish that U.S. trial shortly.

分析師很少討論，但在內部和醫生中討論很多的是 ACURATE Neo2。我們現在有一個大尺寸。該業務在歐洲做得非常好，實際上每個季度都在增強勢頭。我們急於盡快完成美國的試驗。

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。

I guess I'll ask a question on the Italy impact. Just curious why we're only hearing about this from Boston. I don't know if maybe it's -- you're taking a more conservative approach in taking a reserve. And it seems like a big number.

我想我會問一個關於意大利影響的問題。只是好奇為什麼我們只從波士頓聽說這個。我不知道是不是——你在儲備方面採取了更保守的方法。這似乎是一個很大的數字。

I know it seems like Italy wouldn't be that big of a country, so maybe just calculated on more than a year of sales. And I just want to confirm no impact on 2023?

我知道意大利似乎不會是一個大國，所以也許只是按一年多的銷售額計算。我只想確認對 2023 年沒有影響？

And then I'll ask my follow-up now as well, which is on op margins. I think you mentioned gross margin first half higher, lower in the second half on currency. And I just want to make sure there's any puts and takes to consider on the op margin side first half versus second half?

然後我現在也會問我的後續行動，這是在運營利潤率上。我想你提到過上半年毛利率較高，下半年毛利率較低。我只是想確保在上半場和下半場的運營保證金方面有任何看跌期權和考慮因素？

Sure, Travis. I'll take the Italy one first. I can't speak for other companies. I can speak for on behalf of Boston Scientific. It's been an evolving situation, particularly over the last few weeks here because what you have is the Italian government passed a provision back in 2015 with regard to what I mentioned to trying to claw back some excess spending over the allocated budgets within the public hospitals in Italy.

當然，特拉維斯。我會先拿意大利的。我不能代表其他公司。我可以代表波士頓科學公司發言。這是一個不斷變化的情況，特別是在過去幾週這裡，因為你所擁有的是意大利政府在 2015 年通過了一項條款，關於我提到的試圖收回公立醫院超出分配預算的一些超額支出意大利。

But for the last 7-plus years, there's really been -- it's been dormant. There's been limited implementation guidance, there's really been literally no activity around that. That changed, again, over the last few weeks, with some events that put a little more teeth into their desire to collect those monies.

但在過去 7 年多的時間裡，它確實一直處於休眠狀態。實施指南有限，幾乎沒有相關活動。在過去的幾周里，情況再次發生了變化，一些事件讓他們更加渴望收集這些錢。

And so we booked that incremental reserve. We had a reserve on the books, we booked an incremental reserve to cover what we believe will be the amounts that we'll owe as part of that. We're obviously challenging it vehemently through the Italian court system as our other industry participants, we disagree with it. But that outcome will be uncertain, but we picked a reserve that we think is a reasonable reserve given the timeframe.

所以我們預訂了增量儲備。我們在賬面上有儲備金，我們預定了增量儲備金以支付我們認為將作為其中一部分欠下的金額。我們顯然通過意大利法院系統強烈挑戰它，因為我們的其他行業參與者不同意它。但這個結果將是不確定的，但我們選擇了一個我們認為在時間框架內合理的儲備。

He also mentioned do you see an issue in '23 with more of reserve?

他還提到你是否看到 23 年有更多儲備的問題？

The '23 amounts are included in guidance. So the amount of the reserve relates to prior periods, 2015 to 2022, anything that's 2023 and beyond is included in guidance.

'23 金額包含在指南中。因此，儲備金額與之前的時期（2015 年至 2022 年）相關，2023 年及以後的任何內容都包含在指導中。

With respect to op margin, actually, I'm glad you asked that question because it's a bit of a juxtaposition with gross margin, right? So I mentioned that gross margin will be higher in the first half and lower in the second half, which is a bit of a box, the trend we normally have, which I wanted to make sure I got that point out there.

關於營業利潤率，實際上，我很高興你問了這個問題，因為它有點與毛利率並列，對吧？所以我提到上半年毛利率會更高，下半年會更低，這有點像一個盒子，這是我們通常的趨勢，我想確保我明白了這一點。

Relative to operating margin, though, I think you'll see a similar trend where it builds throughout the year. So the gross margin higher in the first half, lower in the second half, but through the rest of the P&L and netting down to operating margin, I would expect you'd see a very similar trend starting in Q1 and building to higher amounts as you go first half, second half. So hopefully, that's clear, Travis.

不過，相對於營業利潤率，我認為你會在全年看到類似的趨勢。因此，上半年的毛利率較高，下半年較低，但通過其餘的損益表和營業利潤率，我希望您會看到從第一季度開始的非常相似的趨勢，並隨著你去上半場，下半場。所以希望，這很清楚，特拉維斯。

The next question comes from Cecilia Furlong with Morgan Stanley.

下一個問題來自摩根士丹利的 Cecilia Furlong。

I wanted to ask on WATCHMAN, specifically what's underlying the double-digit growth outlook that you called out for '23? How you're thinking about market growth as well as Japan and China contributions? And then just a quick follow-up on ACURATE Neo2 with the Prime XL registry. How are you thinking about approval time lines at this point in the U.S.?

我想問 WATCHMAN，具體來說，您為 23 年提出的兩位數增長前景的基礎是什麼？您如何看待市場增長以及日本和中國的貢獻？然後通過 Prime XL 註冊表快速跟進 ACURATE Neo2。您如何看待美國此時的批准時間表？

Sure. On WATCHMAN, we had a terrific year in '22. As I said, maintaining, call it, 90% share, potentially slightly above that, grew 24% for the full year. It's a very healthy market so call it, 25% growth we expect in '23, 2 companies in the marketplace today.

當然。在《守望者》中，我們在 22 年度過了非常棒的一年。正如我所說，保持 90% 的份額，可能略高於該份額，全年增長 24%。這是一個非常健康的市場，所以我們預計 23 年市場上有 2 家公司將增長 25%。

Similar to previous comments, the success of WATCHMAN is really manyfold. The safety, consistency and proven effectiveness through clinical trial in everyday practice at WATCHMAN, physicians are extremely comfortable in using the device. They're very comfortable with the support team they have from Boston in the lab with them and the referring physician community is seeing such strong benefits from the LAA procedure that is helping to drive that market growth.

與之前的評論類似，WATCHMAN 的成功真的是多方面的。通過 WATCHMAN 日常實踐中的臨床試驗，其安全性、一致性和有效性得到證實，醫生們在使用該設備時非常舒適。他們對來自波士頓實驗室的支持團隊感到非常滿意，轉診醫師社區也看到了 LAA 手術帶來的巨大好處，這有助於推動市場增長。

So it's an excellent market. It's also a product that's -- a procedure that's profitable for hospitals. And the procedure time today continues to improve, which is really important for hospitals. So the overall market context is very good.

所以這是一個很好的市場。它也是一種產品——一種對醫院有利可圖的程序。今天的手術時間不斷縮短，這對醫院來說非常重要。所以整體市場環境非常好。

We have the leading platform, and we have a new product, new steerable sheath coming this year and the next-gen WATCHMAN platform coming about a year from now. So we have a differentiated pipeline as well.

我們擁有領先的平台，我們有新產品，今年將推出新的可操縱護套，以及大約一年後推出的下一代 WATCHMAN 平台。所以我們也有一個差異化的管道。

Neo2 is doing extremely well in Europe. We just launched -- or just having some implementation of our XL valves. That's part of the U.S. trial. There was, I think, some -- a bit of inaccurate reporting on that one. We do not expect that XL to slow down the approval process for the U.S.

Neo2 在歐洲做得非常好。我們剛剛推出——或者只是對我們的 XL 閥門進行了一些實施。這是美國試驗的一部分。我認為，關於那件事的報導有些不准確。我們預計 XL 不會減慢美國的審批流程。

So that does not have an impact on U.S. approval. And that XL valve is important because it's about 1/3 of the procedures are using that size valve in Europe. So we're doing quite well, growing faster than market in Europe without that, and eventually, we'll be adding that to approval. So we're excited about that. ACURATE Neo2, we expect it to be approved in 2024 in the U.S.

所以這不會影響美國的批准。那個 XL 閥門很重要，因為在歐洲大約有 1/3 的程序使用那個尺寸的閥門。所以我們做得很好，沒有它，增長速度比歐洲市場快，最終，我們將把它添加到批准中。所以我們對此感到興奮。 ACURATE Neo2，我們預計它將於 2024 年在美國獲得批准。

And the next question, currently, I have is Josh Jennings with Cowen.

下一個問題，目前，我有 Josh Jennings 和 Cowen。

I was hoping to start off with just your Apollo acquisition and get you into the diabetes -- sorry, not diabetes, the obesity segment. And I just wanted to hear about your outlook for that portfolio but also just device-based intervention opportunities in obesity from a higher level and whether this portfolio could become a long-term growth driver for the endoscopy franchise?

我希望從你的阿波羅收購開始，讓你進入糖尿病——抱歉，不是糖尿病，肥胖部分。我只是想听聽您對該產品組合的展望，以及從更高層面對肥胖進行基於設備的干預機會，以及該產品組合是否可以成為內窺鏡特許經營的長期增長動力？

And then the follow-up is just on the neuromodulation business. Congratulations on SOLIS trial results. And I think 3 of the big competitors in the space have a peripheral diabetic neuropathy indication now with different levels of evidence. But I was hoping you could just review Boston's plan to generate clinical evidence for that indication going forward?

然後後續只是關於神經調節業務。祝賀 SOLIS 試驗結果。我認為該領域的 3 個主要競爭對手現在有不同程度的證據表明存在周圍糖尿病性神經病變。但我希望你能回顧一下波士頓為該適應症提供臨床證據的計劃？

Yes. So on Apollo Endosurgery overall, it's really consistent with our overall strategy of category leadership, which is driving above-market growth and continuing to advance new therapies where we can be the leader.

是的。因此，總體而言，在 Apollo Endosurgery 上，它確實與我們的品類領導總體戰略一致，該戰略正在推動高於市場的增長，並繼續推進我們可以成為領導者的新療法。

When we look at endoluminal surgery, we think that is really the next frontier for our endo business. And you see a terrific uptake of endoluminal surgery, I would say, outside the U.S., particularly in Japan, a bit more so in Europe and less so in U.S. And so we think endoluminal surgery will really continue to build momentum over the next coming years and Apollo is a platform that's most used by physicians pick outside the U.S. to perform these procedures with a product called OverStitch and X-TACK.

當我們審視腔內手術時，我們認為這確實是我們腔內手術業務的下一個前沿領域。你會看到腔內手術的普及率非常高，我想說，在美國以外，特別是在日本，在歐洲更多，在美國更少所以我們認為腔內手術將在未來幾年真正繼續建立勢頭Apollo 是一個平台，美國以外的醫生最常使用該平台使用名為 OverStitch 和 X-TACK 的產品執行這些程序。

So we think the addition of Apollo into our current platform will obviously make us the #1 strongest endoluminal surgery portfolio, but also put us in a position, as [Dr. Duncan] would say, to help train the field because these are procedures that require significant physician training to get great outcomes, and we'll be able to do that with the Apollo platform.

因此，我們認為將 Apollo 添加到我們當前的平台中顯然將使我們成為排名第一的最強大的腔內手術產品組合，同時也使我們處於有利地位，因為 [Dr. Duncan] 會說，幫助培訓該領域，因為這些程序需要大量的醫生培訓才能獲得很好的結果，我們將能夠通過 Apollo 平台做到這一點。

And then on Neuromod, he asked about SOLIS.

然後在 Neuromod 上，他詢問了 SOLIS。

On SOLIS with SCS, again, we did see some improvement in that overall SCS business in the fourth quarter, growing 4% in the quarter. SOLIS, we're pleased with the 3-month results that we expected. We expect indication and approval for nonsurgical back by the year-end of 2023.

在帶有 SCS 的 SOLIS 上，我們再次看到第四季度整體 SCS 業務有所改善，本季度增長了 4%。 SOLIS，我們對我們預期的 3 個月結果感到滿意。我們預計到 2023 年底非手術背部的指示和批准。

And we're in early clinical work for PDN right now and haven't announced any timelines, but we'll look to -- continue to invest in that space.

我們目前正在進行 PDN 的早期臨床工作，尚未宣布任何時間表，但我們會繼續投資於該領域。

And that concludes our call for today. So thank you for joining us. 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 the replay. Drew?

我們今天的呼籲到此結束。感謝您加入我們。感謝您對波士頓科學公司的關注。如果我們無法回答您的問題或者您有任何後續行動，請隨時聯繫投資者關係團隊。在您斷開連接之前，Drew 會為您提供重播的所有相關細節。德魯？

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 7345419 until February 8, 2023 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 2023 年 2 月 8 日晚上 11:59 之前使用重播代碼 7345419 撥打 1-877-344-7529 或 1-412-317-0088 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。您現在可以斷開連接。