Boston Scientific Corp (BSX) 2023 Q3 法說會逐字稿

Good day, and welcome to the Boston Scientific Third Quarter 2023 Conference Call. (Operator Instructions) Please note, this event is being recorded. I would now like to turn the conference over to Lauren Tengler, Vice President of Investor Relations. Please go ahead.

美好的一天，歡迎參加波士頓科學公司 2023 年第三季電話會議。 （操作員說明）請注意，正在記錄此事件。現在我想將會議交給投資者關係副總裁 Lauren Tengler。請繼續。

Thank you, [Costas]. 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，[科斯塔斯]。歡迎大家，感謝您今天加入我們。與我一起參加今天電話會議的有董事長兼執行長 Mike Mahoney；執行副總裁兼財務長 Dan Brennan。

We issued a press release earlier this morning announcing our Q3 2023 results, which included reconciliations of the non-GAAP measures used in the release. We have posted a copy of that release as well as reconciliations of the non-GAAP measures used in today's call to the Investor Relations section of our website under the heading Financials and Filings.

今天早些時候，我們發布了一份新聞稿，宣布了 2023 年第三季的業績，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。我們已在我們網站的「投資者關係」部分的「財務和文件」標題下發布了該新聞稿的副本以及今天電話會議中使用的非公認會計原則措施的調節表。

The duration of this morning's call will be approximately 1 hour. Mike and Dan will provide comments on Q3 performance as well as the outlook for our business, including Q4 and full year 2023 guidance. Then we'll take your questions.

今天上午的通話時間約為 1 小時。 Mike 和 Dan 將就第三季的業績以及我們的業務前景發表評論，包括第四季和 2023 年全年指引。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. Ken Stein.

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少於完整時期可比淨銷售額的收購和剝離。

Relevant acquisitions and divestitures excluded for organic growth are Baylis Medical, which closed on February 14, 2022; the majority stake investment in Acotec Scientific and Apollo Endosurgery, which closed in February and April of this year, respectively. Divestitures include the endoscopy pathology business, which closed in April of this year.

被排除在有機成長之外的相關收購和剝離包括 Baylis Medical，該公司於 2022 年 2 月 14 日完成； Acotec Scientific 和 Apollo Endosurgery 的多數股權投資分別於今年 2 月和 4 月完成。剝離的業務包括內視鏡病理業務，該業務已於今年 4 月關閉。

Please note that we have elected to consolidate Acotec results on a 1-quarter lag, which have been included in our Q3 reported adjusted results. Guidance excludes the previously announced agreement to acquire Relievant Medsystems, which is expected to close in the first half of 2024, subject to customary closing conditions. For more information, please refer to our financial and operating highlights deck, which may be found on our Investor Relations website.

請注意，我們選擇將 Acotec 的業績滯後 1 個季度進行合併，該業績已包含在我們第三季報告的調整後業績中。該指南不包括先前宣布的收購 Relievant Medsystems 的協議，該協議預計將於 2024 年上半年完成，但須符合慣例成交條件。欲了解更多信息，請參閱我們的財務和營運亮點，可在我們的投資者關係網站上找到。

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

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

If our underlying assumptions turn out to be incorrect or certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. Factors that may cause such a difference 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.

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

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

此時，我會將其交給麥克。

Well done, Lauren, thank you, and thank you for joining us today. We're pleased with another quarter of excellent results, with momentum continuing fueled by new product innovation, clinical evidence and our talented teams across the globe.

幹得好，勞倫，謝謝你，也謝謝你今天加入我們。我們對又一個季度的優異業績感到高興，新產品創新、臨床證據和我們遍布全球的才華橫溢的團隊繼續推動著這一勢頭。

In Q3 '23, total company sales grew 11% operationally and 10% organically versus Q3 '22, which exceeds the high end of our guidance range of 7% to 9%. This performance is a testament to our category leadership strategy, focus on innovation and strong commercial execution. We believe that most of our global business units grew in line or faster than their respective markets.

與 22 年第三季相比，23 年第三季公司總銷售額營運成長 11%，有機成長 10%，超出了我們指導範圍 7% 至 9% 的上限。這項業績證明了我們的品類領導策略、對創新的關注和強大的商業執行力。我們相信，我們大多數的全球業務部門的成長速度與各自市場的成長速度一致或更快。

Q3 adjusted EPS of $0.50 grew 15% versus Q3 '22, which exceeds the high end of the guidance range of $0.46 to $0.48. Q3 adjusted operating margin was 26.1%, slightly higher than anticipated.

第三季調整後每股收益為 0.50 美元，與 22 年第三季相比增長了 15%，超出了 0.46 美元至 0.48 美元指導範圍的上限。第三季調整後營業利益率為 26.1%，略高於預期。

Now for '23 guidance, we're guiding to Q4 '23 organic revenue growth of 8% to 10% and aligning our full year organic guidance for approximately 11%, the high end of our prior guidance.

現在，對於 23 年指導，我們預計 23 年第 4 季的有機收入將增長為 8% 至 10%，並將全年有機指導調整為約 11%，這是我們之前指導的上限。

Our Q4 '23 adjusted EPS estimate is $0.49 to $0.52 and we are raising our full year adjusted EPS range to $1.99 to $2.02.

我們的 23 年第 4 季調整後每股盈餘預估為 0.49 美元至 0.52 美元，我們將全年調整後每股盈餘範圍上調至 1.99 美元至 2.02 美元。

I'll now provide additional highlights of Q3, along with comments on our 2023 outlook, and then Dan will provide more details on the financials.

我現在將提供第三季的更多亮點，以及對 2023 年前景的評論，然後 Dan 將提供有關財務狀況的更多詳細資訊。

Regionally, and on an operational basis, the U.S. grew 9% versus Q3 '22, and driven by strong performance within our WATCHMAN, EP, Endo and Urology businesses. Europe, Middle East and Africa grew 11% on an operational basis versus Q3 '22. Performance of the region was broad-based with double-digit growth in 7 out of our [10 -- 8] business units.

從地區來看，在營運基礎上，美國的銷售額比 22 年第三季成長了 9%，這得益於我們的 WATCHMAN、EP、Endo 和泌尿科業務的強勁表現。與 22 年第三季相比，歐洲、中東和非洲的營運成長了 11%。該地區的業績基礎廣泛，我們的 [10 - 8] 個業務部門中有 7 個部門實現了兩位數成長。

Within the quarter, we saw a strong growth in EP with ongoing momentum and demand for FARAPULSE and POLARx. Asia Pac grew 19% operationally versus third quarter '22, led by strength in Japan and China. Japan grew strong double digits in the quarter with ongoing momentum from new products, most notably AGENT DCB resume POLAR FIT and WATCHMAN FLX. Physician demand for our differentiated AGENT DCB remains high, and we've taken a market leadership position within the quarter after launching earlier this year.

在本季度內，我們看到 EP 的強勁成長，以及對 FARAPULSE 和 POLARx 的持續成長動能和需求。與 22 年第三季相比，亞太地區的營運成長了 19%，其中日本和中國的實力強勁。日本在新產品（尤其是 AGENT DCB 恢復的 POLAR FIT 和 WATCHMAN FLX）的持續推動下，本季實現了兩位數的強勁成長。醫生對我們差異化的 AGENT DCB 的需求仍然很高，自今年早些時候推出以來，我們在本季度內佔據了市場領導地位。

Double-digit growth in China was led by our imaging and Complex PCI portfolio as well as the commercial execution of the team more broadly. These results were further supported by the performance of the Acotec business, and we continue to expect double-digit growth in China for the full year.

中國的兩位數成長得益於我們的影像和複雜 PCI 產品組合以及更廣泛的團隊的商業執行。這些業績得到了 Acotec 業務業績的進一步支持，我們繼續預計全年中國業務將實現兩位數成長。

I'll now provide some additional commentary on the business units. In the quarter, Urology sales grew 11% organically with international growth of 18%, fueled by new products and globalization efforts with all regions outside the U.S. growing double digits.

我現在將對業務部門提供一些補充評論。本季度，在新產品和全球化努力的推動下，泌尿科銷售額有機成長 11%，其中國際成長 18%，美國以外的所有地區均達到兩位數成長。

Globally, the stone management franchise grew double digits driven by LithoVue and Laser therapies. Rezum had another strong quarter of double-digit growth backed by long-term clinical data supporting international momentum with a leave nothing behind message resonating in Asia.

在 LithoVue 和雷射療法的推動下，全球石材管理業務實現了兩位數成長。 Rezum 又一個強勁的季度兩位數成長，長期臨床數據支持國際勢頭，並且不遺餘力的訊息在亞洲引起共鳴。

Endoscopy sales grew 11% organically and 12% operationally versus third quarter '22 with broad-based strength across all regions. Our single-use imaging and AXIOS technologies continue to perform well, both growing double digits within the quarter. And earlier this month, we received U.S. marketing authorization for an expanded indication of the AXIOS stent to include gallbladder drainage, increasing access to more patients with this platform.

與 22 年第三季相比，內視鏡銷售額有機成長 11%，營運成長 12%，在所有地區都有廣泛的實力。我們的一次性成像和 AXIOS 技術持續表現良好，本季均實現兩位數成長。本月早些時候，我們獲得了美國的營銷授權，將 AXIOS 支架的適應症擴大到包括膽囊引流，使更多患者能夠使用該平台。

Neuromodulation sales grew 3% organically versus third quarter '22. Our Brain franchise grew low double digits in the quarter with strength from new product launches, including the Vercise Neural Navigator 5 Software, which is our fifth generation DBS programming solution furthering our leadership in image-guided programming for more streamlined DBS programming in the U.S.

與 2022 年第三季相比，神經調節銷售額有機成長了 3%。我們的Brain 特許經營權在本季度實現了低兩位數的增長，得益於新產品的發布，其中包括Vercise Neural Navigator 5 軟體，這是我們的第五代DBS 編程解決方案，進一步鞏固了我們在影像引導編程方面的領導地位，從而在美國實現更簡化的DBS 編程。

Our Pain business grew low single digits driven by spinal cord stimulation sales, which were slightly below our expectations. We are optimistic about the opportunities ahead of our Pain business, included in our recent U.S. approval to expand the indication of our WaveWriter Alpha SCS system to include DPN, which is expected to launch early '24.

在脊髓刺激銷售的推動下，我們的疼痛業務實現了低個位數成長，略低於我們的預期。我們對疼痛業務面臨的機會持樂觀態度，其中包括我們最近美國批准將我們的 WaveWriter Alpha SCS 系統的適應症擴大到包括 DPN，該系統預計將於 24 年初推出。

We're also excited to add to our portfolio with our recently announced agreement to acquire Relievant Medsystems and its INTERCEPT procedure. INTERCEPT is the only U.S. cleared system for vertebrogenic pain expanding our portfolio of pain offerings, which is expected to close in the first half of 2024.

我們也很高興透過最近宣布的收購 Relievant Medsystems 及其 INTERCEPT 程序的協議來豐富我們的產品組合。 INTERCEPT 是美國唯一獲得批准的椎源性疼痛系統，擴大了我們的疼痛產品組合，預計將於 2024 年上半年完成。

Peripheral Intervention sales grew 8% organically and 13% operationally, which includes the results of Acotec versus third quarter '22. Our Arterial franchise delivered another strong quarter, growing low double digits, led by ongoing success globally with our drug-eluting portfolio.

外圍幹預銷售額有機成長 8%，營運成長 13%，其中包括 Acotec 與 22 年第三季相比的業績。在我們的藥物洗脫產品組合在全球範圍內持續取得成功的帶動下，我們的 Arterial 特許經營業務又迎來了一個強勁的季度，實現了兩位數的低增長。

In Venous data from the REAL-PE study was presented earlier this week, demonstrating a statistically significant lower major bleeding rates in patients with pulmonary embolism who are treated with EKOS compared to a competitive mechanical thrombectomy device. The REAL-PE study analyzed nearly real-time EHR data for over 2,200 PE patients from 2009 to 2023. This study provides new clinical evidence for providers in determining the optimal modality for each patient's needs.

本週稍早發布的 REAL-PE 研究的靜脈數據顯示，與競爭性機械血栓切除裝置相比，接受 EKOS 治療的肺栓塞患者的大出血率在統計學上顯著降低。 REAL-PE 研究分析了 2009 年至 2023 年超過 2,200 名 PE 患者的近實時 EHR 數據。這項研究為醫療服務提供者確定適合每位患者需求的最佳方式提供了新的臨床證據。

Our Interventional Oncology franchise grew double digits including ongoing momentum with our Embold Coil launch as well as strong demand for our cancer therapies. Within the quarter, we received FDA clearance to expand the indication of the Visual ICE Cryoablation System to treat pain associated with tumors that have metastasized to bone in patients who are unable to receive standard radiation therapy.

我們的介入性腫瘤學特許經營業務實現了兩位數成長，包括我們的 Embold Coil 推出的持續勢頭以及對我們的癌症療法的強勁需求。在本季度內，我們獲得 FDA 批准，擴大 Visual ICE 冷凍消融系統的適應症，以治療無法接受標準放射治療的患者中與骨轉移腫瘤相關的疼痛。

Our Cardiology Group delivered another excellent quarter with organic sales growth of 11% versus third quarter '22. Within Cardiology, Interventional Cardiology therapy sales grew 7% organically versus third quarter '22. Our Structural Heart Valves franchise grew double digits in the third quarter, led by ACURATE neo2 sales performance in Europe and growth within our Coronary Therapies franchise is fueled by ongoing success of our imaging technologies.

我們的心臟病學集團又迎來了一個出色的季度，與 2022 年第三季相比，有機銷售額成長了 11%。在心臟病學領域，介入性心臟病學治療銷售額與 22 年第三季相比有機成長了 7%。在歐洲ACURATE neo2 銷售業績的推動下，我們的結構性心臟瓣膜特許經營權在第三季度實現了兩位數增長，而我們的成像技術的持續成功推動了我們的冠狀動脈治療特許經營權的增長。

We're pleased to have received clearance for the AVVIGO+ Guidance System. AVVIGO is our next-generation platform that provides high-quality, fast imaging with improved physiologic assessment of coronary vessels and lesions.

我們很高興獲得 AVVIGO+ 導引系統的許可。 AVVIGO 是我們的下一代平台，可提供高品質、快速的影像，並改善對冠狀血管和病變的生理評估。

We continue to be pleased with the performance of AGENT DCB in Japan. Importantly, our AGENT IDE trial results were presented yesterday as a late breaker at TCT with data demonstrating statistical superiority of the AGENT Drug Coated Balloon versus uncoated balloon angioplasty for the treatment of patients with in-stent restenosis. With our recent regulatory submission to FDA, we anticipate approval of AGENT, the first drug coated balloon indicated for the coronary arteries within the U.S. in the second half of '24.

我們仍然對 AGENT DCB 在日本的表現感到滿意。重要的是，我們的 AGENT IDE 試驗結果於昨天在 TCT 上發布，數據表明 AGENT 藥物塗層球囊與未塗層球囊血管成形術相比，在治療支架內再狹窄患者方面具有統計學優勢。隨著我們最近向 FDA 提交監管申請，我們預計 AGENT 將於 2024 年下半年在美國獲得批准，這是第一個適用於美國冠狀動脈的藥物塗層球囊。

WATCHMAN sales grew 23% organically versus third quarter '22. We're very pleased with the excellent performance of this franchise and now treated more than 350,000 patients globally. Last month, we received FDA approval of the latest generation WATCHMAN FLX Pro, which is designed to improve visualization during device placement, to enhance healing post implant and treat a broader range of patient anatomies.

與 22 年第三季相比，《WATCHMAN》的銷售額有機成長了 23%。我們對這家特許經營機構的出色表現感到非常滿意，目前已在全球範圍內治療了超過 350,000 名患者。上個月，我們獲得了 FDA 對最新一代 WATCHMAN FLX Pro 的批准，該產品旨在改善設備放置過程中的可視化，增強植入後的癒合並治療更廣泛的患者解剖結構。

Additionally, enrollment has commenced in HEAL-LAA a post-market study of the WATCHMAN FLX Pro device in the U.S. We continue to expect strong growth from the WATCHMAN business backed by new technologies and significant investment in clinical evidence.

此外，HEAL-LAA 已開始在美國開展 WATCHMAN FLX Pro 設備的上市後研究。我們繼續預計 WATCHMAN 業務將在新技術和臨床證據方面的重大投資的支持下實現強勁增長。

Cardiac Rhythm Management sales grew 5% organically versus third quarter '22. In core CRM, our high-voltage business grew low single digits, and our low-voltage business grew mid-single digits. Our Diagnostics franchise grew double digits in the quarter, fueled by our diverse portfolio of ambulatory ECGs and ICM. We continue to further innovating the space, having launched in the U.S., the next-generation Lux-DX II and the II+ implantable cardiac monitor for long-term monitoring of arrhythmias, providing enhanced diagnostic capabilities and enabling a more efficient workflow.

與 22 年第三季相比，心律管理銷售額有機成長 5%。在核心 CRM 中，我們的高壓業務實現低個位數成長，低壓業務實現中個位數成長。在我們多元化的動態心電圖和 ICM 產品組合的推動下，我們的診斷業務在本季度實現了兩位數成長。我們繼續進一步創新該領域，在美國推出了下一代 Lux-DX II 和 II+ 植入式心臟監視器，用於長期監測心律不整，提供增強的診斷能力並實現更有效率的工作流程。

Electrophysiology sales grew 27% organically versus third quarter '22. International growth of 33% was driven by excellent performance from our differentiated FARAPULSE and POLARx technologies as well as our Access Solutions franchise and the leading VersaCross access platform. U.S. growth of 22% was led by our Access Solutions franchise, along with contribution from the early approval -- I'm sorry, from the approval of the POLAR Cryoablation system, including POLAR FIT, which enables physicians to adjust and expand the cryo balloon to best fit a patient's individual anatomy.

與 2020 年第三季相比，電生理學銷售額有機成長了 27%。 33% 的國際成長得益於我們差異化的 FARAPULSE 和 POLARx 技術以及我們的接取解決方案專營權和領先的 VersaCross 接取平台的卓越效能。美國 22% 的成長得益於我們的 Access Solutions 特許經營權，以及早期批准的貢獻 - 對不起，來自 POLAR Cryoablation 系統的批准，包括 POLAR FIT，它使醫生能夠調整和擴張冷凍球囊以最適合患者的個人解剖結構。

Also within the quarter, we launched VersaCross Connect for POLARSHEALTH, which provides safe and efficient access to the left side of the heart during procedures, expanding our access solutions portfolio. Clinical evidence generation remains a key priority, and we're pleased to have completed enrollment in the first phase of the ADVANTAGE AF clinical trial studying FARAPULSE for the treatment of patients with persistent AFib.

同樣在本季度，我們推出了適用於 POLARSHEALTH 的 VersaCross Connect，它可以在手術過程中安全、高效地進入心臟左側，從而擴展了我們的通路解決方案組合。臨床證據產生仍然是關鍵優先事項，我們很高興完成了 ADVANTAGE AF 臨床試驗第一階段的入組，研究 FARAPULSE 用於治療持續性 AFib 患者。

Additionally, we commenced enrollment and treated our first patient in an extension arm of the ADVANTAGE study to evaluate FARAPOINT, which is a point-by-point PFA focal catheter for CTI ablations, used to treat atrial flutter.

此外，我們開始入組並治療了 ADVANTAGE 研究延伸組中的第一位患者，以評估 FARAPOINT，這是一種用於 CTI 消融的點對點 PFA 局部導管，用於治療心房撲動。

Finally, within the quarter, we achieved important milestones in bringing our leading PFA technology to the U.S. Recall data from our ADVENT IDE trial was presented at ESC at the end of August, comparing FARAPULSE to standard-of-care thermal modalities meeting the primary end points. We've also committed our U.S. regulatory submission and continue to anticipate the approval of FARAPULSE in the U.S. in the second half of '24.

最後，在本季度內，我們在將領先的PFA 技術引入美國方面取得了重要的里程碑。我們的ADVENT IDE 試驗的召回數據於8 月底在ESC 上發布，將FARAPULSE 與滿足主要終點的標準護理熱模式進行了比較點。我們也承諾向美國監管機構提交申請，並繼續預計 FARAPULSE 將於 2024 年下半年在美國獲得批准。

Through the first 9 months of this year, we have grown organic sales 12% while growing adjusted EPS 18% with broad-based growth across all of our business units and regions. This performance is supportive of the goal we laid out last month at our Investor Day, where we aspire to be highest performing large-cap med tech company over the next 3 years. We believe our focus on talent and culture, our relentless pursuit of innovation, while doing the right thing for society, and operating responsibly, sets us up to deliver a unique set of financial goals over the '24 to '26 long-range period.

今年前 9 個月，我們的有機銷售額增長了 12%，調整後每股收益增長了 18%，所有業務部門和地區均實現了廣泛增長。這項業績支持了我們上個月在投資者日所設定的目標，即我們渴望在未來三年內成為業績最高的大型醫療科技公司。我們相信，我們對人才和文化的關注，對創新的不懈追求，同時為社會做正確的事情並負責任地運營，使我們能夠在 24 至 26 年間實現一套獨特的財務目標。

Our LRP goals include growing sales, 8% to 10% CAGR over the period, while expanding adjusted operating margins by 150 basis points over the 3 years, with double adjusted EPS growth annually and improvement of our free cash flow conversion to approximately 70% by 2026.

我們的LRP 目標包括銷售額成長，期間複合年增長率為8% 至10%，同時在3 年內將調整後營業利潤率擴大150 個基點，每年調整後每股收益翻倍，並將我們的自由現金流轉換率提高至約70% 2026 年。

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

這樣，我會將其轉交給 Dan，以提供有關財務狀況的更多詳細資訊。

Thanks, Mike. Third quarter 2023 consolidated revenue of $3.527 billion represents 11.2% reported revenue growth versus third quarter 2022 and includes a 10 basis point tailwind from foreign exchange, which was lower than expected due to the strengthening of the U.S. dollar throughout the quarter. Excluding this $4 million tailwind from foreign exchange, operational revenue growth was 11.1% in the quarter.

謝謝，麥克。 2023 年第三季合併收入為 35.27 億美元，較 2022 年第三季報告的營收成長 11.2%，其中包括來自外匯的 10 個基點的推動力，由於美元整個季度走強，該收入低於預期。排除這 400 萬美元的外匯推動因素，本季營運收入成長 11.1%。

Sales from acquisitions and divestitures contributed 90 basis points, resulting in 10.2% organic revenue growth, exceeding our guidance range of 7% to 9%. Q3 2023 adjusted earnings per share of $0.50 grew 15% versus 2022, exceeding the high end of our guidance range of $0.46 to $0.48, driven predominantly by our strong sales performance.

收購和剝離的銷售額貢獻了 90 個基點，實現了 10.2% 的有機收入成長，超出了我們 7% 至 9% 的指導範圍。 2023 年第三季調整後每股收益為 0.50 美元，與 2022 年相比增長 15%，超出了我們指導範圍 0.46 美元至 0.48 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 third quarter was 70.2%, slightly lower than our expectations, primarily driven by foreign exchange. In light of our Q3 results, we now anticipate that full year 2023 adjusted gross margin will only slightly improve on a year-over-year basis. Strong sales performance drove third quarter adjusted operating margin of 26.1%, resulting in a year-to-date adjusted operating margin also of 26.1%.

第三季調整後毛利率為70.2%，略低於我們的預期，主要受外匯影響。根據我們第三季的業績，我們現在預計 2023 年全年調整後毛利率將僅較去年同期略有改善。強勁的銷售業績推動第三季調整後營業利潤率達到 26.1%，導致年初至今調整後營業利潤率也達到 26.1%。

Our year-to-date performance sets us up well to achieve our full year 2023 adjusted operating margin goal of approximately 26.4%, which represents 80 basis points of expansion versus 2022. On a GAAP basis, the third quarter operating margin was 19.6%, which includes a $111 million credit, primarily related to certain IP litigation matters.

我們今年迄今的業績使我們能夠很好地實現 2023 年全年調整後營業利潤率目標約 26.4%，這比 2022 年擴張 80 個基點。按照 GAAP 計算，第三季度營業利潤率為 19.6%，其中包括1.11 億美元的信貸，主要與某些智慧財產權訴訟事項有關。

Moving to below the line. Third quarter adjusted interest and other expenses totaled $81 million, which was in line with our expectations. On an adjusted basis, our tax rate for the third quarter was 12.4% favorable to our expectations, driven by certain discrete tax items in the quarter. Our operational tax rate was 13.9%, in line with expectations.

移至線下。第三季調整後利息和其他費用總計 8,100 萬美元，符合我們的預期。在調整後的基礎上，受本季某些離散稅項的推動，我們第三季的稅率為 12.4%，符合我們的預期。我們的營業稅率為13.9%，符合預期。

Fully diluted weighted average share outstanding ended at $1.475 billion in Q3. Free cash flow for the quarter was $509 million, with $698 million from operating activities less $190 million net capital expenditures.

第三季完全稀釋加權平均已發行股本為 14.75 億美元。本季自由現金流為 5.09 億美元，其中營運活動產生的 6.98 億美元減去淨資本支出 1.90 億美元。

Excluding special items, adjusted free cash flow was $582 million, as a result of our strong year-to-date adjusted free cash flow generation, we now expect full year 2023 adjusted free cash flow in excess of $2.4 billion.

不包括特殊項目，調整後自由現金流為 5.82 億美元，由於我們年初至今調整後自由現金流生成強勁，我們現在預計 2023 年全年調整後自由現金流將超過 24 億美元。

Our top capital allocation priority remains strategic tuck-in M&A, followed by annual share repurchases to offset dilution from employee stock grants, which we announced at last month's Investor Day. As of September 30, 2023, we had cash on hand of $952 million and our gross debt leverage was 2.3x.

我們的首要資本配置優先事項仍然是策略性併購，其次是年度股票回購，以抵消員工股票授予帶來的稀釋，這是我們在上個月的投資者日宣布的。截至 2023 年 9 月 30 日，我們手頭現金為 9.52 億美元，總負債槓桿率為 2.3 倍。

I'll now walk through guidance for Q4 and full year 2023. We expect full year 2023 operational revenue growth to be approximately 12%, which excludes an approximate 100 basis point headwind from foreign exchange higher than our previous estimate due to the strengthening of the U.S. dollar. Excluding the impact of closed acquisitions and divestitures, we expect full year 2023 organic revenue growth to be approximately 11% versus 2022.

現在，我將介紹2023 年第四季和全年的指引。我們預計2023 年全年營運收入成長約為12%，其中不包括由於經濟走強而導致的外匯阻力，該阻力比我們先前的估計高出約100 個基點美元。排除已完成收購和資產剝離的影響，我們預計 2023 年全年有機收入將比 2022 年增長約 11%。

We expect fourth quarter 2023 operational revenue growth to be in a range of 9% to 11% versus Q3 2022 with a neutral impact from foreign exchange based on current rates, excluding the contribution from closed acquisitions and divestitures, we expect fourth quarter 2023 organic revenue growth to be in a range of 8% to 10%. We continue to expect our full year 2023 adjusted below-the-line expenses to be approximately $340 million. Our full year 2023 operational tax rate is now expected to be approximately 13.5% under current legislation and forecasted geographic mix of sales. As a result of a lower operational tax rate and favorable discrete items recognized in the third quarter, we now expect our adjusted tax rate to be approximately 12%.

我們預計2023 年第四季營運收入成長將較2022 年第三季在9% 至11% 之間，根據當前匯率，匯率影響呈中性，不包括已完成收購和資產剝離的貢獻，我們預計2023年第四季有機收入成長率將在8%至10%之間。我們仍預計 2023 年全年調整後的離線費用約為 3.4 億美元。根據現行法令和預測的銷售地域組合，我們 2023 年全年的營業稅率預計約為 13.5%。由於營業稅率較低以及第三季確認的有利離散項目，我們現在預計調整後的稅率約為 12%。

We expect a fully diluted weighted average share count of approximately 1.478 billion shares for Q4 2023 and 1.464 billion shares for the full year 2023. We expect full year adjusted earnings per share to be in a range of $1.99 to $2.02 representing 17% to 18% growth versus 2022.

我們預計2023 年第四季的完全稀釋加權平均股數約為14.78 億股，2023 年全年為14.64 億股。我們預計全年調整後每股收益將在1.99 美元至2.02 美元之間，佔17 % 至18%與 2022 年相比的成長。

We continue to anticipate a neutral impact from foreign exchange on full year 2023 adjusted earnings per share. We expect fourth quarter adjusted earnings per share to be in a range of $0.49 to $0.52. For more information, please check our Investor Relations website for Q3 2023 financial and operational highlights which outlines more details on Q3 results and 2023 guidance.

我們繼續預期外匯對 2023 年全年調整後每股盈餘的影響為中性。我們預計第四季度調整後每股收益將在 0.49 美元至 0.52 美元之間。欲了解更多信息，請查看我們的投資者關係網站，了解 2023 年第三季度的財務和運營亮點，其中概述了有關第三季度業績和 2023 年指導的更多詳細信息。

In closing, I'm very proud of our year-to-date financial performance with top-tier organic revenue growth of 12%, adjusted operating margin of 26.1% and adjusted earnings per share growth of 18%. I look forward to continued momentum in the fourth quarter to close out 2023, which will set a stage towards achieving our long-range financial goals.

最後，我對我們今年迄今的財務表現感到非常自豪，頂級有機收入增長了 12%，調整後營業利潤率為 26.1%，調整後每股收益增長了 18%。我期待第四季繼續保持勢頭，直至 2023 年結束，這將為實現我們的長期財務目標奠定基礎。

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

接下來，我會將其轉回勞倫，他將主持問答。

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

謝謝，丹。科斯塔斯，讓我們在接下來的 30 分鐘左右的時間裡提問。 （操作員說明）。科斯塔斯，請繼續。

(Operator Instructions) And the first question comes from the line of Robert Marcus with JPMorgan.

（操作員說明）第一個問題來自摩根大通的羅伯特馬庫斯。

And congrats on a great quarter. And since many of us are at TCT, had the nice AGENT DCB trial as well. I had 2 questions. I'm going to -- I'll just go with one here. As we go back to the Analyst Day, you pointed to 8% to 10% growth and 150 basis points of operating margin expansion over the 3-year time frame. And I believe one of the comments was, at the beginning of the range, it will be towards the lower end and accelerate as you have some of your big new product launches coming.

並祝賀這個季度的出色表現。由於我們中的許多人都在 TCT，因此也進行了很好的 AGENT DCB 試驗。我有兩個問題。我要——我就在這裡選一個。當我們回到分析師日時，您指出在 3 年內成長 8% 至 10%，營業利潤率擴張 150 個基點。我相信其中一條評論是，在該範圍的開始，它將朝著低端發展，並隨著一些大型新產品的發布而加速。

So I'm looking at 2024 here, and I see the Street at 8% to 9% organic sales growth and about 50 basis points margin expansion. I just want to make sure we're interpreting the comments you made at the Analyst Day correctly. And any thoughts you have on directionality for next year?

因此，我在這裡展望 2024 年，我認為華爾街的有機銷售成長率將達到 8% 至 9%，利潤率將擴大約 50 個基點。我只是想確保我們正確解釋了您在分析師日發表的評論。您對明年的方向有什麼想法嗎？

Sure, Robbie. I think relative to the Analyst Day commentary, let me just reiterate just to make sure we're all on the same page. So as you said, 8% to 10% organic revenue growth over the period '24 to '26. 150 basis points of margin expansion over that 3-year period, which would put us -- assuming we're at that 26.4% at the end of this year, kind of near that 28%, which is a nice jumping off point for that 30% long-term goal.

當然，羅比。我認為相對於分析師日的評論，讓我重申一下，以確保我們都達成共識。正如您所說，24 至 26 年間有機收入成長 8% 至 10%。在這三年期間，利潤率擴張了 150 個基點，假設我們今年年底的利潤率為 26.4%，這將使我們接近 28%，這是一個很好的起點30%的長期目標。

And then we said that the 2025 revenue growth rate would likely be higher than our 2024 revenue growth rate due to the launches that are coming in 2024. So that's really the commentary that we had relative to Investor Day.

然後我們說，由於 2024 年即將推出，2025 年的營收成長率可能會高於 2024 年的營收成長率。這確實是我們對投資者日的評論。

And obviously, 2023 shaping up to be a great year, a good jumping off point heading into '24. But relative to specifics around '24, we're working through our '24 annual planning process here in the fourth quarter. And as you would expect, we'll use that as the basis to give you the guidance when we get to our Q4 earnings call in January.

顯然，2023 年將是偉大的一年，是進入 24 世紀的良好起點。但相對於 24 年左右的具體情況，我們正在第四季完成 24 年度規劃流程。正如您所期望的，當我們在一月份召開第四季度財報電話會議時，我們將以此為基礎為您提供指導。

The next question is from line of Joanne Wuensch with Citibank.

下一個問題來自花旗銀行的 Joanne Wuensch。

Since many are sitting here at TCT, I think I'm going to focus on that. Including -- I'd love some feedback on the data that's been presented here, particularly on the AGENT trial. And then I found the WATCH-TAVR trial also interesting. So anything you can comment on that would be wonderful.

由於 TCT 裡有很多人，我想我將重點放在這一點上。包括——我希望獲得對這裡提供的數據的一些反饋，特別是關於 AGENT 試驗的反饋。然後我發現 WATCH-TAVR 試驗也很有趣。所以你能評論的任何事情都會很棒。

Dr. Stein, you want to comment?

史坦博士，您想發表評論嗎？

Yes. Thanks, Mike. Let me start again, Joanne, we're really pleased by all of the data that we saw at TCT. I'll begin with AGENT and literally could not be happier with the ultimate results for that randomized trial, which, again, as I hope everyone recognizes, right, is intended to get approval of the first drug-coated balloon indicated for use in the coronaries in the United States for in-stent restenosis, right?

是的。謝謝，麥克。讓我重新開始，Joanne，我們對在 TCT 看到的所有數據感到非常滿意。我將從AGENT 開始，對於該隨機試驗的最終結果，我真的非常滿意，正如我希望每個人都認識到的那樣，該試驗的目的是獲得第一個藥物塗層球囊的批准，該球囊適用於美國進行冠狀動脈支架內再狹窄，對嗎？

in-stent restenosis accounts for approximately 10% of U.S. coronary interventions today. Having a drug-coated balloon will allow interventionalist to address these stent failures while leaving nothing behind. We've seen how well it's performing where we do have it approved in Japan. And just to reiterate, really the incredible results from the trial. That endpoint of target lesion failure at 12 months with really marked statistical and clinical superiority to plain old balloon angioplasty. And importantly, both clinically important reductions in target for (inaudible) and reductions in the need for target lesion revascularization.

目前，支架內再狹窄約占美國冠狀動脈介入治療的 10%。擁有藥物塗層球囊將使介入醫生能夠解決這些支架故障，同時不會留下任何痕跡。我們已經看到它在日本獲得批准時的表現有多好。重申一下，試驗的結果確實令人難以置信。 12 個月時目標病變失敗的終點確實比普通舊式球囊血管成形術具有顯著的統計和臨床優越性。重要的是，臨床上重要的目標減少（聽不清楚）和目標病變血管重建需求的減少。

And then yes, so that was yesterday, day before yesterday, we saw the results of WATCH-TAVR. And so WATCH-TAVR, I think it was important investigator-initiated trial looking at the combined use of the legacy WATCHMAN 2.5 device at the same time of TAVR in high-risk patients with atrial fibrillation undergoing TAVR.

然後是的，那就是昨天，前天，我們看到了 WATCH-TAVR 的結果。因此，WATCH-TAVR，我認為這是一項重要的由研究者發起的試驗，旨在研究在接受 TAVR 的房顫高風險患者進行 TAVR 的同時聯合使用傳統 WATCHMAN 2.5 設備。

And I think on the one hand, we sort of acknowledge that combined use of WATCH-TAVR does face a challenge in reimbursement environment, but also important, the trial validates the safety and the efficacy of the legacy WATCHMAN 2.5 device as compared to control therapy, including the use of NOACs in this population.

我認為，一方面，我們承認 WATCH-TAVR 的聯合使用確實面臨報銷環境的挑戰，但同樣重要的是，該試驗驗證了傳統 WATCHMAN 2.5 設備與對照治療相比的安全性和有效性，包括在該人群中使用NOAC。

The next question is from the line of Rick Wise with Stifel.

下一個問題來自 Rick Wise 和 Stifel。

And it's wonderful to see such an excellent quarter. I guess if I focus on one, maybe you could expand on your -- Mike, on your -- if you want to do it, your Neuromod comments, just your latest thinking just broadly, what's going to help reaccelerate the business or what's next from here.

很高興看到如此出色的季度。我想如果我專注於一個，也許你可以擴展你的- 邁克，你的- 如果你想做的話，你的Neuromod 評論，只是你最新的廣泛思考，什麼將有助於重新加速業務或下一步是什麼從這裡。

But more specifically, the PDN indication approval how does that affect the business? When does it start contributing? How would you have us think about the beneficial contribution there?

但更具體地說，PDN 適應症的批准對業務有何影響？什麼時候開始貢獻？您希望我們如何看待那裡的有益貢獻？

In the third quarter, as I mentioned, we're proud that most of all of our businesses grew at least at most likely, most of them grew above market, likely with the exception of the one that you asked about Neuromod.

正如我所提到的，在第三季度，我們感到自豪的是，我們的大多數業務至少有可能實現成長，其中大多數成長高於市場水平，可能除了您詢問的關於Neuromod 的業務之外。

So in the neuromod business, we grew roughly 3% in the quarter. I'll just start off before I jump to SCS, the brain business, our DBS business continues to do well, continues to grow share. And in third quarter, it grew double digits again with the Neural Navigator. That business continues to become a larger part of the overall mix.

因此，在 Neuromod 業務中，我們本季成長了大約 3%。在我跳到 SCS 之前，我先開始講，大腦業務，我們的 DBS 業務繼續表現良好，份額繼續增長。第三季度，神經導航器的出現再次達到兩位數成長。該業務繼續成為整體業務的重要組成部分。

Global SCS still is the largest piece that's been under pressure, as you pointed out. The pressure points really come from additional of probably a couple of new competitors in the marketplace, some competitive launches and our DPN approval, which we're very excited about, which you highlighted, we received in October, but we don't expect to launch our DPN platform until likely first quarter near the mid-first quarter 2024.

正如您所指出的，全球南海仍然是承受壓力的最大部分。壓力點實際上來自市場上可能有幾個新的競爭對手、一些競爭性的發布以及我們的DPN 批准，我們對此感到非常興奮，您強調了這一點，我們在10 月收到了這些批准，但我們預計不會我們的 DPN 平台可能會在 2024 年第一季中期左右推出。

So this will certainly help us with our core SCS business with that additional indication. And also with the Relievant company that we've signed, but not yet closed. We expect to close that in 2024. So we think the combination of the DPN to our existing SCS base combined with the Relievant and also our RF platform gives us a really nice category leadership position to treat pain with a variety of options, which will be differentiated.

因此，這肯定會幫助我們開展核心 SCS 業務，並提供額外的指示。我們也與 Relievant 公司簽約，但尚未結束。我們預計將在2024 年完成這一目標。因此，我們認為DPN 與我們現有的SCS 基礎相結合，再加上Relievant 和我們的RF 平台，為我們提供了一個非常好的類別領導地位，可以透過多種選擇來治療疼痛，這將是差異化。

So we do expect likely some softness to continue in the fourth quarter and we obviously aim to improve on those results in 2024 based on what I just highlighted.

因此，我們確實預計第四季度可能會繼續出現一些疲軟情況，而我們的目標顯然是根據我剛才強調的內容在 2024 年改善這些結果。

The next question is from the line of Vijay Kumar with Evercore ISI.

下一個問題來自 Evercore ISI 的 Vijay Kumar。

Congrats on the front and the data being presented at TCT. If I may, I want to stick to on the financial side. Dan, just to clarify, the '24 commentary, if the acceleration is all being driven by new products and these new products are being launched, I think you said back half of next year. Should we be perhaps thinking about the lower end of that 8% to 10%. And I think you mentioned gross margins FX impact here. So it looks like Q4 is going to look similar to 3Q. How to think about any FX impact on gross margins as we look at the outlook?

恭喜 TCT 上展示的前沿內容和數據。如果可以的話，我想堅持在財務方面。 Dan，我想澄清一下，24 世紀的評論，如果加速都是由新產品推動的，而這些新產品正在推出，我想你說的是明年下半年。我們是否應該考慮 8% 到 10% 的下限。我想你在這裡提到了毛利率的外匯影響。因此，第四季看起來將與第三季相似。當我們展望前景時，如何考慮匯率對毛利率的影響？

Sure. So I'll hit the gross margin one, first. The gross margin in the third quarter was a little bit lower than the expected, and it was predominantly driven by FX at that 70.2%. So we had been targeting kind of to be approaching 71% for the full year this year. We were 70.5% last year. Just tempering those -- that commentary to say, you know what, we might not hit the approaching 71%. We might be -- we'll be near to 70.5%. But maybe not as high as approaching 71%. So a bit of a nuance there, but driven by FX.

當然。所以我首先要談的是毛利率。第三季的毛利率略低於預期，主要由外匯推動，為 70.2%。因此，我們的目標是今年全年接近 71%。去年我們是70.5%。只是調整一下——那篇評論說，你知道嗎，我們可能達不到接近 71% 的目標。我們可能會接近 70.5%。但可能沒有那麼高，接近 71%。因此存在一些細微差別，但由外匯驅動。

And we had mentioned for 20 -- the long-range plan at Investor Day for '24, '5 and '6, that there'd be a bit of an FX headwind in gross margin in '24 that should get better over that time frame of '24, '5, '6.

我們在 20 年投資者日上提到了 24 年、5 年和 6 年的長期計劃，24 年的毛利率將面臨一些外匯逆風，但到那時應該會有所改善'24、'5、'6幀。

Relative to '24 organic revenue growth, no, there's really not much to assume other than we'll let you know on January 31 when we have our call. We have 8% to 10% as the CAGR for the 3 years. As I mentioned, we'll work through our annual planning process here over the back half of this quarter, and we'll let you know. We do have some nice launches obviously in '24, as you mentioned, many in the back half. But we'll let you know on January 31, what we think the range will be for '24.

相對於 24 年的有機收入增長，不，除了我們會在 1 月 31 日接到電話時通知您之外，實際上沒有太多可以假設的。我們的 3 年複合年增長率為 8% 到 10%。正如我所提到的，我們將在本季後半段完成年度規劃流程，並將通知您。正如您所提到的，我們確實在 24 年推出了一些不錯的產品，其中許多是在後半段。但我們會在 1 月 31 日告知您 24 年的範圍。

The next question is from the line of Larry Biegelsen with Wells Fargo.

下一個問題來自富國銀行的 Larry Biegelsen。

Mike, we've made it this far without a GLP-1 question. But I'm going to ask it anyway. Obviously, diabetes and obesity are risk factors for many diseases such as cardiovascular disease. How are you thinking about the potential long-term impact of GLP-1s on your businesses? And any high-level thoughts, Mike, on how investors have reacted to GLP-1s in general.

Mike，到目前為止，我們已經沒有 GLP-1 問題了。但我還是要問一下。顯然，糖尿病和肥胖是心血管疾病等許多疾病的危險因子。您如何看待 GLP-1 對您業務的潛在長期影響？麥克，以及關於投資者對 GLP-1 的整體反應的任何高層想法。

Dr. Stein, you want to give a comment on GLP-1?

Stein博士，您想對GLP-1發表評論嗎？

Yes. Thanks. Thanks, Mike. I think, I'll begin -- right, I'm as a Doc, I think you have to acknowledge these are promising agents. I think on the other hand, as a Doc and a realist, through the launch of other promising agents in the past, and I think statins are a really good example.

是的。謝謝。謝謝，麥克。我想，我會開始 - 是的，我作為一名醫生，我認為你必須承認這些是有前途的代理人。另一方面，我認為，作為一名醫生和現實主義者，透過過去推出其他有前途的藥物，我認為他汀類藥物是一個很好的例子。

I think, got to acknowledge -- and particularly with these drugs, given issues of cost, issues of convenience, and issues of tolerability, we expect it will take at least a decade to reach peak penetration of these drugs in the indicated population. And even after a decade, we expect that only a minority of American patients with obesity will be taking these drugs.

我認為，必須承認，特別是對於這些藥物，考慮到成本問題、便利性問題和耐受性問題，我們預計這些藥物在指定人群中的滲透率至少需要十年才能達到高峰。即使十年後，我們預計只有少數美國肥胖患者會服用這些藥物。

So right, if you think about these barriers to usage, I begin by saying we see very limited short-term impact on cardiovascular disease. And even in the long term, right? Our analysis taking into account, again, penetration ramp of these drugs, as I said, and taking into account what we know this far -- thus far about reported 20% reduction in cardiovascular event rates suggest to us that the impact on U.S. coronary and peripheral procedure volumes will be minor even at peak.

所以，如果你考慮到這些使用障礙，我首先要說的是，我們認為對心血管疾病的短期影響非常有限。即使從長遠來看，對嗎？正如我所說，我們的分析再次考慮到這些藥物的滲透率上升，並考慮到我們迄今為止所知道的情況——迄今為止報告的心血管事件發生率降低了20%，這表明，這對美國冠狀動脈和心血管疾病的影響即使在高峰期，外圍手術量也很小。

And I think it's important to state, so we -- even with these drugs, continue to expect both of these procedures to continue to grow in volume over the next decade.

我認為重要的是要說明，因此，即使有了這些藥物，我們仍預計這兩種手術的數量在未來十年內將繼續增長。

Furthermore, I think it's also really important to point out that cardiovascular disease is a global issue, that there is less attribution to obesity in other regions, particularly Asia, making it less amenable to prevention with these drugs, which are frankly also very likely to be less accessible outside of the U.S.

此外，我認為指出心血管疾病是一個全球性問題也非常重要，在其他地區，特別是亞洲，肥胖的歸因較少，因此不太適合用這些藥物進行預防，坦白說，這些藥物也很可能在美國以外的地方不太容易到達

Also any decrease in cardiovascular mortality events will necessarily be accompanied by a corresponding increase in the prevalence of other diseases that are associated with aging. Diseases in the areas that are really very well served by our products, including things like cardiac pacing, interventional oncology for many forms of cancer, a deep brain stimulation.

此外，心血管死亡率事件的任何減少都必然伴隨著與老化相關的其他疾病的盛行率相應增加。我們的產品確實能很好地服務於那些領域的疾病，包括心臟節律器、針對多種癌症的介入性腫瘤學、深部腦部刺激等。

And finally, right, the assumptions that I'm talking to in terms of our modeling, right, don't consider other procedural growth factors like an aging population over this period and certainly doesn't consider the long track record that we have of focusing and executing on innovation.

最後，對了，我在模型方面所討論的假設，對吧，不要考慮其他程序性增長因素，例如這段時期的人口老齡化，當然也沒有考慮我們擁有的長期記錄專注並執行創新。

The next question is from the line of Travis Steed with Bank of America.

下一個問題來自美國銀行的 Travis Steed。

I did want to ask about FARAPULSE. It sounds like the update was expected approval in the second half '24. Just curious when that was filed with the FDA. And then maybe you can talk a little bit about scaling that up in the U.S. and the potential to see pull-through on the ancillary products like mapping.

我確實想問一下 FARAPULSE 的事。聽起來更新預計會在 24 年下半年獲得批准。只是好奇什麼時候向 FDA 提交的。然後也許你可以談談在美國擴大這一規模，以及在地圖等輔助產品上實現拉動的潛力。

Maybe you take the timing of launch and you can speak to the value to the full portfolio?

也許您可以考慮發布的時間，並談論整個產品組合的價值？

Yes. Sure, Lauren. So yes, on timing, again, as we've said, I think everyone knows, right, our foundational pivotal scale data to submit to the FDA was Advent, presented those results. As Mike said, at ESC, at the end of August with simultaneous publication in New England Journal of Medicine, hit all of our endpoints, very clean data set. And so again, as we've said, we've now completed our regulatory submission to the FDA and things are in regulators' hands. So continue to expect approval second half of next year. And I think all of the EPs that I've spoken in the U.S. can't wait to get their hands on it.

是的。當然，勞倫。所以，是的，在時間上，正如我們所說，我想每個人都知道，對吧，我們提交給 FDA 的基礎關鍵規模數據是 Advent，展示了這些結果。正如 Mike 所說，8 月底在 ESC 上同時發表在《新英格蘭醫學雜誌》上，達到了我們所有的終點，非常乾淨的數據集。正如我們所說，我們現在已經完成了向 FDA 的監管提交，一切都在監管機構手中。因此繼續期待明年下半年的批准。我想我在美國演講過的所有歐洲議會議員都迫不及待地想親自使用它。

You saw the results in the third quarter which are quite strong with both POLAR and FARAPULSE. I think what's important is our supply chain team has done a terrific job over the past 18 months in building supply of both catheters and the capital equipment needed. So we expect to see a more significant install cadence to the back half of this quarter and in the first quarter. So we feel like we've really significantly improved our supply capabilities, and you'll see that in '24 in Europe, and we'll be ready for the U.S. launch.

您看到了第三季 POLAR 和 FARAPULSE 的結果都相當強勁。我認為重要的是我們的供應鏈團隊在過去 18 個月在建立導管和所需資本設備的供應方面做得非常出色。因此，我們預計本季後半段和第一季的安裝節奏將會更加明顯。所以我們覺得我們確實顯著提高了我們的供應能力，你會在 24 年在歐洲看到這一點，我們將為美國的推出做好準備。

The next question is from the line of Danielle Antalffy with UBS.

下一個問題來自瑞銀集團的 Danielle Antalffy。

And congrats on a great quarter and the data here at TCT. Just a quick question on Q4 top line guide. I imagine there's some conservatism baked in here, but if I'm looking at it correctly, is implying a little bit of a deceleration and not to be nitpicky here, but just want to make sure we're understanding of what the tailwinds versus headwinds are as we go into Q4 and heading into 2024.

恭喜 TCT 取得了出色的季度業績和數據。只是一個關於第四季頂線指南的簡單問題。我想這裡有一些保守主義，但如果我正確地看待它，這意味著有點減速，而不是在這裡挑剔，但只是想確保我們理解什麼是順風與逆風當我們進入第四季度並進入2024 年時。

Sure, Danielle. Yes, I think of note, if you think back to our July guidance, obviously, we didn't give specific Q4 guidance, but implied in that guidance would have been 7% to 9%. So the 8% to 10% that we have for the fourth quarter is a bit of acceleration from where that would have been.

當然，丹妮爾。是的，我想值得注意的是，如果你回想一下我們 7 月的指導，顯然，我們沒有給出具體的第四季度指導，但該指導中暗示了 7% 到 9%。因此，我們第四季的 8% 到 10% 比原本的水平有所加速。

As always, we think the 8% to 10% is a prudent number for the quarter and believe it's the right number for the quarter for -- to close out the year. It will put us at 11% -- approximately 11% organic revenue growth for the year. So I think that's a great year for the company. And you combine that with the other metrics that we have, not just revenue, but the 11% organic revenue growth, you'd see 80 basis points of margin expansion at that 26.4% adjusted op margin. And then you get to 17% to 18% full year EPS at that $1.99 to kind of that milestone over $2 to get to that $2.02. That's a good year.

像往常一樣，我們認為 8% 到 10% 是本季度的謹慎數字，並相信這是結束今年的季度的正確數字。這將使我們今年的有機收入成長率達到 11%——約 11%。所以我認為這對公司來說是偉大的一年。如果將其與我們擁有的其他指標（不僅僅是收入，還有 11% 的有機收入成長）結合起來，您會看到利潤率擴張了 80 個基點，調整後的營運利潤率為 26.4%。然後你的全年每股收益將達到 17% 到 18%，達到 1.99 美元，超過 2 美元達到 2.02 美元。那是美好的一年。

The next question is from the line of Matt Taylor with Jefferies.

下一個問題來自馬特泰勒和傑弗里斯的對話。

Actually I wanted to ask one on neuromodulation. You talked about results below expectations in light of the competitive dynamics. So I was hoping you could comment on that. And whether you expect any improvement in growth now, you have the PDN indication.

其實我想問一個關於神經調節的問題。您談到了鑑於競爭動態而導致的結果低於預期。所以我希望你能對此發表評論。無論您現在是否期望成長有所改善，您都有 PDN 指示。

Sure, Matt. Yes, there's been -- a couple of new entrants into the field over the last 12 months. And so they've taken a little bit of market share. Overall, the market is likely, I don't know, 5% to 6%-ish and this year, we're likely to -- in SCS U.S. likely be below the market. I mentioned earlier, a big driver there is not having the support of DPN which we just recently received in October. And we expect to be able to offer that capability in line with some of our competitors in first quarter 2024. So we do expect to have a softer fourth quarter and then we expect acceleration improvement in '24 versus '23 for our SCS business. In our brain business, DBS continues to take share and grow double digits. And again, mentioned it's likely the only division that's grown below the market.

當然，馬特。是的，在過去的 12 個月裡，已經有一些新進業者進入該領域。因此他們佔據了一點市場份額。總體而言，我不知道，市場可能會上漲 5% 至 6% 左右，而今年，我們在美國南海可能會低於市場水平。我之前提到過，那裡的一個主要推動者沒有得到我們最近在 10 月剛收到的 DPN 的支持。我們預計能夠在 2024 年第一季提供與我們的一些競爭對手一致的能力。因此，我們確實預計第四季度會比較疲軟，然後我們預計我們的 SCS 業務將在 24 年相對於 23 年加速改善。在我們的大腦業務中，星展銀行繼續佔據份額並以兩位數成長。再次提到，它可能是唯一一個成長低於市場的部門。

The next question is from is from the line of Josh Jennings with TD Cowen.

下一個問題來自 Josh Jennings 和 TD Cowen 的線路。

Congratulations on the strong results. And I wanted to follow up on Travis's question on FARAPULSE. Was hoping to just better understand where your U.S. EP sales force stands today and how you're building that out -- plan to build that out and for the FARAPULSE launch? And then just on top of that, just thinking about the full integration of FARAPULSE RHYTHMIA and developing the FARAVIEW capabilities. Is there anything of note that we should be thinking about that would provide clinical advantages that could catalyze stronger demand for RHYTHMIA once that integration is completed, I believe, at the year-end of '24.

祝賀取得了優異的成績。我想跟進 Travis 在 FARAPULSE 上提出的問題。是否希望更好地了解您的美國 EP 銷售團隊目前的狀況以及您如何構建它 - 計劃構建它並為 FARAPULSE 發布？除此之外，還要考慮 FARAPULSE RHYTHMIA 的完全整合並開發 FARAVIEW 功能。我相信，在 24 年底完成整合後，有什麼值得注意的事情可以提供臨床優勢，從而促進對 RHYTHMIA 的更強勁需求。

Sure. Yes, I won't go into too many specifics on our commercial strategy. We do have a scaled and trained EP sales force. As you imagine, given the capabilities we have with our WATCHMAN division and our EP business and our CRM business. So we have a scaled EP force that's been trained up now. And what's great to see is they're successfully selling Cryo today.

當然。是的，我不會詳細介紹我們的商業策略。我們確實擁有一支規模化且訓練有素的 EP 銷售團隊。正如您想像的那樣，考慮到我們的 WATCHMAN 部門、EP 業務和 CRM 業務的能力。因此，我們現在已經擁有一支經過訓練的規模化的 EP 部隊。令人高興的是他們今天成功銷售了 Cryo。

So having the approval of that, and we had a really nice initial, I don't know, 30 days or so of cryo openings. So we expect to see cryo to be a nice revenue driver for us in 2024 as we wait for the FARAPULSE approval. So we do have a scaled, highly capable EP commercial team. And Ken, if you want to comment on the RHYTHMIA offerings.

因此，在得到批准後，我們有了一個非常好的初始，我不知道，大約 30 天的冷凍開放。因此，在我們等待 FARAPULSE 批准的過程中，我們預計冷凍將在 2024 年成為我們良好的收入驅動力。所以我們確實擁有一支規模化、能力強的EP商業團隊。 Ken，如果您想對 RHYTHMIA 產品發表評論。

Yes. Thanks, Josh. And again, we're very excited about FARAPULSE as it stands today that we have disclosed. We do have a next generation of FARAWAVE catheter, right, which is the ablation catheter part of the FARAPULSE system that will include an embedded NAV sensor that will work with a novel iteration to the RHYTHMIA software that we're calling FARAVIEW that we do have targeted for year end of '24. And our goal here really, Josh, is I said we're never going to compel people to use RHYTHMIA if they want to use FARAPULSE. But we're going to make the FARAWAVE and FARAVIEW system compelling for physicians to use. And there are really some very novel things that we're able to do with that system combination that we believe is going to improve physician workflow and hopefully lead to even better patient outcomes with the combined system, even on top of the great outcomes that we saw in Advent.

是的。謝謝，喬許。再說一次，我們對我們今天披露的 FARAPULSE 感到非常興奮。我們確實有下一代 FARAWAVE 導管，對吧，它是 FARAPULSE 系統的消融導管部分，它將包括一個嵌入式 NAV 感測器，該感測器將與 RHYTHMIA 軟體的新穎迭代配合使用，我們稱之為 FARAVIEW，我們確實有目標是24 年底。喬什，我們的目標實際上是，我說過，如果人們想使用 FARAPULSE，我們永遠不會強迫他們使用 RHYTHMIA。但我們將讓 FARAWAVE 和 FARAVIEW 系統吸引醫師使用。我們確實能夠利用該系統組合做一些非常新穎的事情，我們相信這些事情將改善醫生的工作流程，並希望透過組合系統帶來更好的患者結果，甚至在我們已經取得的巨大成果之上。在降臨節中看到。

The next question is from the line of Chris Pasquale with Nephron Research.

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

I have a follow-up for Dr. Stein on AGENT. The results were certainly impressive versus PTA, but it was noted from the podium that about 85% of ISR cases in the U.S. today are being treated with drug-eluting stent. So do you have plans to follow up the IDE study with a randomized trial versus DBS? And maybe just some thoughts on how you see agents fitting into the treatment paradigm versus that standard of care.

我在 AGENT 上有 Stein 博士的後續報導。與 PTA 相比，結果確實令人印象深刻，但講台上指出，目前美國約 85% 的 ISR 病例正在接受藥物洗脫支架治療。那麼您是否計劃透過隨機試驗與 DBS 來跟進 IDE 研究？也許只是關於您如何看待藥物適應治療範式與護理標準的一些想法。

Yes, Chris. Not going to get into what our post-approval research strategy is going to look like. I think there's a lot to be learned when you see how drug coated balloons are used in Japan and how they're used in Europe today, right? And patients with in-stent restenosis have failed the stent.

是的，克里斯。不會討論我們的核准後研究策略會是什麼樣子。我認為當您看到日本如何使用藥物塗層氣球以及當今歐洲如何使用它們時，您可以學到很多東西，對嗎？而支架內再狹窄的患者則出現了支架失效的情況。

And fool me once, shame on you. Fool me twice, shame on me. I don't think that there are a lot of physicians who want to be putting additional foreign objects into someone who's already had an in-stent restenosis. So we really believe the results that we saw with AGENT are compelling and compelling enough to move the vast majority of interventionalists to use AGENT in place of either plain old balloon angioplasty or in place of, again, yet another stent in the in-stent restenosis area.

還騙了我一次，你真丟臉。騙我兩次，真丟臉。我認為沒有很多醫生願意將額外的異物放入已經發生支架內再狹窄的患者體內。因此，我們確實相信，我們在AGENT 上看到的結果是令人信服的，足以促使絕大多數介入醫生使用AGENT 來代替普通的舊式球囊血管成形術，或再次代替支架內再狹窄中的另一個支架區域。

I think the only other thing I'll say is, clearly, there are a lot of potential indications for the use of the AGENT product beyond in-stent restenosis. And we'll certainly be looking at research and development of those as we get beyond approval and use for the first indication.

我想我要說的唯一另一件事是，顯然，除了支架內再狹窄之外，AGENT 產品的使用還有很多潛在的適應症。當我們獲得第一個適應症的批准和使用時，我們肯定會關注這些產品的研究和開發。

The next question is from the line of Michael Polark with Wolf Research.

下一個問題來自 Wolf Research 的 Michael Polark。

I have a question on price cost. On price, the message has been historically, you're kind of a little negative. We've moved it at the portfolio level to neutral. As we jump into '24, what's a good base case? Neutral, again, a little up. A little down. On the cost side, kind of where are you seeing opportunities, raw materials, freight labor, where are you seeing tensions?

我有一個關於價格成本的問題。關於價格，歷史上一直有這樣的訊息，你有點消極。我們已將其在投資組合層面調整為中性。當我們進入 24 世紀時，什麼是好的基本狀況？再次中性，略微上升。有點低落。在成本方面，您在哪裡看到機會、原材料、貨運勞動力，您在哪裡看到緊張局勢？

And then the last piece of this is, one of your large competitors did announce an inventory obsolescence charge this quarter. I think we all can see that inventories for the sector overall are quite higher than they used to be because of the COVID stresses and strains. What -- can I get an update on Boston's status on inventory?

最後一點是，您的一個大型競爭對手確實在本季宣布了庫存報廢費用。我認為我們都可以看到，由於新冠疫情的壓力和壓力，整個行業的庫存比以前高得多。什麼——我可以獲得波士頓庫存狀態的最新資訊嗎？

Sure. Mike, happy to light on that question. So on the pricing. Historically, we've been in that kind of very low single-digit decline for many years. We're starting to envision a world where we could be flat. So that's a goal of ours as we go forward over the LRP to get to flat pricing, which obviously helps revenue and helps all the way down through the rest of the P&L.

當然。麥克，很高興回答這個問題。那麼在定價上。從歷史上看，我們多年來一直處於這種非常低的個位數下降狀態。我們開始設想一個平坦的世界。因此，這是我們的目標，因為我們在 LRP 上取得統一定價，這顯然有助於收入，並有助於一直降低損益表的其餘部分。

On the cost side, as you look at the traditional areas that we've talked about that have been impacted over the past couple of years, when you take freight, I'd say that's gotten better, but it's certainly not back to where it was. So I'd say improving but still elevated. And obviously, the conflict in the Middle East has us focused on fuel and oil as that runs a risk of increasing off of that.

在成本方面，當你看到我們談到的在過去幾年中受到影響的傳統領域時，當你接受貨運時，我想說這已經變得更好了，但它肯定還沒有回到原來的水平曾是。所以我想說的是有所改善，但仍然有所改善。顯然，中東衝突讓我們專注於燃料和石油，因為這有增加的風險。

The inflation impact on our direct material costs, again, I would say -- it's there seems -- we're seeing signs of that stabilizing over time, but it's absolutely elevated from where it was. So we still do see impact of there.

我想說，通貨膨脹對我們的直接材料成本的影響似乎是存在的，隨著時間的推移，我們看到了這種影響趨於穩定的跡象，但它絕對比原來的水平有所上升。所以我們仍然看到了那裡的影響。

And then the consistency of supply -- it's not fully back to normal, again, but it has improved. So we're optimistic about the future that we see a better macro environment for cost of goods in that category, but we're not there yet is what I would say. And then relative to the inventory, yes, I mean I would say for -- we've been building inventory over the last 2 or 3 years, right? Our back order has been elevated higher than we have liked. The team has done a great job over the last 12 months of getting that more in line with where we've been historically. So I would not point to charges from our perspective as a big driver because we're still a bit in catch-up mode and making sure that we have the right amount of inventory to supply. So I think we're focused on having the right inventory, but we're not at the point where we have too much inventory.

然後是供應的一致性——雖然還沒有完全恢復正常，但已經有所改善。因此，我們對未來感到樂觀，因為我們看到該類別商品成本的宏觀環境會更好，但我想說的是，我們還沒有實現這一目標。然後相對於庫存，是的，我的意思是，我們在過去的兩三年裡一直在建立庫存，對嗎？我們的延期交貨訂單已經超出了我們的預期。在過去 12 個月裡，團隊做得非常出色，使這一目標更加符合我們的歷史記錄。因此，從我們的角度來看，我不會指出收費是一個重要的推動因素，因為我們仍處於追趕模式，並確保我們有適量的庫存可供供應。因此，我認為我們的重點是擁有正確的庫存，但我們還沒有達到庫存過多的地步。

Mr. Polark, have you finished with your questions?

波拉克先生，您的問題問完了嗎？

Yes.

是的。

Yes. Can we take the last question?

是的。我們可以回答最後一個問題嗎？

The next -- our last question comes from the line of Matthew O'Brien with Piper Sandler.

下一個——我們的最後一個問題來自馬修·奧布萊恩和派珀·桑德勒的對話。

I know you guys are a domestic company, but the performance in EMEA and APAC specifically were notable and specifically APAC was really, really strong this quarter. Can you just give us a little more sense for -- because I think those 2 collectively were roughly half your growth this quarter. The durability of the performance in those geographies? Is it a function of just more and more products into those areas. And so that's pretty straightforward? Or is it share taking that's required? Or what's really required to continue to deliver maybe not this level of growth, which is really strong again, but very strong growth going forward where that's a significant contributor to top line for '24, '25 and beyond.

我知道你們是一家國內公司，但歐洲、中東和非洲和亞太地區的表現特別引人注目，特別是亞太地區本季的表現非常非常強勁。您能否給我們更多的了解——因為我認為這兩個因素加起來大約是您本季成長的一半。在這些地區的性能是否持久？這是否只是越來越多的產品進入這些領域的結果。那麼這很簡單嗎？或是否需要認購股份？或者，真正需要繼續實現的可能不是這種水準的成長（這種成長再次非常強勁），而是未來非常強勁的成長，這對 24 年、25 年及以後的收入做出了重要貢獻。

Sure. Yes, starting with Europe, it's really not -- thankfully, it's not a new phenomenon for our team in Europe which we also referenced in Middle East, Africa. Last year, they grew 12%, and they're on track to grow another double digits again in 2023.

當然。是的，從歐洲開始，這確實不是——值得慶幸的是，這對我們歐洲團隊來說並不是一個新現象，我們在中東和非洲也提到過。去年，它們增長了 12%，並且預計在 2023 年再次實現兩位數增長。

So the European team, it's really a combination clearly of share taking given the markets aren't growing double digits in Europe. And our European team has benefited from the portfolio of having many of the product launches that we talked about for second half of '24 in the U.S. already in that marketplace.

因此，考慮到歐洲市場並沒有以兩位數的速度成長，歐洲團隊顯然是一個份額佔據的組合。我們的歐洲團隊受益於我們討論的 24 年下半年在美國市場推出的許多產品的組合。

So to do an excellent job of launching our innovative products taking share in the more developed Western European markets and also building a pretty significant capability in the appropriate emerging markets in Europe that also grows double digits. So the team has just done a really nice job of executing and driving our innovation with the launches.

因此，我們要出色地推出我們的創新產品，在更發達的西歐市場佔據份額，並在歐洲相應的新興市場建立相當重要的能力，並實現兩位數的成長。因此，該團隊在執行和推動我們的創新與發布方面做得非常出色。

Asia Pac had another strong quarter this year. That region also will grow double digit -- grew double digits last year and double digits again this year. And I would say the new news here is really just the strength of Japan is excellent in the quarter. And we expect another strong quarter for them in the fourth quarter. Again, it's all back to our people and our portfolio.

亞太地區今年又一個強勁的季度。該地區也將實現兩位數增長——去年增長兩位數，今年再次增長兩位數。我想說的是，這裡的新消息實際上只是日本在本季的實力非常出色。我們預計第四季度他們將再次表現強勁。同樣，這一切都回到了我們的員工和我們的投資組合。

And the team in Japan launching POLARx, AGENT, AVVIGO will be the next platform to launch in Japan. So that team has done a really nice job. In China, I was just there for about a week, and that team continues to grow nicely, strong double digits despite all the challenges that are well known in the marketplace, again, based on the strength of our portfolio, some of the alliances that we're doing and our team in China is quite strong. So they continue to -- so it's not a new event for us this quarter. Those regions have been delivering that for quite some time.

日本團隊推出的 POLARx、AGENT、AVVIGO 將是下一個在日本推出的平台。所以這個團隊做得非常好。在中國，我只在那裡待了大約一周，儘管市場上存在眾所周知的所有挑戰，但該團隊仍在繼續良好地增長，強勁的兩位數，同樣，基於我們投資組合的實力，一些聯盟我們正在做的事情，我們在中國的團隊非常強大。所以他們繼續下去——所以這對我們本季來說並不是什麼新事件。這些地區已經提供這項服務相當長一段時間了。

Thanks, Mike, and thank you 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.

謝謝麥克，也謝謝你今天加入我們。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, Costas will give you the pertinent details for the replay. Thank you.

在您斷開連接之前，科斯塔斯將為您提供重播的相關詳細資訊。謝謝。

Ladies and gentlemen, please note that a recording will be available in 1 hour by dialing either 1 (877) 344-7529 or 1 (412) 317-0088 using replay code 7607776 until November 2, 2023 at 11:59 p.m. ET. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

女士們、先生們，請注意，在2023 年11 月2 日晚上11:59 之前，撥打1 (877) 344-7529 或1 (412) 317-0088 使用重播代碼7607776，即可在1 小時內獲得錄音。等。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。