Boston Scientific Corp (BSX) 2024 Q3 法說會逐字稿

內容摘要

波士頓科學公司公佈了強勁的第三季收益,營運和有機銷售成長超出了預期。該公司專注於類別領導地位,並預計 AF 解決方案將持續成長。

2024 年第四季和全年前景樂觀,有機成長預計在 15% 左右。儘管試驗暫時暫停,但該公司對其產品仍然充滿信心,並為未來的成長做好了準備。

波士頓科學公司正在日本和中國推出產品,預計在中國的推出速度會較慢,但仍致力於提供強勁的財務表現。

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good morning and welcome to the Boston Scientific third-quarter 2024 earnings call.

    早安,歡迎參加波士頓科學公司 2024 年第三季財報電話會議。

  • (Operator Instructions) Please note, this event is being recorded.

    (操作員說明)請注意,正在記錄此事件。

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

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

  • Please go ahead.

    請繼續。

  • Jonathan Monson - Senior Vice President - Investor Relations

    Jonathan Monson - Senior Vice President - Investor Relations

  • Thanks, Drew, and thanks everyone for joining us.

    謝謝德魯,也謝謝大家加入我們。

  • With me today are Mike Mahoney, Chairman and Chief Executive Officer; and Dan Brennan, Executive Vice President and Chief Financial Officer.

    今天與我在一起的有董事長兼執行長 Mike Mahoney;執行副總裁兼財務長 Dan Brennan。

  • During the Q&A session, Mike and Dan will be joined by our Chief Medical Officer, Dr. Ken Stein; and Art Butcher, President of our MedSurg and Asia Pacific businesses.

    在問答環節,我們的首席醫療官 Ken Stein 博士將與 Mike 和 Dan 一起參加; Art Butcher,我們的 MedSurg 和亞太區業務總裁。

  • We issued a press release earlier this morning announcing our Q3 results, which included reconciliations of the non-GAAP measures used in this release.

    今天早些時候,我們發布了一份新聞稿,宣布了我們第三季度的業績,其中包括本新聞稿中使用的非公認會計原則指標的調節。

  • The release as well as reconciliations of the non-GAAP measures used in today's call can be found on the Investor Relations section of our website.

    今天電話會議中使用的非公認會計原則措施的發布和調節可以在我們網站的投資者關係部分找到。

  • Please note, on the call, operational revenue excludes the impact of foreign currency fluctuations, and organic revenue further excludes acquisitions and divestitures for which there are less than a full period of comparable net sales.

    請注意,在電話會議上,營業收入不包括外匯波動的影響,有機收入進一步不包括少於完整時期可比淨銷售額的收購和剝離。

  • Guidance excludes the previously-announced agreement to acquire Axonics, which is expected to close in the fourth quarter of 2024, subject to customary closing conditions.

    該指引不包括先前宣布的收購 Axonics 的協議,該協議預計將於 2024 年第四季完成,但須符合慣例成交條件。

  • For more information, please refer to the Q3 financial and operational highlights deck, which may be found on the Investor Relations section of our website.

    欲了解更多信息,請參閱第三季度財務和營運亮點,可在我們網站的投資者關係部分找到。

  • On this call, all references to sales and revenue are organic, and relative growth is compared to the same quarter of the prior year, unless otherwise specified.

    在本次電話會議中,除非另有說明,所有提及的銷售和收入都是有機的,相對增長是與去年同期相比。

  • This call contains forward-looking statements regarding, among other things, our financial performance, business plans, and product performance and development.

    本次電話會議包含有關我們的財務表現、業務計劃以及產品性能和開發等方面的前瞻性陳述。

  • These statements are based on our current beliefs using information available to us as of today's date and are not intended to be guarantees of future events or performance.

    這些聲明基於我們當前的信念,使用了截至今天為止我們可獲得的信息,並不旨在成為對未來事件或業績的保證。

  • If our underlying assumptions turn out to be incorrect or certain risks or uncertainties materialize, actual results could vary from those projected by the forward-looking statements.

    如果我們的基本假設被證明是不正確的,或者某些風險或不確定性成為現實,實際結果可能與前瞻性陳述的預測有所不同。

  • Factors that may cause such differences are discussed in our periodic reports and other filings with the SEC, including the Risk Factors section of our most recent annual report on Form 10-K.

    我們的定期報告和向 SEC 提交的其他文件中討論了可能導致此類差異的因素,包括我們最新 10-K 表格年度報告的風險因素部分。

  • Boston Scientific disclaims any intention or obligation to update these forward-looking statements, except as required by law.

    波士頓科學公司不承擔任何更新這些前瞻性聲明的意圖或義務,除非法律要求。

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

    此時,我會將其交給麥克。

  • Mike?

    麥克風?

  • Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

    Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

  • Thanks, John.

    謝謝,約翰。

  • Thank you, everyone, for joining us today.

    謝謝大家今天加入我們。

  • Our Q3 results exceeded our expectations, and we continue to invest in our portfolio and capabilities to deliver differentiated performance over the long term.

    我們第三季的業績超出了我們的預期,我們將繼續投資於我們的產品組合和能力,以實現長期差異化的業績。

  • In Q3 '24, total company operational sales grew 19% and organic sales grew 18%, exceeding the high end of our guidance range of 13% to 15%.

    2024 年第三季度,公司總營業銷售額成長 19%,有機銷售額成長 18%,超出了我們指導範圍 13% 至 15% 的上限。

  • Our excellent growth is and will continue to be focused on our category leadership strategy, fueled by innovation, clinical evidence generation, and the winning spirit of our global team.

    我們的卓越成長現在並將繼續集中在我們的類別領導策略上,並由創新、臨床證據生成和我們全球團隊的獲勝精神推動。

  • Q3 adjusted EPS of $0.63 grew 27%, exceeding the high end of our guidance range of $0.57 to $0.59. In Q3, adjusted operating margin was 27.2%.

    第三季調整後每股收益為 0.63 美元,成長 27%,超出了我們指導範圍 0.57 至 0.59 美元的上限。第三季度,調整後營業利益率為 27.2%。

  • Turning to our fourth quarter and the full-year '24 outlook.

    轉向我們的第四季和 24 年全年展望。

  • We're guiding to organic growth of 14% to 16% for fourth quarter and raising our full-year guidance to approximately 15%, reflecting momentum across our broad portfolio, particularly in AF solutions.

    我們預計第四季度的有機成長為 14% 至 16%,並將全年指引提高至 15% 左右,反映了我們廣泛的產品組合(特別是自動對焦解決方案)的勢頭。

  • Our fourth-quarter adjusted EPS guidance is now $0.64 to $0.66, and we expect our full-year adjusted EPS to be $2.45 to $2.47, representing growth of 20% to 21%.

    我們第四季調整後每股盈餘指引目前為 0.64 至 0.66 美元,預計全年調整後每股盈餘為 2.45 至 2.47 美元,成長 20% 至 21%。

  • Dan will provide more details on our financials in a few minutes, and I'll provide additional highlights on our third-quarter results along with our comments and our outlook.

    丹將在幾分鐘內提供有關我們財務狀況的更多詳細信息,我將提供有關我們第三季度業績的更多亮點以及我們的評論和前景。

  • Regionally, on an operational basis, the US grew 24% with double-digit growth or higher in six of eight business units.

    從地區來看,美國業務成長了 24%,其中 8 個業務部門中有 6 個實現了兩位數或更高的成長。

  • Our EP business continues to deliver impressive performance fueled by FARAPULSE new account openings and very strong reorder rates.

    在 FARAPULSE 新帳戶開設和非常強勁的再訂購率的推動下,我們的 EP 業務繼續取得令人印象深刻的業績。

  • Europe, Middle East, and Africa grew 14% on an operational basis.

    歐洲、中東和非洲的營運成長了 14%。

  • This performance was driven by continued above-market performance in EP, where we continue to expand our PFA leadership, complex PCI, and structural heart.

    這一業績是由 EP 領域持續高於市場的業績所推動的,我們在該領域繼續擴大我們的 PFA 領導地位、複雜的 PCI 和結構核心。

  • In TAVI, we received CE Mark and recently launched our next-generation ACURATE Prime valve.

    在 TAVI,我們獲得了 CE 標誌,並於最近推出了下一代 ACURATE Prime 閥門。

  • I also want to announce that following a nearly 30-year career at Boston Scientific, our President of EMEA, Eric Thepaut , will retire in December and Xavier Bertrand, currently the Vice President of Peripheral Interventions in EMEA, will be appointed the new President of EMEA.

    我還想宣布,在波士頓科學公司(Boston Scientific) 工作了近30 年後,我們的歐洲、中東和非洲(EMEA) 總裁Eric Thepaut 將於12 月退休,目前歐洲、中東和非洲(EMEA) 外圍幹預副總裁Xavier Bertrand 將被任命為歐洲、中東和非洲地區。

  • I want to thank Eric for his many significant contributions to the organization and congratulate Xavier on his new role.

    我要感謝艾瑞克(Eric)對該組織做出的許多重大貢獻,並祝賀澤維爾(Xavier)擔任新職務。

  • Asia Pac grew 12% operationally with excellent performance in China, Australia, New Zealand, and grew mid-teens despite recent VBP implementations.

    亞太地區的營運成長了 12%,在中國、澳洲和紐西蘭表現出色,儘管最近實施了 VBP,但仍實現了十幾歲左右的成長。

  • In Japan, we received PMDA approval of the FARAPULSE PFA system and anticipate reimbursement and commercial launch in the coming weeks.

    在日本,我們獲得了 PMDA 對 FARAPULSE PFA 系統的批准,並預計在未來幾週內獲得報銷和商業推出。

  • I'll now provide some additional commentary on our business units.

    我現在將對我們的業務部門提供一些補充評論。

  • Urology sales grew 10% with double-digit growth in stone management and prostate health, including double-digit growth in both Rezum and SpaceOAR.

    泌尿科銷售額成長 10%,結石管理和攝護腺健康業務達到兩位數成長,其中 Rezum 和 SpaceOAR 均達到兩位數成長。

  • Within the quarter, we continue to see momentum from the launches of LithoVue Elite and the Tenacio Pump with our AMS 700 device.

    在本季度內,我們繼續看到 LithoVue Elite 和 Tenacio Pump 與我們的 AMS 700 設備一起推出的勢頭。

  • And looking forward, we expect to close the previously announced acquisition of Axonics in the fourth quarter, and we're excited to add this excellent business into Boston Scientific in our urology business.

    展望未來,我們預計將在第四季度完成之前宣布的對 Axonics 的收購,我們很高興將這項出色的業務納入波士頓科學公司的泌尿科業務中。

  • Endoscopy sales grew 7% organically and 8% operationally with strong growth particularly in the US.

    內視鏡銷售額有機成長 7%,營運成長 8%,成長強勁,尤其是在美國。

  • Our anchor products continue to drive above-market growth with AXIOS and Exalt D, both growing double-digits in the quarter.

    我們的主打產品 AXIOS 和 Exalt D 繼續推動高於市場的成長,本季均實現兩位數成長。

  • We also continue to see strong double-digit growth in our Endoluminal Surgery franchise.

    我們的腔內手術特許經營業務也持續實現兩位數的強勁成長。

  • We're pleased to recently receive a Category 1 CPT code for the ESG weight loss procedure, which is expected to further momentum within this business.

    我們很高興最近收到 ESG 減肥程序的 1 類 CPT 代碼,預計這將進一步推動該業務的發展。

  • Neuromodulation sales grew 3% organically and 17% operationally including Relievant, which will turn organic in November.

    神經調節銷售額有機成長 3%,營運成長 17%,其中 Relievant 將於 11 月實現有機成長。

  • Our brain franchise returned to low double-digit growth in the quarter in the US, supported by de novo implants and competitive replacements.

    在從頭植入和競爭性替代品的支持下,我們的大腦特許經營權在本季度在美國恢復了兩位數的低增長。

  • Our pain franchise grew low-single-digits organically and double-digits operationally.

    我們的疼痛專營權有機成長了低個位數,營運成長了兩位數。

  • Our global SCS performance was below our expectations in a market that continues to be challenged, offset by growth in the rest of the pain portfolio, which reflects the value of our category leadership strategy.

    在一個持續面臨挑戰的市場中,我們的全球 SCS 表現低於我們的預期,但被其他疼痛產品組合的成長所抵消,這反映了我們品類領導策略的價值。

  • Peripheral intervention sales grew 10% organically and 12% operationally.

    週邊幹預銷售額有機成長 10%,營運成長 12%。

  • Within our vascular business, we saw mid-single-digit growth in arterial with continued double-digit growth in drug-eluting therapies and low double-digit growth in venous.

    在我們的血管業務中,我們看到動脈業務實現中個位數成長,藥物洗脫療法持續實現兩位數成長,靜脈業務實現低兩位數成長。

  • We're also pleased to have closed our acquisition of Silk Road Medical in mid-September, adding the innovative TCAR system to our vascular portfolio.

    我們也很高興在 9 月中旬完成了 Silk Road Medical 的收購,將創新的 TCAR 系統添加到我們的血管產品組合中。

  • Our interventional oncology and embolization franchise grew double-digits again driven by continued momentum from recent launches in embolization and sustained double-digit growth in TheraSphere.

    在最近推出的栓塞治療和 TheraSphere 持續兩位數成長的持續推動下,我們的介入性腫瘤和栓塞治療業務再次實現兩位數成長。

  • Cardiology delivered another exceptional quarter with sales growing 29%.

    心臟病學季度又表現出色,銷售額成長 29%。

  • Within cardiology, interventional cardiology therapies grew 14%.

    在心臟病學領域,介入性心臟病學治療成長了 14%。

  • Mid-teens growth in coronary therapies was supported by the launch of the US AGENT performance, continued global adoption of coronary imaging with our AVVIGO+ platform, and our Calcium portfolio.

    US AGENT 績效的推出、我們的 AVVIGO+ 平台和鈣產品組合在全球範圍內持續採用冠狀動脈成像,為冠狀動脈治療的成長提供了支持。

  • The US AGENT launch continues to exceed our expectations with both new account openings and strong reorder rates.

    US AGENT 的推出繼續超越我們的預期,無論是新帳戶的開設還是強勁的再訂購率。

  • We also recently commenced enrollment in the AGENT IDE long lesion substudy and completed enrollment in our Vitalist early feasibility study in high-risk PCI patients.

    我們最近也開始招募 AGENT IDE 長病變子研究,並完成了針對高風險 PCI 患者的 Vitalist 早期可行性研究的招募。

  • Congratulations to the team on that milestone.

    祝賀團隊實現這一里程碑。

  • Our structural heart valves franchise grew double digits in the third quarter led by another quarter of above-market growth of ACURATE Neo2 in Europe.

    我們的結構性心臟瓣膜特許經營權在第三季度實現了兩季度增長,其中 ACURATE Neo2 在歐洲的增長又高於市場水平。

  • In the US, we continue to collaborate with the FDA in our regulatory strategy, and data from the US ACURATE IDE will be presented at TCT on October 30.

    在美國,我們繼續與 FDA 在監管策略上合作,來自美國 ACURATE IDE 的數據將於 10 月 30 日在 TCT 上公佈。

  • WATCHMAN grew 18% with continued conversion to WATCHMAN FLX Pro in the US and Japan.

    隨著美國和日本市場持續轉向 WATCHMAN FLX Pro,WATCHMAN 成長了 18%。

  • And globally, we surpassed 500,000 patients treated with the WATCHMAN device, driven by our innovation, clinical evidence, and patient awareness efforts.

    在我們的創新、臨床證據和患者意識努力的推動下,全球有超過 50 萬名患者接受了 WATCHMAN 設備的治療。

  • Key near-term catalyst for WATCHMAN drive our confidence in delivering high growth in this business, including the recently implemented DRG for concomitant LAAC and AF ablation.

    WATCHMAN 的關鍵近期催化劑增強了我們對該業務實現高成長的信心,包括最近實施的用於同時進行 LAAC 和 AF 消融的 DRG。

  • And if positive, the data readout from the OPTION trial, which will be presented as a late-breaking clinical trial at the American Heart Association Conference on November 16.

    如果結果為陽性,則會讀取 OPTION 試驗的數據,該試驗將在 11 月 16 日的美國心臟協會會議上作為一項最新臨床試驗進行展示。

  • We also recently commenced enrollment of our SIMPLIFY trial, which studying the less intensive post-procedure drug regimen, enabled by our latest generation WATCHMAN FLX Pro and continue to expect data from the CHAMPION trial in the first half of '26.

    我們最近也開始招募我們的 SIMPLIFY 試驗,該試驗研究強度較低的術後藥物治療方案,由我們最新一代的 WATCHMAN FLX Pro 啟用,並繼續期待 26 年上半年 CHAMPION 試驗的數據。

  • Cardiac Rhythm Management sales grew 2% in the quarter.

    本季心律管理銷售額成長了 2%。

  • In the third quarter, our diagnostics franchise grew high-single-digits, driven by our implantable cardiac monitors, LUX-Dx, which both received CE Mark within the quarter.

    第三季度,在我們的植入式心臟監測儀 LUX-Dx 的推動下,我們的診斷業務實現了高個位數成長,這兩款產品均在本季度獲得了 CE 標誌。

  • In Core CRM, strong international growth was offset by below-market growth in the US.

    在核心 CRM 領域,國際市場的強勁成長被美國低於市場水準的成長所抵消。

  • We're excited about new and upcoming product launches in this business, including the expanded indication of our INGEVITY lead for conduction system pacing, which received FDA approval in the quarter and our EMPOWUR leadless pacemaker, which we now have submitted to the FDA.

    我們對該業務中新產品和即將推出的產品感到興奮,包括用於傳導系統起搏的INGEVITY 導線的擴展適應症,該導線已在本季度獲得FDA 批准,以及我們的EMPOWUR 無導線起搏器(現已提交給FDA)。

  • Electrophysiology sales grew an exceptional 177% in the quarter, driven by continued commercial execution, pull-through in our Access Solutions business, and increased procedure volumes driven by excellent outcomes as well as efficiencies gained with FARAPULSE.

    本季電生理學銷售額成長了 177%,這得益於持續的商業執行、接取解決方案業務的突破,以及 FARAPULSE 帶來的卓越結果和效率帶來的手術量增加。

  • We have now treated over 125,000 patients with FARAPULSE, driving rapid and transformative conversion from RF and cryo to PFA, specifically using FARAPULSE.

    我們現已使用 FARAPULSE 治療了超過 125,000 名患者,推動了從射頻和冷凍到 PFA 的快速變革性轉變,特別是使用 FARAPULSE。

  • As a result of this accelerated conversion in the market, we now expect PFA to likely exceed our previously communicated range of 40% to 60% of global AF ablations by 2026.

    由於市場加速轉變,我們現在預計到 2026 年 PFA 可能會超過我們先前公佈的全球 AF 消融的 40% 至 60% 的範圍。

  • We are excited about the recent FARAPULSE approvals in both Japan and China and expect these launches to have a meaningful impact on our global EP business in 2025.

    我們對 FARAPULSE 最近在日本和中國獲得批准感到興奮,並預計這些產品的推出將對我們 2025 年的全球 EP 業務產生有意義的影響。

  • Recently, we received USA approval of the FARAWAVE NAV Catheter, which combined with a FARAVIEW Software to visualize cardiac ablation procedures exclusively with our OPAL HDx mapping system.

    最近,我們獲得了美國對 FARAWAVE NAV 導管的批准,該導管與 FARAVIEW 軟體相結合,可透過我們的 OPAL HDx 繪圖系統專門實現心臟消融手術的可視化。

  • We are pleased to have completed the follow-up Phase 1 of the ADVANTAGE AF clinical trial, which is evaluating FARAPULSE in the treatment of patients with drug-refractory persistent AF.

    我們很高興完成了 ADVANTAGE AF 臨床試驗的後續第一階段,該試驗正在評估 FARAPULSE 對藥物難治性持續性 AF 患者的治療效果。

  • And we expect to submit the results of the trial to the FDA later this quarter and anticipating presenting the results in early '25 with label expansion expected in the second half of '25.

    我們預計將在本季稍後向 FDA 提交試驗結果,並預計在 25 年初提交結果,並預計在 25 年下半年進行標籤擴展。

  • We're also studying in a very new patient population of drug-naive persistent AF patients in AVANT GUARD.

    我們也在 AVANT GUARD 中研究了一個非常新的患者群體,即未接受過藥物治療的持續性心房顫動患者。

  • As we have neared the end of this enrollment, we have elected to temporarily pause the trial to assess a few unanticipated observations.

    由於我們的招募已接近結束,我們選擇暫時暫停試驗以評估一些意外的觀察結果。

  • It is our intention to resume enrollments in the near-term.

    我們打算在短期內恢復招生。

  • And based on the totality of clinical evidence and commercial real-world experience, we remain extremely confident in the unique performance of FARAPULSE.

    基於全部臨床證據和商業現實經驗,我們對 FARAPULSE 的獨特表現仍然充滿信心。

  • In closing, we're very proud of the performance of our global teams and are confident in the sustainability of our top-tier financial performance.

    最後,我們對全球團隊的表現感到非常自豪,並對我們頂級財務表現的可持續性充滿信心。

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

    接下來,我將請丹提供有關財務狀況的更多詳細資訊。

  • Daniel Brennan - Chief Financial Officer, Executive Vice President

    Daniel Brennan - Chief Financial Officer, Executive Vice President

  • Thanks, Mike.

    謝謝,麥克。

  • Third-quarter 2024 consolidated revenue of $4,209 million represents 19.4% reported growth versus third quarter of 2023 and includes a 10-basis-point headwind from foreign exchange, which was favorable versus our expectations.

    2024 年第三季合併營收為 42.09 億美元,較 2023 年第三季成長 19.4%,其中包括 10 個基點的外匯阻力,這比我們的預期有利。

  • Excluding this $4 million foreign exchange headwind, operational revenue growth was 19.5% in the quarter.

    排除這 400 萬美元的外匯不利因素,本季營運收入成長 19.5%。

  • Sales impact from closed acquisitions contributed 130 basis points, resulting in 18.2% organic revenue growth, exceeding our third-quarter guidance range of 13% to 15%.

    完成收購對銷售的影響貢獻了 130 個基點,導致有機收入成長 18.2%,超出了我們第三季 13% 至 15% 的指導範圍。

  • Q3 2024 adjusted earnings per share of $0.63 grew 27% versus 2023, exceeding the high end of our guidance range of $0.57 to $0.59, primarily driven by our strong sales performance.

    2024 年第三季調整後每股收益為 0.63 美元,較 2023 年增長 27%,超出了我們指導範圍 0.57 美元至 0.59 美元的上限,這主要是由於我們強勁的銷售業績所致。

  • Adjusted gross margin for the third quarter was 70.4%, slightly lower than anticipated, driven primarily by foreign exchange.

    第三季調整後毛利率為 70.4%,略低於預期,主要受外匯影響。

  • We continue to expect second-half adjusted gross margin to be higher than the first half and full-year adjusted gross margin to be slightly below our 2023 rate.

    我們繼續預期下半年調整後毛利率將高於上半年,全年調整後毛利率將略低於 2023 年的水準。

  • Third-quarter adjusted operating margin was 27.2%, which expanded 110 basis points versus the prior-year period.

    第三季調整後營業利益率為 27.2%,比去年同期成長 110 個基點。

  • Given our strong year-to-date performance, we now expect full-year adjusted operating margin to be approximately 27%.

    鑑於我們今年迄今的強勁表現,我們目前預計全年調整後營業利潤率約為 27%。

  • We believe this strikes a nice balance of delivering incremental margin from our sales upside and continuing to invest appropriately to drive strong topline performance.

    我們相信,這在從銷售成長中提供增量利潤和繼續適當投資以推動強勁的營收業績之間取得了良好的平衡。

  • On a GAAP basis, third quarter operating margin was 17.4%.

    以 GAAP 計算,第三季營業利潤率為 17.4%。

  • Moving to below the line.

    移至線下。

  • Third-quarter adjusted interest and other expenses totaled $65 million, which was favorable to our expectations primarily due to higher interest income.

    第三季調整後利息和其他費用總計 6,500 萬美元,符合我們的預期,主要是由於利息收入增加。

  • On an adjusted basis, our tax rate for the third quarter was 13.2%, which includes favorable discrete tax items.

    調整後,我們第三季的稅率為 13.2%,其中包括有利的離散稅項。

  • Our operational tax rate for the quarter was 13.5%.

    我們本季的營業稅率為 13.5%。

  • Fully diluted weighted average shares outstanding ended at 1,487 billion in the third quarter.

    第三季完全稀釋加權平均流通股數為 14,870 億股。

  • Free cash flow for the third quarter was $822 million, with $1.002 billion from operating activities, less $180 million in net capital expenditures, which includes payments of $208 million related to acquisitions, restructuring, litigation, and other special items.

    第三季自由現金流為8.22億美元,其中10.02億美元來自營運活動,減去1.8億美元的淨資本支出,其中包括與收購、重組、訴訟和其他特殊項目相關的支出2.08億美元。

  • In 2024, we continue to expect full-year free cash flow to exceed $2 billion, which includes approximately $900 million of expected payments related to special items.

    到 2024 年,我們繼續預計全年自由現金流將超過 20 億美元,其中包括約 9 億美元的與特殊項目相關的預期付款。

  • As of September 30, 2024, we had cash on hand of $2.5 billion, and our gross debt leverage ratio was 2.4 times.

    截至2024年9月30日,我們手上現金為25億美元,總負債槓桿率為2.4倍。

  • Our top capital allocation priority remains strategic tuck-in M&A followed by annual share repurchases to offset dilution from employee stock grants.

    我們的首要資本配置優先事項仍然是策略性併購,然後是年度股票回購,以抵消員工股票授予帶來的稀釋。

  • Our legal reserve was $250 million as of September 30, roughly flat versus Q2 2024. $53 million of this reserve is already funded through our qualified settlement funds.

    截至 9 月 30 日,我們的法定準備金為 2.5 億美元,與 2024 年第二季大致持平。 其中 5,300 萬美元的準備金已透過我們的合格結算基金提供資金。

  • I'll now walk through guidance for Q4 and full year 2024.

    我現在將介紹第四季和 2024 年全年的指導。

  • We expect full year 2024 reported revenue growth to be approximately 16.5% versus 2023.

    我們預計 2024 年全年報告營收將較 2023 年成長約 16.5%。

  • Excluding an approximate 50-basis-point headwind from foreign exchange, based on current rates, we expect full year 2024 operational revenue growth to be approximately 17%.

    排除約 50 個基點的外匯阻力,根據當前匯率,我們預計 2024 年全年營運收入成長約為 17%。

  • Excluding a 200-basis-point contribution from closed acquisitions, we expect full-year 2024 organic revenue growth to be approximately 15% versus 2023.

    排除已完成收購帶來的 200 個基點貢獻,我們預計 2024 年全年有機收入成長將比 2023 年成長約 15%。

  • We expect fourth-quarter 2024 reported revenue growth to be in a range of 16.5% to 18.5% versus fourth-quarter 2023.

    我們預計 2024 年第四季報告的營收成長將比 2023 年第四季在 16.5% 至 18.5% 之間。

  • Excluding an approximate 50-basis-point tailwind from foreign exchange based on current rates, we expect fourth-quarter 2024 operational revenue growth to be 16% to 18%; and excluding a 200-basis-point contribution from closed acquisitions, we expect fourth-quarter 2024 organic revenue growth to be in a range of 14% to 16% versus 2023.

    根據當前匯率,排除匯率帶來的約 50 個基點的推動因素,我們預計 2024 年第四季營運收入成長將為 16% 至 18%;排除已完成收購帶來的 200 個基點的貢獻,我們預計 2024 年第四季的有機收入成長將比 2023 年在 14% 至 16% 之間。

  • We continue to expect full-year 2024 adjusted below-the-line expenses to be approximately $300 million.

    我們仍預期 2024 年全年調整後的離線費用約為 3 億美元。

  • We also continue to expect a full-year 2024 operational tax rate of approximately 13.5% and an adjusted tax rate of approximately 12.5%, which contemplates current legislation, including enacted laws and issued guidance under OECD Pillar 2 rules.

    我們也繼續預期 2024 年全年營業稅率約為 13.5%,調整後稅率約為 12.5%,其中考慮了現行立法,包括根據經合組織第二支柱規則頒布的法律和發布的指南。

  • We expect full-year adjusted earnings per share to be in the range of $2.45 to $2.47, representing growth of 20% to 21% versus 2023, including an approximate $0.04 headwind from foreign exchange, which is unchanged from our previous expectations.

    我們預計全年調整後每股收益將在 2.45 美元至 2.47 美元之間,較 2023 年增長 20% 至 21%,其中包括約 0.04 美元的外匯阻力,這與我們之前的預期相同。

  • We expect fourth-quarter adjusted earnings per share to be in a range of $0.64 to $0.66.

    我們預計第四季度調整後每股收益將在 0.64 美元至 0.66 美元之間。

  • Before we move to Q&A, I want to provide a few housekeeping items related to 2025 that may be helpful with your modeling.

    在我們進行問答之前,我想提供一些與 2025 年相關的日常用品,可能對您的建模有所幫助。

  • There will be one less business day in 2025, which comes in Q1.

    2025 年第一季將減少一個工作天。

  • Note that in 2024, we have two extra business days versus 2023, one here in Q3 and one upcoming in Q4.

    請注意,與 2023 年相比,2024 年我們多了兩個工作日,一個在第三季度,一個在第四季度。

  • Below the line, we expect a meaningful increase versus 2024 related to higher adjusted net interest expense.

    在此線之下,我們預計與 2024 年相比將出現有意義的成長,這與調整後的淨利息支出較高有關。

  • In 2024, we will earn approximately $100 million of nonrecurring interest income on the cash raised earlier this year to fund the Axonics acquisition which we expect to close here in the fourth quarter.

    到 2024 年,我們將透過今年稍早籌集的現金賺取約 1 億美元的非經常性利息收入,為 Axonics 收購提供資金,我們預計該收購將於第四季度完成。

  • In 2025, we also have approximately $1.6 billion of bonds coming due, which we expect to look to refinance, likely at higher rates than the existing bonds while maintaining our strong balance sheet.

    到 2025 年,我們還有約 16 億美元的債券到期,我們預計將尋求再融資,利率可能高於現有債券,同時保持強勁的資產負債表。

  • The good news is, this incremental expense should largely be offset by the operating income dollars associated with the deals we have closed in 2024 and the expected close of Axonics.

    好消息是,這筆增量費用應該會在很大程度上被我們 2024 年完成的交易和 Axonics 預期完成相關的營業收入所抵消。

  • Based on current global tax legislation, we expect our tax rate to be in line with our historical rate of approximately 14% operational and 13% adjusted.

    根據目前的全球稅收立法,我們預計我們的稅率將與我們約 14% 的營運稅率和 13% 的調整後稅率保持一致。

  • In 2025, we will aim to outperform our markets, deliver meaningful margin improvement, and grow adjusted earnings per share double-digits and faster than sales towards our goal of being the highest performing large-cap med-tech company as we said at last year's Investor Day.

    到2025 年,我們的目標是超越市場,實現顯著的利潤率改善,調整後每股收益實現兩位數增長,且比銷售額增長更快,以實現我們在去年的年度報告中所說的成為表現最好的大型醫療科技公司的目標。

  • For more information, check our Investor Relations website for Q3 2024 financial and operational highlights which outlines more details on Q3 results and 2024 guidance.

    如需了解更多信息,請查看我們的投資者關係網站,了解 2024 年第三季度的財務和營運亮點,其中概述了有關第三季度業績和 2024 年指導的更多詳細信息。

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

    接下來,我會將其轉回喬恩,他將主持問答。

  • Jonathan Monson - Senior Vice President - Investor Relations

    Jonathan Monson - Senior Vice President - Investor Relations

  • Thanks, Dan.

    謝謝,丹。

  • Drew, let's open it up for questions for the next 40 minutes or so.

    Drew,讓我們在接下來的 40 分鐘左右的時間裡提問。

  • In order for us to take as many questions as possible, please limit yourself to one question.

    為了讓我們能夠回答盡可能多的問題,請限制您只回答一個問題。

  • Drew, please go ahead.

    德魯,請繼續。

  • Operator

    Operator

  • (Operator Instructions) Robbie Marcus, JPMorgan

    (操作員指示)Robbie Marcus,摩根大通

  • Robert Marcus - Analyst

    Robert Marcus - Analyst

  • My one question, there's so much to ask about here.

    我的一個問題是,這裡有很多東西要問。

  • In our checks, we hear consistently that the upcoming OPTION trial that we'll see at AHA, combined with the recently started on October 1 reimbursement for concomitant, WATCHMAN and PF ablation, has already started to kick in the gear and OPTION could meaningfully alter the usage patterns ahead of CHAMPION in the first half of '26.

    在我們的調查中,我們一致聽到即將在 AHA 進行的 OPTION 試驗,加上最近於 10 月 1 日開始的伴隨 WATCHMAN 和 PF 消融的報銷,已經開始啟動,OPTION 可能會有意義地改變26 年上半年的使用模式領先CHAMPION。

  • So I wanted to get your thoughts on the importance of both concomitant and should OPTION be positive what that can mean for both of those franchises, both in the short and long term.

    因此,我想了解您對兩者的重要性的看法,以及選項是否應該是積極的,這對這兩個特許經營權意味著什麼,無論是短期還是長期。

  • Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

    Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

  • Sure.

    當然。

  • I'll comment and Dr. Stein can add probably more helpful color.

    我會發表評論,斯坦因博士可以添加可能更有用的顏色。

  • Clearly, independently, both platforms are doing incredibly well.

    顯然,兩個平台獨立地都表現得非常好。

  • WATCHMAN on its own with all the clinical evidence, and you saw the amazing results of FARAPULSE today.

    WATCHMAN 本身擁有所有臨床證據,您今天看到了 FARAPULSE 的驚人結果。

  • And doctors are so comfortable with both procedures.

    醫生對這兩種手術都非常滿意。

  • It's a very safe procedure.

    這是一個非常安全的過程。

  • The concomitant reimbursement, we view as quite positive.

    我們認為隨之而來的報銷非常積極。

  • It's also very positive economic for the hospital, benefits for the patient, the procedure will be performed safety.

    這對醫院來說也有非常積極的經濟效益,對病人來說也有好處,手術將安全地進行。

  • So we're really pleased with that concomitant.

    所以我們對此非常滿意。

  • And so it's clearly an ongoing long-term tailwind for WATCHMAN and also further helps FARAPULSE.

    因此,這顯然對 WATCHMAN 來說是一個持續的長期推動力,也進一步幫助了 FARAPULSE。

  • Both platforms, as you know, have a number of different clinical trials to continue to expand indications.

    如您所知,這兩個平台都有多項不同的臨床試驗來繼續擴大適應症。

  • And Dr. Stein, any other comments you'd like to make on it?

    史丹博士,您對此還有什麼其他評論嗎?

  • Kenneth Stein - Senior Vice President, Global Chief Medical Officer

    Kenneth Stein - Senior Vice President, Global Chief Medical Officer

  • No.

    不。

  • Sure, Mike.

    當然,麥克。

  • Thanks, Robbie.

    謝謝,羅比。

  • I again reiterate what Mike said at the outset, right?

    我再次重申麥克一開始所說的話,對吧?

  • I mean, the ability to do concomitant procedures and get reimbursed with them under the new CMS DRG, it's one of those things that it's positive for patients, it's positive for the health care system and hospitals and it's certainly positive for us given the unique advantages in doing concomitant procedures when you think of the safety and efficiency of FARAPULSE, and you think of the safety and efficiency and frankly excellent outcomes with FARAPULSE and with WATCHMAN FLX and WATCHMAN FLX Pro.

    我的意思是,能夠進行伴隨手術並根據新的CMS DRG 獲得報銷,這是對患者、醫療保健系統和醫院都有積極作用的事情之一,鑑於獨特的優勢,這對我們來說當然也是積極的在執行伴隨程序時,當您想到 FARAPULSE 的安全性和效率時,您會想到 FARAPULSE 以及 WATCHMAN FLX 和 WATCHMAN FLX Pro 的安全性和效率以及坦率地說出色的結果。

  • Again, just to give some sense of the importance of this, right, there are approximately 350,000 ablations performed in the US every year for atrial fibrillation.

    再次強調一下,美國每年大約有 35 萬例心房顫動消融手術,以說明這一點的重要性。

  • And roughly half of those patients are at high risk of stroke according to things like the CHA2DS2-VASc scoring system.

    根據 CHA2DS2-VASc 評分系統等數據,約有一半的患者面臨中風的高風險。

  • I think we are all anxiously looking forward to see the OPTION data when it gets read out and the impact that will have, I think stating the obvious will depend on what those data show.

    我認為我們都焦急地期待著看到選項資料被讀出時以及它將產生的影響,我認為陳述顯而易見的事情將取決於這些資料顯示的內容。

  • And if they do show a compelling benefit to WATCHMAN, right, how big is that benefit?

    如果它們確實為《守望者》帶來了令人信服的好處,那麼這個好處有多大?

  • And then, again, to reiterate what Mike said, beyond OPTION, we also have the CHAMPION trial.

    然後,再次重申 Mike 所說的,除了 OPTION 之外,我們還有 CHAMPION 試驗。

  • Expecting that trial to read out in early '26, which would look at WATCHMAN versus the new oral anticoagulants in all comers.

    預計該試驗將於 26 年初公佈,該試驗將在所有方面比較 WATCHMAN 與新型口服抗凝血劑。

  • Operator

    Operator

  • Joanne Wuensch, Citi

    喬安妮‧溫施,花旗銀行

  • Joanne Wuensch - Analyst

    Joanne Wuensch - Analyst

  • I want to talk about the amazing results of FARAPULSE that we just saw.

    我想談談我們剛剛看到的 FARAPULSE 的驚人結果。

  • And specifically, how you're thinking about moving?

    具體來說,您是如何考慮搬家的?

  • I was really interested in one quote that you said to exceed 40% to 60% of global AF procedures by 2026.

    我對您所說的 2026 年將超過全球 AF 手術的 40% 到 60% 的一句話非常感興趣。

  • Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

    Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

  • Sure.

    當然。

  • So this has just been a tremendous launch.

    所以這只是一次巨大的發布。

  • Just a quick shout out to our operations supply chain team for staying ahead of the manufacturing.

    快速感謝我們的營運供應鏈團隊在製造方面保持領先地位。

  • Extremely high demand for this product and the excellence that we're seeing in the field by the commercial and clinical teams.

    我們在商業和臨床團隊中看到了對該產品的極高需求以及該領域的卓越表現。

  • So doctors are moving surprisingly quickly towards FARAPULSE, surprising to what we thought it would be a year ago.

    因此,醫生們正在以驚人的速度向 FARAPULSE 邁進,這超出了我們一年前的預期。

  • So when we had the Investor Day, we weren't quite sure because we had didn't have approval in the US.

    因此,當我們舉辦投資者日時,我們不太確定,因為我們沒有獲得美國的批准。

  • We saw excellent momentum in Europe.

    我們在歐洲看到了良好的動力。

  • And now our operations team is scaled to meet the demand.

    現在我們的營運團隊已擴大規模以滿足需求。

  • And those same excellent clinical outcomes and procedural efficiencies, and safety benefits that patients received in Europe are being felt throughout the world now.

    患者在歐洲獲得的同樣出色的臨床結果、手術效率和安全益處現在正在全世界範圍內感受到。

  • We've been planning over 120,000 of them.

    我們已經計劃了超過 120,000 個。

  • So that was our point estimate about a year ago or so.

    這就是我們大約一年前的點估計。

  • And based on the rapid uptake, we're confident in stating that we do expect it to be at the high end and likely exceed that 40% to 60% based on how quickly physicians are transforming, especially for PVI from traditional RF and cryo to FARAPULSE.

    基於快速的採用,我們有信心地說,我們確實預計它會處於高端,並且根據醫生轉變的速度,可能會超過 40% 到 60%,特別是對於從傳統射頻和冷凍到 PVI 而言法拉脈衝。

  • And it has also been supported by the studies within ADVENT that show the benefits of FARAPULSE versus traditional RF.

    它也得到了 ADVENT 內部研究的支持,這些研究顯示了 FARAPULSE 相對於傳統射頻的優勢。

  • So it's a great time in the market for the physicians and the patients.

    因此,對於醫生和患者來說,現在是市場的好時機。

  • And we've also proven based on our competitive launches in Europe who have been out for a while that we clearly are the market leader in PFA and we have lots of plans in place to continue to extend that leadership with clinical differentiation and product enhancements.

    我們還根據我們在歐洲推出的具有競爭力的產品證明,我們顯然是 PFA 的市場領導者,並且我們制定了很多計劃,透過臨床差異化和產品增強來繼續擴大這一領先地位。

  • Operator

    Operator

  • Larry Biegelsen, Wells Fargo

    拉里·比格爾森,富國銀行

  • Larry Biegelsen - Analyst

    Larry Biegelsen - Analyst

  • I'll echo my congratulations on a really phenomenal quarter here.

    我將在此對這個非常出色的季度表示祝賀。

  • Dr. Stein, given the importance of FARAPULSE, can you provide more color on the AVANT GUARD trial and the observations you saw?

    Stein 博士,考慮到 FARAPULSE 的重要性,您能否提供有關 AVANT GUARD 試驗以及您看到的觀察結果的更多資訊?

  • And related to that, there are going to be more PFA ablation choices soon, including from the market leader.

    與此相關的是,很快就會有更多的 PFA 消融選擇,包括來自市場領導者的選擇。

  • Once these new PFA catheters are launched, what are the factors that will lead existing FARAPULSE customers to stay with FARAPULSE or choose FARAPULSE if they haven't adopted it yet?

    一旦這些新的 PFA 導管推出,哪些因素會導致現有 FARAPULSE 客戶繼續使用 FARAPULSE 或在尚未採用 FARAPULSE 的情況下選擇 FARAPULSE?

  • Kenneth Stein - Senior Vice President, Global Chief Medical Officer

    Kenneth Stein - Senior Vice President, Global Chief Medical Officer

  • Yeah.

    是的。

  • Sure, Larry.

    當然,拉里。

  • Let me take those successively.

    讓我依序採取這些。

  • So first, on AVANT GUARD.

    首先是 AVANT GUARD。

  • Again, as Mike said, due to a few unanticipated observations in the trial which is studying a completely new population, which is drug-naive patients with persistent AF, which FARAPULSE is not currently indicated to treat, we did elect to temporarily pause enrollment until we develop better understanding of the observations.

    同樣,正如Mike 所說,由於試驗中出現了一些意想不到的觀察結果,該試驗正在研究一個全新的人群,即患有持續性AF 的未接受藥物治療的患者,FARAPULSE 目前尚不適合治療這種患者,我們確實選擇暫時暫停招募,直到我們對觀察結果有了更好的理解。

  • While none of the observations were life-threatening, we did make a decision to temporarily pause, but it is our intention to resume enrollments in the near-term.

    雖然沒有任何觀察危及生命,但我們確實決定暫時暫停,但我們打算在短期內恢復招生。

  • And this in no way at all affects our confidence in the overall performance of the FARAPULSE system as it's being used today commercially or in other clinical trials.

    這絲毫不會影響我們對 FARAPULSE 系統整體表現的信心,因為它目前已在商業或其他臨床試驗中使用。

  • Again, as Mike said in his opening comments, we remain confident that we're going to obtain expanded indication for drug-refractory persistent AF patients.

    正如麥克在開場白中所說,我們仍然有信心為藥物難治性持續性心房顫動患者獲得擴大的適應症。

  • And that's the data from our ADVANTAGE Phase I trial.

    這就是我們 ADVANTAGE 第一階段的數據。

  • Again, as Mike said, we expect to submit that data to the FDA later this quarter.

    正如麥克所說,我們預計將在本季稍後向 FDA 提交該數據。

  • We expect to present that data in early 2025, with indication expansion expected to come in the second half of 2025.

    我們預計在 2025 年初公佈該數據,並預計在 2025 年下半年出現指標擴張。

  • And again, I just want to close by emphasizing that this patient population that we're studying in AVANT GUARD, which is drug-naive persistent AF patients has not previously been studied, it's a population that's not indicated for ablation today under guidelines, and it's not the population that's being treated today with FARAPULSE system.

    最後,我想再次強調,我們在 AVANT GUARD 中研究的患者群體是未曾接受過藥物治療的持續性 AF 患者,之前尚未對其進行過研究,根據指南,該群體目前不適合進行消融治療,並且今天接受FARAPULSE 系統治療的並不是人群。

  • And I also want to emphasize that we remain highly confident in the global performance of FARAPULSE, which has now been used to treat more than 125,000 patients across more than 65 different countries and is supported by extensive clinical data demonstrating positive outcomes for the device.

    我還想強調的是,我們對 FARAPULSE 的全球表現仍然充滿信心,該產品現已用於治療超過 65 個不同國家的 125,000 多名患者,並得到了表明該設備積極結果的大量臨床數據的支持。

  • And I think that also leads into your second question, right, which is why is FARAPULSE going to maintain category leadership in Pulsed Field Ablation and what's going to prompt new users to continue to newly adopt the system.

    我認為這也引出了你的第二個問題,對吧,這就是為什麼 FARAPULSE 將在脈衝場消融領域保持類別領先地位,以及什麼將促使新用戶繼續新採用該系統。

  • And it's several things.

    這有幾件事。

  • I think, first of all, it's just the compelling ease of use and straightforward nature of doing the ablation with FARAPULSE.

    我認為,首先,使用 FARAPULSE 進行消融具有令人信服的易用性和簡單性。

  • It's just a tremendous clinical experience that people have when they start using the system.

    當人們開始使用該系統時,就會獲得巨大的臨床經驗。

  • I am not aware of anyone who started using this and then has stopped and gone back to thermal ablation.

    我不知道有誰開始使用這個,然後又停止並回到熱消融。

  • It's also an extensive clinical trial data that we've got supporting it.

    我們也擁有大量的臨床試驗數據來支持它。

  • As Mike mentioned, right, we had a sub-analysis, the ADVENT data, which is the first data that anyone has had to actually show superiority and efficacy outcomes when we look at AF burden as a secondary analysis of the ADVENT data.

    正如麥克所提到的,正確的,我們有一個子分析,即ADVENT 數據,當我們將AF 負擔視為ADVENT 數據的二次分析時,這是任何人都必須真正顯示優越性和療效結果的第一個數據。

  • It's supported by published clinical data now in approximately 20,000 patients globally.

    目前已發表的全球約 20,000 名患者的臨床數據支持了這一觀點。

  • And again, as Mike said, right, in Europe, where we've seen commercial systems launch, right, we really have not seen that meaningfully detract from the position that FARAPULSE has as the leading PFA system in those markets.

    再次,正如 Mike 所說,在歐洲,我們已經看到了商業系統的推出,對吧,我們確實沒有看到這明顯損害了 FARAPULSE 在這些市場中作為領先 PFA 系統的地位。

  • And then last, just to make sure it doesn't get lost in all the other stuff here, right, the approval and the launch now of FARAWAVE NAV Catheter and FARAVIEW mapping system, which really becomes the first mapping system that's really designed around PFA, I think, provides just maybe it's the cherry on top of that sundae in terms of answering your question.

    最後,只是為了確保它不會迷失在這裡的所有其他內容中,對吧,FARAWAVE NAV 導管和 FARAVIEW 測繪系統的批准和推出,這確實成為第一個真正圍繞 PFA 設計的測繪系統我認為,就回答你的問題而言,這也許是聖代冰淇淋上的櫻桃。

  • Larry Biegelsen - Analyst

    Larry Biegelsen - Analyst

  • Thank you so much.

    太感謝了。

  • Operator

    Operator

  • Rick Wise, Stifel

    里克懷斯、斯蒂菲爾

  • Frederick Wise - Analyst

    Frederick Wise - Analyst

  • Thank you, and good morning, everybody.

    謝謝大家,大家早安。

  • I'm hoping, Mike, that you or Dr. Stein will expand on the NAV Cat comments from a couple of aspects.

    麥克,我希望您或斯坦因博士能夠從幾個方面擴展 NAV Cat 的評論。

  • Just are you ready to fully launch and train?

    您準備好全面啟動和訓練了嗎?

  • Will NAV Cat have a price premium, given premier technology first to market with something like this integrated.

    鑑於首先將此類整合技術推向市場的一流技術,NAV Cat 的價格會更高嗎?

  • Can we assume that you're going to sell it at a higher price?

    我們可以假設你會以更高的價格出售它嗎?

  • And just last and related to what Dr. Stein was talking about as well.

    最後一個也與史坦博士所談論的內容有關。

  • If FARAWAVE is approved for, only AFib, obviously a huge portion of the market, how does it, how are you going to manage the argument that other imaging mapping systems, obviously are approved for all imaging?

    如果 FARAWAVE 僅被批准用於 AFib,顯然佔據了市場的很大一部分,那麼您將如何管理其他成像映射系統顯然已被批准用於所有成像的論點?

  • Just where will FARA NAV fit in, in the broader, the larger scheme?

    在更廣泛、更大的計劃中,FARA NAV 將融入何處?

  • Thank you.

    謝謝。

  • Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

    Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

  • Dr. Stein?

    斯坦博士?

  • Kenneth Stein - Senior Vice President, Global Chief Medical Officer

    Kenneth Stein - Senior Vice President, Global Chief Medical Officer

  • Yes, Rick.

    是的,瑞克。

  • Let me take the second part of that question first and then get on to what some of the advantages are that we see unique to FARAVIEW right, which is on our refreshed OPAL HDx platform.

    讓我先回答這個問題的第二部分,然後談談我們認為 FARAVIEW 獨有的一些優勢,它位於我們更新的 OPAL HDx 平台上。

  • And so again, right, the OPAL platform is approved for mapping navigation across the whole spectrum of cardiac arrhythmias.

    因此,OPAL 平台被批准用於繪製整個心律不整範圍的導航圖。

  • Now when we look at the use specifically as it integrates with FARAWAVE and FARAWAVE NAV like FARAWAVE is an AF ablation catheter.

    現在,當我們具體考慮其用途時,因為它與 FARAWAVE 和 FARAWAVE NAV 集成,就像 FARAWAVE 是 AF 消融導管一樣。

  • And I think part of the reason that we've seen the success that we've had, part of the reason I was able to give the answer that I did to Larry, right, is that it's just exquisitely beautifully designed for ablating atrial fibrillation.

    我認為我們已經取得了成功,部分原因是我能夠向拉里給出答案,對吧,它是為消融心房顫動而精心設計的。

  • It's a fantastic tool for pulmonary vein isolation.

    它是肺靜脈隔離的絕佳工具。

  • And again, we hope to share our data from our ADVANTAGE clinical trial showing how it is also can be used to treat persistent atrial fibrillation.

    再次,我們希望分享 ADVANTAGE 臨床試驗的數據,展示它如何用於治療持續性心房顫動。

  • But it is really explicitly not designed to be the catheter to tackle some other arrhythmias.

    但它確實顯然不是被設計為解決其他一些心律不整的導管。

  • The next catheter in our pipeline is our FARAPOINT Catheter.

    我們管道中的下一個導管是 FARAPOINT 導管。

  • And that catheter was studied in Phase II of our ADVANTAGE clinical trial.

    此導管在我們的 ADVANTAGE 臨床試驗的第二階段進行了研究。

  • And we have completed enrollment in that Phase II of ADVANTAGE and are continuing to follow those patients.

    我們已經完成了 ADVANTAGE II 期的入組工作,並將繼續追蹤這些患者。

  • And to start, we'd expect to qualify that catheter for use for treating arrhythmia called atrial flutter as an adjunct to atrial fibrillation ablation procedures.

    首先,我們希望該導管能用於治療稱為心房撲動的心律不整,作為心房顫動消融手術的輔助手段。

  • But beyond that, right, it could see FARAPOINT used, right, for really any sort of arrhythmia where you would prefer a point catheter form factor.

    但除此之外,FARAPOINT 還可以用於治療任何類型的心律不整(您可能更喜歡點導管形狀因素)。

  • And then next to follow after that, right, is our so-called map and ablate catheter.

    接下來是我們所謂的地圖和消融導管。

  • It's a large focal lesion catheter called FARAFLEX, right, which, again, all of these will integrate with FARAWAVE on OPAL, right?

    這是一個名為 FARAFLEX 的大型病灶導管,對吧,所有這些都將與 OPAL 上的 FARAWAVE 集成,對嗎?

  • And that would really give us building the capability to be able to target the vast majority of arrhythmias that are seen in clinical practice.

    這確實會讓我們有能力針對臨床實務中出現的絕大多數心律不整進行治療。

  • In terms of FARAVIEW specifically, again, I think it's really important to emphasize.

    就 FARAVIEW 而言,我再次強調這一點非常重要。

  • This is the first mapping and navigation software that's built around understanding Pulsed Field Ablation.

    這是第一個圍繞著理解脈衝場消融而建構的繪圖和導航軟體。

  • And so it gives a lot of advantages to users to want to use it to navigate a catheter.

    因此,它為想要使用它來導航導管的用戶提供了許多優勢。

  • It gives dynamic visualization of the FARAWAVE catheter as it moves into its various configurations, whether it's a basket or a flower or anything in between.

    當 FARAWAVE 導管移動到其各種配置時,無論它是籃子、花或介於兩者之間的任何東西,它都能動態顯示 FARAWAVE 導管。

  • And it's also got a unique feature of called field tagging, where physicians will be able to see where the pulsed field will intersect with tissue and hopefully allow them to better strategize where and when and how to put lesions in when they're doing an ablation procedure.

    它還具有稱為場標記的獨特功能,醫生將能夠看到脈衝場將與組織相交的位置,並希望使他們能夠在進行消融時更好地制定在何處、何時以及如何放置病變的策略程式.

  • Frederick Wise - Analyst

    Frederick Wise - Analyst

  • That's an amazing answer.

    這是一個了不起的答案。

  • And just the price premium part?

    僅僅是價格溢價部分?

  • Thank you.

    謝謝。

  • Kenneth Stein - Senior Vice President, Global Chief Medical Officer

    Kenneth Stein - Senior Vice President, Global Chief Medical Officer

  • Yes, I'm not going to comment on pricing on specific products, Rick.

    是的,我不會評論特定產品的定價,瑞克。

  • Operator

    Operator

  • David Roman, Goldman Sachs

    大衛羅曼,高盛

  • David Roman - Analyst

    David Roman - Analyst

  • I was hoping to switch gears a little bit from the EP side of the business.

    我希望從 EP 業務方面稍微改變方向。

  • And maybe if you could spend a few minutes on the performance of the franchises kind of ex-WATCHMAN and EP, which are still trending very well, although a slowdown from where you started the year.

    也許你可以花幾分鐘來了解《前守望者》和《EP》等系列的表現,儘管與年初相比有所放緩,但它們的趨勢仍然非常好。

  • How are you thinking about resource allocation and just the focus on those businesses and maintaining ongoing support for those franchises in light of the success of PFA?

    鑑於 PFA 的成功,您如何考慮資源分配以及對這些業務的關注以及對這些特許經營商的持續支持?

  • And how should we think about the growth drivers in some of those more established categories on a go-forward basis?

    我們應該如何在未來的基礎上思考一些較成熟的類別的成長動力?

  • Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

    Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

  • Sure.

    當然。

  • I'll take that.

    我會接受的。

  • I'll give Dr. Stein some oxygen here.

    我會給斯坦博士一些氧氣。

  • We run as a very decentralized business units.

    我們作為一個非常分散的業務部門運作。

  • And so we have -- the leaders of these divisions that's all they do.

    所以我們有這些部門的領導者,這就是他們所做的一切。

  • They have global teams, thousands of employees.

    他們擁有全球團隊和數千名員工。

  • They wake up and think about peripheral inventions, interventional oncology, endoscopy, urology, neuromod all day long and ICTx, which grew at what 15% in the quarter.

    他們一醒來就整天想著外圍發明、介入性腫瘤學、內視鏡檢查、泌尿科、neuromod 和 ICTx,這些技術在本季增加了 15%。

  • So there's tremendous focus by their teams on the global execution of these businesses.

    因此,他們的團隊非常關注這些業務的全球執行。

  • We just announced the closing of Silk Road.

    我們剛剛宣布絲綢之路關閉。

  • We anticipate announcing the closing of Axonics in the fourth quarter here.

    我們預計將在第四季度宣布 Axonics 的關閉。

  • Just as Ken said, we attempt to drive this category leadership in terms of our breadth of portfolio and unique innovation across each division.

    正如肯所說,我們試圖透過我們的產品組合廣度和每個部門的獨特創新來推動這一類別的領導地位。

  • And we have different varying degrees of success in that.

    我們在這方面取得了不同程度的成功。

  • But in general, we're very strong in that area.

    但總的來說,我們在這方面非常強大。

  • So in terms of capital allocation, we've obviously invested significantly in the manufacturing ramp of PFA as well as ongoing R&D and clinical studies as well as commercial capabilities to continue to enhance our mapping sales force.

    因此,就資本配置而言,我們顯然在 PFA 的生產、持續的研發和臨床研究以及商業能力方面投入了大量資金,以繼續增強我們的測繪銷售團隊。

  • But that in no way has detracted from the investments that we're making across these other businesses, which are really the foundation of the company.

    但這絕對不會影響我們對其他業務的投資,而這些投資確實是公司的基礎。

  • And despite doing both those at the same times, we continue to improve our margin profile, which I think shows the testament and the winning spirit of the team.

    儘管同時進行這兩項工作,我們仍在繼續改善我們的利潤狀況,我認為這顯示了團隊的證明和獲勝精神。

  • So we have a rich pipeline of products organically within these business units.

    因此,我們在這些業務部門內有機地擁有豐富的產品線。

  • You've seen the performance for the quarter and the full year.

    您已經看到了本季和全年的業績。

  • We did see a bit of a slowdown in some procedure volume in the summertime in July, August, specifically in our endo, uro business.

    我們確實看到七月、八月夏季的某些手術量有所放緩,特別是在我們的內視鏡、尿道手術業務中。

  • But we saw a nice procedure bounce back in September and essentially grew kind of in line where we have for the past eight quarters in those businesses.

    但我們在 9 月看到了良好的反彈,並且基本上與這些業務過去八個季度的成長一致。

  • So we have a lot of confidence in them and we don't, Dr. Stein and I may spend a bit more time on PFA, certainly Dr. Stein does.

    所以我們對他們很有信心,但我們沒有,史丹博士和我可能會在 PFA 上花更多的時間,史丹博士當然會這樣做。

  • But we don't take the gas pedal down on the other businesses at all in the company.

    但我們並沒有對公司的其他業務鬆懈。

  • Operator

    Operator

  • Patrick Wood, Morgan Stanley

    派崔克伍德,摩根士丹利

  • Patrick Wood - Analyst

    Patrick Wood - Analyst

  • Perfect.

    完美的。

  • Thank you very much for taking my question.

    非常感謝您回答我的問題。

  • I guess just one on capacity in totality for the system.

    我想只有一個關於系統整體容量的問題。

  • Obviously, I get PFA adding some efficiencies to the system overall.

    顯然,我發現 PFA 為整個系統提高了一些效率。

  • But for EPs, between WATCHMAN and everything, there's a tremendous call on people's time.

    但對於 EP 來說,《守望者》和其他所有事情之間,對人們的時間有巨大的要求。

  • We saw in structural heart a little bit of noise on one of the players saying there were capacity constraints.

    我們在結構核心中看到其中一位玩家有一點噪音說容量有限。

  • How are you viewing that going forward?

    您如何看待未來的發展?

  • And how quickly do you think the system can adapt to enable you to keep growing these franchise and still have capacity to actually get them done?

    您認為系統能夠以多快的速度進行調整,使您能夠繼續發展這些特許經營權,並且仍然有能力實際完成它們?

  • Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

    Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

  • Well, we're still relatively early in our launch.

    嗯,我們的發布還處於相對早期的階段。

  • In the US, we got approved in February.

    在美國,我們在二月獲得了批准。

  • We started launching in late February and March.

    我們在二月下旬和三月開始推出。

  • So that we still have a number of new accounts that have not used FARAPULSE in the US.

    這樣我們在美國還有一些沒有使用FARAPULSE的新帳號。

  • And we have yet to launch in Japan and we've yet to launch in a meaningful way in China in many other countries.

    我們還沒有在日本推出,也沒有在中國和其他許多國家以有意義的方式推出。

  • So we're still quite early in the launch in very major markets.

    因此,我們在主要市場的推出仍處於相當早期的階段。

  • And we're seeing, in currently launched accounts, we're seeing many accounts move from one system originally to two, three and sometimes four systems.

    我們看到,在目前啟動的帳戶中,我們看到許多帳戶從最初的一個系統轉移到兩個、三個甚至有時四個系統。

  • So they're increasing their utilization of FARAPULSE across their multiple labs.

    因此,他們正在多個實驗室提高 FARAPULSE 的使用率。

  • So we have a lot to do to continue to increase share within existing accounts.

    因此,我們還有很多工作要做,以繼續增加現有帳戶中的份額。

  • And then thirdly, because of the efficiencies of the system, the hospitals are improving their workflow, and most accounts are doing, I don't know, Ken, 25%, 30% more procedure volume in a day.

    第三,由於系統的效率,醫院正在改進他們的工作流程,大多數帳戶都在做,我不知道,肯,一天的程序量增加了 25%、30%。

  • So there's a lot of efficiencies and the hospitals win economically and the patients benefit as do the physicians.

    因此,效率很高,醫院在經濟上獲勝,病人和醫生都受益。

  • And then to your term on capacity, that's why this concomitant procedure is also a big win for the workflow of the hospital and the patient.

    然後就容量而言,這就是為什麼這個伴隨程序對於醫院和病人的工作流程來說也是一個巨大的勝利。

  • So now an extra 10, 15 minutes for the appropriate patient, you can do a FARAPULSE system as well as the LAAC with WATCHMAN.

    因此,現在對於適當的患者,您可以額外進行 10、15 分鐘,使用 FARAPULSE 系統以及使用 WATCHMAN 進行 LAAC。

  • So it also drives procedural efficiency, which is very unique to Boston Scientific versus our competitors.

    因此,它也提高了程序效率,這是波士頓科學公司與我們的競爭對手相比非常獨特的。

  • So when we design these platforms, we look at operational efficiency and also the economics of the hospital.

    因此,當我們設計這些平台時,我們會考慮營運效率以及醫院的經濟效益。

  • And we think FARAPULSE and WATCHMAN and concomitant are all very helpful to hospitals efficiency.

    我們認為 FARAPULSE 和 WATCHMAN 及其伴隨物都對醫院效率有很大幫助。

  • And we're still really early in the launch of FARAPULSE.

    我們還處於 FARAPULSE 發布的早期階段。

  • Operator

    Operator

  • Travis Steed, Bank of America

    特拉維斯·斯蒂德,美國銀行

  • Travis Steed - Analyst

    Travis Steed - Analyst

  • I wanted to follow up on the AVANT GUARD trial pausing.

    我想跟進 AVANT GUARD 試驗暫停的情況。

  • I guess a lot of questions on that this morning.

    我想今天早上有很多問題。

  • So it seems like the observations you saw didn't change your thoughts drastically if you're restarting the trial soon.

    因此,如果您很快重新開始試驗,您看到的觀察結果似乎並沒有徹底改變您的想法。

  • And then just making sure that maybe help us understand why this doesn't really change your view on safety of FARAPULSE overall or mitigate the real-world data you have or and maybe just help us understand this patient population that's in this trial today, how they're getting treated today would be great?

    然後確保這可能有助於我們理解為什麼這不會真正改變您對 FARAPULSE 整體安全性的看法或減輕您擁有的現實世界數據,或者也許只是幫助我們了解今天參與這項試驗的患者群體,如何他們今天接受治療會很棒嗎?

  • Thanks a lot.

    多謝。

  • Kenneth Stein - Senior Vice President, Global Chief Medical Officer

    Kenneth Stein - Senior Vice President, Global Chief Medical Officer

  • Yes.

    是的。

  • Sure, Travis.

    當然,特拉維斯。

  • Let me again begin, at least the patient population.

    讓我再次開始,至少是患者群。

  • And so right today standard of care for patients with newly diagnosed persistent atrial fibrillation is to get a trial of antiarrhythmic drug therapy first.

    因此,目前新診斷的持續性心房顫動患者的護理標準是先嘗試抗心律不整藥物治療。

  • And then guidelines would say only to be referred for ablation if they actually fail antiarrhythmic drug therapy.

    然後指引會說,只有在抗心律不整藥物治療確實失敗的情況下才會轉診進行消融。

  • Obviously because even though we've paused enrollment for the moment, there's still an ongoing clinical trial.

    顯然,因為儘管我們暫時暫停了招募,但臨床試驗仍在進行中。

  • So I really can't get into any detail on the observations.

    所以我真的無法詳細了解觀察結果。

  • Again, just to reassure everyone, nothing that we saw certainly was life-threatening.

    再一次,只是為了讓大家放心,我們所看到的一切肯定不會危及生命。

  • And I think we are very highly confident in the overall safety profile, overall efficacy and again overall efficiency of FARAPULSE system.

    我認為我們對 FARAPULSE 系統的整體安全性、整體功效和整體效率非常有信心。

  • And again that's just based on the extensive experience that we've got with it, which is both commercial experience, as we said, over 125,000 patients now have been treated with this system globally as well as extensive clinical data that's been published in approximately 20,000 patients and data that we see from all of our ongoing clinical trials.

    再說一次,這只是基於我們在該系統上所獲得的豐富經驗,這既是商業經驗,正如我們所說,目前全球已有超過125,000 名患者接受了該系統的治療,以及大約20,000 名患者已發表的廣泛臨床數據我們從所有正在進行的臨床試驗中看到的患者和數據。

  • Operator

    Operator

  • Danielle Antalffy, UBS.

    丹妮爾·安塔菲,瑞銀集團。

  • Danielle Antalffy - Analyst

    Danielle Antalffy - Analyst

  • Hey, good morning, everyone.

    嘿,大家早安。

  • Thanks so much for taking the question.

    非常感謝您提出問題。

  • Congrats on this amazing quarter.

    恭喜這個令人驚嘆的季度。

  • I'm kind of speechless.

    我有點無言了

  • But just wanted to ask, I appreciate there's not going to be a lot you can say, Dan, I appreciate the comments that you did give on 2025.

    但我只是想問一下,我很高興你能說的不多,丹,我很感謝你對 2025 年發表的評論。

  • But specifically, as we think about sales, you noted above-market sales growth.

    但具體來說,當我們考慮銷售時,您注意到高於市場的銷售成長。

  • I mean market can be a moving target a little bit here about how you think about the market's growing next year.

    我的意思是,關於您如何看待明年市場的成長,市場可能會成為一個移動目標。

  • So I was hoping maybe you could give a little bit more color, if possible, even if it's just highlighting tailwinds and headwinds from a sales growth perspective to think about as we look ahead to 2025.

    因此,我希望如果可能的話,您可以提供更多的色彩,即使只是強調從銷售成長角度考慮的順風和逆風,以供我們展望 2025 年時考慮。

  • Thanks so much.

    非常感謝。

  • Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

    Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

  • I'll start and then Dan, you can clean up my mess.

    我先開始,然後丹,你來收拾我的爛攤子。

  • So we're excited, obviously, about '24 growing estimated 15% over a comp of 12% of 2023.

    因此,顯然,我們對 24 年預計將成長 15%(較 2023 年的 12%)感到興奮。

  • And as we head into 2025, obviously, we'll have a nice comp at approximately 15%.

    進入 2025 年,顯然,我們將獲得約 15% 的良好補償。

  • But there's so many good things going on with the company.

    但該公司發生了很多好事。

  • Thank you for the non-FARAPULSE question that was asked earlier about the other businesses like PI and ICTx and neurology commonly growing double-digits and the strength of endo and we want to strengthen neuromod and US CRM a bit more.

    感謝您先前提出的非 FARAPULSE 問題,涉及 PI 和 ICTx 等其他業務,以及通常以兩位數增長的神經病學以及 Endo 的實力,我們希望進一步加強 Neuromod 和 US CRM。

  • And so but as we look at 2025, the big headlines obviously are FARAPULSE and WATCHMAN.

    因此,當我們展望 2025 年時,頭條新聞顯然是 FARAPULSE 和 WATCHMAN。

  • We do think the Japan launch and China launch will drive meaningful growth for the franchise.

    我們確實認為日本的推出和中國的推出將推動該系列的有意義的成長。

  • And as I mentioned just prior, there's a number of new accounts to open in the US and there's a lot of penetration in current accounts to add additional volume to both FARAPULSE.

    正如我之前提到的,在美國開設了許多新帳戶,經常帳戶的滲透率很高,這為 FARAPULSE 增加了額外的交易量。

  • You've heard all about the concomitant reimburse for WATCHMAN.

    您已經聽過《守望者》的附帶報銷。

  • So those are all nice tailwinds for the company.

    所以這些對公司來說都是很好的推動力。

  • The procedure volumes we see is relatively consistent.

    我們看到的程序量是比較一致的。

  • We did see a bit of a slowdown in July, August, but strengthening in September.

    我們確實看到七月、八月有所放緩,但九月有所加強。

  • And so we think procedure volumes will maintain strong versus as they are now.

    因此,我們認為手術量將比現在保持強勁。

  • And we see strong global performance.

    我們看到全球表現強勁。

  • So obviously, we'll have some more challenging comps.

    顯然,我們將會有一些更具挑戰性的比賽。

  • There will be some more competition in PFA, but we're doing very well, I guess, that competition in Europe.

    PFA 將會有更多的競爭,但我想我們在歐洲的比賽中表現得很好。

  • I don't know, Dan, also we have the AGENT, which throw one out to the cardiology team, which has performed quite well.

    我不知道,丹,我們還有代理人,他們向心臟病學團隊扔了一個,該團隊表現得相當不錯。

  • So we'll find out about reimbursement on that product in the next coming weeks.

    因此,我們將在接下來的幾週內了解該產品的報銷情況。

  • That should add some additional momentum to that franchise.

    這應該會為該系列增添一些額外的動力。

  • Daniel Brennan - Chief Financial Officer, Executive Vice President

    Daniel Brennan - Chief Financial Officer, Executive Vice President

  • I think that summarizes it well.

    我認為這總結得很好。

  • And just to give you a sense of the process, it's no different than it is any year.

    只是為了讓您了解這個過程,這與任何一年都沒有什麼不同。

  • We have our annual operating plan process that's alive and well here through the fourth quarter.

    我們的年度營運計劃流程一直持續到第四季。

  • We'll review that as we go through the end of the quarter and into early next year and we'll let you know what we think for 2025 at our Q4 earnings call.

    我們將在本季末和明年初回顧這一點,並在第四季財報電話會議上讓您知道我們對 2025 年的看法。

  • Operator

    Operator

  • Anthony Petrone, Mizuho Group.

    安東尼‧佩特龍,瑞穗集團。

  • Anthony Petrone - Analyst

    Anthony Petrone - Analyst

  • Thanks and congrats on a strong quarter here.

    感謝並恭喜本季表現強勁。

  • I think the question will be on the go-to-market next year, 2025, you go back to the October 18 press release and you have FARAWAVE NAV Catheter out there, but it indicates that it's exclusive to OPAL on the mapping side.

    我認為問題將在於明年,即 2025 年的上市,你回到 10 月 18 日的新聞稿,你會發現 FARAWAVE NAV 導管在那裡,但這表明它在測繪方面是 OPAL 獨有的。

  • So in other words, the company is coming with a closed loop offering here next year.

    換句話說,該公司明年將推出閉環產品。

  • And presumably, we'll have competitors that are coming with a bundled approach.

    據推測,我們將會有採用捆綁方法的競爭對手。

  • So maybe the question here is just when we enter '25, it seems that three competitors will be out there with a bundled approach to PFA with mappers.

    因此,也許這裡的問題是,當我們進入 25 年時,似乎三個競爭對手將與地圖製作者一起使用 PFA 捆綁方法。

  • So maybe just walk through that dynamic a little bit.

    所以也許只是稍微了解一下這種動態。

  • Congratulations again on the quarter.

    再次恭喜本季。

  • Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

    Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

  • Yes.

    是的。

  • I'll just comment and Ken, again, you can finish this.

    我只是發表評論,肯,你可以完成這個。

  • So today customers using FARAPULSE with our legacy RHYTHMIA mapping system and they're also using it with our two primary competitors today.

    因此,今天,客戶將 FARAPULSE 與我們的傳統 RHYTHMIA 繪圖系統一起使用,並且他們今天也將其與我們的兩個主要競爭對手一起使用。

  • So the OPAL platform will not be closed out in such a way that if a physician wants to continue to use a competitive mapping system with FARAPULSE, they still can.

    因此,OPAL 平台不會以這樣的方式被關閉:如果醫生想要繼續使用 FARAPULSE 的競爭性繪圖系統,他們仍然可以。

  • We do think that with the OPAL mapping system, specifically with FARAPULSE, the user experience will be more meaningful and more streamlined and differentiated.

    我們確實認為,透過 OPAL 地圖系統,特別是 FARAPULSE,使用者體驗將更有意義、更精簡和差異化。

  • So we're not closing the system and that we're shutting out competitive systems from doing FARAPULSE cases.

    因此,我們不會關閉該系統,而是將競爭系統排除在 FARAPULSE 案例之外。

  • But we're quite confident in the user experience, the overall economics and the value of the OPAL integration with FARAPULSE to be differentiated versus what they're using today.

    但我們對 OPAL 與 FARAPULSE 整合的使用者體驗、整體經濟效益和價值非常有信心,與他們目前使用的產品相比,具有差異化優勢。

  • Kenneth Stein - Senior Vice President, Global Chief Medical Officer

    Kenneth Stein - Senior Vice President, Global Chief Medical Officer

  • Yes.

    是的。

  • I mean, Anthony, just to again build on what Mike said, right, we do not feel that we've got to force people to use our products.

    我的意思是,安東尼,再次以麥克所說的為基礎,對吧,我們認為我們不必強迫人們使用我們的產品。

  • And what we see with FARAWAVE is people want to use it.

    我們從 FARAWAVE 看到的是人們想要使用它。

  • And people have used it in a variety of different ways and we are going to continue to support their ability to use it in the way that they want to.

    人們以各種不同的方式使用它,我們將繼續支持他們以他們想要的方式使用它的能力。

  • And that includes people who use no mapping navigation at all, which is really through the predominant use case that we see in Europe and throughout a lot of the world or use it with a mapping and navigation system.

    這包括根本不使用地圖導航的人,這實際上是透過我們在歐洲和世界各地看到的主要用例或將其與地圖和導航系統一起使用的人。

  • We're going to continue to keep the original , right, the FARAWAVE Catheter without the NAV sensor on the market for people who want to use it with a competitive mapping system.

    我們將繼續在市場上保留原始的(右)不帶 NAV 感測器的 FARAWAVE 導管,供那些想要將其與有競爭力的測繪系統一起使用的人使用。

  • FARAWAVE NAV, because it's got a magnetic NAV sensor and it does have to get tied into a particular mapping system, which for us is the refreshed OPAL HDx system with FARAVIEW.

    FARAWAVE NAV,因為它有一個磁性 NAV 感測器,而且它必須連接到特定的地圖系統,對我們來說,這是帶有 FARAVIEW 的更新版 OPAL HDx 系統。

  • But we're not going to force people to use it.

    但我們不會強迫人們使用它。

  • We think it's got enough compelling differentiated advantages compared to what else is out there that people are going to want to use it.

    我們認為,與其他產品相比,它具有足夠引人注目的差異化優勢,人們會想要使用它。

  • Operator

    Operator

  • Vijay Kumar, Evercore ISI.

    維傑·庫馬爾,Evercore ISI。

  • Vijay Kumar - Analyst

    Vijay Kumar - Analyst

  • Mike, maybe one for you on next week's ACURATE Neo2 results here.

    麥克,也許下週的 ACURATE Neo2 結果就在這裡為您提供。

  • What is the regulatory strategy?

    監理策略是什麼?

  • Do you expect to file with the FDA?

    您希望向 FDA 提交申請嗎?

  • And I think you mentioned that you expect to have a successful launch in the US.

    我想你有提到你希望在美國成功推出。

  • Is that referring to Neo2 or some other generation of the valves?

    這是指 Neo2 或其他一代的閥門嗎?

  • So maybe talk about your TAVR strategy in the US?

    那麼能否談談您在美國的 TAVR 策略?

  • Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

    Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

  • Sure.

    當然。

  • So as we've talked about before, the ACURATE Neo2 trial on the 1,500 patient will be TCT on what Wednesday?

    正如我們之前討論過的,對 1,500 名患者進行的 ACURATE Neo2 試驗將於哪週三進行 TCT?

  • Daniel Brennan - Chief Financial Officer, Executive Vice President

    Daniel Brennan - Chief Financial Officer, Executive Vice President

  • October 30.

    10 月 30 日。

  • Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

    Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

  • October 30.

    10 月 30 日。

  • So that is an important milestone to see that clinical trial data that will be presented.

    因此,這是一個重要的里程碑,將呈現臨床試驗數據。

  • And we'll actually be holding an investor meeting that day with Joe Fitzgerald and Lance Bates and the team to talk about the broader cardiology portfolio and the plan for ACCURATE post the data.

    實際上,那天我們將與喬·菲茨杰拉德(Joe Fitzgerald)和蘭斯·貝茨(Lance Bates)以及團隊舉行投資者會議,討論更廣泛的心臟病學投資組合以及準確發布數據的計劃。

  • As you know, we've continued to have excellent momentum in Europe.

    如您所知,我們在歐洲繼續保持良好的勢頭。

  • You saw the third quarter results.

    您看到了第三季的業績。

  • We continue to grow above-market.

    我們的成長持續高於市場水平。

  • And kudos to the team on the launch of Prime, the next-generation ACURATE Neo2, which they just recently started implementing in Europe.

    感謝團隊推出了 Prime,即下一代 ACURATE Neo2,最近才剛開始在歐洲實施。

  • Vijay Kumar - Analyst

    Vijay Kumar - Analyst

  • Sorry, and does it mean you expect to file with the FDA, Mike?

    抱歉,麥克,這是否意味著您希望向 FDA 提交文件?

  • And what does successful launch mean?

    發射成功意味著什麼?

  • Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

    Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

  • Well, a successful launch, we've never provided share, attainment goals just like we don't provide a share for FARAPULSE.

    好吧,一次成功的發布,我們從未提供過份額、實現目標,就像我們不為 FARAPULSE 提供份額一樣。

  • So we obviously want to grow the business.

    所以我們顯然希望發展業務。

  • It's a very large market, very mature, market growing, I don't know, 8% -- 7%, 9% and we continue to do quite well in the US, but we'll provide more information at the TCT at the investor call there.

    這是一個非常大的市場,非常成熟,市場正在成長,我不知道,8% - 7%, 9%,我們在美國繼續做得很好,但我們將在 TCT 上提供更多資訊投資者致電那裡。

  • Operator

    Operator

  • Matt Miksic, Barclays.

    馬特·米克西奇,巴克萊銀行。

  • Matt Miksic - Analyst

    Matt Miksic - Analyst

  • Hey, thanks so much for fitting us in and congrats on a really impressive quarter and all the great growth drivers you have running.

    嘿,非常感謝您讓我們參與其中,並祝賀您度過了一個令人印象深刻的季度以及您所擁有的所有偉大的增長動力。

  • I had a question just on maybe for Dan on some of the dynamics in the gross margin line in the quarter you mentioned FX being one of the primary headwinds.

    我有一個問題想問 Dan,關於您提到外匯是主要阻力之一的季度毛利率的一些動態。

  • But as you move into '25, maybe you can talk a little bit about where the leverage in the model is, if it's stable gross margin and levering some of the operating investments that you're making?

    但當你進入 25 年時,也許你可以談談模型中的槓桿在哪裡,如果它是穩定的毛利率並槓桿化你正在進行的一些營運投資?

  • Maybe just some color on how that -- how you see that progressing at this point?

    也許只是一些關於如何做到這一點的顏色 - 您如何看待目前的進展?

  • Thanks.

    謝謝。

  • Daniel Brennan - Chief Financial Officer, Executive Vice President

    Daniel Brennan - Chief Financial Officer, Executive Vice President

  • Sure, Matt.

    當然,馬特。

  • The Q3 story is actually pretty simple.

    第三季的故事其實非常簡單。

  • So we were 70.4% gross margin in Q3, slightly below what we would have expected and that's really driven by foreign exchange in the quarter.

    因此,我們第三季的毛利率為 70.4%,略低於我們的預期,這實際上是由本季的外匯推動的。

  • So simple story for Q3.

    第三季的故事很簡單。

  • We've said consistently that we believe our full year adjusted gross margin will be below last year.

    我們一直表示,我們相信全年調整後的毛利率將低於去年。

  • Last year, we were 70.7%.

    去年,我們是70.7%。

  • So we've consistently said, you know what, we're probably not going to hit that 70.7% in 2024, that's okay because we're actually driving 70 basis points of adjusted operating margin expansion without that kind of testament to the hallmark of the DNA of the company of continuing to drive margin expansion through all lines of the P&L.

    因此,我們一直在說,你知道嗎,我們可能不會在 2024 年達到 70.7%,這沒關係,因為我們實際上正在推動調整後營業利潤率擴張 70 個基點,而沒有那種證明繼續通過損益表的所有項目推動利潤率擴張是公司的基因。

  • So 2024 gross margin, not going to contribute, that's okay because we have the SG&A and other horses to ride there.

    因此,2024 年的毛利率不會有所貢獻,但這沒關係,因為我們有 SG&A 和其他馬匹可以騎。

  • As you go into '25 and beyond, I think all lines of the P&L could contribute.

    當你進入 25 年及以後,我認為損益表的所有項目都可以做出貢獻。

  • I think gross margin is part of that.

    我認為毛利率是其中的一部分。

  • And how does that happen?

    這是怎麼發生的?

  • A big piece of that will be product mix.

    其中很大一部分將是產品組合。

  • So call FARAPULSE today, the single-use catheter, that's a nice margin, but you have a lot of that, the capital placements that we have.

    所以今天打電話給 FARAPULSE,一次性導管,這是一個不錯的利潤,但我們有很多這樣的資本配置。

  • As Mike mentioned, we're still launching this.

    正如麥克所提到的,我們仍在推出這個。

  • It's only six or seven months into the launch.

    距離推出僅六、七個月。

  • So we're still launching a lot of capital, placing a lot of capital.

    因此,我們仍在啟動大量資金,投入大量資金。

  • And next year, we'll have Japan and China.

    明年,我們將有日本和中國。

  • So we'll still be doing that.

    所以我們仍然會這樣做。

  • We'll be effectively launching there.

    我們將在那裡有效地啟動。

  • But I think the story is as you go into '25 and work through '25 and beyond, FARAPULSE becomes accretive overall as the single-use catheter kind of swamps the overall margin within FARAPULSE and is accretive to overall Boston Scientific.

    但我認為故事是,當你進入25 年並一直工作到25 年及以後,FARAPULSE 整體上會變得增值,因為一次性導管淹沒了FARAPULSE 的整體利潤,並且對整體波士頓科學公司來說是增值的。

  • WATCHMAN is obviously helpful.

    WATCHMAN 顯然很有幫助。

  • You heard a lot of commentary on the call today about the some of the tailwinds that could be there for WATCHMAN.

    您在今天的電話會議上聽到了很多關於《守望者》可能帶來的一些好消息的評論。

  • That's great news for the gross margin line.

    這對毛利率來說是個好消息。

  • So I think the takeaway is gross margin, '25 and beyond, gross margin can be a contributor to the overall operating margin journey that's been so successful for the company for the last decade.

    因此,我認為重點是毛利率,25 年及以後,毛利率可以為公司在過去十年中取得如此成功的整體營業利潤率做出貢獻。

  • Operator

    Operator

  • Josh Jennings, TD Cowen.

    喬許·詹寧斯,TD·考恩。

  • Josh Jennings - Analyst

    Josh Jennings - Analyst

  • Congratulations on another home run quarter.

    恭喜又一個本壘打季度。

  • I wanted to just check the box, Mike, you called out or you called out your ops and supply chain team for keeping up with the demand for FARAPULSE and staying on time.

    我只想勾選這個框,麥克,你打電話或你打電話給你的營運和供應鏈團隊,以滿足 FARAPULSE 的需求並保持準時。

  • I just want to make sure that there's no manufacturing capacity issues next year if that franchise continues to outperform internal expectations?

    我只是想確保如果該特許經營權繼續超出內部預期,明年不會出現製造能力問題?

  • And then also just sorry to follow up on a two-parter.

    然後也很抱歉跟進兩方。

  • But wanted to just get your team's view on this mapping segment.

    但只是想了解您的團隊對此映射部分的看法。

  • I mean our understanding is that mapping capital and diagnostic mapping catheters, the kind of the percentage of the overall ablation market, it's even higher than the ablation catheter segment and just I know you guys are now well positioned there, but just to review that and maybe just the revenue -- the business model for Boston Scientific, whether there's FARAPULSE NAV Catheter will be single-use for PVIs and or and then just how you're building out your diagnostic mapping catheter portfolio.

    我的意思是,我們的理解是,繪製資本和診斷繪製導管,佔整個消融市場的百分比,甚至高於消融導管部分,我知道你們現在在這方面處於有利位置,但只是回顧一下,也許只是收入- 波士頓科學公司的商業模式,是否有FARAPULSE NAV 導管將是PVI 的一次性使用,或者然後是您如何建立診斷標測導管產品組合。

  • Sorry for the multipart.

    抱歉,多部分。

  • Kenneth Stein - Senior Vice President, Global Chief Medical Officer

    Kenneth Stein - Senior Vice President, Global Chief Medical Officer

  • Hey, Josh, I'll take the second part first and then we can get to the supply issue.

    嘿,喬什,我先討論第二部分,然後我們才能討論供應問題。

  • So just for clarity.

    所以只是為了清楚起見。

  • Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

    Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

  • Let me just jump up.

    讓我跳起來吧。

  • There is no supply issue.

    不存在供應問題。

  • So let's talk about that.

    那我們來談談這個吧。

  • So kudos to the team.

    所以對團隊表示敬意。

  • Let me take the first part.

    讓我來看第一部分。

  • We do not anticipate, even despite the high demand, our team has done a great job on the catheter supply and the console supply.

    儘管需求量很大,我們預計我們的團隊在導管供應和控制台供應方面仍然做得很好。

  • So we don't anticipate any supply shortages.

    因此,我們預計不會出現任何供應短缺。

  • Kenneth Stein - Senior Vice President, Global Chief Medical Officer

    Kenneth Stein - Senior Vice President, Global Chief Medical Officer

  • Thanks.

    謝謝。

  • I should not have used that word.

    我不應該使用這個詞。

  • Yes, in terms of just for clarity.

    是的,只是為了清楚起見。

  • So the FARAWAVE NAV Catheter, it is a single-use device.

    因此 FARAWAVE NAV 導管是一次性設備。

  • It is, again, current indicated for PVI for patients with paroxysmal atrial fibrillation.

    目前,PVI 再次適用於陣發性心房顫動患者。

  • As we said at the ADVANTAGE clinical trial is our clinical trial to get label expansion for the FARAWAVE Catheter family for use in patients with drug refractory persistent atrial fibrillation.

    正如我們在 ADVANTAGE 臨床試驗中所說,我們的臨床試驗旨在擴大 FARAWAVE 導管系列的標籤,用於治療藥物難治性持續性心房顫動患者。

  • And again I think what we really want to emphasize here is that there's some really significant differentiated advantages to FARAVIEW versus other systems that are currently on the market for mapping a navigation of PFA catheters, right?

    我想再次強調的是,與目前市場上用於繪製 PFA 導管導航的其他系統相比,FARAVIEW 具有一些非常顯著的差異化優勢,對吧?

  • And that's specifically ability to dynamic visualization of the catheter shape as it changes ability also to do field tagging and so ability to plan where to put lesions in when you're doing an ablation procedure.

    這特別是導管形狀動態可視化的能力,因為它還改變了進行現場標記的能力,以及在進行消融手術時計劃將病變放置在何處的能力。

  • Josh Jennings - Analyst

    Josh Jennings - Analyst

  • And just in terms of the diagnostic mapping catheter portfolio buildout, you guys do have a high-density mapping catheter in the pipeline is my understanding, but just wanted to get a better look on that.

    就診斷標測導管組合建設而言,據我了解,你們確實有高密度標測導管正在醞釀中,但只是想更好地了解這一點。

  • Kenneth Stein - Senior Vice President, Global Chief Medical Officer

    Kenneth Stein - Senior Vice President, Global Chief Medical Officer

  • Yes.

    是的。

  • I mean, Josh, we already have a high-density mapping catheter, right, which is our ORION catheter, which can be used on the refreshed OPAL system.

    我的意思是,喬什,我們已經有了一個高密度標測導管,對吧,這是我們的 ORION 導管,它可以在更新的 OPAL 系統上使用。

  • And then as we go down the road, right, we've talked about additional catheters and be part of the FARAPULSE family, which includes FARAPOINT and includes our FARAFLEX catheter, which would have the capability to do both high-density mapping and also do PFA ablation in the same catheter.

    然後,當我們沿著這條路走下去時,對吧,我們討論了額外的導管並成為 FARAPULSE 系列的一部分,其中包括 FARAPOINT 和我們的 FARAFLEX 導管,它既能夠進行高密度測繪,也能夠進行在同一導管中進行PFA 消融。

  • Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

    Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

  • They're all -- just I'll just add on and we'll move on to the next one.

    它們都是——我只是補充一下,然後我們將繼續下一個。

  • There are elements of the procedure that we don't compete in today that pie like ice catheters and others.

    手術中有一些元素是我們今天不參與競賽的,例如冰導管等。

  • So we're doing extremely well in the ablation portion of it.

    所以我們在消融部分做得非常好。

  • We expect OPAL to do quite well in the mapping segment, which we've been underscaled in, but there are still segments within the EP procedure mix that we don't play in today that we're shooting to fill out in the portfolio over time.

    我們預計 OPAL 在測繪領域會表現得很好,但我們在這方面的規模一直被低估,但 EP 程序組合中仍然有一些我們今天沒有參與的領域,我們正在拍攝以填補投資組合中的部分時間。

  • I'll just make one other comment on FARAPULSE relates to China for -- it wasn't a question, but we're excited about the approval in Japan and in China.

    我只想對 FARAPULSE 與中國相關的另一條評論——這不是一個問題,但我們對日本和中國的批准感到興奮。

  • We do expect the China launch to be a bit slower than what you typically see in the US and Japan based on obviously, not product or team, but it's more on getting approvals and registries and launch cadence in terms of the volume of new accounts.

    我們確實預計中國的發布速度會比您通常在美國和日本看到的速度慢一些,這顯然不是基於產品或團隊,而是更多地取決於獲得批准和註冊以及新帳戶數量方面的發布節奏。

  • We've done some recent openings there that have gone quite well, but we don't anticipate the same aggressive launch in China that you've seen in US.

    我們最近在那裡開設了一些新店,進展順利,但我們預計中國不會像在美國那樣積極推出。

  • We do expect to have a very strong launch in Japan.

    我們確實希望在日本有一個非常強勁的推出。

  • And also just a shout out to the China team.

    也是對中國隊的讚揚。

  • Despite the significant VBP headwinds that we've seen, which have impacted our IVUS franchise and there will be more VBPs in 2025.

    儘管我們看到了 VBP 的巨大阻力,這影響了我們的 IVUS 特許經營權,並且 2025 年將會有更多的 VBP。

  • We continue to grow essentially at the company average in China despite those headwinds when many of our peers have faced tougher results.

    儘管我們的許多同行面臨更艱難的業績,但我們仍繼續以中國公司的平均水平基本增長。

  • Jonathan Monson - Senior Vice President - Investor Relations

    Jonathan Monson - Senior Vice President - Investor Relations

  • Drew, let's take one more question.

    德魯,我們再問一個問題。

  • Operator

    Operator

  • Matt O'Brien, Piper Sandler.

    馬特·奧布萊恩,派珀·桑德勒。

  • Matthew O'Brien - Analyst

    Matthew O'Brien - Analyst

  • I'd much rather focus on all the positive things going on here, but I'm looking at the stock down now versus up prior to this AVANT GUARD commentary.

    我更願意關注這裡發生的所有積極的事情,但我現在關注的是股票的下跌,而不是在 AVANT GUARD 評論之前上漲。

  • So Dr. Stein, I'm not sure exactly what you can say, but is there any kind of safety signal that we should be aware of?

    所以史丹博士,我不確定你到底能說什麼,但是有什麼我們應該注意的安全訊號嗎?

  • And then if you can't comment on that, is there anything to think about in terms of this patient population really being the cause of the difference, maybe extra lesions that need to be created, higher risk benefit requirements because it's drug-naive patients.

    然後,如果你不能對此發表評論,是否有什麼需要考慮的,因為這個患者群體確實是差異的原因,也許需要產生額外的病變,更高的風險福利要求,因為它是未接受過藥物治療的患者。

  • Just anything along those lines that you can share because I think folks are pretty nervous this morning just based on how important FARAPULSE is to the business.

    您可以分享任何類似的內容,因為我認為人們今天早上非常緊張,因為 FARAPULSE 對業務的重要性。

  • Thanks.

    謝謝。

  • Kenneth Stein - Senior Vice President, Global Chief Medical Officer

    Kenneth Stein - Senior Vice President, Global Chief Medical Officer

  • Yes, Matt, again, because this is an ongoing trial, I can't get into any details.

    是的,馬特,再說一遍,因為這是一項正在進行的試驗,所以我無法透露任何細節。

  • Again, what I can say is we are highly confident in the safety of the system.

    我再說一遍,我們對系統的安全性充滿信心。

  • Again, we've got extensive commercial use data and over 125,000 patients treated.

    同樣,我們擁有廣泛的商業使用數據和超過 125,000 名患者的治療。

  • We've got extensive published clinical trial data and other ongoing clinical trials and are highly confident in the safety, the efficiency and the efficacy of the FARAPULSE system.

    我們擁有大量已發表的臨床試驗數據和其他正在進行的臨床試驗,並對 FARAPULSE 系統的安全性、效率和功效充滿信心。

  • Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

    Michael Mahoney - Chairman of the Board, President, Chief Executive Officer

  • We expect to re-launch this trial soon.

    我們預計很快就會重新啟動這項試驗。

  • Jonathan Monson - Senior Vice President - Investor Relations

    Jonathan Monson - Senior Vice President - Investor Relations

  • All right.

    好的。

  • Thanks, Ken.

    謝謝,肯。

  • Thanks, Mike, and thanks, everyone for joining us today.

    謝謝麥克,也謝謝大家今天加入我們。

  • We appreciate your interest in Boston Scientific.

    我們感謝您對波士頓科學公司的興趣。

  • If we weren't able to get to your question or if you have any follow-ups, please don't hesitate to reach out to the Investor Relations team.

    如果我們無法解答您的問題或您有任何後續行動,請隨時聯絡投資者關係團隊。

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

    在您斷開連接之前,Drew 將為您提供重播的所有相關詳細資訊。

  • Thanks, everyone.

    謝謝大家。

  • Have a great day.

    祝你有美好的一天。

  • Operator

    Operator

  • Please note, a recording will be available in one hour by dialing either 1877-344-7529 or 1412-317-0088 using replay code 2607711 until October 30, 2024, at 11:59 PM Eastern Time.

    請注意,在東部時間 2024 年 10 月 30 日晚上 11:59 之前,使用重播代碼 2607711 撥打 1877-344-7529 或 1412-317-0088,一小時內即可獲得錄音。

  • The conference has now concluded.

    會議現已結束。

  • Thank you for attending today's presentation.

    感謝您參加今天的演講。

  • You may now disconnect.

    您現在可以斷開連線。