愛德華生命科學 (EW) 2025 Q3 法說會逐字稿

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

  • Greetings, and welcome to the Edwards Lifesciences' third-quarter 2025 conference call. (Operator Instructions) Please note, this conference is being recorded.

    大家好,歡迎參加 Edwards Lifesciences 2025 年第三季電話會議。(操作員說明)請注意,本次會議正在錄音。

  • I will now turn the conference over to your host, Mark Wilterding, Senior Vice President, Global Finance. Thank you. You may begin.

    現在我將把會議交給主持人,全球財務高級副總裁馬克·威爾特丁。謝謝。你可以開始了。

  • Mark Wilterding - Senior Vice President, Investor Relations and Treasurer

    Mark Wilterding - Senior Vice President, Investor Relations and Treasurer

  • Thank you, Diego, and thank you, everyone, for joining us this afternoon. With me on today's call is our CEO, Bernard Zovighian; and our CFO, Scott Ullem. Also joining us for the Q&A portion of the call will be Dan Lippis, our global leader of TAVR and Daveen Chopra, who has global responsibility for TMTT and Surgical.

    謝謝你,迭戈,也謝謝各位今天下午的到來。今天和我一起參加電話會議的有我們的執行長伯納德·佐維吉安和我們的財務長史考特·烏勒姆。參與本次電話會議問答環節的還有我們的全球 TAVR 負責人 Dan Lippis 和負責 TMTT 和外科手術的全球負責人 Daveen Chopra。

  • Just after the close of regular trading, Edwards Lifesciences released third quarter 2025 financial results. During this call, management will discuss the results included in the press release and accompanying financial schedules and then use the remaining time for Q&A.

    在常規交易結束後不久,愛德華生命科學公司發布了 2025 年第三季財務業績。在本次電話會議中,管理層將討論新聞稿和隨附的財務報表中包含的結果,然後利用剩餘時間進行問答環節。

  • Please note that management will be making forward-looking statements that are based on estimates, assumptions and projections. These statements speak only as of the date of which they were made, and Edwards does not undertake any obligation to update them after today.

    請注意,管理層將根據估計、假設和預測做出前瞻性聲明。這些聲明僅代表其發布之日的情況,Edwards 不承擔在今天之後更新這些聲明的任何義務。

  • Additionally, the statements involve risks and uncertainties that could cause actual results to differ materially. Information concerning factors that could cause these differences can be found in today's press release and Edwards' other SEC filings, all of which are available on the company's website at edwards.com.

    此外,這些聲明涉及風險和不確定性,可能導致實際結果與預期結果有重大差異。有關可能導致這些差異的因素的資訊可以在今天的新聞稿和 Edwards 向美國證券交易委員會提交的其他文件中找到,所有這些文件都可以在公司網站 edwards.com 上找到。

  • Unless otherwise noted, our commentary on sales growth refers to constant currency sales growth which is defined in the quarterly press release issued earlier today. Reconciliations between GAAP and non-GAAP numbers mentioned during the call are also included in today's press release. Quarterly and full year growth rates refer to continuing operations.

    除非另有說明,我們對銷售成長的評論指的是以固定匯率計算的銷售成長,其定義請參閱今天稍早發布的季度新聞稿。本次電話會議中提到的 GAAP 和非 GAAP 數據的調整表也包含在今天的新聞稿中。季度和全年成長率均指持續經營業務。

  • With that, I'd like to turn the call over to Bernard for his comments.

    接下來,我想把電話交給伯納德,請他表達意見。

  • Bernard Zovighian - Chief Executive Officer, Director

    Bernard Zovighian - Chief Executive Officer, Director

  • Thank you, Mark and welcome everyone. Thank you for joining us today. We are pleased with the year-to-date performance of the company, including the most recent third quarter, our focus on structural heart has positioned us to execute our growth strategy with agility this year and also give us confidence in 2026 and beyond. This strong Q3 results represent another quarter of double-digit sales growth.

    謝謝馬克,也歡迎各位。感謝您今天蒞臨。我們對公司今年迄今的業績感到滿意,包括最近的第三季。我們對結構性心臟病的關注使我們能夠靈活地執行今年的成長策略,也讓我們對 2026 年及以後充滿信心。第三季強勁的業績標誌著又一個季度實現了兩位數的銷售成長。

  • Sales in the quarter grew 12.6% to $1.55 billion driven by our comprehensive portfolio across multiple therapeutic areas, aortic, pulmonic, mitral and tricuspid as well and -- as well as an established presence in countries around the world.

    本季銷售額成長 12.6%,達到 15.5 億美元,這得益於我們在多個治療領域(包括主動脈、肺動脈、二尖瓣和三尖瓣)的全面產品組合,以及我們在世界各地建立的穩固業務。

  • We were pleased with the better-than-expected results reflecting the performance of our talented employees. Based on our strong performance in Q3, we are raising full year sales growth guidance to the high end of a previous 9% to 10% range and are also raising our EPS guidance range to between $2.56 and $2.62.

    我們對超越預期的業績感到滿意,這反映了我們優秀員工的出色表現。基於第三季強勁的業績表現,我們將全年銷售成長預期上調至先前 9% 至 10% 區間的高端,並將每股收益預期區間上調至 2.56 美元至 2.62 美元之間。

  • As we look ahead to '26 and beyond, the company is in a good position with multiple growth drivers to deliver sustainable top line growth. While the composition and contribution from product lines and region could vary, you could expect Edwards to grow sales and profitability in line with our commitment from last year. We look forward to talking more about this at the upcoming investor conference in December.

    展望 2026 年及以後,公司擁有多個成長動力,處於有利地位,能夠實現可持續的營收成長。雖然各產品線和地區的組成和貢獻可能會有所不同,但您可以預期 Edwards 的銷售額和盈利能力將按照我們去年的承諾實現成長。我們期待在12月即將舉行的投資者大會上就此進行更深入的探討。

  • This week was an important week for Edwards. And this quarterly call comes on the heels of TCT, where I was pleased to see many of you at the conference, physicians feature a significant amount of compelling data on Edwards' groundbreaking transcatheter therapies, including SAPIEN, EVOQUE and SAPIEN M3.

    本週對愛德華茲來說是重要的一周。本次季度電話會議緊隨 TCT 之後召開,我很高興在 TCT 會議上見到了你們中的許多人,醫生們展示了大量關於 Edwards 突破性經導管療法的令人信服的數據,包括 SAPIEN、EVOQUE 和 SAPIEN M3。

  • Our unique leadership commitment to high-quality evidence was once again showcased by the multiple late-breaking clinical trials as well as concurrent publication in the New England Journal of Medicine and Lancet.

    我們對高品質證據的獨特領導承諾再次透過多項最新臨床試驗以及在《新英格蘭醫學雜誌》和《柳葉刀》上的同步發表而得到體現。

  • On Monday, at TCT, physicians presented seven-year data for the PARTNER III pivotal trial, which represents the most extensive clinical follow-up to date for low-risk TAVR and surgical patients. The results confirm that rates of all-cause mortality for TAVR remain low and comparable to the surgical control arm. Additionally, SAPIEN performance and durability indicators were excellent and comparable to SAVR.

    週一,在 TCT 會議上,醫生們公佈了 PARTNER III 關鍵性試驗的七年數據,這是迄今為止對低風險 TAVR 和外科手術患者進行的最廣泛的臨床追蹤。結果證實,TAVR 的全因死亡率仍很低,與外科手術對照組相當。此外,SAPIEN 的效能和耐久性指標非常出色,與 SAVR 相當。

  • Also, during the TCT conference 10 years a follow-up on multiple generation of SAPIEN was featured. Long-term data from the PARTNER IIa and the PARTNER II S3i studies demonstrated sustainable performance, excellent durability and consistent clinical outcomes of Edwards' TAVR matching the performance of SAVR.

    此外,在 TCT 會議 10 週年之際,也重點介紹了 SAPIEN 多代細胞的後續研究。PARTNER IIa 和 PARTNER II S3i 研究的長期數據顯示,Edwards 的 TAVR 具有可持續的性能、優異的耐久性和一致的臨床結果,與 SAVR 的性能相當。

  • So overall, when taken together, the SAPIEN platform has been the most steadied valve with more than 15 years of world-class clinical trials involving over 10,000 patients, 10 New England Journal of Medicine publication and 1.2 million patients treated around the world.

    綜上所述,SAPIEN 平台是最穩定的瓣膜,擁有超過 15 年的世界級臨床試驗經驗,涉及超過 10,000 名患者,在《新英格蘭醫學雜誌》上發表了 10 篇論文,並在全球範圍內治療了 120 萬名患者。

  • It is clear, but in addition to offering an early clinical benefit with superiority at one-year for low-risk patients. The excellent performance of TAVR with SAPIEN 3 is now proven at seven years. This impressive durability is further supported by the 10-year results of the PARTNER II trials.

    很明顯,除了能為低風險患者提供早期臨床獲益,並在一年內取得優越療效外,該療法還能帶來其他益處。經七年驗證,TAVR 與 SAPIEN 3 的卓越表現已得到證實。PARTNER II 試驗的 10 年結果進一步證實了其令人印象深刻的耐用性。

  • At the end of the day, this groundbreaking evidence sets a new global benchmark, one that is exceptionally reassuring for both patients and physicians, and sets the stage for continued long-term adoption of SAPIEN to treat patients suffering from aortic stenosis.

    歸根結底,這項突破性的證據樹立了新的全球標桿,這對患者和醫生來說都極具安慰作用,並為 SAPIEN 長期持續用於治療主動脈瓣狹窄患者奠定了基礎。

  • TCT also featured multiple important studies focus on Edwards' portfolio of mitral and tricuspid replacement therapies, including the largest real-world registry data on EVOQUE and the one-year result of the first ever pivotal trial for any transfemoral mitral replacement therapy via ENCIRCLE trial for SAPIEN M3.

    TCT 還重點介紹了多項重要研究,重點關注 Edwards 的二尖瓣和三尖瓣置換療法產品組合,包括 EVOQUE 的最大真實世界註冊數據,以及透過 ENCIRCLE 試驗對 SAPIEN M3 進行的首個經股動脈二尖瓣置換療法的關鍵性試驗的一年結果。

  • Just over two years ago, TRISCEND II 6-month data was presented at TCT 2023. To date, more than 5,000 patients have benefited from this novel therapy solving the large unmet patient needs. And the 1,000-plus patients, the real-world data presented at this year TCT demonstrates that the clinical community is embracing this technology broadly across many centers and is excelling at caring for these patient with consistent procedure times and high-quality results for both safety and efficacy. The TVT data on 30 days shows consistent TR elimination in 19% of patients, a very low major life-threatening bleeding rate of 1.3%, a new pacemaker rate of 15%.

    兩年多前,TRISCEND II 的 6 個月資料在 TCT 2023 上公佈。迄今為止,已有超過 5000 名患者受益於這種新型療法,解決了大量未被滿足的患者需求。而今年 TCT 上展示的 1000 多名患者的真實世界數據表明,臨床界正在許多中心廣泛接受這項技術,並且在護理這些患者方面表現出色,手術時間穩定,安全性和有效性均達到高質量水平。TVT 30 天數據顯示,19% 的患者三尖瓣逆流得到持續消除,危及生命的大出血發生率非常低,為 1.3%,新起搏器植入率為 15%。

  • To put this EVOQUE pacemaker rate into perspective. It is now competitive to the pacemaker rate seen today in self-expanding TAVR valves available in major regions. It is inspiring to see the practice of medicine progressing for improved patient care.

    為了更直觀地理解EVOQUE起搏器的頻率。目前,其價格與主要地區可用的自膨脹式TAVR瓣膜的起搏器價格相比具有競爭力。看到醫學實踐不斷進步,從而改善患者護理,令人鼓舞。

  • Turning to mitral replacement. We know that there are many patients who cannot be treated with by today's existing technology, including TEER and at TCT the ENCIRCLE study demonstrated meaningful early benefits for these patients, on all important measures like mortality, quality of life and reinforce the growth potential of this therapy in the years ahead.

    轉向二尖瓣置換術。我們知道,目前有許多患者無法透過現有技術進行治療,包括TEER。在TCT,ENCIRCLE研究證明,這些患者在死亡率、生活品質等所有重要指標上都獲得了顯著的早期獲益,並鞏固了該療法在未來幾年內的成長潛力。

  • The introduction of SAPIEN M3 marks the beginning of increased physician awareness and referrals to the heart team to support treatment for this many patients in need. Over the past decade, we built a comprehensive portfolio of TMTT technologies.

    SAPIEN M3 的推出標誌著醫生開始更加重視並轉介至心臟團隊,以支持眾多需要治療的患者。在過去十年間,我們建構了全面的 TMTT 技術組合。

  • These ensure physicians have an opportunity to select the optimal treatment for their mitral and tricuspid patients, whether replacement or TEER, this is creating compounding value across the care continuum for all stakeholders, especially patients.

    這些措施確保醫生有機會為他們的二尖瓣和三尖瓣患者選擇最佳治療方案,無論是置換還是經皮內鏡下瓣膜置換術(TEER),這為所有利益相關者,特別是患者,在整個護理過程中創造了複合價值。

  • And in terms of the impact to Edwards, while the contribution to growth from our portfolio of repair and replacement therapy could vary by quarter or year, we know PASCAL, EVOQUE and M3 will be key contributors as TMTT grows to an estimated $2 billion by 2030.

    就對 Edwards 的影響而言,雖然我們修復和替代療法產品組合對成長的貢獻可能因季度或年份而異,但我們知道,隨著 TMTT 到 2030 年增長到預計的 20 億美元,PASCAL、EVOQUE 和 M3 將成為關鍵貢獻者。

  • I am proud of the Edwards team and our physician partners for advancing each of these important clinical trials. Edwards is the world's only company to provide physicians with a complete portfolio of therapies addressing aortic, mitral, pulmonic and tricuspid valve diseases, built on the foundation of our unique strategy and an unprecedented body of evidence.

    我為愛德華茲團隊和我們的醫生合作夥伴感到自豪,他們推進了每項重要的臨床試驗。Edwards 是世界上唯一一家能夠為醫生提供針對主動脈瓣、二尖瓣、肺動脈瓣和三尖瓣疾病的完整治療方案的公司,這得益於我們獨特的策略和前所未有的證據體系。

  • Leveraging our 65 years of deep expertise, we are also extending into heart failure and aortic regurgitation which are next-generation contributors to patient impact and growth. We have aligned our internal resources to support growth across these multiple therapeutic areas. This focus on structural heart has positioned the company for agile execution of our strategy and provide a foundation for sustainable multiyear growth.

    憑藉我們 65 年的深厚專業知識,我們還將業務拓展到心臟衰竭和主動脈瓣逆流領域,這些都是對患者產生影響和促進發展的下一代因素。我們已調配內部資源,以支持這些多個治療領域的成長。這種對結構性心臟的關注,使公司能夠靈活地執行我們的策略,並為多年可持續成長奠定基礎。

  • When I reflect on all of this, I am proud of our impact when Edwards leads, everyone benefits, physicians, providers, payers and most importantly, patients who can enjoy restored quality of life and live longer.

    回顧這一切,我為愛德華茲領導下所取得的成就感到自豪,每個人都從中受益,包括醫生、醫療服務提供者、支付方,最重要的是,患者可以享受恢復的生活品質並活得更久。

  • Now I'd like to provide an overview of the third quarter sales performance by product group. In TAVR, our third quarter global sales of $1.15 billion increase 10.6% over the prior year. TAVR growth in the quarter was better than expected as clinicians demonstrated a renewed focus on prioritizing treatment for patients suffering from aortic stenosis.

    現在我想按產品組概述一下第三季的銷售業績。在經導管主動脈瓣置換術 (TAVR) 方面,我們第三季的全球銷售額為 11.5 億美元,比去年同期成長 10.6%。本季TAVR的成長優於預期,因為臨床醫師重新重視優先治療患有主動脈瓣狹窄的患者。

  • During the quarter, sales growth increased in multiple regions. Supported by new evidence, guideline updates and expanded education. Growth was comparable in the US and OUS. On a global basis, Edwards' pricing and competitive position remain largely stable.

    本季度,多個地區的銷售額均有所成長。以新的證據、指南更新和擴大的教育為支持。美國和美國境外的成長情況相當。從全球範圍來看,愛德華茲的定價和競爭地位基本上保持穩定。

  • We are pleased that aortic stenosis management is experiencing significant transformation. Supported by the combination of evidence of superiority in low-risk patients in one-year, unprecedented data and long-term value performance and durability, expanded asymptomatic indication, and updated ESC/EACTS guidelines, combined with the global expert consensus publication.

    我們很高興看到主動脈瓣狹窄的治療正在發生重大變革。一年內低風險患者療效優於其他療法的證據、前所未有的數據、長期價值表現和持久性、擴大的無症狀適應症、更新的 ESC/EACTS 指南,以及全球專家共識出版物,共同支持了這一結論。

  • These guidelines for valvular heart disease establish a simplified care pathway for severe AS patients and enable a proactive approach to disease management. They underscore that timely intervention should be considered for all severe aortic stenosis patients regardless of symptoms and heart function, which is a meaningful step forward from the prior practice of watchful waiting.

    這些瓣膜性心臟病指南為重度主動脈瓣狹窄患者建立了一條簡化的照護路徑,並實現了對疾病管理的積極主動性。他們強調,對於所有重度主動脈瓣狹窄患者,無論其症狀和心臟功能如何,都應考慮及時幹預,這比以前採取的觀察等待做法向前邁出了重要一步。

  • In the US, strong third quarter procedure growth was driven by a continued focus within the clinical community on the importance of timely intervention and streamlining the management of patients with severe AS.

    在美國,第三季手術量強勁成長,這得益於臨床界持續關注及時介入的重要性以及簡化重度 AS 患者的管理。

  • We were encouraged by the release of the updated American Society of Echocardiography guidelines which categorize severe AS, as a critical finding that should be communicated with urgency and encourage echocardiologists to actively participate in patient management.

    我們對美國超音波心臟檢查學會更新的指南的發布感到鼓舞,該指南將嚴重主動脈瓣狹窄列為一項關鍵發現,應緊急傳達,並鼓勵超音波心動圖專家積極參與患者管理。

  • The evolution of policy and guideline changes together with the potential of a new US NCD will provide important catalysts, resulting in a multiyear growth opportunity for US TAVR. Outside of the US, we continue to focus on increasing therapy adoption. Especially in areas where many patients go without care.

    政策和指南的變化以及美國出現新的非傳染性疾病的可能性,將提供重要的催化劑,從而為美國經導管主動脈瓣置換術 (TAVR) 帶來多年的成長機會。在美國以外,我們持續致力於提高治療普及率。尤其是在許多病人得不到治療的地區。

  • In Europe, Edwards sales growth was driven by the broad-based adoption of our SAPIEN platform in addition to the exit of a competitor, which resulted in a rebalancing of the market and a modest contribution to our sales. In Japan, TAVR sales growth continued to improve, reflecting a gradual recovery in market growth. Rest of the World, growth remains strong.

    在歐洲,愛德華茲的銷售成長得益於我們 SAPIEN 平台的廣泛採用,以及競爭對手的退出,這導致市場重新平衡,並對我們的銷售額做出了適度貢獻。在日本,TAVR 銷售成長持續改善,反映出市場成長的逐步復甦。世界其他地區,成長依然強勁。

  • In summary, due to our strong Q3 results, we are raising our full year TAVR guidance to 7% to 8% from our previous 6% to 7% range. Longer term, we continue to expect mid- to high single-digit growth in TAVR, supported by proven long-term evidence, new indication, further guideline and policy changes and finally, the potential to serve patients with moderate AS.

    總而言之,由於我們第三季業績強勁,我們將全年 TAVR 預期成長率從先前的 6% 至 7% 上調至 7% 至 8%。從長遠來看,我們繼續預期 TAVR 將保持中高個位數成長,這得益於已證實的長期證據、新的適應症、進一步的指南和政策變化,以及最終為中度 AS 患者提供服務的潛力。

  • Now let's turn to our TMTT product group. Our differentiated PASCAL mitral and tricuspid repair system and our unique replacement portfolio of EVOQUE and SAPIEN M3 delivered another strong quarter of growth. Third quarter sales of $144 million increased 53% year-over-year, fueled by the strong performance of both PASCAL and EVOQUE. Globally, we observed a continued trajectory of double-digit global procedure growth for mitral and significantly higher growth for tricuspid.

    現在讓我們來看看我們的 TMTT 產品組。我們差異化的 PASCAL 二尖瓣和三尖瓣修復系統以及我們獨特的 EVOQUE 和 SAPIEN M3 置換產品組合,又實現了強勁的季度成長。第三季銷售額達 1.44 億美元,年成長 53%,主要得益於 PASCAL 和 EVOQUE 的強勁表​​現。在全球範圍內,我們觀察到二尖瓣手術量持續維持兩位數成長,而三尖瓣手術量的成長則更為顯著。

  • The new ESC/EACTS guidelines released in the third quarter also included updates related to the management of patients with mitral and tricuspid diseases which further supports increased global use of transcatheter therapies for these patients.

    第三季發布的新的 ESC/EACTS 指南還包括與二尖瓣和三尖瓣疾病患者管理相關的更新,這進一步支持在全球範圍內增加對這些患者的經導管治療。

  • Continued global adoption of PASCAL and EVOQUE in new and existing centers fueled additional substantial growth. We've upsell physician excitement and support of a differentiation of PASCAL and the strong predictable outcome of EVOQUE, including consistent tricuspid regurgitation elimination.

    PASCAL 和 EVOQUE 在全球範圍內的新舊中心持續被採用,推動了進一步的顯著成長。我們提升了醫生對 PASCAL 的差異化優勢和 EVOQUE 的強有力可預測結果(包括持續消除三尖瓣逆流)的興奮和支持。

  • Over the last quarter, we released several new groundbreaking clinical evidence updates presented at the ESC Congress pricing to outcomes now show a hard endpoint benefit of EVOQUE versus optimal medical therapy. The data show that the most severe TR patients experienced a combined reduction in mortality and heart failure hospitalization, which is a meaningful advancement.

    在過去的一個季度裡,我們發布了幾項新的突破性臨床證據更新,並在 ESC 大會上進行了展示。這些更新顯示,EVOQUE 相對於最佳藥物治療具有明確的終點效益。數據顯示,病情最嚴重的 TR 患者的死亡率和心臟衰竭住院率均下降,這是一個意義重大的進步。

  • In addition, as previously mentioned, at TCT, we were pleased to share the largest real-world data set of EVOQUE early commercial experience from the STS, ACC, TVT Registry. The data showed excellent outcome with consistent elimination of TR and a positive safety profile.

    此外,如同先前所提到的,在 TCT 大會上,我們很高興分享了來自 STS、ACC、TVT 註冊中心的 EVOQUE 早期商業經驗的最大真實世界資料集。數據顯示,此方法取得了優異的療效,能夠持續消除TR,且安全性良好。

  • We also presented additional TRISCEND I and TRISCEND II sub analysis TCT. And the totality of this new evidence strengthen confidence in tricuspid replacement therapy with EVOQUE and the impact it can have on this greatly underserved patient population.

    我們也展示了 TRISCEND I 和 TRISCEND II 的附加子分析 TCT。所有這些新證據都增強了人們對使用 EVOQUE 進行三尖瓣置換療法的信心,以及該療法對這一嚴重缺乏服務的患者群體所能產生的影響。

  • Moving to SAPIEN 3, M3, our early introduction in Europe is off to a great start, providing exceptional clinical outcome to patient in need and supported by our dedicated field team. The one-year results from the ENCIRCLE pivotal trial, studying SAPIEN M3 showed excellent outcome for this first approved transseptal mitral valves.

    過渡到 SAPIEN 3、M3,我們在歐洲的早期引入取得了良好的開端,為有需要的患者提供了卓越的臨床效果,並得到了我們敬業的現場團隊的支持。ENCIRCLE 關鍵性試驗的一年結果顯示,SAPIEN M3 作為首個核准的經隔二尖瓣,取得了優異的療效。

  • The data showed that in critically sick group of patients who were unsuitable for TEER and surgery now had an option to eliminate their MR, while drastically improving their quality of life with a high survival rate. We now expect U.S. approval by early 2026.

    數據顯示,對於不適合進行TEER和手術的重症病人群體,現在他們可以選擇消除二尖瓣逆流,同時大幅提高生活質量,並且存活率很高。我們現在預計美國將在 2026 年初批准該項目。

  • In closing with PASCAL, EVOQUE and our SAPIEN M3, we are advancing our vision to meet the complex needs of underserved patients with mitral and tricuspid disease, with a differentiated portfolio comprised of repair and replacement technology. We are pleased with our year-to-date performance in TMTT and remain on track to achieve our full year sales guidance of $530 million to $550 million.

    最後,憑藉 PASCAL、EVOQUE 和我們的 SAPIEN M3,我們正在推進我們的願景,以滿足患有二尖瓣和三尖瓣疾病的弱勢患者的複雜需求,我們擁有差異化的產品組合,包括修復和置換技術。我們對TMTT今年迄今的業績感到滿意,並有望實現全年5.3億美元至5.5億美元的銷售目標。

  • In our Surgical product group, third quarter global sales of $258 million increased 5.6% over the prior year. Growth was driven by continued adoption of our RESILIA therapy in addition to positive procedure growth for the many patients best treated surgically.

    在我們的外科產品集團中,第三季全球銷售額為 2.58 億美元,比去年同期成長 5.6%。成長的驅動力來自於 RESILIA 療法的持續推廣,以及許多最適合接受手術治療的患者的手術量積極增長。

  • Our RESILIA portfolio achieved double-digit growth with contribution from INSPIRIS, KONECT and MITRIS therapies. We continue to generate dividends on the RESILIA portfolio and expand access globally. We see market approval for KONECT in Europe, at the end of the second quarter, we have been able to expand this therapy to patients across European countries during the third quarter.

    在 INSPIRIS、KONECT 和 MITRIS 療法的貢獻下,我們的 RESILIA 產品組合實現了兩位數的成長。我們持續從 RESILIA 投資組合中獲得收益,並擴大全球市場覆蓋範圍。我們看到 KONECT 在歐洲獲得了市場批准,在第二季末,我們能夠在第三季將這種療法推廣到歐洲各國的患者。

  • I think it is also important to highlight the strong Edwards surgical valve performance in the recent PARTNER III seven-year data. The majority of patients in the control arm were treated with Edwards' surgical virus and the results were comparable to TAVR at seven years. This performance reflects over 65 years of valve leadership and innovation.

    我認為同樣重要的是要強調愛德華茲外科瓣膜在最近的 PARTNER III 七年數據中的出色表現。對照組的大多數患者接受了 Edwards 的外科病毒治療,七年後的結果與 TAVR 相當。這項業績反映了該公司65多年來在閥門領域的領先地位和創新精神。

  • In summary, we continue to expect that our full year 2025 surgical global sales will be in the mid-single digits, driven by RESILIA portfolio adoption across our key markets and growth in heart valve procedures for patients best treated surgically.

    總而言之,我們仍然預計,在主要市場對 RESILIA 產品組合的採用以及最適合接受手術治療的心臟瓣膜手術患者數量增長的推動下,我們 2025 年全年的全球外科手術銷售額將達到中等個位數增長。

  • And now Scott will cover the details of the company financial performance.

    接下來,斯科特將詳細介紹公司的財務表現。

  • Scott Ullem - Chief Financial Officer, Corporate Vice President

    Scott Ullem - Chief Financial Officer, Corporate Vice President

  • Thanks a lot, Bernard. As Bernard mentioned, we are encouraged with our stronger-than-expected third quarter performance and the progress we made during the quarter, advancing our strategic initiatives. Our double-digit sales growth drove adjusted earnings per share of $0.67, well above our expectations, driven by both stronger-than-expected top line performance and certain spending delayed to Q4.

    非常感謝,伯納德。正如伯納德所提到的,我們對第三季度超出預期的業績以及本季度取得的進展感到鼓舞,我們在推進戰略舉措方面取得了顯著成效。兩位數的銷售成長推動調整後每股收益達到 0.67 美元,遠超預期,這主要得益於比預期更強的營收表現以及某些支出推遲到第四季度。

  • Our GAAP earnings per share for the quarter was $0.50. A full reconciliation between our GAAP and adjusted EPS for this and other items is included with today's release. I'll now cover additional details of our P&L. For the third quarter, our adjusted gross profit margin was 77.9%, in line with our expectations compared to 80.7% in the same period last year.

    本季我們以美國通用會計準則計算的每股收益為0.50美元。今天的新聞稿中包含了我們按美國通用會計準則計算的每股收益與調整後每股收益之間關於此項及其他項目的完整調節表。接下來我將詳細介紹我們的損益表。第三季度,我們調整後的毛利率為 77.9%,與預期相符,去年同期為 80.7%。

  • This year-over-year change was primarily driven by foreign exchange and operational expenses. We continue to expect our full year 2025 adjusted gross profit margin to be within our original guidance range of 78% and 79%. Our guidance continues to assume some pressure from the weakening dollar.

    這一同比變化主要受外匯和營運費用的影響。我們仍預期 2025 年全年調整後的毛利率將維持在 78% 至 79% 的原預期範圍內。我們的預期仍然假設美元走軟會帶來一定壓力。

  • Selling, general and administrative expense in the third quarter was $515 million or 33.1% of sales compared to $420 million -- $421 million in the prior year. We continue to expect increased SG&A spending this period due to deferral of certain first half spending and investments expected in the fourth quarter to advance our strategy.

    第三季銷售、一般及行政費用為 5.15 億美元,佔銷售額的 33.1%,而上年同期為 4.2 億美元,而去年同期為 4.21 億美元。由於上半年部分支出延遲以及為推進我們的策略而預計在第四季度進行的投資,我們預計本期銷售、管理及行政費用將繼續增加。

  • R&D expense was $281 million in the third quarter or 18.1% of sales compared to $253 million or 18.7% of sales in the same period last year. This increase in spending and decrease in R&D as a percentage of sales reflects our intentional strategic prioritization of investments in our expanding structural heart portfolio.

    第三季研發費用為 2.81 億美元,佔銷售額的 18.1%,去年同期為 2.53 億美元,佔銷售額的 18.7%。支出增加而研發投入佔銷售額的比例下降,反映了我們有意將投資重點放在不斷擴大的結構性心臟病產品組合上的策略性優先策略。

  • Third quarter adjusted operating profit margin of 27.5% benefited from our better-than-expected sales performance and the deferral of certain spending to the fourth quarter. As mentioned on our Q1 and Q2 earnings calls, we continue to expect lower second half operating margin levels compared to the first half driven by the timing of key investments.

    第三季調整後營業利潤率為 27.5%,這得益於我們好於預期的銷售業績以及將某些支出推遲到第四季度。正如我們在第一季和第二季財報電話會議上提到的那樣,由於關鍵投資的時間安排,我們仍然預計下半年的營業利潤率將低於上半年。

  • We continue to anticipate full year 2025 operating margin of 27% to 28%, implying a Q4 operating margin in the mid-20s, consistent with prior guidance. We remain committed to annual constant currency operating profit margin expansion over the full year 2025 level in 2026 and beyond consistent with our guidance at last year's investor conference.

    我們繼續預期 2025 年全年營業利潤率為 27% 至 28%,這意味著第四季度營業利潤率在 20% 左右,與先前的預期一致。我們仍致力於在 2026 年及以後實現年度固定匯率營業利潤率的成長,高於 2025 年全年水平,這與我們在去年投資者大會上的指導意見一致。

  • Turning to taxes. Our reported tax rate this quarter was 16.1% or 16.9%, excluding the impact of special items, in line with our expectations for the quarter. We continue to expect our 2025 tax rate, excluding special items, to be between 15% and 18%.

    接下來談談稅務問題。本季我們報告的稅率為 16.1%,若不計特殊項目的影響,則為 16.9%,與我們對本季的預期一致。我們仍然預計,2025 年的稅率(不包括特殊項目)將在 15% 到 18% 之間。

  • Turning to the balance sheet. We continue to maintain a strong and flexible balance sheet with approximately $3 billion in cash and cash equivalents as of the end of the quarter. The Board of Directors has increased the company's repurchase authorization, resulting in approximately $2 billion remaining under the current authorization. Average diluted shares outstanding during the quarter were 586 million.

    接下來看一下資產負債表。截至本季末,我們持續保持穩健且靈活的資產負債表,擁有約 30 億美元的現金及現金等價物。董事會提高了該公司的股票回購授權額度,目前授權額度下還剩餘約 20 億美元。本季平均稀釋後流通股數為 5.86 億股。

  • Based on year-to-date share repurchases of over $800 million, including the previously announced accelerated share repurchase of $500 million, we now expect lower full year shares outstanding to be between 585 million to 590 million versus original guidance of 585 million to 595 million.

    根據今年迄今超過 8 億美元的股票回購額(包括先前宣布的 5 億美元加速股票回購計畫),我們現在預計全年流通股數將低於先前預期的 5.85 億至 5.9 億股。

  • Foreign exchange rates increased third quarter reported sales growth by 210 basis points or $24 million compared to the prior year. FX rates negatively impacted our third quarter gross profit margin by 110 basis points compared to the prior year. As a reminder, our program is designed to mitigate the foreign exchange impact on earnings per share compared to our initial guidance for the year.

    外匯匯率上漲導致第三季報告銷售額較上年同期成長 210 個基點,即 2,400 萬美元。與去年同期相比,匯率波動使我們第三季的毛利率下降了 110 個基點。再次提醒大家,我們的計畫旨在減輕外匯波動對每股盈餘的影響,使其低於我們年初的預期。

  • At current rates, we continue to expect FX to have an approximately $30 million upside to full year 2025 sales compared to the prior year. I'll finish with comments related to sales and earnings per share guidance. As Bernard mentioned, we are increasing our underlying growth rate guidance for TAVR to 7% to 8%, with sales of $4.4 billion to $4.5 billion and our total company sales growth guidance to now be at the high end of 9% to 10%.

    以目前的匯率計算,我們仍然預計 FX 到 2025 年全年銷售額將比上一年增長約 3000 萬美元。最後,我將就銷售額和每股盈餘預期發表一些看法。正如伯納德所提到的,我們將 TAVR 的基礎成長率預期提高到 7% 至 8%,銷售額為 44 億美元至 45 億美元,公司整體銷售成長預期目前為 9% 至 10% 的高端。

  • For the fourth quarter, we're projecting total company sales of $1.51 billion to $1.59 billion and adjusted earnings per share of $0.58 to $0.64, bridging to our full year earnings per share range of $2.56 and to $2.62. We're looking forward to providing more forward-looking commentary at our investor conference on December 4. We remain confident in delivering the long-term financial goals for the company and each business unit that we provided at last year's investor conference.

    我們預計第四季公司總銷售額為15.1億美元至15.9億美元,調整後每股收益為0.58美元至0.64美元,從而與全年每股收益預期2.56美元至2.62美元的目標相銜接。我們期待在12月4日的投資者會議上提供更多前瞻性分析。我們仍有信心實現公司及各業務部門在去年投資者大會上提出的長期財務目標。

  • And I do have one additional piece of personal news. After 12 years at Edwards, I'm going to be transitioning out of the CFO role by mid-2026. The company has initiated a process to select a successor. We have considered this transition and a CFO succession plan carefully, and I'm confident we'll have a smooth transition. I look forward to serving as a strategic adviser to Edwards after a new CFO is in place.

    我還有一件私事要告訴大家。在 Edwards 工作 12 年後,我將於 2026 年年中卸任財務長一職。本公司已啟動遴選繼任者的程序。我們已經認真考慮了這次過渡和財務長繼任計劃,我相信我們會順利過渡。我期待在新任財務長到任後,擔任愛德華茲的策略顧問。

  • And now is a good time to pass the baton. The company is in a strong strategic and financial position, and I have confidence that Edwards will continue to perform at a high level in the years ahead. I care deeply about Edwards and know what a special company it is, and it has been an honor and a privilege to serve as CFO for almost half of the company's history as a publicly traded company, and I'm committed to a smooth transition next year.

    現在正是交接棒的好時機。該公司擁有強大的策略和財務實力,我相信愛德華茲在未來幾年將繼續保持高水準的業績。我非常關心 Edwards 公司,也知道它是多麼特別的公司。能夠擔任公司近一半上市歷史的財務官,我深感榮幸。我致力於明年順利完成過渡。

  • So with that, back to you, Bernard.

    那麼,現在把鏡頭交還給伯納德。

  • Bernard Zovighian - Chief Executive Officer, Director

    Bernard Zovighian - Chief Executive Officer, Director

  • Thank you, Scott. You have been a valued and key partner to me for over 10 years. first, as colleagues on the executive leadership team through the CEO transition two years ago. And now in this last 2.5 years since I became CEO.

    謝謝你,斯科特。十多年來,您一直是我的重要夥伴。首先,兩年前,我們作為執行領導團隊的同事,共同經歷了執行長的過渡。而現在,自從我擔任執行長以來,已經過了兩年半的時間。

  • We have worked closely to find the right time for you personally and also for Edwards for the CFO transition and why we will be saving you in your current role, I am pleased that you will continue in the CFO role until the transition occurs by mid-2026, and remain at Edwards as a strategic adviser beyond the transition period.

    我們密切合作,為您個人以及 Edwards 公司尋找合適的財務長過渡時機,並解釋了為什麼我們將保留您目前的職位。我很高興您將繼續擔任財務長一職,直到 2026 年年中完成過渡,並在過渡期後繼續留在 Edwards 公司擔任策略顧問。

  • So I am confident that we will have a smooth hand off during this transition, and we are initiating a process to identify the successor. In closing, after more than 20 years of innovation that has benefited more than 1 million patient lives. And this week's seven-year PARTNER III results. Edwards TAVR is positioned for strong sustainable growth as many patients remain undiagnosed and untreated.

    因此,我相信我們能夠順利完成交接,並且我們正在啟動尋找繼任者的流程。最後,經過 20 多年的創新,已經使超過 100 萬名患者受益。本周公布七年期 PARTNER III 業績。由於許多患者仍未得到診斷和治療,Edwards TAVR有望實現強勁的永續成長。

  • Moreover, we are achieving many significant milestone in TMTT that give us confidence about treating the many mitral and tricuspid patients in need. And surgical is positioned for durable long-term growth, driven by a portfolio of differentiated technology.

    此外,我們在 TMTT 方面取得了許多重要的里程碑,這讓我們有信心治療眾多需要治療的二尖瓣和三尖瓣患者。外科手術業務憑藉一系列差異化技術,有望實現持久的長期成長。

  • In addition, we are leveraging our structural heart expertise and extending into heart failure and AR, which are next generation contributors to patient impact. Altogether, we are convinced of a tremendous opportunity to drive success in the future through our patient focus, breakthrough technologies and leadership.

    此外,我們正在利用我們在結構性心臟病方面的專業知識,並將研究範圍擴展到心臟衰竭和主動脈瓣逆流,這些都是對患者產生影響的下一代因素。總而言之,我們堅信,透過以患者為中心、突破性技術和領導地位,我們將在未來取得巨大的成功。

  • With that, back to you, Mark.

    那麼,馬克,把鏡頭交還給你。

  • Mark Wilterding - Senior Vice President, Investor Relations and Treasurer

    Mark Wilterding - Senior Vice President, Investor Relations and Treasurer

  • Thank you very much, Bernard. Before we open it up for questions, I'd like to remind you about our 2025 investor conference on Thursday, December 4 at our headquarters here in Irvine. This event will include updates on our latest technologies, views on the longer-term market potential, as well as our outlook for 2026. More information and a registration form are available on our website.

    非常感謝你,伯納德。在正式開始提問環節之前,我想提醒大家,我們將於 12 月 4 日星期四在我們位於爾灣的總部舉行 2025 年投資者大會。本次活動將介紹我們最新的技術進展、對長期市場潛力的看法,以及我們對 2026 年的展望。更多資訊和註冊表格可在我們的網站上找到。

  • With that, we're ready to take your questions.

    那麼,我們就可以回答你們的問題了。

  • (Event Instructions) Diego, over to you.

    (活動說明)迭戈,輪到你了。

  • Operator

    Operator

  • (Operator Instructions)

    (操作說明)

  • Travis Steed, Bank of America.

    特拉維斯·斯蒂德,美國銀行。

  • Travis Steed - Analyst

    Travis Steed - Analyst

  • Hey, congrats on a good quarter. Maybe to start with the TAVR growth in this quarter, the 10.6%. It sounded like just a modest contribution from the Boston exit. So if you can just maybe talk about some of your underlying trends and what was the strength this quarter? And is this kind of full year TAVR 7% to 8%, and if you exclude the Boston exit, is that kind of the right way to think about sustainable TAVR growth kind of longer term?

    嘿,恭喜你本季業績出色。或許可以從本季的 TAVR 成長率說起,為 10.6%。聽起來像是波士頓出口公司做出的微不足道的貢獻。所以,您能否談談貴公司的一些潛在趨勢,以及本季有哪些優勢?如果排除波士頓退出市場的情況,那麼全年TAVR手術量是否能達到7%到8%?從長遠來看,這種想法是否正確,即TAVR手術量能否達到永續成長?

  • Bernard Zovighian - Chief Executive Officer, Director

    Bernard Zovighian - Chief Executive Officer, Director

  • No. Thanks, Travis. Yes, we are very pleased about the quarter. We had a strong quarter, better than expected. There are a number of things that contributed to this great performance in Q3.

    不。謝謝你,崔維斯。是的,我們對本季的業績非常滿意。本季業績表現強勁,超乎預期。第三季取得如此優異的業績,有許多因素促成了這個結果。

  • The first one is we didn't have so much evidence, so much news on TAVR and SAPIEN for a long time. Remember, the early TAVR, then you know the ESC guidelines on asymptomatic patients, the global consensus document and then all of them at each congresses, physicians, we are talking about it presenting a sub-analysis. So this created a halo where TAVR now is at the center of a conversation for most of the heart team in the US, but also outside of the US. So that's clearly a big catalyst.

    首先,很長一段時間以來,我們沒有那麼多關於TAVR和SAPIEN的證據和新聞。記住,早期的TAVR,然後你了解ESC關於無症狀患者的指南,全球共識文件,然後在每次大會上,醫生們都在談論它,並進行亞組分析。因此,TAVR 現在成為美國大多數心臟團隊討論的焦點,在美國以外也是如此。所以這顯然是一個重要的催化劑。

  • Also, what we didn't experience that usually we experienced during Q3 the summer usually the summer seasonality usually is very pronounced. And this year, we didn't experience it. So we had a higher Q3 and we have a lower impact from the summer seasonality. So all of that together basically contributed to the great quarter. We -- if you ask us about Q4 and the rest, we will talk about next year maybe late year.

    此外,我們在第三季沒有經歷通常在夏季會經歷的情況,夏季的季節性通常非常明顯。而今年,我們卻沒有經歷這一切。因此,我們第三季業績較高,受夏季季節性因素的影響較小。所以所有這些因素加在一起,基本上促成了本季的出色表現。如果您問我們關於第四季度及以後的情況,我們可能會在明年晚些時候再談。

  • But for Q4 -- we expect a good Q4, better than we originally thought, but I will not take the Q3 results as the new normal for TAVR.

    但對於第四季——我們預計第四季會不錯,比我們最初預想的要好,但我不會將第三季的結果視為TAVR的新常態。

  • Travis Steed - Analyst

    Travis Steed - Analyst

  • Great. That's helpful. And then since we were just at TCT a couple of days ago and you had a seven-year and 10-year data there, maybe just talk about now that you've had a few days to talk to doctors kind of what you're hearing from customers and the physician community and kind of the importance of that data and how it could or might not change practice.

    偉大的。那很有幫助。既然我們幾天前剛參加過 TCT 大會,而且您當時也展示了七年和十年的數據,那麼現在您已經有幾天時間與醫生們交流,能否談談您從客戶和醫生群體那裡聽到了什麼,以及這些數據的重要性,以及這些數據可能會如何改變(或不會如何改變)醫療實踐。

  • Bernard Zovighian - Chief Executive Officer, Director

    Bernard Zovighian - Chief Executive Officer, Director

  • Yeah. So maybe I ask, Dan, our new leader of the TAVR franchise, he was at TCT. He talked to so many customers. He was the architect behind all of the symposium that you attended. So maybe I asked Dan to comment on that.

    是的。所以,我或許可以問問丹,我們TAVR特許經營權的新領導人,他之前在TCT工作過。他跟很多顧客都聊過。你參加的所有研討會都是他一手策劃的。所以,我可能請丹就此發表一下看法。

  • Daniel Lippis - Corporate Vice President - JAPAC (Japan, Greater China and Asia Pacific)

    Daniel Lippis - Corporate Vice President - JAPAC (Japan, Greater China and Asia Pacific)

  • Yeah, Travis. Thanks for the question. Obviously, important meeting for us and more importantly, very, very important data that was presented there answering probably the last of the unanswered questions on TAVR, which is what are these TAVR valves look like at the critical window of vulnerability, which is this five- to seven-year period. And it's nice, it's reassuring to be able to now answer that definitively, at least with the SAPIEN 3 platform. And as you can imagine, physicians were very, very positive.

    是的,特拉維斯。謝謝你的提問。顯然,這對我們來說是一次重要的會議,更重要的是,會上提出的數據非常非常重要,可能解答了關於 TAVR 的最後一個未解之謎,那就是 TAVR 瓣膜在關鍵脆弱期(即五到七年期間)是什麼樣子。現在至少借助 SAPIEN 3 平台,我們可以明確地回答這個問題,這令人欣慰,也讓人感到安心。正如你所想,醫生們對此非常非常樂觀。

  • Obviously, the conversations kind of sort of stand with like it's a shame that a lot of people were maybe betting against, it was no surprise to me. Congratulations. And I think overall, everyone is super positive. I think it gives physicians and patients just again, reassurance to treat earlier in the disease progression pathway and maybe younger, and that's the direction of TAVR that we see.

    顯然,大家的討論似乎都在說,很多人可能都在押注失敗,這很可惜,這對我來說並不意外。恭喜。我覺得整體來說,大家都非常樂觀。我認為這再次讓醫生和患者放心,可以在疾病進展早期甚至更年輕的時候進行治療,而這正是我們看到的 TAVR 的發展方向。

  • Also, with the guideline evolution, et cetera, that's the way that it's going. We now see clinical benefit for treating earlier in the disease pathway. But also new evidence that's come out, Bernard mentioned so much new data coming out just consistently over the last 12 months, but a lot of new evidence to suggest that there's economic consequence if you treat later in the process. And all this is driving just a renewed focus both domestically and internationally on TAVR programs. So that's probably the best way to sum up TCT.

    此外,隨著指南的演變等等,事情的發展方向就是這樣。我們現在看到,在疾病早期階段進行治療具有臨床益處。但也有新的證據出現,伯納德提到,在過去的 12 個月裡,不斷湧現大量新數據,許多新證據表明,如果在治療後期進行治療,將會產生經濟後果。所有這些都促使國內外重新關注經導管主動脈瓣置換術(TAVR)計畫。所以,這大概是對 TCT 最好的總結了。

  • Travis Steed - Analyst

    Travis Steed - Analyst

  • That's really helpful. Thanks a lot and congrats on a good quarter.

    這真的很有幫助。非常感謝,也恭喜你們本季業績優異。

  • Operator

    Operator

  • Larry Biegelsen, Wells Fargo.

    拉里·比格爾森,富國銀行。

  • Larry Biegelsen - Analyst

    Larry Biegelsen - Analyst

  • Good afternoon. Thanks for taking the question. And Scott, congratulations on all the success at Edwards, I know you'll be around for a couple more quarters, but I enjoyed working with you and we'll miss working with you when you leave.

    午安.感謝您回答這個問題。史考特,恭喜你在愛德華茲公司取得的所有成功,我知道你還會再待幾個季度,但我很享受與你共事的時光,你離開後我們會想念你的。

  • So for my question, Bernard, it sounds like you're comfortable with the 10% plus organic growth and 50 to 100 basis points margin expansion next year. What's giving you the confidence this early and Scott, as of today, would FX positively or negatively impact margins next year? And I had 1 follow-up.

    所以,伯納德,我的問題聽起來你對明年10%以上的有機成長和50到100個基點的利潤率擴張感到滿意。是什麼讓你這麼早就充滿信心?史考特,截至目前,你認為匯率波動會對明年的利潤率產生正面還是負面影響?我還有 1 次後續跟進。

  • Bernard Zovighian - Chief Executive Officer, Director

    Bernard Zovighian - Chief Executive Officer, Director

  • Yes, no, thanks, Larry. To be fair, when I look back, we always -- that I always had confidence. And let me give you a context on why I am seeing that. We have been studying this platform, SAPIEN for 20 years. We have been iterating this platform for 20 years. We know what this platform is delivering for patients, more than 1 million patients receive in this platform.

    好的,不用了,謝謝,拉里。公平地說,當我回顧過去時,我們一直——我一直都很有信心。讓我解釋一下我為什麼會看到這種情況。我們已經研究 SAPIEN 這個平台 20 年了。我們已經對這個平台進行了20年的迭代開發。我們知道這個平台為患者帶來了什麼,超過 100 萬名患者透過這個平台獲得了服務。

  • So when we gave you the guidance last year about TAVR for the foreseeable future, basically mid- to high single digit. And the company, on average, 10% with leverage EPS, we knew that. And when I say that, we knew that because all what we do is rational, is science-based, you don't have surprises. So it's like the seven years maybe was a surprise to some, but for us, it was a confirmation about what we knew here. So no change to the guidance we gave you last year in December, Larry.

    所以,去年我們向大家提供了關於 TAVR 在可預見的未來價格的指導意見,基本上就是中高個位數。我們知道,該公司平均槓桿率達到 10% 的每股盈餘。我說這話的時候,我們知道,因為我們所做的一切都是理性的,都是以科學為基礎的,所以不會有任何意外發生。所以,這七年或許對某些人來說是個驚喜,但對我們來說,這證實了我們在這裡所知道的一切。所以,拉里,我們去年12月給你的指導意見沒有改變。

  • Scott Ullem - Chief Financial Officer, Corporate Vice President

    Scott Ullem - Chief Financial Officer, Corporate Vice President

  • Yeah, Larry, I'll just add to that. First of all, thanks for nice comments, appreciate it. Just to reiterate what Bernard said, last year, we said on average, 10% over the year's constant currency. And we think that 10% growth on the top line for Edwards in 2026, will be within the range that we provided at the investor conference.

    是的,拉里,我再補充一點。首先,感謝大家的好評,非常感謝。正如伯納德所說,去年我們表示,平均而言,比當年的固定匯率高出 10%。我們認為,Edwards 公司 2026 年營收成長 10% 的目標,將符合我們在投資者大會上給出的預期範圍。

  • But remember, now with the third quarter results and the momentum that we see in the business going into the end of the year, we now have a higher bar that we'd need to clear when we're calculating that year-over-year growth rate.

    但請記住,隨著第三季業績的公佈以及我們看到的業務在年底前的發展勢頭,我們在計算同比增速時,需要達到更高的標準。

  • As it relates to your question on FX, I thought you might ask the question, we're just going to have to hold off for five weeks until we get to December 4. We're still running all the numbers, and we'll take you through when we take you through our guidance, we'll take you through the impact of FX on guidance.

    至於你提出的外匯問題,我想你可能會問,我們只能等到 12 月 4 日,也就是五週後才能知道答案。我們仍在進行各項數據分析,稍後會向您詳細介紹我們的指導意見,以及外匯波動對指導意見的影響。

  • Larry Biegelsen - Analyst

    Larry Biegelsen - Analyst

  • All right. Fair enough. And just for my follow-up, Bernard, as you approach the scheduled trial for the JenaValve deal, what's your level of confidence you could overturn the FTC block? And just remind us of where SAPIEN X4 stands and when we'll see the pivotal data. Thank you.

    好的。很公平。伯納德,我還有一個後續問題,隨著 JenaValve 交易案的預定審判日期臨近,你對推翻聯邦貿易委員會的禁令有多大信心?請提醒我們 SAPIEN X4 目前進展如何,以及何時能看到關鍵數據。謝謝。

  • Bernard Zovighian - Chief Executive Officer, Director

    Bernard Zovighian - Chief Executive Officer, Director

  • These are important questions. So let me take the first one and maybe Dan take the second one. We continue to pursue this regulatory approval for JenaValve for a very simple reason. You know us. We have identified these large unmet needs.

    這些都是重要的問題。那我就先選第一個,第二個也許丹選。我們繼續爭取 JenaValve 獲得監管部門批准的原因很簡單。你們認識我們。我們已經確定了這些尚未被滿足的巨大需求。

  • These patients have no solutions. And we know that when we come into a space. We bring our leadership, our innovation power, our commitment. We make a big difference, patient benefits. So we believe here we have great facts.

    這些患者沒有解決辦法。我們知道,當我們進入一個空間時。我們帶來我們的領導力、創新能力和承諾。我們帶來了巨大的改變,患者從中受益。所以我們相信我們掌握了確鑿的事實。

  • At the same time, we will know in Q1. So before Q1, I can tell you, Larry. But I really hope that we are going -- we will have a favorable ruling at the end because, again, these patients are waiting.

    同時,我們將在第一季得知結果。所以,在第一季之前,我可以告訴你,拉里。但我真心希望我們能夠──最終能夠得到一個有利的判決,因為,再說一遍,這些病人都在等待。

  • Daniel Lippis - Corporate Vice President - JAPAC (Japan, Greater China and Asia Pacific)

    Daniel Lippis - Corporate Vice President - JAPAC (Japan, Greater China and Asia Pacific)

  • Thank you, Larry, hello, just regarding X4. First of all, very excited about our pipeline. X4 has the real potential to be a game changer in TAVR. And that trial, the ALLIANCE trial completed at the end of 2024. Right now, the patients are in follow-up phase, right?

    謝謝你,拉里,你好,我只是想問一下關於X4的問題。首先,我們對我們的產品線感到非常興奮。X4 有潛力成為 TAVR 領域的變革者。而那項試驗,即 ALLIANCE 試驗,已於 2024 年底完成。目前,這些患者正處於追蹤階段,對嗎?

  • And so until that the patients have gone through that period and the trial is complete and the data is analyzed, we don't have a whole lot more to say about X4.

    因此,在患者度過這段時期、試驗完成、數據分析完成之前,我們對 X4 沒有太多可說的。

  • Larry Biegelsen - Analyst

    Larry Biegelsen - Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • David Roman, Goldman Sachs.

    大衛羅曼,高盛集團。

  • David Roman - Analyst

    David Roman - Analyst

  • Thank you. Good afternoon, everyone, and Scott, I'll add my congratulations on moving on. I finally remember your first analyst meeting in 2013, I think Edwards was a small-cap growth stock at $4 billion. So I think you're certainly leaving the company in a good position, although we'll miss working with you.

    謝謝。大家下午好,史考特,我也要恭喜你晉級。我終於想起了你在 2013 年的第一次分析師會議,我記得 Edwards 當時是一家市值 40 億美元的小市值成長股公司。所以我認為當你離開公司時,公司情況一片大好,雖然我們會想念和你一起工作的日子。

  • Two questions for me. One, just starting on the TAVR side. When you look at the PREVUE-VALVE study that was presented at TCT and think about the early TAVR study in context, can you maybe just help us look forward and I know we're all focused on like indication expansion and asymptomatic patients.

    我有兩個問題。第一,剛開始做經導管主動脈瓣置換術(TAVR)。當您查看在 TCT 上展示的 PREVUE-VALVE 研究,並結合早期 TAVR 研究的背景進行思考時,您能否幫助我們展望未來?我知道我們都專注於適應症擴展和無症狀患者。

  • But to what extent is there an opportunity here to see broader diagnostic rates for AS increase that would not only trickle through to your TAVR business, but also be a tailwind to the surgical valve business as well?

    但是,在多大程度上,AS 的診斷率會提高,這不僅會惠及您的 TAVR 業務,還會對外科瓣膜業務產生正面影響?

  • Bernard Zovighian - Chief Executive Officer, Director

    Bernard Zovighian - Chief Executive Officer, Director

  • That's a good question. And we have not talked about it when we were at TCT together. So this study was an investigator-initiated study. And if you look at it in a big picture, it validates our assumption on the size of AS market potential, the number of patients, but also it is validating basically the incidence and prevalence of all valvular heart disease. So at the high level, it's positive.

    這是個好問題。我們一起在TCT的時候也沒有談論過這件事。所以這項研究是研究者發起的研究。從宏觀角度來看,這不僅驗證了我們對主動脈瓣狹窄市場潛力規模和患者數量的假設,而且也基本上驗證了所有瓣膜性心臟病的發生率和盛行率。所以從宏觀層面來看,這是正面的。

  • There is more to learn from, but we look at this one as a positive one for the next years to look at. Dan, do you want to add anything to that?

    還有很多值得我們學習的地方,但我們認為這是一個積極的信號,值得我們在未來幾年加以關注。丹,你還有什麼要補充的嗎?

  • Daniel Lippis - Corporate Vice President - JAPAC (Japan, Greater China and Asia Pacific)

    Daniel Lippis - Corporate Vice President - JAPAC (Japan, Greater China and Asia Pacific)

  • Yeah. David, I think a very, very important study and one that I anticipate is going to be referenced a lot, right? And it looks at the prevalence from a unique lens, right? Typically, when we try to establish incidence prevalence and market opportunity, it's coming starting from the basis point of who's actually got an echo.

    是的。大衛,我認為這是一項非常非常重要的研究,而且我預計它會被很多人引用,對吧?它以獨特的視角審視了這種現象的普遍性,對吧?通常,當我們試圖確定發病率、盛行率和市場機會時,都是從誰實際患有迴聲病這一基本點出發的。

  • And what this study was trying to do is to take a look at the prevalence, if you like, of the disease from a out of system population or nondiagnosed population. And so it kind of brings a completely different lens and a very novel way of doing it to help our understanding of the disease.

    這項研究的目的是檢視系統外人群或未確診人群中該疾病的盛行率。因此,它帶來了一種完全不同的視角和一種非常新穎的方式來幫助我們了解這種疾病。

  • As Bernard said, when you look at the data that we've had available from an aortic stenosis perspective, it kind of validates kind of some of the assumptions that we had maybe even suggesting that the disease is larger than what we thought. But it's pretty much in that ballpark.

    正如伯納德所說,從主動脈瓣狹窄的角度來看,它在某種程度上驗證了我們的一些假設,甚至可能表明這種疾病比我們想像的還要嚴重。但差不多就是那個範圍。

  • What I would say about what is the opportunity here. As you see, whether it's this evidence, whether it's early TAVR, whether it's the sub-analyses of early TAVR, whether it's the PARTNER III and the new standard now we have for TAVR with long-term durability, all of this is going to get disseminated.

    我想說的是,這裡蘊藏著怎樣的機會。正如你所看到的,無論是這項證據,還是早期的TAVR,還是早期TAVR的子分析,還是PARTNER III以及我們現在擁有的具有長期耐久性的TAVR新標準,所有這些都將得到傳播。

  • It's going to be part of an education process. It's going to be democratized in the community and it's going to lead to greater awareness and greater referral and greater adoption. And I think that that's part of our strategy, part of the plan, why we are investing so heavily.

    這將成為教育過程的一部分。它將在社區內普及,這將提高人們的意識,促進轉診和推廣。我認為這是我們策略的一部分,也是計劃的一部分,這就是我們投入如此巨資的原因。

  • And so confident about the impact, but it all helps. So thanks for the question.

    我對最終效果充滿信心,但所有的一切都會有所幫助。謝謝你的提問。

  • David Roman - Analyst

    David Roman - Analyst

  • And maybe on the TMTT side, I think you said M3 approval coming in early 2026. Can you maybe help us think through how to compare and contrast the M3 launch with EVOQUE? And I think Dr. Sharma at your analyst meeting on Monday kind of describe tricuspid valves as they once forgotten valve, that's starting to gain attention from the clinical community with the now treatment solutions that are out there. But I think mitral valve procedure volumes are low, is a much more mainstream and well-understood disease states.

    或許在 TMTT 這邊,我想你說過 M3 的審核會在 2026 年初進行。您能否幫我們思考如何比較和對比 M3 和 EVOQUE 的上市情況?我認為 Sharma 博士在周一的分析師會議上將三尖瓣描述為曾經被遺忘的瓣膜,隨著現在治療方案的出現,它開始受到臨床界的關注。但我認為二尖瓣手術量較低,這是一種更主流且易於理解的疾病狀態。

  • So help us think about how -- what are the factors influencing the M3 launch and whether using the EVOQUE launch is a good template or not?

    那麼,請大家思考一下──影響 M3 上市的因素有哪些呢?使用 EVOQUE 的上市模式是否是一個好的範本?

  • Daveen Chopra - Corporate Vice President - Transcatheter Mitral and Tricuspid Therapies

    Daveen Chopra - Corporate Vice President - Transcatheter Mitral and Tricuspid Therapies

  • No. Thanks so much for the question, Dave. It's Daveen here. Yes, we did say that we expect US approval in early 2026.

    不。戴夫,非常感謝你的提問。我是戴文。是的,我們確實說過,我們預計美國將在 2026 年初批准我們的申請。

  • And if you look at the SAPIEN M3 launch, we now have a couple of months of the launch in Europe. And in Europe, what we're seeing is that we have a kind of continuing limited control launch. And we're really focusing on the high-value model. We've got really important physician training, Edwards' people really working very closely with physicians to make sure we've got great outcomes in every case.

    如果你看看 SAPIEN M3 的發布,現在它在歐洲已經發布了幾個月了。而在歐洲,我們看到的是一種持續的、有限制的發射。我們真正關注的是高價值模式。我們擁有非常重要的醫生培訓體系,Edwards 的人員與醫生們密切合作,以確保我們在每個病例中都能取得良好的結果。

  • And what we're seeing from physicians is that they're actually pretty excited about this technology. As you said, they treat mitral patients today, and the SAPIEN M3 product is specifically focused on patients who are unsuitable for both TEER as well as surgery.

    我們從醫生那裡了解到,他們對這項技術感到非常興奮。正如您所說,他們現在治療二尖瓣疾病患者,而 SAPIEN M3 產品專門針對那些既不適合 TEER 也不適合手術的患者。

  • So for them, I think that we do see patients in the system who are unsuitable and so their excitement is getting to see great results for these patients with M2. However, to your point about comparison to the EVOQUE thing, I think I wouldn't get ahead of ourself in saying that with us, it's kind of this control launch, high training and making sure that we go one center at a time, to kind of ensure that we get the best possible outcomes and results.

    所以對他們來說,我認為我們確實看到系統中存在一些不適合接受治療的患者,因此他們很高興看到這些 M2 患者取得了顯著的治療效果。不過,關於您提到的與 EVOQUE 的比較,我認為我們不應該妄下斷言。對我們來說,這是一種控制性啟動、高強度培訓,並確保我們一次只在一個中心進行,以確保我們獲得最佳的結果。

  • Operator

    Operator

  • Vijay Kumar, Evercore ISI.

    Vijay Kumar,Evercore ISI。

  • Vijay Kumar - Equity Analyst

    Vijay Kumar - Equity Analyst

  • Hi guys, thanks for taking my question and congrats on nice sprint here, Scott. Congratulations to you as well, and wishing you the best of your transition.

    大家好,感謝你們回答我的問題,也恭喜Scott這次衝刺表現出色。也恭喜你,祝你過渡期一切順利。

  • Maybe my first question on this TAVR performance in 3Q, why isn't this performance a reflection of asymptomatic approval? I'm curious why you think the strength wouldn't sustain?

    關於 TAVR 在第三季的表現,我的第一個問題是:為什麼這種表現不能反映出無症狀患者的接受度?我很好奇你為什麼認為這種強度無法持續?

  • Bernard Zovighian - Chief Executive Officer, Director

    Bernard Zovighian - Chief Executive Officer, Director

  • Yeah. Maybe, Dan, you want to take.

    是的。丹,或許你想帶走。

  • Daniel Lippis - Corporate Vice President - JAPAC (Japan, Greater China and Asia Pacific)

    Daniel Lippis - Corporate Vice President - JAPAC (Japan, Greater China and Asia Pacific)

  • Yeah. Vijay, I think your question is, is the Q3 performance a reflection of asymptomatic approval. And I'm not sure if you specifically mean adoption or treatment of asymptomatic patients. But certainly, it is the asymptomatic approval, the indication, the evidence is reflected in what we're seeing here as along with -- I mean, I really can't recall over my 15 years, a period of 12 months where the scientific and academic podiums have just been so focused on TAVR with so much new evidence, so much new discussion, subanalyses, et cetera.

    是的。Vijay,我認為你的問題是,第三季度的業績是否反映了無症狀批准。我不確定你具體指的是收養還是治療無症狀患者。但可以肯定的是,無症狀批准、適應症和證據都反映在我們在這裡看到的情況中——我的意思是,在我15年的職業生涯中,我真的想不起來有哪12個月的時間,科學和學術講台如此專注於TAVR,有如此多的新證據、如此多的新討論、亞組分析等等。

  • So for sure, the asymptomatic evidence and indication is playing a part here. But as we've also seen in other indication approvals where a new indication shines the light on a previous indication and you see a renewed focus on that. And we're seeing that here, for sure, because there's also new data.

    所以可以肯定的是,無症狀的證據和跡像在這裡發揮了作用。但正如我們在其他適應症批准中看到的那樣,新的適應症會讓人們重新關注先前的適應症,導致人們再次關注該適應症。我們在這裡確實看到了這一點,因為也有了新的數據。

  • There's also new data to say that timely and urgent intervention brings both clinical and economic benefit for symptomatic severe aortic stenosis, which is part of the analysis of that data.

    新的數據還表明,及時緊急的干預對有症狀的嚴重主動脈瓣狹窄患者俱有臨床和經濟效益,這也是該數據分析的一部分。

  • Regarding is asymptomatic patients entering into the treatment pathway in Q3, and is that driving the current performance, we don't see any specific evidence of that. It has to be caveated by the fact that there isn't coverage for the asymptomatic indication, right, at the moment.

    關於第三季無症狀患者進入治療途徑是否是造成目前業績下滑的原因,我們沒有看到任何具體的證據。需要說明的是,目前無症狀感染者不在健保範圍內。

  • So it's hard to see that encoded CMS data. But we do have ways of looking at upstream patient populations to see what's coming through the funnel. And right now, we don't see any significant evidence that the growth is being driven by referral and treatment of asymptomatic patients.

    所以很難看到編碼後的CMS資料。但我們確實有辦法查看上游患者群體,看看哪些患者正在接受治療。目前,我們沒有看到任何確鑿的證據表明,這種增長是由轉診和治療無症狀患者所推動的。

  • So I think that, that's an opportunity to come.

    所以我認為,這是一個值得把握的機會。

  • Bernard Zovighian - Chief Executive Officer, Director

    Bernard Zovighian - Chief Executive Officer, Director

  • And this is probably what is most exciting, Vijay, that we have seen this momentum in Q3 just by having a renewed focus, given all of this data, all this positive data. Also, we benefited from the seasonality of the summer. But it is -- so the big catalysts are still in front of us.

    Vijay,最令人興奮的是,鑑於所有這些數據,所有這些積極的數據,我們僅僅通過重新聚焦,就在第三季度看到了這種勢頭。此外,我們也受惠於夏季的季節性因素。但事實的確如此——所以,真正重要的催化劑還在我們面前。

  • And this is what we have been saying. We are very confident about this multiyear opportunity for TAVR. This is what made us confident again that this is just in my mind, when I say always to the team, it is just the beginning.

    這就是我們一直以來所說的。我們對TAVR的這項多年發展機會非常有信心。正是這一點讓我們再次確信,這只是我個人的想法,我總是對團隊說,這只是個開始。

  • Vijay Kumar - Equity Analyst

    Vijay Kumar - Equity Analyst

  • Understood. That's helpful. And Scott, maybe one quick one for you. there was a litigation charge. And it was non-GAAP, could you just remind us on what the charge was?

    明白了。那很有幫助。史考特,或許我還要問你一個問題。有一項訴訟指控。而且這是非GAAP費用,可以提醒我們一下費用具體是多少嗎?

  • Scott Ullem - Chief Financial Officer, Corporate Vice President

    Scott Ullem - Chief Financial Officer, Corporate Vice President

  • Yeah. Thanks for the question, Vijay. There's a lot that happens behind the scenes with just ins and outs of running our business. As you know, in medical technology, there is -- it's not uncommon to have litigation activities underway. And so we take reserves periodically based upon what we think that exposure looks like and you'll see that reflected in today's GAAP P&L.

    是的。謝謝你的提問,Vijay。在公司營運的各個層面,幕後有很多事情發生。如您所知,在醫療技術領域,訴訟活動並不罕見。因此,我們會根據我們認為的風險敞口情況定期提列準備金,您將在今天的 GAAP 損益表中看到這一點。

  • Vijay Kumar - Equity Analyst

    Vijay Kumar - Equity Analyst

  • Understood. Thanks guys.

    明白了。謝謝各位。

  • Operator

    Operator

  • Matt Taylor, Jefferies.

    馬特泰勒,傑富瑞集團。

  • Matt Taylor - Analyst

    Matt Taylor - Analyst

  • Hi, thanks for taking the question. I wanted to circle back on TCT. You had a really nice showing kind of across the board. And I think maybe stuff the most to us was how positive the real-world tricuspid data was. And you talked about having a toolbox there, and you'll have that in mitral next year. So my question is really, after this tricuspid data and having the toolbox there.

    您好,感謝您回答這個問題。我想再談TCT。你們整體表現都非常出色。我覺得對我們來說最重要的可能是現實世界中三尖瓣數據的結果非常正面。你之前提到要在那裡放一個工具箱,明年在米特拉爾就會有。所以我的問題其實是,在獲得這些三尖瓣資料並擁有相應的工具箱之後。

  • Do you expect some acceleration in the tricuspid adoption could we also see that in mitral next year? Maybe you could just talk about that in general and the pace of acceleration we might see.

    您預期三尖瓣置換術的普及速度會加快嗎?明年二尖瓣置換術的普及速度會加快嗎?或許你可以泛泛地談談這個問題,以及我們可能會看到的加速發展的速度。

  • Daveen Chopra - Corporate Vice President - Transcatheter Mitral and Tricuspid Therapies

    Daveen Chopra - Corporate Vice President - Transcatheter Mitral and Tricuspid Therapies

  • Yeah. Thanks, Matt, for the question. Obviously, we were very excited to see the EVOQUE data coming from TCT. And I think what we saw from EVOQUE is that we see this continued trend of a great real-world outcome.

    是的。謝謝馬特的提問。顯然,我們非常高興看到 TCT 提供的 EVOQUE 數據。我認為我們從 EV​​OQUE 車型中看到的是,這種趨勢仍在繼續,並且在現實世界中取得了良好的成果。

  • First, starting at ESC a couple of months ago where we saw these hard endpoints for the most severe TR patients, and now we see with the TCT data, the improved safety, both in bleeding and conduction versus what we saw in the randomized trial.

    首先,幾個月前在 ESC 會議上,我們看到了最嚴重的 TR 患者的這些硬終點,現在透過 TCT 數據,我們看到了出血和傳導方面的安全性改善,與我們在隨機試驗中看到的情況相比。

  • And I think what we're seeing is that we're seeing how the elimination of TR is leading to just change in patient's life. And I think what we're also seeing from Europe where we have both repair and replacement for tricuspid is that you really need both technologies to really get -- treat the maximum number of patients with the best possible outcomes.

    我認為我們看到的是,消除 TR 正在為患者的生活帶來改變。我認為,我們從歐洲也看到了類似的情況,那裡既有三尖瓣修復術也有置換術,要真正做到——以最佳效果治療盡可能多的患者,確實需要這兩種技術。

  • And so I think with that, as we get to your point, is having the full portfolio even on tricuspid and now then coming with mitral, you start seeing this compounding effect where when you have multiple treatment options each patient is getting the best possible outcome, you could treat the maximum possible number of patients.

    所以我覺得,正如你所說,擁有完整的治療方案,即使是針對三尖瓣疾病,現在又增加了二尖瓣疾病,就會產生這種複合效應,當有多種治療選擇時,每個患者都能獲得最佳治療效果,從而可以治療盡可能多的患者。

  • And with that, you see this continued strength and growth. And so in the words of seeing you were asking about specific of the acceleration of TR, I think what we're seeing is very, very strong growth in TR. I mean, this year, you see overall that our overall business is growing at over 50%.

    由此可見,這種勢頭和成長勢頭仍在持續。所以,正如你所問到的,關於 TR 加速的具體情況,我認為我們看到的是 TR 非常非常強勁的成長。我的意思是,今年整體而言,我們的整體業務成長超過 50%。

  • And so I think we're going to see this continued growth in TR and these provide nice tailwinds. Nice real-time examples to help continuously support the strong growth in TR to really treat an awesome number of patients in the years to come.

    所以我認為我們將看到 TR 繼續成長,這些因素將帶來良好的順風。優秀的即時案例將有助於持續支持 TR 的強勁成長,從而在未來幾年真正治療大量的患者。

  • Scott Ullem - Chief Financial Officer, Corporate Vice President

    Scott Ullem - Chief Financial Officer, Corporate Vice President

  • Great, thank you very much.

    太好了,非常感謝。

  • Operator

    Operator

  • Robbie Marcus, JPMorgan.

    羅比馬庫斯,摩根大通。

  • Robbie Marcus - Analyst

    Robbie Marcus - Analyst

  • Great. Congrats on a good quarter. And Scott, wish you all the best, we'll miss working with you. Two quick ones for me. First one, I know you've been working a lot in the past couple of years to try and improve efficiency in the cath lab, and you have some AI initiatives and educational initiatives and just wondering how that's going, what you're doing exactly and how much efficiency and extra capacity you've been able to help drive such good TAVR volumes?

    偉大的。恭喜你本季業績出色。史考特,祝你一切順利,我們會想念和你一起工作的時光。我這裡只做兩道簡單的題目。首先,我知道您在過去幾年裡一直在努力提高導管室的效率,您也開展了一些人工智慧項目和教育項目,我想知道這些項目進展如何,您具體做了哪些工作,以及您在提高效率和增加產能方面取得了多大成效,從而推動了TAVR手術量的大幅增長?

  • Daniel Lippis - Corporate Vice President - JAPAC (Japan, Greater China and Asia Pacific)

    Daniel Lippis - Corporate Vice President - JAPAC (Japan, Greater China and Asia Pacific)

  • Yeah. Thanks, Robbie. Maybe I'll take that question for you. Like, we've got a number of programs in flight, if you like, whether it be at an early pilot stage or various stages of ramp. Specifically, as it relates to capacity building or efficiencies, one of the big programs that we have is Benchmark.

    是的。謝謝你,羅比。或許我可以替你回答這個問題。例如,我們有很多專案正在進行中,無論處於早期試點階段還是不同的試運行階段。具體來說,就能力建構或效率而言,我們的一項重要計畫是基準測試。

  • And that has been in development and being -- and all about improving efficiencies for better patient outcomes in the hospitals. It couldn't be a better time to be applying that right now with the renewed focus on TAVR as the timely treatment and more urgent treatment of these patients is in the spotlight. But at a high level, we've got programs that we execute on the ground, right, with our field team.

    而這一切都在不斷發展和完善中——其目的都是為了提高醫院的效率,從而改善患者的治療效果。現在正是應用這項技術的最佳時機,因為隨著人們對經導管主動脈瓣置換術 (TAVR) 的重新關注,及時治療和更緊急地治療這些患者成為了關注的焦點。但從宏觀層面來說,我們有切實可行的方案,由我們的現場團隊負責執行。

  • We are in just about every single case. And these are either targeted towards improving the efficiencies in the cath labs or in the program itself or with referral activity and education of evidence and guidelines and new data, et cetera.

    幾乎在所有情況下,我們都是如此。這些措施要么旨在提高導管室或計畫本身的效率,要么旨在開展轉診活動,並進行證據、指南和新數據的教育等等。

  • We have also partnerships with tech companies and AI-based companies that look at echo screening and upstream identification of patients and workflow solutions so that, that can be done economically. And so we're working on that. We have very sophisticated marketing programs, looking at targeting direct-to-patient activity through social media, et cetera.

    我們也與科技公司和人工智慧公司建立了合作關係,致力於超音波篩檢、患者上游識別和工作流程解決方案,以便能夠以經濟的方式完成這些工作。所以我們正在努力解決這個問題。我們擁有非常成熟的行銷方案,著眼於透過社群媒體等方式直接面向患者進行行銷活動。

  • And then just the partnerships that we have with societies and others with GCs, with patients, et cetera, around dissemination and education and clinical evidence. So all of this comes together and kind of helps us sort of run the process of moving the needle of patient activation. And I hope that gives you some idea of what we're doing on the ground with our physician and hospital partners.

    此外,我們也與協會、其他組織、遺傳諮詢機構、患者等建立了合作關係,圍繞傳播、教育和臨床證據等方面合作。因此,所有這些因素結合起來,有助於我們推進患者活化進程。我希望這能讓您對我們與醫生和醫院合作夥伴在現場進行的工作有所了解。

  • Bernard Zovighian - Chief Executive Officer, Director

    Bernard Zovighian - Chief Executive Officer, Director

  • And so Dan, you gave here a full picture on all of what we do on the TAVR side. Maybe Daveen, a couple of things on TMTT?

    所以丹,你在這裡全面介紹了我們在TAVR所做的一切。戴文,或許可以談談TMTT上的幾件事?

  • Daveen Chopra - Corporate Vice President - Transcatheter Mitral and Tricuspid Therapies

    Daveen Chopra - Corporate Vice President - Transcatheter Mitral and Tricuspid Therapies

  • Yes, a couple of quick things. If you think about, right Dan, for a more established procedure like TAVR went through a lot of great examples there. On TMTT, when you're creating a brand-new therapy, right, you can imagine there's so many things to quickly help improve their time in the cath lab, their time to go home, their time for pre-having a patient before you even have a procedure.

    是的,還有幾件事要簡單說一下。丹,你想想,對於像TAVR這樣更成熟的手術來說,已經有很多很好的例子了。在 TMTT 中,當你創造一種全新的療法時,你可以想像有很多事情可以快速幫助改善他們在導管室的時間、回家的時間、甚至在進行手術之前為患者準備的時間。

  • So what we see is actually with things like replacement technology, both mitral tricuspid and even to some extent with TEER as we establish and grow these new therapies, we are constantly improving efficiencies across the board in almost all aspects. So I think for us, that just comes with the therapy development that happens, it helps really line you up for long-term success.

    因此,我們看到,隨著我們建立和發展這些新療法,像是二尖瓣、三尖瓣置換技術,甚至在某種程度上包括TEER置換技術,我們在幾乎所有方面都在不斷提高效率。所以我覺得對我們來說,隨著治療的發展,這確實有助於為長期的成功奠定基礎。

  • Bernard Zovighian - Chief Executive Officer, Director

    Bernard Zovighian - Chief Executive Officer, Director

  • Thanks. So we do a lot here, and I'm glad we were able to share some of what we do, but we do much more than that.

    謝謝。所以我們在這裡做了很多工作,我很高興我們能夠分享我們的一些工作內容,但我們做的遠不止這些。

  • Robbie Marcus - Analyst

    Robbie Marcus - Analyst

  • Maybe if I could just ask a quick follow-up for Scott on -- we had really good margin expansion. I think you've committed to 50 to 100 basis points, and I don't want to steal any thunder from the Analyst Day, but you're one of the biggest spenders in R&D at $1.1 billion, and it's clearly given you a great product pipeline and portfolio with a lot of big trials wrapping up, how do you think about R&D and what's the right level of spend over the forward horizon? How are you thinking about that?

    或許我可以幫 Scott 快速問一下後續問題——我們的利潤率成長非常顯著。我認為你們已經承諾將利率提高 50 到 100 個基點,我不想搶了分析師日的風頭,但你們是研發投入最大的公司之一,投入高達 11 億美元,這顯然為你們帶來了強大的產品線和產品組合,並且許多大型試驗即將完成。你們如何看待研發,以及在未來一段時間內,適合的研發投入水準是多少?你對此有何看法?

  • Scott Ullem - Chief Financial Officer, Corporate Vice President

    Scott Ullem - Chief Financial Officer, Corporate Vice President

  • Thanks for the question. Look, we think about R&D as an investment in the top line. And the most important thing that we do here is innovate to drive sustainable organic top line sales growth. We've also said though, at last year's investor conference, and you'll hear it again at this year's investor conference that top line growth will outpace R&D spending growth.

    謝謝你的提問。我們把研發視為對營收的投資。我們在這裡最重要的工作就是創新,以推動可持續的有機銷售成長。不過,我們在去年的投資人大會上也說過,而且在今年的投資人大會上你們還會再聽到,營收成長將超過研發支出成長。

  • And you saw it in the third quarter, where we went from nearly 19% R&D as a percentage of sales last third quarter to 18.1% of sales this quarter. And so that gives you a sense of how R&D as a percentage of sales is going to trend.

    您在第三季已經看到了這一點,研發支出佔銷售額的比例從上個季度的近 19% 下降到本季的 18.1%。這樣你就能大致了解研發支出佔銷售額的比例會如何變動。

  • Again, it's still the most important driver of our strategy, of our innovation strategy and of our sustainable top line growth expectations. But it's also something we're going to be pretty disciplined about prioritizing where we're investing those R&D dollars.

    再次強調,它仍然是我們策略、創新策略以及永續營收成長預期的最重要驅動力。但我們也會在研發資金的投資方向上保持相當的自律,優先考​​慮投資方向。

  • Operator

    Operator

  • And ladies and gentlemen, that's all the time we have for questions today. So I'll now turn it back to Bernard Zovighian for closing remarks.

    女士們、先生們,今天的提問時間就到此為止了。現在我將把發言權交還給伯納德·佐維吉安,讓他做總結發言。

  • Bernard Zovighian - Chief Executive Officer, Director

    Bernard Zovighian - Chief Executive Officer, Director

  • Okay, everyone. Thanks for your continued interest in Edwards. Scott, Mark and I welcome any additional questions by telephone. And I wish you a great day. Thank you, everyone.

    好了,各位。感謝您一直以來對愛德華茲公司的關注。Scott、Mark 和我歡迎您透過電話提出任何其他問題。祝您今天過得愉快。謝謝大家。

  • Operator

    Operator

  • Thank you. And with that, we conclude today's call. All parties may disconnect. Have a good day.

    謝謝。今天的電話會議到此結束。所有參與者均可中斷連線。祝你有美好的一天。