愛德華生命科學 (EW) 2025 Q4 法說會逐字稿

Greetings, and welcome to Edwards Lifesciences fourth-quarter 2025 results conference call. (Operator Instructions) Please note that this conference is being recorded.

各位好，歡迎參加 Edwards Lifesciences 2025 年第四季業績電話會議。（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, Gerianne Sarte. Thank you. You may begin.

現在我將把會議交給主持人傑里安娜·薩特。謝謝。你可以開始了。

Thank you. Good afternoon, and thank you for joining us. This is Gerianne Sarte. I'm the incoming Senior Vice President of Investor Relations. 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, Surgical, and IHFM.

謝謝。下午好，感謝各位的參與。這是傑里安娜·薩特。我是即將上任的投資人關係資深副總裁。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；以及負責 TMTT、外科和 IHFM 全球業務的 Daveen Chopra。

Just after the close of regular trading, Edwards Lifesciences released fourth-quarter and full-year 2025 financial results. During today's call, management will discuss the results included in the press release and accompanying financial schedules and then use the remaining time for Q&A.

常規交易結束後不久，愛德華生命科學公司發布了 2025 年第四季和全年財務表現。在今天的電話會議上，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 on which they are 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 from those expressed or implied by the forward-looking statements. 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前瞻性聲明中明示或暗示的結果有重大差異。造成這些差異的因素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 financial results press release issued earlier today. Reconciliation between GAAP and non-GAAP numbers mentioned during this call are also included in today's press release. Quarterly and full-year growth rates refer to continuing operation.

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財務業績新聞稿。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。

With that, I'll turn the call over to Bernard for his comments.

接下來，我將把電話交給伯納德，請他發表評論。

Thank you, Gerianne, and welcome, everyone. I am pleased to introduce Gerianne Sarte as our new Head of Investor Relations at Edwards. Gerianne has an extensive background in medtech and as a leader in our global finance organization prior to moving to this new position. You'll be seeing and hearing from her going forward, and I know she looks forward to getting to know you.

謝謝你，Gerianne，也歡迎各位。我很高興地向大家介紹 Gerianne Sarte，她將擔任 Edwards 新的投資人關係主管。在擔任這個新職位之前，Gerianne 在醫療技術領域擁有豐富的經驗，並且是我們全球財務部門的領導者。今後你會常常見到她，聽到她的消息，我知道她也很期待認識你。

Now, let me turn to discussing Q4 and 2025 results. We delivered a strong quarter, growing at 11.6% and a strong full year 2025, growing at 10.7%. This is the result of our differentiated strategy with a clear vision around three key elements: focusing thoroughly on structural heart; solving large, urgent, and very complex patient needs; and pursuing unique opportunities to innovate and lead. This is only possible due to our deeply experienced teams, their excellent execution, and their commitment to patients worldwide.

現在，讓我來討論一下第四季和 2025 年的業績。我們本季業績強勁，成長了 11.6%，並預計 2025 年全年業績也將保持強勁成長，達到 10.7%。這是我們差異化策略的結果，該策略圍繞著三個關鍵要素展開，具有清晰的願景：徹底專注於結構性心臟病；解決大量、緊急和非常複雜的患者需求；以及尋求獨特的創新和領導機會。這完全得益於我們經驗豐富的團隊、出色的執行力以及對全球患者的承諾。

With our achievement in 2025, we are entering 2026 with strength and momentum globally with many growth catalysts in each area across the company.

憑藉我們在 2025 年的成就，我們以強勁的實力和勢頭進入 2026 年，在全球範圍內，公司各個領域都有許多成長催化劑。

Starting with TAVR, there is a renewed focus on SAPEIN across the healthcare ecosystem, led by the seven-year PARTNER III and the 10-year PARTNER II data which confirm the long-term durability and proven valve performance of a SAPIEN platform.

從 TAVR 開始，整個醫療保健生態系統重新關注 SAPEIN，這主要得益於七年的 PARTNER III 和十年的 PARTNER II 數據，這些數據證實了 SAPIEN 平台的長期耐用性和久經考驗的瓣膜性能。

This data presented last October at TCT reinforced the confidence physician and patients, having Edwards' TAVR and set a new clinical benchmark for safety, efficacy, durability, and lifetime management of patients. In addition, the practice-changing early TAVR trial is resonating with the clinical community, starting with the guideline changes in Europe. Together, all of these will have a lasting impact on the continued expansion of a SAPIEN platform globally.

去年十月在 TCT 上公佈的這些數據增強了醫生和患者對 Edwards TAVR 的信心，並為安全性、有效性、持久性和患者終身管理設定了新的臨床基準。此外，改變臨床實踐的早期 TAVR 試驗引起了臨床界的共鳴，首先是歐洲指南的改變。所有這些因素加在一起，將對 SAPIEN 平台在全球的持續擴張產生持久影響。

Continuing with TMTT, growth is fueled by a comprehensive portfolio of repair and replacement therapies and strengthened by new options for patients. These include the launch of SAPIEN M3, the scaling of EVOQUE, the upcoming introduction of next-gen PASCAL in Q4 this year, and the introduction of PASCAL for US tricuspid patients also in Q4. Together, these are significant advancements for mitral and tricuspid patients and represent large opportunities to achieve our $2 billion revenue expectation for TMTT in 2030.

TMTT 繼續保持成長勢頭，其成長動力來自全面的修復和替代療法組合，並因給患者提供新的選擇而得到加強。其中包括 SAPIEN M3 的推出、EVOQUE 的擴展、即將於今年第四季推出的下一代 PASCAL，以及同樣在第四季度推出的美國三尖瓣疾病患者的 PASCAL。總而言之，這些對二尖瓣和三尖瓣疾病患者來說都是重大進步，也代表著我們在 2030 年實現 TMTT 20 億美元收入預期的巨大機會。

Overall, for Edwards in 2026, we have increased confidence in meeting our 8% to 10% sales growth guidance as well as in our EPS guidance. We are looking forward to an updated national coverage determination for TAVR, which may present a potential tailwind later this year, recognizing that our impressive results in 2025 have set a higher bar for 2026, especially in the second half.

整體而言，對於 Edwards 公司 2026 年的發展，我們更有信心實現 8% 至 10% 的銷售成長預期以及每股盈餘預期。我們期待TAVR的最新全國覆蓋範圍決定，這可能會在今年晚些時候帶來潛在的利好，同時我們也意識到，我們在2025年取得的令人矚目的成績為2026年，特別是下半年，設定了更高的標準。

Long term, we are well-positioned to execute our compelling growth strategy. And specifically over the next three years, we will be pioneering new therapies, launching next generation of existing technologies as well as expanding indication to impact more patients.

從長遠來看，我們已做好充分準備，執行我們引人注目的成長策略。具體來說，在接下來的三年裡，我們將率先研發新療法，推出現有技術的下一代產品，並擴大適應症範圍，以惠及更多患者。

Our talented team of 16,000 employees create, develop, and enable treatment of patients globally, with a highly differentiated and complete portfolio of therapy to address aortic, pulmonic, mitral, and tricuspid valve diseases. We take very seriously responsibility of investing in the development of safe and effective value therapies with proven long-term durability.

我們才華橫溢的 16,000 名員工組成的團隊，致力於為全球患者創造、開發和提供治療方案，擁有高度差異化和完整的治療組合，以解決主動脈瓣、肺動脈瓣、二尖瓣和三尖瓣疾病。我們非常重視投資開發安全有效且具有長期療效的價值療法的責任。

Valve technology requires dedicated focus and generation of world-class clinical evidence that will continue to differentiate Edwards. I am confident that our technology will remain the first choice of clinicians to transform the care of their patients.

瓣膜技術需要專注投入和世界一流的臨床證據，這將繼續使 Edwards 脫穎而出。我相信，我們的科技仍將是臨床醫師革新病患照護方式的首選。

Leveraging our experience, we are extending into structural heart failure and aortic regurgitation, or AR, for the many patients who are not well served today. This will create additional growth opportunities and extend our structural heart leadership.

憑藉我們的經驗，我們將服務範圍擴展到結構性心臟衰竭和主動脈瓣逆流（AR）領域，為目前許多未得到良好服務的患者提供幫助。這將創造更多成長機會，並鞏固我們在心臟結構領域的領先地位。

In 2027 and beyond, we continue to expect average annual sales growth of 10% with constant currency operating margin expansion as we continue to address patients in need by advancing novel therapies to extend lives improve quality of life and provide greater impact and efficiency for health systems.

2027 年及以後，我們將繼續維持 10% 的年均銷售額成長，同時以固定匯率計算的營業利潤率也將持續提高。我們將繼續推動創新療法，延長患者的生命，提高患者的生活質量，並為醫療系統帶來更大的影響和效率。

Now, I will provide an overview of Q4 sales performance by product group. TAVR overall procedural growth in the quarter remained in the high-single digit. And for Edwards, TAVR's fourth-quarter global sales of $1.16 billion increased 10.6% over the prior year and slightly sequentially over a high Q3, which was inconsistent with typical summer seasonality. The Q4 performance reflected clinicians elevated focus on SAPIEN therapy and proactive disease management of patients suffering from severe aortic delays. Edwards' TAVR procedural growth was comparable across the US and OUS. And our average price and competitive position were stable on a global basis.

接下來，我將按產品組別概述第四季的銷售業績。本季TAVR手術總量成長維持在高個位數水準。對 Edwards 而言，TAVR 第四季全球銷售額為 11.6 億美元，比上年同期成長 10.6%，比第三季略有成長，這與典型的夏季季節性不符。第四季業績反映出臨床醫生更加重視 SAPIEN 療法，並積極主動地對患有嚴重主動脈延遲的患者進行疾病管理。Edwards 的 TAVR 手術量在美國和美國境外的成長情況相當。我們的平均價格和全球競爭力都保持穩定。

While early TAVR studied TAVR AS patients without symptom, we are encouraged by the impact this study has had on increasing the sense of urgency for the treatment of patients who have symptoms. The timely referral evaluation and treatment of patients with severe aortic stenosis is fueled by a large and growing body of evidence on the long-term outcomes of SAPIEN valves.

雖然早期的 TAVR 研究對像是無症狀的 TAVR AS 患者，但我們對這項研究在提高人們對治療有症狀患者的緊迫感方面所產生的影響感到鼓舞。大量且不斷增長的證據表明，SAPIEN瓣膜具有良好的長期療效，這為及時轉診評估和治療重度主動脈瓣狹窄患者提供了有力支持。

Our position as the only TAVR therapy with a symptomatic indication will provide additional benefits along with the potential of an updated TAVR NCD and US and Japan guideline evolution. These additive catalysts provide multiple layers of durable growth.

我們作為唯一具有症狀適應症的 TAVR 療法，其地位將帶來額外的益處，同時 TAVR NCD 更新以及美國和日本指南的演變也具有潛在意義。這些添加劑催化劑可提供多層持久生長。

In addition to the long-term data presented at TCT, more than 30 distinguished physician thought leaders published the first-ever AS global consensus document. This validates the movement away from the outdated practice of watchful waiting and further supports the importance of guideline management of CV AS patients.

除了在 TCT 上公佈的長期數據外，30 多位傑出的醫學思想領袖還發表了首個 AS 全球共識文件。這證實了摒棄過時的觀察等待做法的正確性，並進一步支持了對心血管主動脈瓣狹窄患者進行指引管理的重要性。

Let me turn to some US commentary. We saw intentional and urgent treatment of severe aortic stenosis patients, fueled by a large and growing body of world-class evidence on the SAPIEN platform and the increased adoption of SAPEIN 3 ultra resilience. We are pleased that CMS formally opened the process to reconsider the NCD for TAVR. This decision has the potential to improve timely and equitable access to life-saving TAVR therapy. The initial 30-day public comment period closed on January 14, and we look forward to the process continuing.

讓我轉而談談美國方面的一些評論。我們看到，在大量且不斷增長的世界級證據的推動下，嚴重主動脈瓣狹窄患者得到了有意識的緊急治療，這得益於 SAPEIN 平台以及 SAPEIN 3 超彈性技術的日益普及。我們很高興 CMS 正式啟動了重新考慮 TAVR 的 NCD 的流程。這項決定有可能改善及時、公平地獲得挽救生命的TAVR治療的機會。最初的 30 天公眾意見徵詢期已於 1 月 14 日結束，我們期待這一過程繼續進行。

In Q4, we expanded our partnership with the American Heart Association as the founding sponsor of a heart valve initiative. This new initiative is focused on timely diagnosis and treatment to save lives and improve care for millions living with heart valve disease. It is a multiyear program to elevate heart bound disease as a critical focus area for hospital systems through adherence to specific quality metric based care, expanded data collection, enhanced healthcare professional education, and patient engagement.

第四季度，我們擴大了與美國心臟協會的合作關係，成為心臟瓣膜計畫的創始贊助商。這項新措施旨在及時診斷和治療，以挽救生命，並改善數百萬心臟瓣膜疾病患者的照護。這是一個多年計劃，旨在透過堅持以特定品質指標為基礎的護理、擴大數據收集、加強醫療保健專業人員教育和患者參與，將心臟相關疾病提升為醫院系統的關鍵關注領域。

In Europe, fourth-quarter results reflected healthy underlying TAVR procedure growth as well as our consistent execution across the region. Updated guidelines from the European Society of Cardiology and the European Association for Cardiothoracic surgery are reshaping clinical discussions around proactive disease management and reinforcing the role of TAVR for a broader patient population. We also continue to see modest year-over-year share improvement in several key countries, strengthening our leadership position in the wake of a competitor's exit.

在歐洲，第四季度業績反映了TAVR手術業務的健康成長以及我們在該地區的持續高效運作。歐洲心臟病學會和歐洲心胸外科協會更新的指南正在重塑圍繞積極疾病管理的臨床討論，並加強了經導管主動脈瓣置換術 (TAVR) 在更廣泛患者群體中的作用。在幾個主要國家，我們的市場份額也繼續保持小幅同比增長，這在競爭對手退出市場後鞏固了我們的領先地位。

In summary for TAVR, we are pleased with our strong Q4 results and full year 2025 performance. SAPIEN growth globally was supported by rising clinical urgency for intentional proactive disease management and long-term evidence demonstrating the proven durability and valve performance of SAPIEN 3.

總而言之，對於 TAVR 業務，我們對第四季度強勁的業績和 2025 年全年業績感到滿意。SAPIEN 在全球範圍內的成長得益於臨床上對主動疾病管理的日益增長的迫切需求，以及長期證據證明 SAPIEN 3 具有經證實的耐用性和瓣膜性能。

As we look ahead, we are well-positioned to continue the momentum and remain focused on driving our patient access strategy, generating additional clinical evidence and delivering on our innovation pipeline to address the growing patient needs across the world. These strengths reinforce our confidence in Edwards' TAVR as a durable growth engine and a meaningful contributor to long-term value creation.

展望未來，我們已做好充分準備，繼續保持發展勢頭，專注於推進患者准入策略，產生更多臨床證據，並推進創新研發，以滿足全球日益增長的患者需求。這些優勢增強了我們對 Edwards 的 TAVR 作為持久成長引擎和長期價值創造的重要貢獻者的信心。

Now, let's turn to our TMTT product group. Our comprehensive portfolio of repair and replacement therapies offers meaningful opportunities to physicians to best treat their mitral and tricuspid patients. This drove another strong quarter with TMTT growing over 40% to $156 million. We were also pleased that for the full year, TMTT sales exceeded $0.5 billion. Continued global adoption of PASCAL and EVOQUE contributed to overall growth. Physicians continue to provide positive feedback on PASCAL's differentiated benefits for treatment of their patients who need transcatheter edge-to-edge repair.

現在，讓我們來看看我們的 TMTT 產品組。我們全面的修復和置換療法組合為醫生提供了有意義的機會，以更好地治療他們的二尖瓣和三尖瓣患者。這推動TMTT又一個強勁的季度成長，成長超過40%，達到1.56億美元。我們也欣喜地看到，TMTT 全年銷售額超過 5 億美元。PASCAL 和 EVOQUE 在全球範圍內的持續普及促進了整體成長。對於需要經導管緣對緣修復的患者，醫師們持續給予 PASCAL 差異化優勢治療的正面回饋。

With EVOQUE, we are expanding the number of centers and training more physicians while focusing on excellent patient outcomes. The recent FDA approval of SAPIEN M3 expands our mitral portfolio in the US and represents the first transcatheter replacement option suffering from mitral disease.

透過 EVOQUE，我們正在擴大中心數量並培訓更多醫生，同時專注於取得卓越的患者療效。最近，FDA 批准了 SAPIEN M3，這擴大了我們在美國二尖瓣產品組合的規模，並且代表了第一個用於治療二尖瓣疾病的經導管置換方案。

Similar to our other therapy launches, the strategic introduction of SAPIEN M3 is leveraging our proven high-value support model and focusing on outstanding clinical outcomes. We are initially opening sites that were previously in our in-circle pivotal clinical trials and physician interest in this technology is growing.

與我們其他療法的推出類似，SAPIEN M3 的策略性引入是利用我們成熟的高價值支持模式，並專注於卓越的臨床結果。我們首先開放的是先前在我們核心臨床試驗範圍內開展的試驗點，而且醫生對這項技術的興趣正在增長。

With PASCAL and EVOQUE growing globally and now with the introduction of SAPIEN M3 in the US and Europe, Edwards continues to deliver on our vision of offering a portfolio of therapies to treat more mitral and tricuspid patients. Overall, PASCAL adoption globally is delivering differentiated outcome for patients. The introduction of next-gen PASCAL in Q4 will further distinguish this important therapy for patients who need edge-to-edge repair.

隨著 PASCAL 和 EVOQUE 在全球範圍內的發展，以及 SAPIEN M3 在美國和歐洲的推出，愛德華茲繼續實現我們的願景，即提供一系列療法來治療更多的二尖瓣和三尖瓣疾病患者。整體而言，PASCAL 在全球的應用為患者帶來了不同的治療效果。第四季推出的下一代 PASCAL 將進一步凸顯這種對需要邊緣對邊緣修復的患者的重要療法。

The upcoming US approval of PASCAL for tricuspid patients will provide an enhanced therapy alternative, and the scaling of EVOQUE and launch of SAPIEN M3 will further advance treatment for tricuspid and mitral patients. This represents multiyear growth opportunities starting in 2026 and contributing to achieving $2 billion of revenue in 2030 and additional growth beyond.

PASCAL 即將獲得美國批准用於治療三尖瓣疾病患者，這將提供一種更完善的治療選擇；EVOQUE 的規模化生產和 SAPIEN M3 的上市將進一步推進三尖瓣和二尖瓣疾病患者的治療。這代表著從 2026 年開始的多年成長機會，並有助於在 2030 年實現 20 億美元的收入，以及此後的進一步成長。

Finally, this year, we continue to expect sales in the range of $740 million to $780 million.

最後，我們預計今年的銷售額將在 7.4 億美元至 7.8 億美元之間。

In our Surgical product group, fourth-quarter global sales of $254 million increased 2% over the prior year. The underlying fundamentals of our Surgical product group remains strong while growth in Q4 was impacted by end of year distributor inventory adjustments in one country.

在我們的外科產品集團，第四季度全球銷售額為 2.54 億美元，比去年同期成長 2%。儘管第四季成長受到一個國家年底經銷商庫存調整的影響，但我們外科產品組的基本面依然強勁。

Full-year Surgical sales grew 4.3% and for the first time, exceeded $1 billion. We continue to expect mid-single-digit sales growth rate in Surgical in 2026, driven by continued adoption of our resilient therapies that offer extended durability of our surgical therapies, including INSPIRIS, KONECT, and MITRIS. We were encouraged by new data presented at the recent STS meeting, including strong one-year data from the MOMENTIS study. MOMENTIS is studying long-term durability for the Edwards' MITRIS systems for surgical mitral valve replacement, and one-year result from the study demonstrated 100% freedom from SVD, impressive stable hemodynamic performance, and excellent safety. This specifically designed surgical valve customized for mitral patients will advance and improve care.

全年外科手術產品銷售額成長 4.3%，首次突破 10 億美元大關。我們預計 2026 年外科手術業務的銷售額將維持中等個位數的成長率，這主要得益於我們具有持久療效的外科手術療法（包括 INSPIRIS、KONECT 和 MITRIS）的持續普及。最近的 STS 會議上公佈的新數據令我們感到鼓舞，其中包括 MOMENTIS 研究的強勁的一年期數據。MOMENTIS 正在研究 Edwards 的 MITRIS 系統在外科二尖瓣置換術中的長期耐用性，該研究的一年結果表明，該系統 100% 沒有發生結構性瓣膜退化 (SVD)，具有令人印象深刻的穩定血流動力學性能和出色的安全性。這種專為二尖瓣疾病患者量身設計的外科瓣膜將推進和改善治療。

We are also pursuing multiple new innovation to advance surgical solutions for patients, including left atrial appendage closure or LAAC. This is a new therapeutic area that is a complementary solution to specific vascular procedures, and we are planning on a preliminary introduction of our new surgical LAAC technology later this year.

我們也積極探索多項創新技術，以推進患者的外科治療方案，包括左心耳封堵術（LAAC）。這是一個全新的治療領域，是對特定血管手術的補充解決方案，我們計劃在今年稍後初步推出我們新的外科左心耳封堵術技術。

In summary, we still expect to deliver our mid-single-digit sales growth rate guidance in 2026. And finally, we are looking forward to seeing 10-year data from our COMMENCE trial at the AATS conference in May, studying long-term durability of our best-in-class resilient tissue.

總而言之，我們仍然預計在 2026 年實現中等個位數的銷售成長率目標。最後，我們期待在 5 月的 AATS 會議上看到我們 COMMENCE 試驗的 10 年數據，該試驗旨在研究我們一流的彈性組織的長期耐久性。

And now, Scott will cover the details of the company's financial performance.

接下來，斯科特將詳細介紹公司的財務表現。

Thanks, Bernard. Today, I will provide a wrap-up of 2025, including detailed results of our fourth quarter and guidance for the first quarter and full year 2026.

謝謝你，伯納德。今天，我將對 2025 年進行總結，包括第四季度的詳細業績以及對 2026 年第一季和全年的展望。

We were pleased with our better-than-expected Q4 sales performance with strength across all product groups. Total sales of $1.57 billion grew 11.6% year over year. Our adjusted earnings per share was $0.58. This lower-than-expected EPS was driven by higher spending on patient access initiatives and a higher-than-expected tax rate. It is important to note that we have increased confidence in our 2026 earnings per share guidance of $2.90 to $3.05.

我們對第四季度超出預期的銷售業績感到滿意，所有產品系列均表現強勁。總銷售額達15.7億美元，年增11.6%。我們調整後的每股收益為 0.58 美元。低於預期的每股盈餘是由於病患准入計畫支出增加以及稅率高於預期所致。值得注意的是，我們對 2026 年每股收益預期（2.90 美元至 3.05 美元）更有信心。

Our GAAP EPS for the quarter was $0.11, which included one-time charges related to the JenaValve acquisition that did not close as well as litigation expenses. A full reconciliation between our GAAP and adjusted EPS for this and other items is included with today's release.

本季 GAAP 每股收益為 0.11 美元，其中包括與未完成的 JenaValve 收購相關的一次性費用以及訴訟費用。今天的公告中包含了我們根據 GAAP 計算的每股盈餘與調整後每股盈餘之間關於此項及其他專案的完整調整表。

And now, I'll cover additional details of our P&L. For the fourth quarter, our adjusted gross profit margin was 78.3%, in line with our expectations compared to 79.0% in the same period last year. This expected year-over-year change was driven by additional manufacturing expenses related to the fast expansion of new therapies. We continue to expect our full-year 2026 adjusted gross profit margin to be within our original guidance range of 78% to 79%.

接下來，我將詳細介紹我們的損益表。第四季度，我們調整後的毛利率為 78.3%，與預期相符，去年同期為 79.0%。這項預期中的同比變化是由與新療法快速推廣相關的額外生產成本所驅動的。我們仍預期 2026 年全年調整後的毛利率將維持在 78% 至 79% 的原預期範圍內。

Selling, general and administrative expense in the quarter was $603 million or 38% of sales compared to 35% of sales in the prior year. We increased SG&A spending in the fourth quarter to fund strategic investments in order to amplify patient access to therapy, such as early TAVR education, investment in field resources, and the AHA heart valve initiative. Some of the strategic spending was delayed from previous quarters in the year.

本季銷售、一般及行政費用為 6.03 億美元，佔銷售額的 38%，而去年同期佔銷售額的 35%。我們在第四季度增加了銷售、一般及行政費用，以資助策略性投資，從而擴大患者獲得治療的機會，例如早期經導管主動脈瓣置換術 (TAVR) 教育、投資現場資源以及美國心臟協會 (AHA) 心臟瓣膜計劃。今年部分戰略支出項目因故推遲，此前幾季尚未實施。

Research and development expense was $268 million in the fourth quarter or 17.1% of sales compared to $271 million or 19.6% of sales in the same period last year. This decrease in R&D as a percentage of sales reflects our strategic prioritization of investments in our expanding structural heart portfolio. We continue to expect 2026 R&D as a percentage of sales to be approximately 17%.

第四季研發費用為 2.68 億美元，佔銷售額的 17.1%，去年同期為 2.71 億美元，佔銷售額的 19.6%。研發投入佔銷售額比例的下降反映了我們對不斷擴大的結構性心臟病產品組合的投資策略優先性。我們仍預期 2026 年研發支出將佔銷售額的比例約為 17%。

Fourth-quarter adjusted operating profit margin of 23.7% was aligned with our previous guidance of mid-20%. Our full-year 2025 adjusted operating profit margin of 27% was within our original expectations for the year.

第四季調整後營業利潤率為 23.7%，與我們之前 20% 左右的預期相符。我們2025年全年調整後的營業利益率為27%，符合我們最初的預期。

For 2026, we expect approximately 150 basis points constant currency operating margin expansion, which includes less spending related to removing JenaValve from our operating plans for the year. We continue to plan for 50 to 100 basis points of operating margin expansion annually on average in 2027 and beyond. We continue to plan to deliver leveraged earnings per share.

2026 年，我們預計以固定匯率計算的營業利潤率將增長約 150 個基點，其中包括因將 JenaValve 從我們當年的營運計劃中移除而減少的支出。我們計劃在 2027 年及以後，平均每年實現 50 至 100 個基點的營業利潤率成長。我們將繼續按計劃實現槓桿化的每股收益。

Turning to taxes. Our reported tax rate this quarter was 29% or 17.9%, excluding the impact of special items, which was above our expectation for the quarter, driven by Pillar Two impact and country income mix. We continue to expect our 2026 tax rate, excluding special items, to be between 16% and 19%.

接下來談談稅務問題。本季我們報告的稅率為 29%，若不計特殊項目的影響，則為 17.9%，高於我們對本季的預期，這主要得益於第二支柱的影響和國家收入結構。我們仍然預計，2026 年的稅率（不包括特殊項目）將在 16% 到 19% 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 December 31. Edwards currently has approximately $2 billion remaining under its share repurchase authorization.

接下來看一下資產負債表。截至12月31日，我們擁有約30億美元的現金及現金等價物，資產負債表仍穩健且靈活。愛德華茲目前在其股票回購授權範圍內還有約 20 億美元剩餘。

Average diluted shares outstanding during the quarter were 582 million. We continue to expect average diluted shares outstanding for 2026 to be between 580 million to 585 million.

本季平均稀釋後流通股數為 5.82 億股。我們仍預期 2026 年平均稀釋後流通股數將在 5.8 億股至 5.85 億股之間。

Foreign exchange rates increased fourth-quarter reported sales growth by 170 basis points or $20 million compared to the prior year. FX rates had minimal impact on our fourth-quarter gross profit margin compared to the prior year. Relative to our October guidance, FX rates had a nominal impact on fourth-quarter earnings per share. At current rates, we now expect FX to have an approximately $40 million upside to full-year 2026 sales compared to the prior year.

外匯匯率上漲使第四季報告的銷售額比去年同期成長了 170 個基點，即 2,000 萬美元。與去年同期相比，匯率波動對我們第四季的毛利率影響甚微。與我們 10 月的預期相比，匯率波動對第四季每股盈餘的影響微乎其微。以目前的匯率計算，我們預計 FX 2026 年全年銷售額將比上一年增長約 4,000 萬美元。

I'll finish with comments related to our outlook. We have increased confidence in meeting our 2026 full-year sales growth rate guidance of 8% to 10% and earnings per share guidance of $2.90 to $3.05. The product group sales guidance we provided at investor conference remains unchanged.

最後，我將談談我們對未來的展望。我們更有信心實現2026年全年8%至10%的銷售成長率預期和2.90美元至3.05美元的每股盈餘預期。我們在投資者會議上提供的產品組銷售預期保持不變。

For the first quarter, we're projecting sales of $1.55 billion to $1.63 billion. We expect slightly higher growth rates in the first half of 2026, following unusual summer seasonality that benefited 2025. We are expecting adjusted EPS in Q1 of $0.70 to $0.76, representing mid-teens growth at the midpoint of that range.

我們預計第一季銷售額為 15.5 億美元至 16.3 億美元。繼 2025 年夏季異常季節性因素帶來利多之後，我們預計 2026 年上半年的成長率將略高一些。我們預計第一季調整後每股收益為 0.70 美元至 0.76 美元，以該區間中點計算，成長幅度為 15% 左右。

And with that, I'll pass it back to Bernard.

好了，現在我把麥克風遞回給伯納德。

Thank you, Scott. In closing, we finished 2025 strong and achieved many lasting catalysts. We have increased confidence in our top-line and bottom-line guidance for 2026. Our strategy of focusing on structural heart is demonstrating impactful results for the company and the patients we serve and is positioning us for long-term sustainable growth and value creation.

謝謝你，斯科特。綜上所述，我們以強勁的勢頭結束了 2025 年，並​​取得了許多持久的成就。我們對 2026 年的營收和利潤預期更有信心。我們專注於結構性心臟病的策略正在為公司和我們服務的患者帶來顯著的成果，並使我們處於長期可持續成長和價值創造的地位。

With that, I will turn it back over to Gerianne.

這樣，我就把麥克風交還給傑瑞安娜了。

Thank you, Bernard. We're ready to take your questions. (Event Instructions)

謝謝你，伯納德。我們已準備好回答您的問題。（活動須知）

(Operator Instructions) Robbie Marcus, JPMorgan.

（操作說明）羅比·馬庫斯，摩根大通。

Great. Congrats on a good quarter. Thanks for taking the questions. Two for me. First, maybe just on TAVR, 10.6%, another very strong quarter. I would have to imagine you're taking some share even excluding the Boston Scientific exit.

偉大的。恭喜你本季業績出色。謝謝您回答問題。我兩個。首先，或許就 TAVR 而言，佔 10.6%，又是一個非常強勁的季度。即使不考慮波士頓科學公司的退出，我估計你也會持有部分股份。

So maybe just speak to the strength you're seeing, the confidence in it, and any regional differences? And just one thing, if you can talk to volumes versus sales. I imagine the delta's price, but I had some questions on that.

所以，或許可以談談你所看到的實力、信心以及任何地區差異？還有一件事，如果你能談談銷量和銷售額的差異就好了。我大致估算了一下價格，但對此還有一些疑問。

Thanks, Robbie. Good afternoon, everyone. Yeah, one is we are very pleased about the quarter overall in the year for Edwards.

謝謝你，羅比。大家下午好。是的，首先，我們對 Edwards 今年本季的整體表現非常滿意。

With regards to TAVR, very pleased about the quarter. Like you said, we're growing 10.6% year over year. And what we see is really the results of our strategy here, where last year, we brought a very compelling evidence, early TAVR, PARTNER III, 7 years; PARTNER II, 10 years. And all of this gave confidence. All of this also enable a renewed focus on TAVR as a category and specifically the SAPIEN platform.

關於經導管主動脈瓣置換術（TAVR），我對本季的業績非常滿意。正如你所說，我們比去年同期增長了 10.6%。而我們現在看到的，正是我們策略的成果。去年，我們帶來了非常有說服力的證據，早期經導管主動脈瓣置換術（TAVR）的 PARTNER III 研究，追蹤 7 年；PARTNER II 研究，追蹤 10 年。這一切都增強了他們的信心。所有這些都使得人們重新關注 TAVR 這個類別，特別是 SAPIEN 平台。

So this is creating the physicians to talk more about TAVR, to talk more about SAPIEN. This is enabling a physician to treat their patients a little bit early. This is also enabling providers to prioritize TAVR.

所以，這促使醫生們多談論經導管主動脈瓣置換術（TAVR），多談SAPIEN系統。這使得醫生能夠更早地對病人進行治療。這也使得醫療機構能夠優先考慮經導管主動脈瓣置換術（TAVR）。

So it is all of that together, but I'm going to ask you, Dan, to give you more specific details about the quarter.

所以，這一切都是綜合起來的，但丹，我想請你提供一些關於本季的具體細節。

Yeah. Thanks, Bernard. And Robbie, you're spot on. Like the overall procedural growth rate in the quarter was in the high-single digit. And so there is a gap. And you're absolutely on the money as far as share gain and pricing contributing to that gap.

是的。謝謝你，伯納德。羅比，你說得完全正確。本季整體手術量成長率接近兩位數。因此，這裡存在差距。你說的完全正確，股價上漲和定價確實會造成這種差距。

Largely on the share perspective, I mean, the share gain that we had from the Boston Scientific exit, contributed a big chunk of that. We are pleased to see the stickiness of that share gain from quarter three to quarter four. We took our piece of that. But most of the competitors in Europe also benefited from Boston's exit. I would say that we benefited about in line with our competitive position in the market.

從股份角度來看，我們從退出波士頓科學公司獲得的股份成長，很大程度上促成了這一增長。我們很高興看到第三季到第四季市佔率的成長動能得以維持。我們也分得了我們應得的那一份。但波士頓的退出也讓歐洲的大多數競爭對手受益。我認為我們所獲得的收益與我們在市場上的競爭地位基本相符。

But if you look at globally, like overall, our competitive position remains relatively stable, I would say. I mean, for sure, we're not weaker in Q4 than we were in Q3. But another piece of this is S3UR penetration, right? And we continue to see very strong adoption of this outstanding platform, a lot of positive feedback from physicians. And so this is also contributing like you mentioned a little bit on the price side.

但從全球範圍來看，整體而言，我認為我們的競爭地位仍然相對穩定。我的意思是，可以肯定的是，我們第四季的實力並不比第三季弱。但 S3UR 滲透率也是其中一個重要的組成部分，對吧？我們持續看到這個卓越平台得到非常強勁的採用，並收到來自醫生的許多正面回饋。所以，正如你所提到的，這也對價格方面產生了一定影響。

Great. Maybe, Scott, just if you could talk to the increased spend on market access, you highlighted in fourth quarter, step up in SG&A was roughly $100 million, which is pretty substantial. So maybe just dig into that, where did the spending go? And how should we think about that rolling in? Do we think of that as one-time cost? Thanks.

偉大的。史考特，或許你可以談談你在第四季重點提到的市場准入支出增加的問題，銷售、一般及行政費用的增幅約為 1 億美元，這相當可觀。所以或許應該深入調查一下，這些錢都花到哪裡去了？我們該如何看待這種湧入的情況？我們是否將其視為一次性成本？謝謝。

Yeah. Thanks, Robbie. I appreciate the question. We had planned a step-up in the fourth-quarter spending, and we decided to be aggressive in light of the reception we were getting to the things Bernard mentioned earlier, the asymptomatic trial, the 7-year results, the 10-year results. And so we intentionally upped their spending in the fourth quarter, $112 million year over year. We were still in operating margin terms in the area that we had expected for the fourth quarter. So we had said mid-20% and that was sort of in the range of where we came in.

是的。謝謝你，羅比。感謝您的提問。我們計劃在第四季度加大投入，鑑於伯納德之前提到的那些事情，例如無症狀試驗、7 年結果和 10 年結果，我們決定採取積極主動的措施。因此，我們特意增加了他們在第四季度的支出，比去年同期增加了 1.12 億美元。從營業利益率來看，我們第四季的利潤率仍然符合預期。所以我們之前說的是20%左右，而這和我們最終的投入水準差不多。

We invested more aggressively in PATIENT access, so asymptomatic amplification. Bernard mentioned the American Heart Association partnership. We've also been reinforcing our field force in THV and also in TMTT. Some of the spending was delayed from earlier quarters in 2025.

我們加大了對病患就醫的投入，因此無症狀感染的傳播也加劇了。伯納德提到了與美國心臟協會的合作關係。我們也一直在加強我們在 THV 和 TMTT 的現場力量。部分支出從 2025 年之前的季度推遲到現在。

So following this elevated level of spending in Q4, we are planning a more moderated operating expense growth and SG&A expense growth in 2026, which is how we get to the operating margin guidance of the high end of our original 28% to 29%.

因此，在第四季度支出水準提高之後，我們計劃在 2026 年將營運費用成長和銷售、一般及行政費用成長控制在較為溫和的水平，這樣我們才能實現最初 28% 至 29% 的營運利潤率預期上限。

The other benefit in that margin increase or margin expansion is the exclusion of the original spending that we had planned for JenaValve.

利潤率提高或利潤率擴張的另一個好處是，我們無需支付原計劃用於 JenaValve 的支出。

Maybe, Dan, do you want to talk a little bit more about some of these initiatives?

丹，或許你想再多談談這些舉措？

Yeah. I think like a couple of big ones here. So with the change in the European guidelines. This is the biggest shift that we've seen in over 10 years. And it's a real important shift from watchful waiting to intentional and urgent treatment of severe aortic stenosis earlier in the disease pathway. This is a big shift.

是的。我覺得這裡面有幾個大問題。因此，歐洲的指導方針也隨之改變。這是我們十多年來看到的最大變化。這是從觀察等待到在疾病早期階段對嚴重主動脈瓣狹窄進行有針對性和緊急治療的一個重要轉變。這是一個巨大的轉變。

It involves change management and change of behavior, particularly at the referral level. And so we see an opportunity here to bend the curve of adoption of these guideline changes. And so we have a number of significant amplification programs that we have started and started to implement in Europe. This is a big one.

它涉及變革管理和行為改變，尤其是在轉介層面。因此，我們看到了一個扭轉這些指導方針變更採納趨勢的機會。因此，我們已經在歐洲啟動並開始實施一些重要的推廣計劃。這是件大事。

Second one, as Scott and Bernard mentioned, our partnership with the AHA. This is an important one, and this is a multiyear partnership, and it's designed to do the same thing, democratize and educate on the importance of treating earlier in the disease pathway for aortic stenosis. And so this is all designed to improve diagnosis and treatment of severe AS through guideline-based care through extended data collection, but also heavy on education. And so these are two big ones.

第二點，如 Scott 和 Bernard 所提到的，是我們與 AHA 的合作關係。這是一項重要的合作，也是一項多年合作，其目的在於普及和教育人們在主動脈瓣狹窄疾病早期階段進行治療的重要性。因此，這一切都是為了透過擴大數據收集，以指南為基礎的護理來改善重度僵直性脊椎炎的診斷和治療，同時也非常重視教育。所以，這是兩件大事。

We also invested further in some of the sort of short-range pilot stage marketing programs to improve treatment rates and patient and referral education in the United States. And like Scott said, there are some field -- we're very much a high-touch field clinical field force, and with volumes increasing, we need to get ahead of those resources in the field. They take time. They take time to train and get people certified. So we got ahead a little bit of that, but also a big chunk we got behind early in the year and a lot of that caught up with us in Q4. So they are the big items.

我們也進一步投資了一些短期試點階段的行銷項目，以提高美國的治療率以及病患和轉診教育水準。正如 Scott 所說，我們有一些現場——我們是一支高度依賴現場服務的臨床現場隊伍，隨著業務量的增加，我們需要提前做好準備，利用現場資源。這需要時間。他們需要時間進行培訓並獲得認證。所以我們在一部分方面取得了一些進展，但年初的時候我們又落後了很大一部分，而這些落後的局面在第四季度又給我們造成了很大的影響。所以它們都是大件物品。

Travis Steed, Bank of America.

特拉維斯·斯蒂德，美國銀行。

Hey, everybody, congrats. Just wanted to maybe focus on for TAVR and total company growth. Anything to kind of call out for cadence over the year? And I wasn't clear on an organic basis, what Q1 was to me since I didn't have the FX impact in Q1? And any comments on kind of like the January trends that you've seen so far to give you confidence in the guide? Then I have a follow-up.

嘿，各位，恭喜！只是想專注於TAVR和公司的整體發展。一年有什麼需要特別注意的，例如節奏方面？而且，由於第一季沒有受到外匯影響，我並不清楚第一季對我來說意味著什麼。對於目前為止你觀察到的1月份趨勢，你有什麼看法可以增強你對這份指南的信心嗎？然後我還有一個後續問題。

Thanks, Travis. Yeah. So I mentioned that we expect about $40 million of tailwind from FX to sales. This has changed since our investor conference. A lot of that falls in the first quarter. And so we're expecting Q1 sales growth on a reported basis to be about 300 basis points higher than the underlying growth that we are expecting in Q1.

謝謝你，崔維斯。是的。所以我提到過，我們預計外匯市場將為銷售額帶來約 4000 萬美元的利好。自從我們召開投資者大會以來，情況已經改變了。其中很多都發生在第一季。因此，我們預計第一季報告的銷售成長將比我們預期的第一季實際成長高出約 300 個基點。

Now remember, the first half growth rates in 2026 should be higher than the second-half growth rates. And maybe Dan, I'll ask you to talk a little bit more about that.

請記住，2026 年上半年的成長率應該高於下半年的成長率。丹，或許我會請你再多談談這方面的問題。

Yeah, thanks. Scott. Yeah, it's true. The growth rate in our guidance moves down a little bit over the course of this year. As previously, we guided that the front half will be stronger than the back half in '26, and this is because we have much tougher, much higher year-over-year comps in the second half.

嗯，謝謝。斯科特。是的，沒錯。今年，我們預測的成長率將略有下降。正如之前預測的那樣，2026 年上半年的表現將強於下半年，這是因為下半年的同比數據要高得多，競爭也更加激烈。

We also applied classical seasonality and other assumptions to the year that weren't the case in 2025. That makes it a little bit more of a challenge. But the Q4 results that we had in 2025 give us increased confidence in our 6% to 8% guidance. And this is really important.

我們也對某一年應用了經典的季節性和其他假設，但這些假設在 2025 年並不適用。這就增加了一些挑戰性。但我們在 2025 年第四季的業績讓我們對 6% 至 8% 的成長預期更有信心。這一點非常重要。

On top of that, we have these meaningful tailwinds and catalysts later in the year that give us confidence in the mid- to high-single digit beyond 2026.

除此之外，今年稍後我們還將迎來一些重要的順風和催化劑，這讓我們有信心在 2026 年後實現個位數中高成長。

Got it. And then I have a follow-up on the TAVR NCD. You called it a potential tailwind later this year. Just wanted to kind of think about how you're seeing that help growth more centers, faster patient pathways and if you read the public comments, they're all mostly positive on expanding the indication, but there's a bit more debate on the care team. So curious if you think how that shapes up in the final and how that might impact the different scenarios you're thinking about?

知道了。然後我還要跟進一下 TAVR NCD。你稱它今年晚些時候可能會成為一股順風。我只是想思考一下，您認為這有助於發展更多中心，並加速病患就診流程。如果您閱讀公眾評論，您會發現他們大多對擴大適應症持正面態度，但護理團隊內部對此仍有一些爭議。我很想知道你認為這在最終結果中會如何發展，以及這會對你正在考慮的不同情況產生怎樣的影響？

Yeah. So I'll take this one. I think, obviously, it's very, very important. The first phase -- first of all, it's important that the process was formally reopened. That was really important that happened right before the end of the year.

是的。那我就選這個吧。我覺得，這顯然非常非常重要。第一階段—首先，重要的是正式重新啟動該程序。那件事發生得非常重要，就在年底前。

And the first phase is now over, as Bernard mentioned. So we expect the initial draft around the June timeframe. There will be a second round of public commentary at that point. And then assuming that the normal CMS process follows the final determination could be in the Q4 timeframe.

正如伯納德所說，第一階段現在已經結束了。因此，我們預計初稿將在六月左右出爐。屆時將進行第二輪公眾意見徵詢。然後，假設 CMS 的正常流程按照最終決定執行，那麼最終決定可能在第四季度做出。

So if you think about impact for 2026, negligible, but probably important and more relevant in 2027 and beyond.

因此，如果考慮 2026 年的影響，那麼微乎其微，但到 2027 年及以後，可能會變得重要且更具相關性。

Now, the key priority areas for us is to ensure timely and equitable access to care for patients. And the big win for patients would be coverage to label and any changes that may reduce procedural complexity or help improve equitable access to care. So that's what we're focused on. But we need to see what the draft looks like, and we look forward to the process continuing.

現在，我們的首要任務是確保患者能夠及時、公平地獲得醫療服務。對患者而言，最大的好處將是藥品標籤的覆蓋範圍，以及任何可能降低手術複雜性或有助於提高醫療服務公平性的改變。所以這就是我們關注的重點。但我們需要看看草案是什麼樣子，我們期待這個過程繼續下去。

And like you mentioned, we're also pleased that most of the commentary was positive and largely in line with our thinking.

正如您所提到的，我們也欣慰地看到，大多數評論都是正面的，並且與我們的想法基本一致。

Larry Biegelsen, Wells Fargo.

拉里·比格爾森，富國銀行。

Good afternoon. Thanks for taking the question. Two for me. I wanted to just ask about the LAA opportunity. How big is that market today? There's a competitor that has a device which sales of, I think, over $200 million. How is yours differentiated, and how do you want us to think about your LAA sales ramp over the next few years? And I have a follow-up.

午安.感謝您回答這個問題。我兩個。我只是想問一下關於 LAA 的機會。如今這個市場有多大？有一家競爭對手的產品銷售額，我認為超過 2 億美元。你們的方案有何不同之處？你們希望我們如何看待你們未來幾年的LAA銷售成長計​​畫？我還有一個後續問題。

Thanks, Larry. We apply always the same filter when we decide to get into a new space. It is all about -- is there a big unmet patient needs. Can we have an impact? Can we bring differentiated technologies? And so we look at this one and we say, yes, yes, and yes.

謝謝你，拉里。當我們決定進入一個新領域時，我們總是採用相同的篩選標準。關鍵在於——是否存在未被滿足的重大患者需求。我們能產生影響力嗎？我們能否引進差異化技術？所以我們看到這個，我們說，是的，是的，是的。

So how big it is? We don't know very well in this segment yet. But we believe -- there is some technology out there. We believe there is still met patient needs. And long term, we believe we can have an impact here.

它到底有多大？我們在這個領域還不太了解。但我們相信——已經有一些技術可以解決這個問題。我們認為目前仍能滿足患者的需求。從長遠來看，我們相信我們能在這裡產生影響。

But I'm going to ask Daveen which is very close to this one to add some comments.

但我會請與此非常接近的戴文補充一些評論。

Thanks, Bernard. Thanks, Larry, for the question. Yeah. Obviously, as we mentioned, we're looking to enter the market later this year. And if you look at existing technologies out there, we think there's still unmet patient needs. And that's where we believe, obviously, that we can come out with the technology in this new therapeutic area for Edwards Surgical, we can come out with a solution that can really help patient care.

謝謝你，伯納德。謝謝你的提問，拉里。是的。正如我們之前提到的，我們計劃在今年稍後進入市場。縱觀現有技術，我們認為仍有未被滿足的患者需求。顯然，我們相信，在這個新的治療領域，我們可以為 Edwards Surgical 開發出相應的技術，我們可以開發出真正有助於患者護理的解決方案。

And we see this as a complementary solution to our specific valvular procedures that we're already in. So as a result of that, we kind of see kind of a measured commercial rollout and opportunity to be a growth driver in the future for Edwards Surgical.

我們認為這是我們目前進行的特定瓣膜手術的補充解決方案。因此，我們看到了一種穩步推進的商業推廣，並有機會在未來成為 Edwards Surgical 的成長動力。

That's super helpful. Bernard, we saw a long list of catalysts in '26 in your press release today. And I think people will notice that you didn't mention moderate AS. So can you talk about why you left that out? And how you're thinking about the moderate opportunity today? Thanks for taking the question.

這太有幫助了。伯納德，我們在你今天的新聞稿中看到了 2026 年的一長串催化劑清單。而且我認為人們會注意到你沒有提到中度AS。那麼，你能說說你為什麼漏掉了這一點嗎？那麼，您如何看待現今的適度投資機會？感謝您回答這個問題。

Thanks, Larry. I'm glad you saw you have a long list and indeed, it is a very long list. And let me first talk a little bit about why all of these catalysts and then I will get your question about moderate. The risk is very long because of our very unique strategy, where we invest early, we are very committed.

謝謝你，拉里。很高興你看到了你的清單很長，的確，那是一個非常長的清單。首先讓我簡單談談為什麼會有這些催化劑，然後再回答你關於「適度」的問題。由於我們採取了非常獨特的策略，即早期投資並全力投入，因此風險非常大。

We have a flawless execution, I'm sure you have seen that. The kind of results we have had in 2025 is pretty spectacular. Financially, having all of these catalysts, new technologies, new evidence, lasting evidence, lasting impact. All of them are basically in place for this year.

我們的執行堪稱完美，我相信你已經看到了。我們在2025年所取得的成果相當驚人。從經濟角度來看，擁有所有這些催化劑、新技術、新證據、持久證據和持久影響。今年這些工作基本上都已就緒。

With moderate for sure, moderate is a big category. We know that the moderate, your prevalence is bigger than the severe one. We know it is big, but at the same time, we don't know what the study result will be. So we are waiting to know more about progress of the PROGRESS trial, which will be presented at TCT to talk more about it.

當然，中等水平是一個很大的類別。我們知道，中度病例的盛行率高於重度病例。我們知道這件事意義重大，但同時，我們也不知道研究結果會是什麼。因此，我們正在等待了解 PROGRESS 試驗的更多進展，該試驗將在 TCT 上進行展示，以便更詳細地討論。

What you'll have the least, what you have seen is where we know for sure where this is coming and the type of impact we are going to have, progress and moderate, big opportunity. We don't know yet we'll have the steady results.

你所擁有的最少，你所看到的，是我們確切知道它將要發生什麼以及我們將產生的影響類型，進步和適度，巨大的機會。我們還不知道能否獲得穩定的結果。

David Roman, Goldman Sachs.

大衛羅曼，高盛集團。

Thank you. Good afternoon, everybody. I was hoping you could go into a little bit more detail on the comments regarding lifetime management for TAVR. And maybe more specifically talk about what you think the implications will be to valve and vendor selection, balloon expandable versus self-expandable? How that might end up being a contributor to incremental market share gains as you think about the TAVR business here in 2026 and beyond?

謝謝。大家下午好。我希望您能更詳細地談談關於TAVR終身管理的評論。或許可以更具體地談談您認為球囊擴張式閥門與自擴張式閥門在閥門和供應商選擇方面會有哪些影響？展望 2026 年及以後的 TAVR 業務，最終將如何有助於市場佔有率的逐步成長？

So I know that Dan has a lot of passion about this one. So I'm going to let Dan talk about this.

所以我知道丹對這件事充滿熱情。那麼，我讓丹來談談這件事。

No, you're on the right point, David. I mean, look, the evidence, and when I say evidence, I'm talking the early TAVR evidence, the subanalysis from EARLY TAVR, the evidence that the likes of Philippe Généreux has published now on acute valve syndrome. And then you've got PARTNER III and PARTNER II long-term data on top of this all pointing to the fact that you're going to get a better clinical and economic benefit if you treat earlier in the disease pathway. This is a huge shift.

不，你說的沒錯，大衛。我的意思是，你看，證據，當我說證據時，我指的是早期的TAVR證據，早期TAVR的亞組分析，以及像Philippe Généreux這樣的人現在發表的關於急性瓣膜綜合徵的證據。此外，PARTNER III 和 PARTNER II 的長期數據也表明，如果在疾病早期階段進行治療，將會獲得更好的臨床和經濟效益。這是一個巨大的轉變。

And it changes the conversation between doctors and patients. So if you can imagine a year ago or a little bit more, you might have -- it might have been something along the lines of, let's see if we can eat this out another 6 months or 12 months or maybe a patient would want to thinking that they're trying to time their treatment and trying to figure out how to make their valve last as long as possible to avoid secondary or tertiary procedures. And this conversation has completely shifted because the evidence says that the benefit of doing that is not -- there's no upside to that, right? There's no upside to waiting anymore.

它改變了醫生和患者之間的對話方式。所以，如果你能想像一下一年前或更久以前，你可能會想——大概是這樣的，看看我們能不能再撐6個月或12個月，或者病人可能會想，他們正在努力把握治療時機，並努力弄清楚如何讓他們的瓣膜盡可能長時間地使用，以避免二次或三次手術。而這場討論已經完全轉變了，因為證據表明這樣做沒有好處——這樣做沒有任何好處，對吧？再等下去沒有任何好處了。

And so this brings into the very important conversation and concept of lifetime management, this is very, very important because you got to get the first procedure right to make sure you've got options and the right options for patients for their second procedure, whether that be another valve and valve or whether that be coronary artery access, PCI, or [what have you].

因此，這就引出了一個非常重要的議題和概念──終身管理。這一點至關重要，因為必須確保第一次手術成功，才能確保患者在第二次手術時有合適的選擇，無論是再次進行瓣膜置換手術，還是進行冠狀動脈介入治療（PCI）或其他手術。[你有什麼]

And so we think our platform is uniquely positioned, both acutely and with lifetime management options, whether that be secondary or tertiary procedures. And I think that's going to be one of the key value propositions that we have not only immediately but in the years to come.

因此，我們認為我們的平台具有獨特的優勢，無論是急性治療還是終身管理方案，無論是二次治療還是三次治療。我認為這不僅是我們眼下的關鍵價值主張之一，而且在未來幾年也將如此。

And maybe just a clarification there. So in that scenario, is it reasonable to expect that just a significant percentage of patients receiving TAVR either in the asymptomatic or call it the sub population that creates a unique opportunity for SAPIEN?

或許還需要澄清一下。那麼在這種情況下，是否有合理的預期，接受 TAVR 治療的患者中，無論是無症狀患者還是次人群，都會有相當一部分人為 SAPIEN 創造獨特的機會？

And maybe just my follow-up, I'd ask you on capital allocation. You've obviously pulled -- the JenaValve deal did not end up coming to fruition. You bought back a good amount of stock last year, but you've also made some key hires to the business development team. Maybe just talk to us about your latest thinking here on capital allocation.

最後，我還想問一個關於資本配置的問題。顯然你已經撤資了——JenaValve的交易最終沒有實現。去年你回購了相當數量的股票，但你也為業務發展團隊招募了一些關鍵人才。或許您可以和我們談談您最近在資本配置方面的想法。

Yeah. So as far as the -- look, whether it be younger patients or whether it be elderly patients, there's a good chance now with modern medicine in the way that this is going, that patients will outlive their first valve. I mean, it's -- I think lifetime management considerations is not just now for youthful patients.

是的。所以就目前來看——無論是年輕患者還是老年患者，以現代醫學的發展趨勢來看，患者很有可能比他們的第一個瓣膜活得更久。我的意思是，我認為終身管理的考量不僅僅是針對年輕患者。

And in fact, more and more, we see -- we find ourselves in scenarios where certain valve platforms were chosen with the idea that the patient would not outlive that valve. And then finding the options for that patient limited at that time point, which is really disappointing. So this lifetime management thing, getting the first procedure, right, upfront is a big thing. It is a conversation that everybody is focused on in the clinical community.

事實上，我們越來越發現，在某些情況下，選擇某些瓣膜平台時，考慮到患者的壽命不會超過瓣膜的壽命。然後發現當時該患者的選擇有限，真的很令人失望。所以，這種終身管理，也就是第一次治療要正確、及時地進行，是一件非常重要的事。這是臨床界所有人都在關注的議題。

Now, as far as strategic allocation, look, we think valve and valve and whether you throw in leaflet modification or other types of things associated with secondary procedures, we think this is going to be very real. It's small now, but it will be growing. It's all about the denominator and the numerator. And so we're looking at ways as we always do to lead in this space, and that's something that we're looking at very, very closely.

至於策略性分配，我們認為，無論是瓣膜和瓣膜，還是瓣膜改良或其他與二次手術相關的項目，我們都認為這將是非常現實的。它現在規模很小，但將來會成長。關鍵在於分母和分子。因此，我們一如既往地尋找引領這一領域的方法，這也是我們正在非常密切關注的事情。

The other thing that obviously we do is we look at how we apply our field force here and how we invest in our field force and what kind of value that we bring with our service model as these conversations and these types of procedures evolve in terms of how to get the best outcome for a patient at any given time.

顯然，我們也會考慮如何運用我們的現場團隊，如何投資於我們的現場團隊，以及隨著這些對話和這類流程的演變，我們的服務模式能帶來什麼樣的價值，從而在任何特定時間為患者帶來最佳結果。

And on capital allocation, David, our priorities have not changed. Our first priority is investing in the business to support our growth. And that comes in the form of making sure we've got sufficient production capacity. And as we mentioned at the investor conference, we are increasing our production capacity to keep up with the growth in TAVR, TMTT, and Surgical. It also involves making external investments.

至於資本配置方面，戴維，我們的優先事項並沒有改變。我們的首要任務是投資於業務發展，以支持我們的成長。而這需要確保我們有足夠的生產能力。正如我們在投資者大會上提到的，我們正在提高產能，以滿足 TAVR、TMTT 和外科手術業務的成長需求。它還包括進行外部投資。

And so we've got a number of different activities underway. We've always been active in M&A. As you know, most of the things that we invest in or purchase tend to be smaller in size because we're focused on structural heart. But that's going to be a continual direction for allocation of capital.

因此，我們正在進行許多不同的活動。我們一直積極參與併購活動。如你所知，我們投資或購買的大多數東西往往體積較小，因為我們專注於結構性心臟。但這將是資本配置的持續方向。

And then share repurchase is one of our best ways to return capital to shareholders. And we continued our share repurchase activities in the fourth quarter. We bought back about $40 million, bringing the total repurchase in 2025 to just under $900 million.

股票回購是我們向股東返還資本的最佳方式之一。第四季度，我們持續進行股票回購活動。我們回購了約 4,000 萬美元的股票，使 2025 年的總回購額略低於 9 億美元。

We still have about $2 billion of authorization remaining. And you should expect that we're going to continue to look for opportunistic times to repurchase more shares.

我們還有大約20億美元的授權額度剩餘。你們應該預料到，我們將繼續尋找合適的時機回購更多股票。

Joanne Wuensch, Citi.

Joanne Wuensch，花旗銀行。

Good afternoon, and thank you so much for taking my question. Could you give us a little bit of a state of the union on how M3 is being taken up in the United States and any -- or what impacts are going outside the United States?

下午好，非常感謝您回答我的問題。您能否簡單介紹M3在美國的推廣情況，以及它對美國以外的影響？

And then if you could just sort of flesh out and give a little bit more color on the guideline changes that are happening in Europe and how to think about those impacts for the remainder of the year? Thank you.

然後，您能否詳細說明歐洲正在發生的指導方針變化，以及這些變化對今年剩餘時間的影響？謝謝。

Thanks, Joanne, It's Daveen. I appreciate the question. Talk a little bit about the SAPIEN M3 launch. We're just starting in the US, right? We got approval, obviously, right before the end of the year. And it's kind of scaling in line with our expectations here in the US if we're just starting to open up centers, really focusing on centers who are, in our own circle, pivotal clinical study first.

謝謝你，喬安妮，我是戴文。感謝您的提問。請簡單談談SAPIEN M3的發布情況。我們才剛開始在美國開展業務，對吧？很顯然，我們在年底前就獲得了批准。在美國，如果我們剛開始開設中心，並且真正專注於我們自己圈子裡那些關鍵的臨床研究中心，那麼它的規模發展就符合我們的預期。

In Europe, we're scaling in line with expectations as well, but it's still pretty early in the process. I think what we like that we're seeing is that we're getting really high procedural success, and we're getting really great patient outcomes.

在歐洲，我們的規模擴張也符合預期，但目前仍處於早期階段。我認為我們樂見的是，我們的手術成功率非常高，病患的治療效果也非常好。

As a matter, I was with a patient just the other week, who had previously had mitral valve surgery and then needed an M3 surgery had failed. And for him, hearing about the difference of life made when he had no other tier or surgical alternatives with mitral regurgitation really hurting his life and how we just got so much better, just -- it warmed my heart so much to kind of hear that.

事實上，就在前幾週，我遇到了一位病人，他之前做過二尖瓣手術，後來需要進行 M3 手術，但手術失敗了。對他來說，聽到他因為二尖瓣逆流而生活發生了翻天覆地的變化，以及我們後來的生活變得多麼好，這讓我感到非常溫暖。當時他別無選擇，只能接受手術治療。聽到這些，我真的非常感動。

So because of that, we're seeing this physician excitement because there's a group of patients who didn't -- who don't really have tier or have great surgical options, which M3 really becomes a good opportunity. So for us, we're continuing to appropriately kind of scale up, open up new centers and bring this therapy to new patients. So that's kind of SAPIEN M3.

正因如此，我們看到醫生們感到興奮，因為有一部分患者沒有——他們沒有真正意義上的分級或很好的手術選擇，而 M3 確實成為了一個好機會。因此，我們將繼續適當擴大規模，開設新的中心，並將這種療法帶給新的患者。所以這就是 SAPIEN M3 的雛形。

And maybe moving on to kind of European guidelines -- start with TAVR guidelines or the European guidelines -- already talking about the FMR guidelines a little bit.

或許可以轉向歐洲指南——從 TAVR 指南或歐洲指南開始——已經稍微談到了 FMR 指南。

So yeah, in the European guidelines with FMR, they're now Class I for functional micro-regurgitations for reduction of heart failure hospitalization. So we're seeing, I think, increased awareness, specifically in mitral and tricuspid increased awareness for these two diseases and increase kind of referrals happening with this guideline shifts. So we see it as helping continue that double-digit tier market growth that we've been seeing?

是的，根據歐洲關於功能性二尖瓣逆流 (FMR) 的指南，它們現在被列為 I 類，用於減少心臟衰竭住院治療的功能性微逆流。所以，我認為我們看到人們對二尖瓣和三尖瓣疾病的認識有所提高，隨著指引的轉變，轉診病例也增加了。所以我們認為這將有助於延續我們一直以來看到的兩位數市場成長？

And maybe passing on to TAVR for a comment on the guidelines, Dan?

丹，或許可以向TAVR諮詢一下關於這些指引的意見？

Joanne, as you may recall, the guidelines on the TAVR side changed in a meaningful way on two fronts. One is they reduce the age recommendation for TAVR going from 75 to 70. That's one big element of the change. And then the other element was this whole concept of recommending proactive disease management regardless of symptom or heart function. So this is basically taking changing the dogma of watchful waiting in Europe. And so this is a huge shift.

Joanne，你可能還記得，TAVR 方面的指導方針在兩個方面發生了重大變化。其中一項措施是將經導管主動脈瓣置換術 (TAVR) 的建議年齡從 75 歲降低到 70 歲。這是變革中的一個重要因素。另一個要素是，無論症狀或心臟功能如何，都建議積極主動地進行疾病管理。所以這基本上是在改變歐洲「密切觀察」的教條。所以這是一個巨大的轉變。

Now that is a -- that requires a lot of education. You can imagine, we're seeing -- definitely, we did see healthy procedural growth in Q4 in Europe and some of the large countries contributed to that in a meaningful way.

這需要大量的教育。您可以想像，我們看到——當然，我們在第四季度確實看到了歐洲手術量的健康增長，一些大國也為此做出了重要貢獻。

But the way that we look at this is the guidelines won't be a light switch, whether it be in Europe or the US or Japan, but give us an opportunity as those get disseminated as those get democratized and then put into practice, it's just layers and layers of durable growth for us. And so that's kind of how it's playing out, not a light switch, but definitely momentum.

但我們看待這個問題的方式是，這些指導方針不會像電燈開關一樣一勞永逸，無論是在歐洲、美國還是日本，但它們會給我們帶來機會，隨著這些方針的傳播、民主化和實踐，它們會為我們帶來持久增長的層層遞進。所以事情的發展大致就是這樣，不是一蹴而就，但肯定是有動力的。

Thank you.

謝謝。

Matt Taylor, Jefferies.

馬特泰勒，傑富瑞集團。

Thanks for taking the question. I wanted to dig into the better performance we've seen in TAVR, especially in the US the last couple of quarters and just ask you what you thought is causing that, you're not benefiting from Boston. There, really are you gaining share? Can you estimate how much early TAVR has been contributing or are there other factors? What's really caused the increase in growth in the US in the last couple of quarters?

感謝您回答這個問題。我想深入探討我們最近幾季在經導管主動脈瓣置換術（TAVR）方面，尤其是在美國，所看到的更好的表現，並問問您認為是什麼原因造成的，您並沒有從波士頓受益。這樣真的能擴大市佔率嗎？能否估算早期經導管主動脈瓣置換術（TAVR）對結果的影響有多大，還是有其他因素？過去幾季美國經濟成長的真正原因是什麼？

So yeah, thanks for the question. And I think without trying to be on repeat here, but this data, this very, very compelling data, not just on the early TAVR and the asymptomatic side and not just clinical but also economic data. I mean, I can't stress how important the economic data -- benefit of the economics, treatment of patients and the hospital economics earlier in the disease pathway is having an effect as much as the clinical data. So these two things tied with definitive durability data is creating a wave of confidence in the community to have a different conversation.

是的，謝謝你的提問。我不想在這裡重複，但這些數據，這些非常、非常有說服力的數據，不僅涉及早期 TAVR 和無症狀方面，不僅涉及臨床數據，還涉及經濟數據。我的意思是，經濟數據的重要性怎麼強調都不為過——經濟效益、病患治療以及醫院經濟狀況在疾病早期階段的影響，與臨床數據一樣重要。因此，這兩件事再加上確鑿的耐久性數據，正在社群中掀起一股信心浪潮，從而展開一場不同的討論。

It is also forcing, if you like, the aortic stenosis patient, the TAVR patient to be prioritized differently and to be treated with urgency.

這也迫使主動脈瓣狹窄患者、TAVR 患者得到不同的優先考慮，並得到緊急治療。

Typically, you might see a little bit more rearranging of the patient list to bring more sick patients to the front of the list and the more healthier patients towards the back of the list rather than just getting through the list and this conversation is completely different now and people are focusing on this intentional and urgent treatment of symptomatic AS. So this is regardless of whether the patient is asymptomatic or not. This is the impact that it is having on symptomatic aortic stenosis is what we see largely driving our growth.

通常情況下，你會看到對病人名單進行一些調整，將病情較重的病人安排在名單前面，將病情較輕的病人安排在名單後面，而不是簡單地按順序就診。現在情況完全不同了，人們關注的重點是針對僵直性脊椎炎症狀的有意識和緊急治療。所以這與患者是否有症狀無關。我們看到，這種對有症狀主動脈瓣狹窄的影響，在很大程度上推動了我們的成長。

When we look at the claims data, we don't see asymptomatic patients coming in, in waves through the claims data. And that shouldn't be a surprise because the NCD doesn't cover asymptomatic indications at the moment. So right now, that's not a huge surprise.

當我們查看理賠數據時，並沒有發現無症狀患者成批湧入理賠數據。這不足為奇，因為目前國家傳染病防治計劃不涵蓋無症狀感染。所以現在看來，這並不令人感到意外。

What we do see though, since the indication in the United States, we do see increase in the number of echos. We do see increase in the number of referrals. We do see a decrease in time from referral to CT, which is the heart team evaluation. And interestingly enough, we do see a relatively sharp increase in stress tests for patients, and nobody typically likes to do stress tests. And so that's also an interesting finding that we see in the data. And so definitively, this is all positive momentum and is driving a lot of growth.

不過，自從美國出現相關跡像以來，我們確實看到迴聲數量增加。我們確實看到轉診數量增加。我們看到從轉診到 CT 掃描（即心臟團隊評估）的時間確實有所減少。有趣的是，我們看到患者壓力測試的數量出現了相對急劇的增加，而通常沒有人喜歡做壓力測試。所以，這也是我們在數據中發現的一個有趣的現象。因此，毫無疑問，這一切都是積極的勢頭，並正在推動巨大的成長。

But as I mentioned before, the other thing that is supporting and contributing to the performance in Q3 and Q4 is the success of SAPIEN 3 Ultra RESILIA. That's making a meaningful contribution to our performance. And we're pretty happy with that.

但正如我之前提到的，對第三季和第四季業績起到支撐和促進作用的另一因素是 SAPIEN 3 Ultra RESILIA 的成功。這對我們的業績做出了有意義的貢獻。我們對此相當滿意。

And big picture here, if you process all of this that Dan talked about, this is what gives us confidence in our guidance for the year for TAVR, 6% to 8% and our guidance beyond 2026 for TAVR from mid- to high-single digits. All what we are doing right now, all the things we have been doing, all of these catalysts are impacting severe symptomatic patients. And so the asymptomatic patients are still in front of us. This is why we are so confident as to have TAVR as the durable growth opportunity for Edwards.

從大局來看，如果你把丹所說的所有內容都考慮進去，這就是我們對今年TAVR成長預期（6%至8%）以及2026年後TAVR成長預期（中高個位數）充滿信心的原因。我們現在所做的一切，我們一直在做的一切，所有這些催化劑都在影響重症患者。因此，無症狀感染者仍然在我們面前。正因如此，我們才如此確信TAVR是Edwards公司持續成長的機會。

Thank you.

謝謝。

Vijay Kumar, Evercore ISI.

Vijay Kumar，Evercore ISI。

Hey, guys, thanks for taking my question. My first one was a quick housekeeping. Scott, I think called out that SAVR was impacted by some distributor adjustments. Could you quantify what that is? And isn't Q1 guidance implying a 10% TAVR growth?

嘿，各位，謝謝你們回答我的問題。我的第一份工作是簡單的家事。斯科特指出，SAVR 受到了經銷商一些調整的影響。你能量化一下那是什麼嗎？第一季業績指引不是暗示TAVR手術量將成長10%嗎？

Sorry, Vijay, could you say the first part of your question one more time, please?

抱歉，Vijay，你能再說一次你問題的第一部分嗎？

Sorry. On SAVR, you called out a distributor impact in that Q4. Could you quantify what the impact is? Are those sales coming back in Q1 or no? And just curious on what gets us to Q1 sales guidance? Is it SAVR? Are we modeling TAVR of 10% growth?

對不起。關於 SAVR，你指出了第四季經銷商的影響。你能量化一下這種影響嗎？第一季銷售額會恢復嗎？我很好奇，第一季的銷售預期是如何得出的？是SAVR嗎？我們是否在模擬TAVR 10%的成長？

Yeah, sure. Thanks for the question. The surgical inventory adjustment was in one country, it was the end of the year, and it was really adjusting inventories in the distribution channel. In China, we go through distributors, and we work very carefully on managing inventory levels. And so this is just something that we did at the end of the year. We still expect mid-single-digit growth from Surgical in 2026 and beyond. So think of this as a one-time event.

當然可以。謝謝你的提問。手術器械庫存調整隻在一個國家進行，當時正值年底，實際上是在調整分銷管道的庫存。在中國，我們透過分銷商進行銷售，並且我們非常謹慎地管理庫存水準。所以，這只是我們在年底做的一件事。我們仍預期 2026 年及以後外科業務將維持中等個位數的成長。所以，就把這件事看成是一次性事件吧。

Sorry. Q1?

對不起。Q1？

Yeah. So Q1, the guidance implies -- I mentioned before, on a reported basis, about 300 basis points higher than the underlying growth guidance. we haven't broken out specific underlying growth guidance, but know that the growth in the first half of the year is higher than the growth in the second half of the year. And overall, we're increasingly confident about the 6% to 8% full-year growth guidance for TAVR.

是的。因此，第一季業績指引意味著──我之前提到過──按報告數據計算，比潛在成長指引高出約300個基點。我們沒有公佈具體的潛在成長指引，但可以肯定的是，上半年的成長高於下半年。總體而言，我們對 TAVR 全年 6% 至 8% 的成長預期越來越有信心。

That's helpful. And then maybe one on the moderate AS. What is, I guess, the right way to think about moderate AS, when these patients are unclear, do they look like low-risk TAVR patients? Is this asymptomatic TAVR patient? What's the right way to think about moderate AS and what's the underlying mortality rate in untreated moderate AS patients?

那很有幫助。然後或許可以考慮治療中度AS。我想，對於中度主動脈瓣狹窄患者，當這些患者的狀況不明確時，該如何正確看待他們？他們看起來像低風險的經導管主動脈瓣置換術（TAVR）患者嗎？這是無症狀的TAV​​R患者嗎？我們該如何正確看待中度主動脈瓣狹窄？未經治療的中度主動脈瓣狹窄患者的潛在死亡率是多少？

Maybe let me start with Vijay. First, when we decide to start a big pivotal study, randomized study, multiyear randomized studies like this one. It is because we believe we can show the benefit to patients. It is because we believe it is a big opportunity because we believe in that case, SAPIEN 3 will have a big positive impact on these patients. So that's just to make sure that you feel our confidence and our belief behind progress and the moderate AS patient population.

或許我可以先從維傑說起。首先，當我們決定進行一項大型關鍵性研究、隨機研究、多年隨機研究時，就像這項研究一樣。這是因為我們相信我們能夠向患者證明其益處。這是因為我們相信這是一個巨大的機遇，因為我們相信，在這種情況下，SAPIEN 3 將對這些患者產生巨大的正面影響。所以，這樣做是為了確保您感受到我們對進展以及中度僵直性脊椎炎患者群體的信心和信念。

Having said that, we know the importance of highly scientific clinical studies, and as a company relying a lot on world-class evidence, we are trying not to talk a lot about before having simple results. We know the importance of it. But -- so it is why some studies are more like post-market studies, marketing studies. So people have a freedom to talk about it. And here, we want to have a very high bar in terms of clinical dividend. So we have confidence, belief it's the large patient population, and we are going to wait TCT to share more about it.

話雖如此，我們也知道高度科學的臨床研究的重要性，作為一家非常依賴世界級證據的公司，我們在獲得明確的結果之前盡量避免過多談論此事。我們知道它的重要性。但是——所以有些研究更像是上市後研究、行銷研究。所以人們可以自由地談論這件事。而且，我們希望在臨床效益方面設定非常高的標準。所以我們有信心，相信這是因為患者群體龐大，我們將等待 TCT 分享更多相關資訊。

Now, Dan, do you have anything that you want to share in addition to what I said here?

丹，除了我剛才說的，你還有什麼想補充的嗎？

Yeah. The only additional color that I would say is as we learned a ton from now asymptomatic early TAVR trial about how unpredictable the nature of the diseases and any -- and this whole idea of that it's a progressive, predictable disease has been thrown out the window even on early TAVR.

是的。我唯一想補充的是，我們從目前無症狀的早期 TAVR 試驗中了解到，這種疾病的性質是多麼不可預測，而且——這種認為它是一種進行性、可預測的疾病的想法，即使在早期 TAVR 中也被徹底推翻了。

And we -- this is not an asymptomatic trial, right? Progress is not a symptomatic moderate, right? So we're talking about a symptomatic patient population. And we don't know the results of the trial. We don't know what it looks like. What we do know is it enrolled very fast, right? And that's usually a bit of an indicator of things.

而且──這不是一項無症狀試驗，對吧？進步不是一種症狀輕微的表現，對吧？所以我們討論的是有症狀的患者群。我們不知道試驗結果。我們不知道它長什麼樣子。我們知道的是，它的報名速度非常快，對吧？這通常能反映出一些情況。

And so we're excited to sort of just learn more about how this can inform this patient population and how transcatheter therapies may fit into this. But until we see the data, until we get past TCT, there's not a lot more to add.

因此，我們很興奮能夠更多地了解這如何能為患者群體提供信息，以及經導管療法如何融入其中。但是，在我們看到數據之前，在 TCT 問題解決之前，沒有什麼可補充的了。

Thank you.

謝謝。

Thank you. And ladies and gentlemen, we have reached the end of the question-and-answer session. So I will now hand the floor back over to Bernard Zovighian for closing remarks. Thank you.

謝謝。女士們、先生們，問答環節到此結束。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。謝謝。

Yeah. Thank you so much. Thanks for your continued rise in Edwards. Scott, Gerianne, and myself welcome any additional questions by telephone. Thank you so much, and have a great rest of your day.

是的。太感謝了。感謝您在愛德華茲的持續進步。Scott、Gerianne 和我歡迎您透過電話提出任何其他問題。非常感謝，祝您今天餘下的時間過得愉快。

Thank you. And this concludes today's conference. All parties may disconnect. Thank you.

謝謝。今天的會議到此結束。所有參與者均可中斷連線。謝謝。