愛德華生命科學 (EW) 2025 Q1 法說會逐字稿

Greetings, and welcome to the Edwards Lifesciences first quarter 2025 results. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce you to your host, Mark Wilterding, Senior Vice President, Global Finance. Thank you, Mark. You may begin.

您好，歡迎了解 Edwards Lifesciences 2025 年第一季業績。（操作員指示）提醒一下，本次會議正在錄音。現在我很高興向你們介紹主持人、全球金融資深副總裁馬克‧威爾特丁 (Mark Wilterding)。謝謝你，馬克。你可以開始了。

Thanks, Alicia, 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 Larry Wood, our Group President of TAVR and Surgical; Daveen Chopra, our global leader of TMTT; and Wayne Markowitz, our Global Leader of Surgical. Just after the close of regular trading, Edwards Lifesciences released first quarter 2025 financial results.

謝謝艾莉西亞，也謝謝大家今天下午加入我們。和我一起參加今天電話會議的還有我們的執行長 Bernard Zovighian 和財務長 Scott Ullem。我們的 TAVR 和外科集團總裁 Larry Wood 也將參加本次電話會議的問答環節； Daveen Chopra，我們的 TMTT 全球負責人；以及我們的外科全球領導者 Wayne Markowitz。常規交易結束後不久，Edwards Lifesciences 發布了 2025 年第一季財務業績。

During today's call, management will discuss those results included in the press release and accompanying financial schedules and then use the remainder of time for Q&A. 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 were made and Edwards does not undertake any obligation to update them after today.

在今天的電話會議中，管理層將討論新聞稿和隨附財務計劃中包含的結果，然後利用剩餘時間進行問答。請注意，管理層將根據估計、假設和預測做出前瞻性陳述。這些聲明僅代表聲明發布之日的觀點，Edwards 不承擔在今日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，可能導致實際結果大不相同。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 的其他 SEC 文件中找到，所有這些文件都可以在公司網站 edwards.com 上找到。

Edwards' guidance reflects its current estimates of the impact from tariffs that are in effect or has been announced as of the time of this press release and assume such tariffs remain in place for the remainder of 2025. Any modification to such tariffs or new tariffs could have a material impact on the company's future financial results and guidance.

Edwards 的指導反映了其對截至本新聞稿發佈時生效或已宣布的關稅影響的當前估計，並假設此類關稅在 2025 年剩餘時間內繼續有效。對此類關稅的任何修改或新關稅都可能對公司未來的財務表現和指導產生重大影響。

Unless otherwise noted, our commentary on sales growth refers to constant currency sales growth, which is defined in the quarterly results press release issued earlier today. Reconciliations 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 operations and do not include discontinued operations.

除非另有說明，我們對銷售成長的評論均指以固定匯率計算的銷售成長，該成長已在今天稍早發布的季度業績新聞稿中進行了定義。今天的新聞稿中還包括了本次電話會議中提到的 GAAP 和非 GAAP 數據之間的對帳。季度和全年成長率指的是持續經營，不包括已終止經營。

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

說到這裡，我想把電話轉給伯納德，請他發表評論。

Thank you, Mark. Welcome, everyone, and Yes, please? (technical difficulty) total company sales grew 8% to $1.41 billion in the first quarter, reflecting the benefits of our broad and differentiated portfolio of therapies to treat patients with structural heart disease. The many milestones achieved in Q1 are the result of our focused strategy and our decades of unwavering dedication to driving breakthrough innovation in pioneering and leading categories.

謝謝你，馬克。歡迎大家，可以嗎？（技術難度）第一季公司總銷售額成長 8%，達到 14.1 億美元，反映了我們廣泛且差異化的治療組合對治療結構性心臟病患者的優勢。第一季取得的許多里程碑是我們專注的策略和數十年來堅定不移地致力於推動開創性和領先類別的突破性創新的結果。

Collectively, these milestones mark the significant progress we have made to unlock this large and growing opportunity to transform care for millions of structural heart patients around the world. I'd like to thank our 16,000 global employees for their many contributions to advancing patient care. TAVR growth in the quarter was better than expected as clinicians continue to adopt our best-in-class SAPIEN technology.

總的來說，這些里程碑標誌著我們在開啟這一巨大且不斷增長的機會以改變全球數百萬結構性心臟病患者的護理方面所取得的重大進展。我要感謝我們全球 16,000 名員工為促進病患照護所做的許多貢獻。由於臨床醫生繼續採用我們一流的 SAPIEN 技術，本季 TAVR 成長優於預期。

Looking ahead to the rest of the year, we continue to believe that the results of early TAVR trial represents a multiyear growth opportunity that will begin with the expected indication approval in the second quarter and expand with the evolution of policy and guideline changes in the US and globally.

展望今年剩餘時間，我們仍然相信早期 TAVR 試驗的結果代表著多年的成長機會，該機會將從第二季預期的適應症批准開始，並隨著美國和全球政策和指南的變化而擴大。

And in late 2026, we look forward to the presentation of the results of a groundbreaking progress trial, which has the potential to further expand the therapy to many new patients with moderate AS. I am proud of our commitment to TAVR innovation and high-quality science that is increasing access to treatment options for all AS patients. We continue to be pleased with TMTT's strong momentum, reflecting our portfolio of differentiated repair and replacement technologies, and we are raising our 2025 TMTT sales guidance range to $530 million to $550 million.

我們期待在 2026 年底看到一項突破性進展試驗的結果，該試驗有可能進一步將這種療法擴展到許多新的中度 AS 患者。我為我們致力於 TAVR 創新和高品質科學的承諾感到自豪，這將增加所有 AS 患者獲得治療選擇的機會。我們繼續對 TMTT 的強勁發展勢頭感到滿意，這反映了我們差異化的維修和更換技術組合，我們將 2025 年 TMTT 的銷售預期範圍上調至 5.3 億美元至 5.5 億美元。

As a reminder, our successful TMTT strategy position us to become the first to develop and launch a transcatheter tricuspid valve with EVOQUE in 2024. Today, I am also very proud of the recent approval of our Sapien M3 in Europe, the world's first transcatheter mitral valve replacement system, which will benefit many patients with mitral regurgitation who have limited treatment options. This breakthrough technology demonstrates our team's long-term and steadfast commitment to solving large, unmet patient needs.

提醒一下，我們成功的 TMTT 策略使我們在 2024 年成為第一個與 EVOQUE 合作開發和推出經導管三尖瓣的公司。今天，我也非常自豪我們的Sapien M3最近在歐洲獲得批准，這是世界上第一個經導管二尖瓣置換系統，它將使許多治療選擇有限的二尖瓣逆流患者受益。這項突破性技術顯示了我們團隊長期堅定地致力於解決大量未滿足的患者需求。

Edwards with EVOQUE, M3 and PASCAL is uniquely positioned to meet the broad and diverse needs of patients with tricuspid and mitral valve diseases. In Surgical, our category-leading business continues to benefit from increasing adoption of our premium RESILIA portfolio in INSPIRIS, MITRIS and KONECT. Edwards continues to invest in surgical innovation and evidence as we expand access to our therapies globally.

擁有 EVOQUE、M3 和 PASCAL 的 Edwards 具有獨特的優勢，能夠滿足三尖瓣和二尖瓣疾病患者的廣泛而多樣化的需求。在外科領域，我們領先的業務繼續受益於 INSPIRIS、MITRIS 和 KONECT 對我們優質 RESILIA 產品組合的日益採用。隨著我們在全球擴大治療管道，Edwards 繼續投資於外科手術創新和證據。

Last week, at the Heart valve Society Meeting, eight-year data were presented, demonstrating the excellent durability of a company's novel RESILIA issue, which is used in a wide range of Edwards surgical platform as well as SAPIEN 3 Ultra RESILIA. The results represent the longest follow-up study on the durability of valves which highlights our dedication to pioneering unique innovation with patients of all ages living longer and seeking higher quality of life, the importance of lifetime management has never been greater.

上週，在心臟瓣膜學會會議上，展示了八年的數據，證明了該公司新型 RESILIA 的出色耐用性，該產品廣泛應用於 Edwards 手術平台以及 SAPIEN 3 Ultra RESILIA。該結果代表了對瓣膜耐久性的最長的跟踪研究，凸顯了我們致力於開拓獨特的創新，使各年齡段的患者能夠活得更長，並追求更高的生活質量，終生管理的重要性從未如此重要。

We also continue to make steady progress advancing our portfolio of emerging opportunities, which we discussed at our investor conference in December. Our team continued to build capabilities to reach the millions of patients around the world who suffer from structural heart failure. And in aortic regurgitation, we're enrolling patients in joining the pivotal trial for the Edwards J-Valve AR system.

我們也將繼續穩步推進新興機會組合，我們在 12 月的投資者會議上對此進行了討論。我們的團隊不斷增強能力，以救助全球數百萬患有結構性心臟衰竭的患者。在主動脈瓣關閉不全方面，我們正在招募患者參與 Edwards J-Valve AR 系統的關鍵試驗。

Turning to our 2025 financial outlook. We are confident in our full year total company sales growth guidance of 8% to 10%. And we have plans in place to offset the estimated impact of a currently announced tariffs and the estimated dilution from the JenaValve acquisition, which we are planning to close midyear. As a result of our plans, we are in a position to deliver on our original EPS guidance of $2.40 to $2.50. Our priorities continue to be serving the patients who count on us and maintaining the highest level of service and support to our physician partners around the world.

轉向我們的 2025 年財務展望。我們對全年公司總銷售額成長 8% 至 10% 的預期充滿信心。我們已製定計劃來抵消目前宣布的關稅預計帶來的影響以及收購 JenaValve 預計帶來的稀釋，我們計劃在年中完成收購。根據我們的計劃，我們能夠實現最初的每股收益預期 2.40 美元至 2.50 美元。我們的首要任務仍然是為依賴我們的患者提供服務，並為世界各地的醫生合作夥伴提供最高水準的服務和支援。

Looking ahead to 2026 and beyond, Edwards is positioned to transform care for the many structural heart patient needs. We are confident that our strategic focus, unique innovation strategy and exceptional work of our employees around the world will deliver significant value to patients, the health care ecosystem, and shareholders.

展望 2026 年及以後，Edwards 將致力於改變眾多結構性心臟病患者的照護需求。我們相信，我們的策略重點、獨特的創新策略以及全球員工的出色工作將為患者、醫療保健生態系統和股東帶來巨大的價值。

Now I will provide some additional detail by product group for Q1. In TAVR, our first quarter global sales of $1.05 billion increased 5.4% over the prior year or 6.5% when adjusted for billing days, which was a little higher than expected. Growth was comparable in the US and OUS. Edwards' strong competitive position and pricing remained stable globally with some regional variability.

現在我將按產品組提供第一季的一些更多詳細資訊。在 TAVR 方面，我們第一季的全球銷售額為 10.5 億美元，比上年同期成長 5.4%，按結算天數調整後成長 6.5%，略高於預期。美國和澳洲的成長情況相當。Edwards 的強大競爭地位和定價在全球範圍內保持穩定，但存在一些地區差異。

I am proud of our team's commitment to leading with science, supported by a decade of clinical research that set the standard for quality evidence and physician decision-making. This significant body of high-quality science from rigorous FDA trials underscores the excellent clinical outcomes delivered by Edwards premium SAPIEN technology.

我為我們團隊致力於以科學為先導而感到自豪，並以十年的臨床研究為後盾，為品質證據和醫生決策樹立了標準。經過嚴格的 FDA 試驗的大量高品質科學證據凸顯了 Edwards 優質 SAPIEN 技術所帶來的出色臨床效果。

Last month, at the American College of Cardiology Conference, new clinical data from the EARLY TAVR trial studying patients with asymptomatic severe AS were released. The data highlighted that delaying -- delayed aortic valve replacement in this patient population was associated with worse outcomes. Additionally, a new study using cardiac biomarkers reveal that the rapid and unpredictable progression of disease. Both studies underscore the need for urgent referrals for treatment, evaluation for severe AS patients regardless of symptoms.

上個月，在美國心臟學會會議上，發布了針對無症狀嚴重主動脈瓣狹窄患者的 EARLY TAVR 試驗的新臨床數據。數據強調，對於該患者群體來說，延遲主動脈瓣置換會導致更糟糕的結果。此外，一項使用心臟生物標記的新研究表明疾病的進展迅速且難以預測。兩項研究都強調了對嚴重 AS 患者進行緊急轉診治療和評估的必要性，無論其症狀如何。

Also at ACC, new groundbreaking data from the DETECT-AS study, we are presented. DETECT-AS is the first randomized trial evaluating the impact of physician notification or (technical difficulty) for their patient with severe AS that meet treatment guidelines.

此外，在 ACC，我們也展示了 DETECT-AS 研究的突破性新數據。DETECT-AS 是第一個評估醫生通知或（技術難度）對符合治療指南的嚴重 AS 患者的影響的隨機試驗。

The study found that these ECO alerts increased both treatment and survival rate for patients with severe AS. In the US, our leading SAPIEN 3 Ultra RESILIA continues to demonstrate strong performance. We are advancing initiatives to help hospitals treat structural heart patients efficiently and manage increasing procedure volumes.

研究發現，這些 ECO 警報提高了嚴重 AS 患者的治療率和存活率。在美國，我們領先的 SAPIEN 3 Ultra RESILIA 繼續表現出強勁的表現。我們正在推進舉措，幫助醫院有效地治療結構性心臟病患者並管理不斷增加的手術量。

We are encouraged by hospitals that have demonstrated the ability to scale to accommodate for severe growth. We are encouraged by discussion with key clinicians on the long-term impact of EARLY TAVR data to streamline patient care. In addition, we expect asymptomatic indication approval in the second quarter. Outside of the US, we continue to focus on the value of our differentiated technology and increasing therapy adoption, especially in areas where TAVR remains underutilized and many patients go without care.

我們對那些已經展現出適應急劇增長能力的醫院感到鼓舞。我們與主要臨床醫生討論了早期 TAVR 數據對簡化患者護理的長期影響，這讓我們感到鼓舞。此外，我們預計無症狀適應症將在第二季獲得批准。在美國以外，我們繼續關注差異化技術的價值並提高治療的採用率，特別是在 TAVR 尚未充分利用且許多患者無法接受護理的地區。

In the first quarter, sales growth was supported by the continued expansion of SAPIEN 3 Ultra RESILIA in Europe. SAPIEN 3 Ultra RESILIA continues to deliver exceptional clinical outcomes reinforcing the differentiation of this best-in-class platform. In Japan, we continue to face weaker procedure growth environment and competitive pressure. We remain dedicated to addressing the significant undertreatment of AS among the substantial elderly population in Japan.

第一季度，銷售額的成長得益於 SAPIEN 3 Ultra RESILIA 在歐洲的持續擴張。SAPIEN 3 Ultra RESILIA 持續提供卓越的臨床結果，強化了這個一流平台的差異化。在日本，我們持續面臨較弱的流程成長環境和競爭壓力。我們將繼續致力於解決日本大量老年人口中嚴重缺乏僵直性脊椎炎治療的問題。

In summary, for TAVR, we are maintaining our full year sales growth guidance of 5% to 7%. Long term, we are enthusiastic about the durable mid- to high single-digit growth opportunity in TAVR, supported by the upcoming EARLY TAVR indication approval, guideline and policy changes and the potential to serve patients with moderate AS.

總而言之，對於 TAVR，我們維持 5% 至 7% 的全年銷售成長預期。從長遠來看，我們對 TAVR 領域持久的中高個位數成長機會充滿熱情，這得益於即將獲得的早期 TAVR 適應症批准、指南和政策變化以及為中度 AS 患者提供服務的潛力。

Turning to TMTT. Our unique and increasingly differentiated portfolio drove another quarter of impressive growth with a meaningful contribution to overall company performance. We are pleased with first quarter sales of $115 million, representing growth of about 60% and led by increased adoption and balanced contribution from PASCAL and EVOQUE in the US, Europe and globally.

轉向 TMTT。我們獨特且日益差異化的產品組合推動了另一個季度的令人矚目的成長，為公司整體業績做出了有意義的貢獻。我們對第一季 1.15 億美元的銷售額感到滿意，成長了約 60%，這得益於美國、歐洲和全球範圍內 PASCAL 和 EVOQUE 的採用率提高和均衡貢獻。

We continue to see strong therapy adoption and expansion across both mitral and tricuspid. Globally, mitral TEER procedures continue to grow double digits and the developing tricuspid opportunity is growing even faster across both repair and replacement. PASCAL continues to demonstrate its value for patient care, its differentiated features are driving distinguished clinical outcome and adoption is increasing at both new and existing sites around the world.

我們繼續看到二尖瓣和三尖瓣治療的強勁採用和擴展。在全球範圍內，二尖瓣 TEER 手術數量繼續以兩位數增長，而三尖瓣修復和置換手術機會的增長速度甚至更快。PASCAL 繼續證明其對患者護理的價值，其差異化功能正在推動卓越的臨床結果，並且在全球新建和現有站點的採用率都在不斷提高。

The EVOQUE commercial launch is progressing well in the US and Europe, with continuing excellent patient outcome. At the end of March, we were pleased to see the finalization of the NCD for transcatheter tricuspid valve replacement for patients suffering from tricuspid disease. With the new NCD, EVOQUE is now covered for all Medicare beneficiaries who meet the criteria outlined in the final coverage policy, expanding patient access to this important therapy. We are pleased with the recent approval of the SAPIEN M3 mitral valve replacement system in Europe.

EVOQUE 在美國和歐洲的商業推廣進展順利，病患療效持續良好。三月底，我們很高興地看到，針對三尖瓣疾病患者進行經導管三尖瓣置換術的國家強制規定終於出台。有了新的 NCD，EVOQUE 現在已涵蓋所有符合最終覆蓋政策中概述的標準的醫療保險受益人，從而擴大了患者獲得這種重要療法的機會。我們很高興看到 SAPIEN M3 二尖瓣置換系統最近在歐洲獲得批准。

This revolutionary transcatheter valve therapy is built on the proven SAPIEN platform, which has been used in more than 8,000 procedures in the mitral position. We continue to expect that results from the ENCIRCLE pivotal trial studying M3 will be presented at the TCT Conference in October 2025.

這種革命性的經導管瓣膜治療建立在成熟的 SAPIEN 平台之上，該平台已在二尖瓣手術中得到 8,000 多例應用。我們繼續預計，研究 M3 的 ENCIRCLE 關鍵試驗結果將於 2025 年 10 月在 TCT 會議上發表。

In addition, as part of our deep commitment to advancing science for patients with structural heart disease, a European post market follow-up study is planned to continue evaluation of SAPIEN M3 following patients out to five years. As previously shared, we expect US approval of Sapien M3 to follow in 2026. The Launch plan for SAPIEN M3 in Europe is focused on creating a new category as we have done many times before and achieving excellent patient outcomes.

此外，作為我們致力於為結構性心臟病患者推進科學研究的堅定承諾的一部分，我們計劃開展一項歐洲上市後追蹤研究，繼續對 SAPIEN M3 進行為期五年的追蹤評估。如同先前所述，我們預計美國將於 2026 年批准 Sapien M3。SAPIEN M3 在歐洲的發布計畫專注於創造一個新的類別，就像我們之前多次做過的那樣，並取得出色的患者治療效果。

With our decades of experience, we are uniquely positioned to bring SAPIEN M3 to the many patients in need across Europe. We will work with all stakeholders to ensure patient access to this novel therapy providing physician training and working with policymakers to establish proper therapy coverage.

憑藉數十年的經驗，我們擁有獨特的優勢，可以將 SAPIEN M3 帶給歐洲各地眾多有需要的患者。我們將與所有利益相關者合作，確保患者能夠獲得這種新療法，為醫生提供培訓，並與政策制定者合作建立適當的治療覆蓋範圍。

Edwards is the only company that offers the transcatheter portfolio that includes both replacement and repair treatment option for both the mitral and tricuspid valves, meeting the complex needs of underserved patients. We are committed to bringing this portfolio to patients in need around the world and expect meaningful impact from these advanced therapies in '26 and beyond.

Edwards 是唯一一家提供經導管產品組合的公司，該產品組合包括二尖瓣和三尖瓣的置換和修復治療選擇，可滿足服務不足患者的複雜需求。我們致力於將這項產品組合帶給世界各地有需要的患者，並期望這些先進的療法在 2026 年及以後產生有意義的影響。

In our Surgical product group, first quarter global sales of $251 million increased 3% over the prior year. We continue to see positive procedure growth globally for the many patients, best treated with Edwards premium RESILIA portfolio, including MITRIS, INSPIRIS and KONECT.

在我們的外科產品組，第一季全球銷售額為 2.51 億美元，比上年增長 3%。我們繼續看到全球眾多患者的治療程序呈現積極的成長態勢，最好採用 Edwards 優質 RESILIA 產品組合進行治療，包括 MITRIS、INSPIRIS 和 KONECT。

We continue to generate high-quality evidence on our RESILIA tissue technology. As shown in the eight-year data presented at the recent Heart Valve Society meeting RESILIA tissue valves had significantly improved freedom from structural valve deterioration and freedom from reoperation compared to non-RESILIA valves.

我們將繼續為我們的 RESILIA 組織技術提供高品質的證據。正如最近心臟瓣膜學會會議上公佈的八年數據所示，與非 REILIA 瓣膜相比，RESILIA 組織瓣膜在避免結構性瓣膜惡化和避免再次手術方面有顯著提高。

Also in the quarter, our surgical team made progress advancing important innovation around the world. MITRIS launched in China with positive surgeon feedback, and we anticipate receiving CE Mark approval for the KONECT aortic valve conduit in Europe before year-end. And now Scott will cover the detail of the company's financial performance.

本季度，我們的外科手術團隊也在全球推動重要創新方面取得了進展。MITRIS 在中國推出後得到了外科醫生的積極回饋，我們預計 KONECT 主動脈瓣導管將在年底前在歐洲獲得 CE 標誌認證。現在斯科特將詳細介紹公司的財務表現。

Great. Thanks a lot, Bernard. As Bernard mentioned, we are pleased with our first quarter total company sales performance and progress on our strategic milestones, which gives us confidence in our full year outlook. We are raising our original sales guidance range for TMTT to $530 million to $550 million, driven by more favorable foreign exchange and continued business momentum.

偉大的。非常感謝，伯納德。正如伯納德所提到的，我們對第一季公司整體銷售業績和策略里程碑的進展感到滿意，這使我們對全年前景充滿信心。受更有利的外匯匯率和持續的業務成長勢頭的推動，我們將 TMTT 的原始銷售預期範圍上調至 5.3 億美元至 5.5 億美元。

Total company, TAVR and surgical sales growth guidance ranges remain unchanged, but the company is increasing our original total company sales dollar guidance range by $100 million to account for recent movement in FX rates. Edwards now expects total company sales of $5.7 billion to $6.1 billion in 2025.

公司總體、TAVR 和外科銷售成長指引範圍保持不變，但公司將原來的公司總銷售額指導範圍提高了 1 億美元，以適應近期外匯匯率的變動。愛德華茲目前預計 2025 年公司總銷售額將達 57 億美元至 61 億美元。

So now I'll cover additional details of our Q1 results, starting with earnings per share. We generated adjusted EPS of $0.64 in the quarter with solid operating performance. Our GAAP EPS for the quarter was $0.62. A full reconciliation between our GAAP and non-GAAP measures, including adjusted EPS and other items is included with today's release.

現在我將介紹我們第一季業績的更多細節，首先是每股收益。本季度，我們的調整後每股收益為 0.64 美元，營運表現穩健。本季我們的 GAAP EPS 為 0.62 美元。今天的發布中包含了我們的 GAAP 和非 GAAP 指標之間的完整對賬，包括調整後的每股收益和其他項目。

Moving on to other elements of the P&L. For the first quarter, our adjusted gross profit margin was 78.7% compared to 78.5% in the same period last year. We are maintaining our full year 78% to 79% gross margin guidance at this stage. However, we do expect some pressure from the weakening dollar, the impact of announced tariffs and the expected close of the JenaValve acquisition.

繼續討論損益表的其他要素。第一季度，我們的調整後毛利率為 78.7%，去年同期為 78.5%。目前，我們維持全年 78% 至 79% 的毛利率預期。然而，我們確實預計美元疲軟、宣布的關稅的影響以及 JenaValve 收購的預期完成將帶來一些壓力。

Selling, general and administrative expenses in the quarter were $466 million or 33% of sales which was better than our expectation for the quarter, driven by lower sequential spending and deferral of certain strategic investments originally planned for Q1.

本季的銷售、一般和行政費用為 4.66 億美元，佔銷售額的 33%，好於我們對本季度的預期，這得益於連續支出的下降以及原定於第一季度進行的某些戰略投資的推遲。

Research and development expense of $255 million in the first quarter was equivalent to 18% of sales, a reduction from 19.6% of sales in the previous quarter. This lower ratio of spending reflects the company's prioritized investments in our structural heart portfolio in areas where we believe there are significant opportunities for breakthrough innovation and profitable growth. Adjusted operating profit margin in the first quarter of 29.1% was driven by better-than-expected sales and favorable mix as well as some variable expenses delayed beyond Q1.

第一季研發費用為 2.55 億美元，相當於銷售額的 18%，低於上一季的 19.6%。較低的支出比例反映了公司對結構性核心投資組合的優先投資，我們認為這些領域存在突破性創新和獲利成長的重大機會。第一季調整後的營業利潤率為 29.1%，這得益於好於預期的銷售額和有利的產品組合，以及一些延遲到第一季之後的變動費用。

We expect pressure on our operating margin as a result of the weakening dollar, the impact of announced tariffs and the expected midyear close of the JenaValve acquisition. However, we are implementing plans to mitigate these anticipated costs, and we maintain our full year operating margin guidance of 27% to 28% and our EPS guidance of $2.40 to $2.50. We continue to expect our 2025 tax rate excluding special items, to be between 15% and 18%.

我們預計，由於美元疲軟、已宣布的關稅的影響以及預計在年中完成的 JenaValve 收購，我們的營業利潤率將面臨壓力。不過，我們正在實施計劃以降低這些預期成本，並維持全年營業利潤率指引 27% 至 28%，每股收益指引 2.40 美元至 2.50 美元。我們仍預期 2025 年的稅率（不包括特殊項目）將在 15% 至 18% 之間。

Foreign exchange rates decreased first quarter reported sales growth by 170 basis points or $22 million compared to the prior year. FX rates positively impacted our first quarter gross profit margin by 40 basis points compared to the prior year. Relative to our February guidance, FX rates had a nominal impact on first quarter earnings per share.

與去年同期相比，外匯匯率導致第一季銷售額成長下降 170 個基點，即 2,200 萬美元。與去年同期相比，外匯匯率對我們第一季的毛利率產生了 40 個基點的正面影響。相對於我們二月的指引，外匯匯率對第一季每股盈餘的影響很小。

At current rates, we now estimate no impact from foreign exchange on reported sales in 2025 relative to 2024 versus our investor conference guidance of a $100 million reduction. As a reminder, our hedging strategy is designed to mitigate the impact of foreign currency fluctuations on the original EPS guidance we provided in December.

依照目前的匯率，我們估計外匯對 2025 年報告銷售額的影響相對於 2024 年不會產生，而我們的投資者會議指引是減少 1 億美元。提醒一下，我們的對沖策略旨在減輕外匯波動對我們 12 月提供的原始每股盈餘指引的影響。

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. During the first quarter, the company entered into an ASR agreement and repurchased stock through a preestablished plan totaling $300 million. Edwards has approximately $1 billion remaining under our share repurchase authorization. Average diluted shares outstanding during the quarter were $588 million.

轉向資產負債表。我們持續保持強勁且靈活的資產負債表，截至本季末，現金和現金等價物約為 30 億美元。第一季度，該公司簽訂了 ASR 協議，並透過預先制定的計劃回購了總額為 3 億美元的股票。根據我們的股票回購授權，Edwards 還剩餘約 10 億美元。本季平均攤薄流通股數為 5.88 億美元。

We continue to expect average diluted shares outstanding for 2025 to be between $585 million to $595 million. So I'll finish with one final guidance comment. For the second quarter, we're projecting sales of $1.45 billion to $1.53 billion and adjusted earnings per share of $0.59 to $0.65. And with that, I'll pass it back to Bernard.

我們繼續預期 2025 年平均稀釋流通股數將在 5.85 億美元至 5.95 億美元之間。最後，我將以最後一則指導意見作結。對於第二季度，我們預計銷售額為 14.5 億美元至 15.3 億美元，調整後每股收益為 0.59 美元至 0.65 美元。說完這些，我就把它交還給伯納德。

Thanks, Scott. Before I close this afternoon, I want to take a moment to acknowledge an important anniversary for the company. It was 25 years ago this month that we rang the bell at the New York Stock Exchange and officially began our journey as Edward Lifesciences.

謝謝，斯科特。在今天下午結束之前，我想花點時間來慶祝公司的一個重要周年紀念日。25年前的這個月，我們在紐約證券交易所敲響了鐘聲，正式以愛德華生命科學公司的名義開始了我們的旅程。

Since then, we have transformed care for millions of structural heart patients around the world, solving large and complex patient needs and pioneering therapeutic categories. And Our future is bright, our foundation remains strong, and we will continue to bring new innovation to the many structural heart patients in need around the world. With that, turn it back to Mark.

自那時起，我們改變了全球數百萬結構性心臟病患者的照護方式，解決了大量複雜的患者需求並開拓了治療類別。我們的未來是光明的，我們的基礎仍然牢固，我們將繼續為世界各地眾多有需要的結構性心臟病患者帶來新的創新。說完，就把它交還給馬克。

Thank you very much, Bernard. We are ready to take your questions. As a reminder, please limit the number of questions to one plus one follow-up to allow for broad participation. If you have additional questions, please reenter the queue and management will answer as many participants as possible during the remainder of the call. Alicia, I'll turn it over to you.

非常感謝，伯納德。我們已準備好回答您的問題。提醒一下，請將問題數量限制為一個加一個後續問題，以便廣泛參與。如果您還有其他問題，請重新進入隊列，管理層將在通話的剩餘時間內盡可能回答參與者的問題。艾莉西亞，我把它交給你。

(Operator Instructions) Larry Biegelsen, Wells Fargo.

（操作員指示）富國銀行的 Larry Biegelsen。

Congrats on a good start to the year here. And Scott, you can probably anticipate the first question. You're maintaining the EPS guidance despite the tariffs and the JenaValve acquisition and maybe even currency. So obviously, people would love to hear you parse out how much each of those impact 2025? And how much lower could the gross margin be relative to the guidance? And I have one follow-up.

恭喜您今年有一個好的開始。斯科特，你可能已經預料到第一個問題了。儘管存在關稅、JenaValve 收購甚至貨幣因素，您仍維持 EPS 指導。所以顯然，人們很想聽您分析一下這些因素對 2025 年的影響有多大？相對於預期，毛利率可能低多少？我還有一個後續問題。

Sure. So let's go through the three elements, Larry. Thanks for the question. On FX, our hedging program is designed to mute the impact of foreign exchange changes on our EPS. So the real impact is from tariffs and the JenaValve acquisition.

當然。那麼讓我們來看看這三個要素，拉里。謝謝你的提問。在外匯方面，我們的對沖計劃旨在減輕外匯變化對我們每股收益的影響。因此，真正的影響來自關稅和 JenaValve 收購。

For tariffs, it's probably about $0.05 to EPS based upon the tariffs that are already in place. And just a little color -- commentary on tariffs. We may not be as complex as some others because we operate just a handful of production facilities that are strategically located with our key business regions.

對於關稅，根據已經實施的關稅，其每股收益可能約為 0.05 美元。只是一些關於關稅的稍微有點色彩的評論。我們可能不像其他一些公司那麼複雜，因為我們只經營少數位於我們主要業務區域戰略位置的生產設施。

And we also already have a lot of production in the US and so I think $0.05 associated with the 10% tariffs. Now that's just for 2025. The tariff impact is higher than that. But as you know, they get capitalized into inventory and recognized in our P&L as finished goods are sold. So the bigger impact is in 2026, but it's premature to be offering any guidance or speculation about what tariffs could look like when we get out there.

而且我們在美國已經有很多生產，所以我認為 10% 的關稅與 0.05 美元有關。這只是針對 2025 年而言的。關稅的影響要高於此。但如您所知，它們被資本化為庫存，並在成品售出時計入我們的損益表中。因此，更大的影響是在 2026 年，但現在就對那時的關稅狀況​​提供任何指導或猜測還為時過早。

For JenaValve, we think the impact is probably in the range of $0.05 to $0.10. Keep in mind, we don't have current information. We haven't closed the deal yet but based upon our estimates and the preliminary plans we have for integration; that's probably a good modeling assumption at this point.

對於 JenaValve，我們認為影響可能在 0.05 美元到 0.10 美元之間。請記住，我們沒有最新資訊。我們尚未完成交易，但根據我們的估計和整合的初步計劃；目前這可能是一個很好的建模假設。

That's very helpful. And a follow-up for Daveen on tricuspid. Congratulations on the NCD for EVOQUE. How do you see the NCD impacting the ramp of EVOQUE?

這非常有幫助。並追蹤 Daveen 關於三尖瓣的情況。恭喜 EVOQUE 獲得 NCD。您如何看待 NCD 對 EVOQUE 的影響？

Thanks, Larry. Thanks so much for the question, right? We continue to be excited as EVOQUE as a new category for us, right? It's a great product. And the NCD, as you know, was effective now in March of 2025 and this is a transcatheter tricuspid valve replacement NCD.

謝謝，拉里。非常感謝您提出這個問題，對嗎？EVOQUE 對我們來說是一個新類別，我們對此繼續感到興奮，對嗎？這是一個很棒的產品。如您所知，NCD 於 2025 年 3 月生效，這是經導管三尖瓣置換術 NCD。

The NCD ensures that both the standard Medicare as well as the large Medicare Advantage patient groups have access to EVOQUE as outlined in the final coverage policy. This coverage policy was very much in line with our expectations. So it's kind of built into our guidance this year.

NCD 確保標準醫療保險以及大型醫療保險優勢患者群體都可以按照最終覆蓋政策使用 EVOQUE。這個覆蓋政策非常符合我們的預期。所以它已經融入我們今年的指導中。

We love the components of this NCD, including within an FDA-approved indication, under a heart team and in the context of the CED or coverage with evidence development to collect additional data on the therapy. So overall, it is in line with our expectations of 2025 being full steam with activating new sites and continuing to treat more patients with EVOQUE who are getting excellent outcomes. And this is the start of a great multiyear kind of growth opportunity for treating more patients.

我們喜歡這種 NCD 的組成部分，包括在 FDA 批准的適應症範圍內、在心臟團隊的領導下以及在 CED 或覆蓋範圍內，透過證據開發來收集有關治療的更多數據。因此，總體而言，這符合我們對 2025 年的期望，即全力啟動新站點並繼續使用 EVOQUE 治療更多獲得優異療效的患者。這是一個巨大的多年成長機會的開始，可以為更多的患者提供治療。

David Roman, Goldman Sachs.

高盛的大衛‧羅曼（David Roman）。

I wanted just to start on the TAVR business. And maybe you could talk us through a little bit what you're seeing on the ground as it relates to either referral patterns or physician engagement post the presentation of EARLY TAVR now that we're kind of six months-Ish following TCT. And then maybe walk us through specifically what happens once you get the indication expansion approved and what the plan is to start to support market development effort and when we should see that show up in numbers. Then I have one follow-up.

我只是想開始 TAVR 業務。也許您可以向我們稍微介紹一下您在實地看到的情況，因為這與早期 TAVR 介紹後的轉診模式或醫生參與度有關，現在我們已經進行了六個月左右的 TCT 治療。然後，請您具體介紹一下，一旦適應症擴展獲得批准，將會發生什麼，以及開始支持市場開發工作的計劃是什麼，以及我們何時應該看到數字上的體現。然後我還有一個後續問題。

Thanks, David. Yes, that's a great question. Well, first of all, I think the data set was very strong that we presented at TCT, but it does take physicians a little bit of time to work their way through the data and really understand the important nuances.

謝謝，大衛。是的，這是一個很好的問題。嗯，首先，我認為我們在 TCT 上展示的數據集非常強大，但醫生確實需要花一點時間來研究數據並真正理解重要的細微差別。

We followed up those -- the TCT with a very strong deep dive at ACC, and there was a few things that came out of that. One was the unpredictable nature of these patients that have asymptomatic aortic stenosis. And I think one of the things that a lot of people have been utilizing and have been focused on is the use of biomarkers and the thought being that biomarkers would be predictive and would help physicians understand what asymptomatic patients they should refer and what patients they could safely wait on.

我們跟進了這些——TCT 在 ACC 進行了非常深入的研究，並且取得了一些成果。一是這些無症狀主動脈瓣狹窄患者的病情難以預測。我認為很多人一直在利用並關注的事情之一就是生物標誌物的使用，他們的想法是生物標誌物具有預測性，可以幫助醫生了解他們應該轉診哪些無症狀患者以及他們可以安全地等待哪些患者。

And I think the surprising data that came out at ACC said the biomarkers were actually not predictive. They did not predict which patients had more serious events versus which patients just had a progression to more mild symptoms. So I think it just really stresses that these patients need to get referred. They need to get worked up by the heart team. And we've continued to work with the clinical community and our positions to make sure we amplify that message.

我認為 ACC 公佈的令人驚訝的數據表明生物標誌物實際上並不具有預測性。他們無法預測哪些患者的病情較為嚴重，哪些患者的症狀只是發展到較輕微。所以我認為這確實強調了這些患者需要轉診。他們需要心臟團隊的幫助。我們將繼續與臨床界和我們的部門合作，以確保擴大此訊息的影響力。

But of course, all we can do right now is just to educate people on the publications on the data. We can't actually promote in any way, shape or form treating patients who are truly asymptomatic because we don't have the indication yet. We do expect that to come before midyear, so we're on track for that. And the minute we get the indication approval; we have a very detailed education plan. We can then begin reaching out to the referral base and doing all of the other things that we want to do to help amplify this message.

但當然，我們現在所能做的只是讓人們了解有關數據出版物的資訊。我們實際上無法以任何方式、形式或形式推廣治療真正無症狀的患者，因為我們還沒有發現跡象。我們確實希望這會在年中之前實現，所以我們正在按計劃進行。一旦我們獲得適應症批准；我們有一個非常詳細的教育計劃。然後，我們可以開始聯繫推薦基礎並做所有其他我們想做的事情來幫助擴大這一訊息。

And but again, we expect the approval to happen in Q2.

但我們再次預計批准將在第二季進行。

Got it. And then on the TMTT side, as you kind of look 12 to 24 months forward, I believe you'll have tricuspid repair and replacement, mitral repair and replacement available US and OUS. So can you maybe help us just think about market segmentation a little bit in that category, how should we think about mix between repair and replacement today and going forward? And whether this category is more of a sort of toolbox approach for physicians or you think it converts to a one size fits all, be it in mitral or tricuspid?

知道了。然後在 TMTT 方面，展望未來 12 到 24 個月，我相信您將在美國和 OUS 進行三尖瓣修復和置換、二尖瓣修復和置換。那麼，您能否幫助我們稍微思考一下該類別中的市場細分，我們應該如何考慮當前和未來的維修和更換之間的組合？您認為這一類別是否更像是一種醫生的工具箱方法，或者它是否可以轉化為適合所有情況的方法，無論是二尖瓣還是三尖瓣？

Thanks, David. Let me start, and then I will ask Daveen to add some additional details. I want to start where we were a few years ago. We knew that TEER technology and repair technology were not going to be sufficient to unlock the full potential of a mitral and tricuspid space. So it is why we went in with the toolbox. And we brought first PASCAL, highly differentiated. And you have seen the kind of impact in the way (technical difficulty) to patients with PASCAL.

謝謝，大衛。讓我先開始，然後我會請 Daveen 添加一些額外的細節。我想從幾年前的情況開始說起。我們知道 TEER 技術和修復技術不足以充分發揮二尖瓣和三尖瓣空間的潛力。這就是我們帶著工具箱進去的原因。我們首先推出了高度差異化的 PASCAL。而且您已經看到了 PASCAL 對患者造成的影響（技術難度）。

But we know that many patients cannot be treated with TEER. So therefore, we -- we launched -- we were the first to launch EVOQUE, which is going very well, and we see we are putting more patients than just TEER patient, tricuspid patients with EVOQUE. Here with M3, it is the beginning of the same journey here. It is going to take us multiple years to train physicians, expand. So to give you a sense about segmentation right now, it is a little bit early, but Daveen is very close to that.

但我們知道，許多患者無法透過 TEER 治療。因此，我們 — — 我們推出了 — — 我們是第一個推出 EVOQUE 的公司，而且進展非常順利，我們看到我們為更多的患者（不僅僅是 TEER 患者、三尖瓣患者）提供了 EVOQUE。有了 M3，我們就開始同一段旅程。我們需要花費數年的時間來培訓醫生並擴大規模。因此，為了讓您了解目前的細分情況，現在還為時過早，但 Daveen 已經非常接近了。

So maybe I'll ask Daveen to bring some color here.

所以也許我會請戴文來這裡帶來一些色彩。

Yes. As Bernard said, it's hard to give exact segmentation, but I'll try to give you at least some thoughts we have. Today in Europe now, as Bernard said, we have now repair and replacement for each mitral and tricuspid. So we believe with the two technologies together, we can treat a larger group of patients.

是的。正如伯納德所說，很難給出精確的細分，但我會嘗試至少告訴你我們的一些想法。正如伯納德所說，如今在歐洲，我們已經對每個二尖瓣和三尖瓣進行了修復和更換。因此我們相信，透過結合這兩種技術，我們可以治療更多的患者。

Clearly, in the mitral side, again, in Europe, M3 has just gotten approved. And for SAPIEN M3, it will be overtime to really build out this category to train physicians to get appropriate payment, et cetera, over time. And for that, we see -- we remember that the M3 that this is a product that's geared toward the TEER and mitral surgery unsuitable patients, so for patients who don't have TEER or surgery options.

顯然，在二尖瓣方面，在歐洲，M3 剛剛獲得批准。對於 SAPIEN M3，需要加班才能真正建立這個類別，以便培訓醫生獲得適當的報酬等等。就此而言，我們看到——我們記得 M3 是一款針對 TEER 和二尖瓣手術不適合患者的產品，因此適用於沒有 TEER 或手術選擇的患者。

So over time, we still believe TEER for coming years will be the largest part. And then eventually over time, mitral will continue to grow -- mitral replacement will continue to grow in its treatment of people offering that new option.

因此，隨著時間的推移，我們仍然相信未來幾年 TEER 將佔最大份額。最終隨著時間的推移，二尖瓣將不斷增長——二尖瓣置換術將繼續在為人們提供新選擇的治療中不斷發展。

In tricuspid in Europe, again, it's a little difference in the US -- than the US where tricuspid TEER has been around for many years. And now the new category of EVOQUE has been recently created in Europe, where we're now adding more patients to the pool who are both tricuspid surgery and tricuspid TEER ineligible.

同樣，歐洲的三尖瓣與美國的三尖瓣稍有不同——在美國，三尖瓣 TEER 已經存在很多年了。現在，歐洲最近創建了新的 EVOQUE 類別，我們正在為患者庫中添加更多既適合三尖瓣手術又不適合三尖瓣 TEER 的患者。

So now we're adding new patients who don't have an option in producing these amazing results. And so that's how we see the European market progressing in the next couple of years. The US will have a little bit different dynamics, but you'll still see that because TEER has been very well established in the mitral space, we see mitral replacement as an additive therapy, bringing patients off the sideline and offering a solution that they didn't have before.

因此，現在我們正在增加沒有其他選擇的新患者來獲得這些驚人的結果。這就是我們對未來幾年歐洲市場發展的預測。美國的情況會略有不同，但您仍然會看到，由於 TEER 在二尖瓣領域已經非常成熟，我們將二尖瓣置換術視為一種附加療法，讓患者不再處於邊緣狀態，並為他們提供以前沒有的解決方案。

In the tricuspid space, as you know, both repair and replacement entered the US market at similar times. So the clinical community right now is learning together about, hey, which is the best repair patient and which is the best replacement patient. We've seen from experience in Europe so far that having a repair and a replacement solution is really important for treating the maximum number of patients. And but the exact ratio, we're going to figure that out together with clinicians in the coming years.

如您所知，在三尖瓣領域，修復和置換都是在相似的時間進入美國市場的。因此，臨床界目前正在共同學習，哪一個是最佳的修復患者，哪一個是最佳的替代患者。我們從迄今為止的歐洲經驗中看到，修復和替換解決方案對於治療盡可能多的患者確實非常重要。但具體的比例，我們將在未來幾年與臨床醫生一起弄清楚。

Travis Steed, Bank of America.

美國銀行的特拉維斯·斯蒂德 (Travis Steed)。

Congrats on the quarter. First question I wanted to ask on TAVR capacity constraints and the potential for the TAVR, NCD [loosened] some of the requirements or essentially broadened some of the number of centers available to treat and some of the ways that some of the capacity constraints could be eased over time.

恭喜本季取得佳績。我想問的第一個問題是關於 TAVR 的容量限制以及 TAVR 的潛力，NCD [放寬] 了一些要求或基本上擴大了一些可供治療的中心數量，以及一些可以隨著時間的推移緩解容量限制的方法。

Sure. Thanks for the question. Yes, we certainly feel it's the time to reopen the NCD. We think there's a number of things that need to be updated. The first is the NCD needs to specifically cover asymptomatic patients just to ensure national coverage is standardized for all the patients that need that therapy. I think the second thing is we know that adding hospitals that could offer this therapy would improve care and give more people access.

當然。謝謝你的提問。是的，我們確實認為現在是重新開放 NCD 的時候了。我們認為有許多內容需要更新。首先，NCD 需要專門覆蓋無症狀患者，以確保對所有需要該治療的患者進行標準化的全國覆蓋。我認為第二件事是我們知道增加可以提供這種療法的醫院將改善護理並讓更多人獲得這種療法。

And I think that's another important element. In terms of more broadly on capacity, I think some of the acute capacity issues that we dealt with last year, I think we're through the worst of that. We still see centers working actively to add capabilities. And we try to partner really closely with them. We offer clinic coordinator training courses.

我認為這是另一個重要因素。從更廣泛的容量角度來看，我認為我們去年處理的一些嚴重的容量問題，我認為我們已經度過了最糟糕的時期。我們仍然看到各中心積極努力地增加能力。我們努力與他們建立密切的合作關係。我們提供診所協調員培訓課程。

So if that's the constraint. We can certainly help them train their staff. Some places, it's more about anesthesia, so we can bring in experts to help them adopt conscious sedation. If they're just limited to two or three cases a day, we can bring in things like our benchmark program that can allow them to do more cases in the same time and the same footprint.

如果這就是限制。我們當然可以幫助他們培訓員工。有些地方比較注重麻醉，所以我們可以請專家來幫助他們採用清醒鎮靜方法。如果他們每天只能處理兩到三個案件，我們可以引入基準程序之類的工具，讓他們能夠在相同的時間和相同的空間內處理更多的案件。

So we continue to work with them. I think the reality is we have a lot of new technology. We have a lot of new indications coming. I think hospitals realize that, and I think they are investing. We've seen that, and they'll continue to do so. But the reality is they need to keep doing that because the indications right now it's going to be in the near term, asymptomatic, but we know we already have EVOQUE. We know we have M3 coming. And then we're only 1.5 years away from seeing the PROGRESS data, which could be another indication expansion.

因此我們繼續與他們合作。我認為現實是我們擁有很多新技術。我們有很多新的跡象。我認為醫院意識到了這一點，並且他們正在投資。我們已經看到了這一點，而且他們還會繼續這樣做。但現實是，他們需要繼續這樣做，因為目前的跡象表明，在短期內，病毒是無症狀的，但我們知道我們已經有了 EVOQUE。我們知道 M3 即將到來。然後我們只需 1.5 年的時間就能看到 PROGRESS 數據，這可能是另一個指示擴展。

So I think the hospitals are more in tune with what the requirements are going to be on a go forward. So I think it's going to be all those things coming together. I think it's going to be policy. I think it's going to be guidelines, and I think it's going to be those investments that are going to be the long-term solutions to capacity.

因此我認為醫院更了解未來的需求。所以我認為所有這些事情都會結合在一起。我認為這將成為一項政策。我認為這將成為指導方針，我認為這將成為解決產能問題的長期解決方案。

Great. That's helpful. And then I have a follow-up, just a modeling question on Q2 TAVR. I think the Street said 5.8%. Just curious if there's any color you want to provide on how to model Q2 TAVR in the remainder of the year in the second half? And any days benefit to kind of call out over the course of the year for the remaining portion of the year?

偉大的。這很有幫助。然後我有一個後續問題，只是關於 Q2 TAVR 的一個建模問題。我認為華爾街的預期是 5.8%。我只是好奇您是否想提供一些關於如何在下半年剩餘時間內模擬 Q2 TAVR 的詳細資訊？在這一年剩餘的時間裡，有哪些日子可以用於福利領取？

(technical difficulty) that growth in the first quarter. And to get to the midpoint of our 5% to 7% growth rate guidance for the year, it tells you we need something in the 6% range for each of Q2, Q3 and Q4. Obviously, there's going to be some differences. We've got some changes coming during the course of the year, including the symptomatic indication. But probably the right place to model, Travis is in that 6% range with some expected variability quarter-to-quarter.

(技術難度) 第一季​​度的成長。為了達到我們今年 5% 至 7% 的成長率預期的中間值，這意味著我們在第二季、第三季和第四季的成長率都需要達到 6% 左右。顯然，會存在一些差異。我們在這一年中經歷了一些變化，包括症狀指示。但可能是正確的建模位置，Travis 處於 6% 的範圍內，預計季度間會有一些變化。

Robbie Marcus, JPMorgan.

摩根大通的羅比·馬庫斯。

Great. Good quarter. Two for me. Scott, maybe just on the EPS offsets, offsetting $0.10 to $0.15 for Edwards is a big move and really impressive. Maybe speak to sort of the undertaking you're doing to be able to offset that kind of headwind between tariffs and JenaValve dilution.

偉大的。好季度。對我來說是兩個。斯科特，也許僅在 EPS 抵消方面，對 Edwards 來說，抵消 0.10 美元至 0.15 美元是一個重大舉措，確實令人印象深刻。也許可以談談您正在採取的措施，以便抵消關稅和 JenaValve 稀釋之間的不利因素。

Yes. Thanks for the question. Obviously, we've been anticipating the approval of the JenaValve and running a bunch of scenarios in the event that we're successful in getting it closed, which we think we will. Our guidance for the year did not anticipate an impact from JenaValve, but we've had plans to be able to take action when we got some confirmation and more confidence that we're going to get it closed. So we're ready to go.

是的。謝謝你的提問。顯然，我們一直在期待 JenaValve 的批准，並在成功關閉它的情況下運行了一系列場景，我們認為我們會成功。我們今年的指導方針並未預料到 JenaValve 的影響，但我們已經計劃在得到一些確認和更有信心將其關閉後採取行動。所以我們準備出發了。

We do think that spending will step up a bit in the second quarter because it was lower than what we originally had planned and expected in Q1, and that's really the reason why we ended up with $0.64 a share in EPS in the first quarter.

我們確實認為第二季度的支出會略有增加，因為它低於我們最初在第一季計劃和預期的支出，這也是為什麼我們第一季的每股收益為 0.64 美元的原因。

We're going to be looking at things like investments that we are planning to make that are more discretionary in 2025 that will not impact our sales guidance for this year. But at this point, we're not going to get into a lot more of the detail about where those items are. I mentioned in the prepared remarks that we're really focusing hard on prioritizing our R&D investments and really focusing on things that can drive top line organic growth and profitable growth and earnings over the long term.

我們將考慮一些事項，例如我們計劃在 2025 年進行的投資，這些投資更具自由裁量權，不會影響我們今年的銷售預期。但目前，我們不會詳細討論這些物品的存放位置。我在準備好的演講中提到，我們確實非常重視優先考慮我們的研發投資，並真正關注那些能夠推動長期營收有機成長、獲利成長和收益的事情。

And we're going to keep doing that. And again, I think we can continue to execute our focused strategy while also doing what we need to do to offset those headwinds that we're facing now in 2025.

我們將繼續這樣做。而且，我認為我們可以繼續執行我們的重點策略，同時採取我們需要採取的措施來抵消我們在 2025 年面臨的阻力。

So just to add on that, Scott, well said. I will say we are very pleased about the way we are starting the year, strong Q1 sales, slightly better than expected, EPS, top end of our range. We are -- we have achieved so many milestones in Q1, you have seen all of them where we are going to be able to create a new category for us, think about a multiyear growth opportunity ahead of us based on these new milestones.

所以，我再補充一點，史考特，說得很好。我想說的是，我們對今年的開局感到非常滿意，第一季的銷售強勁，略好於預期，每股收益處於我們產品範圍的最高水平。我們——我們在第一季取得瞭如此多的里程碑，你們已經看到了所有這些里程碑，我們將能夠為我們創造一個新的類別，想想基於這些新里程碑我們未來多年的成長機會。

Then full year outlook, confident 8 to 10, raising of the TMTT guidance and being able to offset JenaValve dilution and basically the tariff impact. We feel good about the year. We feel good about how we are running the company.

然後是全年展望，有信心 8 到 10，提高 TMTT 指導並能夠抵消 JenaValve 的稀釋和基本上關稅的影響。我們對今年感到滿意。我們對公司的經營方式感到滿意。

Great. Maybe -- just a quick follow-up. The TMTT guidance range. Part of it is FX, part of its underlying. First quarter was good, but still pretty much in line with the Street. How are you thinking about the split between FX and underlying and sort of the key drivers of progression in the raise guide through the rest of the year.

偉大的。也許——只是一個快速的跟進。TMTT 指導範圍。其中一部分是外匯，一部分是其標的。第一季表現不錯，但仍與華爾街的預期基本一致。您如何看待外匯和標的之間的分離，以及今年剩餘時間內加薪指南進展的關鍵驅動因素。

Sure. I'll just confirm on FX and then pass it over to Daveen to talk about just the operational performance and our outlook for the rest of the year. For FX, think about this $100 million benefit that we're getting through the movement in FX rates and just spreading that across our businesses, probably about half of the increase in TMTT guidance comes from FX and the other half from operational.

當然。我只需確認外匯情況，然後將其交給 Daveen 來談論營運表現和我們對今年剩餘時間的展望。對於外匯，想想我們透過外匯匯率變動獲得的 1 億美元收益，並將其分攤到我們的所有業務中，大概 TMTT 指引成長的一半來自外匯，另一半來自營運。

And then the balance of that $100 million would be spread across the other businesses. Of course, TAVR would be the biggest place for that to go. Daveen, do you want to talk about the other half of the guidance increase?

然後，這 1 億美元的餘額將分攤到其他業務。當然，TAVR 是實現這一目標的最佳途徑。Daveen，你想談談指導增幅的另一半嗎？

Yes. On the operational side of things, as you can imagine, we continue to see great momentum on both PASCAL as well as EVOQUE. So both are kind of key drivers, both in Q1 and going forward as we just treat more and more patients from maybe even I'll give you just a geography components. So it was good to look at that way as well. We see both coming from both the US and Europe.

是的。從營運方面來看，正如您所想像的，我們繼續看到 PASCAL 和 EVOQUE 都保持著強勁的發展勢頭。因此，兩者都是關鍵驅動因素，無論是在第一季還是未來，因為我們治療的患者越來越多，甚至可能來自不同的地理區域。所以從這個角度來看也是好事。我們看到兩者都來自美國和歐洲。

And in both these markets, PASCAL continues to show its differentiation. And EVOQUE as a new category continues to treat new patients that don't have great outcomes. So we see continued growth happening from that side as well. .

在這兩個市場中，PASCAL 繼續展現其差異化。EVOQUE 作為一個新類別，繼續治療那些沒有良好療效的新患者。因此，我們也看到該方面正在持續成長。。

Vijay Kumar, Evercore ISI.

維傑·庫馬爾（Vijay Kumar），Evercore ISI。

Scott, I had a couple of guidance clarifications, if you will. Maybe on the EPS guidance here, you called out the tariff headwinds in JenaValve. Are we expecting to offset that increment, $0.10 to $0.15 of headwinds completely? Or should we be perhaps looking at the bottom half of the guidance range, just maybe walk us through on what the offsets are.

史考特，如果你願意的話，我有幾個指導說明。也許在 EPS 指導中，您指出了 JenaValve 的關稅阻力。我們是否希望完全抵消這一增量，即 0.10 美元到 0.15 美元的逆風？或者我們應該看看指導範圍的下半部分，也許只是引導我們了解偏移量是多少。

Yes. So it's a little premature to be more precise about where within that $2.40 to $2.50, we may fall. And the reason is because we haven't closed JenaValve yet. So part of this depends upon the timing of that close and when we start picking up some of that burn. And part of it depends upon what the integration plan looks like and what we're actually going to execute. That's why we gave a range, and that's why we think that the $2.40 to $2.50 range in EPS can accommodate different scenarios.

是的。因此，現在就更精確地預測跌幅可能在 2.40 美元至 2.50 美元之間還為時過早。原因是我們還沒有關閉 JenaValve。因此，這部分取決於結束的時間以及我們何時開始收取一些費用。部分原因在於整合計劃是什麼樣的以及我們實際上要執行什麼。這就是我們給出範圍的原因，也是我們認為 EPS 2.40 美元到 2.50 美元的範圍可以適應不同情況的原因。

Understood. Maybe one on international. Japan was a little light maybe talk about trends within Japan.

明白了。也許有一個是國際的。日本有點輕鬆，也許談論的是日本國內的趨勢。

Yes. Thanks, Vijay, for the question. So for sure, our results in the quarter and even in the last quarter was less than expected, a little bit disappointing for us, but we are very optimistic about Japan. What we have seen is a couple of things happening. Weaker procedure growth environment and we need to better understand that what's happening there and also some competitive pressure.

是的。謝謝 Vijay 提出這個問題。因此可以肯定的是，我們本季乃至上一季的業績都低於預期，這對我們來說有點令人失望，但我們對日本非常樂觀。我們看到發生了幾件事。程式成長環境較弱，我們需要更好地了解那裡發生的事情以及一些競爭壓力。

So what we are doing is a couple of things is one is enhancing our capability in the region in Japan to accelerate market growth, one and better position our technology. You know that when our technology are very differentiated.

因此，我們正在做幾件事：一是增強我們在日本地區的能力，以加速市場成長，二是更好地定位我們的技術。你知道我們的技術有很大的差異。

When we bring our technology to patients, evidence demonstrating that they live longer, better quality of life, they avoid hospitalization, complication. So this is the kind of value we bring. We have a good story to tell. And I believe we are going to have all the Japanese physicians responding very well to this. We are also enhancing our capability in Japan to address the situation. So overall, long term in Japan, we see a big potential.

當我們將我們的技術帶給患者時，有證據表明他們活得更長，生活品質更好，可以避免住院和併發症。這就是我們帶來的價值。我們有一個好故事要說。我相信所有日本醫生都會對此做出積極的反應。我們也正在增強日本應對局勢的能力。因此總體而言，從長遠來看，我們看到了日本的巨大潛力。

Aging population. There is a lot of AS patients, mitral patients, tricuspid patients, so clearly, an opportunity for us and opportunity to change patient care there.

人口老化。這裡有很多僵直性脊椎炎患者、二尖瓣患者、三尖瓣患者，所以顯然，這對我們來說是一個機會，也是一個改變病人照護的機會。

Matt Taylor, Jefferies.

馬特泰勒，傑富瑞。

I did want to follow up on TMTT. I heard your comments and I guess I just wanted to confirm that none of the guidance range was really around M3. And also just wanted to think about how to maybe compare and contrast the launch of the mitral replacement versus what you've seen with EVOQUE in tricuspid? Should we expect it to be similar? And can you talk about when the European launch will start to contribute and what to expect from the US ?

我確實想跟進 TMTT。我聽到了您的評論，我想我只是想確認沒有任何指導範圍確實在 M3 左右。另外，只是想思考如何比較和對照二尖瓣置換術與三尖瓣置換術中 EVOQUE 的表現？我們是否應該期待它是相似的？您能談談歐洲的發布何時會開始發揮作用以及對美國的期望是什麼嗎？

Yes, sure. This is Daven, Matt. I can take that question. So first -- to the first part of your question, yes, you're correct that we had built in M3 into our original range for the year already and the change in guidance did not have to do with the specific CE mark or the timing of the CE Mark. We'd already kind of built it in.

是的，當然。這是戴文，馬特。我可以回答這個問題。首先——對於您問題的第一部分，是的，您說得對，我們已經將 M3 納入了我們今年的原始範圍，並且指導的變化與特定的 CE 標誌或 CE 標誌的時間無關。我們已經將它內建進去了。

And as we look at this kind of therapy, we're beginning with a very controlled launch that's emphasis on this really high-touch model that we have of supporting physicians and patients to ensure the highest quality outcome. The indication though of mitral replacement in Europe is different, is more similar to EVOQUE in Europe and different than what we see Evoke in the US, meaning, as I mentioned, mitral replacement is for patients who are unsuitable for mitral surgery or for TEER.

當我們研究這種療法時，我們首先會進行非常嚴格的控制，並專注於我們擁有的這種高接觸模式，以支持醫生和患者，確保最高品質的治療結果。然而，歐洲二尖瓣置換術的適應症有所不同，與歐洲的 EVOQUE 更相似，而與我們在美國看到的 Evoke 不同，這意味著，正如我所提到的，二尖瓣置換術適用於不適合進行二尖瓣手術或 TEER 的患者。

So for that, yes, we expect a gradual buildup. And in Europe, as you can imagine, we're drawing on our therapy and our experience in how to create categories because each country in Europe is very unique. The different ways of getting incremental payment and coverage for our therapies. And we've got to work on that one at a time, and that takes time. Additionally, we've got to train physicians, train our own team and build it up.

因此，是的，我們預計這一進程將會逐步推進。在歐洲，正如您所想像的，我們正在利用我們的治療方法和經驗來創建類別，因為歐洲每個國家都非常獨特。獲得我們治療的增量付款和保險的不同方式。我們必須逐一解決這個問題，這需要時間。此外，我們還必須培訓醫生，培訓我們自己的團隊並建立它。

So we really see SAPIEN M3 in Europe being more of a gradual long-term, important category of adding new patients with mitral disease to be treated. And hopefully that helps.

因此，我們確實認為歐洲的 SAPIEN M3 是一個漸進的、長期的、重要的類別，可以增加需要治療的新二尖瓣疾病患者。希望這能有所幫助。

That's great. And then maybe you could just finish with the US, how that will be different?

那太棒了。然後也許你可以只談美國，那會有什麼不同？

Yes. So in the US from different than EVOQUE in the US, as you can imagine, mitral replacement, again in the US will also have an indication unsuitable for TEER or mitral surgery. So again, these patients are already in the funnel.

是的。因此，與美國的 EVOQUE 不同，正如您所想像的，在美國，二尖瓣置換術也不適合進行 TEER 或二尖瓣手術。所以，這些病人已經進入漏斗了。

They may not be appropriate for surgery or TEER. They don't have any other option. And now for many of those patients, M3 will be an option. EVOQUE, as you know, when we launched it, had a different -- broader indication for people for health status improvement for people with tricuspid disease.

它們可能不適合手術或 TEER。他們沒有其他選擇。現在，對於許多患者來說，M3 將是一種選擇。如您所知，當我們推出 EVOQUE 時，它具有不同的——更廣泛的適應症，可改善三尖瓣疾病患者的健康狀況。

So there's not this layer of first, are you appropriate for TEER or surgery. So with that, we would expect that the US mitral launch in general would be at a slightly slower rate probably -- would be at a slower rate than we think we saw with EVOQUE.

因此，首先不存在這一層，您是否適合進行 TEER 或手術。因此，我們預計美國 Mitral 的推出速度總體上可能會稍微慢一些 - 比我們認為的 EVOQUE 的速度要慢。

But either way, we really see that the great news about this is that this technology replacement is really complementing TEER and adding patients to allow us for that kind of multiple years of growth as we add more -- add more patients with this new treatment.

但無論如何，我們確實看到，關於這一點的好消息是，這項技術替代確實補充了 TEER 並增加了患者，使我們能夠實現這種多年的增長，因為我們會增加更多 - 使用這種新療法增加更多患者。

Joanne Watson Wuensch, Citibank.

喬安妮‧沃森‧文施 (Joanne Watson Wuensch)，花旗銀行。

I just want to pause on the early TAVR label expansion and NCD because I think there's a couple of different things that are happening here. And correct me if I'm wrong, one is the label expansion. The second one is the NCD. NCD could expand the number of centers include expand maybe something else?

我只是想暫停早期 TAVR 標籤擴展和 NCD，因為我認為這裡發生了幾件不同的事情。如果我錯了，請糾正我，一個是標籤擴充。第二個是NCD。NCD 可以擴大中心數量，包括擴大其他內容嗎？

And I've also heard from some decisions may be an expectation that it might eliminate the need for a cardiac surgery team in the OR. So could you just sort of like clarify what you think may happen? And then how long after all of that starts to layer on? Do you think procedures start to ramp?

我還聽說，一些決定可能期望它能夠消除手術室對心臟手術團隊的需求。那麼，您能否稍微解釋一下您認為可能會發生什麼？那麼所有這些要多久才會開始分層呢？您認為程式開始加速了嗎？

Yes. Thanks, Joanne. I think there's a multitude developments here. The first thing is the label expansion, which obviously is under FDA's control. And again, we expect that to happen in Q2. So that's kind of step one. The national coverage decision, that's kind of the purview of CMS and they'll decide when they want to reopen that and when they want to reevaluate it.

是的。謝謝，喬安妮。我認為這裡有許多發展。首先是標籤擴展，這顯然是在 FDA 的控制之下。我們再次預計這將在第二季發生。這就是第一步。全國覆蓋範圍的決定屬於 CMS 的職權範圍，他們將決定何時重新開放該決定以及何時重新評估該決定。

And given the safety of TAVR that's been demonstrated in the national registry that we have that really confirms the outstanding results across all of the centers that we've opened. We do expect there to be an expansion in the number of centers. How many will that be? That's going to be up to how they write the policy and how that plays out. And we'll see how they decide to streamline the team and try to make the health care system more efficient.

鑑於我們擁有的國家註冊中心已經證明 TAVR 的安全性，這確實證實了我們開設的所有中心都取得了出色的成果。我們確實預計中心數量會增加。那會有多少？這將取決於他們如何制定政策以及如何實施。我們將看到他們如何精簡團隊並努力提高醫療保健系統的效率。

The third big element is guidelines, which fall under the society purview and how do they take this data, how do they update the guidelines, so that patients with severe aortic stenosis, but haven't yet pursued to symptoms, how do we make sure that they move through the health care system, they're properly screened and they're treated in accordance with what the data suggests.

第三個重要因素是指南，它屬於社會職權範圍，社會如何獲取這些數據，如何更新指南，以便患有嚴重主動脈瓣狹窄但尚未出現症狀的患者，我們如何確保他們通過醫療保健系統，接受適當的篩檢，並根據數據建議進行治療。

And I think we're still in that education process with a lot of folks. There are sometimes people think that asymptomatic patients are automatically younger patients, but what we saw in the trial is I think the average age was 76, where for a low-risk trial, it was 73%. So these aren't necessarily younger patients. We're not necessarily treating them at a much younger age. So I think these things are all important things that we just need to keep reiterating.

我認為我們仍在對許多人進行這樣的教育。有時人們認為無症狀患者一定是較年輕的患者，但我們在試驗中看到，我認為平均年齡為 76 歲，而在低風險試驗中，這一比例為 73%。所以這些不一定是較年輕的患者。我們不一定會對他們進行更年輕的治療。所以我認為這些都是重要的事情，我們只需要不斷重申。

And again, once we have the approval, it really takes the shackles off of being able to really advance our education platform and advance our ability to promote this. But until we get the FDA approval, we're just kind of at a standstill beyond what the physicians themselves, the investigators and people do it at the big medical meetings.

再說一次，一旦我們獲得批准，它就會真正解除我們推進教育平台和提高我們推廣教育平台能力的桎梏。但在我們獲得 FDA 批准之前，我們只能處於一種停滯狀態，超出醫生、研究人員和人們在大型醫學會議上所做的範圍。

Peter Chickering, Deutsche Bank.

彼得‧奇克林，德意志銀行。

Following up on these NCD questions. Our call is that the physicians is that CMS is actually in sort of final discussions with the societies and the health systems about relaxing this entity to be certified (technical difficulty) centers and that this change could actually be coming in May or in June. Is this timing something that you guys have heard as well?

跟進這些 NCD 問題。我們呼籲醫生注意，CMS 實際上正在與社會和衛生系統進行最後的討論，關於放寬該實體成為認證（技術難度）中心的規定，並且這一變化實際上可能會在五月或六月到來。你們也聽過這個時間嗎？

There is no predetermined timing. It opens whenever CMS decides that they want to open it and that is completely within their purview. No one, frankly, has any influence over that. It's completed within their realm of control. So anybody that provides specific timing, they're simply speculating as to when they think that could happen. So I don't have any insights beyond what I've already stated, and it's going to be up to them.

沒有預定的時間。只要 CMS 決定要打開它，它就會打開，這完全在他們的權限範圍內。坦白說，沒有人能夠影響這一點。這是在他們的控制範圍內完成的。因此，任何提供具體時間的人都只是在推測他們認為何時會發生這種情況。因此，除了我已經說過的以外，我沒有任何見解，這取決於他們。

Again, we do expect that a new policy. I think we have plenty of experience with the technology now. I do think the new policy will reflect the safety that we've demonstrated. And I do expect that at some point, the policy is going to reopen. And I think one of the catalysts in front of CMS is going to be the asymptomatic approval.

再次，我們確實期待一項新政策。我認為我們現在對該技術已經有了豐富的經驗。我確實認為新政策將反映我們所展示的安全。我確實希望在某個時候，該政策能夠重新開放。我認為 CMS 面臨的催化劑之一就是無症狀批准。

And one of the things we've seen historically, when we first got approval for SAPIEN , it was under local coverage, and it did lead to some inconsistencies with how things were done and that really drove CMS to open the NCD because they wanted to make sure that patients across all of their constituents could be treated under a national policy.

從歷史上看，當我們首次獲得 SAPIEN 批准時，它處於地方覆蓋範圍內，這確實導致了執行方式上的一些不一致，這確實促使 CMS 開放 NCD，因為他們希望確保所有選民的患者都能在國家政策下接受治療。

So I expect that to happen again when exactly is going to be completely up to them. But when they do, then we get to engage with them, we get to start that process and hopefully end up with a policy that is going to allow more patients access to life-saving therapy.

所以我預計這種情況會再次發生，具體時間完全由他們決定。但當他們這樣做時，我們就會與他們接觸，開始這個過程，並希望最終制定一項政策，讓更多的患者能夠獲得挽救生命的治療。

Great. Then a follow-up here. Can you guys give us an update on how the demand for training for EVOQUE going? And any color on how many sites have been trained? And -- or in a process to be trained?

偉大的。然後在這裡進行跟進。你們能否向我們介紹一下 EVOQUE 訓練需求的最新情況？並且對多少個站點進行了顏色訓練？並且——或者處於訓練過程中？

No, sure. This is Daveen again. Yes. So first, in terms of EVOQUE sites, as you can imagine, as I think I mentioned before we started those first 50 or 60 clinical trial sites. And then from that continuing to invest in new sites that are -- work with sites that are investing in tricuspid disease. So that number is a growing number.

不，當然。我又是 Daveen。是的。首先，就 EVOQUE 站點而言，正如您所想像的，正如我之前提到的，我們啟動了前 50 或 60 個臨床試驗站點。然後從那時起繼續投資新的站點 — — 與投資三尖瓣疾病的站點合作。所以這個數字還在不斷增加。

We continuously are booking trial sites out for several months in advance. So right now, if you're interested in a trial site, it's at least a couple of months away. So it's been consistently like that where the demand from physicians to get trained has been always a little bit greater than maybe our ability to open sites just in the ramp. And this really, as you know, has to do with the value proposition where people are seeing how the elimination of TR with EVOQUE is really changing patients' lives and a result both physicians and patients are asking for the technology.

我們經常提前幾個月預訂試驗場地。因此，現在，如果您對試用站點感興趣，至少還需要幾個月的時間。因此，情況一直如此，醫生對培訓的需求總是比我們在坡道上開設站點的能力要大一些。如您所知，這確實與價值主張有關，人們看到使用 EVOQUE 消除 TR 確實改變了患者的生活，因此醫生和患者都要求這項技術。

And so in general, though, as you can imagine, as Larry just mentioned, there are, what, 850 TAVR centers or so. I mean it's a very big number. And our goal is some number of those would be great for tricuspid treatment including EVOQUE, and we continue each year just to keep opening and training new centers for many years to come, just like TAVR did over the course of many years.

所以總的來說，正如你可以想像的，正如 Larry 剛才提到的，大約有 850 個 TAVR 中心。我的意思是這是一個非常大的數字。我們的目標是，其中的一些中心將非常適合包括 EVOQUE 在內的三尖瓣治療，並且我們每年都會繼續開設和培訓新的中心，就像 TAVR 多年來所做的那樣。

Chris Pasquale, Nephron.

克里斯·帕斯誇萊（Chris Pasquale），Nephron。

The 2.6% surgical growth this quarter was the slowest we've seen from that business in a while. I know selling days had a bit of an impact. Can you just talk about your confidence in being able to sustain mid-single-digit growth in that segment, especially now that the RESILIA platforms have really become dominant in many of your big markets that you don't have as much of a tailwind from mix.

本季手術業務成長率為 2.6%，這是我們一段時間以來看到的最慢的成長率。我知道銷售天數有一點影響。您能否談談您對能夠維持該領域中等個位數成長的信心，尤其是現在 RESILIA 平台已經在您許多大市場中佔據主導地位，而您在這些市場中並沒有獲得太多的混合推動力。

Yes, Chris, thanks for the question there. In Q1, we did have some challenging comps when we considered -- compare it to prior year when the business was growing in the high single-digit range. And I think looking forward in 2025, as you heard from Bernard, we're launching MITRIS in China. We've got some other potential tailwinds later on this year with the approval of KONECT in Europe. And so we are remaining confident in our current guidance in the mid-single-digit range for 2025.

是的，克里斯，謝謝你的提問。在第一季度，我們確實遇到了一些具有挑戰性的比較——與去年同期相比，當時業務成長率處於高個位數。我認為展望 2025 年，正如您從伯納德那裡聽到的，我們將在中國推出 MITRIS。隨著 KONECT 在歐洲獲得批准，今年稍後我們還將獲得其他一些潛在的順風。因此，我們對 2025 年中等個位數成長範圍的當前預期仍然充滿信心。

Great. That's helpful. And I know this may be a bit difficult to answer, given that the deal hasn't closed yet, but we saw some updated data from the ALIGN AR trial at ACC, continues to look solid. We're about 18 months out now from the original data presentation. Just any help you can give us in terms of what we should expect for a regulatory pathway and approval timing for that product?

偉大的。這很有幫助。我知道這個問題可能有點難回答，因為交易還沒有完成，但我們看到了 ACC 的 ALIGN AR 試驗的一些更新數據，看起來仍然很穩健。距離最初的數據呈現，現在已經過去了大約 18 個月。您能否就該產品的監管途徑和審批時間方面為我們提供一些幫助？

Yes. Actually, we don't have anything that we can talk about on that. We're sort of pencils down until the deal closes. So we don't have any direct knowledge. We're not in conversation with them. Until the deal closes, we're sort of on the outside looking in. So I don't have any more information than what you saw presented at ACC.

是的。實際上，我們對此沒有什麼好談的。我們會一直等待，直到交易完成。所以我們沒有任何直接的知識。我們沒有與他們交談。在交易完成之前，我們只能站在外面觀察。因此，我沒有比您在 ACC 上看到的更多資訊。

Patrick Wood, Morgan Stanley.

摩根士丹利的派崔克‧伍德。

I guess maybe on PASCAL, doing pretty well. Where are we at in terms of accounts sort of breadth versus depth? I'm thinking like, is the utilization sort of where you would like it to be? I'm trying to how wide you all versus how deep within individual accounts.

我猜也許在 PASCAL 上，表現相當不錯。就帳戶的廣度和深度而言，我們處於什麼位置？我在想，利用率是否達到了您所希望的水平？我正在嘗試了解你們的帳戶有多廣以及個人帳戶有多深。

Yes, sure. If you think about PASCAL overall, we continue to see that this product has future differentiation that we believe is leading to really predictable and positive outcomes for patients. And that -- and you see that in accounts who currently have access to PASCAL that as they use PASCAL more and more, they see those great patient outcomes, and then they want to use it more.

是的，當然。如果從整體上考慮 PASCAL，我們會繼續看到該產品具有未來的差異化，我們相信這將為患者帶來真正可預測的正面結果。而且 — — 您可以看到，在目前可以使用 PASCAL 的帳戶中，隨著他們越來越多地使用 PASCAL，他們看到了患者的良好治療結果，然後他們就想更多地使用它。

And then as you can imagine, they then tell their friends through different types of programs at congresses, so that sites who today who don't use PASCAL are interested in trying to use it. And so that's how we see it spreading in both increased depth in certain centers as well as opening new centers.

然後你可以想像，他們透過會議上不同類型的程式告訴他們的朋友，以便今天不使用 PASCAL 的網站有興趣嘗試使用它。這就是我們看到的它如何在某些中心擴大傳播範圍以及開闢新的中心。

In terms of the number of centers, maybe specific, I'll just speak to the US, again, maybe I'll use the generic, if they are 850 TAVR centers, give or take, in the US or so, our goal is to grow into as many of these that make sense. But today, we're definitely in less than fewer than 50% of them. So there's still a lot of opportunity for growth, both in new accounts as well as increasing penetration and seeing those great patient outcomes in the sites that currently use PASCAL.

就中心數量而言，也許具體來說，我只會談到美國，同樣，也許我會使用通用的數字，如果美國有 850 個 TAVR 中心，或多或少，我們的目標是發展盡可能多的這樣的中心。但今天，我們參與的比例肯定還不到 50％。因此，仍然有很多成長機會，包括新帳戶、滲透率的提高以及在目前使用 PASCAL 的站點中看到出色的患者治療效果。

That's helpful. And then very quickly, there's been a lot of sort of shuffle around of the FDA overall and people fire, rehire that sort of things. Is there any expectation from you guys that approval time lines, long term could be affected or anything like that? Or is this a short-term noise that we can ignore.

這很有幫助。隨後很快，FDA 內部就發生了很多變動，人員解僱、重新聘用等等。你們是否預期審批時間表、長期計畫會受到影響或類似情況？或者這只是我們可以忽略的短期噪音。

Yes. Obviously, the situation is a fluid one, and we are watching. But so far, we don't see any change with the FDA approval timeline, response to any submission, all of that. So we feel like the people at the FDA are very professional. They are very committed to the space, and we don't see any impact and we don't believe we will see an impact. But obviously, it is a fluid situation that we need to monitor.

是的。顯然，情勢瞬息萬變，我們正在關注。但到目前為止，我們還沒有看到 FDA 批准時間表、對任何提交的回應等有任何變化。所以我們覺得 FDA 的人非常專業。他們非常致力於這個領域，我們沒有看到任何影響，我們也不相信會看到影響。但顯然，這是我們需要監控的不穩定情況。

Thank you. At this time, this concludes the allotted question-and-answer session time. I would like to pass the call back over to management for any closing remarks.

謝謝。至此，分配的問答時間就結束了。我想將電話轉回給管理階層，以便他們做最後的總結發言。

Yes. So thank you, everyone, for your interest. So beyond the strong start of the year, I'm very excited about what we were able to achieve in Q1 with this very strong catalyst. If you step back and you look at them, we are on track to get an early TAVR indication approval in Q2. We had an NCD for EVOQUE.

是的。謝謝大家的關注。因此，除了今年開局強勁之外，我對我們在這一強大催化劑的作用下在第一季的成就感到非常興奮。如果你退一步來看，我們預計在第二季度獲得早期 TAVR 適應症批准。我們有 EVOQUE 的 NCD。

Sapien M3 CE Mark, which basically represents the start of a new category for us, RESILIA (technical difficulty) amazing outcome. So all of that together gives us confidence in what we told you in December at our investor conference. We believe we are very well positioned to transform care for the many structural heart patients and we are continuing to target total company sales growth of 10% annually on average.

Sapien M3 CE Mark，這基本上代表了我們一個新類別的開始，RESILIA（技術難度）令人驚嘆的成果。所有這些都讓我們對 12 月投資者會議上所說的話充滿信心。我們相信，我們完全有能力改變眾多結構性心臟病患者的護理，並且我們將繼續以平均每年 10% 的公司總銷售額增長率為目標。

So again, very pleased about the year, the numbers, all of the catalysts. I think all of our people, 16,000 employees, are doing amazing work, and I want to thank them for that. Thanks for your interest in the company. And if you need any questions, do not hesitate you to call CE Mark, Scott, or myself. Have a great rest of your day. Thank you

所以，我對今年的業績、數據以及所有催化劑感到非常滿意。我認為我們所有的員工，16,000 名員工，都在做著出色的工作，我要為此感謝他們。感謝您對本公司的關注。如果您有任何疑問，請隨時致電 CE Mark、Scott 或我本人。祝您今天剩餘的時間過得愉快。謝謝

That concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

今天的電話會議到此結束。現在您可以斷開線路。感謝您的參與。