愛德華生命科學 (EW) 2025 Q2 法說會逐字稿

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

您好，歡迎參加 Edwards Lifesciences 2025 年第二季業績電話會議。（操作員指示）請注意，本次會議正在錄音。

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

現在我將會議交給主持人、全球金融資深副總裁馬克‧威爾特丁 (Mark Wilterding)。謝謝。你可以開始了。

Thank you very much, Diego, and thank you, all, 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 Global Group President of TAVR and Surgical; Daveen Chopra, our Global Leader of TMTT; Wayne Markowitz, our Global Leader of Surgical; and Dan Lippis, Corporate Vice President. Just after the close of regular trading, Edwards Lifesciences released second-quarter 2025 financial results.

非常感謝你，迭戈，也感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 和我們的財務長 Scott Ullem。參加電話會議問答環節的還有我們的 TAVR 和外科全球集團總裁 Larry Wood、我們的 TMTT 全球負責人 Daveen Chopra、我們的外科全球負責人 Wayne Markowitz 和公司副總裁 Dan Lippis。常規交易結束後不久，Edwards Lifesciences 發布了 2025 年第二季財務業績。

During the call today, management will discuss the results included in the press release and accompanying financial schedules and use the remaining 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中包含的結果和隨附的財務計劃，並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 have been announced to date and assume such tariffs remain in place for the remainder of 2025. Any modifications to such tariffs or any new tariffs could have a material impact on the company's future financial results and guidance.

Edwards 的指導反映了其對現行或迄今已宣布的關稅影響的當前估計，並假設此類關稅將在 2025 年剩餘時間內繼續有效。對此類關稅的任何修改或任何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。

Finally, 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 the call are also included in today's press release. Quarterly and full-year growth rates refer to continuing operations.

最後，除非另有說明，我們對銷售成長的評論是指以固定貨幣計算的銷售成長，該成長在今天稍早發布的季度業績新聞稿中有定義。今天的新聞稿中還包括了電話會議中提到的 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。

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, and welcome, everyone. Thank you for joining us today.

謝謝你，馬克，歡迎大家。感謝您今天加入我們。

Before getting into the numbers, let me highlight the many significant achievements we have made across the company. When we introduce our sharpened focused strategy, we did so in anticipation of an asymptomatic AS approval, the expansion of EVOQUE launch, the expected introduction of SAPIEN M3, and our strategic entry into structural heart failure and aortic regurgitation, which represents remarkable synergies to our 65 years of valve leadership. These areas represent large and growing opportunities, and we are just getting started.

在介紹數字之前，請容許我先強調我們整個公司所取得的許多重大成就。當我們推出更聚焦的策略時，我們預期無症狀 AS 的批准、EVOQUE 發布的擴大、SAPIEN M3 的預期推出，以及我們策略性地進入結構性心臟衰竭和主動脈瓣關閉不全領域，這代表著我們 65 年瓣膜領導地位的顯著協同效應。這些領域代表著巨大且不斷成長的機遇，而我們才剛起步。

Our focus on structural heart has positioned the company for agile execution of our strategy and provides the foundation for sustainable growth. It is supported by our conviction in mid- to high-single-digit TAVR growth over the long term given the undertreatment globally. The potential of our market-leading surgical valve franchise based on compelling ATA resilient data. And finally, the significant patient benefits of our pioneering TMTT technologies.

我們對結構核心的關注使公司能夠靈活執行我們的策略並為永續成長奠定了基礎。鑑於全球治療不足，我們堅信 TAVR 長期內將維持中高個位數成長。基於令人信服的 ATA 彈性數據，我們的市場領先的手術瓣膜特許經營權具有潛力。最後，我們先進的 TMTT 技術為患者帶來了顯著的益處。

While TAVR is and will remain an important growth driver for our company, Edwards is increasingly defined by a balanced portfolio of differentiated therapies across aortic, mitral, and tracker speed that will position us for leadership for many years to come as we help even more patients around the world.

雖然 TAVR 現在是、將來仍將是公司的重要成長動力，但 Edwards 越來越被定義為在主動脈、二尖瓣和追蹤速度方面均衡的差異化治療組合，這將使我們在未來許多年內保持領先地位，幫助世界各地更多的患者。

During the call today, we will go into more details on the company's strong second-quarter performance across product groups and geographies and our confidence in the outlook for Edwards in the years ahead.

在今天的電話會議中，我們將詳細介紹公司第二季度在各個產品組和地區的強勁表現，以及我們對 Edwards 未來幾年前景的信心。

We are pleased to report double-digit sales growth in the second quarter, driven by broad-based growth across our unique portfolio of structural heart therapies. Total sales of $1.53 billion grew 10.6% which was better than expected. Based on our strong first half performance and the many catalysts across our portfolio, we are increasingly confident in our full-year outlook and are raising our full-year 2025 sales growth guidance to 9% to 10% and adjusted EPS guidance to the high end of our original range of $2.40 to $2.50.

我們很高興地報告，第二季的銷售額實現了兩位數成長，這得益於我們獨特的結構性心臟治療產品組合的廣泛成長。總銷售額達 15.3 億美元，成長 10.6%，優於預期。基於我們上半年的強勁表現和投資組合中的眾多催化劑，我們對全年前景越來越有信心，並將 2025 年全年銷售成長預期上調至 9% 至 10%，並將調整後的每股收益預期上調至原定 2.40 美元至 2.50 美元區間的高端。

Now, I will provide some additional detail by product group for Q2. In TAVR, our second quarter global sales of $1.1 billion increased 7.8% over the prior year. Growth was comparable in the US and OUS. On a global basis, Edward's competitive position and pricing remains stable.

現在，我將按產品組提供第二季的一些更多詳細資訊。在 TAVR 領域，我們第二季的全球銷售額為 11 億美元，比前一年成長了 7.8%。美國和澳洲的成長情況相當。在全球範圍內，愛德華的競爭地位和定價保持穩定。

TAVR growth in the quarter was better than expected as clinicians continue to adopt our best-in-class SAPIEN technology. We are encouraged by the renewed focus on TAVR across the clinical community since the early TAVR data released last October.

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。自去年 10 月發布早期 TAVR 數據以來，整個臨床界重新關注 TAVR，這令我們感到鼓舞。

We are pleased with the recent approvals that make the SAPIEN M3 platform the first and only TAVR to receive US and European approvals for the asymptomatic indication. These two approvals enable all patients diagnosed with severe AS to be evaluated and considered for treatment with TAVR regardless of symptoms.

我們很高興看到最近獲得的批准，SAPIEN M3 平台成為第一個也是唯一一個獲得美國和歐洲批准用於無症狀適應症的 TAVR。這兩項批准使得所有被診斷患有嚴重 AS 的患者無論症狀如何都可以接受評估並考慮接受 TAVR 治療。

The evolution of policy and guideline changes together with the potential of a new US NCD will provide important catalysts, resulting in a multiyear growth opportunity for TAVR overall. And we remain focused on continuing our deep commitment to advancing evidence for AS patients with three important studies in May at the EuroPCR conference, results of the Optum real-world study of more than 24,000 patients demonstrated that intervening on aortic stenosis before symptoms develop reduces the economic and resource burden on the healthcare system and improves patient outcomes.

政策和指南的演變以及美國新 NCD 的可能性將提供重要的催化劑，從而為 TAVR 帶來多年的整體成長機會。我們將繼續致力於為 AS 患者提供更深入的證據，在 5 月份的 EuroPCR 會議上進行了三項重要研究，其中 Optum 對超過 24,000 名患者進行的真實世界研究的結果表明，在症狀出現之前對主動脈瓣狹窄進行幹預可減輕醫療保健系統的經濟和資源負擔並改善患者的治療效果。

Additionally, compared with asymptomatic severe AS, delaying treatment until the disease progressed resulted in a higher rate of death within one year after aortic valve replacement. Alongside data from the early TAVR trial, these results reinforce the value of early referrals and evaluation by our heart valve team for all patients with severe AS.

此外，與無症狀的嚴重 AS 相比，延遲治療直至病情進展會導致主動脈瓣置換術後一年內死亡率更高。結合早期 TAVR 試驗的數據，這些結果強化了我們的心臟瓣膜團隊對所有嚴重 AS 患者進行早期轉診和評估的價值。

Second, at the New York Valve conference last month, 10 years outcome from the PARTNER II study were presented under correctly excellent long-term outcomes and durability of Edwards TAVR platform. This is the first FDA-approved TAVR study to report 10-year follow-up and represent the largest TAVR patient cohort studied through 10 years.

其次，在上個月的紐約瓣膜會議上，PARTNER II 研究的 10 年結果在 Edwards TAVR 平台優異的長期結果和耐用性下進行了展示。這是 FDA 批准的首個報告 10 年追蹤結果的 TAVR 研究，也是 10 年來研究中規模最大的 TAVR 患者群體。

Finally, new data from the DETECT AS study were also presented. The sub analysis demonstrated that electronic provider notification, or echo alerts, increased both treatment and survival rates in all patients with severe AS.

最後，也展示了 DETECT AS 研究的新數據。子分析表明，電子提供者通知或迴聲警報可提高所有嚴重 AS 患者的治療率和存活率。

Looking ahead to TCT in October, we expect to be the first company to present seven-year data studying a low surgical risk cohort of TAVR patients. I am proud of our team's commitment to advancing robust dividends to improve outcomes for patients with severe aortic stenosis, supported by a decade of clinical research. This significant body of high-quality science underscores the excellent clinical outcomes delivered by Edwards' premium SAPIEN technology, which has benefited over 1 million patients around the world since its launch.

展望十月份的 TCT，我們有望成為第一家展示研究 TAVR 低手術風險患者群體的七年數據的公司。我為我們團隊致力於透過十年臨床研究的支持，提供強勁的紅利來改善嚴重主動脈瓣狹窄患者的預後而感到自豪。這項重要的高品質科學成果凸顯了 Edwards 優質的 SAPIEN 技術所帶來的卓越臨床效果，自推出以來已惠及全球超過 100 萬名患者。

In the US, we are pleased that the clinical conversations about the successful early TAVR trial have brought a renewed focus to streamlining the management of patients with severe AS, enabling closer follow-up and more timely treatment of patients with aortic stenosis.

在美國，我們很高興看到關於早期 TAVR 試驗成功的臨床討論重新將焦點集中在簡化嚴重 AS 患者的管理上，從而能夠對主動脈瓣狹窄患者進行更密切的隨訪和更及時的治療。

Outside of the US, we continue to focus on the value of our differentiated technology and increasing therapy adoption, especially in areas where many patients go without care. In Europe, the exit of competitor resulted in a rebalancing of market share and a modest contribution to our sales. In Japan, TAVR sales grew in the mid-single digits, an improvement over last quarter and consistent with the company's total sales growth in the region. Rest of the world, growth remains strong.

在美國以外，我們繼續關注差異化技術的價值和提高治療的採用率，特別是在許多患者無法接受護理的地區。在歐洲，競爭對手的退出導致市場佔有率重新平衡，並對我們的銷售做出了適度的貢獻。在日本，TAVR 銷售額實現了中等個位數成長，較上一季有所改善，與該公司在該地區的總銷售額成長一致。世界其他地區成長依然強勁。

In summary, we are raising our full-year guidance to 6% to 7%, up from previous guidance of 5% to 7%. Longer term, we are enthusiastic about the mid- to high single-digit growth opportunities in TAVR, supported by the recent early TAVR indication approvals, future guideline and policy changes, including an updated NCD. And finally, you have a potential to serve patients with moderate AS.

總而言之，我們將全年預期從先前的 5% 至 7% 上調至 6% 至 7%。從長遠來看，我們對 TAVR 的中高個位數成長機會充滿信心，這得益於近期早期 TAVR 適應症的批准、未來指南和政策變化（包括更新的 NCD）。最後，您有潛力為中度 AS 患者提供服務。

I also want to take this opportunity to share with you that Larry Wood, who has been leading the TAVR team, has made the personal decision to depart Edwards in early September and pursue a leadership opportunity outside of cardiovascular. We sincerely thank Larry for his 40 years of dedication to Edwards and our patients. During that time, Edwards TAVR has helped more than 1 million aortic stenosis patients around the world.

我也想藉此機會與大家分享一個消息：一直領導 TAVR 團隊的 Larry Wood 已做出個人決定，將於 9 月初離開 Edwards，尋求心血管領域以外的領導機會。我們真誠感謝拉里 40 年來對愛德華茲和我們病人的奉獻。在此期間，Edwards TAVR 已幫助全球超過 100 萬名主動脈瓣狹窄患者。

As we heard today, TAVR is well-positioned for continued growth, and success and we are pleased to announce that Dan Lippis will assume leadership of TAVR franchise globally. We are fortunate to have a very well-prepared successor who has more than 50 years of deep TAVR experience in the US and Europe. Most recently, Dan has also been leading our JPAC region with responsibility for our full portfolio of technologies.

正如我們今天所聽到的，TAVR 已做好持續成長和成功的準備，我們很高興地宣布 Dan Lippis 將擔任全球 TAVR 特許經營的領導。我們很幸運能擁有一位準備充分的繼任者，他在美國和歐洲擁有 50 多年的豐富 TAVR 經驗。最近，Dan 也領導我們的 JPAC 地區，負責我們所有的技術組合。

I'm very confident that the TAVR leadership team will build on our momentum and deliver long-term success. Dan and Larry will work together on a smooth transition through early September.

我非常有信心，TAVR 領導團隊將延續我們的勢頭並取得長期成功。丹和拉里將共同努力，確保九月初的順利過渡。

Now, let's turn to our key TMTT product group. Our unique portfolio of repair and replacement therapies to treat mitral and tricuspid diseases drove another quarter of impressive growth with a meaningful contribution to overall company performance.

現在，讓我們來看看我們的關鍵 TMTT 產品組。我們獨特的修復和替代療法組合用於治療二尖瓣和三尖瓣疾病，推動了另一個季度的顯著增長，為公司整體業績做出了有意義的貢獻。

Second-quarter sales of $133 million grew 57%, reflecting the strength and differentiation of our portfolio of repair and replacement technologies and demonstrating our team's long-term and steadfast commitment to solving large unmet patient needs.

第二季的銷售額為 1.33 億美元，成長了 57%，反映了我們修復和更換技術組合的優勢和差異化，並表明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。

PASCAL and EVOQUE were both significant contributors to growth as they continue to scale. With the addition of SAPIEN M3, Edwards is uniquely positioned to meet the broad and diverse needs of patients with mitral and tricuspid valve diseases.

隨著 PASCAL 和 EVOQUE 規模不斷擴大，它們都對成長做出了重要貢獻。隨著 SAPIEN M3 的加入，Edwards 擁有獨特的優勢，可以滿足二尖瓣和三尖瓣疾病患者的廣泛而多樣化的需求。

Mitral tier procedures continue to grow in the double digits globally, and the developing track speed opportunity is growing much faster across both repair and replacement.

全球二尖瓣手術持續以兩位數的速度成長，而修復和置換過程中發展軌道速度的機會也成長得更快。

Adoption of our differentiated PASCAL technology remains strong in both new and existing centers around the world. We continue to see growing interest in the therapy, reinforcing the significant unmet needs of these patients.

我們差異化的 PASCAL 技術在全球新建和現有中心的採用率仍然很高。我們持續看到人們對這種療法的興趣日益濃厚，這進一步證實了這些患者尚未滿足的巨大需求。

We are also pleased to announce the completion of enrollment in our 1,000-patient European [my class] post-approval study in patients with both DMR and FMR. Publications and presentation of data from this study continue to demonstrate the excellent clinical results delivered by the state-of-the-art PASCAL technology.

我們也很高興地宣布，我們針對 1,000 名 DMR 和 FMR 患者的歐洲 [我的類別] 上市後研究的招募工作已經完成。本研究的出版物和數據展示繼續證明了最先進的 PASCAL 技術所帶來的出色臨床效果。

The EVOQUE commercial launch is progressing well in the US and Europe with excellent real-world outcome for patients in line with the successful TRISCEND II clinical trial results. Consistent with Edwards science-based approach to establishing categories for the many patients in need, we are continuing to generate evidence for EVOQUE.

EVOQUE 在美國和歐洲的商業發布進展順利，為患者帶來了出色的現實世界結果，與成功的 TRISCEND II 臨床試驗結果一致。與 Edwards 基於科學的方法為眾多有需要的患者建立類別一致，我們正在繼續為 EVOQUE 產生證據。

At the recent New York valve conference, results from a real-world 176-patient study across 12 centers and 5 countries in Europe demonstrated excellent clinical outcomes that were similar or better than the results shown in TRISCEND II patient receiving EVOQUE. And we look forward to an EVOQUE late-breaking substudy at next month European Society of Cardiology Conference.

在最近舉行的紐約瓣膜會議上，來自歐洲 12 個中心和 5 個國家的 176 名患者的真實世界研究結果顯示出出色的臨床結果，其結果與接受 EVOQUE 治療的 TRISCEND II 患者的結果相似或更好。我們期待下個月歐洲心臟學會會議上公佈 EVOQUE 的最新突破性子研究。

We have also begun enrollment in the large TRISCEND III clinical trial in Europe. This prospective multicenter study of up to 500 real-world patients with TR disease will track clinical outcomes out to five years.

我們也開始招募歐洲大型 TRISCEND III 臨床試驗的參與者。這項前瞻性的多中心研究針對多達 500 名真實患有 TR 疾病的患者，將追蹤五年內的臨床結果。

In summary, for EVOQUE, there is a great demand for the therapy, and we are continuing to develop important evidence to support expansion globally.

總而言之，對於 EVOQUE 而言，該療法的需求很大，我們正在繼續開發重要的證據來支持其在全球範圍內的擴張。

We are pleased with the addition of our latest TMTT technology, the pioneering SAPIEN M3 valve, which received CE mark approval in Q2. Clinical feedback, while early, has been positive. We will deploy our differentiated high-value model to support therapy expansion with a continued focus on ensuring access and excellent confirmations. We continue to expect that results from the ENCIRCLE pivotal trials studying SAPIEN M3 will be presented at the TCT conference later this year. And we now expect US approval of SAPIEN M3 to follow in the first half of 2026.

我們很高興增加了最新的 TMTT 技術，即開創性的 SAPIEN M3 閥門，該閥門在第二季度獲得了 CE 標誌認證。臨床回饋雖然還處於早期階段，但一直是正面的。我們將部署差異化的高價值模式來支持治療擴展，並繼續專注於確保可及性和出色的確認。我們繼續期待研究 SAPIEN M3 的 ENCIRCLE 關鍵試驗結果將在今年稍後的 TCT 會議上公佈。我們目前預計美國將在 2026 年上半年批准 SAPIEN M3。

In closing, with PASCAL, EVOQUE, and the recent CE mark SAPIEN M3, our vision for TMTT has developed into a growth portfolio of groundbreaking transcatheter repair and replacement technologies, meeting the complex need of underserved patients with mitral and tricuspid diseases. We are committed to bringing this impactful therapies to the many patients in need around the world.

最後，憑藉 PASCAL、EVOQUE 和最近的 CE 標誌 SAPIEN M3，我們對 TMTT 的願景已發展成為突破性的經導管修復和置換技術的增長組合，滿足了二尖瓣和三尖瓣疾病患者複雜的需求。我們致力於為世界各地許多有需要的患者提供這種有效的治療方法。

We are pleased with our year-to-date performance in TMTT and remain on track to achieve our full-year sales guidance to $530 million to $550 million. In our Surgical product group, second quarter global sales of $267 million increased 6.8% over the prior year. We continue to see positive procedure growth globally for the many patients best treated surgically with our premium resilient technologies, including INSPIRIS, MITRIS, and KONECT.

我們對今年迄今為止 TMTT 的表現感到滿意，並有望實現全年銷售目標 5.3 億美元至 5.5 億美元。在我們的外科產品組，第二季全球銷售額為 2.67 億美元，比上年增長 6.8%。我們持續看到全球許多患者透過我們的優質彈性技術（包括 INSPIRIS、MITRIS 和 KONECT）接受手術治療，手術量呈現積極成長動能。

Our surgical team is making progress around the world advancing important innovation for patients. We continue to see the impact across the clinical community from the recent presented RESILIA ATM data demonstrated excellent durability and better freedom from reoperation due to structural valve deterioration compared to non-resilient valves.

我們的外科團隊正在世界各地取得進展，為患者帶來重要的創新。我們繼續看到最近提出的 RESILIA ATM 數據對整個臨床界的影響，該數據表明與非彈性瓣膜相比，其具有出色的耐用性，並且更好地避免了由於結構性瓣膜損壞而導致的再次手術。

We are also pleased to have received CE mark approval for KONECT in Europe during the quarter. For the full year, we continue to expect mid-single-digit sales growth in our Surgical product group.

我們也很高興本季 KONECT 在歐洲獲得了 CE 標誌認證。就全年而言，我們繼續預計外科產品組銷售額將實現中等個位數成長。

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

現在，史考特將介紹公司財務業績的細節。

Thanks a lot, Bernard, and good afternoon, everyone. As Bernard mentioned, we are pleased with our better-than-expected Q2 performance and the progress we made during the quarter advancing our strategic initiatives. Our double-digit sales growth drove adjusted earnings per share of $0.67. Our GAAP EPS for the quarter was $0.57, which included a onetime charge related to our portfolio of external investments. A full reconciliation between our GAAP and adjusted earnings per share for this and other line items is included with today's release.

非常感謝，伯納德，大家下午好。正如伯納德所提到的，我們對第二季度好於預期的業績以及本季在推進策略舉措方面取得的進展感到滿意。我們的銷售額實現了兩位數成長，推動調整後每股收益達到0.67美元。本季度，我們的GAAP每股收益為0.57美元，其中包括與外部投資組合相關的一次性費用。今天的發布中包含了此項和其他項目的 GAAP 和調整後每股收益的完整對帳。

And now, I'll cover additional details of our P&L. For the second quarter, our adjusted gross profit margin was 77.6%, in line with our expectations compared to 80% in the same period last year. This year-over-year change was driven by additional manufacturing expenses related to the expansion of new therapies as well as foreign exchange.

現在，我將介紹我們的損益表的更多細節。第二季度，我們的調整後毛利率為 77.6%，符合我們的預期，去年同期為 80%。這一同比變化是由於與新療法擴展以及外匯相關的額外製造費用所致。

We continue to expect our full-year 2025 adjusted gross profit margin to be within our original guidance range of 78% and 79%. Our guidance continues to assume some pressure from the weakening dollar and the impact of announced tariffs, albeit less than initially expected as well as the acquisition of JenaValve, which is not closed yet.

我們繼續預計 2025 年全年調整後毛利率將在我們最初的 78% 和 79% 指導範圍內。我們的指導意見繼續假設美元疲軟和宣布的關稅的影響會帶來一些壓力，儘管這些壓力低於最初的預期，以及尚未完成的對 JenaValve 的收購。

Selling, general, and administrative expenses in the quarter was $502 million or 32.8% of sales compared to $448 million in the prior year. We expect increased SG&A spending in the second half of the year due to deferral of certain spending year-to-date as well as anticipated spending related to JenaValve.

本季銷售、一般及行政費用為 5.02 億美元，佔銷售額的 32.8%，去年同期為 4.48 億美元。我們預計下半年銷售、一般及行政費用 (SG&A) 支出將會增加，原因是年初至今某些支出被推遲，以及與 JenaValve 相關的預期支出。

Research and development expense was $276 million in the second quarter or 18% of sales compared to $272 million or 19.8% of sales in the same period last year. This increase in spending and decrease in R&D as a percentage of sales reflects our strategic prioritization of investments in our expanding structural heart portfolio.

第二季研發費用為 2.76 億美元，佔銷售額的 18%，去年同期為 2.72 億美元，佔銷售額的 19.8%。支出的增加和研發費用佔銷售額百分比的下降反映了我們對不斷擴大的結構性心臟產品組合的投資策略優先性。

The year-over-year improvement in second quarter adjusted operating profit margin of 28.2% benefited from our better-than-expected sales performance and the deferral of certain spending to the second half of the year. As mentioned on the Q1 earnings call, we continue to expect lower second-half operating margin levels compared to the first half, reflecting expenses associated with the planned acquisition of JenaValve. We continue to expect full year 2025 operating margin of 27% to 28%.

第二季調整後營業利潤率年增 28.2%，得益於我們好於預期的銷售業績以及將某些支出推遲到下半年。正如在第一季財報電話會議上提到的那樣，我們仍然預計下半年的營業利潤率將低於上半年，這反映了與計劃收購 JenaValve 相關的費用。我們繼續預計 2025 年全年營業利潤率將達到 27% 至 28%。

We remain committed to annual constant currency operating profit margin expansion in 2026 and beyond consistent with our guidance at our investor conference in December.

我們仍致力於在 2026 年及以後實現年度固定匯率營業利潤率的擴大，這與我們在 12 月投資者會議上的指導一致。

Turning to taxes. Our reported tax rate this quarter was 16.1% or 16.8%, excluding the impact of special items in line with our expectation for the quarter. We continue to expect our 2025 tax rate, excluding special items, to be between 15% and 18%.

談到稅收。我們本季報告的稅率為 16.1% 或 16.8%，不包括特殊項目的影響，符合我們對本季的預期。我們仍預期 2025 年的稅率（不包括特殊項目）將在 15% 至 18% 之間。

Turning to the balance sheet. We continue to maintain a strong and flexible balance sheet with approximately $3 billion in cash and cash equivalents as of June 30. Edwards currently has approximately $1 billion remaining under its share repurchase authorization.

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 6 月 30 日，現金和現金等價物約為 30 億美元。目前，Edwards 的股票回購授權剩餘金額約為 10 億美元。

Average diluted shares outstanding during the quarter were $588 million. Based on year-to-date share repurchases, we now expect lower full-year shares outstanding to be between $585 million to $590 million, versus original guidance of $585 million to $595 million.

本季平均攤薄流通股數為 5.88 億美元。根據今年迄今的股票回購情況，我們目前預計全年流通股數將在 5.85 億美元至 5.9 億美元之間，而最初的預期是 5.85 億美元至 5.95 億美元。

Foreign exchange rates increased second-quarter reported sales growth by 130 basis points or $15 million compared to the prior year. FX rates negatively impacted our second-quarter gross profit margin by 60 basis points compared to the prior year. Relative to our April guidance, FX rates had a nominal impact on second quarter earnings per share. At current rates, we now expect FX to have an approximately $30 million upside to full-year 2025 sales compared to the prior year.

與去年同期相比，外匯匯率導致第二季銷售額成長 130 個基點，即 1,500 萬美元。外匯匯率對我們第二季的毛利率產生了負面影響，與去年同期相比，下降了 60 個基點。相對於我們四月份的指導，外匯匯率對第二季每股收益的影響很小。以目前的速度，我們預計 FX 2025 年全年銷售額將比前一年增加約 3,000 萬美元。

I'll finish with comments related to the sales and EPS guidance. As Bernard mentioned, we are increasing our underlying growth rate guidance for TAVR to 6% to 7%, driven by strong performance and our sales guidance range for TAVR to $4.3 billion to $4.5 billion to also reflect stronger OUS currencies.

最後，我將發表與銷售和每股收益指引相關的評論。正如伯納德所提到的，由於業績強勁，我們將 TAVR 的基本成長率預期上調至 6% 至 7%，並將 TAVR 的銷售預期範圍上調至 43 億美元至 45 億美元，以反映美國貨幣走強。

We are also increasing our total company sales growth guidance to 9% to 10%, with sales of $5.9 million to $6.1 million. We now expect full-year adjusted earnings per share guidance at the high end of our original range of $2.40 to $2.50.

我們也將公司整體銷售額成長預期上調至 9% 至 10%，銷售額達到 590 萬美元至 610 萬美元。我們現在預計全年調整後每股收益將達到我們最初設定的 2.40 美元至 2.50 美元區間的高端。

Regarding JenaValve and the potential impact on our P&L this year, we are reaching the end of the regulatory review process and expect a decision soon. We remain hopeful that we will be able to close the acquisition during the third quarter. For the third quarter, we're projecting sales of $1.46 billion to $1.54 billion and adjusted earnings per share of $0.54 to $0.60.

關於 JenaValve 及其對我們今年損益的潛在影響，我們即將完成監管審查程序，並期待很快做出決定。我們仍然希望能夠在第三季完成收購。對於第三季度，我們預計銷售額為 14.6 億美元至 15.4 億美元，調整後每股收益為 0.54 美元至 0.60 美元。

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

說完這些，我就把它交還給伯納德。

Thank you, Scott. We are pleased with our strong performance in the first half of 2025 and our outlook for the full year. The milestones achieved showcase the strength of our focused strategy to drive breakthrough innovation in pioneering and leading categories.

謝謝你，斯科特。我們對 2025 年上半年的強勁表現和全年展望感到滿意。這些里程碑的實現彰顯了我們在開拓性和領先領域推動突破性創新的重點策略的實力。

Looking ahead to '26 and beyond, Edwards is positioned to transform care for the many structural heart patients in need. We are confident that our unique innovation strategy, supported by the many important catalysts across our portfolio, and the exceptional work of our 16,000 employees around the world will deliver significant value to patients, the healthcare ecosystem, and shareholders.

展望 26 年及以後，愛德華茲將致力於為眾多有需要的結構性心臟病患者提供更好的照護。我們相信，我們獨特的創新策略，在我們投資組合中的許多重要催化劑的支持下，以及我們遍布全球的 16,000 名員工的出色工作下，將為患者、醫療保健生態系統和股東帶來巨大的價值。

With that, I turn it back over to Mark.

說完，我把麥克風交還給了馬克。

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

非常感謝，伯納德。我們現在準備好回答您的問題。（活動須知）

(Operator Instructions) Robbie Marcus, JPMorgan.

（操作員指示）摩根大通的羅比馬庫斯 (Robbie Marcus)。

Great. Good afternoon, and congrats on a very nice quarter. Maybe to start, two for me. First one, US TAVR looks like when I try and back in based on the color you gave, it was a little better than the Street expected. So what really drove that? Was there asymptomatic already coming into play? Or any other trends or color you could add would be helpful. Thanks.

偉大的。下午好，恭喜您本季取得如此出色的成績。也許一開始，對我來說是兩個。首先，根據您給出的顏色，當我嘗試恢復時，美國 TAVR 看起來比華爾街預期的要好一些。那麼，真正推動這現象的是什麼呢？無症狀感染者是否已經出現？或者您添加的任何其他趨勢或顏色都會有所幫助。謝謝。

Hey, Robbie. Thanks for the question. Yes, the quarter came better than expected for TAVR. And we are very pleased about what we have seen. If you big picture we are the leader in TAVR. We have been focusing a lot on bringing evidence. And this early TAVR study drove a lot of conversation among the clinical community.

嘿，羅比。謝謝你的提問。是的，本季 TAVR 的表現優於預期。我們對所見所聞感到非常高興。如果您放眼全局，我們就是 TAVR 領域的領導者。我們一直非常注重提供證據。這項早期的 TAVR 研究引起了臨床界的大量討論。

So what we have experienced since the approval is a renewed focus on TAVR, a renewed focus on how to better manage these patients, how to make sure that these patients are timely taking care of. So all of that together, basically, we created a catalyst in the TAVR space.

因此，自從批准以來，我們重新關注 TAVR，重新關注如何更好地管理這些患者，如何確保這些患者得到及時照顧。所以，所有這些加在一起，基本上，我們在 TAVR 領域創造了一個催化劑。

And the good news about that, it is just starting. We are waiting for a big catalyst. We are waiting for guidelines. We are waiting for NCD, which are yet to come. So that's great to see this kind of positivity in the space, the reaction of the clinical community, and at the end of the day, for a leader like us to be leading this conversation.

好消息是，一切才剛開始。我們正在等待一個強大的催化劑。我們正在等待指導方針。我們正在等待尚未到來的NCD。很高興看到這個領域的這種積極性、臨床界的反應，以及最終由我們這樣的領導者來引領這場對話。

I'm going to ask Larry to provide additional details here also.

我還想請拉里在這裡提供更多詳細資訊。

Yeah. Thanks, Bernard, and thanks, Robbie, for the question. Yes. I don't think we're seeing a lot of asymptomatic patients come in. I think in centers that participated in the early TAVR trial, we probably see a little bit of it, so there might be some in there.

是的。謝謝伯納德和羅比提出這個問題。是的。我認為我們沒有看到很多無症狀患者住院。我認為在參與早期 TAVR 試驗的中心，我們可能會看到一點，所以其中可能會有一些。

But I think as Bernard kind of alluded to, I think what we're seeing is just a renewed attention on the management of patients with severe aortic stenosis. And I think this dataset was very powerful. And we know in the system from a lot of the work that [Samuel] has done that even patients with mild symptoms often get held in the process and don't move forward for referral for therapy. And I think people are paying a lot more attention to these patients. And I think this new dataset is just reprioritize these patients within the structural heart programs. And so I think that's a little bit of what we're seeing. And obviously, we're very pleased with the quarter.

但我認為，正如伯納德所暗示的那樣，我們看到的只是人們對嚴重主動脈瓣狹窄患者管理的重新關注。我認為這個數據集非常強大。我們從 [Samuel] 所做的大量工作中了解到，即使是症狀輕微的患者，也經常會在治療過程中受到阻礙，無法繼續轉診接受治療。我認為人們對這些病人給予了更多的關注。我認為這個新的資料集只是在結構性心臟計畫內重新確定了這些患者的優先順序。所以我認為這就是我們所看到的。顯然，我們對本季的表現非常滿意。

Great. Maybe a follow-up for me. US TAVR obviously gets a lot of attention, and we hear less about outside US trends. So maybe you could talk about what you saw outside the US, in Japan, and particularly Europe with the exit of your competitor?

偉大的。或許對我來說這是一個後續行動。美國 TAVR 顯然受到了很多關注，而我們聽到的有關美國以外趨勢的資訊較少。那麼，您能否談談您在美國、日本，特別是歐洲以外看到競爭對手退出後的情況？

Yeah. Thank you, Robie. Maybe I'm going to take this opportunity to ask Dan to answer this question. We are very fortunate to have amazing talent that it was, and Dan Lippis is going to come here in the US and lead the TAVR franchise.

是的。謝謝你，羅比。也許我要藉此機會請丹回答這個問題。我們非常幸運擁有如此出色的人才，丹·利皮斯 (Dan Lippis) 將來到美國領導 TAVR 特許經營業務。

So maybe Dan, you want to answer this question.

所以也許丹，你想回答這個問題。

Sure. Thanks, Bernard. Hopefully, you can hear me well. First of all, it's been a real privilege working alongside Larry so closely for the last 15 years. First in the US, then in Europe, and now most recently in Asia. And given that I led the TAVR team in Europe, maybe I'll start with Europe.

當然。謝謝，伯納德。希望您能聽清楚我的話。首先，過去 15 年來能夠與拉里密切合作是我的榮幸。首先是在美國，然後在歐洲，最近又在亞洲。鑑於我曾領導歐洲的 TAVR 團隊，也許我會從歐洲開始。

The rollout of our S3 platform is progressing really nicely. And the feedback from physicians continues to be very positive. But I guess what we're most optimistic about is the recent asymptomatic indication, and we think that's going to be a real game changer for the longer term.

我們的 S3 平台的推出進展非常順利。醫生們的回饋仍然非常正面。但我想我們最樂觀的是最近的無症狀跡象，我們認為從長遠來看，這將真正改變局面。

Switching to Japan. This is an important market for us. We remain very dedicated to expanding our therapy there. The undertreatment is significant, and the overly population there is very substantial. And while we're market leaders there, we are working really hard to regain some of the ground we've lost as new competitors have entered the market. And beyond that, we continue to grow in a very nice manner internationally beyond Europe and Japan.

轉到日本。這對我們來說是一個重要的市場。我們仍然致力於在那裡擴大我們的治療方法。那裡的治療不足現像很嚴重，而人口過剩現象卻非常嚴重。雖然我們是該市場的領導者，但隨著新競爭對手進入市場，我們正在努力奪回一些失去的市場。除此之外，我們在歐洲和日本以外的國際市場也持續以非常好的方式發展。

So hopefully, that answers your question.

希望這能回答你的問題。

Thanks, Dan. And thanks for the question, Robbie.

謝謝，丹。謝謝你的提問，羅比。

Travis Steed, Bank of America.

美國銀行的特拉維斯·斯蒂德 (Travis Steed)。

Hey, thanks for the question. Congrats on the good quarter. I wanted to ask about EPS, both more kind of shorter term, why not maybe raise the EPS even more at this point. Tariffs are probably, what, a couple of cents better and you beat the Street by $0.05.

嘿，謝謝你的提問。恭喜本季取得良好業績。我想問一下 EPS，兩者都是短期的，為什麼不在此時進一步提高 EPS。關稅可能只高出幾美分，你就比華爾街便宜了 0.05 美元。

And then kind of longer term, when you think about EPS leverage, do you think you can grow EPS faster and then the 10% revenue growth that you kind of laid out going forward?

那麼從長遠來看，當您考慮 EPS 槓桿時，您是否認為您可以更快地提高 EPS 成長率，然後實現您未來制定的 10% 的收入成長率？

Hey, Travis, it's Scott. Thanks for the question. we had a nice second quarter, and we saw the benefits of that drop through to the bottom line. We ended up coming in above the top end of our guidance range, which was not expected.

嘿，崔維斯，我是史考特。感謝您的提問。我們第二季表現不錯，我們看到了獲利下降的好處。我們最終的業績超出了預期的指導範圍上限。

At the same time, we've got some headwinds that we talked about last quarter, and those have not necessarily all abated. And so especially things like JenaValve, where we expect to have a negative effect on our earnings per share when it closes, that gives us some cause for pause.

同時，我們也面臨上季談到的一些不利因素，這些因素不一定會全部消退。因此，特別是像 JenaValve 這樣的事情，我們預計當它關閉時會對我們的每股收益產生負面影響，這給了我們一些暫停的理由。

But overall, we're feeling good about the trends in earnings per share this year. That's why we raised our guidance from $240 to $250 million all the way to the high end of $240 million to $250 million.

但總體而言，我們對今年每股收益的趨勢感到樂觀。這就是為什麼我們將預期從 2.4 億美元到 2.5 億美元一路上調至 2.4 億美元到 2.5 億美元的高端。

In terms of longer-term EPS expectations, you know our plan, which is to, on average, grow the top-line double digits and to get some leverage on the bottom line beyond that. So our expectations and our intentions have not changed, and we're going to stay focused on not just delivering short term in 2025, strong earnings per share, but longer-term, consistent, sustainable, growing EPS as well.

就長期每股收益預期而言，您知道我們的計劃，即平均而言，實現兩位數的營收成長，並在獲利方面獲得一些槓桿。因此，我們的期望和意圖沒有改變，我們將繼續專注於不僅在 2025 年實現短期強勁的每股收益，而且還要實現長期、一致、可持續、增長的每股收益。

Great, thank you. Maybe just a question on the international competitor that's exited the market. When you think about the share you're capturing there? Is it kind of in line with your international share above or below? Just kind of get a sense for kind of that opportunity?

太好了，謝謝。也許這只是一個關於退出市場的國際競爭對手的問題。您考慮過您在那裡獲得的份額嗎？它與您的國際份額是否一致？只是對那種機會有一點感覺嗎？

Yeah. Thanks for the question, Travis. What I will say is our first order of business when our competitor exited the market was to make sure we reached out to the centers that we knew were heavy users of their technology and make sure that we had inventory there that we had people there that we were able to train folks and make sure that they were -- the patients didn't get delayed or denied access to high-quality care. So that was sort of really our focus, and that's what drove a little bit of the benefit that we saw there.

是的。謝謝你的提問，崔維斯。我想說的是，當我們的競爭對手退出市場時，我們的首要任務是確保我們能夠聯繫到那些我們知道大量使用其技術的中心，並確保我們在那裡有庫存，有人員可以培訓他們，並確保他們——患者不會因為延誤或無法獲得高品質的護理。所以這確實是我們的重點，這也是我們看到的一些好處的來源。

I think longer term, they sold at a different price point than we did. So I think it's on us to speak to the value of our technology and why it's worth our price point, and that's what the team is focused on right now. And so we'll see how that plays out over the longer term. But certainly, we're optimistic that our platform has showed really well, and we continue to put data on the board that I think highlights the advantages and why our platform is what we charge for it.

我認為從長遠來看，他們的銷售價格與我們不同。因此我認為我們應該說明我們的技術的價值以及為什麼它值這個價位，這也是團隊現在關注的重點。因此，我們將觀察其長期發展。但當然，我們對我們的平台表現非常好感到樂觀，並且我們會繼續在董事會上發布數據，我認為這些數據凸顯了我們平台的優勢以及我們收費的原因。

Larry Biegelsen, Wells Fargo.

富國銀行的拉里·比格爾森。

Hi, good afternoon. Thanks for taking the question. Congrats on the nice quarter. Larry, congratulations on all your success at Edwards. You're going out on a high note and it's hard to imagine Edwards without you. It was a pleasure working with you, and I wish you the best of luck in your new role. So I'll start with a question for you.

嗨，下午好。感謝您回答這個問題。恭喜本季取得良好成績。拉里，祝賀你在愛德華茲的一切成功。你正以高昂的姿態離開，很難想像愛德華茲沒有你將會是什麼樣子。與您共事非常愉快，並祝福您在新的職位上一切順利。因此我首先要問您一個問題。

Larry, when do you expect CMS to reopen the NCD? And what's the likelihood of moving to a single operator? And if that happens, what do you think the implications are? And I had one follow-up.

拉里，您預計 CMS 何時會重新開放 NCD？轉向單一運營商的可能性有多大？如果發生這種情況，您認為會產生什麼影響？我還有一個後續行動。

Yeah. Thanks, Larry. Thanks for your kind words, and thanks for your question. We think the time to open the NCD is now. The ball is really in CMS's court, but we're going to continue to work with them. And provide information to them and hopefully, it open sooner rather than later because there's a number of changes that need to be made.

是的。謝謝，拉里。感謝您的善意，也感謝您的提問。我們認為現在是開放 NCD 的時候了。目前球仍在 CMS 手中，但我們將繼續與他們合作。並向他們提供信息，希望它能盡快開放，因為有很多改變需要做。

The first one is making sure that asymptomatic gets covered so that all asymptomatic patients are eligible for therapy across the country. And so that's really important. But this technology has advanced so far at this point that I think everybody agrees, we could streamline the operator requirements and the facility requirements. And that's going to open up access for patients and improve care for patients because we know there's waiting list and there's other challenges, and that will relieve a lot of the capacity in the system challenges that we have now.

一是確保無症狀感染者得到覆蓋，使全國所有無症狀感染者都有資格接受治療。所以這真的很重要。但這項技術目前已經發展到如此程度，我想大家都同意，我們可以簡化對操作員的要求和設施的要求。這將為患者提供更多就醫機會，改善患者的護理，因為我們知道有等候名單和其他挑戰，這將大大緩解我們目前面臨的系統容量挑戰。

I think the big advantage to, if we go to one specialty doing the procedure is, in essence, you would have two teams now that could do procedures. You could have a surgeon-led TAVR team and you can have a cardiology led over team, which would allow people to optimize their patient flow through. So I think that would be a big benefit.

我認為，如果我們去一個專科進行手術，那麼最大的優勢就是，從本質上講，你現在有兩個團隊可以進行手術。您可以擁有一個由外科醫生領導的 TAVR 團隊，也可以擁有一個由心臟病學領導的團隊，這將允許人們優化患者流程。所以我認為這將是一個很大的好處。

And when we look at the data, the conversion now from TAVR to surgery is the same rate as the conversion rate between PCI and surgery. And obviously, we don't have all these restrictions and requirements. So we think the time is now, we just need to continue to work with them and make the case for it. And hopefully, they open it sooner rather than later.

當我們查看數據時，我們發現現在從 TAVR 到手術的轉換率與 PCI 到手術之間的轉換率相同。顯然，我們沒有所有這些限制和要求。所以我們認為現在是時候了，我們只需要繼續與他們合作並為此辯護。希望他們能盡快開放。

That's helpful. And Bernard or Scott, you said a goal of 10%. It's a follow-up to an earlier question. You set a goal of 10% annual top-line growth, I think 50 to 100 basis points of margin improvement and double-digit EPS growth in 2026 and beyond. You have a lot of momentum now. You have catalysts coming like M3 and hopefully, JenaValve. Is there anything you're aware of today that would cause you to be below those goals next year? Thanks for taking the question.

這很有幫助。伯納德或斯科特，你說的目標是 10%。這是對先前問題的後續回答。你設定的目標是每年營業收入成長 10%，我認為到 2026 年及以後，利潤率將提高 50 到 100 個基點，每股盈餘將達到兩位數成長。你現在動力十足。您有像 M3 和 JenaValve 這樣的催化劑。您今天是否意識到了什麼會導致您明年無法實現這些目標？感謝您回答這個問題。

No, I can. Thanks, Larry. Let me start, and I'm sure Scott can add any details here. No, we are confident, Larry. Like you said, we are we passed on a great quarter. We are on track to have a great year, better than expected.

不，我可以。謝謝，拉里。讓我開始吧，我相信斯科特可以在這裡添加任何細節。不，我們有信心，拉里。正如您所說，我們度過了一個偉大的季度。我們預計迎來豐收的一年，甚至比預期的還要好。

We have so many catalysts across the company in TAVR, in TMTT, in surgical. We have some new businesses also coming our way. There are so many things to do in the US, outside of the US, so I feel very confident. And it is very much aligned to what I shared with you at the investor conference last year, we saw that coming. We knew it was coming. And we are making all of this happen.

我們公司在 TAVR、TMTT 和外科手術方面擁有眾多催化劑。我們也有一些新的業務正在進行中。在美國國內和國外都有很多事情可以做，所以我感到非常有信心。這與我去年在投資人會議上與大家分享的內容非常一致，我們已經預見了這一點。我們知道它會發生。我們正在讓這一切成為現實。

I am super proud of the team we have. This team is amazing. We have a very bold strategy altogether. We are the only company having this kind of bold strategy, a very unique innovation process, and we are executing in a very flawless fashion. We make things happen. And that's truly who we are as a company, and so I'm very confident about our commitment here for 2025, '26, and beyond.

我對我們的團隊感到非常自豪。這支球隊太棒了。我們總體上有一個非常大膽的戰略。我們是唯一一家擁有這種大膽策略、獨特創新流程的公司，而且我們正在以非常完美的方式執行。我們讓事情發生。這就是我們作為一家公司的真實面貌，因此我對我們在 2025 年、2026 年及以後的承諾充滿信心。

Scott, anything to add?

史考特，還有什麼要補充的嗎？

I share that view. We feel positive about not just the top line, but what contributes to the bottom line as well. At the same time, there are all kinds of different scenarios that can unfold. And so part of this has to do with uncertainties like tariff exposure that none of us can predict. Part of this is just what happens to the baseline against which we're comparing 2026. But we're just based upon all the different scenarios. We're feeling pretty good at this point in July of '25 as we look ahead to the full year 2026 and the ability to meet those annual average targets that we laid out in December.

我同意這個觀點。我們不僅對營業收入感到樂觀，而且對獲利也同樣感到樂觀。同時，各種不同的情景都有可能出現。因此，部分原因在於我們無法預測的關稅風險等不確定性。這部分只是我們與 2026 年進行比較的基線所發生的事情。但我們只是基於所有不同的場景。2025 年 7 月，當我們展望 2026 年全年並有能力實現 12 月制定的年度平均目標時，我們感覺非常好。

David Roman, Goldman Sachs.

高盛的大衛‧羅曼（David Roman）。

Thank you, and congrats, everybody. I wanted to start on the TMTT business and maybe very specifically around EVOQUE. There have been a variety of publications. I wouldn't call them studies necessarily questioning some of the safety and real-world outcomes around EVOQUE. But I think when we last engaged with you, you talked about the impact that learning curve has had on centers and those centers that had greater experience we're seeing better outcomes. Can you maybe just elaborate a little bit on what you're seeing from a real-world evidence standpoint as it relates to adverse events surrounding EVOQUE and when we might be able to see some of that data in a more public setting?

謝謝大家，恭喜大家。我想開始從事 TMTT 業務，也許具體來說是圍繞 EVOQUE 的業務。已有多種出版品。我不會稱它們為必然質疑 EVOQUE 的一些安全性和現實世界結果的研究。但我認為，當我們上次與您接觸時，您談到了學習曲線對中心的影響，而那些經驗豐富的中心我們看到了更好的結果。您能否從現實世界證據的角度稍微詳細說明您所看到的情況，因為它與 EVOQUE 周圍的不良事件有關，以及我們何時可以在更公開的環境中看到其中一些數據？

Yeah. No, sure, David. I really appreciate the question. I think for EVOQUE, we continue to see a lot of excitement around EVOQUE. We see a lot of physician excitement and we see a lot of patient excitement how the technology is changing their life.

是的。不，當然，大衛。我非常感謝你的提問。我認為對於 EVOQUE 而言，我們繼續看到圍繞 EVOQUE 的許多令人興奮的事情。我們看到很多醫生和患者對這項技術如何改變他們的生活感到興奮。

I think we saw in TRISCEND II that there's -- that's the baseline clinical data we have for this product. And what we've seen in the real world is actually results that are similar or better than TRISCEND II.

我認為我們在 TRISCEND II 中看到了——這是我們針對該產品的基線臨床數據。我們在現實世界中看到的結果實際上與 TRISCEND II 相似或更好。

So for instance, even at the very recent New York Valves conference, we saw coming out of our European almost 200 patients. We saw initial results coming from that study at 12 centers across five European countries. Results that were equal to or better than TRISCEND II.

例如，即使在最近的紐約瓣膜會議上，我們也看到來自歐洲的近 200 名患者。我們看到了來自五個歐洲國家 12 個中心的研究的初步結果。結果等於或優於 TRISCEND II。

Beyond that, we also New York valves had a one-year study on echo gradients that continue to show how the right ventricle and the heart gets so much better with EVOQUE.

除此之外，我們還對紐約瓣膜進行了為期一年的迴聲梯度研究，該研究繼續顯示了右心室和心臟在使用 EVOQUE 後如何變得更好。

And you'll see, I think, coming up both at ESC, some more sub-analysis on EVOQUE and going in the future, you'll see TVT registry analysis. But I think for us, it's a continued data set after data set showing similar real-world outcomes that we've seen from TRISCEND II.

我認為，您會看到在 ESC 上對 EVOQUE 進行更多的子分析，並且在未來，您將看到 TVT 註冊分析。但我認為對我們來說，這是一個連續的資料集，顯示了我們從 TRISCEND II 看到的類似的現實世界結果。

Maybe, David, to add something on what Daveen just said. And in a typical adverse fashion, Daveen's team is continuing to innovate. So we have a Gen 1 today. We are very pleased with Gen 1. But the same way we did with SAPIEN, we are Gen 5 today. You can expect EVOQUE Gen 2, Gen 3, Gen 4, and each platform will be better. The physicians will have more experience. We will bring more evidence. We will have more innovation. So you can expect the same kind of trajectory where we are going to create this amazing category for so many patients in need. But right now, the demand, like Daveen said, is very high. We can barely fulfill the demand.

大衛，也許我可以對戴文剛才說的話補充一些內容。並且以典型的逆境方式，戴文的團隊正在持續創新。所以我們今天有了第一代。我們對 Gen 1 非常滿意。但就像我們對 SAPIEN 所做的那樣，我們今天已經是第五代了。您可以期待 EVOQUE Gen 2、Gen 3、Gen 4，並且每個平台都會變得更好。醫生將擁有更多的經驗。我們將提供更多證據。我們將會有更多的創新。因此，您可以期待同樣的軌跡，我們將為眾多有需要的患者創建這個令人驚嘆的類別。但正如戴文所說，目前需求非常高。我們幾乎無法滿足需求。

Okay. Very helpful. And then maybe, Scott, I appreciate the continued emphasis on the P&L. And maybe just kind of summarizing things longer term. I think if you look back over Edwards the past several years, at one point in time, the company was generating 10% plus top line growth with low-30s operating margins. Is it realistic to think that, that is the direction you aim to take the business now and that the company did operate at 30%-plus at 1 point and 10% and given the totality of drivers you have here that, that's a reasonable profile to think about longer term?

好的。非常有幫助。那麼也許，斯科特，我很欣賞你繼續強調損益表。或許只是對事物進行長期總結。我認為，如果回顧過去幾年的 Edwards 業績，你會發現，該公司的營業利潤率一度達到 30% 出頭，同時營收成長率也超過了 10%。您認為這是您目前為企業制定的方向嗎？如果公司在 1 點和 10% 時確實以 30% 以上的成長率運營，並且考慮到您擁有的所有驅動因素，那麼從長遠來看，這是一個合理的情況嗎？

Yeah. I think at this point, we're not going to set a specific target. 30% is a nice round number, but we're not really focused on hitting a three handle so much as we are focused on increasing our operating profit margin by 50 to 100 basis points annually going forward starting in 2026.

是的。我認為目前我們不會設定一個具體的目標。 30% 是一個不錯的整數，但我們並不是真正專注於達到這個目標，而是專注於從 2026 年開始每年將我們的營業利潤率提高 50 到 100 個基點。

Matt Taylor, Jefferies.

馬特泰勒，傑富瑞。

Hi. Thanks for taking the question. I just wanted to ask a couple of follow-ups on some of the nuanced TAVR dynamics that were asked about before. One is, would you venture a guess that what proportion of the Boston Scientific exited sales you could get? What's kind of your fair share of that?

你好。感謝您回答這個問題。我只是想就之前詢問的一些細微的 TAVR 動態問題進行一些後續詢問。一是，您能猜一下您能獲得波士頓科學退出銷售額的比例嗎？您該分擔多少？

And then Larry was asking before about the NCD, and I understand the motivations to open that up. But what actual impact do you think that could have on capacity and volumes if it were to change to one operator and to reduce the volume requirements, et cetera?

然後拉里之前問過有關 NCD 的問題，我理解公開這個問題的動機。但是，如果改為一個運營商並減少數量要求等，您認為這會對容量和數量產生什麼實際影響？

Yeah. Thanks, Matt. Thanks for the question. It's really too early to comment on both, but I'll try to give you some directional comments.

是的。謝謝，馬特。謝謝你的提問。現在對這兩者發表評論還為時過早，但我會嘗試給你一些方向性的評論。

I think as it relates to Boston, the biggest thing is that there's a difference in price point here. And I think this has been one of the things that we've been talking about for a while that I'm sure everybody is aware of.

我認為就波士頓而言，最大的問題是這裡的價格點有差異。我認為這是我們一段時間以來一直在談論的事情之一，我相信每個人都知道這一點。

Our platform is backed by the most evidenced by long-term data by our long-term clinical trials. I mean, we just put out 10-year data from our PARTNER II trial that shows the incredible durability of our platform and low reintervention rates. And what we really need is people to value that long-term data and value all the things that our platform brings to the table rather than making their decisions based on price.

我們的平台得到了長期臨床試驗最有力的長期數據支持。我的意思是，我們剛剛發布了 PARTNER II 試驗的 10 年數據，顯示了我們的平台具有令人難以置信的耐用性和較低的再乾預率。我們真正需要的是人們重視長期數據並重視我們的平台帶來的一切，而不是根據價格做出決定。

But we're going to have to see how the market plays itself out. If they stay price focused, then they'll just move to another similarly priced product, if there's a lesson to be learned from this hopefully, it's that evidence matters and these long-term trials matter. And so we'll see what our fair share is when we get to the end of that.

但我們必須觀察市場如何表現。如果他們仍然關注價格，那麼他們就會轉向另一種價格相似的產品，如果希望從中學習的話，那就是證據很重要，這些長期試驗很重要。因此，當我們到達終點時，我們就會知道我們應得的份額是多少。

As it relates to the NCD, it's impossible to know what they're going to do with operator requirements, and it's impossible to know what they're going to do with facility requirements. But given where this procedure has come and how safe it is in the long-term data, and we've already proven that we can roll it out to more than 850 centers really successfully and drive high-quality outcomes. There really is a time to open up a lot more centers that would be able to do this procedure that had the expertise. How many they allow us to open will determine how much it will impact capacity, and we'll see how that goes.

就 NCD 而言，我們不可能知道他們將如何處理操作員要求，也不可能知道他們將如何處理設施要求。但考慮到此程序的進展以及長期數據的安全性，我們已經證明我們可以非常成功地將其推廣到 850 多個中心並帶來高品質的結果。確實現在是時候開設更多擁有專業知識並能夠完成此項程序的中心了。他們允許我們開放多少家門市將決定其對容量的影響有多大，我們將拭​​目以待。

But if we look at the other NCDs that have been done recently, there seems to be directionally taking a lot of these operator requirements away and taking a lot of these facility requirements away. And so given the evidence we have on TAVR, well over 1 million, 1.2 million patients treated with our platform alone. We seem to have a lot of data and a compelling case to make for reducing a lot of these restrictions. But we'll just have to see how that plays out when it opens.

但如果我們看看最近完成的其他 NCD，似乎在方向上取消了許多對操作員的要求，也取消了許多對設施的要求。因此，根據我們掌握的有關 TAVR 的證據，僅使用我們的平台治療的患者就超過 100 萬，即 120 萬。我們似乎擁有大量數據和令人信服的證據來支持減少這些限制。但我們只能看看它開幕時的表現如何。

Anthony Petrone, Mizuho Group.

瑞穗集團的安東尼‧佩特羅內 (Anthony Petrone)。

Thanks. And I'll echo Larry, congratulations. Great working with you, and good luck on the next chapter year. Maybe a little bit on the US TAVR backlog. It typically sits at around somewhere in the three- to six-month range and with asymptomatic not being in there in this quarter, it seems like at least something changed that the backlog was able to be mined a little bit more efficiently. So maybe just a little bit on TAVR backlog in the US? And maybe did you see any workflow improvements. And I'll have one quick follow-up on mitral.

謝謝。我同意拉里的觀點，祝賀你。很高興與您合作，祝您下個篇章一切順利。也許與美國 TAVR 積壓情況有關。它通常位於三到六個月左右的範圍內，並且由於本季度沒有出現無症狀感染者，因此似乎至少發生了一些變化，積壓病例能夠更有效地處理。那麼，也許您能稍微了解一下美國的 TAVR 積壓情況嗎？也許您看到了任何工作流程的改進。我將對二尖瓣進行一次快速跟進。

Thanks, Anthony, and thanks for your kind words. I think what you're calling a little bit of backlog there. I don't know that we would necessarily use that terminology. I think as patients move through the system, there's just a lot of steps they have to go through. They have to see two specialties.

謝謝，安東尼，謝謝你的好意。我認為您所說的情況是存在一些積壓。我不知道我們是否一定會使用這個術語。我認為，當患者通過系統時，他們必須經歷許多步驟。他們必須看兩門專科醫生。

They have to be scheduled for multiple visits. They have to get a CT, and there's all those things that they have to go through the process. And depending on the center and depending on what their image capacity is and the waiting times to get imaging, it can easily take a patient three to six months to work through that system, and that's just what it takes to do.

他們必須安排多次訪問。他們必須接受 CT 檢查，並完成所有必要的檢查。根據中心的情況、影像容量以及等待成像的時間，患者可能需要三到六個月的時間才能透過該系統完成檢查，而這正是需要做的。

I think what I referenced earlier and what I think we are seeing now is just a real renewed focus on these patients. I don't think we've seen a marked reduction in the time that patients are moving through the system. I think we're probably hopefully seeing an uptick in referrals and just a renewed focus on making sure these patients get timely referral and timely treatment.

我認為我之前提到的以及我們現在看到的只是對這些患者的真正重新關注。我認為我們並沒有看到患者在系統中移動的時間明顯減少。我認為我們希望看到轉診數量的增加，並且重新關注確保這些患者得到及時轉診和及時治療。

So I think that's what we're seeing now. But it's going to take a couple of quarters to really quantify this and that's what we're waiting for. But clearly, we've seen some momentum here and a lot of attention.

所以我認為這就是我們現在所看到的。但要真正量化這一點還需要幾個季度的時間，而這正是我們正在等待的。但顯然，我們已經看到了一些勢頭和大量關注。

If you were at the New York valve meeting, they opened the meeting with the early TAVR data. There was a huge debate about how patients should be referred. And then Samuel talked about the tech AS and that, that completely normalized the gender bias that we see in treatment rates. So there's just a tremendous amount of attention on this, and I think that's what's really driving things from a mind share standpoint.

如果您參加了紐約瓣膜會議，他們會以早期的 TAVR 數據來​​開啟會議。關於如何轉診患者存在著激烈的爭論。然後塞繆爾談到了技術 AS，這完全使我們在治療率中看到的性別偏見正常化。因此，人們對此給予了極大的關注，我認為從心智共享的角度來看，這才是推動事情發展的真正因素。

And then a quick follow-up on mitral. just when you think about mitral following TAVR, severe asymptomatic is kind of the on-label indication. The penetration in severe asymptomatic is marked in the low-single digits and Abbott's out there with the repair MR study, which I think reads out early next year. And so where do you see severe asymptomatic for mitral from minimally invasive in terms of penetration? And what do you think can happen when we get more data potentially from competition here early next year?

然後快速跟進二尖瓣。當您想到 TAVR 之後的二尖瓣時，嚴重無症狀是一種標籤適應症。嚴重無症狀感染者的滲透率處於低個位數，而雅培正在進行修復性 MR 研究，我認為該研究結果將於明年年初公佈。那麼，從穿透性方面來看，您認為嚴重無症狀二尖瓣狹窄與微創治療有何不同？您認為當我們明年年初從這裡的比賽中獲得更多數據時會發生什麼？

No, sure. I appreciate the question. If you look at the treatment of mitral disease, we see that the -- there's a huge number of patients with mitral disease, very similar to what we see in the severe symptomatic aortic stenosis numbers in the US but the actual number of treatments are much, much smaller. As a result, we're much, much earlier than TAVR as we think about, hey, how do we just penetrate how do we penetrate or how do we help more patients with this technology.

不，當然。我很感謝你提出這個問題。如果你看一下二尖瓣疾病的治療，我們會發現，患有二尖瓣疾病的患者數量非常多，與我們在美國看到的嚴重症狀性主動脈瓣狹窄的數量非常相似，但實際治療的數量要少得多。因此，我們比 TAVR 更早、更早地思考，嘿，我們如何滲透，如何滲透，或者我們如何利用這項技術來幫助更多的患者。

And you spoke about it from a little bit of a tier angle, but I think we look about it a little bit more broadly, meaning that mitral disease today, there are so many different patient anatomies where we actually really believe having multiple modalities, both here and mitral replacement will help us help treat the most number of patients.

您是從層級角度談論這個問題的，但我認為我們應該從更廣泛的角度來看待這個問題，也就是說，對於當今的二尖瓣疾病，患者的解剖結構有如此之多的不同，我們實際上真的相信，多種治療方式，包括二尖瓣置換術，將幫助我們治療最多的患者。

And again, probably a little bit differently than aortic stenosis. We have both degenerative unfunctional etiologies where different technologies like repair and replacement can help these technologies a little bit more differently.

再次強調，這可能與主動脈瓣狹窄略有不同。我們有兩種退化性無功能原因，而修復和替換等不同技術可以以稍微不同的方式幫助這些技術。

And so what we're starting to see in Europe, and we've just got M3 now into our European market, is that M3 is really adding treatment to patients who didn't have treatment before. And I know you're speaking a little bit about it from a asymptomatic or other kind of thing. I guess, I'll just speak about it from a severe symptomatic group where they're tons of patients out there who tier unfortunately, is not a great solution for, and it's ineligible. And with M3 now, we have can treat a larger number of people.

因此，我們開始在歐洲看到，我們剛剛將 M3 引入歐洲市場，M3 確實為以前未接受過治療的患者增加了治療。我知道您是從無症狀或其他方面談論這個問題的。我想，我只是從嚴重症狀群體的角度來談論這個問題，這個群體中有大量的患者，不幸的是，這不是一個很好的解決方案，而且它不符合條件。現在有了 M3，我們可以治療更多的人。

And we're excited that with M3 now in Europe will eventually be bringing it to the U.S. now in the first half of next year. So the US can fulfill that next part of having both a repair and a replacement technology to help treat mitral.

我們很高興 M3 現在已經在歐洲上市，並最終將於明年上半年進入美國市場。因此，美國可以實現下一步目標，即擁有修復和替換技術來幫助治療二尖瓣。

So for us, I understand how you took it from in, I guess I'll put it on to, we have so many patients coming through the pool right now. There's such undertreatment that people today with mitral disease don't have a treatment that as we get repair and replacement. We have a whole great number of patients to just help with these new solutions.

所以對我們來說，我理解你是如何從中得到答案的，我想我會把它放在現在，我們有這麼多的病人來到這裡。由於治療不足，現今患有二尖瓣疾病的患者無法獲得像修復和更換那樣的治療。我們有大量的患者來幫助解決這些新問題。

Vijay Kumar, Evercore ISI.

維傑·庫馬爾（Vijay Kumar），Evercore ISI。

Hey, guys. Thanks for taking my questions. Larry, I wish you all the best in your transition. Maybe my first question, Scott, for you on the back half margins here is -- I know there are moving parts between FX tariff. Can you just walk us through what the implied back half gross margins? And I think the EPS guidance for 3Q in place, maybe a 25%-ish kind of operating margins. Am I looking at the right way on margins. And if 25% is the right number, are you assuming a full quarter of JenaValve impact?

嘿，大家好。感謝您回答我的問題。拉里，我祝福你的轉變一切順利。斯科特，也許我對您關於後半部分利潤率的第一個問題是——我知道外匯關稅之間存在變化。您能否向我們介紹一下隱含的後半部毛利率是多少？我認為第三季的每股盈餘預期，營業利潤率可能在 25% 左右。我是否以正確的方式看待利潤？如果 25% 是正確的數字，您是否假設 JenaValve 的影響會持續整個季度？

There are several questions in there. Let me try to hit them. I'll start with the last one. So for JenaValve, our hope is that we get to close in August. So we'd see some impact in Q3, a full quarter of impact in Q4. That's in the assumption for 2025.

其中有幾個問題。讓我試著打他們一下。我先從最後一個開始。因此對於 JenaValve 來說，我們希望能夠在 8 月完成。因此，我們會在第三季看到一些影響，在第四季看到整個季度的影響。這是對 2025 年的假設。

In terms of margins, FX has hurt our gross profit margin rate. It's actually benefited earnings per share because we're getting more sales and profit from outside of the US translated into the weaker US dollar. So it's sort of the or lower gross margin rate but higher EPS dollars.

就利潤率而言，外匯影響了我們的毛利率。這實際上有利於每股收益，因為我們在美國以外獲得了更多的銷售額和利潤，而美元則走弱。因此，這相當於毛利率較低但每股收益較高。

And I think what was the rest of your question, Vijay?

我想你的其餘問題是什麼，維傑？

Tariff, what is the tariff impact essentially?

關稅，關稅影響本質上是什麼？

And operating margin. So for tariffs, we said think a $0.05 for the full year back last quarter, it's probably less than half of that now is our current expectation, which is similar to what you probably heard from other companies.

以及營業利潤率。因此，對於關稅，我們說認為上個季度全年的關稅為 0.05 美元，現在可能還不到這個數字的一半，這是我們目前的預期，這與您可能從其他公司聽到的情況類似。

In terms of operating margin, yeah, mid-20% operating margins for the second half of this year is the right modeling assumption. It's lower than the first half of this year, both because of some deferred expenses that we expect to incur going forward as well as the JenaValve impact that you'd see. This has not changed from last quarter. Last quarter, the same math for the second half around 25%-ish and same expectation now at this point.

就營業利潤率而言，是的，今年下半年 20% 左右的營業利潤率是正確的模型假設。它低於今年上半年，既是因為我們預計未來會產生一些遞延費用，也是因為您會看到 JenaValve 的影響。這與上一季相比沒有變化。上個季度，下半年的計算結果相同，約 25% 左右，目前的預期也相同。

That's helpful, Scott. And if I may, one more. You said double-digit revenues and EPS for 2016. Do you expect operating leverage for 2026?

這很有幫助，斯科特。如果可以的話，我再說一句。您說 2016 年的營收和每股盈餘將達到兩位數。您預計 2026 年的經營槓桿率是多少？

Well, first of all, we did not say double-digit revenue for 2026. We said that we feel good about the prospects as we look ahead to 2026, certainly our target, as you know, because that's our annual average revenue target, but don't assume that 10% is going to be the bottom of our guidance range when we get to the December investor conference.

首先，我們並沒有說 2026 年的營收會達到兩位數。我們說過，展望 2026 年，我們對前景感到樂觀，這當然也是我們的目標，正如你所知，因為這是我們的年度平均收入目標，但不要以為 10% 會成為我們 12 月投資者會議時的指導範圍的底線。

In terms of operating leverage, yeah, as we've said, we're targeting 50 to 100 basis points of EBIT margin on a constant currency basis increase starting in 2026.

就營運槓桿而言，正如我們所說，我們的目標是從 2026 年開始，以固定匯率計算，息稅前利潤率提高 50 至 100 個基點。

Matt Miksic, Barclays.

巴克萊銀行的馬特‧米克西克 (Matt Miksic)。

Hey. Thanks so much for taking questions. Congrats on a really strong quarter. echo everyone's comments. Larry, and it's been great with you. Hope we could continue to connect in your ventures.

嘿。非常感謝您回答問題。恭喜本季業績表現強勁。贊同大家的評論。拉里，和你在一起很愉快。希望我們能夠在您的事業中繼續保持聯繫。

So maybe following up on some of the questions on average strength in the quarter. How should we think about that Q2 strength as we move into what's kind of a typical seasonal Q3?

因此，也許可以跟進有關本季平均實力的一些問題。當我們進入典型的季節性第三季時，我們應該如何看待第二季的強勁表現？

And then also just any comments on Japan is bounced back nice, Europe is strong, but rest of world really looked like it accelerated this year -- from last year. Maybe any comments on that? I have one follow-up on TMTT, if I could.

然後，關於日本的任何評論都得到了很好的反彈，歐洲表現強勁，但世界其他地區今年看起來確實比去年加速了。對此有什麼評論嗎？如果可以的話，我對 TMTT 有一個後續行動。

Yeah. Thanks, Matt. Thanks for your kind words. I think we adjust our guidance accordingly, so we tried to account for all of the things that we know right now and where our confidence is. And so we do typically see seasonality in Q3 probably more pronounced in Europe than it is in the US, but we tend to see it a little bit globally. But all of that is factored near our guidance, and I think we feel great about the momentum and where we're going. And so hopefully, that continues, and that's what we expect.

是的。謝謝，馬特。謝謝你的好意。我認為我們會相應地調整我們的指導，所以我們試圖解釋我們現在所知道的所有事情以及我們的信心所在。因此，我們通常會看到第三季的季節性在歐洲比在美國更為明顯，但我們傾向於在全球範圍內看到這種情況。但所有這些都已考慮到我們的指導方針，我認為我們對目前的勢頭和未來發展方向感到非常滿意。所以希望這種情況能夠持續下去，這也是我們所期望的。

Japan, we remain focused on a little bit of share recapture there and reaccelerating that market. And that's really where we are there, and we're continuing to work on that. And I think we're all committed to driving that in that manner.

在日本，我們仍然專注於重新奪回那裡的份額並重新加速該市場的發展。這就是我們目前所處的狀態，我們正在繼續為此努力。我認為我們都致力於以這種方式推動這一目標。

Sure. Yeah, in rest of world? That was the part that I saw really popped up here this year.

當然。是的，在世界其他地方嗎？這是我今年看到的真正出現的部分。

Yeah. TAVR is a global business, Matt. We are very pleased about that. We are present almost in every country. It is a global business. It's growing everywhere, going well. So yes, we mentioned the rest of the world because it is not just about the US, even though the largest region for us are the US, Europe, and Japan. But rest of the world matter and is doing very well.

是的。TAVR 是一項全球性業務，馬特。我們對此感到非常高興。我們的業務幾乎遍及每個國家。這是一項全球性業務。它到處都在生長，進展順利。是的，我們提到了世界其他地區，因為這不僅涉及美國，儘管對我們來說最大的地區是美國、歐洲和日本。但世界其他地區也很重要，而且做得很好。

Quick. And then just cut on TMTT. A lot of enthusiasm coming out of our valves, it's obvious that you have a lot of broadway here as you'll be the only provider, I think, for some time on repair replacement in tricuspid or mitral. I know you're getting a lot of attention to those accounts. Maybe talk about what it is not competition at the moment anyway across all of those indications. What are some of the places you're spending your time? Is it new centers? Is it imaging and radiology support training? Maybe help us understand what are the gating factors to growth as you kind of -- as you say, work as fast as you can to meet that demand.

快的。然後就在 TMTT 上剪切。我們的瓣膜表現出很大的熱情，很明顯你們在這裡有很多優勢，因為我認為，在一段時間內，你們將是三尖瓣或二尖瓣修復置換的唯一供應商。我知道你對這些帳戶非常關注。也許可以談談，從目前所有這些跡象來看，這還不是競爭。您常去哪些地方度過您的時光？是新的中心嗎？這是影像學和放射學支援培訓嗎？也許可以幫助我們了解成長的限制因素是什麼——正如您所說，盡快工作以滿足需求。

Matt, let me start. I love your comments. Indeed, we are going to be the only provider of repair and replacement technology for many years. And this is the result of who we are as a company and our unique innovation strategy. We are bold. We are long-term focused, and we invest where nobody else is investing.

馬特，讓我開始吧。我喜歡你的評論。事實上，我們將在未來多年成為維修和更換技術的唯一提供者。這是我們公司的特性和獨特的創新策略的結果。我們很勇敢。我們著眼於長遠，投資於別人未投資的領域。

So eight years ago, we believe in this portfolio. And today, indeed, we have this portfolio, and we are the only one who is going to have this kind of portfolio for many years. So thanks, we are going to take care of patients. We are going to help you train physicians to make sure they can take care of these patients.

所以八年前，我們相信這個投資組合。今天，我們確實擁有這樣的投資組合，而且我們將是未來許多年唯一擁有這種投資組合的公司。謝謝，我們會照顧病人的。我們將幫助您培訓醫生，以確保他們能夠照顧這些病人。

But Daveen, you want to talk about where are you spending your time and all of these

但是戴文，你想談談你把時間花在哪裡，所有這些

No, I'll add a little bit more to it. Clearly, there are a lot of angles to therapy development, and that's what we're doing here. We're taking new therapies and bringing it to patients. And so for us, right, there's a part about technologies we've been talking about, how do we launch these new technologies for the first time and get them to patients to add new treatment.

不，我會再添加一點內容。顯然，治療方法的發展有許多角度，而這正是我們在這裡所做的。我們正在採取新的治療方法並將其帶給患者。所以對我們來說，我們一直在談論技術的一部分，我們如何首次推出這些新技術並將它們提供給患者以增加新的治療方法。

And then, yeah, there's new geographies around the world. We're launching PASCAL for the first time in countries around the world and eventually EVOQUE and eventually M3 will then follow up.

是的，世界各地出現了新的地理區域。我們將首次在世界各國推出 PASCAL，隨後將推出 EVOQUE 和 M3。

And then there's new clinical data that's coming out. We look forward to the ENCIRCLE clinical data at TCT, et cetera. And to do all this, you've got to have that great market access, making sure you have not only regulatory approval, reimbursement and to your point is great physician training, et cetera, to ensure that our field force has trained well and physicians are trained well.

然後就有新的臨床數據出來。我們期待TCT等的ENCIRCLE臨床數據。要做到這一切，你必須擁有良好的市場准入，確保你不僅獲得監管部門的批准和報銷，而且還有良好的醫生培訓等等，以確保我們的現場人員和醫生都得到良好的培訓。

So it's hard to pinpoint just one area, but I think the hope way I give you is that we're added -- we're putting these different layers on top of each other, and they're going to lead to layer or catalyst factor catalysts of growth as we keep moving forward across therapies, geographies, et cetera.

因此，很難只指出一個領域，但我認為我給你的希望是，我們正在添加 - 我們將這些不同的層次疊加在一起，隨著我們在療法、地域等方面不斷前進，它們將導致增長的層或催化劑因素催化劑。

Chris Pasquale, Nephron Research.

克里斯‧帕斯誇萊 (Chris Pasquale)，腎元研究機構。

Thanks for squeezing me in. I wanted to circle back to the NCD and how that could change things from a practical perspective when it does come. I'm curious what you're seeing so far from the local MACs when asymptomatic cases do get submitted. Are they getting paid for smoothly or is that a meaningful friction point in certain regions?

謝謝你把我擠進來。我想回到 NCD 的話題，以及當它真正到來時，它將如何從實際角度改變現狀。我很好奇，當無症狀病例提交時，您從當地 MAC 那裡看到了什麼。他們是否能順利獲得報酬，或者這在某些地區是否是一個重大的摩擦點？

And then maybe help frame the situation over in Europe for us. Does having the indication over there ensure broad access, or are there other states steps that need to take place. And if it's the latter, what's the time line we should think about for those?

然後也許可以幫助我們了解歐洲的情況。那裡的指示是否能確保廣泛的訪問，或者是否需要採取其他州的措施。如果是後者，我們應該考慮的時間表是怎麼樣的？

Yeah. Thanks for your question, Chris. In terms of how things could change from a practical perspective, I think it's a lot of things we talked about before in terms of operator requirements in terms of the patient flow, in terms of the facility requirements. And so I don't know I have a lot more to add to that.

是的。謝謝你的提問，克里斯。至於從實際角度看事情會如何變化，我認為我們之前討論過很多事情，包括操作員要求、病患流量、設施要求等。所以我不知道我還能補充什麼。

In terms of how the local MACs cover this, when something is not covered in a national coverage decision, people submit on a case-by-case basis and those get evaluated individually by local MACs. I will say, in the early TAVR clinical trial, I'm not aware of anybody having difficulty getting their patients covered. So I don't know how much of a headwind it is. But that being said, we do know that there are some big hospital systems that are saying, we're going to wait until the NCDs updated because we simply don't want to take the risk of having cases rejected by a local MAC.

就當地 MAC 如何涵蓋此問題而言，當某些內容未在國家覆蓋範圍之內時，人們將根據具體情況提交申請，並由當地 MAC 進行單獨評估。我想說的是，在早期的 TAVR 臨床試驗中，我還沒有發現有人在為其患者提供保障方面遇到困難。所以我不知道逆風有多大。但話雖如此，我們確實知道有一些大型醫院系統表示，我們將等到 NCD 更新，因為我們根本不想冒病例被當地 MAC 拒絕的風險。

And so this is why we've always said that asymptomatic is going to be a little bit of a slow burn. First, you're going to get the indication, the next thing that we need to do is the NCD and guidelines, and we'll see which of those go first. But each one of these things, I think, is incrementally going to change how patients get managed. And that's why we've always said that we think this has it's not going to be a step function, but it's going to be a long-time contributor to what we're doing as we streamline these things.

這就是為什麼我們總是說無症狀感染者的情況會比較緩慢。首先，你會得到指示，接下來我們需要做的是 NCD 和指南，我們會看看哪一個先進行。但我認為，這些事情中的每一件都會逐漸改變患者的管理方式。這就是為什麼我們總是說，我們認為這不會是一個階梯式的功能，但它將對我們簡化這些事情的工作產生長期的貢獻。

In terms of Europe, they -- talking about Europe, it's not a homogeneous place. Every country has their own different reimbursement systems. I think much like the US, getting the indication first is the number one thing. And so we do have the CE mark. We just recently received that. And so that really is what starts the process.

就歐洲而言，他們——談論歐洲，它不是一個同質性的地方。每個國家都有自己不同的報銷制度。我認為與美國非常相似，首先獲得指示是最重要的事情。因此我們確實有 CE 標誌。我們最近才收到該訊息。這就是真正啟動這項進程的過程。

And so having those approvals, both FDA and CE mark give us a unique opportunity to engage on guidelines. It gives us the opportunity to engage with the reimbursement groups and make sure this gets covered for patients. But we just got this approval literally like a week ago. So it's probably a little early in the process for us to be very definitive, but it gives us a license to go start having those conversations because it's now on label.

因此，獲得這些批准，FDA 和 CE 標誌為我們提供了參與指導方針的獨特機會。這使我們有機會與報銷團體合作，並確保患者能夠獲得報銷。但我們一周前才獲得批准。因此，現在就下定論可能還為時過早，但它給了我們開始進行這些對話的許可，因為它現在已經在標籤上了。

Great. Thanks, Larry, and best of luck with your next adventure.

偉大的。謝謝，拉里，祝你下次冒險好運。

Thank you, and we have reached the end of the Q&A session. I'll now hand the floor back to Bernard Zovighian for closing remarks.

謝謝，問答環節已經結束。現在我將發言權交還給 Bernard Zovighian，請他作最後發言。

Okay, everyone. Thanks for your continued interest in Edwards. Scott, Mark, (inaudible) and I welcome any additional questions by telephone. Thank you so much, and have a great day.

好的，各位。感謝您對 Edwards 的持續關注。斯科特、馬克（聽不清楚）和我歡迎您透過電話提出任何其他問題。非常感謝，祝您有愉快的一天。

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

謝謝。今天的電話會議到此結束。各方均可斷開連線。