愛德華生命科學 (EW) 2024 Q4 法說會逐字稿

Greetings, and welcome to the Edwards Lifesciences Corporation fourth-quarter 2024 results.

大家好，歡迎關注 Edwards Lifesciences Corporation 2024 年第四季業績。

(Operator Instructions) As a reminder, this conference is being recorded.

（操作員指示）提醒一下，本次會議正在錄音。

It is now my pleasure to introduce you to your host, Mark Wilterding, SVP of Global Finance. Thank you, Mark. You may begin.

現在我很高興向您介紹主持人、全球財務高級副總裁馬克威爾特丁 (Mark Wilterding)。謝謝你，馬克。你可以開始了。

Thank you, Alicia. Good afternoon, and thank you all for joining us.

謝謝你，艾莉西亞。下午好，感謝大家加入我們。

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; and Wayne Markowitz, our global leader of Surgical. Just after the close of regular trading, Edwards Lifesciences released fourth-quarter 2024 financial results.

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 和外科全球集團總裁 Larry Wood 也將參加本次電話會議的問答部分； Daveen Chopra，我們的 TMTT 全球負責人；以及我們的外科全球負責人 Wayne Markowitz。常規交易結束後不久，Edwards Lifesciences 發布了 2024 年第四季財務業績。

During today's call, management will discuss the results included in the press release and accompanying financial schedules and then use the remaining time for Q&A. 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.

在今天的電話會議上，管理層將討論新聞稿中包含的結果和隨附的財務計劃，然後利用剩餘的時間進行問答。請注意，管理層將根據估計、假設和預測做出前瞻性陳述。這些聲明僅代表發布當日的觀點，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 on 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，所有這些文件均可在公司網站 edwards.com 上查閱。

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.

除非另有說明，我們對銷售成長的評論均指固定匯率銷售成長，該成長已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 數字之間的對帳。

Quarterly and full-year growth rates refer to continuing operations and do not include contributions from Critical Care, which was sold in Q3 of 2024 and a small non-core product group that reduces the sales of Surgical.

季度和全年增長率指的是持續經營業務，不包括重症監護（於 2024 年第三季度出售）的貢獻以及減少外科銷售額的小型非核心產品組。

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

說到這裡，我想把電話轉給伯納德，請他發表評論。伯納德？

Thank you, Mark. Welcome, everyone, and thank you for joining us. We have a lot to cover today, including our Q4 and full-year 2024 results, as well as our vision for 2025 and beyond. You will recall at the December investor conference, we talked about Edward's 4Q strategy and our vision to solve a large complex and growing unmet patient needs in structural heart. We have a very unique strategy to create, define, and build new categories, and this will position us for extended leadership and sustainable, long-term growth.

謝謝你，馬克。歡迎大家，感謝大家的加入。今天我們要討論的內容很多，包括我們的 2024 年第四季和全年業績，以及我們對 2025 年及以後的願景。您會記得，在 12 月的投資者會議上，我們討論了 Edward 的第四季度策略以及我們解決結構性心臟領域大量複雜且不斷增長的未滿足患者需求的願景。我們擁有非常獨特的策略來創造、定義和建立新的類別，這將使我們保持領導地位並實現可持續的長期成長。

Now I want to reflect on the full year 2024. It was a year of strong growth and meaningful progress for Edwards as our 16,000 employees advanced life-saving structural heart technologies for patients around the world. We are pleased with our solid 2024 full-year financial performance, where sales grew 9% to $5.4 billion, in line with our original total company sales growth guidance.

現在，我想回顧一下 2024 年全年。這是 Edwards 強勁成長、取得重大進步的一年，我們的 16,000 名員工為世界各地的患者推進了拯救生命的結構性心臟技術。我們對 2024 年全年穩健的財務表現感到滿意，銷售額成長 9% 至 54 億美元，符合我們最初的公司總銷售額成長預期。

While we got there in a different way than we originally anticipated, with TAVR growth lower than expected, we were pleased that TMTT overachieved the expectation. We continue to focus on the substantial long-term prospects for TAVR. And we expect TMTT to become an even more important contributor to Edwards' growth as our unique and broadening portfolio of technologies addresses the unmet needs of more patients.

雖然我們實現這一目標的方式與最初預期不同，TAVR 成長低於預期，但我們很高興 TMTT 超出了預期。我們將繼續關注 TAVR 的長期前景。我們預計，隨著我們獨特且不斷擴大的技術組合能夠滿足更多患者未滿足的需求，TMTT 將成為 Edwards 發展更重要的貢獻者。

We made a number of strategic decisions to strengthen our company. In Q3, we completed the sale of Critical Care, and we took action to optimize Edwards in order to increase agility and accelerate innovation. We also invested significantly in internal research and development to augment our portfolio with new breakthrough technologies.

我們做出了許多策略決策來增強公司實力。在第三季度，我們完成了 Critical Care 的出售，並採取行動優化 Edwards，以提高靈活性並加速創新。我們也對內部研發進行了大量投資，以新的突破性技術擴充我們的產品組合。

In addition, we completed the strategic acquisition of JC Medical, Innovalve, and Endotronix. These acquisitions provide an expanded opportunity in new therapeutic areas to address the unmet needs of aortic regurgitation, mitral disease, and heart failure patients. Together, these strategic decision and investments reinforce our confidence in Edwards' sustainable long-term growth.

此外，我們也完成了對JC Medical、Innovalve和Endotronix的策略性收購。這些收購為新的治療領域提供了擴大的機會，以滿足主動脈瓣關閉不全、二尖瓣疾病和心臟衰竭患者尚未滿足的需求。總之，這些策略決策和投資增強了我們對 Edwards 長期可持續成長的信心。

Turning to the fourth quarter, our first full quarter focused solely on structural heart, total company sales grew 9%. We were pleased with our sales performance that was ahead of expectation and drove higher-than-expected earnings per share.

展望第四季度，我們第一個完整季度僅關注結構性心臟，公司整體銷售額成長了 9%。我們對超出預期的銷售業績感到滿意，並推動每股收益高於預期。

We exited the year in a strong position with three important growth drivers, TAVR, mitral, and tricuspid; and two emerging opportunities, structural heart failure and AR. Our foundation, fortified by our patient-focused culture, is more solid than ever and the strategic decision we made in 2024 position us well for 2025 and beyond.

我們在年度結束時表現出色，擁有三大重要成長動力，即 TAVR、二尖​​瓣和三尖瓣；以及兩個新興機遇，結構性心臟衰竭和 AR。我們以病人為中心的文化為我們奠定了堅實的基礎，而我們在 2024 年所做的策略決策為我們在 2025 年及以後的發展做好了準備。

Looking ahead to 2025, the results of EARLY TAVR trial represent a catalyst for improved patient care that will begin to materialize after FDA approval in mid-2025 and set the stage for guideline and policy changes in the US and globally, which present a multi-year growth opportunity.

展望 2025 年，EARLY TAVR 試驗的結果代表著改善病患照護的催化劑，這種改善將在 2025 年中期獲得 FDA 批准後開始實現，並為美國和全球的指導方針和政策變化奠定基礎，從而帶來多年的成長機會。

In TMTT, we are transforming care for the millions of patients suffering from mitral and tricuspid valve disease. We are pleased with the impressive trajectory of the business, which is now a meaningful contributor to Edward's growth. TMTT is on track to deliver over $500 million in sales in 2025.

在 TMTT，我們正在為數百萬患有二尖瓣和三尖瓣疾病的患者改變治療方法。我們對業務的出色發展軌跡感到滿意，它現在已成為 Edward 成長的重要貢獻者。TMTT 預計在 2025 年實現超過 5 億美元的銷售額。

In Surgical, our category-leading business, is positioned to grow consistently and expand globally, driven by increasing adoption of our premium RESILIA-based technology, INSPIRIS, MITRIS, and KONECT. As you can see, 2025 is set to be another meaningful year for Edwards with multiple catalysts across our businesses that will contribute to our 8% to 10% total company sales growth guidance this year.

在外科領域，我們的領先業務將持續成長並在全球擴張，這得益於我們基於 RESILIA 的優質技術、INSPIRIS、MITRIS 和 KONECT 的日益普及。如您所見，2025 年對 Edwards 來說將是另一個意義重大的一年，我們業務中的多個催化劑將為我們今年 8% 至 10% 的總公司銷售額成長預期做出貢獻。

And beyond 2025, Edwards will be in better position to transform care and to have a positive impact on more lives with our pioneering innovations and expanded global leadership in structural heart. Our plan is to grow total company sales 10% annually on average with some variability based on the timing of key catalysts, while strengthening profit margins to drive long-term value for shareholders. We expect that the actions our employees around the world have taken to advance our strategy will deliver significant value to patients and the health care ecosystem.

2025 年以後，Edwards 將憑藉我們在結構性心臟領域的開創性創新和不斷擴大的全球領導地位，更好地轉變醫療服務，並對更多人的生活產生積極影響。我們的計劃是使公司總銷售額每年平均成長 10%，並根據關鍵催化劑的時機進行一定幅度的調整，同時提高利潤率，為股東創造長期價值。我們期望，我們遍布全球的員工為推進我們的策略而採取的行動將為患者和醫療保健生態系統帶來重大價值。

Now I'll provide some additional detail by product group for Q4 and 2024. In TAVR, our full-year 2024 global sales of $4.1 billion increased 6% year over year. Our US and OUS sales growth rates were similar. In the fourth quarter, our global sales of $1.04 billion increased 5.3% over the prior year. Growth was driven by the US and Europe.

現在，我將按產品組提供第四季度和 2024 年的一些更多詳細資訊。在 TAVR 方面，我們 2024 年全年全球銷售額為 41 億美元，較去年同期成長 6%。我們的美國和澳洲的銷售成長率相似。第四季度，我們的全球銷售額為 10.4 億美元，比上年增長 5.3%。成長主要由美國和歐洲推動。

Edwards' strong competitive position and pricing remained stable globally. Although we experienced a few instances of regional pressure, we remain confident in our differentiated technology, high-quality evidence, and the value we demonstrate to patients, clinicians, and health care systems.

Edwards 的強大競爭地位和定價在全球範圍內保持穩定。儘管我們經歷了一些地區壓力，但我們仍然對我們的差異化技術、高品質證據以及我們向患者、臨床醫生和醫療保健系統展示的價值充滿信心。

Our commitment to advancing clinical evidence and expanding indication for patients was highlighted by results from the EARLY TAVR trial, which we are presented at the annual TCT Conference in October. EARLY TAVR is the first and largest randomized control trial to date, studying asymptomatic severe AS patient and the impact of early intervention with SAPIEN.

我們致力於推進臨床證據和擴大患者適應症，EARLY TAVR 試驗的結果突顯了這一點，我們將在十月份的年度 TCT 會議上展示這一結果。EARLY TAVR 是迄今為止第一個也是最大的隨機對照試驗，研究無症狀重度 AS 患者及其使用 SAPIEN 早期介入的影響。

The trial results demonstrated superior outcome for asymptomatic severe AS patients, receiving the SAPIEN platform compared with guideline recommended clinical surveillance, or simply, watchful waiting. Even patient without symptoms of severe artic stenosis have a deadly disease that can progress rapidly and in an unproductible way and require urgent treatment.

試驗結果顯示，對於無症狀嚴重 AS 患者，使用 SAPIEN 平台的治療效果比指南建議的臨床監測或簡單的觀察等待更好。即使沒有嚴重動脈狹窄症狀的患者也患有這種致命的疾病，疾病會迅速且無療效地發展，需要緊急治療。

This data is compelling and will drive changes to the standard of care to streamline patient flow, improve outcomes, and reduce costs to the system.

這些數據令人信服，將推動護理標準的改變，以簡化患者流程、改善治療結果並降低系統成本。

In the US, we continue to be pleased with the performance of our market-leading SAPIEN 3 Ultra RESILIA platform. Capacity remains the focus as we continue to see rapid growth in structural heart procedures. In the near term, new technologies and education put pressure on the system, but in the longer term, it provides a hospital the clarity and incentive to make investments to expand their ability to treat structural heart patients.

在美國，我們繼續對市場領先的 SAPIEN 3 Ultra RESILIA 平台的表現感到滿意。隨著我們繼續看到結構性心臟手術的快速增長，容量仍然是關注的重點。從短期來看，新技術和教育會給該系統帶來壓力，但從長遠來看，它為醫院提供了明確的指導方針和激勵，以進行投資以擴大其治療結構性心臟病患者的能力。

Outside of the US, in the fourth quarter, sales growth was supported by the continued launch of SAPIEN 3 Ultra RESILIA in Europe. We are pleased with the exceptional patient outcomes delivered with this best-in-CLASP platform and we expect this momentum to continue as more centers adopt the technology.

在美國以外，第四季度的銷售成長得益於 SAPIEN 3 Ultra RESILIA 在歐洲的持續推出。我們對這款最佳 CLASP 平台為患者帶來的卓越治療效果感到非常滿意，我們預計，隨著越來越多的中心採用該技術，這種勢頭將繼續下去。

Sales in Japan grew at a slower pace than in other major regions, but still increased sequentially and year over year. We remain dedicated to expanding this therapy to address significant undertreatment of aortic stenosis among the substantial elderly population in Japan. Long term, outside of the US, we foresee excellent opportunities for growth as international adoption of TAVR therapy remains quite low in many regions.

日本的銷售額成長速度低於其他主要地區，但仍比上一季和上年有所成長。我們將繼續致力於擴大這種治療方法，以解決日本大量老年人口中主動脈瓣狹窄嚴重治療不足的問題。長期來看，在美國以外，我們預見到良好的成長機會，因為在許多地區，TAVR 治療的國際採用率仍然很低。

Turning to TMTT. Our unique portfolio of repair and replacement technologies for both mitral and tricuspid valves continues to deliver strong growth with an increasing contribution to overall company performance. The PASCAL repair system, the EVOQUE tricuspid replacement system, and the forthcoming SAPIEN M3 mitral replacement system provide the broader set of treatment option to the many patients with varying mitral and tricuspid valve disease.

轉向 TMTT。我們獨特的二尖瓣和三尖瓣修復和置換技術組合持續保持強勁成長，對公司整體業績的貢獻日益增大。PASCAL 修復系統、EVOQUE 三尖瓣置換系統以及即將推出的 SAPIEN M3 二尖瓣置換系統為眾多患有不同程度的二尖瓣和三尖瓣疾病的患者提供了更廣泛的治療選擇。

We are pleased with both our fourth quarter and full-year sales results. In Q4, we reported $105 million in sales. Full-year sales of $352 million increased 77% year over year. Sales of the PASCAL repair system and the EVOQUE tricuspid replacement system both contributed meaningfully to growth. PASCAL adoption is strong in both the US and globally and the EVOQUE launch is expanding in the US and Europe.

我們對第四季和全年的銷售業績感到滿意。第四季度，我們報告的銷售額為 1.05 億美元。全年銷售額3.52億美元，較去年成長77%。PASCAL 修復系統和 EVOQUE 三尖瓣置換系統的銷售均對成長做出了重大貢獻。PASCAL 在美國和全球範圍內的採用都很強勁，EVOQUE 的推出也正在美國和歐洲擴大。

PASCAL continues to demonstrate its value for patient care. It's differentiated features are driving excellent clinical outcome leading to increased adoption at existing centers and encouraging new centers to use the technology. The base of compelling clinical evidence is strengthening with longer-term follow-up data from randomized trials as well as new real-world evidence.

PASCAL 繼續證明其對病患照護的價值。它的差異​​化特徵正在推動出色的臨床結果，從而增加現有中心的採用率並鼓勵新中心使用該技術。隨著隨機試驗的長期追蹤數據以及新的現實世界證據的出現，令人信服的臨床證據基礎正在不斷加強。

Physicians appreciate the Edwards' high-touch clinical support model, which improved the efficiency of planning and performing procedures while ensuring optimal outcome for patients. The EVOQUE commercial launch continues to progress well in the US and Europe.

醫生們對 Edwards 的高接觸臨床支持模式表示讚賞，該模式提高了計劃和執行程序的效率，同時確保了患者的最佳結果。EVOQUE 在美國和歐洲的商業發布繼續進展順利。

We are investing in our field-based teams to have deep expertise and remain committed to our disciplined approach to launching the therapy, prioritizing excellent patient outcomes. We are observing strong growing in price in EVOQUE from both providers and patients, which reinforces the significant unmet needs of these patients.

我們正在投資我們的現場團隊，以獲得深厚的專業知識，並繼續致力於我們啟動治療的嚴謹方法，優先考慮患者的良好治療結果。我們觀察到來自供應商和患者的 EVOQUE 價格都在強勁增長，這進一步證明了這些患者尚未滿足的巨大需求。

We are pleased that CMS continues to develop a final national coverage determination, or NCD, for transcatheter tricuspid valve replacement. We believe the policy, as proposed, provides a pathway for Medicare patient access to EVOQUE. We look forward to the final NCD, which we expect by the end of Q1 2025.

我們很高興 CMS 繼續制定經導管三尖瓣置換術的最終全國覆蓋決定（NCD）。我們相信，該保單將為醫療保險患者使用 EVOQUE 提供一條途徑。我們期待最終的 NCD，預計在 2025 年第一季末。

In mitral replacement, we continue to look forward to European approval of SAPIEN M3 by midyear 2025, with US approval expected to follow in 2026. We expect the result of the ENCIRCLE study, our US pivotal trial studying SAPIEN M3, to be presented at this year TCT Conference in October.

在二尖瓣置換術中，我們繼續期待歐洲在 2025 年中期批准 SAPIEN M3，並預計美國將在 2026 年批准。我們預計，ENCIRCLE 研究（我們對 SAPIEN M3 進行的美國關鍵試驗）的結果將在今年 10 月的 TCT 會議上發表。

In summary, our bold vision for TMTT has become a reality. We are confident in our unique portfolio strategy with repair and replacement options to treat patients suffering from mitral and tricuspid disease. Our full-year 2025 TMTT guidance remains consistent with the expectation we laid out at our Analyst Day with sales between $500 million and $530 million, driven by our two differentiated commercial technologies, PASCAL and EVOQUE.

總而言之，我們對 TMTT 的大膽願景已經成為現實。我們對我們獨特的投資組合策略充滿信心，該策略透過修復和更換選項來治療患有二尖瓣和三尖瓣疾病的患者。我們對 2025 年全年 TMTT 的預期與我們在分析師日提出的預期保持一致，銷售額在 5 億至 5.3 億美元之間，這得益於我們兩項差異化的商業技術 PASCAL 和 EVOQUE。

In our Surgical product group, full-year 2024 global sales of $981 million increased 6% versus the prior year. Fourth-quarter global sales of $244 million increased 5% over the prior year, with healthy global adoption of Edwards' premium RESILIA portfolio with MITRIS, INSPIRIS, and KONECT.

在我們的外科產品組中，2024 年全年全球銷售額為 9.81 億美元，比前一年增長 6%。第四季全球銷售額為 2.44 億美元，較上年增長 5%，Edwards 的高端 RESILIA 產品組合（包括 MITRIS、INSPIRIS 和 KONECT）在全球範圍內得到了廣泛採用。

We continue to expect positive procedural growth globally for the many patients best treated surgically, including complex and concomitant procedures. We are generating evidence on the RESILIA portfolio to expand access globally, the excellent outcome of our one-year, multi-center, real-world KONECT study were shared at the recent STS conference.

我們持續期待全球範圍內，對於眾多透過手術得到最佳治療的患者，包括複雜手術和伴隨手術，能夠實現積極的成長。我們正在對 RESILIA 產品組合產生證據以擴大其在全球範圍內的覆蓋範圍，我們在最近的 STS 會議上分享了為期一年、多中心、真實世界的 KONECT 研究的出色成果。

In summary, before I turn the call over to Scott, we continue to expect that our full-year 2025 Surgical sales growth will be in the mid-single digits, driven by continued adoption of our RESILIA portfolio and growth in overall heart valve surgeries globally.

總而言之，在我將電話轉給斯科特之前，我們繼續預計 2025 年全年外科銷售增長將達到中等個位數，這得益於我們 RESILIA 產品組合的持續採用以及全球心臟瓣膜手術整體增長。

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

現在，史考特將介紹公司的財務業績細節。

All right. Thanks a lot, Bernard. Today, I'm going to provide a wrap-up of 2024, including detailed results of our fourth-quarter and guidance for the first quarter and full year of 2025. We were pleased with our better-than-expected Q4 sales performance with strength across all product groups. Total sales of $1.39 billion grew 9% on a year-over-year basis.

好的。非常感謝，伯納德。今天，我將對 2024 年進行總結，包括我們第四季的詳細業績以及 2025 年第一季和全年的指引。我們對第四季銷售業績優於預期感到滿意，所有產品組均表現強勁。總銷售額為 13.9 億美元，較去年同期成長 9%。

Adjusted earnings per share was $0.59, led by strong top-line performance. GAAP earnings per share was $0.58. A full reconciliation between our GAAP and adjusted earnings per share is included in today's press release.

調整後每股收益為 0.59 美元，主要得益於強勁的營收表現。每股 GAAP 收益為 0.58 美元。今天的新聞稿中包含了我們的 GAAP 和調整後每股收益之間的完整對帳。

I'll now cover additional details of our P&L. For the fourth quarter, our adjusted gross profit margin was 79%, compared to 80% in the same period last year. We continue to expect our full-year 2025 adjusted gross profit margin to be between 78% and 79%.

我現在將介紹我們的損益表的更多細節。第四季度，我們的調整後毛利率為79%，去年同期為80%。我們繼續預計 2025 年全年調整後毛利率將在 78% 至 79% 之間。

Selling, general, and administrative expenses in the quarter were $492 million or 35.5% of sales, compared to $417 million in the prior year. This increase in spending reflects growth in our TMTT field-based teams, transition expenses following the sale of Critical Care, and strategic growth acquisitions. We plan to hold operational SG&A spending approximately flat at these levels throughout 2025 and expect a lower SG&A ratio over time.

本季銷售、一般及行政開支為 4.92 億美元，佔銷售額的 35.5%，去年同期為 4.17 億美元。支出的增加反映了我們 TMTT 現場團隊的成長、出售重症監護後的過渡費用以及策略性成長收購。我們計劃在 2025 年全年將營運銷售、一般及行政管理費用 (SG&A) 保持在這些水平上大致持平，並預計銷售、一般及行政管理費用比率會隨著時間的推移而降低。

Research and development expenses in the fourth quarter grew 12% over the prior year to $271 million, or 19.6% of sales. This increase was primarily the result of a full quarter of R&D spend from previously announced acquisitions that closed in 2024. We expect to maintain R&D spending at these levels during 2025 and to moderate R&D as a percentage of sales over time.

第四季研發費用較上年同期成長 12%，達到 2.71 億美元，佔銷售額的 19.6%。這一成長主要得益於 2024 年完成的先前宣布的收購中整整四分之一的研發支出。我們預計在 2025 年期間研發支出將維持在這些水平，並且隨著時間的推移降低研發佔銷售額的百分比。

Adjusted operating profit margin in Q4 of 25.6% was in line with our expectation for the quarter. Our guidance for 2025 operating margins continues to be 27% to 28%, with annual operating profit margin expansion thereafte,r as we outlined at the company's investor conference back in December.

第四季調整後的營業利潤率為 25.6%，符合我們對該季度的預期。我們對 2025 年營業利潤率的預期仍為 27% 至 28%，此後年度營業利潤率將會擴大，正如我們在 12 月的公司投資者會議上所概述的那樣。

Turning to taxes. Our reported tax rate this quarter was 11.6% or 13.3%, excluding the impact of special items, in line with our expectation for the quarter. For the full year 2024, our reported tax rate was 9.8% or 11.0%, excluding the impact of special items.

談到稅收。我們本季報告的稅率為 11.6%（不包括特殊項目的影響）或 13.3%，符合我們對本季的預期。2024 年全年，我們的報告稅率為 9.8% 或 11.0%，不包括特殊項目的影響。

As a reminder, our original 2024 adjusted tax rate guidance range was 14% to 17%. And we benefited last year from several one-time tax events, resulting in a lower than originally expected rate. We continue to expect our 2025 tax rate, excluding special items, to be between 15% and 18%.

提醒一下，我們最初的 2024 年調整後稅率指引範圍是 14% 至 17%。去年我們受益於幾次一次性稅收事件，導致稅率低於最初的預期。我們繼續預期 2025 年的稅率（不包括特殊項目）將在 15% 至 18% 之間。

Regarding tariffs, based on what we know today, our guidance ranges could accommodate any potential impact of tariffs, which we expect to be immaterial for Edwards. Foreign exchange rates increased fourth-quarter reported sales growth by 60 basis points, or $7 million compared to the prior year. FX rates negatively impacted our fourth-quarter gross profit margin by 30 basis points compared to the prior year.

關於關稅，根據我們今天所了解的情況，我們的指導範圍可以適應關稅的任何潛在影響，我們預計這對 Edwards 來說並不重要。外匯匯率導致第四季度報告的銷售額增長了 60 個基點，與去年同期相比增長了 700 萬美元。外匯匯率對我們第四季的毛利率產生了負面影響，與去年同期相比，下降了 30 個基點。

Relative to our October guidance, FX rates had a nominal impact on fourth quarter earnings per share. At current rates, we now expect FX to have an approximately $130 million, or 2.5 percentage points downside to sales in 2025 compared to the prior year.

相對於我們十月份的指引，外匯匯率對第四季每股盈餘的影響很小。以目前的速度，我們預計 FX 2025 年的銷售額將比前一年下降約 1.3 億美元，即下降 2.5 個百分點。

Turning to the balance sheet. We continue to maintain a strong and flexible balance sheet with approximately $3 billion in cash and cash equivalents as of December 31, 2024. Average diluted shares outstanding during the quarter were $591 million. We continue to expect average diluted shares outstanding for 2025 to be between $585 million and $595 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 2024 年 12 月 31 日，現金和現金等價物約為 30 億美元。本季平均攤薄流通股數為 5.91 億美元。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。

We have approximately $1.4 billion remaining under our current share repurchase authorization. Our healthy balance sheet gives us the flexibility to advance our growth strategy, and we look forward to a year of robust financial performance in 2025.

我們目前的股票回購授權剩餘金額約為14億美元。我們健康的資產負債表使我們能夠靈活地推進我們的成長策略，我們期待 2025 年實現強勁的財務表現。

I'll finish with comments related to guidance. We are maintaining the financial guidance for 2025 that we provided at our December investor conference. Absent additional moves in foreign exchange, we expect total company sales of $5.6 billion to $6 billion; TAVR sales of $4.1 billion to $4.4 billion; TMTT sales of $500 million to $530 million; and Surgical sales of $970 million to $1.05 billion.

我將以與指導相關的評論來結束。我們將維持 12 月投資者會議上提供的 2025 年財務指引。如果不包括外匯方面的其他變動，我們預計公司總銷售額將達到 56 億至 60 億美元； TAVR 銷售額為 41 億美元至 44 億美元； TMTT銷售額為5億至5.3億美元；外科手術銷售額為 9.7 億美元至 10.5 億美元。

We expect a sequential increase in first quarter sales. We also expect Q1 total company and TAVR year-over-year growth rates to be below the low end of our full-year guidance ranges of 8% to 10% and 5% to 7%, respectively.

我們預計第一季的銷售額將季增。我們也預計第一季公司整體和 TAVR 年成長率將低於我們全年指引範圍的低端，分別為 8% 至 10% 和 5% 至 7%。

We expect some benefit from the asymptomatic TAVR approval in the US and even more support for growth when guidelines and policy change in the future. For the first quarter, we're projecting sales of $1.35 billion to $1.43 billion and adjusted earnings per share of $0.58 to $0.64.

我們預計，美國批准無症狀 TAVR 將帶來一些好處，而且在未來指導方針和政策發生變化時，還將為成長提供更多支持。我們預計第一季銷售額為 13.5 億美元至 14.3 億美元，調整後每股收益為 0.58 美元至 0.64 美元。

And with that, back to you, Bernard.

現在，回到你身上，伯納德。

Thank you, Scott. In conclusion, we are proud of our employees and their significant achievement in transforming care for structural heart patients around the world. As we enter 2025 solely focused on structural heart disease, we are stronger than ever before with significant growth driver in TAVR and TMTT and emerging opportunities in other areas of structural heart. I am optimistic about the tremendous opportunities in front of us.

謝謝你，斯科特。總之，我們為我們的員工以及他們在改變世界各地結構性心臟病患者護理方面所取得的重大成就感到自豪。隨著我們進入 2025 年，完全專注於結構性心臟病，我們比以往任何時候都更加強大，TAVR 和 TMTT 具有顯著的增長動力，並且在結構性心臟的其他領域也出現了新興機會。我對我們面前的巨大機會充滿樂觀。

With that, I'll turn it back to Mark.

說完這些，我就把話題轉回給馬克。

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

非常感謝，伯納德。我們已準備好回答您的問題。(活動須知)

Alicia, I'll turn it back over to you.

艾莉西婭，我會把它交還給你。

(Operator Instructions) David Roman with Goldman Sachs.

（操作員指示）高盛的 David Roman。

Thank you, and good afternoon, everybody. I wanted just to start on the TMTT side. Maybe you could my first question. Just help us reflect a little bit on some of the dynamics that drove the performance here in 2024 that ended above your expectations. And then what needs to unfold operationally still to see an acceleration from the $420 million where you're annualizing in Q4 up to the $500 million plus over -- that's reflected in your guidance here.

謝謝大家，下午好。我只是想從 TMTT 方面開始。也許你可以問我第一個問題。請幫我們稍微反思一下推動 2024 年業績表現超出您預期的一些動力。然後，從營運角度來看，還需要做些什麼才能看到從第四季度的 4.2 億美元加速增長到 5 億美元以上 - 這反映在您的指導下。

Thank you, David. Good question. So I'm going to start. If you remember, we started the year in 2024, where it was mainly PASCAL and Europe was a big contributor. And throughout the year, EVOQUE became a growth contributor also in US also for PASCAL. So if you see that this TMTT portfolio contribution is evolving. But as you can see, we are very excited. We are very pleased. You remember, we had a vision a long time ago, and we were the only company having this vision.

謝謝你，大衛。好問題。那我要開始了。如果你還記得的話，我們是在 2024 年開始的，那時主要是 PASCAL，歐洲是主要貢獻者。並且全年，EVOQUE 也成為 PASCAL 在美國市場的成長貢獻者。因此，如果您看到這個 TMTT 投資組合貢獻正在演變。但正如你所看到的，我們非常興奮。我們非常高興。你記得，我們​​很久以前就有一個願景，而且我們是唯一一家擁有這個願景的公司。

And this vision has become a reality. But I'm going to ask Daveen to add some color commentary here.

而這願景已經成為現實。但我要請戴文在這裡添加一些詳細評論。

Yeah. I'll add a little bit to that. Thanks, David, for the question. As Bernard said, over the course of 2024, I think we saw the creation of a new therapy with EVOQUE, and we started treating patients, and we're starting to see that start is journey where we're still in launch mode, and we're still growing. So as you can imagine, in 2025, EVOQUE will continue to grow.

是的。我對此做一點補充。謝謝戴維提出這個問題。正如伯納德所說，在 2024 年期間，我認為我們看到了使用 EVOQUE 創造的一種新療法，我們開始治療患者，我們開始看到這一旅程的開始，我們仍處於啟動模式，並且我們仍在成長。因此你可以想像，到 2025 年，EVOQUE 將繼續成長。

Additionally, on the PASCAL side of things, the US has been -- it was probably only in the second full year of launch. And for PASCAL, we continue to open centers, both the US and Europe and throughout the world and grow as physicians see the differentiation of PASCAL, they continue to use it more in their existing practice. So for us throughout 2025, PASCAL will also grow.

此外，就 PASCAL 方面而言，美國可能才剛推出第二年。對於 PASCAL，我們將繼續在美國、歐洲和世界各地開設中心，隨著醫生看到 PASCAL 的差異化，我們將繼續在現有實踐中更多地使用它。因此對我們來說，在整個 2025 年，PASCAL 也會成長。

So we see both PASCAL and EVOQUE as two key growth drivers for us and growth also continued to come with a huge emphasis both on Europe and the US.

因此，我們將 PASCAL 和 EVOQUE 視為我們的兩個關鍵成長動力，而且成長也將繼續專注於歐洲和美國。

And then maybe just for my follow-up here. I'm trying to piece some of this together between how you exited Q4 and then the Q1 guidance calling for revenue growth, both in TAVR and total company below the low end of the ranges here.

然後也許只是為了我的後續行動。我試圖將您退出第四季度的方式與第一季的指引拼湊在一起，第一季的指引要求收入成長，無論是 TAVR 還是整個公司的收入都低於此範圍的低端。

Because when I just reflect on Q4, you had the hurricane dynamic early in the quarter, but you also had the exit of Boston Scientific pressures in Europe, not the exit, but the pressure on their business that they described. You're seeing EVOQUE and PASCAL launch. So just as I think about the business here, Q4 versus the dynamics that you're calling here in Q1, maybe you could just help us piece together the sequential deceleration and then correspondingly, the acceleration reflected in the full-year outlook?

因為當我回顧第四季時，你會發現本季初出現了颶風，但同時也面臨波士頓科學公司退出歐洲的壓力，不是退出，而是他們所描述的業務壓力。您將看到 EVOQUE 和 PASCAL 的發布。因此，當我思考這裡的業務時，與您在第一季所稱的動態相比，也許您可以幫助我們拼湊出連續的減速，然後相應地拼湊出全年展望中反映出的加速？

Thank you, David. So let me try maybe high level at the company level, then we can ask either Daveen and Larry to add some comments here. So we expect -- so first, we finished the year strong in Q4, and we are very pleased about it across the board, across the other company.

謝謝你，大衛。因此，讓我嘗試在公司層面進行高層交流，然後我們可以請 Daveen 和 Larry 在這裡添加一些評論。因此，我們預計——首先，我們在第四季度強勁結束了這一年度，我們對此感到非常高興，對整個公司而言都是如此。

We see -- we expect a sequential increase in Q1 sales, but from a growth rate standpoint, for TAVR and for the full company to be maybe below the low end of our full year ranges. There are a few things we know in 2025.

我們看到 - 我們預計第一季的銷售額將環比成長，但從成長率的角度來看，TAVR 和整個公司的成長率可能低於我們全年預期的低端。到 2025 年，我們會知道一些事情。

The first one is that TMTT, so PASCAL, EVOQUE are going to continue to scale throughout the year. The second one is that asymptomatic, approval midyear will represent a catalyst here later. But I'm going to add maybe Daveen to start first about TMTT scaling and then Larry.

第一個是TMTT，所以PASCAL、EVOQUE 將在全年繼續擴大規模。第二個是無症狀，年中的批准將成為以後的催化劑。但我可能會先加入 Daveen 來開始討論 TMTT 擴展，然後再加入 Larry。

Yeah, sure. Thanks, Bernard, on that. As you imagine, over the course of 2024, you saw TMTT almost sequentially grow in a linear rate, right? We continue to add and grow each time as we got that increased adoption and entered new markets. And for us, we see that continuing in 2025, where we expect over the course of the year, our revenue growth to just linearly continue up and that will lead us to our guidance.

是的，當然。謝謝您，伯納德。正如您所想的，在 2024 年期間，您會看到 TMTT 幾乎以線性速率連續增長，對嗎？隨著我們獲得越來越多的採用並進入新的市場，我們每次都繼續增加和發展。對我們來說，我們預計這種趨勢將在 2025 年持續下去，在這一年中，我們的收入成長將持續呈線性上升，這將引導我們實現預期目標。

Yeah. Thanks, David. On TAVR, I think we had a good Q4, and we felt good about it. And I think it was indicative that perhaps we're starting to see a little bit of improvement in some of the capacity stuff, although it's still very much a work in progress. I think what typically happens is the last couple of weeks in December tend to really slow down for patient screening and those things, and that usually gives us a slow start to January.

是的。謝謝，大衛。關於 TAVR，我認為我們的第四季表現良好，我們對此感覺很好。我認為這表明我們或許開始看到一些容量方面的進步，儘管這項工作仍在進行中。我認為通常發生的情況是，12 月的最後幾週患者篩檢等工作進展緩慢，這通常會導致 1 月的開局緩慢。

But all of that is factored into our guidance. And I think as Daveen -- sorry, as Bernard described the year, I think that's how we planned it.

但所有這些都已考慮到我們的指導中。我認為，正如戴文——抱歉，正如伯納德所描述的那樣，我認為這就是我們的計劃。

Great Thanks for all the color.

非常感謝所有的顏色。

Robbie Marcus, JPMorgan.

摩根大通的羅比馬庫斯 (Robbie Marcus)。

Great. Congrats on a nice quarter and thanks for taking the question. First for me, maybe a P&L question as we think about 2025. Scott, the mix of operating expense came in a bit different than The Street was thinking. Any color you could give us now with the rebased business ex critical care, how we should be thinking about SG&A and R&D each separately to get to the guidance you provided?

偉大的。恭喜您度過了一個愉快的季度，感謝您回答這個問題。對我來說，首先，當我們考慮 2025 年時，這可能是個損益問題。史考特，營業費用的構成與華爾街的想法略有不同。您能否向我們提供關於重新調整後的業務（例如重症監護）的任何信息，我們應該如何分別考慮銷售、一般和行政費用以及研發費用，以獲得您提供的指導？

Sure. Thanks for the question. We provided guidance at the investor conference for operating profit, and we didn't really break out SG&A and R&D as a percentage of sales, but I can give you a little bit of color on how we think Q4 is going to translate into our full year 2025 operating profit.

當然。謝謝你的提問。我們在投資者會議上提供了營業利潤的指引，但並沒有真正將銷售、一般及行政開支和研發費用佔銷售額的百分比列出，但我可以稍微介紹一下我們認為第四季度將如何轉化為我們 2025 年全年營業利潤。

We think the improvement of about 200 basis points in operating profit versus Q4 will be about half R&D improvement as a percentage of sales, so about 100 basis points and half, SG&A as a percentage of sales, which is a combination of the actual spending that we run through that line netted with the benefit that we get from the amortization of our unfavorable contract liability that shows up in the new line in our income statement called other income.

我們認為，與第四季度相比，營業利潤提高約 200 個基點，其中研發費用佔銷售額的百分比提高約一半，即銷售、一般及行政費用佔銷售額的百分比約為 100 個基點和一半，這是我們通過該線路運行的實際支出與我們從不利合同負債攤銷中獲得的收益的總和，該收益出現在我們的收益中的新線路。

So we're positive about the ability to improve operating margins through both SG&A and R&D management, keeping those spend levels flat in 2025 with the quarterly spend in Q4, and we're also confident about our ability to continue to grow margins in 2026 and beyond.

因此，我們對透過銷售、一般及行政開支和研發管理來提高營業利潤率的能力持樂觀態度，使 2025 年的支出水平與第四季度的季度支出保持持平，並且我們對在 2026 年及以後繼續提高利潤率的能力充滿信心。

Just as reference, our spending in 2025, will be a lower growth rate than our revenue growth rate, and that's one of the reasons why the ratio is coming down.

作為參考，我們在 2025 年的支出成長率將低於我們的收入成長率，這就是該比率下降的原因之一。

So to add on what Scott said, if you think about big picture here from a P&L standpoint, our #1 commitment is to invest for sustainable and profitable growth. So what you can expect beyond 2025 is our EPS growing faster than our top line growth.

因此，補充一下斯科特所說的，如果你從損益表的角度考慮大局，我們的首要承諾就是投資於可持續的獲利成長。因此，你可以預期，2025 年以後我們的每股盈餘成長速度將快於營收成長速度。

Maybe a follow-up, Bernard, you mentioned in the script, there were a few instances of regional pressure. You still came in above The Street on TAVR. Maybe you could just speak to the regional pressures and how transient or permanent they are and also highlight some of the areas of strength.

也許是後續，伯納德，你在劇本中提到，有一些地區壓力的例子。您仍然可以通過 TAVR 進入 The Street 上方。或許您可以談談區域壓力以及這些壓力是短暫的還是永久的，並強調一些優勢領域。

Yeah, I was talking about a few small pockets around the globe. One is, for instance, Japan. And we look at Japan as a big growth opportunity for us. If you think about what we do as a company, anything in a structural heart disease is treating the disease of the aging. And if there is one country where it is a perfect match between where is unmet patient need and what we do is Japan.

是的，我談論的是全球範圍內的幾個小地區。例如一個國家是日本。我們認為日本對我們來說是一個巨大的成長機會。如果你思考我們作為一家公司所做的事情，你會發現任何治療結構性心臟病的方法都可以用於治療老化疾病。如果有一個國家能與我們所做的工作完美匹配，那就是日本。

We were not satisfied with our growth in Q4 in Japan, but we are very committed to enhance our capability in the region, bring our renovation very low faster to make sure Japan can present a growth opportunity in the years to come.

我們對日本第四季的成長並不滿意，但我們致力於增強我們在該地區的能力，更快地完成我們的革新，以確保日本在未來幾年能夠提供成長機會。

Thank you very much.

非常感謝。

Larry Biegelsen, Wells Fargo.

富國銀行的拉里·比格爾森。

Good afternoon. Thanks for the quesiton. And Daveen, congrats on a really nice quarter in TMTT and Edwards, overall. So I wanted to start with you, Daveen. That's why I pointed that out on EVOQUE, what have you seen since the NTAP started on October 1? And how are you thinking about the impact from the NCD, which should be finalized in March? And I had one follow-up.

午安.謝謝你的提問。戴文，總體而言，恭喜 TMTT 和 Edwards 本季表現非常出色。所以我想從你開始，戴文。這就是為什麼我在 EVOQUE 上指出這一點，自 10 月 1 日 NTAP 開始以來，您看到了什麼？您如何看待將於 3 月最終確定的 NCD 帶來的影響？我還有一個後續行動。

Thanks for the question and the nice comps you said. I'll just make 1 comment before I dive into the NTAP as we talk about EVOQUE. It's interesting. I've got a chance over the last couple of weeks to actually meet a handful of different EVOQUE patients and spend some time with them. And it's amazing to hear their stories.

感謝您的提問以及您給予的優秀評價。在我們深入探討 NTAP 並討論 EVOQUE 之前，我只想發表 1 則評論。這很有趣。過去幾週我有機會實際見到了一些不同的 EVOQUE 患者並與他們一起度過了一段時間。聽到他們的故事真是令人驚奇。

One person who was a 62-year-old CEO of a technology staffing company, who is a biker, wake surfer and now suddenly could barely walk up the stairs and EVOQUE got him back to do the things that he wanted to do.

有一位 62 歲的技術招聘公司首席執行官，他是一名騎行者、尾流衝浪者，現在突然幾乎無法走上樓梯，而 EVOQUE 讓他重新可以做他想做的事情。

The other person was a 79-year-old lady who was in hospice care, hospice care. And now you would never know anything is wrong with her and she is excited and happy to be alive and is actually a patient advocate for tricuspid disease now, started that recently.

另一人是一位 79 歲的老太太，正在接受臨終關懷。現在你永遠不會知道她有什麼問題，她對自己還活著感到興奮和高興，實際上她現在是三尖瓣疾病的患者倡導者，最近才開始這樣做。

And why I'm telling you the story is that these kinds of stories are what's spreading, I think, among the community, spreading among both physicians among patients. And as a result, we see a really strong demand for EVOQUE, a lot of desire from both physicians and patients because they see these excellent results for the patients or really changes their life.

我之所以要告訴你們這個故事，是因為我認為這類故事正在社區中流傳，在醫生和病人之間流傳。因此，我們看到市場對 EVOQUE 的需求非常強勁，醫生和患者都有很大的渴望，因為他們看到了 EVOQUE 為患者帶來的優異效果或確實改變了他們的生活。

And it's a procedure, as we know, is very predictable. It's very -- and it gets -- we're getting clinical results in the market today or today that were similar to a clinical trial.

我們知道，這是一個非常可預測的過程。它非常——而且它得到了——我們今天在市場上獲得的臨床結果或今天獲得的臨床結果與臨床試驗類似。

So for us, NTAP or the coming NCD allow more patients to access, or allow to continue the access we're seeing. So built into our guidance this year, we're assuming a positive NCD coming at the end of Q1. And I see things like NCD as potential opportunities to slow us down if they don't go as we plan. But really, we see them as continuing the growth and the opportunity for patients to get access to this product that they want. So for us, it's definitely built in.

因此對我們來說，NTAP 或即將推出的 NCD 允許更多患者獲得治療，或允許繼續獲得治療。因此，根據我們今年的指導，我們假設第一季末將出現正面的 NCD。我認為，如果 NCD 等現象沒有按照我們的計劃進行，就有可能減慢我們的發展速度。但實際上，我們看到他們正在繼續發展，並為患者提供他們想要的產品的機會。所以對我們來說，它絕對是內建的。

It's definitely a part of the growth we're seeing, and it's a part of the interest we see from both physicians and patients.

這絕對是我們看到的成長的一部分，也是我們看到的醫生和病人興趣的一部分。

That's helpful. And one for Larry. Just it would be great to hear you talk about what you're seeing and hearing in the field following early TAVR. -- when do you expect the data to positively impact procedures? Is it the indication? Is it guidelines? What do you need? Or is it just everything contributing?

這很有幫助。還有一個給拉里。我很高興能聽到您談論在早期 TAVR 之後您在現場看到和聽到的情況。 ——您預期數據何時會對程序產生正面影響？是指示嗎？這是指導方針嗎？你需要什麼？還是只是一切都有貢獻？

Yeah, I think you're probably right on the second comment there. It's going to be a little bit of everything. I think as education expands, we're going to take opportunities that meetings like ACC and PCR to really amplify the message and make sure the referring community really understands the data and they understand the significance of the data. I think the message is moved through the implant community, but we need to move upstream to the referral community. And so we'll be working hard to to amplify that.

是的，我認為你對第二條評論的看法可能是正確的。這會是一切事物中的一點點。我認為隨著教育的擴展，我們將利用 ACC 和 PCR 等會議的機會來真正擴大資訊範圍，並確保推薦社群真正理解數據並理解數據的重要性。我認為訊息是透過植入社區傳遞的，但我們需要向上游傳遞到轉診社區。因此，我們將努力擴大這一點。

Clearly, indication is a big thing. Once it's on label, that certainly is helpful because it gives us ability to promote directly where until that happens, we're not allowed to promote directly.

顯然，指示是一件大事。一旦貼上標籤，這肯定會有所幫助，因為它使我們有能力直接推廣，而在此之前，我們無法直接推廣。

But then longer term, it's going to be guideline changes, it's going to be updates to policies and all those things. And that's why I think we really tried to highlight this in the investor conference. We see this is going to be a multiyear catalyst.

但從長遠來看，這將是指導方針的改變，將是政策的更新和所有這些事情。我認為這就是我們在投資者會議上大力強調這一點的原因。我們認為這將成為多年的催化劑。

This isn't going to be short term or just one immediate bolus of patients. We see this as a long-term catalyst for us. And certainly, if hospitals improve their capacity and as hospitals look to invest in their capacity, I think the confidence of this data and a continual stream of additional AS patients is what's going to really motivate them to make those investments.

這不會是短期的，也不會是一次性的緊急治療。我們認為這對我們來說是一個長期的催化劑。當然，如果醫院提高其治療能力並且醫院希望對其治療能力進行投資，我認為這些數據的可信度和不斷湧入的 AS 患者才是真正激勵他們進行這些投資的因素。

Thanks, Larry.

謝謝，拉里。

Pito Chickering, Deutsche Bank.

德意志銀行的 Pito Chickering。

Good afternoon, guys. Following up on Larry's question there. Beyond the US hospitals that were part of the trial, like how many more hospitals have been trained to implant EVOQUE at this point? And any color on how many doctors at this point, including those during the trials have been trained? And I guess how many are signed up at this point to be trained at this going forward?

大家下午好。繼續回答 Larry 提出的問題。除了參與試驗的美國醫院之外，目前還有多少家醫院接受過植入 EVOQUE 的訓練？目前，包括試驗期間的醫生在內，有多少醫生接受過訓練？我猜現在有多少人報名接受這方面的訓練？

Yeah. So this is Daveen. I'll answer that. Thanks for the question. Yeah, as you mentioned, we started off with our rollout of EVOQUE by focusing on those those TRISCEND II hospitals, which is about 50 or so in the US.

是的。這就是戴文。我來回答這個問題。謝謝你的提問。是的，正如您所說，我們在推出 EVOQUE 時首先關注的是 TRISCEND II 醫院，美國大約有 50 家這樣的醫院。

But from there, there are many other high-volume tricuspid centers. And now we've been focusing on those centers and they continue to grow. So each month, we have training programs here in Irvine and around the US where more and more centers get grown.

但從那裡開始，還有許多其他高容量的三尖瓣中心。現在我們一直關注這些中心並且它們還在繼續發展。因此，我們每個月都會在爾灣和美國各地舉辦培訓項目，越來越多的中心在這裡成長。

So it's almost just a continuous linear growth, but we still feel like that we're pretty early in the number of centers that are going to be training EVOQUE. We're very early in that. And so for us, it's just a linear growth, and we'll definitely continue from there.

因此，這幾乎只是一種連續的線性增長，但我們仍然覺得，培訓 EVOQUE 的中心數量還處於相當早期的階段。我們還處於早期階段。所以對我們來說，這只是線性成長，我們肯定會繼續下去。

Right. As TMTT is becoming a bigger part of the revenue engine for you guys. Can you give us a US OUS split for TMTT in the fourth quarter, so you need that as a launch pad for modeling 2025?

正確的。TMTT 正在成為你們收入引擎中越來越重要的一部分。您能否提供一下第四季度 TMTT 的美國 OUS 拆分情況，以便您需要它作為 2025 年建模的啟動平台？

Yeah, Daveen again. Yeah, we don't break out the exact numbers. But I think as I mentioned before, right, we originally started in Europe. So Europe side of the OUS is still our largest market, but the US is coming online.

是的，又是戴文。是的，我們沒有公佈具體的數字。但我認為正如我之前提到的，我們最初是在歐洲開始的。因此，美國以外的歐洲市場仍然是我們最大的市場，但美國也正在崛起。

As we go forward, though, we still expect Europe to be larger, but the US will be our second big driver as we move forward in 2025.

然而，隨著我們繼續前進，我們仍然預計歐洲將會變得更大，但隨著我們在 2025 年繼續前進，美國將成為我們的第二大推動力。

Thank you.

謝謝。

Travis Steed, Bank of America.

美國銀行的特拉維斯·斯蒂德 (Travis Steed)。

Congrats on the good quarter. I just wanted to follow up on the Q1 guidance. You said TAVR growth below 5% to 7%. Just want to confirm first that, that 5% to 7% is constant currency. And I know there's a selling day headwind. If you could just quantify that if it's 150 basis points. And excluding the selling day, are you back into that 5% TAVR guidance range?

恭喜本季取得良好業績。我只是想跟進第一季的指導。您說 TAVR 成長率低於 5% 至 7%。首先要確認的是，5% 到 7% 是固定貨幣。我知道銷售日有逆風。如果您可以量化它，如果它是 150 個基點。除了出售日之外，您是否回到了 5% TAVR 指導範圍？

Travis, you said it well, you got it exactly right. So 5% to 7% full-year guidance for TAVR sales growth is an underlying constant currency basis. And the impact of the one less selling day is about 1 point, not 1.5, but around 1 point globally. And so that would take you back to somewhere close to where we ended up in Q4. 5.3% was the range. So somewhere in that number is what we're expecting and modeling for TAVR in Q1.

崔維斯，你說得很好，你說得完全正確。因此，TAVR 銷售全年成長 5% 至 7% 的預期是基於基本固定匯率計算的。而減少一天的銷售量的影響大約是 1 個百分點，而不是 1.5 個百分點，而是在全球範圍內 1 個百分點左右。這樣你就回到了接近第四季的情況。範圍是 5.3%。因此，該數字中的某個數字就是我們對第一季 TAVR 的預期和建模。

Great. That's helpful. And then the second question, just so we could get an update on CLASP IIF and CLASP II TR, the functional mitral repair and tricuspid repair products. Just curious how those trials are going and timelines for that opportunity?

偉大的。這很有幫助。然後是第二個問題，只是為了讓我們能夠獲得有關 CLASP IIF 和 CLASP II TR、功能性二尖瓣修復和三尖瓣修復產品的最新資訊。只是好奇這些試驗進展如何以及該機會的時間表？

Yeah. No problem. (inaudible). This is Daveen again. I think as we mentioned in the investor conference back in December, the CLASP IIF pivotal trial will continue to enroll throughout 2025. So for that, we don't have any other timelines about the continued enrollment.

是的。沒問題。（聽不清楚）。我又是戴文。我認為，正如我們在 12 月的投資者會議上提到的那樣，CLASP IIF 關鍵試驗將在 2025 年全年持續招募。因此，我們沒有關於繼續招生的任何其他時間表。

I would like to note though, especially at London Valves this year, actually just not that long ago, we actually showed in our my CLASP study some great results for PASCAL in these FMR patients. We had over 300 patients a two-year follow-up that showed an 81% MR-01, which is a great message, and we see great results from Europe.

我想指出的是，尤其是在今年的倫敦閥門展會上，實際上就在不久前，我們實際上在 CLASP 研究中展示了 PASCAL 在這些 FMR 患者中取得的一些出色成果。我們對 300 多名患者進行了為期兩年的追蹤調查，結果顯示 MR-01 達到 81%，這是一個好消息，而且我們在歐洲也看到了很好的成果。

Moving over to CLASP II TR. So this is the tricuspid indication for PASCAL. I think as you remember, we announced that in Q4 we finished the enrollment. So there is a 12-month follow up on the trial, so one year follow-up.

轉到 CLASP II TR。這就是 PASCAL 的三尖瓣適應症。我想您還記得，我們​​宣佈在第四季度完成了招生。因此，該試驗的追蹤時間為 12 個月，也就是一年。

From there, it usually takes a couple of quarters to put together your PMA submission and then submit it and it's at least six months for FDA approval, so you can run the timelines from there, but that was finished enrollment in Q4 2024.

從那時起，通常需要幾個季度的時間來整理您的 PMA 申請，然後提交它，並且至少需要六個月的時間才能獲得 FDA 批准，因此您可以從那裡開始運行時間表，但這已在 2024 年第四季度完成註冊。

Great. Thanks a lot.

偉大的。多謝。

Vijay Kumar, Evercore ISI.

維賈伊·庫馬爾（Vijay Kumar），Evercore ISI。

Hey, guys. Thanks for taking the question and congrats on a nice TMTT print. Maybe my first question back on the guidance here for Q1. I think Q4, when we look at the TAVR number, there were a number of one-off items, right? I think you had three lesser days, maybe some hurricane impact to have some China noise. I guess why all of that, I think Q4 came in above expectations at five, given some of those items won't repeat, why shouldn't Q1 be better? Is there any one-offs outside of the extra day -- 1 lesser day that we should be thinking of?

嘿，大家好。感謝您回答這個問題，並祝賀您取得了出色的 TMTT 印刷品。我第一個問題可能是關於第一季的指引。我認為，第四季度，當我們查看 TAVR 數字時，有許多一次性項目，對嗎？我認為你們度過了三天不太好的時光，也許是受颶風影響，聽到了一些中國噪音。我猜想為什麼所有這一切，我認為第四季的表現超出預期，考慮到其中一些項目不會重複，為什麼第一季不應該更好呢？除了額外的一天（減少 1 天）之外，還有哪些一次性事件值得我們考慮嗎？

So Vijay, it's Scott. I'll start and then maybe turn it over to Larry, if he has any additional color. The 1 day is probably the most noteworthy thing. Remember, in our call, we had talked about the early signals from China on the hurricanes. But at that point, I said we didn't know what the impact was going to be.

那麼 Vijay，我是 Scott。我會開始，然後也許把它交給拉里，如果他有任何其他顏色的話。這1天可能是最值得注意的事。記得，我們​​在通話中討論了中國針對颶風發出的早期訊號。但那時，我說我們不知道會產生什麼影響。

Turned out that was not a big influence on our results for Q4. It had something to do with it, but I wouldn't call that exceptionally noteworthy. Really, in Q1, we're feeling good about TAVR's growth. And like I said, with the exception of that 1 day, difference in selling days versus Q4, there's not a whole lot to report.

事實證明，這對我們第四季的業績沒有太大影響。這和它有一定關係，但我並不認為這有什麼特別值得注意的。確實，在第一季度，我們對 TAVR 的成長感到非常滿意。正如我所說的，除了與第四季度相比銷售天數多 1 天之外，沒有太多可報告的內容。

Yeah. Just to add on to that. As I mentioned earlier, we typically see a slowdown at the end of the year, and this is very typical. We've seen this for many years now. And it just empties the funnel a little bit from the patients that are screened and having their CTs and everything.

是的。只是想補充一下。正如我之前提到的，我們通常會在年底看到經濟放緩，這是非常典型的。我們已經看到這種情況很多年了。它只是從接受篩檢並進行 CT 檢查等的患者中清空了一點漏斗。

So we just typically see a little bit of a slow start to January. And so that factors into our guidance. But we do expect the growth rates to be higher in the subsequent quarters.

因此，我們通常會看到 1 月的開局稍微緩慢一些。這也成為我們指導的因素。但我們確實預計接下來幾季的成長率會更高。

Understood. And Bernard, maybe my follow-up for you. I think you noted NCD language around tricuspid was in line with expectations. I think there is a CED criteria. And when I look at the physician criteria, there is a cross-pollination collaboration between a variety of physicians rate.

明白了。伯納德，也許我可以跟進一下你的情況。我認為您注意到三尖瓣周圍的 NCD 語言符合預期。我認為存在一個 CED 標準。當我查看醫生標準時，發現各種醫生之間存在著相互影響的合作。

It seems a little bit more onerous versus when you look at the TAVR guidelines. So curious how we're thinking about the NCD proposals? And do you expect any changes to the proposed language?

與 TAVR 指南相比，這似乎更加繁重。那麼好奇我們是如何看待 NCD 提案的呢？您期望所提議的語言會有任何改變嗎？

No, I think we feel good about where we are with all of the progress we have made with CMS and the societies. We recommended language from CMS is aligned with our expectation. This will provide access to a Medicare patient rework, which is going to be a catalyst for the many years to come. But maybe Daveen want to add anything here?

不，我認為我們對 CMS 和社會所取得的所有進展感到非常滿意。我們推薦的 CMS 語言與我們的期望一致。這將為醫療保險患者提供重新治療的機會，這將成為未來許多年的催化劑。但也許戴文想在這裡添加一些內容？

Yeah, a couple of small comments. Just obviously, when a patient as you read in the NCD is under the care of a multi-specialty heart team, and there are different kinds of members of the heart team, and that's under the care of. So that's a group of people who are not necessarily individually evaluating it. They're not necessarily part of the procedure. They are people who as needed are part of the care program of the patient.

是的，一些小評論。很明顯，正如您在 NCD 中讀到的，當一個病人接受多專業心臟團隊的護理時，這個心臟團隊有不同類型的成員，他們負責照顧病人。因此，這群人不一定會單獨評估它。它們不一定是該程式的一部分。他們是根據需要參與患者護理計劃的人。

So for us, we feel like that's been very normal and expected and actually a good thing for patients. But back to maybe Bernard's comments in the overall, we generally feel very positive about where the NCD is, we love that. We appreciate that there's coverage with evidence determination, or CED, which enables this timely access.

因此對我們來說，我們覺得這是非常正常且意料之中的，實際上對患者來說是一件好事。但回到伯納德的整體評論，我們總體上對 NCD 的現狀感到非常樂觀，我們喜歡這一點。我們很欣賞證據認定（CED）的覆蓋，這使得我們能夠及時獲得這些資訊。

And we're actually quite happy or quite proud of the responsibility we have to lead the CED process to gather more data and roll out this therapy. And we don't believe CED or any other parts of the NCD draft that we all see online will actually affect our rollout plans. It's right on line with where we had hoped the NCD would come up. So we're pretty positive on it.

我們實際上非常高興或非常自豪能夠領導 CED 進程，收集更多數據並推出這種療法。我們不認為 CED 或我們在網路上看到的 NCD 草案的任何其他部分實際上會影響我們的推出計劃。這與我們所希望的 NCD 的出現完全一致。所以我們對此非常樂觀。

Thanks for clarifying.

謝謝澄清。

Rick Wise, Stifel.

瑞克懷斯（Rick Wise），Stifel。

Good afternoon, everybody. Sorry, I'm in the airport, it might be a little noisy. I want to follow up one more time on the first quarter TAVR guidance and early TAVR. Scott, I just want to be clear in my own mind. When you gave us guidance at the Analyst Day, obviously, you were thinking about the quarters of '25.

大家下午好。抱歉，我在機場，可能會有點吵。我想再次跟進第一季的 TAVR 指導和早期 TAVR。斯科特，我只是想弄清楚自己的情況。當您在分析師日向我們提供指導時，顯然您考慮的是 25 年的季度。

Is your -- have you shaded your TAVR expectations in some way with your comments and guided in the first quarter, is it any different than it was as the year set up, as you thought it would be back in December when we talked. And then I'll follow up on early TAVR.

您是否在第一季的評論和指導中以某種方式暗示了您的 TAVR 預期，它是否與今年 12 月我們談話時您所認為的有所不同？然後我將跟進早期 TAVR。

Thanks for the question, Rick. No, our guidance expectations haven't really changed at all. We were pleased with the fourth quarter results. But for the reasons that Larry indicated, we still think the guidance for 2025 is the right guidance. Q1, we knew about the one selling day back when we gave the guidance, so that's no new information.

謝謝你的提問，里克。不，我們的指導預期其實根本沒有改變。我們對第四季的業績感到滿意。但出於拉里指出的原因，我們仍然認為 2025 年的指導是正確的指導。Q1，我們在給予指導時就知道了銷售日，所以這並不是什麼新資訊。

And as Larry just said, we're expecting higher growth rates in the quarters after Q1 and 2025. But really, no change in our expectations.

正如拉里剛才所說，我們預計第一季和 2025 年之後的幾個季度的成長率會更高。但實際上，我們的期望並沒有改變。

Okay. And Larry, just not to go over, you've been very clear, but perhaps you saw the work I did on early TAVR, just didn't tried to trona it that a bunch of docs said that they're already starting to see an increase in referral volumes. And just to ask you, even though it might be early, are you seeing -- are you hearing the same thing that I heard? I mean, obviously, as the year unfolds and as you -- as education expands, there's going to be more. But are you seeing that same impact that, that small sample that I wrote about articulate.

好的。拉里，我們不必再重複了，你已經說得很清楚了，但也許你看到了我在早期 TAVR 上所做的工作，只是沒有嘗試去嘗試，因為很多醫生說他們已經開始看到轉診量的增加。我只是想問您一下，儘管現在可能還為時過早，但您是否看到——您聽到的和我聽到的一樣嗎？我的意思是，顯然，隨著時間的推移和教育的擴展，還會有更多的事情發生。但是，您是否看到了與我所寫的那個小樣本相同的影響？

Thanks, Rick. So we hear anecdotally. We hear about a patient there, a patient here or there. And some physicians certainly are talking more about it. Again, the implant community is probably much more up to speed on the early tab data than the referral community is.

謝謝，里克。我們聽到的是軼事。我們聽說那裡有病人，這裡或那裡有病人。一些醫生確實對此進行了更多的討論。再次強調，植入者社群可能比轉診者社群更了解早期標籤數據。

And so it's going to take a little bit of time to get this out. I don't think there's any question that the early TAVR data is compelling and that it's going to lead to more patients coming into the system. I don't think there's any doubt about that.

所以要解決這個問題需要一點時間。我認為，毫無疑問，早期的 TAVR 數據是令人信服的，而且它將吸引更多的患者進入系統。我想這一點毫無疑問。

I think the thing that balances that how fast can hospitals continue to address these capacity challenges, to be able to treat this additional inflow of patients. And we're -- we're working on this from a number of different angles because the other thing that comes into play is we're working on quality metrics, things like Target AS. Right now, waiting list can grow in the US and it's not really measured.

我認為需要權衡的是，醫院能多快繼續應對這些容量挑戰，以便能夠治療新增的患者。我們正在從多個不同角度進行這項工作，因為另一個需要考慮的問題是，我們正在研究品質指標，例如 Target AS。目前，美國的等候名單可能會越來越長，但卻沒有真正的衡量標準。

But in the future, people are going to have quality metrics such as 90 days from diagnosis to treatment. And I think that's going to make the difference in terms of how patients flow through the system.

但在未來，人們將有品質指標，例如從診斷到治療需要 90 天。我認為這會對患者在系統中的流動方式產生影響。

Thanks, Larry. Thanks, Scott.

謝謝，拉里。謝謝，斯科特。

Matt Miksic, Barclays.

巴克萊銀行的馬特‧米克西克 (Matt Miksic)。

Hey. Thanks so much for taking the question. I just have one follow-up on an earlier question. First, just around centers. I know you're growing out of the initial triennial trial centers for EVOQUE. I'm just wondering if you have like a round number that you think this can go to Teverson centers like the 850. Is this over time, half of that?

嘿。非常感謝您回答這個問題。我只想針對之前的一個問題進行跟進。首先，只圍繞中心。我知道你們的 EVOQUE 試驗中心最初的三年期試驗中心已經不存在了。我只是想知道您是否有一個大概的數字，認為這可以達到 850 這樣的 Teverson 中心。這是加時賽嗎，是那的一半嗎？

Is there a one-third of that, an actual number that we should just think about as getting to? And I have 1 quick follow-up if I could.

有沒有這個數字的三分之一，一個我們應該考慮要達到的實際數字？如果可以的話我還有 1 個快速的後續問題。

Yeah. No -- this is Daveen again. It's hard to fully judge because we know it's the structural heart world of centers is the TAVR world of numbers now, right, which is over 800 centers or the exact number. But we think obviously that it's going to be some portion of that, and it's going to have a a track that gets up there. it's hard to figure out now how each center is going to be prepared and work together to start a tricuspid program. So it's hard to put an exact number on.

是的。不——我又是戴文。很難全面判斷，因為我們知道現在結構性心臟中心的數量是 TAVR 的數量，對吧，確切的數字是超過 800 個中心。但我們顯然認為它會是其中的一部分，而且它會有一條通往那裡的軌道。現在很難弄清楚各個中心將如何做好準備並合作啟動三尖瓣治療計畫。因此很難給出一個確切的數字。

But if you put an upper bound, it's definitely probably the structural programs of 850. But I think for us, we're going to work with centers one at a time to help to get them ready, to help give them the imaging and work with them to how to get the best treatment of tricuspid disease, but yeah, it's going to be a continual lender thing that we'll figure out together.

但如果設定一個上限，那肯定是 850 個結構性項目。但我認為對我們來說，我們將一次與一個中心合作，幫助他們做好準備，幫助他們提供影像並與他們合作如何獲得三尖瓣疾病的最佳治療，但是，是的，這將是一個持續的貸款人問題，我們將共同解決。

Got it. And then the follow-up, just very closely related. Some of the feedback we had conversations with clinicians last year who did the launch and is obviously excitement about having to valve, but then we identify these patients, how many can you get in, the time to do the procedure, the reimbursement for the procedure, times of training, all these kinds of early start-up factors.

知道了。然後是後續行動，非常密切相關。我們去年與進行發布會的臨床醫生進行了一些交流，他們收到的一些反饋顯然表明，他們對於使用瓣膜非常興奮，但隨後我們確定了這些患者，可以接收多少人，手術時間，手術報銷金額，培訓時間，所有這些早期啟動因素。

Maybe if you could talk a little bit about how you see this year your ability to start mitigating some of those early start-up challenges in getting volumes going and adoption going, et cetera? Thanks so much.

也許您可以稍微談談您如何看待今年您在開始緩解早期創業過程中遇到的一些挑戰，包括提高銷售量和推廣應用程式等方面的能力？非常感謝。

Yeah. And I think what the pathway of EVOQUE to treating more patients is similar to the start of any new therapy, right? We see early on that it's reproducible. It's a predictable procedure. Please imagine the first couple of times you do and it takes a little bit longer.

是的。我認為 EVOQUE 治療更多患者的途徑與任何新療法的開始類似，對嗎？我們很早就發現它是可重複的。這是一個可預測的過程。請想像一下您最初幾次這樣做時會花費更長的時間。

But then as you do a little bit more, you start getting a little better and a little bit faster at it. And similar to the pre-case planning or the referrals. As Larry said, like even with asymptomatic patients, initially, hey, referring physicians, they've been holding on to these tricuspid patients.

但隨著你做得越來越多，你就會開始做得更好、更快。與案件前期規劃或轉介類似。正如拉里所說，即使是無症狀的患者，最初，轉診醫生也一直在照顧這些三尖瓣患者。

They're not necessarily looking for them. But then they start seeing that tricuspid patients can be treated and are getting fantastic results. Then they start referring them. And then initially, almost stenographers and ecosystems of hospitals, you maybe got the planning right, but you need to practice in it better, so it takes something that may be a little bit efficient and gets more efficient.

他們不一定在尋找它們。但後來他們開始發現三尖瓣患者可以得到治療，並且取得了顯著的效果。然後他們開始推薦他們。然後最初，幾乎對於速記員和醫院的生態系統來說，你可能已經做出了正確的規劃，但你需要更好地實踐，所以它需要一些可能更有效率的東西，並且會變得更有效率。

So what we'll see is that the centers who have started EVOQUE or any tricuspid programs will continue to get more efficient, and we'll see that new centers that will come on new centers that will start online will take a little bit longer and do a little bit of fewer cases. Maybe I'll do one or two the first day.

因此，我們將看到，已啟動 EVOQUE 或任何三尖瓣計畫的中心將繼續變得更加高效，我們將看到，新中心的上線將花費更長的時間，處理的病例也會更少一些。也許第一天我會做一兩件。

But now we see centers that do three to five in a day and continue in one room and continue to create that efficiency. So I don't see this as especially unusual for a new structural heart therapy. It's in line. And we see that the -- we know that there are a lot of tricuspid patients out there and this long-term work of continuing to create awareness of this disease, diagnosis at the cardiologists, referrals to the heart teams.

但現在我們看到中心每天進行三到五次手術，並在一個房間裡繼續進行，並繼續創造這種效率。因此，我並不認為這對於一種新型結構性心臟療法有什麼不尋常之處。是在線的。我們看到——我們知道有很多三尖瓣患者，並且需要長期努力來繼續提高人們對這種疾病的認識、讓心臟病專家進行診斷以及將患者轉診到心臟團隊。

That's a process that the world did for TAVR. The world did for mitral, and we think the world will do appropriately with our support in tricuspid as well.

這就是世界為 TAVR 所做的過程。世界在二尖瓣方面取得了很好的成績，我們認為，在我們的支持下，世界在三尖瓣方面也會取得很好的成績。

Very helpful. Thanks.

非常有幫助。謝謝。

Matthew Taylor, Jefferies.

馬修·泰勒（Matthew Taylor），傑富瑞（Jefferies）。

Hi. Thanks for taking the question and congrats on a nice quarter. I wanted to ask a follow-up question on growth in TMTT in 2025. I know you don't give all the details of US, OUS, or mitral tricuspid, but I was wondering if you could give us any framework or guidepost to help us understand how much growth is coming from those different sources? Or are they growing similarly?

你好。感謝您回答這個問題，並祝賀您度過了一個愉快的季度。我想問一個關於 2025 年 TMTT 成長的後續問題。我知道您沒有提供 US、OUS 或二尖瓣三尖瓣的所有細節，但我想知道您是否可以提供任何框架或指導，以幫助我們了解這些不同來源的增長量？還是它們的生長方式相似？

Maybe if you could talk about share expectations in those different markets? Anything like that would be helpful to think about modeling?

您能否談談這些不同市場的股票預期？任何類似的東西都會對思考建模有幫助嗎？

So maybe let me start, Matt. We are not thinking about share. We are creating markets. The vision we had a long time ago was about creating a category. This patient have very few options a few years ago.

那麼也許讓我來開始吧，馬特。我們沒有考慮份額。我們正在創造市場。我們很久以前就有一個願景，就是創造一個類別。幾年前，這位患者的選擇非常少。

And with our portfolio, we have many options. And more to come with the forthcoming M3 and mitral replacement technology. So we are not thinking about share. We are thinking about patient outcome. We are thinking about training physicians to make sure they can scale their practice.

憑藉我們的投資組合，我們擁有多種選擇。還有更多即將推出的 M3 和二尖瓣置換技術。所以我們沒有考慮份額。我們正在考慮患者的結果。我們正在考慮培訓醫生，以確保他們能夠擴大其實踐規模。

We are thinking about how to create a large category, defining in a category. And truly, this is the way we are thinking about it. At Investor Conference, I think we gave you some vision for 2030. We believe our TMTT business could be a $2 billion business from $300 million or so last year to $500 million or so this year. clearly, clearly amazing trajectory based on all of these.

我們正在思考如何創建一個大的類別，並在一個類別中定義。確實，這就是我們思考這個問題的方式。在投資人會議上，我想我們給了你們一些 2030 年的願景。我們相信，我們的TMTT業務價值可能會從去年的3億美元左右增加到今年的5億美元左右，達到20億美元。顯然，基於所有這些，這顯然是一個令人驚嘆的軌跡。

But I'm going to ask Daveen to talk more about this year.

但我要請戴文多談談今年的情況。

Yeah. Just to give a couple more details, but I'll first add in to that. I completely agree with Bernard that for us, we know that there are just millions of patients with tricuspid and mitral disease who just can't live the quality of life that they want, and we feel like we have an opportunity to help them. And so as you move more directly in 2025, right, there are multiple drivers.

是的。只是想提供更多細節，但我將首先補充這一點。我完全同意伯納德的觀點，對於我們來說，我們知道有數百萬患有三尖瓣和二尖瓣疾病的患者無法過上他們想要的生活質量，我們覺得我們有機會幫助他們。因此，隨著你在 2025 年更加直接行動，就會有多個驅動因素。

Both Europe and the US will be both large growth drivers for TMTT as we -- in 2025 versus 2024. Both PASCAL and EVOQUE will be large growth drivers for TMTT in 2025 versus 2024. And the Bernard's comment just about M3, M3 was just starting in Europe. So it will be much smaller, just an initial starting.

相較於 2024 年，歐洲和美國都將成為 TMTT 的巨大成長動力。與 2024 年相比，PASCAL 和 EVOQUE 都將成為 2025 年 TMTT 的主要成長動力。伯納德 (Bernard) 對 M3 的評論是，M3 在歐洲才剛起步。因此它將小得多，只是一個初始階段。

So for that, I hope that gives a little bit of help on just how we look at the two geographies and the two products and to Bernard's point, it's not about share. It's about how do we discover, find and treat just more patients and grow the overall number of procedures that can help patients.

因此，我希望這能為我們如何看待這兩個地區和這兩種產品提供一點幫助，正如伯納德所說，這與份額無關。關鍵在於我們如何發現、找到並治療更多的患者，以及如何增加可以幫助患者的治療程序總數。

Great. Thank you, guys.

偉大的。謝謝你們。

Joanne Wuensch, Citibank.

花旗銀行的 Joanne Wuensch。

Good evening and thank you for taking the question. Can we pause for a second on M3? It sounds like it's on track for CE Mark approval near the end of the year with some revenue contribution and then you're going to have data at TCT 2025. Can you remind us what that market opportunity is and why that's an important product in the portfolio?

晚上好，感謝您回答這個問題。我們可以在 M3 上暫停一下嗎？聽起來它有望在年底前獲得 CE 標誌批准，並帶來一些收入貢獻，然後您將在 2025 年 TCT 上獲得數據。您能否提醒我們這個市場機會是什麼以及為什麼它是產品組合中的重要產品？

Sure. Yeah. This is Daveen as well. So just a reminder, CE Mark from M3, we expect in mid-2025 in Europe with approval in the US in 2026 and the pivotal study, the ENCIRCLE study of 300 patients who were unsuitable for TR, the one-year follow-up we expect to release at TCT this fall.

當然。是的。這也是戴文 (Daveen)。因此提醒一下，我們預計 M3 的 CE 標誌將於 2025 年中期在歐洲獲得批准，並於 2026 年在美國獲得批准，而關鍵研究即針對 300 名不適合 TR 的患者進行的 ENCIRCLE 研究，我們預計將於今年秋季在 TCT 上發布為期一年的追蹤結果。

And I pressed on unsuitable for TR, I think that's really the indication of where we see M3 fitting in the treatment of patients. We know that TR is an amazing technology. and there are many patients who get fantastic results. But when you talk to physicians and you talk to patients, there are many patients who are suboptimal for TR, either anatomically or for other clinical reasons. And it's a pretty large group of patients.

我堅持 TR 不適合，我認為這確實表明了 M3 適合治療患者。我們知道 TR 是一項令人驚嘆的技術。很多患者都獲得了顯著療效。但是當您與醫生和患者交談時，您會發現許多患者由於解剖學或其他臨床原因，並不適合進行 TR。這是一個相當龐大的患者群。

There's ranges out there that we hear from many different doctors. I don't want to quote because it is pretty large ranges. And we think for that M3 really offers opportunities these patients to get a treatment or before they wouldn't have had one.

我們從許多不同的醫生那裡聽到了不同的意見。我不想引用，因為範圍相當大。我們認為 M3 確實為這些患者提供了接​​受治療的機會，否則他們以前將無法獲得治療。

But when we start off a new procedure and new therapy like we did with EVOQUE or like we did with any other therapy, we are going to start off by really focusing on physician training, having a great team of Edwards people supporting each case, ensuring top-notch clinical outcomes and building up a new therapy in a way that this will hopefully become a new leg to the stool of TMTT growth in the years in the future and provides multiple years of growth to get to, as Bernard said, that $2 billion of revenue in 2030.

但是，當我們開始一項新程序和新療法時，就像我們對 EVOQUE 或任何其他療法所做的那樣，我們首先會真正關注醫生培訓，讓一支優秀的 Edwards 團隊支持每個病例，確保一流的臨床結果並建立一種新療法，希望這將成為未來幾年 TMTT 增長的新支柱，並提供多年的增長，正如 Bernard 所說的那樣，在 2030 億美元的收入。

Joanne, did you have a follow-up? Or are you good?

喬安妮，你有後續消息嗎？或者說你很好？

No, I'm good. That was awesome. Thank you so much. Have a great night.

不，我很好。那太棒了。太感謝了。祝你有個美好的夜晚。

Thank you, Joanne. I'll turn it over to Bernard for some closing comments.

謝謝你，喬安妮。我將把這個發言權交給伯納德，請他發表一些結束語。

Yeah. No. Thank you. Maybe some closing comments very quickly. First is, we are very pleased about our strong finish to 2024 with total company sales growth of 9%. We are confident in our 2025. We are positioned for strong financial performance led by diversified source of growth, TAVR, mitral and tricuspid. And beyond 2025, we see an exciting future, we tackle large growing markets, and all of this will result in sustainable revenue, EPS growth and shareholder value creation.

是的。不。謝謝。也許很快就會有一些結束語。首先，我們對 2024 年公司總銷售額成長 9% 的強勁表​​現感到非常高興。我們對2025充滿信心。我們預計透過多元化的成長源、TAVR、二尖​​瓣和三尖瓣實現強勁的財務業績。2025 年以後，我們看到了令人興奮的未來，我們將應對龐大的成長型市場，所有這些都將帶來可持續的收入、每股盈餘成長和股東價值創造。

So thank you for your continued interest in Edwards. Scott, Mark, Daveen, and I welcome any additional questions by telephone. Thank you, everyone. Have a good afternoon.

感謝您對 Edwards 的持續關注。史考特、馬克、戴文和我歡迎您透過電話提出任何其他問題。謝謝大家。祝您下午愉快。

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

謝謝。今天的電話會議到此結束。現在您可以斷開您的線路。感謝您的參與。