使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Greetings and welcome to the Edwards Lifesciences first-quarter 2026 results. (Operator Instructions) As a reminder, this conference is being recorded.
各位好,歡迎參加愛德華生命科學(Edwards Lifesciences)2026 年第一季財報說明會。(接線員指示) 提醒各位,本次會議將被錄音。
It is now my pleasure to introduce Gerianne Sarte, Senior Vice President, Investor Relations. Thank you. You may begin.
現在我很榮幸介紹投資人關係資深副總裁 Gerianne Sarte。謝謝。您可以開始了。
Gerianne Sarte - Senior Vice President, Investor Relations
Gerianne Sarte - Senior Vice President, Investor Relations
Good afternoon, and thank you for joining us. With me on today's call is our CEO, Bernard Zovighian; and our CFO, Scott Ullem. Also joining us for the Q&A portion of the call will be Dan Lippis, our Global Leader of TAVR; and Daveen Chopra, who has global responsibility for TMTT, Surgical, and IHFM.
各位下午好,感謝各位加入我們。今天與我一同參與電話會議的有我們的執行長 Bernard Zovighian,以及財務長 Scott Ullem。另外,在問答環節也將加入 Dan Lippis(我們的 TAVR 全球負責人)以及 Daveen Chopra(負責 TMTT、外科手術與 IHFM 的全球業務)。
After the close of regular trading, Edwards Lifesciences released first-quarter 2026 financial results. During today's call, management will discuss the results included in the press release and accompanying financial schedules and then use the remaining time for Q&A.
在正常交易時段收盤後,愛德華生命科學發布了 2026 年第一季財務結果。在今天的電話會議中,管理團隊將討論新聞稿及隨附財務附表中的結果,並在剩餘時間進行問答。
Please note that management will be making forward-looking statements that are based on estimates, assumptions, and projections. These statements speak only as of the date on which they are made, and Edwards does not undertake any obligation to update them after today.
請注意,管理團隊將發表以前瞻性陳述為主的內容,這些陳述係基於估計、假設與預測。這些陳述僅截至其作成之日有效,Edwards 不承擔於今日之後更新之任何義務。
Additionally, the statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause these differences can be found in today's press release and Edwards' other SEC filings, all of which are available on the company's website at edwards.com.
此外,這些陳述涉及風險與不確定性,可能導致實際結果與前瞻性陳述所明示或暗示者存在重大差異。可能造成差異的因素可見於今日新聞稿及 Edwards 其他向美國證券交易委員會(SEC)提交的文件,皆可於公司網站 edwards.com 查閱。
Unless otherwise noted, our commentary on sales growth refers to underlying sales growth, which is defined in the financial results press release issued earlier today. Reconciliations between GAAP and non-GAAP numbers mentioned during this call are also included in today's press release. Quarterly and full-year growth rates refer to continuing operations.
除非另有說明,我們對銷售成長的評論係指「基礎銷售成長」(underlying sales growth),其定義載於今日稍早發布的財務結果新聞稿。本次電話會議中提及之 GAAP 與非 GAAP 數字之調節表亦包含於今日新聞稿。季度與全年成長率係指持續營運(continuing operations)。
With that, I'll turn the call over to Bernard for his comments.
接下來我將把電話交給 Bernard 發表評論。
Bernard Zovighian - Chief Executive Officer, Director
Bernard Zovighian - Chief Executive Officer, Director
Thank you, Gerianne, and welcome, everyone. Building on a year in 2025 marked by solid financial performance and strategic progress, we delivered another strong quarter in Q1, achieving 12.7% sales growth, which reflects the impact and durability of our differentiated strategy.
謝謝你,Gerianne,也歡迎各位。在 2025 年穩健的財務表現與策略進展基礎上,我們在第一季再交出強勁成績,實現 12.7% 的銷售成長,反映出我們差異化策略的影響力與持久性。
Our focus on structural heart disease solves large, urgent, and complex patient needs. It allows us to pursue unique opportunities to innovate and lead. None of this will be possible without the exceptional talent of our employees who bring our culture to life each day through their dedication to patients.
我們聚焦於結構性心臟病,致力於解決龐大、迫切且複雜的病患需求。這使我們得以追求獨特的創新與領導機會。若沒有員工的卓越才華,這一切都不可能實現;他們每天以對病患的投入,讓我們的企業文化得以落實。
We've built a workplace where our 16,000 employees around the world can stay and grow with us. I want to thank each of them for being aligned to our vision, inspired in their work, and committed for the long term, which is essential to our continued impact for patients.
我們打造了一個工作環境,讓全球 16,000 名員工能與我們一同長期投入並持續成長。我要感謝每一位同仁與我們的願景一致、在工作中受到啟發並長期承諾,這對我們持續為病患帶來影響至關重要。
Our strategy is underpinned by speed, agility, and disciplined execution, which enables our differentiated sustainable growth. Developing safe and effective valve therapies requires unwavering focus, deep expertise, and the generation of world-class evidence capabilities that distinguish Edwards as a trusted partner. While it takes time to pioneer new therapeutic areas and change the practice of medicine, our innovative therapies have transformed care for many patients and positioned Edwards to continue to lead for many years to come.
我們的策略以速度、敏捷與紀律化執行為基礎,進而支撐我們具差異化且可持續的成長。開發安全且有效的瓣膜治療需要堅定不移的專注、深厚的專業,以及產出世界級證據的能力,這些能力使 Edwards 成為值得信賴的合作夥伴。雖然開創新的治療領域並改變醫療實務需要時間,但我們的創新療法已改變許多病患的照護方式,並使 Edwards 得以在未來多年持續領先。
Looking forward, we are reinforcing our foundation with multiple strategic investments focused on clinical evidence generation, technology advancements, indication expansions, and resources to support patient care. We continue to pursue additional meaningful growth opportunities in each therapeutic category that will have a positive impact on our performance in 2027 and beyond.
展望未來,我們正透過多項策略性投資來強化基礎,重點包括臨床證據產出、技術進步、適應症擴展,以及支援病患照護的資源。我們也持續在各治療類別中追求更多具意義的成長機會,並將在 2027 年及之後對我們的表現帶來正面影響。
In TAVR, there is a renewed focus on the therapy across the healthcare ecosystem. This has been reinforced by definitive 7-year PARTNER 3 and 10-year PARTNER II data, which validate the durability and consistent performance of SAPIEN. Our platform is distinguished by high-quality, long-term evidence grounded in decades of scientific rigor.
在 TAVR 方面,整個醫療照護生態系統對此療法的關注再度升溫。這一點也因具決定性的 7 年期 PARTNER 3 與 10 年期 PARTNER II 數據而更加鞏固,驗證了 SAPIEN 的耐久性與一致的表現。我們的平台以高品質、長期的證據為特色,建立在數十年嚴謹科學研究的基礎之上。
In addition, the practice-changing early TAVR trial results are resonating with the clinical community, validating the movement away from the outdated practice of watchful waiting, and further highlighting the importance of intentional referral and treatment earlier in the disease pathway for severe aortic stenosis. Together, our SAPIEN innovation and evidence have once again elevated the standard for current and future TAVR valve performance, durability, and lifetime management of patient with aortic stenosis.
此外,改變臨床實務的早期 TAVR 試驗結果正引起臨床社群共鳴,驗證了從過時的「觀察等待」(watchful waiting)做法轉向,並進一步凸顯在重度主動脈瓣狹窄的疾病路徑中,更早進行有意識的轉介與治療的重要性。綜合而言,我們的 SAPIEN 創新與證據再次提升了現有與未來 TAVR 瓣膜在性能、耐久性,以及主動脈瓣狹窄病患全生命週期管理方面的標準。
In TMTT, our many years of patient-focused commitment, pioneering development, and strategic investments have resulted in a unique comprehensive portfolio of therapies that enables physicians to offer options to the clinically diverse population of patients suffering from mitral and tricuspid diseases.
在 TMTT 方面,我們多年以病患為中心的承諾、開創性的研發,以及策略性投資,已形成獨特且完整的治療產品組合,使醫師能為罹患二尖瓣與三尖瓣疾病、臨床表現多樣的病患族群提供多元選擇。
With a complementary portfolio of repair and replacement technologies across both valves, we have expanded the population of patients who can benefit from these technologies. We remain deeply committed to ongoing innovation and the generation of high-quality clinical evidence to reach even more people affected by these diseases.
透過涵蓋兩個瓣膜、兼具修復與置換技術的互補產品組合,我們擴大了可受益於這些技術的病患族群。我們仍將深度投入持續創新與高品質臨床證據的產出,以觸及更多受這些疾病影響的人。
In Surgical, we continue to expand our portfolio to address the needs of the many structural heart patients best treated surgically. Our portfolio of resilient tissue technologies including INSPIRIS, KONECT, and MITRIS is backed by years of durability data and continue to support enhanced patient care globally.
在外科手術(Surgical)方面,我們持續擴充產品組合,以滿足眾多最適合以手術治療的結構性心臟病患需求。我們的耐久組織技術產品組合(包括 INSPIRIS、KONECT 與 MITRIS)有多年耐久性數據支持,並持續在全球範圍內促進更佳的病患照護。
The success of our structural heart strategy is evidenced by the significant opportunities across surgical, TAVR, mitral, and tricuspid, and we are in a unique position to advance new technologies, next generation of existing technologies, and to expand indication to benefit even more patients.
我們結構性心臟策略的成功,體現在外科手術、TAVR、二尖瓣與三尖瓣等領域的重大機會;我們也處於獨特位置,能推進新技術、既有技術的下一代產品,並擴大適應症以造福更多病患。
In addition, we are executing our proven innovation strategy to expand into structural heart failure and aortic regurgitation, which represents significant longer-term growth opportunities. We remain steadfast in our commitment to address patients in need by advancing novel therapies to extend lives, improve quality of life, and provide greater impact and efficiency for health systems.
此外,我們正執行已驗證的創新策略,擴展至結構性心衰竭與主動脈瓣逆流領域,這代表顯著的長期成長機會。我們將持續堅定承諾,透過推進創新療法來回應有需求的病患,延長壽命、提升生活品質,並為醫療體系帶來更大的影響力與效率。
Turning to our financial performance. Edwards continues to be well-positioned to invest in innovation while also generating attractive financial results. In 2027 and beyond, we believe our strategy will enable average annual sales growth of approximately 10% as well as operating margin expansion. We expect variability in sales growth rates over time based on the timing of catalysts. Our financial strength and strategic clarity give us confidence in the future.
接著談我們的財務表現。Edwards 仍具備良好條件在投資創新的同時,創造具吸引力的財務成果。我們相信在 2027 年及之後,我們的策略將使平均年度銷售成長約 10%,並帶動營業利益率擴張。我們預期銷售成長率會隨時間因催化劑出現的時點而有所波動。我們的財務實力與清晰的策略方向,使我們對未來充滿信心。
In the first quarter, we generated 12.7% sales growth and strong earnings performance for Edwards, both ahead of expectations, driven by broad-based growth across our product groups. Based on our first-quarter outperformance, we are raising our full-year 2026 sales growth guidance to 9% to 11% and adjusted EPS guidance to $2.95 to $3.05, which demonstrates solid earnings leverage.
第一季我們實現 12.7% 的銷售成長,並為 Edwards 帶來強勁的獲利表現,兩者皆優於預期,主要由各產品組別的廣泛成長所帶動。基於第一季優於預期的表現,我們上調 2026 全年銷售成長指引至 9% 至 11%,並將調整後 EPS 指引上調至 2.95 美元至 3.05 美元,展現穩健的獲利槓桿。
Now I will provide more detail about product group performance. TAVR first-quarter global sales of $1.2 billion increased 11% over the prior year. Globally, procedural growth benefited from a heightened clinical focus on proactive disease management of severe AS, along with long-term evidence, demonstrated the proven durability and valve performance of a SAPIEN platform.
接下來我將更詳細說明各產品組別的表現。TAVR 第一季全球銷售額為 12 億美元,較去年同期成長 11%。在全球範圍內,手術量成長受惠於臨床端對重度主動脈瓣狹窄(severe AS)採取更積極的疾病管理之關注提升,加上長期證據所展現的 SAPIEN 平台已被證明具備耐久性與瓣膜性能。
SAPIEN growth in the US was healthy, and it was even faster outside of the US. Edwards' global competitive position in the first quarter increased slightly year over year, mainly due to the exit of a competitor in Europe. Average selling prices were stable globally. Recent clinical trial results on long-term TAVR performance continue to support patient treatment with SAPIEN TAVR. We are encouraged by the broader momentum that the EARLY TAVR study data has generated across the clinical community for both symptomatic and asymptomatic patients.
SAPIEN 在美國的成長表現穩健,而在美國以外的成長更快。Edwards 在第一季的全球競爭地位較去年同期略有提升,主要因歐洲一名競爭對手退出市場。全球平均銷售價格維持穩定。近期關於 TAVR 長期表現的臨床試驗結果,持續支持以 SAPIEN TAVR 治療患者。我們對 EARLY TAVR 研究數據在臨床社群中所帶動的更廣泛動能感到鼓舞,涵蓋有症狀與無症狀患者。
There has been a shift towards proactive disease management with an increased focus on evaluation and intentional referral of patients with severe aortic stenosis earlier in the disease pathway. This evolution in patient management, combined with a large and growing body of long-term SAPIEN outcomes data, reinforces our confidence in the durable multiyear growth opportunity ahead.
疾病管理正轉向更積極的方式,更加聚焦於對重度主動脈瓣狹窄患者在疾病進程更早期進行評估並有意識地轉介。這種患者管理的演進,加上龐大且持續成長的 SAPIEN 長期結果數據,進一步強化我們對未來具耐久性的多年成長機會之信心。
Over our 70-year history of continuous valve innovation, we have devoted our deep knowledge, experience, and learning to the complex research and development, clinical studies, and manufacturing of surgical and transcatheter heart valves. Each innovation represent a unique challenge. We know the impact of these advanced technologies. and over time, we have seen multiple examples of other valve platforms showing variable performance, which is the reason why long-term clinical evidence from rigorous FDA trials must continue to guide therapy choice for patients.
在我們 70 年持續進行瓣膜創新的歷史中,我們將深厚的知識、經驗與學習投入於外科與經導管心臟瓣膜的複雜研發、臨床研究與製造。每一項創新都代表一項獨特的挑戰。我們了解這些先進技術的影響;而隨著時間推移,我們也看到其他多個瓣膜平台表現不一的例子,這也是為何來自嚴謹 FDA 試驗的長期臨床證據必須持續引導患者的治療選擇。
We are confident in our SAPIEN TAVR therapy with distinguished valve performance, proven long-term clinical evidence, including the 7-year PARTNER 3 data and 10-year PARTNER II data and an asymptomatic indication, all of which are meaningful differentiators. Later this year, we will also learn more about patients with moderate AS when the PROGRESS trial results are presented at the TCT conference.
我們對 SAPIEN TAVR 治療充滿信心,其具備卓越的瓣膜表現與經證實的長期臨床證據,包括 7 年 PARTNER 3 數據與 10 年 PARTNER II 數據,以及無症狀適應症,這些皆為重要的差異化優勢。今年稍晚,當 PROGRESS 試驗結果於 TCT 會議發表時,我們也將進一步了解中度 AS 患者的情況。
Let me now turn to some commentary on US TAVR. In Q1, procedure growth continued to benefit from the heightened clinical focus on proactive management of severe AS, as the clinical community continues to digest and incorporate new evidence into patient care. We believe Edwards' competitive position also benefited slightly year over year.
接下來我談談美國 TAVR 的一些看法。第一季手術量成長持續受惠於臨床界對重度 AS 積極管理的高度關注,因為臨床社群仍在消化並將新證據納入患者照護。我們認為 Edwards 的競爭地位也較去年同期略有受益。
We are also pleased that CMS is conducting the process to reconsider NCD for TAVR. This decision has the potential to improve timely access to life-saving TAVR therapy. The initial 30-day public comment period closed on January 14 of this year, and we look forward to the next steps in the process, including the release of a draft decision memo by June 15 of this year.
我們也很高興 CMS 正在進行重新審視 TAVR 的 NCD 流程。此決定有潛力改善患者及時取得可挽救生命的 TAVR 治療。今年 1 月 14 日已結束最初 30 天的公開意見徵詢期,我們期待流程的下一步,包括在今年 6 月 15 日前發布決策備忘錄草案。
In Europe, first-quarter results demonstrated continued strong commercial execution and sustained physician demand for the SAPIEN platform. The Q1 growth rate also benefited from the exit of a competitor in the prior year. Updated guidelines from the European Society of Cardiology and the European Association for Cardiothoracic Surgery are reshaping clinical discussion around proactive business management, reinforcing the role of TAVR for a broader patient population.
在歐洲,第一季結果展現持續強勁的商業執行力,以及醫師對 SAPIEN 平台的持續需求。第一季成長率也受惠於前一年一名競爭對手退出市場。歐洲心臟病學會與歐洲心胸外科協會更新的指引,正在重塑圍繞積極疾病管理的臨床討論,並強化 TAVR 對更廣泛患者族群的角色。
Outside of Europe, our sales growth was strong across multiple geographies, including Japan, driven by procedural growth and adoption of our SAPIEN 3 Ultra RESILIA platform.
在歐洲以外,我們在多個地區的銷售成長強勁,包括日本,主要由手術量成長以及 SAPIEN 3 Ultra RESILIA 平台的採用所帶動。
In summary for TAVR, based on our Q1 results, we are raising our full-year TAVR sales growth guidance to 7% to 9%. As we look ahead to '27 and beyond, we see compelling mid- to high-single-digit growth opportunities in TAVR, supported by our patient access strategy, expanding clinical evidence, and a differentiated innovation pipeline designed to meet the needs of millions of patients around the world that suffer from aortic stenosis. Together, this will have lasting impact on the continued expansion and success of a SAPIEN platform globally and support a durable, multiyear growth opportunity.
總結 TAVR,基於第一季結果,我們將全年 TAVR 銷售成長指引上調至 7% 至 9%。展望 2027 年及以後,我們看到 TAVR 具備具吸引力的中到高個位數成長機會,並由我們的患者可近性策略、擴增的臨床證據,以及具差異化的創新產品線所支撐;該產品線旨在滿足全球數百萬罹患主動脈瓣狹窄患者的需求。綜合而言,這將對 SAPIEN 平台在全球的持續擴張與成功帶來長期影響,並支持具耐久性的多年成長機會。
Now, let's turn to TMTT. Our unique portfolio of repair and replacement therapies to treat mitral and tricuspid diseases drove first-quarter sales of $173 million, an increase of approximately 42% year over year. We believe that mitral and tricuspid procedural growth globally was in the double digits.
現在讓我們談談 TMTT。我們用於治療二尖瓣與三尖瓣疾病的獨特修復與置換療法產品組合,帶動第一季銷售額達 1.73 億美元,較去年同期成長約 42%。我們認為全球二尖瓣與三尖瓣手術量成長達到雙位數。
In tricuspid, we have seen strong adoption of repair and replacement technologies globally. At the recent ACC scientific session, two-year TRISCEND II data we have presented demonstrated significantly lower all-cause mortality with EVOQUE versus medical treatment when accounting for patient crossover.
在三尖瓣領域,我們看到修復與置換技術在全球的採用強勁。在近期 ACC 科學年會上,我們發表的兩年期 TRISCEND II 數據顯示,在考量患者交叉治療後,EVOQUE 相較於藥物治療可顯著降低全因死亡率。
This new data demonstrated that the EVOQUE replacement system provides significant and sustained elimination of TR, improvements in health status and quality of life, and no added device-related risk. We are also increasing patient access to transcatheter tricuspid valve replacement and driving further adoption of EVOQUE by expanding into new centers. We believe the growing body of clinical evidence, including reductions in all-cause mortality and heart failure hospitalization, will support physicians' continued treatment of patients with tricuspid regurgitation.
這些新數據顯示,EVOQUE 置換系統可顯著且持續地消除 TR,改善健康狀態與生活品質,且不增加任何與裝置相關的風險。我們也正透過拓展至新的中心,提高患者取得經導管三尖瓣置換治療的可近性,並推動 EVOQUE 的進一步採用。我們相信不斷累積的臨床證據(包括全因死亡率與心衰竭住院率的降低)將支持醫師持續治療三尖瓣逆流患者。
Moving to PASCAL. Adoption continues to increase, driven by physician enthusiasm for its unique design and differentiated outcomes and underscored by the significant needs of these patients. Our progress on the PASCAL pipeline remains on track with the next-generation technology expected in Q4 for both mitral and tricuspid in the US and Europe.
接著談 PASCAL。在醫師對其獨特設計與差異化結果的熱忱帶動下,採用率持續提升,同時也凸顯這些患者的重大未滿足需求。我們在 PASCAL 產品線的進展仍按計畫推進,預期第四季在美國與歐洲推出用於二尖瓣與三尖瓣的下一代技術。
We also continue to expect the launch of PASCAL in the US for tricuspid patients in Q4 of this year, which will expand the population of patients that can benefit from this impactful technology. The recent FDA approval of SAPIEN M3 expands our mitral portfolio in the US. Our commercial experience, while early, validates the need for this mitral replacement solution for patients who are not well suited for mitral TEER. Physicians' feedback on patient outcomes and procedural experience with SAPIEN M3 has been positive.
我們也仍預期今年第四季在美國推出用於三尖瓣患者的 PASCAL,這將擴大可受惠於此具影響力技術的患者族群。近期 FDA 核准 SAPIEN M3,擴充了我們在美國的二尖瓣產品組合。我們的商業化經驗雖仍在早期,但已驗證此二尖瓣置換解決方案對於不適合二尖瓣 TEER 的患者之需求。醫師對 SAPIEN M3 的患者結果與手術操作體驗回饋正面。
In summary, for TMTT, strong and increasing utilization of our differentiated therapies, EVOQUE, PASCAL, and SAPIEN M3, combined with double-digit mitral and tricuspid procedure volumes globally, positions Edwards for continued growth. Our portfolio of repair and replacement therapies is allowing physicians to select the best possible technical solution for their patients to get the optimal clinical outcome. This, combined with an expanding body of high-quality clinical evidence, expansion into new indications, and the advancement of next-generation technologies, support our path towards $2 billion of revenue in 2030 and additional growth beyond.
總結而言,就 TMTT 而言,我們具差異化療法 EVOQUE、PASCAL 與 SAPIEN M3 的使用量強勁且持續提升,再加上全球二尖瓣與三尖瓣手術量的雙位數成長,使 Edwards 具備持續成長的有利定位。我們的修復與置換療法產品組合,讓醫師能為其患者選擇最佳可行的技術解決方案,以取得最佳臨床結果。再加上高品質臨床證據的持續擴增、適應症的拓展,以及下一代技術的推進,支持我們朝 2030 年達成 20 億美元營收並在此之後持續成長的路徑。
In 2026, we remain on track to achieve $740 million to $780 million in sales in TMTT, representing 35% to 45% growth. In Surgical, first-quarter global sales of $276 million increased 6% over the prior year, driven by continued adoption of our RESILIA therapies that offer extended durability.
在 2026 年,我們仍按計畫在 TMTT 達成 7.40 億至 7.80 億美元的銷售額,代表 35% 至 45% 的成長。在外科(Surgical)方面,第一季全球銷售額為 2.76 億美元,較去年成長 6%,主要由我們提供更長耐久性的 RESILIA 療法持續被採用所帶動。
INSPIRIS adoption continues to increase globally. KONECT, which facilitates Bentall procedures for patients in need, recently launched in Europe with strong adoption. With the launch of MITRIS in additional markets around the world, we have seen strong uptake of this technology in surgical mitral valve replacement procedures.
INSPIRIS 的採用在全球持續增加。KONECT 可協助有需求的患者進行 Bentall 手術,近期已在歐洲上市並獲得強勁採用。隨著 MITRIS 在全球更多市場推出,我們看到該技術在外科二尖瓣置換手術中的採用表現強勁。
The 10-year data from our COMMENCE trial studied long-term durability of our best-in-class RESILIA tissue will be presented at the upcoming AATS conference. We continue to expect that our surgical tricuspid valve, TRIFORMIS, will launch in the second half of the year. Our surgical left atrial appendage closure program is on track for preliminary introduction later this year.
我們 COMMENCE 試驗的 10 年期數據,研究我們同級最佳的 RESILIA 組織之長期耐久性,將於即將舉行的 AATS 會議上發表。我們仍預期外科三尖瓣產品 TRIFORMIS 將於今年下半年上市。我們的外科左心耳封堵計畫進展順利,預計今年稍晚進行初步導入。
In summary, we continue to expect mid-single-digit sales growth in Surgical in 2026.
總結而言,我們仍預期 2026 年外科(Surgical)業務銷售將呈現中個位數成長。
And now, Scott will cover the details of the company's financial performance.
接下來,Scott 將說明公司財務表現的細節。
Scott Ullem - Chief Financial Officer, Corporate Vice President
Scott Ullem - Chief Financial Officer, Corporate Vice President
Thanks, Bernard. Our better-than-expected Q1 sales performance reflected strength across all product groups and regions. Total sales of $1.65 billion grew 12.7% year over year. We are raising our full year total company sales guidance to 9% to 11%, up from 8% to 10%, and our TAVR sales guidance to 7% to 9%, up from 6% to 8%, driven by strong Q1 results. Edwards now expects total company sales of $6.5 billion to $6.9 billion and TAVR sales of $4.7 billion to $5.0 billion at current exchange rates.
謝謝你,Bernard。我們第一季(Q1)銷售表現優於預期,反映出所有產品群與各地區的強勁動能。總銷售額 16.5 億美元,年增 12.7%。受強勁的 Q1 結果帶動,我們將全年公司總銷售指引上調至 9% 至 11%(原為 8% 至 10%),並將 TAVR 銷售指引上調至 7% 至 9%(原為 6% 至 8%)。以目前匯率計,Edwards 現預期公司全年總銷售為 65 億至 69 億美元,TAVR 銷售為 47 億至 50 億美元。
As a reminder, the first quarter of 2025 was a lower growth rate quarter, and our results in 2025 set a higher bar for 2026, especially in the second half. We continue to expect $740 million to $780 million in TMTT sales and mid-single-digit sales growth in Surgical in 2026. We are also updating our full-year earnings per share guidance to be between $2.95 and $3.05 per share as a result of our first-quarter results.
提醒一下,2025 年第一季屬於較低成長率的一季,而我們 2025 年的表現也為 2026 年設定了更高的比較基期,尤其是在下半年。我們仍預期 2026 年 TMTT 銷售為 7.4 億至 7.8 億美元,且外科(Surgical)業務銷售為中個位數成長。此外,基於第一季表現,我們也將全年每股盈餘指引更新為每股 2.95 至 3.05 美元。
And now, I'll cover additional details of our Q1 results, starting with earnings per share. Adjusted EPS of $0.78 in the quarter benefited from solid operational performance and planned phasing of strategic investments during the course of this year. Our GAAP EPS for the quarter was $0.66. A full reconciliation between our GAAP and non-GAAP measures, including adjusted EPS and other items, is included with today's release.
接下來我將補充 Q1 結果的更多細節,先從每股盈餘開始。本季調整後 EPS 為 0.78 美元,受惠於穩健的營運表現,以及今年內策略性投資的既定投入節奏(phasing)。本季 GAAP EPS 為 0.66 美元。GAAP 與非 GAAP 指標(包含調整後 EPS 與其他項目)之完整調節表已隨今日新聞稿一併提供。
For the first quarter, our adjusted gross profit margin was 78.2% compared to 78.7% in the same period last year. This year-over-year change was driven by a weakening dollar as well as additional manufacturing expenses related to the expansion of new therapies. We are maintaining our full-year 78% to 79% gross margin guidance.
第一季調整後毛利率為 78.2%,去年同期為 78.7%。此年對年變動主要受美元走弱,以及擴展新療法所帶來的額外製造費用影響。我們維持全年毛利率指引為 78% 至 79%。
Selling, general, and administrative expense in the quarter was $522 million or 31.7% of sales compared to $466 million in the prior year. This was in line with our expectations and reflects continued funding of resources we provide to support patient care as well as a higher translation of our OUS expense base from the weakening dollar.
本季銷售、一般及行政費用(SG&A)為 5.22 億美元,占銷售額 31.7%,去年同期為 4.66 億美元。此結果符合我們預期,反映我們持續投入資源以支援病患照護,以及因美元走弱導致我們海外(OUS)費用基礎換算後金額提高。
Research and development expense was $263 million in the first quarter or 16% of sales compared to $255 million or 18% of sales in the same period last year. This decrease in research and development as a percentage of sales and the increase in total expense reflects our strong top-line growth as well as strategic prioritization of investments in our expanding structural heart portfolio. We continue to expect 2026 R&D as a percentage of sales to be approximately 17%.
第一季研發費用為 2.63 億美元,占銷售額 16%,去年同期為 2.55 億美元,占銷售額 18%。研發費用占比下降、但總費用增加,反映我們營收端的強勁成長,以及在擴大的結構性心臟產品組合中對投資進行策略性優先排序。我們仍預期 2026 年研發費用占銷售額約為 17%。
First-quarter adjusted operating profit margin was 31.4%. Our margin benefited from the better-than-expected top-line performance as well as planned phasing of strategic investments during the course of the year. We expect full-year operating margin to be at the high end of the original 28% to 29% guidance, resulting in approximately 150 basis points constant currency operating margin expansion for the full year.
第一季調整後營業利益率為 31.4%。我們的利潤率受惠於優於預期的營收表現,以及全年策略性投資的既定投入節奏。我們預期全年營業利益率將落在原先 28% 至 29% 指引區間的高端,全年將帶來約 150 個基點的固定匯率(constant currency)營業利益率擴張。
In 2027 and beyond, we continue to plan for 50 to 100 basis points of underlying operating margin expansion.
在 2027 年及之後,我們仍規劃每年有 50 至 100 個基點的基礎營業利益率擴張。
We continue to expect our 2026 tax rate, excluding special items, to be between 16% and 19%. The midpoint of this guidance assumes adoption of a side-by-side safe harbor taxation model alongside Pillar Two while the higher end accommodates the event that this legislation does not come into effect before the end of this year.
我們仍預期 2026 年稅率(不含特殊項目)介於 16% 至 19%。此指引中位數假設在「第二支柱」(Pillar Two)架構下採用並行的安全港課稅模式(side-by-side safe harbor taxation model);而較高端則納入若該立法在今年底前未生效的情境。
Foreign exchange rate changes in the first quarter increased reported sales by approximately $15 million versus guidance we provided originally for Q1. On a constant currency basis, sales in the first quarter were near the top end of our guidance range. Year-over-year reported sales growth benefited $49 million or 400 basis points from foreign exchange.
第一季匯率變動使得報告口徑銷售額較我們原先提供的 Q1 指引增加約 1,500 萬美元。以固定匯率計,第一季銷售接近我們指引區間的上緣。年對年報告口徑銷售成長亦受惠於匯率帶來的 4,900 萬美元(或 400 個基點)貢獻。
FX reduced our first-quarter gross profit margin by 30 basis points compared to the prior year. At current rates, we now expect foreign exchange to have an approximately $55 million upside to full-year 2026 sales compared to the prior year, and the majority of this benefit already occurred in the first quarter.
相較去年同期,匯率使第一季毛利率下降 30 個基點。以目前匯率計,我們現在預期匯率將使 2026 年全年銷售相較去年增加約 5,500 萬美元,而其中大部分效益已在第一季實現。
Turning to the balance sheet. We continue to maintain a strong and flexible balance sheet with approximately $2.4 billion in cash and cash equivalents as of the end of the first quarter.
接著談資產負債表。截至第一季末,我們仍維持強健且具彈性的資產負債表,現金及約當現金約 24 億美元。
During the first quarter, the company entered into an accelerated share repurchase agreement to buy back $500 million in shares. Edwards has approximately $1.5 billion remaining under our share repurchase authorization. Average diluted shares outstanding during the quarter were 581 million. We now expect average diluted shares outstanding for 2026 to be between 575 million and 580 million.
第一季期間,公司簽訂加速庫藏股回購協議(accelerated share repurchase agreement),回購 5 億美元股票。Edwards 在股票回購授權額度下尚餘約 15 億美元。本季平均稀釋流通股數為 5.81 億股。我們目前預期 2026 年平均稀釋流通股數介於 5.75 億至 5.80 億股。
For the second quarter, we're projecting sales of $1.66 billion to $1.74 billion, and we are expecting adjusted earnings per share in Q2 of $0.70 to $0.76.
針對第二季,我們預估銷售額為 16.6 億至 17.4 億美元,並預期 Q2 調整後每股盈餘為 0.70 至 0.76 美元。
And with that, I'll pass it back to Bernard.
接下來我把時間交還給 Bernard。
Bernard Zovighian - Chief Executive Officer, Director
Bernard Zovighian - Chief Executive Officer, Director
Thank you, Scott. In summary, our Q1 performance demonstrated the strength of our focused structural heart strategy as well as the impact of our ongoing investments in large opportunities that will continue to support long-term sustainable growth and distinguished value creation.
謝謝你,Scott。總結而言,我們 Q1 的表現展現了我們聚焦的結構性心臟策略之實力,也顯示我們持續投資於重大機會所帶來的影響,這些投資將持續支撐長期且可持續的成長,以及卓越的價值創造。
Before we move to Q&A, I'd like to share that we will be hosting our annual investor conference on Friday, December 4, at the New York Stock Exchange. Additional details will follow as the event gets closer, but we hope you will mark your calendars to join us in New York City as we discuss our patient-focused innovation strategy and the opportunities ahead.
在進入問答之前,我想分享我們將於 12 月 4 日(週五)在紐約證券交易所舉辦年度投資人會議。隨著活動日期接近,我們將提供更多細節;也希望各位預留時間,與我們一同在紐約市討論以病患為中心的創新策略及未來機會。
With that, I will turn it back over to Gerianne to facilitate Q&A.
接下來我把時間交給 Gerianne 來主持問答。
Gerianne Sarte - Senior Vice President, Investor Relations
Gerianne Sarte - Senior Vice President, Investor Relations
Thank you, Bernard. We're ready to take your questions. (Event Instructions)
謝謝你,Bernard。我們準備開始回答各位的問題。(活動說明)
Operator
Operator
(Operator Instructions) David Roman, Goldman Sachs.
(接線員說明)David Roman,Goldman Sachs。
David Roman - Analyst
David Roman - Analyst
Hi. Good afternoon, everyone. I appreciate your taking the questions. Maybe I could just start with TAVR. There was a lot going on during the quarter with respect to industry data around longer-term performance of one of your competitor products. You talked about the increased focus on lifetime management on the last call and at last year's analyst meeting. Can you maybe just help us think through some of the drivers here from some of these data? Are you seeing a class effect on TAVR? Is this questioning device selection for lifetime management? Is this a balloon versus self-expandable valve dynamic? Just help us think through some of the different moving parts here, and what operational considerations are reflected in your guidance.
嗨。各位下午好。感謝你們接受提問。我想也許先從 TAVR 談起。本季業界有不少動態,涉及某家競品在較長期表現方面的產業數據。你們在上次電話會議以及去年分析師會議上談到對「終身管理」(lifetime management)的關注提升。能否請你們協助我們梳理一下,從這些數據來看,背後的一些驅動因素是什麼?你們是否看到 TAVR 存在「類別效應」(class effect)?這是否會引發對於終身管理下器械選擇的質疑?這是否是球囊擴張式與自膨式瓣膜之間的動態差異?請協助我們理解這裡不同變動因素,以及你們指引中反映了哪些營運層面的考量。
Bernard Zovighian - Chief Executive Officer, Director
Bernard Zovighian - Chief Executive Officer, Director
Thank you, David. This is a very comprehensive question here. So let me try with first some big picture comments here.
謝謝你,David。這是一個非常全面的問題。所以我先從一些宏觀層面的評論開始。
I believe we should look at the TAVR category way beyond what happened in the quarter. If you look at what happened in the last, let's say, months, years, what we have done as a company, we produced a ton of data, high-quality data, all of them being highly positive.
我認為我們應該從遠超過單一季度發生了什麼的角度來看待 TAVR 這個類別。如果你回顧過去幾個月、幾年我們公司所做的事情,我們產出了大量高品質的數據,而且幾乎都是非常正面的。
So think about EARLY TAVR for asymptomatic patients. Think about the 7-year data with PARTNER 3. You have a 10-year data PARTNER II. So all of this together and obviously, additional data from a competitor -- but it is not just one thing.
所以想想看針對無症狀患者的 EARLY TAVR。想想 PARTNER 3 的 7 年數據。你還有 PARTNER II 的 10 年數據。把這些全部放在一起,當然也包括競爭對手的額外數據——但這不是單一因素所致。
I believe as a company, what we have produced is pretty amazing. This gave you confidence that SAPIEN has distinguished valve performance, benchmark durability. And your physician, we are confident already, but this gave extra confidence.
我認為以公司而言,我們所產出的成果相當令人驚豔。這讓你對 SAPIEN 具備卓越的瓣膜表現與標竿級耐久性更有信心。而臨床醫師本來就有信心,但這又增添了額外的信心。
And everybody knew that you have a timeframe for valve vulnerability when the valves are failing. It is usually around four or five or six years. So everybody also was obviously clearly looking at PARTNER 3 7 years and 10 years. And to see this kind of data, this gave you the confidence for this renewed focus in TAVR as a category and also is explaining the fact that last year, because of the second part of the year, we had a great result in TAVR. And in Q1, we continue to get a great result in TAVR.
而且大家都知道,瓣膜在失效時會有一個相對脆弱的時間窗。通常大約在四年、五年或六年左右。所以大家也很明顯地在關注 PARTNER 3 的 7 年與 10 年數據。看到這樣的數據,讓你對 TAVR 作為一個類別的重新聚焦更有信心,也解釋了為什麼去年在下半年我們的 TAVR 表現非常好。而在第一季,我們也持續在 TAVR 取得很好的成果。
But maybe I'm going to ask Daniel to add a few comments about this. Dan?
不過也許我會請 Daniel 補充幾點看法。Dan?
Daniel Lippis - Corporate Vice President - TAVR
Daniel Lippis - Corporate Vice President - TAVR
Yeah, thanks, David. Like again, great quarter. Pleased with the results. Encouraged to see the momentum that was built in the back half of 2025 continue into '26, and that contributes a lot, right? Independent of what's going on with our competitors, we expected a good quarter. All the things that Bernard said.
好的,謝謝你,David。再說一次,這是一個很棒的季度。我們對結果感到滿意。也很鼓舞人心地看到 2025 年下半年建立起來的動能延續到 2026 年,而這貢獻很大,對吧?不論競爭對手那邊發生什麼,我們原本就預期會有一個不錯的季度。以及 Bernard 所說的所有那些因素。
It's always nice when it's a little better than expected, and that's the case here in Q1. And that certainly gives us a little extra confidence, and that's reflected in our new guidance.
當結果比預期再好一點時,總是令人高興,而第一季就是如此。這確實讓我們多了一些信心,也反映在我們新的財測指引中。
But I think it's also important just to like -- the competitive data that was dropped, it happened like mid/late February, and so it's really difficult to parse out exactly what is contributing to what at this time. And it was partial data as well.
但我也認為很重要的一點是——競爭性的數據是在二月中下旬發布的,所以在這個時間點要精準拆解到底各自貢獻了什麼,其實很困難。而且那也只是部分數據。
And so we still have to -- and the clinical community still have to understand the full dataset, including all the echo follow-up on patients, et cetera. So I think it's a little early to sort of like get into the details and trying to understand exactly how much of that is contributing. But for sure, the totality of data that has been in play and being presented the clinical community over the last 12 months is contributing. All leading towards patients benefit when treated earlier in the disease pathway with TAVR.
因此我們仍然需要——臨床社群也仍然需要——去理解完整的資料集,包括所有患者的超音波追蹤等。所以我認為現在就深入細節、試圖精確判斷那部分到底貢獻了多少,還稍嫌太早。但可以確定的是,過去 12 個月在臨床社群中持續被討論與發表的整體數據,確實正在發揮作用。而這些都指向同一個結論:在疾病路徑更早期以 TAVR 治療,患者會受益。
Hopefully, that answers your question a little bit.
希望這多少回答了你的問題。
David Roman - Analyst
David Roman - Analyst
That's helpful. I'll be quick on my follow-up here. Just on TMTT, I think if you look at the sequential dollar growth here, Q4 to Q1, one of the more significant step-ups that you've seen just on a dollar basis. Are you -- is this -- what are you seeing just sort of a share gain perspective and then also any early perspective on how M3 might be impacting the business?
這很有幫助。我很快問一下追問。就 TMTT 而言,我想如果你看這裡的季度環比金額成長,從第四季到第一季,以金額來看是你們看到過較顯著的一次跳升。你們——從市占提升的角度來看,你們看到了什麼?另外,對於 M3 可能如何影響業務,有沒有任何早期觀察?
Daveen Chopra - Corporate Vice President - Transcatheter Mitral and Tricuspid Therapies
Daveen Chopra - Corporate Vice President - Transcatheter Mitral and Tricuspid Therapies
Sure. David, this is Daveen. Thanks so much for the question. I think overall, in TMTT, obviously, we continue to be excited about TMTT. We're seeing that this comprehensive portfolio of repair and replacement is really enabling personalized therapy which helps get the best clinical results for patients.
當然。David,我是 Daveen。非常感謝你的提問。我想整體來說,在 TMTT 方面,很明顯我們仍然對 TMTT 感到非常振奮。我們看到這個涵蓋修復與置換的完整產品組合,確實能夠支持個人化治療,進而幫助患者獲得最佳的臨床結果。
So I think overall, as we look across the portfolio across the different platforms, as you said, maybe in PASCAL, we continue to see its products being differentiated, physicians are seeing that differentiating -- differentiation, and that's probably why they're choosing it.
所以整體而言,當我們檢視整個產品組合、不同平台時,正如你所說,例如在 PASCAL 上,我們持續看到其產品具備差異化,臨床醫師也看到了這種差異化——這大概就是他們選擇它的原因。
EVOQUE continues to scale up well. People are seeing, as we talked about, new data coming out, more all-cause mortality improvements of this therapy, which continue to drive its growth.
EVOQUE 也持續順利放量擴張。大家看到——如我們所談到的——新的數據陸續出爐,這項療法在全因死亡率方面有更多改善,持續推動其成長。
And SAPIEN M3 is the newest kid on the block, where we just launched this in the US at the end of the year, and we're starting to see a lot of physician excitement for this product because it's a product for patients where they didn't really have a great solution before. And I think for many of their patients, SAPIEN M3 is getting great clinical results and allowing them to have a great solution for their patients.
而 SAPIEN M3 是最新加入的產品,我們在去年年底剛在美國上市,現在開始看到許多醫師對這個產品感到非常興奮,因為它是針對過去其實沒有很好解決方案的患者所設計的產品。我認為對於他們的許多患者而言,SAPIEN M3 帶來了很好的臨床結果,讓他們能為患者提供一個很好的解決方案。
Operator
Operator
Larry Biegelsen, Wells Fargo.
Larry Biegelsen,富國銀行。
Lawrence Biegelsen - Analyst
Lawrence Biegelsen - Analyst
Good afternoon. Thanks for taking the question. Congrats on a really strong start to the year here. I guess I have to ask one follow-up question, Bernard, on David's question on the six- and seven-year data. It was obviously the big news in the quarter. So what are you -- he asked about the guidance. What are you assuming in the guidance from a share standpoint, from an impact from the low-risk data? If you took share because of that, would that be upside to the guidance you're providing today? And I had one follow-up.
下午好。謝謝讓我提問。恭喜你們今年開局非常強勁。我想我得針對 David 關於六年與七年數據的問題,向 Bernard 追問一題。那顯然是本季度最大的新聞。所以你們——他問的是指引。你們在今天提供的指引中,從市占角度、以及低風險數據帶來的影響角度,假設了什麼?如果你們因此拿到市占,那會不會成為你們今天所提供指引的上行空間?我還有一個追問。
Bernard Zovighian - Chief Executive Officer, Director
Bernard Zovighian - Chief Executive Officer, Director
Thank you, Larry. And thanks, yeah, we had a great quarter. It is always great to start the year strong, especially after having finished last year strong also. So to have this kind of a momentum in the business gives us a lot of confidence.
謝謝你,Larry。也謝謝,是的,我們這一季表現很好。一年能有強勁的開局總是很棒,尤其是在去年也以強勁表現收尾之後。因此,業務能有這樣的動能,讓我們非常有信心。
So if you step back, first, globally, for TAVR, the majority of our performance is coming from market growth. So this renewed focus, all of the data, we talk about Dan and I. So the majority is about your market growth globally and also with some share mainly from the exit of a competitor in Europe.
所以如果你先退一步看,首先在全球 TAVR 方面,我們表現的大部分來自市場成長。也就是這次重新聚焦、所有這些數據——Dan 和我都有提到。因此主要是全球市場成長,另外也有一些市占的貢獻,主要來自某個競爭對手退出歐洲市場。
So yes, we have seen a slight benefit also in the US from a share standpoint. But we try -- you know us very well. We try not to focus too much on share because share is a lagging indicator. Share is never driving a business. We, as a company, we bring data, we bring evidence, we bring best innovation to bring to physicians best tools, best solutions so they can take care of their patients. And therefore, everybody is benefiting. So that's the way we are thinking about it.
所以是的,從市占角度來看,我們在美國也看到了一點小幅受益。但我們會盡量——你們很了解我們——我們不會把焦點放太多在市占上,因為市占是落後指標。市占從來不是驅動業務的因素。我們作為一家公司,帶來數據、帶來證據、帶來最好的創新,為醫師提供最好的工具、最好的解決方案,讓他們能照顧好自己的患者。因此,每個人都能受益。這就是我們思考這件事的方式。
Now, everything that you have seen in the -- everything that we talk about is in the guidance today. And what we try to do with our guidance is to give you a realistic guidance based on what we know today.
現在,你所看到的一切——我們今天談到的所有內容——都已包含在我們今天的指引之中。而我們在指引上所努力做的,是根據我們目前所掌握的資訊,提供一個務實的指引。
So what you talk about happened in mid-February, and we gave you the best of what we know today. providing a realistic guidance is very important to us, Larry.
所以你提到的事情發生在2月中旬,而我們已提供了我們目前所知道的最佳資訊。提供務實的指引對我們來說非常重要,Larry。
Thank you for the question.
謝謝你的提問。
Lawrence Biegelsen - Analyst
Lawrence Biegelsen - Analyst
All right. Bernard, just for my follow-up. It's been a while since it's been since December since we heard about SAPIEN X4. Could you give us a little bit of an update? You talked about confirmatory clinical work. Where does that stand? Thanks for taking the question.
好的。Bernard,作為我的追問。距離我們上次聽到關於 SAPIEN X4 的消息已經有一段時間了,從12月以來。你能否給我們一點最新進展?你提到確認性臨床工作。目前進展到哪一步?謝謝你回答這個問題。
Bernard Zovighian - Chief Executive Officer, Director
Bernard Zovighian - Chief Executive Officer, Director
Thank you, Larry. So I'm going to ask Daniel. He is very close to this one to give you an update on this platform.
謝謝你,Larry。那我會請 Daniel 來回答。他對這個項目非常熟悉,會就這個平台給你更新。
Daniel Lippis - Corporate Vice President - TAVR
Daniel Lippis - Corporate Vice President - TAVR
Yeah, hi, Larry. Thanks for the question. Clearly, we're pretty excited about our TAVR pipeline in general, which includes X4.
是的,嗨,Larry。謝謝你的提問。很明顯,我們對整體 TAVR 產品線都相當興奮,其中也包括 X4。
X4 is a potential game changer for us, especially on the concept of personalized valve sizing. You know that we've set a very, very high bar with S3UR. That continues to differentiate, and we see that in the data that we're just talking about, not only our own data, but also relative to competitive data.
X4 對我們而言可能是改變遊戲規則的產品,特別是在個人化瓣膜尺寸選擇這個概念上。你也知道,我們在 S3UR 上設下了非常、非常高的標準。它仍持續形成差異化,我們也在剛才討論的數據中看到這點,不僅是我們自己的數據,也包括相較於競品的數據。
We talked about in December that when we put X4 in a clinic, we immediately started to see things that we would think like, hey, if we had the opportunity to enhance that product, we should take it, and we are. And that has to go into a confirmatory trial.
我們在12月提到,當我們把 X4 放到臨床使用時,我們立刻開始看到一些情況,讓我們覺得:嘿,如果有機會強化這個產品,我們就應該把握,而我們也正在這麼做。而這需要進入一項確認性試驗。
And so we're going to be collecting that evidence through 2026. And when we've completed that, we'll have more to say about the X4 product and the timelines and all those sorts of things. So that's exactly where we're at.
因此,我們將在2026年期間收集相關證據。等我們完成之後,我們會就 X4 產品、時程以及各種相關事項提供更多說明。所以目前就是這樣的進度。
Lawrence Biegelsen - Analyst
Lawrence Biegelsen - Analyst
Thank you.
謝謝。
Operator
Operator
Travis Steed, Bank of America.
Travis Steed,美國銀行。
Travis Steed - Analyst
Travis Steed - Analyst
Hey, congrats on a good quarter. Maybe ask about capacity. You've had more left atrial appendage closure procedures shifting towards EP. What are you seeing from a capacity standpoint for structural heart doctors when you're in the field? And are you seeing any kind of benefit on the numbers in the market?
嗨,恭喜本季表現不錯。我想問一下產能。你們看到更多左心耳封堵(LAA closure)手術轉向由電生理(EP)來做。你們在第一線看到結構性心臟醫師在產能方面的情況如何?以及你們是否在市場數據上看到任何好處?
Bernard Zovighian - Chief Executive Officer, Director
Bernard Zovighian - Chief Executive Officer, Director
Yeah. Travis, thanks for the question. Capacity has not been an acute matter in the last few quarters. What we have seen is health systems in the US have done a great job managing capacity. They look at their processes, they look at their staffing, they look about how to turn faster the room in between patients.
是的。Travis,謝謝你的提問。過去幾個季度,產能並不是一個急迫的問題。我們看到的是,美國的醫療體系在管理產能方面做得非常好。他們檢視流程、檢視人力配置,也檢視如何在病人之間更快地周轉手術室。
So we have been quite impressed by all what we have been doing. And obviously, we are there also to support them.
所以我們對他們所做的一切印象深刻。當然,我們也在那裡提供支持。
But maybe I can add, Daveen and Dan, to add some color here, if you have seen anything.
不過也許我可以請 Daveen 和 Dan 補充一些背景,如果你們有看到任何情況的話。
Daveen Chopra - Corporate Vice President - Transcatheter Mitral and Tricuspid Therapies
Daveen Chopra - Corporate Vice President - Transcatheter Mitral and Tricuspid Therapies
Yeah. This is Daveen. I'll just make one comment. I think the agility that you talked about, Bernard, is especially true as you start a new therapy like TMTT, right? When you start something like M3 or EVOQUE, you start taking up lab space.
好的。我是 Daveen。我只補充一點。我認為你提到的那種敏捷性(agility),在你開始一項新療法例如 TMTT 時尤其明顯,對吧?當你開始像 M3 或 EVOQUE 這樣的項目時,你會占用導管室(lab)的空間。
But what we've seen is, at least from our standpoint, is that as they put in new lab time, they've worked across the system to ensure that they're not taking away from a place like TAVR or something else from what we've seen. They've continued to be agile and figuring out, hey, how do we get an extra shift in? How do we get an extra lab running? How do we do other things like that. So that's been pretty consistent in what we've seen as centers get going in TMTT.
但至少從我們的角度來看,我們看到的是:當他們新增導管室時段時,他們會在整個體系內協調,確保不會從像 TAVR 或其他項目那邊挪走資源,這是我們所觀察到的。他們持續保持敏捷,思考例如:我們怎麼多開一個班次?我們怎麼多開一間導管室?我們怎麼做其他類似的事情。所以,當各中心開始推動 TMTT 時,我們看到的情況一直都相當一致。
Daniel Lippis - Corporate Vice President - TAVR
Daniel Lippis - Corporate Vice President - TAVR
And if I just add from my side, I think it's the right point. It's different from hospital to hospital.
如果我也從我的角度補充一下,我認為這點說得很對。不同醫院之間確實會有差異。
But from a TAVR perspective, I think what really helps is that it's clearly a priority procedure. And that's based on the evidence. And so there is that ability to navigate some of the acuteness of various hospital challenges.
但從 TAVR 的角度來看,我認為真正有幫助的是,這顯然是一項優先處置。而這是基於證據。因此,在面對各家醫院不同的急迫性挑戰時,確實有能力去調度與因應。
We're on the ground every day with the hospitals trying to understand what their specific issues are, if they have them and how, if anything, we can help, but it's something that we pay close attention to all the time.
我們每天都在第一線與醫院合作,試著了解他們是否有特定問題、問題是什麼,以及如果有任何我們能協助的地方該怎麼做;這也是我們一直非常密切關注的事情。
Travis Steed - Analyst
Travis Steed - Analyst
Helpful. And then maybe a follow-up on the NCD. There's a lot of stuff in the proposed NCD centers heart team. Just curious if you think it will all go through as proposed and how important are each of those things in the NCD proposal. And I had a lot of questions on is -- did US TAVR, was it high-single digits or double digits, if you'd answer that, too?
很有幫助。那再追問一下 NCD。在擬議的 NCD 中,關於中心與心臟團隊有很多內容。想請教你是否認為會如提案所述全部通過?以及在 NCD 提案中,各項內容的重要性如何?另外我也有很多問題是——美國 TAVR 本季成長是高個位數還是雙位數?如果你也能回答這個就太好了。
Bernard Zovighian - Chief Executive Officer, Director
Bernard Zovighian - Chief Executive Officer, Director
So it is very tough to predict what the final NCD will be. You know that we are very pleased. CMS opened over process. The first phase is over. So basically, now we are waiting for, I think, in mid-June to get what the draft NCD will be are positioned, I believe, is fact-based in the interest of a patient to make sure they have a fast access to care. But again, the decision we rely on CMS. That's on the NCD.
要預測最終的 NCD 會是什麼樣子確實非常困難。你知道我們非常高興。CMS 已啟動整個流程。第一階段已經結束。所以基本上,我們現在在等待,我想大約在6月中旬會看到 NCD 草案的內容。我相信,我們的立場是以事實為基礎、以病人利益為出發點,確保他們能快速獲得照護。但再次強調,最終決定取決於 CMS。以上是關於 NCD 的部分。
What's the second part of your question, Travis?
Travis,你問題的第二部分是什麼?
Travis Steed - Analyst
Travis Steed - Analyst
The US TAVR, was it high-single digits or double digits this quarter, and if you have tight rates between the two?
美國 TAVR 本季成長是高個位數還是雙位數?以及你是否能提供兩者之間更精確的成長率?
Bernard Zovighian - Chief Executive Officer, Director
Bernard Zovighian - Chief Executive Officer, Director
Yeah. We don't like to give this kind of specifics. So globally, TAVR grew 11%. What we said is that TAVR in the US was healthy and that the OUS TAVR grew even faster. So I'm sure you can do some math here.
是的。我們不太喜歡提供這類非常具體的數字。就全球而言,TAVR 成長了11%。我們所說的是,美國的 TAVR 表現健康,而美國以外(OUS)的 TAVR 成長更快。所以我相信你可以自己做一些數學推算。
Travis Steed - Analyst
Travis Steed - Analyst
Sure, thank you.
好的,謝謝。
Operator
Operator
Robbie Marcus, JPMorgan.
Robbie Marcus,摩根大通。
Robert Marcus - Analyst
Robert Marcus - Analyst
Great. Thanks for taking the questions, and congrats on a nice quarter. Maybe one on guidance. Really strong quarter here, beat on TAVR, TMTT across-the-board margins. Just wanted to ask sort of the philosophy and the rationale. You took TAVR up 1% for the year, had a big beat in TMTT and left that unchanged. I realize there's a pretty wide guide to start with. And then EPS beat by $0.05, and raised the low end by $0.05. Maybe just give us the rationale, and I realize it's still first quarter, so I imagine conservatism is a big chunk of it.
很好。謝謝讓我提問,也恭喜本季表現亮眼。我想問一個關於指引的問題。本季表現非常強勁,TAVR、TMTT 以及整體毛利率都超出預期。我想了解一下你們的思維與理由。你們把全年 TAVR 指引上調了1%,TMTT 大幅超預期但指引維持不變。我理解一開始的指引區間就相當寬。另外 EPS 超出0.05美元,並把區間下緣上調0.05美元。能否談談背後的理由?我也理解這仍是第一季,所以保守可能是很大一部分原因。
Bernard Zovighian - Chief Executive Officer, Director
Bernard Zovighian - Chief Executive Officer, Director
Thanks, Robbie. So I would say, let me maybe start with the philosophy here on the guidance. I want to be always transparency with you guys and with everyone here to provide a very realistic guidance based on what we do at the time we are providing the guidance. And this is what we are doing here by providing this range.
謝謝你,Robbie。所以我想,讓我先從這裡對指引的理念談起。我希望能一直對各位、以及在座所有人保持透明,並根據我們在提供指引當下所掌握的情況,給出非常務實的指引。而我們現在提供這個區間,就是在做這件事。
Now, if you look at Q1, yes, indeed, Q1 came on strong -- stronger than expected. And it is why we raised the guidance for the year for TAVR and for the company.
現在,如果你看第一季,是的,確實,第一季表現強勁——比預期更強。這也是為什麼我們上調了今年TAVR以及公司整體的全年指引。
Now, there are a couple of things that you need to be aware of is the comp. So if you look at Q1 in 2025, so last year, it was a little bit lower growth rate for us as a company and for TAVR. And so that's one.
現在,有幾件事你需要留意,其中之一是比較基期(comp)。如果你看2025年第一季,也就是去年,對我們公司以及TAVR而言,成長率稍微低一些。這是其一。
Two is we had a great year last year in 2025, especially in the second part of the year. So Q3 and Q4. So this is setting a higher bar for us in 2026 in Q3 and Q4. So we took all of that into consideration.
第二點是,我們在2025年去年有非常好的一年,特別是在下半年。也就是第三季和第四季。因此,這讓我們在2026年的第三季和第四季面臨更高的比較門檻。所以我們把這些都納入考量。
Q1 2025 being low, at 2025, H2 being high, a strong beat in Q1. And based on what we know today, that we give you the best guidance we can, being a realistic guidance. We feel confident about us delivering on this new guidance for TAVR and for the company.
2025年第一季偏低、2025年下半年偏高、以及第一季大幅超預期。基於我們今天所知道的資訊,我們提供我們所能給出的最佳指引,而且是務實的指引。我們對於能夠達成這次更新後的TAVR與公司整體指引感到有信心。
I hope it is helping you, Robbie.
希望這能對你有幫助,Robbie。
Robert Marcus - Analyst
Robert Marcus - Analyst
Great. Maybe just one follow-up. And I realize this is a follow-on to a follow-on. But we did see your main TMTT competitor talk about healthy market growth, but then losing share to you in both mitral and tricuspid.
很好。也許再追問一個問題。我知道這是追問中的追問。但我們確實聽到你們主要的TMTT競爭對手談到市場成長健康,但同時在二尖瓣與三尖瓣兩個領域都把市占讓給了你們。
And we did hear yesterday, I guess, from another one of your competitors talk about their left atrial appendage closure was being utilized a bit less stand-alone by interventional cardiologists as they're shifting focus over to mitral and tricuspid. You're clearly benefiting from all of those trends in commentary. So I was wondering if you agree with those comments that you're seeing in the market and how you're helping to drive that. Thanks.
而且我們昨天也聽到,我想是你們另一位競爭對手提到,他們的左心耳封堵(left atrial appendage closure)在介入心臟科醫師那邊,作為單獨(stand-alone)手術的使用率略有下降,因為醫師把重心轉向二尖瓣與三尖瓣。你們顯然正從這些趨勢與評論中受益。所以我想問,你是否同意你在市場上也看到這些現象,以及你們如何協助推動這些趨勢。謝謝。
Bernard Zovighian - Chief Executive Officer, Director
Bernard Zovighian - Chief Executive Officer, Director
That's a very interesting question, Robbie. And I -- what I tried to do here is maybe again, look at the big picture here. So for some of our competitors, it is about share. We look at this one as we are creating a category.
這是個非常有意思的問題,Robbie。我——我在這裡想做的是,也許再次從大局來看。對某些競爭對手而言,重點在市占。而我們看待這件事的方式是:我們正在創造一個類別(category)。
When 10 years ago, we had the vision and I should say, of a bold vision to go deep into the two disease states, mitral and tricuspid, and decided to invest in a big way in building a portfolio of therapy to be able to solve these unmet patient needs. At the time, 10 years ago, 5 years ago and even today, it was not about share. It was about the patient. It was about the opportunity.
十年前,我們就有這個願景——我應該說,是一個大膽的願景——要深入投入兩種疾病狀態:二尖瓣與三尖瓣,並決定大規模投資,建立一個治療產品組合,以解決這些尚未被滿足的病患需求。在當時,十年前、五年前,甚至到今天,重點都不是市占。重點是病患。重點是機會。
Now fast forward in 2026, guess what? We have a portfolio. We committed. We have made the investment. And now we are benefiting from it.
現在快轉到2026年,猜猜看?我們已經有了產品組合。我們做出了承諾。我們也完成了投資。而現在我們正在從中受益。
So now you ask position what do we have? We have multiple solutions, and they can choose which one is best for what patient.
所以你現在問我們處於什麼位置?我們有多種解決方案,醫師可以選擇對特定病患最合適的那一種。
And that's the difference. This is what's happening. So that's still our view of what's happening here.
這就是差異所在。這就是正在發生的事。所以這仍然是我們對於目前情況的看法。
But I'm going to add, Daveen, you are here, you are close to the action here. So what do you think?
不過我想補充一下,Daveen,你也在現場,而且你更貼近第一線。所以你怎麼看?
Daveen Chopra - Corporate Vice President - Transcatheter Mitral and Tricuspid Therapies
Daveen Chopra - Corporate Vice President - Transcatheter Mitral and Tricuspid Therapies
Yeah. No. I'll just add a little bit on to what you said, Bernard. Clearly, we think that the patient treatment for mitral and tricuspid disease, two diseases that are massively under diagnosed, under awareness, under referral, lots of opportunity for so many more people to get these treatments to help their lives, right? They're still growing. The procedure growth is still growing at double digits across both mitral and tricuspid.
是的。沒錯。我就稍微補充一點你剛才說的,Bernard。很明顯地,我們認為二尖瓣與三尖瓣疾病的病患治療——這兩種疾病在診斷上嚴重不足、認知不足、轉診不足——仍有很大機會讓更多人接受這些治療、改善他們的生活,對吧?它們仍在成長。在二尖瓣與三尖瓣兩個領域,手術量成長仍維持雙位數。
And so for us, clearly, if you look across the board at our therapies, whether you're talking about PASCAL with TEER or EVOQUE or SAPIEN M3, which is brand, brand new, we're growing at a higher rate than we think the market, and that there's tons of opportunity to create massive new categories to treat people, whether you think about it from a mitral side or a tricuspid side or from a repair side or a replacement side.
因此對我們而言,很明顯地,如果你看我們各項治療,不管你談的是採用TEER的PASCAL、EVOQUE,或是全新、全新的SAPIEN M3,我們的成長速度都高於我們認為的市場成長,而且有大量機會去創造全新的大型類別來治療病患——不論你從二尖瓣或三尖瓣的角度,或從修補(repair)或置換(replacement)的角度來看。
And we think that all this when you add this together, and as Bernard talked about, having the portfolio to best treat patients, to give them the best possible solution, really will help us drive to that $2 billion in 2030 that we've talked about and continued growth beyond that. So we are continuing to be very excited about how our portfolios come together to help treat more patients overall.
我們認為,把這些加總起來,再加上Bernard提到的,擁有能夠為病患提供最佳治療的產品組合、給他們最好的可能解決方案,確實將幫助我們推動到我們談過的2030年20億美元目標,並在此之後持續成長。所以我們對於我們的產品組合如何整合、以協助整體治療更多病患,仍然感到非常振奮。
Robert Marcus - Analyst
Robert Marcus - Analyst
Perfect. I appreciate the thoughts. Thanks a lot.
太好了。感謝你們的想法。非常謝謝。
Operator
Operator
Vijay Kumar, Evercore ISI.
Vijay Kumar,Evercore ISI。
Vijay Kumar - Equity Analyst
Vijay Kumar - Equity Analyst
Hey, guys. Congrats on a nice sprint, and thanks for taking my question. I guess one on maybe a guidance kind of question, Scott. You did the ASR. Can you just talk about how you think about share count here for second quarter? And whether there was any weather impact here in Q1, how Q1 played out?
嗨,各位。恭喜這次表現很亮眼,也謝謝讓我提問。我想問一個可能偏指引相關的問題,Scott。你們做了ASR(加速股票回購)。你能談談你們如何看待第二季的股數(share count)嗎?以及第一季是否有任何天氣因素影響、第一季實際表現如何?
Scott Ullem - Chief Financial Officer, Corporate Vice President
Scott Ullem - Chief Financial Officer, Corporate Vice President
Sure. So we completed the accelerated share repurchase. We also did a little bit more repurchase. So something like $520 million total in the quarter. So that brings down the share count a bit. You see the weighted average for the full year is coming down 5 million shares from our original guidance.
當然。我們完成了加速股票回購。我們也額外做了一些回購。所以本季合計大約是5.2億美元。因此股數會稍微下降。你會看到全年加權平均股數相較我們原先指引下降了500萬股。
The accretion dilution is kind of a push. It doesn't have a big impact on the bottom line short term. But obviously, we're buying back shares because we think longer term, it's the right investment.
增厚/稀釋(accretion/dilution)大致相抵。短期內對最終盈餘影響不大。但很明顯地,我們回購股票是因為我們認為從長期來看,這是正確的投資。
Weather impact in Q1, really nominal. I know there was a question back in February when there was some weather that hit the Northeast. And we said back then, a lot of times, it's -- you just don't know whether procedures are going to get rescheduled during the quarter or after the quarter, into the next quarter or whether they go away. In this case, we didn't really see a big impact by the time we got to March 31.
第一季的天氣影響其實非常有限。我知道二月時曾有人問到東北部遭遇一些天氣狀況。我們當時也說,很多時候——你其實不知道手術會不會在當季或季後被重新排程,延到下一季,或是就此取消。就這次而言,截至3月31日,我們並沒有看到明顯的影響。
Vijay Kumar - Equity Analyst
Vijay Kumar - Equity Analyst
Great. And then maybe, Bernard, one for you on the PROGRESS trial. I think last call, there was some concerns on -- maybe you're less bullish on PROGRESS. So can you just maybe talk about -- express your bullishness and progress? And how are you handling crossovers? Are crossovers allowed in this trial? If so, when are crossovers being allowed in PROGRESS?
很好。接著也許,Bernard,想請你談一下 PROGRESS 試驗。我記得上次電話會議時,大家對——也許你對 PROGRESS 沒那麼樂觀——有些疑慮。所以你能否談談——表達一下你對 PROGRESS 的樂觀程度與進展?以及你們如何處理交叉治療(crossovers)?這項試驗允許交叉治療嗎?如果允許,PROGRESS 何時開始允許交叉治療?
Bernard Zovighian - Chief Executive Officer, Director
Bernard Zovighian - Chief Executive Officer, Director
Thanks, Vijay. We tend -- in general, and you know us well. We tend not to talk about trial before we can talk about trial results. So most of our trials are FDA-approved trial, third-party adjudicated. And we treat them very seriously because it does matter to our long-term strategy. They are not marketing trial or so on.
謝謝你,Vijay。我們一般而言——而且你也很了解我們。在能談試驗結果之前,我們通常不會談論試驗。因此我們大多數試驗都是 FDA 核准的試驗,並由第三方進行事件裁定。我們非常嚴肅地看待這些試驗,因為它們確實關係到我們的長期策略。它們不是行銷性試驗之類的。
So right now, the only thing I can tell you about moderate is what I said in the past, which is we are looking for the presentation at TCT this year. And as a matter of fact, we are going to have other trial TCT this year. But this one is going to be a TCT this year.
所以目前,我能告訴你關於 moderate 的唯一資訊,就是我過去說過的:我們預計今年在 TCT 上發表。事實上,我們今年在 TCT 還會有其他試驗。但這一項會在今年的 TCT 上發表。
We were very pleased at the time of enrollment a couple of years ago where this trial enrolled very fast. And usually, it is a good deal of proxy when physicians, treating physicians, they are enrolling the trial. So we see the benefit. But again, I don't know anything about the results, and we usually keep it like it is until the end.
我們在幾年前收案時非常滿意,因為這項試驗收案非常快。通常,當臨床醫師、主治醫師願意把病人納入試驗時,這是一個很好的代理指標。所以我們看得到其效益。但再次強調,我對結果一無所知,而我們通常會維持這樣直到最後。
So every one of us are going to discover the trial at TCT. And believe me, we are going to go deep with the PI, with the investigators, with all of you at TCT. So you will have a full analysis. We will understand all of the learning and all of this. But as of now, yes, we started the trial for a reason, but I don't know more than that.
所以我們每個人都會在 TCT 上一起揭曉這項試驗。相信我,我們會在 TCT 與 PI、與研究者、以及與各位深入討論。所以你們會得到完整的分析。我們會理解所有的學習與所有相關內容。但就目前而言,是的,我們啟動這項試驗是有原因的,但我也只知道這些。
I hope it is helping, Vijay.
希望這對你有幫助,Vijay。
Vijay Kumar - Equity Analyst
Vijay Kumar - Equity Analyst
Yes, that's helpful, Bernard. Thank you.
有的,這很有幫助,Bernard。謝謝你。
Operator
Operator
Joanne Wuensch, Citibank.
Citibank 的 Joanne Wuensch。
Joanne Wuensch - Analyst
Joanne Wuensch - Analyst
Good afternoon, and thank you for taking your question. And I also say a very nice quarter. Two questions. I'll just ask them upfront.
下午好,謝謝你回答問題。我也想說這是一個很不錯的季度。我有兩個問題。我先一次把問題都問完。
The expense management, particularly as I looked at research and development, a little less. So SG&A was really strong in the quarter. How should we think about your maybe new view towards expense management or continued view?
費用管理方面,特別是我看研發費用,似乎低了一些。所以本季 SG&A 表現真的很強。我們應該如何看待你們對費用管理可能的新觀點,或是延續既有的觀點?
And then forgive me, Scott, for asking this, but where are you in the progress towards finding a new CFO? Thank you.
另外請原諒我,Scott,問這個問題,但你們在尋找新任 CFO 的進度到哪裡了?謝謝。
Bernard Zovighian - Chief Executive Officer, Director
Bernard Zovighian - Chief Executive Officer, Director
Thank you. So let me start with R&D. We are very much committed into our R&D investment, organic innovations. And we are -- the guidance for the year is around 17%. So clearly, we are committed.
謝謝。我先從研發談起。我們非常致力於研發投資與內生成長的創新。而且我們——今年的指引大約是 17%。所以很明顯,我們是承諾投入的。
A couple of things is happening. One is we want to have the right priorities. So you have seen the ratio going down from what it was a few years ago, around 19% to 16% in Q1, but 17% for the full year 2026. And we are going to continue looking at making sure we have big investment because structural heart disease have many opportunities, at the same time, managing the priorities and having a ratio continuing to go down.
有幾件事正在發生。第一,我們希望有正確的優先順序。所以你已經看到這個比率從幾年前大約 19% 降到第一季的 16%,但 2026 全年是 17%。我們會持續確保有足夠的大型投資,因為結構性心臟病領域有很多機會;同時也會管理優先順序,讓這個比率持續下降。
We are also helped by the top line increasing. So the top line increasing as managing priority. So this is what we are doing in a very intentional manner and strategic manner.
我們也受惠於營收成長。營收成長同時也有助於我們在管理優先順序。所以這些都是我們以非常有意識且具策略性的方式在做的。
With regards to the CFO, the process is going. And I should say it's going well. But as soon as I have news to report, I will say it in the press release, obviously, because it is an important hire. But good news is Scott is very committed to make sure it is a very successful transition. He has been a very successful CFO for the company over the last 12, 13 years, and he has been a great partner to me and to many of the executive team. So I feel good about the process here. And as soon as I know more, you will hear from me.
至於 CFO,流程正在進行中。我應該說進展得很順利。但只要我有消息可以公布,我會在新聞稿中說明,這當然是一個重要的任命。不過好消息是,Scott 非常投入,確保交接能非常成功。過去 12、13 年他一直是公司非常成功的 CFO,也一直是我以及許多高階主管團隊成員的重要夥伴。所以我對這個流程感到放心。一旦我知道更多,你們就會聽到我更新。
Joanne Wuensch - Analyst
Joanne Wuensch - Analyst
Thank you very much.
非常感謝。
Operator
Operator
Matt Taylor, Jefferies.
Jefferies 的 Matt Taylor。
Matthew Taylor - Equity Analyst
Matthew Taylor - Equity Analyst
Hi, thank you for taking the question. So I just wanted to follow up on the thread before and get some clarity from you on the guidance. When you're increasing the TAVR guidance this year, are you assuming any increase in your competitive position or share gains? Could you characterize that, or is that mostly market growth and your stability with it?
嗨,謝謝你回答問題。我想延續前面的話題,向你確認一下指引的細節。當你們上調今年的 TAVR 指引時,你們是否假設競爭地位會提升或市占會增加?你能否描述一下?還是主要反映市場成長以及你們在其中的穩定表現?
Bernard Zovighian - Chief Executive Officer, Director
Bernard Zovighian - Chief Executive Officer, Director
Thanks, Matt. So the main reason for having increased the guidance was based on our Q1 outperformance based on our earlier expectation. That's the main reason.
謝謝你,Matt。上調指引的主要原因,是基於我們第一季表現優於先前預期。這是主要原因。
Now, if you look at our Q1 performance, this was led by market globally, given our renewed focus on TAVR, led by all of the clinical evidence that we have produced in TAVR with SAPIEN 3, and you know all of them, and also a little bit of share. Share in Europe from the exit of a competitor and also some slight share gain in the US.
另外,如果你看我們第一季的表現,主要是由全球市場帶動,因為我們重新聚焦於 TAVR;也受惠於我們以 SAPIEN 3 在 TAVR 領域所產出的所有臨床證據——你都很清楚——以及一些市占的提升。市占方面,歐洲因一位競爭對手退出而有所提升,美國也有些微的市占增加。
So this is the way we build the guidance based on what we know today, Matt. And obviously, as we know more for the Q2 earnings call, we will provide more analytics if we have to.
所以,Matt,我們就是依據目前所掌握的資訊來建立這份指引。當然,若在第二季財報電話會議時我們掌握更多資訊,必要時也會提供更多分析。
Matthew Taylor - Equity Analyst
Matthew Taylor - Equity Analyst
Thank you. And maybe as a follow-up, could you comment on just the healthcare environment in general. There's been some chatter about concerns with changes in the macro environment and coverage. I think that would impact US because you're levered to Medicare, and these are very necessary procedures, but I'd love any thoughts that you have on the overall environment.
謝謝。另外追問一下,你能否談談整體醫療保健環境?最近有一些討論,擔心總體環境與給付覆蓋的變化。我想這可能會影響美國,因為你們與 Medicare 的關聯度較高,而且這些都是非常必要的手術,但我也很想聽聽你對整體環境的看法。
Bernard Zovighian - Chief Executive Officer, Director
Bernard Zovighian - Chief Executive Officer, Director
Yes. We -- I would say we don't see an intense environment. And again, what you need to realize, as a company, all of our technologies are technologies helping to extend life of patients or improvement of the quality of life of patients.
是的。我們——我會說我們沒有看到環境變得很緊張。而且你需要理解的是,作為一家公司,我們所有的技術都是用來延長病患生命或改善病患生活品質的技術。
So there are -- most of them are life-saving technologies. And there are technologies that patient needs urgently. So we don't feel maybe what you are talking about. And we got some good news also this morning from the new administration.
所以其中大多數都是救命的技術。而且這些技術是病患迫切需要的。因此我們可能沒有感受到你所提到的那些情況。而且今天早上我們也從新政府那邊得到一些好消息。
I don't know if you did follow, but together with CMS and FDA, basically a partner to bring a new policy for breakthrough therapies. And it is exactly what we are doing as a company. And the goal here for this new policy, the name of it is rapid, is basically to make sure that patients have an early and timely access to care in the US. So we look at it.
我不確定你是否有留意,但我們與 CMS 和 FDA 基本上是合作夥伴,共同推動一項針對突破性療法的新政策。而這正是我們公司正在做的事。這項新政策的目標(名稱為 rapid)基本上是要確保病患能在美國更早且及時地獲得照護。所以我們是這樣看待的。
The environment for breakthrough therapy is positive. And the news from this morning, we look at it as even more positive. We have been working with FDA and CMS for decades. And it is great to see that they want to enhance a process which was already working. And I'm sure this process is going to be even better. So we are fully behind it. So very positive about it.
突破性療法的環境是正向的。而今天早上的消息,我們認為更是利多。我們與 FDA 和 CMS 合作已數十年。很高興看到他們希望強化一個原本就運作良好的流程。我相信這個流程會變得更好。因此我們全力支持。所以我們對此非常正面。
Matthew Taylor - Equity Analyst
Matthew Taylor - Equity Analyst
Okay, thank you so much.
好的,非常感謝。
Operator
Operator
Matt Miksic, Barclays.
Barclays 的 Matt Miksic。
Matthew Miksic - Analyst
Matthew Miksic - Analyst
Hi, thanks so much for taking the question. So one follow-up on mitral and one quick follow-up on tricuspid kind of a review forward.
嗨,謝謝讓我提問。我有一個關於二尖瓣的追問,以及一個關於三尖瓣的簡短追問,算是往前看的一些問題。
So I think you know one of the competitors in mitral talked a little bit about the share activity share pressure, which, of course, it in mitral for some time, you can share repair with PASCAL total great some step-up of that activity.
我想你知道,二尖瓣領域的一位競爭對手談到了一些市占活動與市占壓力;當然,這在二尖瓣已經存在一段時間了。你可以看到以 PASCAL 進行修補(repair)的活動,以及這方面活動的提升。
And maybe you could talk a little bit about like what the rollout of M3 looks like in terms of training, in terms of adoption and how, if at all, that is either expanding the accounts that you're in or enhancing engagement with those accounts? Any kind of color like that would help.
也許你可以談談 M3 的推廣在訓練、採用(adoption)方面看起來如何?以及如果有的話,這是否正在擴大你們所涵蓋的客戶(accounts),或是提升與這些客戶的互動深度?任何這類補充說明都會很有幫助。
And then I'd like to just one quick follow-up on tricuspid.
接著我想再就三尖瓣做一個簡短追問。
Daveen Chopra - Corporate Vice President - Transcatheter Mitral and Tricuspid Therapies
Daveen Chopra - Corporate Vice President - Transcatheter Mitral and Tricuspid Therapies
Sure, Matt. This is Daveen. So some quick background. I think we see in the treatment of mitral patients that, as I mentioned before, PASCAL really offers differentiated technology, which the physicians are seeing, and that's why they want to use PASCAL for their patients.
當然,Matt。我是 Daveen。先簡單補充一些背景。我認為我們在二尖瓣病患的治療上看到的是,如我先前提到的,PASCAL 確實提供了具差異化的技術,醫師也看得到這一點,這就是為什麼他們希望為病患使用 PASCAL。
As you look about SAPIEN M3, this product is one for where you may get suboptimal results for either TEER or surgery. So this is offering a potentially solution for patients who don't necessarily have a great surgical or transcatheter solution today.
再看 SAPIEN M3,這個產品是針對那些不論是 TEER 或手術可能得到次佳結果的情況。因此,這為目前不一定有很好的手術或經導管解決方案的病患,提供了一個潛在的解決方案。
And as you can imagine with any new technology, again, only a quarter into the launch, you start off by really working closely with the centers that were a part of your clinical trial. And those are usually our first wave that we start working on and then eventually you start building on to other kind of large mitral centers.
而你也可以想像,任何新技術在推出時——而且現在才上市後第一個季度——一開始會先與參與臨床試驗的中心密切合作。這些通常是我們第一波會先合作的中心,之後再逐步擴展到其他大型二尖瓣中心。
But we're so early in the rollout because we're only a quarter in that you're just kind of starting that process and with a limited number of centers overall.
但我們在推廣上仍非常早期,因為才剛過一個季度,所以你們看到的只是流程剛開始,而且整體中心數量也仍然有限。
Operator
Operator
Matt, do you have a follow-up?
Matt,你還有追問嗎?
Thank you. We'll move on. As that was our last question, I'll hand the floor back to management for closing remarks. Thank you.
謝謝。我們繼續下一位。由於這是我們最後一個問題,我把時間交回給管理團隊做結語。謝謝。
Bernard Zovighian - Chief Executive Officer, Director
Bernard Zovighian - Chief Executive Officer, Director
Thank you, everyone, for your continued interest in Edwards. Scott, Gerianne, Dan, Daveen, and I, obviously, welcome any additional questions by telephones, and I wish you a great rest of your day. Thank you, everyone.
謝謝各位持續關注 Edwards。Scott、Gerianne、Dan、Daveen 和我,當然也歡迎大家透過電話提出任何其他問題,也祝各位今天剩下的時間一切順利。謝謝大家。
Operator
Operator
Thank you. This concludes today's call. All parties may disconnect. Have a good evening.
謝謝。今天的電話會議到此結束。各方可斷線。祝各位晚安。