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Operator
Operator
Greetings and welcome to Edwards Lifesciences third quarter 2024 results conference call. (Operator Instructions) Please note that this conference is being recorded.
歡迎參加 Edwards Lifesciences 2024 年第三季業績電話會議。(操作員說明)請注意,本次會議正在錄製中。
I will now turn the conference over to your host, Mark Wilterding, Senior Vice President of Investor Relations. Thank you. You may begin.
現在我將會議交給東道主投資者關係高級副總裁馬克·維爾特丁 (Mark Wilterding)。謝謝。你可以開始了。
Mark Wilterding - Senior Vice President, Investor Relations
Mark Wilterding - Senior Vice President, Investor Relations
Thank you very much, Diego, and welcome everyone. Thank you for joining us this afternoon. With me on today's call is our CEO, Bernard Zovighian; and our CFO, Scott Ullem. Also joining us for the Q&A portion of the call will be Larry Wood, our Group President of TAVR and Surgical Structural Heart; Daveen Chopra, our Global Leader of TMTT; and Wayne Markowitz, our Global Leader of Surgical Structural Heart.
非常感謝迭戈,歡迎大家。感謝您今天下午加入我們。與我一起參加今天電話會議的是我們的執行長 Bernard Zovighian;以及我們的財務長 Scott Ullem。我們的 TAVR 和外科結構心臟集團總裁 Larry Wood 也將參加電話問答部分。 Daveen Chopra,我們的 TMTT 全球負責人;以及我們的外科結構心臟全球領導者 Wayne Markowitz。
Just after the close of regular trading, Edwards Lifesciences released third quarter 2024 financial results. During today's call, management will discuss those results included in the press release and accompanying financial statements and then use the remaining time for Q&A.
常規交易結束後,Edwards Lifesciences 發布了 2024 年第三季財務業績。在今天的電話會議中,管理層將討論新聞稿和隨附財務報表中包含的結果,然後利用剩餘時間進行問答。
Please note that management will be making forward-looking statements that are based on estimates, assumptions and projections. These statements include but are not limited to financial guidance and expectations for growth opportunities, strategy, leverage, and integration of our acquisitions, regulatory approvals, clinical trials, litigation, reimbursement, competitive matters and foreign currency fluctuations.
請注意,管理層將根據估計、假設和預測做出前瞻性陳述。這些聲明包括但不限於財務指導和對成長機會、策略、槓桿和收購整合的預期、監管批准、臨床試驗、訴訟、報銷、競爭事項和外幣波動。
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. Additionally, the statements involve risks and uncertainties that could cause actual results to differ materially.
這些聲明僅代表發布之日的情況,Edwards 不承擔在今天之後更新這些聲明的任何義務。此外,這些陳述涉及風險和不確定性,可能導致實際結果有重大差異。
Information concerning factors that could cause these differences and important product safety information may be found in the press release, our 2023 Annual Report on Form 10-K and Edwards' other SEC filings, all of which are available on the company's website at edwards.com.
有關可能導致這些差異的因素的資訊以及重要的產品安全信息,請參閱新聞稿、我們的 10-K 表 2023 年年度報告以及 Edwards 的其他 SEC 文件,所有這些都可以在公司網站 edwards.com 上找到。
Unless otherwise noted, our commentary on sales growth refers to constant currency sales growth, which is defined in the quarterly press release issued earlier today. Reconciliations between GAAP and non-GAAP numbers mentioned during this call are also included in today's press release. Growth rates refer to continuing operations and do not include contributions from Critical Care which was sold on September 3.
除非另有說明,我們對銷售成長的評論指的是恆定貨幣銷售成長,這是在今天早些時候發布的季度新聞稿中定義的。本次電話會議中提到的 GAAP 和非 GAAP 數據之間的對帳也包含在今天的新聞稿中。成長率指的是持續經營業務,不包括 9 月 3 日出售的重症監護的貢獻。
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,徵求他的意見。伯納德?
Bernard Zovighian - President, Chief Executive Officer
Bernard Zovighian - President, Chief Executive Officer
(technical difficulty) of $1.4 billion increase 10% on a constant currency basis versus the year-ago period, slightly ahead of our expectations. TAVR and TMTT both contributed significantly to growth in the third quarter as more patients globally benefited from our catheter-based structural heart therapies.
(技術難度)為 14 億美元,以固定匯率計算,較去年同期成長 10%,略高於我們的預期。隨著全球越來越多的患者受益於我們基於導管的結構性心臟治療,TAVR 和 TMTT 都對第三季的成長做出了重大貢獻。
During the quarter, our team made important advancements in our clinical research and new product introduction to address the unmet needs of structural heart patients around the world. Next week at TCT, you will hear more about our commitment to generating important clinical evidence to help physicians and the healthcare ecosystem take care of the many patients in need.
本季度,我們的團隊在臨床研究和新產品推出方面取得了重要進展,以滿足世界各地結構性心臟病患者未滿足的需求。下週,您將在 TCT 上聽到更多關於我們致力於產生重要臨床證據以幫助醫生和醫療保健生態系統照顧許多有需要的患者的承諾。
At the conference, we will be discussing the pivotal clinical data presentation of early TAVR, TRISCEND II and CLASP IID, along with more than 20 other important updates. Edwards is leading the advancement of science in this large, diverse and rapidly growing field.
在會議上,我們將討論早期 TAVR、TRISCEND II 和 CLASP IID 的關鍵臨床數據展示,以及 20 多個其他重要更新。愛德華茲正在這個龐大、多元且快速發展的領域中引領科學進步。
Our priority remains positioning TAVR for long-term growth. In addition to introducing differentiated next-gen technologies, we are leading several global initiatives including reaching more patients through patient awareness, activation and access, and enhancing physician training and support programs.
我們的首要任務仍然是讓 TAVR 實現長期成長。除了引入差異化的下一代技術外,我們還領導了多項全球舉措,包括透過患者意識、激活和訪問來接觸更多患者,以及加強醫生培訓和支持計劃。
For TMTT, we continue to scale our fast growing business, and we are pleased with its trajectory over the last several quarters. Key initiatives include broadening the launch of PASCAL, advancing the introduction of EVOQUE in the US and in Europe, and launching SAPIEN M3 in Europe next year.
對於 TMTT,我們繼續擴大快速成長的業務,我們對其過去幾季的發展軌跡感到滿意。主要舉措包括擴大 PASCAL 的推出範圍、推進 EVOQUE 在美國和歐洲的推出,以及明年在歐洲推出 SAPIEN M3。
Edwards' unique pipeline of innovation should drive strong multi-year growth. We are also committed to bringing differentiated surgical innovation to patients, supported by strong evidence generation, ensuring we remain at the forefront of surgical advancement.
愛德華茲獨特的創新管道應該會推動多年的強勁成長。我們也致力於在強有力的證據支持下為患者帶來差異化的外科創新,確保我們始終處於外科進步的最前線。
Moreover, we are entering new therapeutic areas, such as aortic regurgitation or AR, and implantable heart failure management or IHFM. These initiatives align with our long-term vision of expanding into more therapies, driving sustainable growth for Edwards.
此外,我們正在進入新的治療領域,例如主動脈瓣逆流(AR)和植入式心臟衰竭治療(IHFM)。這些舉措符合我們拓展更多療法、推動 Edwards 永續成長的長期願景。
It was an especially busy quarter as our team around the world delivered on our strategy. We closed the sale of Critical Care in September, took important action to sharpen our focus on structural heart including integrating recent acquisition and right sizing the company for long-term profitable growth.
這是一個特別繁忙的季度,因為我們世界各地的團隊都在執行我們的策略。我們於 9 月完成了重症監護業務的出售,採取了重要行動來加強我們對結構核心的關注,包括整合最近的收購和調整公司規模以實現長期盈利增長。
As we look ahead, we see significant growth opportunities across our differentiated portfolio of leading structural heart therapies for TAVR-AS, TAVR-AR, TMTT, Surgical and IHFM. This commitment will be discussed in detail at the upcoming investor conference, where we will outline our strategies for differentiated value creation in the years ahead.
展望未來,我們在 TAVR-AS、TAVR-AR、TMTT、外科和 IHFM 領先結構性心臟療法的差異化產品組合中看到了巨大的成長機會。這項承諾將在即將召開的投資者會議上詳細討論,我們將在會上概述未來幾年創造差異化價值的策略。
Now, I will provide details on Q3 results by product group. In TAVR, third quarter global sales of $1 billion increased 6% when adjusted for currency and billing days. Edwards' strong competitive position and pricing remain stable globally, although we experienced a few instances of regional pressure.
現在,我將按產品組提供第三季業績的詳細資訊。在 TAVR 中,根據貨幣和計費天數進行調整後,第三季全球銷售額成長了 6%,達 10 億美元。儘管我們經歷了一些區域壓力,但愛德華茲在全球範圍內的強大競爭地位和定價保持穩定。
We are confident in our differentiated technology, high-quality evidence and the value we continue to demonstrate to patients, clinicians and healthcare systems. We remain deeply committed to advancing evidence for AS patients. In August, one-year data from the RIA trial, a first-of-its-kind trial focused exclusively on outcomes for women receiving TAVR were presented at the ESC meeting held in London.
我們對我們的差異化技術、高品質證據以及我們繼續向患者、臨床醫生和醫療保健系統展示的價值充滿信心。我們仍然堅定地致力於為僵直性脊椎炎患者提供證據。8 月,在倫敦舉行的 ESC 會議上公佈了 RIA 試驗的一年數據,這是一項專門關注接受 TAVR 的女性結局的首次試驗。
Investigators reported superior outcome for women receiving the Edwards SAPIEN 3 or SAPIEN 3 Ultra Valves as compared to those receiving surgical aortic valve replacement for the primary endpoints of death, stroke and re-hospitalization at one year.
研究人員報告稱,與接受外科主動脈瓣置換術的女性相比,接受Edwards SAPIEN 3 或SAPIEN 3 Ultra 瓣膜的女性在一年內的主要終點(死亡、中風和再住院)方面獲得了更好的結果。
We are proud of this high-quality clinical research. The outstanding success of TAVR points to the importance of valve selection for women undergoing aortic valve replacement, especially those with small annuli to preserve their option for a future valve-in-valve procedures, ensuring the lifetime management of their disease.
我們為這項高品質的臨床研究感到自豪。TAVR 的巨大成功表明了瓣膜選擇對於接受主動脈瓣置換術的女性的重要性,尤其是那些瓣環較小的女性,以保留未來瓣中瓣手術的選擇,確保疾病的終身管理。
Next week at TCT, the clinical community will hear results from the early TAVR trial. The trial is the first and largest randomized controlled trial to date studying asymptomatic severe AS patients and the impact of early intervention with TAVR.
下週在 TCT 上,臨床界將聽到早期 TAVR 試驗的結果。該試驗是迄今為止第一個也是最大的隨機對照試驗,研究無症狀的嚴重 AS 患者以及 TAVR 早期介入的影響。
Turning to the US, our year-over-year third quarter TAVR sales growth rate was in line with our global TAVR constant currency growth rate. We believe our US competitive position was largely unchanged. In the US, although hospitals and physicians continue to acknowledge our team capacity constraint nationally, it is encouraging that many hospitals are exploring additional investments to address future workflow needs to manage these patients.
轉向美國,第三季 TAVR 銷售額年增率與全球 TAVR 固定匯率成長率一致。我們相信我們在美國的競爭地位基本上沒有改變。在美國,儘管醫院和醫生繼續承認我們的團隊能力在全國範圍內受到限制,但令人鼓舞的是,許多醫院正在探索額外的投資,以滿足未來管理這些患者的工作流程需求。
We know from experience that hospitals have historically demonstrated the ability to scale to support transcatheter procedure growth over time. Outside of the US, in the third quarter, our constant currency TAVR sales growth was in line with our global TAVR growth.
我們從經驗中得知,醫院歷來都表現出擴大規模以支持經導管手術隨著時間的推移而增長的能力。在美國以外,第三季度,我們以固定匯率計算的 TAVR 銷售額成長與全球 TAVR 成長一致。
In Europe, our market position improved sequentially, supported by the continued launch of SAPIEN 3 Ultra RESILIA. We are pleased with the exceptional patient outcome delivered with this platform, and we expect this momentum to continue as more centers adopt our best-in-class TAVR platform.
在歐洲,在 SAPIEN 3 Ultra RESILIA 的持續推出的支持下,我們的市場地位連續提高。我們對平台所帶來的卓越患者治療效果感到滿意,隨著更多中心採用我們一流的 TAVR 平台,我們預計這種勢頭將持續下去。
Additionally, we received CE mark approval for our Alterra system for congenital heart patients. Alterra should result in quality-of-life improvement and a reduction in the number of procedures that this younger patient will require over their lifetimes. We have initiated the introduction of this novel therapy in Europe and initial feedback from clinicians has been positive.
此外,我們用於先天性心臟病患者的 Alterra 系統也獲得了 CE 標誌批准。Alterra 應該會改善生活質量,並減少年輕患者一生中所需的手術次數。我們已開始在歐洲引入這種新型療法,臨床醫生的初步回饋是正面的。
In Japan, slower market growth pressured our results. We remain dedicated to expanding this therapy to address significant under-treatment of AS among the substantial elderly population in Japan. In closing, we are pleased with our Q3 TAVR result, which were slightly above our expectation. Our 5% to 7% growth guidance for the full year remains unchanged.
在日本,市場成長放緩對我們的業績帶來壓力。我們仍然致力於擴大這種療法,以解決日本大量老年族群中嚴重的僵直性脊椎炎治療不足的問題。最後,我們對第三季 TAVR 結果感到滿意,該結果略高於我們的預期。我們對全年 5% 至 7% 的成長指引保持不變。
However, we expect the Q4 year-over-year sales growth rate to be lower due to some one-time items that Scott will describe later. We remain confident that Edwards is positioned for healthy and sustainable TAVR growth, driven by our differentiated TAVR technology, our deep commitment to advancing patient care through high-quality clinical evidence, new indication and our investment in patient activation initiatives.
然而,由於斯科特稍後將描述的一些一次性項目,我們預計第四季度的年比銷售成長率將會較低。我們仍然相信,在我們差異化的TAVR 技術、我們對透過高品質臨床證據、新適應症和對患者激活計劃的投資來推進患者護理的堅定承諾的推動下,Edwards 能夠實現健康和可持續的TAVR增長。
Last quarter, we announced the acquisition of JC Medical and JenaValve, early innovators in the treatment of AR. These acquisitions provide an opportunity in a new therapeutic area to address the unmet needs of AR patients around the world, a deadly disease that impacts more than 100,000 patients in the US alone and is largely untreated today.
上季度,我們宣布收購 AR 治療領域的早期創新者 JC Medical 和 JenaValve。這些收購為新的治療領域提供了一個機會,可以解決世界各地 AR 患者未滿足的需求。
As the pioneer in valve innovation, we believe Edwards is best positioned to develop, study and deliver novel technologies. I am pleased to report that we performed our first implant in the Journey pivotal trial with the Edwards J-Valve AR system, recently acquired from JC Medical.
作為閥門創新的先驅,我們相信 Edwards 最有能力開發、研究和提供新技術。我很高興地報告,我們在 Journey 關鍵試驗中使用最近從 JC Medical 購買的 Edwards J-Valve AR 系統進行了首次植入。
As noted in our announcement of the JenaValve transaction, the acquisition is subject to regulatory review and other customary closing conditions. We are responding to a second request from the FTC in connection with their review and anticipate closing the acquisition mid 2025.
正如我們在 JenaValve 交易公告中所指出的,此次收購需要接受監管審查和其他慣例成交條件。我們正在回應 FTC 的第二項審查請求,並預計在 2025 年中期完成收購。
Now turning to TMTT, our unique innovations, including the PASCAL repair system, the EVOQUE tricuspid replacement system and the upcoming SAPIEN 3 mitral replacement system provide a broad set of treatment options to serve the many diverse and complex patients in need.
現在轉向TMTT,我們獨特的創新,包括PASCAL 修復系統、EVOQUE 三尖瓣置換系統和即將推出的SAPIEN 3 二尖瓣置換系統,提供了廣泛的治療選擇,可以為許多有需要的多樣化和復雜的患者提供服務。
We are pleased with the Q3 result achieving $91 million in sales, representing 74% growth over the prior year. Sales were led by PASCAL growth globally. We continue the initial commercial expansion of EVOQUE in the US and Europe. Globally, we continue to see more patients diagnosed and treated as long as strong therapy adoption, resulting in mitral procedures experiencing ongoing double-digit growth and even stronger tricuspid therapy growth.
我們對第三季的銷售額達到 9,100 萬美元感到高興,比上年增長 74%。PASCAL 在全球的成長帶動了銷售額的成長。我們繼續 EVOQUE 在美國和歐洲的初步商業擴張。在全球範圍內,只要採用強有力的治療方法,我們就會繼續看到更多的患者得到診斷和治療,導致二尖瓣手術持續呈兩位數增長,三尖瓣治療增長更為強勁。
Adoption of a differentiated PASCAL technology is expanding in both new and existing sites around the world. We look forward to presenting the two year outcomes of a CLASP IID pivotal trial studying DMR patients at TCT next week.
差異化的 PASCAL 技術正在世界各地的新工廠和現有工廠中廣泛採用。我們期待下週在 TCT 上公佈研究 DMR 患者的 CLASP IID 關鍵試驗的兩年結果。
We are also pleased to announce the earlier than expected completion of enrollment for the CLASP IITR trial studying TR patients with PASCAL randomized against optimal medical therapy alone. This achievement is great news for patients suffering from tricuspid regurgitation given the differentiated characteristic of PASCAL.
我們也很高興地宣布,CLASP IITR 試驗的入組工作比預期提前完成,該試驗研究隨機接受 PASCAL 治療的 TR 患者與單純最佳藥物治療。鑑於 PASCAL 的差異化特點,這項成果對於三尖瓣逆流患者來說是個好消息。
The EVOQUE launch continues to progress well as we successfully activate new sites in both the US and Europe beyond our initial trial centers. We are also increasing our field teams to deliver on our high-touch model to support new sites as we bring EVOQUE into their clinical practice in order to achieve excellent patient outcomes.
EVOQUE 的推出繼續進展順利,我們在美國和歐洲除了最初的試驗中心之外還成功啟動了新站點。我們也正在增加我們的現場團隊,以提供我們的高接觸模型來支援新站點,同時將 EVOQUE 引入他們的臨床實踐,以實現出色的患者治療效果。
The strong interest in this therapy continues to highlight the large unmet need. The full 400 patient cohort of a TRISCEND II pivotal study at one year will also be presented at TCT next week. In our continued efforts to reach more patients, a fourth and larger size EVOQUE valve, the 56 millimeter was recently approved in the US.
人們對這種療法的濃厚興趣繼續凸顯出巨大的未滿足需求。TRISCEND II 一年關鍵研究的全部 400 名患者群組也將於下週在 TCT 上公佈。在我們不斷努力涵蓋更多患者的過程中,第四種尺寸更大的 EVOQUE 瓣膜(56 毫米)最近在美國獲得批准。
The addition of this larger valve size will expand the addressable patient population. On October 1, EVOQUE became eligible for Medicare's new technology add-on payment. This additional payment above standard reimbursement is in effect for three years and will support increased access to this breakthrough therapy for the many US patients in need.
添加更大尺寸的閥門將擴大可處理的患者群體。10 月 1 日,EVOQUE 獲得了 Medicare 新技術附加付款的資格。這筆高於標準報銷的額外付款有效期為三年,並將支持更多有需要的美國患者獲得這種突破性療法。
Based on the ongoing global adoption of our two therapies, PASCAL and EVOQUE, we remain confident in our full year full year TMTT self-guidance at the high end of $320 million to $340 million. In surgical, third quarter sales from continuing operation of $240 million increased 5% over the prior year. Growth was driven by strong global adoption of Edwards premium surgical technologies INSPIRIS, MITRIS, and KONECT.
基於我們的兩種療法 PASCAL 和 EVOQUE 在全球範圍內的持續採用,我們對全年 TMTT 自我指導保持在 3.2 億至 3.4 億美元的高端充滿信心。在外科領域,第三季持續經營業務銷售額為 2.4 億美元,比上年成長 5%。成長得益於 Edwards 優質手術技術 INSPIRIS、MITRIS 和 KONECT 的全球廣泛採用。
We continue to see positive procedure growth globally for the many patients best treated surgically, including those undergoing complex procedures. We continue to expand the overall [body of] RESILIA evidence and enrollment in Europe for a [momentous] clinical trial studying MITRIS is ahead of schedule.
我們繼續看到全球許多接受最佳手術治療的患者(包括接受複雜手術的患者)的手術數量呈現積極增長。我們繼續擴大 RESILIA 證據的整體範圍,並提前在歐洲進行一項研究 MITRIS 的[重大]臨床試驗。
In addition, a comments AR manuscript has been published in the Journal of Thoracic and Cardiovascular Surgery, which shows positive outcome for patients with AR treated with RESILIA tissue valve after five years.
此外,一篇評論AR手稿已發表在《胸腔和心血管外科雜誌》上,該手稿顯示了接受RESILIA組織瓣膜治療的AR患者五年後的積極結果。
Finally, two investigator initiated registries out of Europe, Endure and Impact have shown favorable outcome in younger and more complex patients who were implanted with the RESILIA INSPIRIS valve. In summary, we continue to believe that our full year 2024 surgical sales growth will be 6% to 8%.
最後,兩名研究人員在歐洲以外發起的登記,Endure 和 Impact 在植入 RESILIA INSPIRIS 瓣膜的年輕且病情較複雜的患者中顯示出良好的結果。綜上所述,我們仍然認為 2024 年全年手術銷售額成長將為 6% 至 8%。
Turning to structural heart failure. In Q3, we closed the acquisition of Endotronix, marking our entry into implantable heart failure management or IHFM. Our vision for IHFM is consistent with our other structural heart technologies to establish a platform that ensures best-in-class outcome for patients in need, resulting in multi years of growth.
轉向結構性心臟衰竭。第三季度,我們完成了對 Endotronix 的收購,標誌著我們進入植入式心臟衰竭治療或 IHFM 領域。我們對 IHFM 的願景與我們的其他結構心臟技術一致,即建立一個平台,確保為有需要的患者提供一流的結果,從而實現多年的成長。
We released strong 12 month results from the proactive HF pivotal trial at the HFSA conference, which demonstrated significant benefit to patients managed with the Cordella system, an implantable pulmonary artery pressure sensor allowing early targeted heart failure intervention.
我們在HFSA 會議上發布了主動心臟衰竭關鍵試驗的12 個月強勁結果,該試驗證明Cordella 系統對患者有顯著益處,Cordella 系統是一種植入式肺動脈壓力感測器,可以進行早期有針對性的心力衰竭幹預。
In addition, the proactive HF2 trial has also been initiated, which will extend the evidence base for implantable heart failure management and further demonstrate the value of data-driven heart failure management.
此外,主動HF2試驗也已啟動,這將擴大植入式心臟衰竭管理的證據基礎,並進一步證明數據驅動的心臟衰竭管理的價值。
With the recent approval of Cordella in the US and the completion of our first cases, our focus is on building our commercial team, deploying physician training, case support to ensure high quality of outcomes. Revenue will ramp over time as we focus on discipline, commercialization, outcome, system usage and patient engagement.
隨著 Cordella 最近在美國獲得批准以及我們第一個病例的完成,我們的重點是建立我們的商業團隊、部署醫生培訓和病例支持,以確保高品質的結果。隨著我們專注於紀律、商業化、結果、系統使用和患者參與,收入將隨著時間的推移而增加。
And now, I will turn the call over to Scott.
現在,我將把電話轉給史考特。
Scott Ullem - Chief Financial Officer, Corporate Vice President
Scott Ullem - Chief Financial Officer, Corporate Vice President
Thanks a lot, Bernard. We were pleased with our financial results in the third quarter, starting with third quarter sales from continuing operations of $1.35 billion. Our continuing operations underlying sales growth was 9.6%, and Edwards adjusted earnings per share was $0.67, both slightly ahead of what we modeled for Q3 guidance provided in July.
非常感謝,伯納德。我們對第三季的財務表現感到滿意,第三季持續經營業務的銷售額為 13.5 億美元。我們持續經營業務的銷售成長為 9.6%,Edwards 調整後每股收益為 0.67 美元,均略高於我們 7 月提供的第三季指引模型。
A full reconciliation between our GAAP and adjusted earnings per share for continuing operations is included with today's press release. The sale of Critical Care, as well as the acquisitions we announced last month, resulted in some new features in the presentation of our financial results this quarter.
今天的新聞稿中包含了我們的公認會計準則與持續經營的調整後每股收益之間的全面調節。出售重症監護業務以及我們上個月宣布的收購,為本季的財務表現帶來了一些新特點。
First, it's important to note that our original sales guidance for Q3 assumed we would own Critical Care for all of Q3. We were pleased to close the sale of Critical Care in early September, so we did not have Critical Care sales in the last month of Q3.
首先,值得注意的是,我們最初的第三季銷售指引假設我們將在整個第三季擁有重症監護服務。我們很高興在 9 月初結束了重症監護的銷售,因此我們在第三季的最後一個月沒有重症監護的銷售。
Second, the discontinued operations in today's release and the 10-Q that we will file in early November are comprised of the two components that represent our plan to exit product groups that are not focused on implantable medical innovations for structural heart disease. The discontinued operations includes Critical Care, as well as a small non-core product group that reduces the reported sales of surgical structural heart.
其次,今天發布的已終止業務以及我們將於 11 月初提交的 10-Q 報告由兩個部分組成,這兩個部分代表我們計劃退出不專注於結構性心臟病植入式醫療創新的產品組。停產的業務包括重症監護,以及一個小型非核心產品組,該產品組減少了外科結構心臟的報告銷售。
Third, as it relates to previously announced acquisitions, we do not expect meaningful contribution to Edwards sales in 2024 and 2025. The additional operating expense from three of the four acquisitions announced is included in our fourth quarter earnings per share guidance. Additionally, there is a new line of the profit and loss statement above operating income called other operating expense and income, reflecting an impact related to Critical Care transition service agreements.
第三,由於這與先前宣布的收購有關,我們預計不會對 Edwards 2024 年和 2025 年的銷售做出有意義的貢獻。宣布的四項收購中的三項所帶來的額外營運費用已包含在我們第四季的每股盈餘指引中。此外,損益表中營業收入上方新增了一行,稱為其他營業費用和收入,反映了與重症監護過渡服務協議相關的影響。
So now I'll cover additional details of our continuing operations P&L. For the third quarter, our adjusted gross profit margin was elevated at 80.7%, slightly higher year-over-year and sequentially due to variable expense timing. We expect fourth quarter gross margin to be in line with the high-end of our 76% to 78% full year guidance range, which is also a reasonable preliminary modeling assumption for 2025.
現在我將介紹我們持續經營損益表的更多細節。第三季度,由於可變費用時間安排,我們的調整後毛利率上升至 80.7%,年比和季比略有上升。我們預計第四季度毛利率將與我們 76% 至 78% 全年指導範圍的高端一致,這也是 2025 年合理的初步建模假設。
Selling, general and administrative expenses in the quarter were $421 million or 31.1% of sales compared to $382 million in the prior year. This increase was driven by an expansion of field-based personnel to support growth of our transcatheter therapies, including the launch and rollout of PASCAL and EVOQUE.
本季的銷售、一般和管理費用為 4.21 億美元,佔銷售額的 31.1%,而去年同期為 3.82 億美元。這一增長是由於現場人員的增加來支持我們經導管療法的發展,包括 PASCAL 和 EVOQUE 的推出和推廣。
Research and development expenses in the third quarter grew 4% over the prior year to $253 million or 18.7% of sales. This increase was primarily the result of continued investments in our transcatheter valve innovations, including increased clinical trial activity.
第三季的研發費用比去年同期成長 4%,達到 2.53 億美元,佔銷售額的 18.7%。這一增長主要是由於我們對經導管瓣膜創新的持續投資,包括臨床試驗活動的增加。
Adjusted operating profit margin in Q3 was elevated at 31.4%, reflecting unusual benefits of variable expense timing. We expect Q4 adjusted operating margin to decline to the mid-20s, resulting in full year 2024 average adjusted operating profit margin of approximately 27% to 28%, which is also a reasonable preliminary modeling assumption for 2025 with forecasts for expanding margin thereafter.
第三季調整後營業利潤率上升至 31.4%,反映出變動費用時機的不尋常優勢。我們預期第四季調整後營業利潤率將下降至20%左右,導致2024年全年平均調整後營業利潤率約為27%至28%,這也是對2025年合理的初步建模假設,預計此後利潤率將擴大。
Turning to taxes, our reported tax rate this quarter was 10.1% or adjusted 12.4%. We expect a similar adjusted tax rate in Q4. As a reminder, our original 2024 adjusted tax rate guidance range was 14% to 17%, and we are benefiting this year from several one-time tax events, resulting in a lower than originally expected rate.
說到稅收,本季我們報告的稅率為 10.1%,調整後為 12.4%。我們預計第四季會有類似的調整後稅率。提醒一下,我們原來的 2024 年調整後稅率指導範圍是 14% 至 17%,今年我們受益於幾起一次性稅收事件,導致稅率低於原來的預期。
Foreign exchange rates decreased third quarter adjusted sales growth by 70 basis points, or $7.9 million compared to the prior year. GAAP earnings per share of $5.13 reflects the one-time gain on the sale of Critical Care. Also unique to this quarter were several special items, including a restructuring charge, a gain on our original investment in Endotronix, and a $30 million charitable donation to support the work of the Edwards Life Sciences Foundation.
外匯匯率使第三季調整後銷售成長較上年下降 70 個基點,即 790 萬美元。GAAP 每股收益為 5.13 美元,反映了出售重症監護業務的一次性收益。本季度的獨特之處還有幾個特殊項目,包括重組費用、我們對 Endotronix 原始投資的收益,以及用於支持愛德華茲生命科學基金會工作的 3000 萬美元慈善捐款。
Turning to the balance sheet, following the Critical Care sale, we had approximately $3.5 billion of cash and cash equivalents as of September 30. You'll see a balance sheet in our 10-Q filing in early November. During the third quarter, the company repurchased $1 billion of stock through a combination of pre-established trading plans and accelerated share repurchase programs.
轉向資產負債表,在出售重症監護後,截至 9 月 30 日,我們擁有約 35 億美元的現金和現金等價物。您將在 11 月初的 10-Q 報告中看到資產負債表。第三季度,該公司透過預先制定的交易計畫和加速股票回購計畫相結合,回購了 10 億美元的股票。
Edwards currently has approximately $1.4 billion remaining under its share repurchase authorization. Based on our year-to-date share repurchase activity, we expect average diluted shares outstanding for Q4 2024 to be between [590 million and 595 million].
Edwards 目前的股票回購授權剩餘約 14 億美元。根據我們今年迄今的股票回購活動,我們預計 2024 年第四季的平均稀釋後流通股將在[5.9億和5.95億]。
I'll finish with comments related to guidance. Our full year guidance for Edwards sales growth of 8% to 10% remains unchanged, as does our guidance for our three product groups.
我將以與指導相關的評論結束。我們對 Edwards 全年銷售成長 8% 至 10% 的指導保持不變,對三個產品組的指導也保持不變。
Our guidance assumes fourth quarter year-over-year TAVR growth below the full year TAVR range of 5% to 7%. Recall, Q4 of 2023 was an especially strong quarter for TAVR. In Q4 of this year, we have seen impact from the hurricanes in the southeast, as well as a one-time impact from a China distributor rebate adjustment and fewer selling days versus Q3.
我們的指引假設第四季 TAVR 年成長低於全年 TAVR 範圍 5% 至 7%。回想一下,2023 年第四季對於 TAVR 來說是一個特別強勁的季度。今年第四季度,我們看到了東南部颶風的影響,以及中國經銷商回扣調整的一次性影響以及銷售天數較第三季度減少的影響。
It's important to note that our daily TAVR procedure volume is still forecasted to be sequentially higher in Q4 versus Q3. We expect Q4 sales of $1.33 billion to $1.39 billion and Q4 earnings per share of $0.53 to $0.57. We look forward to providing detailed 2025 financial guidance at our investor conference in New York on December 4.
值得注意的是,我們預計第四季的每日 TAVR 手術量仍將比第三季連續增加。我們預計第四季銷售額為 13.3 億美元至 13.9 億美元,每股收益為 0.53 美元至 0.57 美元。我們期待在 12 月 4 日於紐約舉行的投資者會議上提供詳細的 2025 年財務指導。
And with that, I'll pass it back to Bernard.
這樣,我會將其傳回給伯納德。
Bernard Zovighian - President, Chief Executive Officer
Bernard Zovighian - President, Chief Executive Officer
Thank you, Scott. We are very confident that our innovative therapy will allow Edwards to treat more patients around the world and continue to drive strong organic growth in the years to come. As patients and clinicians increasingly recognize the significant benefit of breakthrough technologies, we remain as optimistic as ever about the long-term growth opportunity.
謝謝你,斯科特。我們非常有信心,我們的創新療法將使 Edwards 能夠治療世界各地的更多患者,並在未來幾年繼續推動強勁的有機成長。隨著患者和臨床醫生越來越認識到突破性技術的顯著優勢,我們對長期成長機會一如既往地樂觀。
With that, I'll turn it back to Mark.
有了這個,我會把它轉回給馬克。
Mark Wilterding - Senior Vice President, Investor Relations
Mark Wilterding - Senior Vice President, Investor Relations
Thank you very much, Bernard. We're ready to take questions now. In order to allow for broad participation, we ask that you please limit the number of questions to one plus one follow-up. If you have additional questions, please re-enter the queue, and management will answer as many participants as possible during the remainder of the call.
非常感謝你,伯納德。我們現在準備好回答問題。為了讓廣泛參與,我們要求您將問題數量限制為一加一跟進。如果您還有其他問題,請重新進入隊列,管理層將在通話的剩餘時間內回答盡可能多的參與者。
Please refrain from asking questions related to our Early TAVR or TRISCEND II pivotal trials. We will present data on those trials next week at TCT and host investor briefings on both Monday and on Wednesday after the presentation to discuss the results in more detail. We really hope to see you there.
請不要詢問與我們的早期 TAVR 或 TRISCEND II 關鍵試驗相關的問題。我們將在下週的 TCT 上公佈這些試驗的數據,並在演示結束後的周一和周三舉辦投資者簡報會,以更詳細地討論結果。我們真誠地希望在那裡見到您。
Diego, please go ahead with additional details on how participants can access the Q&A portion of the call.
Diego,請繼續提供有關參與者如何存取電話問答部分的更多詳細資訊。
Operator
Operator
(Operator Instructions) Larry Biegelsen, Wells Fargo.
(操作說明)Larry Biegelsen,富國銀行。
Larry Biegelsen - Analyst
Larry Biegelsen - Analyst
Good afternoon. Thanks for taking the question. Scott, I guess maybe help us bridge the Q4 guidance implies about $2.20 on an annual basis, just using the midpoint times four. Can you bridge from the prior guidance of $2.75 at the midpoint? Did it only change for Critical Care, which we thought was always going to be $0.40 diluted? Seems like something else changed, and I had one follow-up.
午安.感謝您提出問題。斯科特,我想也許可以幫助我們彌合第四季度的指導意味著每年約 2.20 美元,僅使用中點乘以四。您能否在先前的指導價 2.75 美元的中點上進行橋接?是否只有重症監護發生了變化,我們認為重症監護總是會稀釋 0.40 美元?似乎還有其他事情發生了變化,我進行了後續行動。
Scott Ullem - Chief Financial Officer, Corporate Vice President
Scott Ullem - Chief Financial Officer, Corporate Vice President
Yeah. Thanks for the question, Larry. There are a couple of things that changed. One was the elimination of Critical Care, which on a full-year basis would have impacted earnings per share to the tune of about $0.35. We're also picking up in the fourth quarter some additional expense related to three of the four acquisitions that we announced earlier, which hit us in Q4. Q4 does not reflect some of the benefits of the right sizing that we conducted earlier and that we will see in 2025.
是的。謝謝你的提問,拉里。有幾件事發生了變化。其中之一是取消重症監護,將影響全年每股收益約 0.35 美元。我們還在第四季度收到了一些與我們之前宣布的四項收購中的三項相關的額外費用,這在第四季度對我們造成了打擊。第四季並沒有反映出我們之前進行的、我們將在 2025 年看到的正確規模調整帶來的一些好處。
Larry Biegelsen - Analyst
Larry Biegelsen - Analyst
That's helpful. And then, just a follow-up on that side --
這很有幫助。然後,只是那邊的後續行動--
Bernard Zovighian - President, Chief Executive Officer
Bernard Zovighian - President, Chief Executive Officer
No, just to add on what Scott said, Larry, obviously we are also expecting growth from our continued operation in 2025 together with the EPS leverage. And we will provide a full guidance during investor conference in December.
不,只是補充一下史考特所說的,拉里,顯然我們也預計 2025 年我們的持續營運以及每股盈餘槓桿會帶來成長。我們將在12月份的投資者會議期間提供全面的指導。
Larry Biegelsen - Analyst
Larry Biegelsen - Analyst
Okay. I mean, that was my follow-up, Scott. I mean, I know you anticipated the question. Just using that Q4 EPS of $0.55 at the midpoint, people are going to multiply and get to $2.20. How should we think about that in the context of 2025 EPS? You gave some helpful color on the operating margin. Is there anything else we should consider when we're trying to kind of model 2025 here?
好的。我的意思是,這是我的後續行動,史考特。我的意思是,我知道你預料到了這個問題。僅使用第四季度 EPS 0.55 美元的中點,人們就會乘以 2.20 美元。在 2025 年每股盈餘的背景下,我們該如何思考這一點?您對營業利潤率給了一些有用的說明。當我們嘗試建立 2025 年模型時,還有什麼是我們應該考慮的嗎?
Scott Ullem - Chief Financial Officer, Corporate Vice President
Scott Ullem - Chief Financial Officer, Corporate Vice President
Yeah. Obviously, the big driver is topline growth, and we'll be prepared to talk about that for Edwards and for different product lines on December 4. And you're right, we tried to give you some building blocks for margins, both operating margin. We talked about the special tax rate benefits we achieved in 2024, which we're not going to model achieving in 2025.
是的。顯然,最大的推動力是營收成長,我們將準備在 12 月 4 日討論 Edwards 和不同產品線的這一點。你是對的,我們試圖為你提供一些利潤的建構模組,包括營業利潤。我們討論了 2024 年實現的特殊稅率優惠,但我們不會對 2025 年實現的情況進行建模。
And as Bernard just mentioned, we're going to see benefits from some of the actions we've taken this year when we hit the full year 2025. So those are the different moving pieces that we can give you for now, and we'll take you through the topline impact in December.
正如伯納德剛才提到的,當我們進入 2025 年全年時,我們將看到我們今年採取的一些行動所帶來的好處。這些是我們目前可以為您提供的不同的動人內容,我們將帶您了解 12 月的營收影響。
Operator
Operator
Vijay Kumar, Evercore ISI.
維傑·庫馬爾,Evercore ISI。
Vijay Kumar - Analyst
Vijay Kumar - Analyst
Hi, guys. Thank you for taking my question. Scott, maybe if I could go back to this Q4 guidance assumptions, I think you called out a few line items on TAVR between the hurricane, China. Could you parse out what the impact of hurricane, I'm assuming we've already seen some impact, and what was China?
嗨,大家好。感謝您回答我的問題。斯科特,也許我可以回到第四季度的指導假設,我認為您在中國颶風期間提出了有關 TAVR 的一些項目。可以分析一下颶風的影響嗎?
Is this just one timer on China? Could there be some lingering impact as we think about next year? And based, I know you said lesser days versus third quarter, but on a year-on-year basis, any change in number of days in Q4?
這只是中國的計時器嗎?當我們考慮明年時,是否會產生一些揮之不去的影響?我知道您說的天數比第三季少,但與去年同期相比,第四季的天數有什麼變化嗎?
Scott Ullem - Chief Financial Officer, Corporate Vice President
Scott Ullem - Chief Financial Officer, Corporate Vice President
Sure. Thanks for the question, Vijay. First on China, this is a one-time adjustment to a rebate for a distributor in China. It does not have anything to do with our operations or our sales growth in China at this point.
當然。謝謝你的提問,維傑。首先是在中國,這是針對中國經銷商的回扣的一次性調整。目前這與我們在中國的營運或銷售成長沒有任何關係。
As it relates to selling days, yeah, there are three fewer selling days in Q4 than there were in Q3, and that impacts us when we start talking about sales dollars. But what's important to know and remember is the procedure volume on an average daily basis is growing sequentially in Q4 over Q3.
是的,與銷售天數相關,第四季的銷售天數比第三季少了三天,當我們開始談論銷售收入時,這會影響我們。但重要的是要了解並記住,第四季度的日均手術量比第三季度連續成長。
Vijay Kumar - Analyst
Vijay Kumar - Analyst
Understood. And then maybe one more related to the guidance here. What is the implied operating margins here for Q4 when you look at the EPS and the revenue sales dollars? Is that something like mid-25s? And I'm just trying to think what is the right run rate here on operating margins as you get the benefit from right-sizing expense line item? And sorry, back on the days -- on a year-on-year basis, was it consistent or did the year-on-year basis change?
明白了。也許還有一個與此處的指導相關的內容。當您查看每股收益和銷售收入時,第四季度的隱含營業利潤率是多少?這是25歲左右的樣子嗎?我只是想想想,當您從正確調整費用項目中獲益時,營業利潤率的正確運行率是多少?抱歉,回顧過去,與去年同期相比,情況是一致的還是同比發生了變化?
Scott Ullem - Chief Financial Officer, Corporate Vice President
Scott Ullem - Chief Financial Officer, Corporate Vice President
Well, I understood the first part of your question. Let me answer it, and then maybe you can help me on the second part of the question. So yes, for Q4, the guidance assumes mid-20s or implies [mid-20s percentage] operating margin. For next year, we expect that to grow to the range of 27% to 28%, which is also the same as our full year 2024 operating margin. And help me with the other piece of your question, Vijay.
嗯,我理解你問題的第一部分。讓我回答一下,然後也許你可以幫我解決問題的第二部分。因此,是的,對於第四季度,該指導假設營業利潤率為 20 多歲或暗示 [20 多歲百分比]。明年,我們預計這一數字將成長至 27% 至 28%,這也與我們 2024 年全年的營業利潤率相同。請幫我解答你的另一個問題,Vijay。
Vijay Kumar - Analyst
Vijay Kumar - Analyst
Sorry, on the days -- fourth quarter days versus fourth quarter '23. I was looking on a year-on-year basis on the days common.
抱歉,關於這些日子——第四季的日子與 23 年第四季的日子相比。我查看的是常見日期的同比情況。
Scott Ullem - Chief Financial Officer, Corporate Vice President
Scott Ullem - Chief Financial Officer, Corporate Vice President
I believe the selling days were comparable or the same in Q4 of 2023 as in 2024. We'll check that. I'll come back on if that's not right.
我認為 2023 年第四季的銷售天數與 2024 年相當或相同。我們會檢查一下。如果那不對的話我會回來的。
Operator
Operator
Robbie Marcus, JPMorgan.
羅比馬庫斯,摩根大通。
Robbie Marcus - Analyst
Robbie Marcus - Analyst
Thanks for taking the questions. I'll switch it over to some of the products. TMTT again came in better than expected. We've seen from your competitor a nice quarter on the repair side. I was wondering if you could talk about on tricuspid repair specifically. I was wondering if you could talk about your tricuspid replacement and how you're seeing doctors choose in the market which patients are appropriate for which and the decision making process.
感謝您提出問題。我會將其切換到某些產品。TMTT再次表現優於預期。我們從你的競爭對手那裡看到了維修方面的一個不錯的季度。我想知道您能否具體談談三尖瓣修復術。我想知道您是否可以談談您的三尖瓣置換術以及您看到醫生如何在市場上選擇哪些患者適合哪些患者以及決策過程。
Daveen Chopra - Corporate Vice President, Transcatheter Mitral and Tricuspid Therapies
Daveen Chopra - Corporate Vice President, Transcatheter Mitral and Tricuspid Therapies
Hey, thanks, Robbie. This is Daveen. Appreciate the question. Maybe I'll just start off with a couple overall comments on EVOQUE. Obviously, we've been very pleased so far with the introduction of EVOQUE in both the US and in Europe. We've really seen strong physician and patient demand, which really enforces that there's a lot of unmet needs for these patients.
嘿,謝謝,羅比。這是戴文。感謝這個問題。也許我會先對 EVOQUE 進行一些總體評論。顯然,到目前為止,我們對 EVOQUE 在美國和歐洲的推出感到非常高興。我們確實看到了醫生和患者的強烈需求,這確實迫使這些患者有許多未被滿足的需求。
And we've loved to see so far with EVOQUE that we've got very predictable times that are very similar to the clinical trial that are very similar from both clinical trial sites as well as new sites. And clinical outcomes are very much similar to TRISCEND II.
到目前為止,我們很高興看到 EVOQUE 的時間非常可預測,與臨床試驗非常相似,臨床試驗地點和新地點都非常相似。臨床結果與 TRISCEND II 非常相似。
And we also have seen in the US where we just have EVOQUE that from our experience in Europe where we have both repair and replacement, we see that it's important to have a portfolio of both repair and replacement technologies to really treat the diversity of these complex patients that are tricuspid patients.
我們在美國也看到,我們只有 EVOQUE,根據我們在歐洲的經驗,我們同時提供維修和更換,我們看到擁有維修和更換技術的組合來真正處理這些複雜的多樣性非常重要。 。
And so right now, we're continuing to open up new centers, activating new sites, focusing on other big tricuspid centers, really with robust training and high clinical support. And we're continuing to add to our clinical kind of support training team.
因此,現在,我們正在繼續開設新的中心,啟動新的地點,專注於其他大型三尖瓣中心,真正提供強有力的培訓和高度的臨床支援。我們正在繼續增加我們的臨床支援培訓團隊。
Specifically, to your question about repair and replacement, I think we're all still figuring that out about who's the right patient for each. We see that there may be some anatomical considerations where one may be better for than another. But I think as a world, we're still all trying to figure this out. But we really do believe that you need both technologies to really see to treat the most number of patients.
具體來說,對於您有關維修和更換的問題,我認為我們仍在弄清楚誰是適合每位患者的患者。我們發現可能存在一些解剖學的考慮,其中一種可能比另一種更好。但我認為作為一個世界,我們仍在努力解決這個問題。但我們確實相信,您需要這兩種技術才能真正治療最多數量的患者。
Two other quick comments are, obviously over time, we believe that EVOQUE in our portfolio, now if you pull back up and look at TMTD, EVOQUE going to become a larger and larger percent of our portfolio. But right now, PASCAL is still our largest growth driver on a year-on-year basis just because it's a more established base and a larger base overall. But we look exciting to treating more and more patients with both EVOQUE and PASCAL.
另外兩個簡短的評論是,顯然隨著時間的推移,我們相信 EVOQUE 在我們的投資組合中,現在如果你回頭看看 TMTD,EVOQUE 將在我們的投資組合中佔據越來越大的比例。但目前,PASCAL 仍然是我們同比最大的成長動力,因為它的基礎更成熟,整體基礎更大。但我們對於使用 EVOQUE 和 PASCAL 治療越來越多的患者感到興奮。
Robbie Marcus - Analyst
Robbie Marcus - Analyst
Great. Maybe just as a quick follow up on TAVR, you've now had three more months to kind of evaluate the market and really dig into the capacity issue. And I'm asking this more from a market perspective because none of your competitors validated a capacity issue.
偉大的。也許就像 TAVR 的快速後續一樣,您現在還有三個月的時間來評估市場並真正深入研究容量問題。我從市場角度多提出這個問題,因為你們的競爭對手都沒有驗證容量問題。
And so, when you see it, I imagine that you're one of the biggest in the structural heart lab. So I imagine you probably have the best view. But how are you thinking about capacity here? Is it more of a TAVR volume issue versus capacity?
因此,當你看到它時,我想你是結構心臟實驗室中最大的人之一。所以我想你可能擁有最好的視野。但是您如何考慮這裡的容量?這更多的是 TAVR 體積問題還是容量問題?
I know the market is still substantial from a top-down basis, just because we don't hear anybody else validating the capacity. So I'd love to get your thoughts there on what you're seeing on the ground. Thanks a lot.
我知道從自上而下的角度來看,市場仍然很大,只是因為我們沒有聽到其他人驗證容量。因此,我很想了解您對實地所見所聞的看法。多謝。
Larry Wood - Corporate Vice President and Group President, Transcatheter Aortic Valve Replacement and Surgical Structural Heart
Larry Wood - Corporate Vice President and Group President, Transcatheter Aortic Valve Replacement and Surgical Structural Heart
Sure. Thanks, Robbie. This is Larry. Yeah. It's something we spend a lot of time on in the quarter. We spend a lot of time with hospital administrators and with our physicians in the field. And I think one of the things to just think about is given our market position overall, we're more dependent on market growth than any of our competitors are.
當然。謝謝,羅比。這是拉里。是的。這是我們本季花費大量時間的事情。我們花了很多時間與醫院管理人員和現場醫生交流。我認為需要考慮的一件事是考慮到我們的整體市場地位,我們比任何競爭對手都更依賴市場成長。
For people that are coming off small bases, if they pick up a little bit of share or a few cases here and there, they don't really necessarily see the capacity constraints in the same way. I also think you just have to look at all of the new technology in the last couple of years that's coming to the [Cath Lab] space. And frankly, we're part of the problem.
對於那些從小基地出來的人來說,如果他們獲得了一點份額或到處都有一些案例,他們不一定會以同樣的方式看到容量限制。我還認為你只需要看看過去幾年出現在 [Cath Lab] 領域的所有新技術。坦白說,我們也是問題的一部分。
As Daveen's growing and bringing in new products like EVOQUE, and we see continued adoption of PASCAL, and you see adoption of other technologies, it's just putting tremendous pressure on the structural heart teams to be able to prioritize patients and to move patients around.
隨著Daveen 的不斷發展並引入EVOQUE 等新產品,我們看到PASCAL 的持續採用,你也看到其他技術的採用,這給結構心臟團隊帶來了巨大的壓力,要求他們能夠優先考慮患者並轉移患者。
Now, we've been very encouraged in our discussions with administrators that they see this as being a long-term growth part of their hospital systems, which means they know I think are starting to realize just not that they're going to have to add some capacity, but they're just not going to be able to move resources around to be able to address the patient needs.
現在,我們在與管理人員的討論中感到非常鼓舞,他們認為這是醫院系統長期增長的一部分,這意味著他們知道我認為他們開始意識到他們不必這樣做增加一些能力,但他們無法調動資源來滿足患者的需求。
So we have heard of hospitals that are now specifically investing in their structural heart space so that you can meet these needs. But it's a little bit different by hospital. There's some places that maybe the constraints are a little bit more physical constraints with rooms than in other places. It's more just a staffing issue, and they can prioritize it.
因此,我們聽說有些醫院現在正在專門投資其心臟結構空間,以便滿足這些需求。但不同醫院的情況略有不同。有些地方的限制可能是房間的物理限制比其他地方多一些。這更只是一個人員配置問題,他們可以優先考慮它。
But one of the reasons we brought together a lot of administrators is so that they could share best practices for how they're trying to manage all of the challenges that they have and try to move that forward. And we'll continue to do that, until this gets resolved. But that's kind of an update on where we are.
但我們將許多管理員聚集在一起的原因之一是,他們可以分享最佳實踐,了解他們如何應對所面臨的所有挑戰,並努力推動這項進程。我們將繼續這樣做,直到問題解決為止。但這是我們現狀的更新。
But one thing I will stress is it's not a shortage of patients. I think we do see backlogs growing. We say time to treat is increasing for our TAVR patients. And that's just the other issue that we have to address because we know these patients don't wait well.
但我要強調的一件事是,病人並不短缺。我認為我們確實看到積壓的情況在增加。我們說 TAVR 患者的治療時間正在增加。這只是我們必須解決的另一個問題,因為我們知道這些患者不會等待。
Bernard, do you have anything to add just as a broader company?
伯納德,作為一家更廣泛的公司,您還有什麼要補充的嗎?
Bernard Zovighian - President, Chief Executive Officer
Bernard Zovighian - President, Chief Executive Officer
No. I think you said it all and well, Larry. We are part of the issue here. We are such an innovator in the space with PASCAL, with EVOQUE and with TAVR. We have a market leading position in TAVR. And you need to realize also that when we bring in EVOQUE in one of the larger TAVR centers, it is taking -- it is needing a lot of resource.
不。我認為你說得很好,拉里。我們是這裡問題的一部分。我們是 PASCAL、EVOQUE 和 TAVR 領域的創新者。我們在 TAVR 領域處於市場領先地位。您還需要意識到,當我們將 EVOQUE 引入較大的 TAVR 中心之一時,它需要大量資源。
We want to make TR is a new disease. So the health basically, this heart team is learning about the new disease is training about the new device. We are -- then they are screening patients. So it's not like, one day kind of adjusting their workflow. It is taking multiple days, weeks, but we are very confident that they are patients, tricuspid patient, mitral patient, AS patient. We are bringing innovative technologies.
我們想讓 TR 成為一種新疾病。因此,基本上,健康方面,這個心臟團隊正在了解新疾病,並正在接受有關新設備的培訓。我們——然後他們正在篩檢患者。所以這不像有一天會調整他們的工作流程。這需要幾天、幾週的時間,但我們非常有信心他們是患者,三尖瓣患者、二尖瓣患者、AS 患者。我們正在帶來創新技術。
The healthcare system have proven to us in the past, they know how to scale, and all of these procedures are profitable. So we are confident that yes, it is an issue right now. We don't believe that it is a long-term issue, which is not going to take a few weeks to solve, but it is not going to take a few years to solve also.
醫療保健系統過去已經向我們證明,他們知道如何擴展,並且所有這些程序都是有利可圖的。所以我們有信心,是的,這是現在的問題。我們不認為這是一個長期問題,它不會需要幾週的時間才能解決,但也不會需要幾年的時間來解決。
Operator
Operator
David Roman, Goldman Sachs.
大衛羅曼,高盛。
David Roman - Analyst
David Roman - Analyst
I wanted to start on just laying out some of the pieces here post TCT. And I appreciate that we won't see the data until next week. But as you think about the subsequent activities that would take place either on the asymptomatic patient population as it relates to label expansion or additional patient activation efforts, what happens next there?
我想首先在 TCT 後在這裡佈置一些部分。我很高興我們要到下週才能看到數據。但是,當您考慮對無症狀患者群體進行的與標籤擴展或額外患者激活工作相關的後續活動時,接下來會發生什麼?
And maybe you can kind of talk through some of the dynamics on the tricuspid side as well, appreciating here that the FDA has already approved EVOQUE and NCD is already underway, and you have the NTAP to support adoption.
也許您也可以談談三尖瓣一側的一些動態,在這裡感謝 FDA 已經批准了 EVOQUE,NCD 已經在進行中,並且您有 NTAP 來支持採用。
But maybe help us think about the activities that happen subsequent to TCT, and then when we should realistically expect to see a benefit of that flow through the business assuming positive outcomes in these studies?
但也許可以幫助我們思考 TCT 之後發生的活動,然後假設這些研究取得正面成果,我們什麼時候應該真正期望看到該業務流程的好處?
Bernard Zovighian - President, Chief Executive Officer
Bernard Zovighian - President, Chief Executive Officer
Thanks, David, for the question. Anything related to TCT, I suggest we wait until next week. What we did in the next week to make sure we can go very deep with you. We have an event on Monday, and we have even Wednesday, after the two presentations. So we will go deep then, and we are also going deep at investor conference. Now with regards to the NCD for EVOQUE, maybe you want to touch on that, Daveen?
謝謝大衛提出這個問題。任何與TCT相關的事情,我建議我們等到下週。我們在下週做了什麼,以確保我們能夠與您進行深入交流。我們週一有一個活動,在兩次演講之後我們甚至在星期三也有活動。所以我們接下來會深入,在投資者大會上我們也會深入。現在,關於 EVOQUE 的 NCD,也許您想談談這一點,Daveen?
Daveen Chopra - Corporate Vice President, Transcatheter Mitral and Tricuspid Therapies
Daveen Chopra - Corporate Vice President, Transcatheter Mitral and Tricuspid Therapies
Yeah. No problem at all. Right now, we are obviously in a national coverage analysis position where CMS is working along their pathway and through their work where we expect to see a draft NCD hopefully come out by year-end, and we hope to have an NCD in place by the end of Q1. And we're fully supportive of CMS's efforts to get this out as quickly as possible to support patients.
是的。完全沒問題。目前,我們顯然處於全國覆蓋率分析的位置,CMS 正在沿著他們的路徑和工作開展工作,我們希望看到 NCD 草案預計在年底前出台,並且我們希望在第一季末。我們完全支持 CMS 盡快解決這個問題以支持患者的努力。
David Roman - Analyst
David Roman - Analyst
Okay. And then maybe just a follow-up on the P&L here and understanding that we'll get the guidance in December. But the 27% to 28% operating margin as a starting point implies flattish year-over-year. So is conceptually the right way to think about that, Scott, that the actions you've taken here to right-size the company effectively help you fund the incremental investments associated with the acquired assets, and that that forms a new base of operating margin off of which we can see expansion longer term?
好的。然後也許只是對損益表進行跟進,並了解我們將在 12 月獲得指導。但以 27% 至 28% 的營業利潤率作為起點,意味著與去年同期持平。因此,從概念上來說,思考這個問題的正確方法是,斯科特,你在這裡採取的調整公司規模的行動有效地幫助你為與所收購資產相關的增量投資提供資金,並形成了新的營業利潤基礎從長遠來看,我們可以看到擴張嗎?
And then maybe just, Daveen, to clarify can you just describe the interplay between the NCD and the NTAP post Q1 of next year?
然後,Daveen,請澄清一下,您能否描述一下明年第一季後 NCD 和 NTAP 之間的相互作用?
Scott Ullem - Chief Financial Officer, Corporate Vice President
Scott Ullem - Chief Financial Officer, Corporate Vice President
Well, I'll start. And you said it perfectly, David, yes, 27% to 28% implies the impact of the acquisitions and the rightsizing moves that we made this year. And it is a base off of which we will grow. And our plan is that we're going to continue to expand operating margins after we get through 2025. Daveen?
好吧,我要開始了。大衛,你說得很好,是的,27% 到 28% 意味著我們今年進行的收購和規模調整舉措的影響。這是我們成長的基礎。我們的計劃是,到 2025 年之後,我們將繼續擴大營業利潤率。戴文?
Daveen Chopra - Corporate Vice President, Transcatheter Mitral and Tricuspid Therapies
Daveen Chopra - Corporate Vice President, Transcatheter Mitral and Tricuspid Therapies
Yeah, sure. So the NTAP, which started October 1 is about incremental payment above the existing DRG. So a hospital center depending on their cost structure and it's very center-dependent, can get incremental payment when they do an EVOQUE case for Medicare for that case.
是的,當然。因此,10 月 1 日開始的 NTAP 是關於現有 DRG 之上的增量付款。因此,醫院中心根據其成本結構並且非常依賴中心,當他們為該病例進行 Medicare 的 EVOQUE 病例時可以獲得增量付款。
The NCD is about coverage meaning which patients are covered or not to get the payment. So the NCD and what is written in the NCD will help determine which patients and which centers do EVOQUE and which patients would get reimbursed. The NTAP helps increase the amount of payment for each patient when they do a case.
非傳染性疾病與承保範圍有關,即哪些患者可以獲得承保,哪些患者不能獲得付款。因此,NCD 以及 NCD 中的內容將有助於確定哪些患者和哪些中心接受 EVOQUE,以及哪些患者可以獲得報銷。NTAP 有助於增加每位病患辦案時的支付金額。
Operator
Operator
Travis Steed, Bank of America.
特拉維斯·斯蒂德,美國銀行。
Travis Steed - Analyst
Travis Steed - Analyst
Hey, thanks for taking the question on. Just wanted to clarify the 27% to 28% op margin. Does that includes the JenaValve the deal that hasn't closed and includes kind of everything, the cost savings? And it seems like that's like [$240 million, $250 million] in earnings range. I don't know if there's a floor or you'd like to comment on that for the EPS side?
嘿,謝謝你提出這個問題。只是想澄清 27% 至 28% 的營運利潤率。這是否包括尚未完成的 JenaValve 交易以及所有內容以及成本節約?收入範圍似乎是[2.4 億美元,2.5 億美元]。我不知道是否有發言權,或者您想對 EPS 方面發表評論嗎?
Scott Ullem - Chief Financial Officer, Corporate Vice President
Scott Ullem - Chief Financial Officer, Corporate Vice President
So the 27% to 28% includes three of the four acquisitions. We're not being very specific about what the implications would be for Jena. As we mentioned, we're responding to questions that we've received and we're expecting that we'll get that closed next year.
因此,27% 至 28% 包括四項收購中的三項。我們並沒有具體說明這對耶拿的影響。正如我們所提到的,我們正在回答收到的問題,預計明年就能解決這個問題。
As it relates to earnings per share, yeah, let's not go there. I don't really want to get overly specific about what that looks like, again, because we want to paint the full picture, including top line growth when we get to the investor conference in December.
因為它與每股收益有關,是的,我們不要去那裡。我真的不想再具體說明具體情況,因為我們想描繪全貌,包括 12 月投資者會議時的營收成長。
Travis Steed - Analyst
Travis Steed - Analyst
That's fair. I don't know if there's any way to quantify the JenaValve addition on that 27% to 28% op margin, but that's going to be the follow-up. But the other question I was going to ask was the 5% to 7% TAVR growth that you've kind of been at this year, is that the way to think about kind of your ongoing steady state?
這很公平。我不知道是否有任何方法可以量化 JenaValve 在 27% 至 28% 營運利潤率上的增加,但這將是後續行動。但我要問的另一個問題是,今年 TAVR 成長了 5% 到 7%,這是考慮持續穩定狀態的方式嗎?
Or do you think there's kind of catalyst that could reaccelerate that going forward? Just trying to think about like bigger picture how you're thinking about the TAVR opportunity for Edwards.
或者你認為有某種催化劑可以重新加速這一進程嗎?只是想從更大的角度思考您如何看待愛德華茲的 TAVR 機會。
Scott Ullem - Chief Financial Officer, Corporate Vice President
Scott Ullem - Chief Financial Officer, Corporate Vice President
Yeah. Travis, we're thinking about it really positively. We've got a lot of positive catalysts for TAVR. And at the same time, it's just premature to start talking about what the growth rates look like. We're excited to lay it all out for you when we get to December.
是的。特拉維斯,我們正在積極地考慮這個問題。我們對 TAVR 有很多積極的催化劑。同時,現在開始討論成長率還為時過早。我們很高興能在 12 月為您提供一切。
Bernard Zovighian - President, Chief Executive Officer
Bernard Zovighian - President, Chief Executive Officer
Maybe adding a general comment about profitability and all these things. As you have seen in Q3, we took action to optimize the company. We are looking very seriously in a very thoughtful fashion, about cost optimization, resource allocation. So what we want to deliver is sustainable, healthy, profitable growth for the years to come as a company. Thank you.
也許添加關於盈利能力和所有這些事情的一般評論。正如您在第三季所看到的,我們採取了行動來優化公司。我們正在以非常深思熟慮的方式非常認真地考慮成本優化和資源分配。因此,我們希望作為一家公司在未來幾年實現可持續、健康、盈利的成長。謝謝。
Operator
Operator
Matt Taylor, Jefferies.
馬特泰勒,杰弗里斯。
Matt Taylor - Analyst
Matt Taylor - Analyst
Hi. Thanks so much for taking the question. So I want to ask about the results, but I just want to ask about the timing of impact. If these trials are positive next week, how quickly do you think you could see some positive lift on TAVR and or TMTT from early TAVR and the tricuspid results?
你好。非常感謝您提出問題。所以我想問結果,但我只想問一下影響的時間。如果下週這些試驗呈陽性,您認為您多久可以看到早期 TAVR 和三尖瓣結果對 TAVR 和/或 TMTT 產生正面影響?
Bernard Zovighian - President, Chief Executive Officer
Bernard Zovighian - President, Chief Executive Officer
Matt, thanks for the question. Again, look, we are going to discuss this in full detail on Monday. It is a little bit not easy for us to discuss before Monday. The trial is embargo, it is a blinded study. We cannot go there right now. But for sure, on Monday, please attend the event and also at the investor conference, Larry is going to talk about TAVR.
馬特,謝謝你的提問。再說一遍,我們將在周一詳細討論這個問題。我們在周一之前討論有點不容易。該試驗是禁運的,是一項盲法研究。我們現在不能去那裡。但可以肯定的是,請參加週一的活動以及投資者會議,Larry 將談論 TAVR。
Operator
Operator
Matt Miksic, Barclays.
馬特·米克西奇,巴克萊銀行。
Matt Miksic - Analyst
Matt Miksic - Analyst
Hey, Thanks so much for taking the question and for the color on 2025. I just wanted to maybe ask Scott, I'm not sure if I missed it, but I appreciate the color on the operating margin. Wondering if at this stage, you're ready to say anything about the gross margin, FX related or otherwise.
嘿,非常感謝您提出問題以及 2025 年的顏色。我只是想問斯科特,我不確定我是否錯過了它,但我很欣賞營業利潤率的顏色。想知道在這個階段您是否準備好談論毛利率、外匯相關或其他方面的內容。
Scott Ullem - Chief Financial Officer, Corporate Vice President
Scott Ullem - Chief Financial Officer, Corporate Vice President
Yeah. Thanks a lot for the question.p I think for gross margin, we're expecting in the fourth quarter that we'll be back to the high end of our original guidance range of 76% to 78%. And that high end of 76% to 78% is also a reasonable preliminary modeling assumption for 2025.
是的。非常感謝您提出問題。76% 至 78% 的高端也是 2025 年合理的初步建模假設。
Obviously, there's a lot that can change between now and then. We got foreign exchange running through there. But at this point, that's as much as we can do to help you out.
顯然,從現在到那時,有很多事情可以改變。我們透過那裡進行外匯交易。但目前,我們能幫到你的就這麼多了。
Operator
Operator
Joanne Wuensch, Citibank.
喬安妮‧溫施,花旗銀行。
Joanne Wuensch - Analyst
Joanne Wuensch - Analyst
Good evening. Thank you so much for taking the question. I'll put them both at the front. Can you quantify the one-time impacts for the fourth quarter for TAVR? It seems like that's causing a little bit of confusion as people are thinking about how that's progressing sequentially.
晚安.非常感謝您提出這個問題。我會把它們都放在前面。您能否量化第四季 TAVR 的一次性影響?當人們思考事情是如何按順序進行時,這似乎引起了一些混亂。
And then my second question has to do with products. I haven't heard you here or talk about for M3 for mitral replacement in a while. And I don't know if you can just give a little bit of update on the timing of that or when we might see anything incremental. Thank you.
我的第二個問題與產品有關。我有一段時間沒有聽到你在這裡或談論 M3 用於二尖瓣置換術了。我不知道您是否可以提供一些有關時間安排的最新信息,或者我們何時會看到任何增量。謝謝。
Scott Ullem - Chief Financial Officer, Corporate Vice President
Scott Ullem - Chief Financial Officer, Corporate Vice President
Joanne, thanks for the question. On the first one, the specific impact that we know is relating to the China distributor adjustment, which is about $5 million. The other items that we mentioned are not something that we're ready to quantify at this point. Obviously, we'll talk about everything that happened in the quarter once we finished the quarter, but that's the one number that we can give you right now.
喬安妮,謝謝你的提問。第一個,我們所知道的具體影響與中國經銷商的調整有關,約500萬美元。我們提到的其他項目目前還沒有準備好量化。顯然,一旦我們完成本季度,我們將討論本季度發生的所有事情,但這是我們現在可以給您的唯一數字。
Daveen Chopra - Corporate Vice President, Transcatheter Mitral and Tricuspid Therapies
Daveen Chopra - Corporate Vice President, Transcatheter Mitral and Tricuspid Therapies
And a follow-up question you had, Joanne, just on about M3. No, we still continue to be excited about SAPIEN M3. This is the first transfemoral Sub-30 French mitral valve replacement system, and it's really built off SAPIEN, which we know has been put in thousands of different mitral positions.
喬安妮,你有一個關於 M3 的後續問題。不,我們仍然對 SAPIEN M3 感到興奮。這是第一個經股動脈 Sub-30 法國二尖瓣置換系統,它實際上是基於 SAPIEN 構建的,我們知道 SAPIEN 已被放置在數千個不同的二尖瓣位置。
So right now, for Europe, last quarter, we announced we continue to anticipate European launch in mid-2025, and we would have the US at some point after. Specifically related to the US, we are in the one-year follow-up period this year of the M3, and then it takes some time obviously to put the data together, get the PMA in and then there as a standard FDA timeline review whether there's a panel or not. But we continue to be excited about SAPIEN M3.
因此,目前,對於歐洲,上個季度,我們宣布繼續預計 2025 年中期在歐洲推出,之後的某個時間我們將在美國推出。具體到美國,我們今年正處於M3的一年跟踪期,然後顯然需要一些時間來整理數據,獲得PMA,然後作為標準的FDA時間表審查是否有或沒有面板。但我們仍然對 SAPIEN M3 感到興奮。
But Larry had a comment too.
但拉里也發表了評論。
Larry Wood - Corporate Vice President and Group President, Transcatheter Aortic Valve Replacement and Surgical Structural Heart
Larry Wood - Corporate Vice President and Group President, Transcatheter Aortic Valve Replacement and Surgical Structural Heart
Just a follow-up on Scott's comment, Joanne. We can't exactly quantify the hurricane in the IV solution issue. We know that we were impacted with cases early in the quarter. But I think that's also behind us. I don't expect this to be a lingering thing throughout the quarter. And as Scott said previously, we are anticipating our average daily cases to be increasing Q4 over Q3. So I don't want to overstate the impact of these one-timer things when you look at it in the bigger picture.
喬安妮,這只是斯科特評論的後續。我們無法準確量化 IV 解決方案問題中的颶風。我們知道我們在本季度初受到了案件的影響。但我認為這也已經過去了。我預計這不會成為整個季度揮之不去的事情。正如史考特之前所說,我們預計第四季的日均病例數將比第三季增加。因此,當你從更大的角度來看時,我不想誇大這些一次性事件的影響。
Operator
Operator
Danielle Antalffy, UBS.
丹妮爾·安塔菲,瑞銀集團。
Danielle Antalffy - Analyst
Danielle Antalffy - Analyst
Hey, good afternoon, everyone. Thanks so much for taking the question and congrats on a good quarter considering everything. Just a quick question on how we should think about the competitive dynamics. And particularly in the US, we'll see some competitive (technical difficulty) next week, we might see a fourth valve come to market.
嘿,大家下午好。非常感謝您提出問題,並祝賀您在考慮到所有方面的情況後取得了良好的季度業績。只是一個關於我們應該如何考慮競爭動態的簡單問題。特別是在美國,下週我們將看到一些競爭(技術困難),我們可能會看到第四種閥門進入市場。
Would love to hear and appreciate you guys have said today your share is stable, but how you're thinking about the future? And even the receptivity so far with three valves of centers for taking on a third valve, who's losing share to that third valve? And also, the pricing dynamic -- sorry, that was a lot, but that's my only question. Thanks so much.
我很想聽到並感謝你們今天說你們的份額是穩定的,但你們對未來有何看法?即使到目前為止中心的三個瓣膜對第三個瓣膜的接受能力,誰正在失去第三個瓣膜的份額?還有定價動態——抱歉,這個問題太多了,但這是我唯一的問題。非常感謝。
Larry Wood - Corporate Vice President and Group President, Transcatheter Aortic Valve Replacement and Surgical Structural Heart
Larry Wood - Corporate Vice President and Group President, Transcatheter Aortic Valve Replacement and Surgical Structural Heart
Hi, Danielle. Maybe I'll start, and then I'll let Bernard comment on just kind of broader company aspects. We do charge a premium for our platform. We believe our S3 UR represents absolute best-in-class technology and best-in-class performance. It takes all of the things that we've always loved about SAPIEN 3 Ultra but added our RESILIA tissue which we have a deep history with from our surgical business. So we think our platform deserves the premium that we charge globally.
嗨,丹妮爾。也許我會開始,然後我會讓伯納德評論更廣泛的公司方面。我們確實對我們的平台收取溢價。我們相信我們的 S3 UR 代表了絕對一流的技術和一流的性能。它繼承了我們一直喜愛的 SAPIEN 3 Ultra 的所有優點,但增加了我們在外科業務中擁有悠久歷史的 RESILIA 組織。因此,我們認為我們的平台值得我們在全球範圍內收取的溢價。
I think we always think carefully about competition. We have deep respect for our competitors. But I think when you look at the body of evidence that we've put on the table through our clinical trials, you look at things like PARTNER 3, 99% of our patients were alive and well at a year.
我認為我們總是仔細考慮競爭。我們非常尊重我們的競爭對手。但我認為,當你查看我們透過臨床試驗提交的大量證據時,你會看到像「伴侶 3」這樣的東西,我們 99% 的患者在一年內都還活著並且狀況良好。
You look at five years, 90% of our patients were still alive. We think that the technology but also the clinical evidence support our best-in-class premise. But it's our responsibility and it's our job to make sure we're always communicating that with our customers. And it's not just about the price of the device, it's the value we bring to their system.
你看看五年來,我們90%的病人還活著。我們認為技術和臨床證據都支持我們一流的前提。但這是我們的責任,也是我們的工作,確保我們始終與客戶溝通這一點。這不僅是設備的價格,而是我們為他們的系統帶來的價值。
And we just simply think that we offer the best there is in lifetime management of these patients and also running a very efficient TAVR program in terms of procedure time and predictability and discharge. But it's our job to continue to make that case, and I think it's about us being able to do that and execute at a high level.
我們只是簡單地認為,我們為這些患者提供最好的終身管理,並在手術時間、可預測性和出院方面運行非常有效的 TAVR 計劃。但我們的工作就是繼續證明這一點,我認為這與我們能夠做到這一點並在高水準上執行有關。
Bernard Zovighian - President, Chief Executive Officer
Bernard Zovighian - President, Chief Executive Officer
So if I look at the entire company, I look at, for instance surgical, 65 years of pioneering innovation. Today, we are by far a global leader in premium pricing. Our valve -- surgical valve are the best valves.
因此,如果我審視整個公司,我會審視(例如外科手術)65 年的開創性創新。今天,我們是優質定價領域的全球領導者。我們的瓣膜-手術瓣膜是最好的瓣膜。
When I look at TAVR, we are the global leader with a premium pricing, and it is the valve -- our TAVR valve is the valve of choice. If you look at what we are doing with EVOQUE, again, we are a pioneer again, we're creating category leading the space. We bring value to the entire health care ecosystem.
當我看到 TAVR 時,我們是全球領導者,定價較高,而這就是瓣膜——我們的 TAVR 瓣膜是首選瓣膜。如果你看看我們在 EVOQUE 上所做的事情,你會發現我們再次成為了先鋒,我們正在創造引領該領域的類別。我們為整個醫療保健生態系統帶來價值。
So one is we are proud about our history. We like our strategy, it's working. What we are bringing is breakthrough technologies, bringing value to patients and all stakeholders. We know that competition is coming, and it has been there for many years. The structural heart is a large space. There are many patients. It is growing. It is attracting a lot of competitors.
一是我們對我們的歷史感到自豪。我們喜歡我們的策略,它正在發揮作用。我們帶來的是突破性技術,為病患和所有利害關係人帶來價值。我們知道競爭即將到來,而且這種競爭已經存在很多年了。結構心臟是一個大空間。有很多病人。它正在增長。它吸引了很多競爭對手。
But we like our position. We like our technology. We like our strategy. And there are more patients to treat in surgical, in TAVR, in TMTT, in heart failure. And this is why we are so confident in us being able to deliver sustainable, profitable growth in the many years to come. Thanks for the question.
但我們喜歡我們的立場。我們喜歡我們的技術。我們喜歡我們的策略。還有更多的患者需要接受手術、TAVR、TMTT、心臟衰竭治療。這就是為什麼我們對自己能夠在未來許多年實現可持續、獲利的成長充滿信心。謝謝你的提問。
Operator
Operator
Patrick Wood, Morgan Stanley.
派崔克‧伍德,摩根士丹利。
Patrick Wood - Analyst
Patrick Wood - Analyst
Beautiful. Thank you. I just had one quick one to follow up on that, which was for TAVR -- can I get a sense -- but could you maybe give us a sense of how you're seeing growth in some of the larger centers relative to the smaller? I'm thinking about the commentary about where EVOQUE and PASCAL have been rolling out and the disruption from that. So for the smaller programs, have you seen a different kind of growth profile than what you've seen in the larger?
美麗的。謝謝。我剛剛有一個快速的跟進,這是關於 TAVR 的——我可以了解一下嗎——但是你能否讓我們了解一些較大的中心相對於較小的中心的增長情況?我正在考慮 EVOQUE 和 PASCAL 推出地點的評論以及由此帶來的干擾。那麼,對於較小的項目,您是否看到了與較大項目不同的成長?
Larry Wood - Corporate Vice President and Group President, Transcatheter Aortic Valve Replacement and Surgical Structural Heart
Larry Wood - Corporate Vice President and Group President, Transcatheter Aortic Valve Replacement and Surgical Structural Heart
This is Larry. That moves around a little bit quarter-to-quarter. I will say that the larger academic programs are the ones that are most likely to be adopting the new therapies and really putting more focus, and those are oftentimes places that are closer to their capacity wall. So we maybe see a little bit of impact in those larger academic programs that are on the forefront of utilizing these new technologies.
這是拉里。每個季度都有一點變化。我想說的是,較大的學術項目是最有可能採用新療法並真正給予更多關注的項目,而這些項目往往更接近其能力牆。因此,我們可能會在那些處於利用這些新技術前沿的大型學術計畫中看到一些影響。
But it's hard to generalize. We have probably close to 850 centers in the US and to a degree, they all have different challenges. But broadly speaking, I think the large academic centers were the early adopters is probably where we feel a significant amount of the pressure.
但這很難一概而論。我們在美國可能有近 850 個中心,在某種程度上,它們都面臨不同的挑戰。但從廣義上講,我認為大型學術中心是早期採用者,這可能是我們感受到巨大壓力的地方。
Operator
Operator
Adam Maeder, Piper Sandler.
亞當梅德,派珀桑德勒。
Adam Maeder - Analyst
Adam Maeder - Analyst
Hi, good evening. Thanks for taking the questions. I'll keep it to one. I wanted to ask about EVOQUE and specifically the NTAP that went into effect on October 1. I'm just wondering if you've seen any kind of noticeable impact to uptake in the past couple of weeks.
嗨,晚上好。感謝您提出問題。我會把它保留為一。我想詢問有關 EVOQUE 的問題,特別是 10 月 1 日生效的 NTAP。我只是想知道過去幾週您是否看到了任何明顯的吸收影響。
How do you think about the impact of improved reimbursement going forward? And then the second part of the question is just on the 56 millimeter valve size, now that that's FDA approved, just curious how big of a patient population does that valve size serve? Thank you.
您如何看待改善報銷的未來影響?問題的第二部分是關於 56 毫米閥門尺寸,既然它已獲得 FDA 批准,只是好奇閥門尺寸能服務多少患者群體?謝謝。
Daveen Chopra - Corporate Vice President, Transcatheter Mitral and Tricuspid Therapies
Daveen Chopra - Corporate Vice President, Transcatheter Mitral and Tricuspid Therapies
No, I appreciate the question, Adam. So talking a little bit first about the NTAP and EVOQUE. Obviously, I think the incremental reimbursement obviously provides a tailwind to people wanting to use EVOQUE. There were some centers who were maybe holding off a little bit or taking a little bit more time to get the EVOQUE training curve leading up to NTAP then they're waiting for NTAP to get on board.
不,我很欣賞這個問題,亞當。首先談談 NTAP 和 EVOQUE。顯然,我認為增量報銷顯然為想要使用 EVOQUE 的人提供了便利。有些中心可能會推遲一點或花費更多時間來獲得 NTAP 之前的 EVOQUE 訓練曲線,然後他們正在等待 NTAP 加入。
But that being said, we're still just seeing such strong demand across the board from different centers to open up new centers that I think it provides a little bit catalyst, but we just have consistent demand from centers. We haven't got a chance to open up yet across the board. So that's probably a comment on NTAP.
但話雖這麼說,我們仍然看到不同中心對開設新中心的全面強烈需求,我認為這提供了一點催化劑,但我們只是從中心得到了一致的需求。我們還沒有機會全面開放。這可能是對 NTAP 的評論。
Specifically on the 56, we're excited with the 56 approval at that fourth size, now larger size on. We don't have perfect data but based on what we've seen from previously screened patients, it maybe adds 20% or 25% applicability to the overall pool. So we're glad to have the size available for those patients who need it.
特別是 56,我們對 56 的第四種尺寸(現在是更大尺寸)的批准感到興奮。我們沒有完美的數據,但根據我們從先前篩選的患者中看到的數據,它可能會為整個池增加 20% 或 25% 的適用性。因此,我們很高興為有需要的患者提供該尺寸。
Operator
Operator
Thank you. And we have run out of time for questions at this point. So I will now hand the floor back to Bernard Zovighian for closing remarks. Thank you.
謝謝。此時我們已經沒有時間提問了。現在,我將把發言權交還給伯納德·佐維吉安 (Bernard Zovigighian),他將發表閉幕詞。謝謝。
Bernard Zovighian - President, Chief Executive Officer
Bernard Zovighian - President, Chief Executive Officer
Yeah. Thank you for your continued interest in Edwards. Scott, Mark, and myself, welcome any additional questions by telephone. Thank you, everyone. And see you next week at TCT.
是的。感謝您對愛德華茲的持續關注。史考特、馬克和我本人歡迎透過電話提出任何其他問題。謝謝大家。下週 TCT 見。
Operator
Operator
Thank you. And with that will conclude today's conference. All parties may disconnect. Have a great day. Thank you.
謝謝。今天的會議到此結束。所有各方都可以斷開連接。祝你有美好的一天。謝謝。